chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: Painful). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Additional Information: GSK Receipt date: 26-MAR-2023 This case was reported by a patient via interactive digital media. The patient just got her/his shingrix shot and very painful. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.
Initial report received from a healthcare professional in the USA on 08/15/2005.  A 39 year old male patient developed with myalgia, headache, sore throat and a macular papular pink colored rash on torso and upper shoulder, 1 day after receiving the injection of menomune on 08/12/2005.  The patient had received vaccine due to possible exposure.  The patient required doctor visit.  At the time of reporting, the patient did not recover.  The symptoms still persisted.
Insomnia, body aches, chills, low grade fever.          I was okay by noon on Thursday.
Moderate soreness at inoculation site (left arm); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 09:45 (Lot number: EL3248) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; POTASSIUM. Vaccination history included: Bnt162b2 ({product=COVID, 19, brand=Pfizer,, lot number=EL3247,, lot unknown=False,, administration Date=17Feb2021,, administration time=02:00 PM,, vaccine location=Left arm,, dose number=1}]), administration date: 17Feb2021, when the patient was 60 years old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09Mar2021 16:00, outcome "recovering", described as "Moderate soreness at inoculation site (left arm)". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: There was no other  vaccine in four weeks. Other medications in two weeks:  Losartan Potassium 50 mg Tabs. Moderate soreness at inoculation site (left arm) about 8 hours after administration. Covid was not given prior to vaccination. The Covid had not been tested post vaccination. There are no Known allergies.  No follow-up attempts are possible. No further information is expected.
Second shingles shot received Wed., June 22, 2022 at 10:30 am.  Had fever 101.4,  muscle aches and headache later the same day into next day.  Thursday afternoon, arm began to turn red, is swollen and warm below the injection site.  Same continues into Friday and Saturday.   This is the same reaction as the first shot.  Went to  urgent care after the first shot and was told to see my doctor if it didn't clear up in a week or so.
Case ws vaccinated for Covid in February 2021, then hospitalized for Covid in January 2022. Hospitalized at: Medical Center  Admitted to hospital for 36 day stay for treatment of Acute respiratory distress syndrome r/t Covid. Symptoms included Fever, chills, cough, SOB, weakness and rash. She also suffered a pulmonary embolism r/t covid. Discharged home on Hospice. She died 3 days after discharge, but Covid was not listed on her death certificate.
Pain radiating to side boob down 6 inches.  pain 9 to the touch on scale of 10.2 large "golf ball sized' lymph nodes.  Not joking); Achy bones; Achy muscles; Feeling of body heaviness; Headache: throbbing; Severe chronic pain in armpit; This is a spontaneous report from a contactable healthcare professional, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 12Apr2021 at 15:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism/Hashimoto. The patient was allergic to surgical metals, pet dander and latex. Concomitant medications included levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL) and losartan (MANUFACTURER UNKNOWN) all from an unknown date for an unknown indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the arm left on 22Mar2021 at 14:00 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 10:00, the patient experienced severe chronic pain in left armpit: pain radiating to side boob down 6 inches, pain 9 to the touch on scale of 10.2 large "golf ball sized' lymph nodes. " Not joking") In addition, achy bones, muscles and feeling of body heaviness.  Headache: throbbing, she felt like shit. The event resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events armpit pain, swollen lymph nodes, ache, muscle pain, discomfort and throbbing headache was not recovered.   No follow-up attempts are needed. No further information is expected.
Redness has gotten bigger; it feeling a little bit warm; redness on the right arm; Hardness when she touches the injected area; A spontaneous report was received from a healthcare facility staff member concerning a 49-year-old  female patient who was participating in the mRNA-1273 Emergency Use Program and developed hardness, and redness, over the injected area.  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (LOT# unknown) on 29-Dec-2020 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   Patient received the Moderna vaccine on 29-Dec-2020 in the right arm..  On 05-Jan-2021, she reported that she had hardness when she touched the injected area.  On 06-Jan-2021, she reported that she had some redness on her right arm and that it felt warm.  Additionally, she stated that the nurse had circled the red area earlier and that she noticed that it had gotten bigger over the course of the day.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the event,   injected site hardness, redness, warm on the right arm, and the redness has gotten bigger over the course of the day,  was not provided.   The outcome of the events, Injected site  hardness, redness, warm, the redness has gotten bigger over the course of the day, was not reported.; 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.
Head ache generalized in temples, 8/10 pain. General malaise throughout the day. Pt given Toradol and SIQ 1 day.
Dizzy; Slept for 3 days/sleeping a lot; Waking up in sweats; Could not walk or stand up; Could not walk or stand up; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), HYPERSOMNIA (Slept for 3 days/sleeping a lot), HYPERHIDROSIS (Waking up in sweats), GAIT DISTURBANCE (Could not walk or stand up) and DYSSTASIA (Could not walk or stand up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced DYSSTASIA (Could not walk or stand up). On an unknown date, the patient experienced DIZZINESS (Dizzy), HYPERSOMNIA (Slept for 3 days/sleeping a lot), HYPERHIDROSIS (Waking up in sweats) and GAIT DISTURBANCE (Could not walk or stand up). At the time of the report, DIZZINESS (Dizzy), HYPERSOMNIA (Slept for 3 days/sleeping a lot), HYPERHIDROSIS (Waking up in sweats), GAIT DISTURBANCE (Could not walk or stand up) and DYSSTASIA (Could not walk or stand up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided. Patient reported not taking any medications for side effects or for any other health conditions.  Company Comment: This is a case concerning a female patient of unknown age, with unknown medical history, who experienced the unexpected events of Hypersomnia, Hyperhidrosis, Gait disturbance, and Dysstasia, and expected event of Dizziness. The events occurred unknown number of days after the first dose of mRNA-1273 vaccine. There is no available information regarding clinical course or treatment medication. The rechallenge was not applicable as events happened after the first dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2021: Follow up received contains No new information.; Sender's Comments: This is a case concerning a female patient of unknown age, with unknown medical history, who experienced the unexpected events of Hypersomnia, Hyperhidrosis, Gait disturbance, and Dysstasia, and expected event of Dizziness. The events occurred unknown number of days after the first dose of mRNA-1273 vaccine. There is no available information regarding clinical course or treatment medication. The rechallenge was not applicable as events happened after the first dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
PT WITH KNOWN H/O SEVERE ALLERGIC REACTION - APPROXIMATELY 15 MINUTES AFTER INJECTION, BEGAN TO COUGH AND EXPERIENCE ITCHY THROAT.  SHE REPORTED THAT THIS IS WHAT HAS HAPPENED WITH OTHER ALLERGIC REACTIONS.  SHE REQUESTED ORAL DIPHENHYDRAMINE HOWEVER SYMPTOMS WORSENED QUICKLY - DETERMINATION WAS MADE TO ADMINISTER EPINEPHRINE.  SHE WAS GIVEN A DOSE OF 0.3 MG EPINEPHINE IM AT 1402.  PT QUICKLY BEGAN TO FEEL BETTER.  SHE WAS GIVEN ORAL BENADRYL 100 MG (PER HER REQUEST - SHE SAYS THIS IS HOW MUCH SHE TAKES EVERY TIME SHE HAS AN ALLERGIC REACTION).  DOSE GIVEN AT 1410.  SHE DID HAVE COMPLETE RESOLUTION OF HER SYMPTOMS.  SHE WAS KEPT IN THE CLINIC FOR OBSERVATION.  AT 1430, PT AGAIN BEGAN EXPERIENCING SYMPTOMS AGAIN, SHE WAS COUGHING AND HAD ITCHY THROAT.  SHE WAS IMMEDIATELY TAKEN TO THE ED.  SHE HAD COUGH, RUNNY NOSE, RASH ON FORARMS ONLY - NOT PRESENT ON CHEST OR BACK OR FACE.  AN IV WAS PLACED BY ULTRASOUND IN HER LEFT AC.  AT 1438, EPI 0.3 MG IM GIVEN 1440 - FAMOTIDINE 20 MG IV GIVEN 1441 - METHYLPREDNISOLONE 125 MG IV GIVEN 1442 - FAMOTIDINE 20 MG IV GIVEN 1443 - DIPHENHYDRAMINE 50 MG IV  1444 - VITALS - 136/94, HR - 92, OXYGEN SAT - 96% ON RA 1445 - PT C/O HEADACHE, STILL COUGHING, RASH PERSISTS 1450 - IPRATROPIUM / ALBUTEROL + RACEMIC EPI GIVEN 1453 - STILL CONTINUOUS DRY COUGH, RASH BETTER 1455 - BREATHING TREATMENT COMPLETE - COUGH MUCH BETTER 1457 - HEIGHT - 63" WEIGHT - 87.7 KG, 97.4 TEMP, HR - 77, OXYGEN SAT 96% 1504 - PT REPORTS FEELING MUCH BETTER, NO COUGH, NO RASH, LUNGS CTA BIL, NSR - HR - 75, 127/89, 96% ON RA 1610 - PT DOING WELL - PLANNING TO BE DISCHARGED - WITH RX FOR EPI PEN AND PREDNISONE 50 MG DAILY X 3 1616 - SYMPTOMS RETURNED, CONTINUOUS COUGH RETURNED, RASH PRESENT ON ARM, OXYGEN SAT 93%, 146/102, HR - 91, RUNNY NOSE 1619 - IPRATROPIUM / ALBUTEROL + RACEMIC EPI GIVEN - LUNGS DIMINISHED IN BASES WTIH STRIDOR HIGHER UP NEW IV PLACED IN LEFT HAND  1620 - 151/91, OXYGEN SAT 99% ON RA, HR - 86
Redness and breaking skin around sweat glands; burning sensation; knee pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE HYPERSENSITIVITY (Redness and breaking skin around sweat glands), BURNING SENSATION (burning sensation) and ARTHRALGIA (knee pain) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010M20A.) for COVID-19 vaccination.     Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and LORAZEPAM for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced INJECTION SITE HYPERSENSITIVITY (Redness and breaking skin around sweat glands), BURNING SENSATION (burning sensation) and ARTHRALGIA (knee pain). At the time of the report, INJECTION SITE HYPERSENSITIVITY (Redness and breaking skin around sweat glands), BURNING SENSATION (burning sensation) and ARTHRALGIA (knee pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant medications were provided No Treatment information provided
At time of the injection, very little side effects took place; after 1 hour of receiving vaccine heat flashes was the first major side effect. 7 hours prior to vaccination, dizziness/exhaustion took place. Very little sleep due to severe body aches and chills. Woke up next morning (7/31/21) with fever just around 101. Fever lasted 3 hours, body aches persisted for the entire day along with chills and migraines. Taking over the counter medications seemed to have mitigated symptoms temporarily. Had to take stronger cold/flu medications in order to sleep. 8/1/21: no fever, body aches still persist, exhaustion and dehydration still persist.
child came in on 11/25/02 for routine booster immunizations.  Mom said child was given tylenol but ran out.  Child developed a high fever 104 and was taken to ER, stayed about 3 hours was given amoxicllin on 12/02/02 for ear infection and congestion by PMD.
Day 1= Vaccination Day 1.  Day 1.  Extreme Facial Flushing/Hotness 20 min post administration. Duration 5 min. No recurrence. 2.  Day 1.  Drop in body temperature. 95.2°F recorded 5 hrs post vaccination and continued 4 days. 3.  Day 3. Bruise and knot at injection site and pain radiating from knot down into thumb. Fatigue.
This spontaneous report was received from a Registered Nurse and refers to a unknown patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored unspecified doses of ROTATEQ orally for prophylaxis (lot number M016238, with an expiration date of 07-DEC-2017) (strength, dose and frequency were not reported). No concomitant medications were provided. The doses of the vaccine experienced a temperature excursion from 32 degrees Fahrenheit (F) to 35 degrees F for 228 hours and from 47 degrees F to 77 degrees F for 18 hours and 20 minutes. The aforementioned temperature was identified due to a data logger. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA003224: US-009507513-1704USA003014: US-009507513-1704USA003226: US-009507513-1704USA003227: US-009507513-1704USA003223: US-009507513-1704USA003225.
per wife, husband's right arm started to swell and move onto his elbow; went to doctor's office the next day and got an antibiotic
just a little bit of injection site soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "just a little bit of injection site soreness".  Additional information: Patient had two vaccine shots for COVID and then patient had the booster shot on 12Nov2021. Patient had normal reaction to the vaccine. It just a little bit of Injection site soreness and that has happened again. Patient was unwilling to provide more information further probing could not be done. Hence, limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
TC to MOC. Stats child developed soreness about 1 am (7-31-12) and a 5" x 5" reddened area by noon (7-31-12) with swelling extending approx 1" beyond reddened area.
Information has been received from a physician concerning an approximately 2 month old male who on 04-JAN-2007 was vaccinated PO with a first dose of rotavirus.  On 05-JAN-2007 the patient developed painful blisters in his mouth.  The patient recovered on 08-JAN-2007.  Unspecified medical attention was sought.  There was no product quality complaint involved.  Additional information has been requested.
Following injection, pt immediately produced an injection site reaction with redness around the site, a little puffiness and warm to the touch as well as feeling a bit feverish. Pt denied and SOB or change in heart rate and asked to remain in the pharmacy for approximately 30 min. When pt appeared well enough to leave, he was instructed to take Benadryl if the inj site reaction looked to be getting worse, ice pack the site and seek emergency medical care if trouble breathing. The following day the patient was followed up with and the site reaction had resolved. He did state however that he felt profuse sweating and dizziness for about 20 minutes after he left the pharmacy but felt fine after that. Pt did mention the following day that he vaguely remembers having had a reaction similar to this in the past but was unsure of the type of vaccine and when it occurred.
LVN giving Pentacel, used the blue bottle containing Polio and DTap and mixed with ActHib, the child received the correct components, although the vaccine was mixed incorrectly.
Headache, Myalgia, fatigue, shortness of breath Narrative:  Employee reported moderate muscle pain 02/02/21employee reported mild headache 02/02/21 until 02/05/21, moderate muscle pain 02/02/21 until 02/04/21, moderate to severe fatigue 02/02/21 until 02/05/21, moderate shortness of breath 02/02/21 until 02/04/21. Resulted in unable to work 02/02/21 until 02/03/21. Did not seek medical attention for the symptoms.  Other Relevant History:
Many small, itchy  bumps  on inside forearm of right arm. bumps had red spots on the most raised part - they looks like small blood blisters.  Within the hour the same happened on left arm in the same spot, but not as severe. 19 hours later, the left arm looks normal while the right forearm looks like it has been poked in numerous spots. Not severe enough to seek medical attention.
administration to 17 year old patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration to 17 year old patient) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration to 17 year old patient). On 24-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration to 17 year old patient) had resolved.        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.   No treatment information was provided.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old male) for mRNA-1273 (lot number 008B1A) with no associated AEs reported.
had second vaccine 6hrs ago and arm really hurts; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (had second vaccine 6hrs ago and arm really hurts) 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 23-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, the patient experienced VACCINATION SITE PAIN (had second vaccine 6hrs ago and arm really hurts). At the time of the report, VACCINATION SITE PAIN (had second vaccine 6hrs ago and arm really hurts) outcome was unknown.            No lab results/concomitant medications were reported.
Pt went to ED with afebrile seizure - eyes rolled back, tonic-clonic movement of arms x 10 mins. That night fever elevated to 100.4 while in hospital.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 17Mar2021 as dose 2, single (Batch/Lot number: unknown), on 16Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 23Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "psoriasis" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing). It was reported that the patient had no known allergies. Concomitant medication(s) included: LEXAPRO, start date: 01Jan2019, stop date: 02Aug2022; WELLBUTRIN, start date: 01Jan2019, stop date: 02Aug2022; VALTREX, start date: 01Jan2019, stop date: 02Aug2022; TREMFYA, start date: 01Jan2021, stop date: 02Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19. COVID 19 Treatment was received with Paxlovid from 24Jul2022 to 28Jul2022 for treatment of COVID-19. The clinical course was reported as After recovering from all symptoms, the following systems reappeared: nasal congestion, cough, sore throat. but no fever. The patient has never tested negative after Paxlovid but the test line was very faint. When the symptoms restarted on the day of reporting, the antigen test showed a bright red test line.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.