chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills; achy joints; tired; This case was reported by a consumer and described the occurrence of chills in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th September 2021, the patient received the 1st dose of Shingrix (intramuscular). On 7th September 2021, 5 hrs after receiving Shingrix, the patient experienced chills, joint pain and tiredness. On an unknown date, the outcome of the chills, joint pain and tiredness were recovered/resolved.   It was unknown if the reporter considered the chills, joint pain and tiredness to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient's wife. The patient received a dose of Shingrix in right arm and had chills, achy joints and being tired. Since all the symptoms were recovered. The patient was referred to health care professional. Medical information number was provided. The reporter consented to follow-up. The case was linked with case US2021192878 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021192878:same reporter
arm where vaccinated red; arm where vaccinated sore; arm where vaccinated swollen; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain and injection site swelling to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received 1st dose of Shingrix vaccine and the patient asked how long should the arm where vaccinated stay red, sore or swollen. No contact details were available.
Patient was scheduled to receive first dose of COVID-19 vaccination Moderna 04/09/2021 and failed to inform staff that the patient had received the first dose COVID-19 vaccine from the pharmacy on 04/02/2021. After the COVID-19 Moderna vaccine was administered and staff member was giving the patient the COVID-19 immunization record card. The patient informed the staff member that he had the same card and handed it to the staff. Staff member contacted the pharmacy and it was confirmed that the patient received first does of COVID-19 vaccine on 04/02/2021.  The patient received two doses of COVID-19 vaccines within 1 week apart.
Aches in neck; Sciatica pain on the right side of body reported to have gotten worse after injection; Aches in shoulder; Electricity going down leg; pain along the leg; patient was not sure if administration was performed to correct area and whether appropriate needle size was used; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Electricity going down leg), NECK PAIN (Aches in neck), SCIATICA (Sciatica pain on the right side of body reported to have gotten worse after injection), PAIN IN EXTREMITY (pain along the leg) and VACCINATION ERROR (patient was not sure if administration was performed to correct area and whether appropriate needle size was used) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. HBS010ARIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sciatica (sciatic nerve). Concomitant products included CELECOXIB and LOVASTATIN for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN (Electricity going down leg), PAIN IN EXTREMITY (pain along the leg) and VACCINATION ERROR (patient was not sure if administration was performed to correct area and whether appropriate needle size was used). On an unknown date, the patient experienced NECK PAIN (Aches in neck), SCIATICA (Sciatica pain on the right side of body reported to have gotten worse after injection) and ARTHRALGIA (Aches in shoulder). At the time of the report, PAIN (Electricity going down leg), NECK PAIN (Aches in neck), SCIATICA (Sciatica pain on the right side of body reported to have gotten worse after injection), PAIN IN EXTREMITY (pain along the leg), VACCINATION ERROR (patient was not sure if administration was performed to correct area and whether appropriate needle size was used) and ARTHRALGIA (Aches in shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medication included blood pressure medications and anti-inflammatory.  No treatment information was provided.   This case was linked to MOD-2021-095213 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: Follow-up received on 22-Mar-2021 included no new information.
Constant fever, constant diarrhea, mild headaches, unable to get out of bed, nausea, numbness and tingling around mouth
Tested positive for Covid-19 on 10/19/2021.  Had Scratchy throat, sinus drainage, watery eyes and low energy
Headache, Myalgia, Arthralgia, CoughWheeze, Diarrhea & NauseaVomiting Narrative:  Employee had to pull car over on her drive home after getting shot in order to throw up x2. She is HX of RA, suffered severe pain in all joints. She developed a cough, congestion, H.A., N&V, Fever, chills, diarrhea and stomach cramps. She missed two days of work due to severity of symptoms. She did call her Endo specialist who recommended Ibuprofen.
LOCALIZED VACCINIA REACTION. PAPULES, EMERGING PUSTULES ON LEFT UPPER ARM, RIGHT UPPER EXTREMITY AND ABDOMEN. ADVISED ORAL DIPHENHYDRAMINE (OTC) AS NEEDED FOR PRURITIS, IF THIS OCCURS.
Patient inadvertently received 1cc of Moderna COVID vaccine instead of 0.5cc. Patient was notified. State of MD was notified.
Dizziness, nausea, rash around injection site, fatigue, swelling and pain around injection site
First Dosage and 3 weeks and 5 days I woke up with bilateral ringing in ears. It is still continuous at 3 weeks.
Flu-like achiness; Soreness in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Flu-like achiness) and MYALGIA (Soreness in injection arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concomitant products included RIVAROXABAN (XARELTO), FLECAINIDE, LEVOTHYROXINE, OMEPRAZOLE, METOPROLOL and AMLODIPINE for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN (Flu-like achiness) and MYALGIA (Soreness in injection arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Flu-like achiness) and MYALGIA (Soreness in injection arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
4 hours post vaccine at 12:45pm got extremely nauseous and heart rate spiked to 110 for approx 15 minutes although was just sitting in a chair. Nausea remained for 4 more hours but heart rate slowly returned to normal (60) by 2:00pm.
soreness in entire arm similar to being stung by a wasp; numbness and soreness in left side of face similar to the feeling after dental work when the shot has worn off. It has been 3 hours that I've felt this. It is still that way.
COVID-19; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not received.  Treatment medication not received.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up document received on 28-JUN-2021- No new information
This spontaneous report was received from a 71 year old female patient with sulfa drug allergy, congestive heart failure diagnosed after the vaccine that may have also been present and undiagnosed at the time of vaccination and back problems. The patient's medical history included shingles experienced in 1981. On an unknown date in September 2012, the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route not reported) as a form of treatment and to prevent a recurrence of her shingles attacks. Concomitant therapies included medication for unspecified allergy, thyroid tablets, hydrocortisone and tizanidine hydrochloride for back problems. The patient explained that the vaccine seemed to work to alleviate her symptoms for a short period of time, however the relief did not last as long as other unspecified and periodic shots she had for treatment of the condition. On an unknown date, the patient experienced stomach discomfort and headache after having the ZOSTAVAX. No medical attention was sought. No laboratory diagnostics studies were performed. The outcome of stomach discomfort and headache was unknown. Additional information has been requested.
Onset of itching & redness about 3 hrs post/vax. Seen in ER & given Corticosteriods & Benadryl.
4/14/21 woke up 5:45 with full body rash, whelps, facial swelling tongue swelling
It was reported that a female patient received a Fluzone SV vaccination on 11/28/2000. Reportedly that same day the patient developed swelling and redness surrounding the injection site, itching and pain from the shoulder to the forearm. From additional correspondence received on 02/21/2001, it was reported, "reviewed, no additional information at this time - CD 02/14/2001". This case is closed.
This spontaneous report as received from a Nurse refers to a patients of unknown age and gender. On an unknown date, the patient was vaccinated with ROTATEQ (dose, duration and route were not reported). The nurse reported that an unknown number of doses of ROTATEQ, that were stored at 32 degrees F. for 30 hours have been administered. No adverse effect report. At the time of the report action taken was not reported. This is one of several reports from the same source. Additional information has been requested.
Upon receiving covid vaccine client started feeling dizzy upon exiting clinic door to sit down in the lobby for 15 min wait. but did notify nurse. At 9:25am  clients spouse seeked help from nurse due to client still feeling dizzy. Nurse took client in a wheelchair into a clinic room. Client mentioned breakfast had been consumed and had drank water prior to coming to todays appointment. Two nurses assisted client in laying down on exam room table. Placed a pillow under clients head. Blood pressure was 124/68. Client also complained of still feeling numbness and tingling in both hands. After 5min. assisted client in sitting up on exam table. Gave client a cup of water. By that time client said numbness & tingling was very minimum and only sensation she had was cold hands. Client mentioned dizziness had improved and was mild. Client felt comfortable in walking out to go home and rest. Clients spouse & nurse walked client to car with no difficulties. Client was in clinic room 10 min total.
Flare up of arthritis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (141010). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "arthritis" (unspecified if ongoing). Concomitant medication(s) included: XELJANZ XR. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization; Bnt162b2 (Dose 2, Single), for COVID-19 immunization. The following information was reported: ARTHRITIS (non-serious) with onset 01Oct2021 12:00, outcome "recovered" (2021), described as "Flare up of arthritis". Therapeutic measures were taken as a result of arthritis.  Additional information: Patient reported she had a flare after doing her COVID-19 booster vaccine about two weeks ago. Patient was treated this with prednisone and rest, and was doing better now. Patient also missed about a week of doses due to insurance issues about a month ago. Patient considered flare up of arthritis as non-serious. Patient stated that event flare up of arthritis is not related to the suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information the reported event flare up of arthritis assessed as unrelated to suspect drug BNT162B2.
rashy  presented on the arm; red area presented on the arm; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 54H72, expiry date 1st October 2021) for prophylaxis.   On 5th September 2019, the patient received the 1st dose of Shingrix .5 ml. In September 2019, less than a week after receiving Shingrix, the patient experienced rash and erythema. On an unknown date, the outcome of the rash and erythema were not recovered/not resolved.   It was unknown if the reporter considered the rash and erythema to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in the left arm. The patient received Shingrix and had rash, red area presented on the arm 2-3 inches below the injection site. It presented 24-48 hours after the injection. The reporter consented to follow up.
(11-19-11) Patient had swelling at the arm and had to get physical therapy to reduce lymph edema. She is feeling better now. (Patient had cancer before and removed lymph node. Doctor now told her not to get immunization in the future).
I broke out in itchy hives all around the left arm injection site, underarm, and left breast.  This occurred one hour after injection and 45 minutes after I left the vaccination site.  I took one Claritin OTC antihistamine and within 15 minutes, all reactions went away.  No other symptoms occurred, not even soreness at the site.
STROKE.  ACCORDING TO PATIENT'S WIFE, HE IS DOING OK.  ONLY WAS HOSPITALIZED FOR A FEW DAYS AND WENT HOME.  NO RECORDS OF HIS HOSPITALIZATION ARE AT ; HE WENT TO MEDICAL CENTER.
Patient noticed redness, itching and swelling under the left arm. Patient was concerned for infection. Examined in local ER and treated with course of Keflex and Benadryl. No further problems noted.
w/in 8 hrs p/vax pt cranky, fever then lethargy over the next 18 hrs (t103-104); vomitting, diarrhea;
This spontaneous report as received from healthcare worker: vaccine coordinator of health department and refers to a patient of unknown age (gender not reported). Healthcare worker stated that registered nurse reported to her that on an unknown date, the patient was vaccination with an expired dose of GARDASIL (dose, route, lot number and exp. date was not reported). No adverse effects reported. Additional information has been requested.
This spontaneous report was received from a healthcare worker referring to two 1 month old unspecified twin patients. The patients' pertinent medical history and concurrent conditions were not reported. On 03-FEB-2016, the patients were vaccinated with VAQTA 25/0.5 ml (dose, route of administration, lot number and expiration date were not provided). The patient's concomitant medications were not reported. At the time of the report, no adverse events were reported and no product quality complaint was involved. Additional information has been requested.
Barely any soreness on the injection site after 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Barely any soreness on the injection site after 3rd shot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 04120A and 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Previously administered products included for Product used for unknown indication: influenza (flu shot) on 14-Sep-2021. Past adverse reactions to the above products included No adverse event with influenza.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Barely any soreness on the injection site after 3rd shot). At the time of the report, VACCINATION SITE PAIN (Barely any soreness on the injection site after 3rd shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Nov-2021, Antibody test: 186 (Inconclusive) 186 and 178 (Inconclusive) 178.         No concomitant medications provided. No treatment medications provided. She was going to have knee surgery soon so she wanted to be fully protected.   This case was linked to MOD-2021-410130, MOD-2021-410126 (Patient Link).
Patient received his first dose of  Covid 19 vaccine at the pharmacy 4/14.  15-20 minutes after the vaccination patient reported feeling chills "like the whole store just dropped 15-20 degrees" and that he was sweating.  He was still joking with pharmacy technicians and appeared in good spirits.  No hives, scratching, or breathing trouble was observed.  Informed pt that this was not an uncommon reaction but it occurred uncommonly quickly.  Patient got in contact with his manager, let her know the situation and left work for the day as a result of his reaction.
Patient developed bladder infection for three months. she was not responding to anything. that triggered to develop colon disease.  after days , she got diagnosed with a auto immune disease. in order for her to get better , they had to removed her intestine due to having covid-19 vaccine right after .
Patient received first dose of COVID-19 vaccine on 8/30/2021.  Patient was then hospitalized on 9/7/2021 with COVID-19 symptoms.  Patient was a no code/no intubation at admission.  Patient ultimately progressed to high flow oxygen  and was made compassionate care and passed away on 9/19/2021.
Symptoms: Lightheaded, elevated blood pressure. Treatment: Given water, monitored another 15 minutes. No further symptoms or treatment.
Patient administered vaccine after the manufacture's date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 168 doses.  The vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to MOD-2022-581986 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow up received included non significant information of secondary reporter was added.
Suspected vaccination failure; had received shingrix not placebo.I recently developed shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient participated in Shingrix clinical trial in year 2014. The patient received 2 doses and was later informed that the patient had received Shingrix and not the placebo. Recently, the patient developed shingles and the patient was much improved at the time of reporting. The patient was asking if the patient should receive another Shingrix vaccine. This case was considered as suspected vaccination failure, since the details regarding laboratory confirmation for herpes zoster was not provided.