chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hotness; not being able to sleep; lethargy; neck pain; amount swelled either infected or allergic reaction; infected; Itchiness / itching at the injection site; Arm swelled; Redness; joint pain; headache; allergic reaction; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (Hotness), INSOMNIA (not being able to sleep), LETHARGY (lethargy), NECK PAIN (neck pain) and IMMUNISATION REACTION (amount swelled either infected or allergic reaction) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051f21a, 031m20a and 025l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BUPROPION, MILNACIPRAN HYDROCHLORIDE (SAVELLA), LISINOPRIL and LEVOTHYROXINE for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient experienced VACCINATION SITE WARMTH (Hotness), INSOMNIA (not being able to sleep), LETHARGY (lethargy), NECK PAIN (neck pain), IMMUNISATION REACTION (amount swelled either infected or allergic reaction), INFECTION (infected), VACCINATION SITE PRURITUS (Itchiness / itching at the injection site), VACCINATION SITE SWELLING (Arm swelled), VACCINATION SITE ERYTHEMA (Redness), ARTHRALGIA (joint pain), HEADACHE (headache) and HYPERSENSITIVITY (allergic reaction). At the time of the report, VACCINATION SITE WARMTH (Hotness), INSOMNIA (not being able to sleep), LETHARGY (lethargy), NECK PAIN (neck pain), IMMUNISATION REACTION (amount swelled either infected or allergic reaction), INFECTION (infected), VACCINATION SITE PRURITUS (Itchiness / itching at the injection site), VACCINATION SITE SWELLING (Arm swelled), VACCINATION SITE ERYTHEMA (Redness), ARTHRALGIA (joint pain), HEADACHE (headache) and HYPERSENSITIVITY (allergic reaction) outcome was unknown.            No treatment medications were provided by the reporter.   Reporter did not allow further contact
pt recv vax 26SEP96 & immed p/vax devel eye quivering & also became dizzy;other people recv vax @ the same time as pt & did not exp these sx;
Injection area became red/swollen. I reported to employee health was given cream after examined by NP. I filed on the adverse reaction, but I have endured intermittent pain injection area since the injection 2 years. Reason for filing additional claim.
Doses administered after more than 1 temperature excursion; Doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 4:27 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 4:27 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age was reported as 63.85 No concomitant product reported by reporter. The reported condition of the vial was not frozen.Vaccine was moved to fridge on 30-Mar-2021,Vaccine was moved to clinic on 03-Apr-2021.Number of vials sent to clinic were 20 and Total doses given for the day were 210 Vaccine underwent temperature excursion on 03-Apr-2021 till 34 degrees Fahrenheit at 9 AM and Best Use Date for the vaccine was 29-Apr-2021. It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Vial was punctured right before administration. No treatment medication reported by reporter.
Woke up with chills; Woke up with / body aches; Woke up with / headache; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On 10th February 2021, the patient received the 2nd dose of Shingles vaccine. In February 2021, less than a day after receiving Shingles vaccine, the patient experienced chills, general body pain and headache. On an unknown date, the outcome of the chills, general body pain and headache were not recovered/not resolved.   It was unknown if the reporter considered the chills, general body pain and headache to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporting for him/herself. The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingrix, the patient woke up with chills, body aches and headache. The patient asked, what could he/she took to help alleviate these symptoms.
TROUBLE BREATHING, HEADACHES, SHORTNESS OF BREATH, FATIGUE, AND TIREDNESS.
Breakthrough case admission after two vaccines  Moderna 3/4/21 Lot# 030L20A;  Moderna 4/1/21 Lot# 017B21A
Patient experienced Bell's Palsy from their first Shingrix Vaccine; This case was reported by a physician via sales rep and described the occurrence of bell's palsy 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 bell's palsy (serious criteria GSK medically significant). Shingrix was discontinued. On an unknown date, the outcome of the bell's palsy was unknown.   The reporter considered the bell's palsy to be possibly related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported a possible Shingrix adverse event for a patient of colleague from another health care professional practice. The patient had experienced Bell's Palsy from Shingrix.  The reporter's colleague had sent the patient to a neurologist who told the patient not to take the second Shingrix vaccine.  No information was known about the colleague or the patient who experienced Bell's Palsy. GSK representative gave permission to be contacted but health care professional did not give permission to be contacted by GSK .
headache; Face blood red and hot to touch; Face blood red and hot to touch; Face blood red and hot to touch, really hurt; Dizzy; Vomiting; nausea; weakness; Face blood red and hot to touch; This is a spontaneous report from a contactable consumer herself (patient). A 70-years-old female patient received first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left on 10Feb2021 13:15 (lot Number: EM9809) as single dose for covid-19 immunisation. Medical history included Pennicyllian, low thyroid, high blood pressure and diabetes II. Concomitant medication included propranolol 80 mg, levothyroxine sodium at 100 mg; nortriptyline. The patient had, terrible headache 2 days, Face blood red and hot to touch, really hurt - 2 ½, days, Dizzy, still slightly, vomiting 2 days could not keep anything down, nausea, weakness on 12Feb2021 02:30 PM. The patient underwent lab tests and procedures which included blood pressure: high, covid-19: positive on if covid prior vaccination: Yes, Low thyroid all are prior to start of thereapy. The outcome of the event was recovered with sequels.
ovaries hurt; my insides hurt; joint pain at every joint; headache; This spontaneous case was reported by a consumer and describes the occurrence of ADNEXA UTERI PAIN (ovaries hurt), PAIN (my insides hurt), ARTHRALGIA (joint pain at every joint) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADNEXA UTERI PAIN (ovaries hurt), PAIN (my insides hurt), ARTHRALGIA (joint pain at every joint) and HEADACHE (headache). At the time of the report, ADNEXA UTERI PAIN (ovaries hurt), PAIN (my insides hurt), ARTHRALGIA (joint pain at every joint) and HEADACHE (headache) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No concomitant medications were given No treatment information was provided   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: EVENTS ADDED; Reporter's Comments: NA; Sender's Comments: NA
Weight gain within 2=1-2 weeks of shot, weight continues to gain, bloating in the abdominal region that has not subsided after 3 months. General inflammation in the body.
This is a spontaneous report from a contactable physician. This report was received via a Pfizer sales representative. An 18-month-old patient of an unspecified gender received the third dose of PREVNAR 13,(lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first and second doses of PREVNAR 13 for immunization. The patient had severe allergies status post 3 doses PCV13. PCV13 tests showed immunity towards only 4 strains of PCV13. The physician was asking when retesting should be performed since the 4th dose had just been administered. The outcome of the events was unknown. The information on the batch number has been requested.
Hiberix vaccine when the needle popped off and some of the vaccine splashed into her eye; vaccine splashed into eye; This case was reported by a other health professional via call center representative and described the occurrence of occupational exposure while administering product in a adult female patient who received Hib (Hiberix) (batch number 97AP3, expiry date 9th November 2023) for prophylaxis.   On 21st February 2023, the patient received Hiberix. On 21st February 2023, unknown after receiving Hiberix, the patient experienced occupational exposure while administering product and exposure via eye contact. On an unknown date, the outcome of the occupational exposure while administering product and exposure via eye contact were unknown.   Additional Information: GSK receipt date: 21-FEB-2023 Reporter comment: The practice manager reports an employee was going to administer a Hiberix vaccine when the needle popped off and some of the vaccine splashed into her eye. At the time of the call, the employee was going to start rinsing eye with water. The reporter consented to follow up. Additional Supportive Information: employee was going to administer a Hiberix vaccine when the needle popped off and some of the vaccine splashed into her eye, which led to occupational exposure while administering product , Exposure via eye contact.
racing heart; This is a spontaneous report from a contactable consumer. A 51-years-old non-pregnant female patient received (BNT162B2, solution for injection,Batch/Lot number was not reported), via an unspecified route of administration in Arm Left on 10Mar2021 09:15 as UNKNOWN, SINGLE DOSE for covid-19 immunization. Medical history was not reported. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. Patient had no allergies and other medical history. Post vaccination Patient was not diagnosed or tested for COVID-19 at the time of vaccination. Patient didn't receive any other vaccinations with in 4weeks time of vaccination.Patient received levothyroxine in two weeks of vaccination. On 10Mar2021 12:00 the patient experienced racing heart.The outcome of the event was not recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
1st dose on 10/15/2019 / on 06/01/2021 for 2nd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 15th October 2019 having batch number BP57E and expiry date 7th December 2021).   On 1st June 2021, the patient received the 2nd dose of Shingrix. On 1st June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: Pharmacist reported that the patient back for 2nd dose of Shingrix more than recommended time after 1st dose which led to lengthening of vaccination schedule. The reporter consented to follow up. This case had been linked with US2021117121 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021117121:same reporter
Fever (100.0F); total body aches; chills; fatigue; This is a spontaneous report from a contactable consumer (patient). A 31-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3247) via an unspecified route of administration in Arm Left on 09Feb2021 10:00 (at the age of 31 years old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) taken within two weeks included fluoxetine hydrochloride (PROZAC), colecalciferol (VITAMIN D [COLECALCIFEROL]), linum usitatissimum seed oil (FLAX SEED OIL), and multivitamin, all taken for an unspecified indication, start and stop date were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3247) via an unspecified route of administration in Arm Left on 19Jan2021 10:00 (at the age of 31 years old) as single for COVID-19 immunisation. Patient did not received other vaccine within four weeks of COVID vaccine. Patient did not have COVID prior to vaccination. The patient experienced fever, total body aches, chills, fatigue on 09Feb2021 23:00. No treatment was given for the adverse events. Patient did not tested for COVID post vaccination. The patient underwent lab tests and procedures which included body temperature: 100.0 fahrenheit on 09Feb2021. Outcome of all the events were recovered on Feb2021.  No follow up attempts are possible. No further information is expected.
Patient received the influenza and HPV Vaccines in the left arm. Patient stated about an hour after vaccination it began to hurt at the site and were not able to extend their left arm past half-way up. Patient states symptoms have not improved and has gotten worst over time.
two days of chills and fever and three days of headaches, dizziness and fatigue.  symptoms are improving except for lingering dizziness.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 24Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 21Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "pre-diabetes" (unspecified if ongoing); "DDD" (unspecified if ongoing); "periodic depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a nurse refers to a 9 weeks old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 03-OCT-2017, the patient was vaccinated with improperly stored  ROTATEQ (dosing details were not reported) (lot # N009948, expiry date: 12-OCT-2018) orally for prophylaxis (incorrect product storage). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA007014: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA000054:
Pfizer Dose 1 3/1/21 (EN6200) Pfizer Dose 2 3/24/21 (ER2613) Pfizer Dose 3 10/2/21 (EW0171) COVID Positive 4/12/22  4/12/22: Patient is a 76 year old female with a past medical history significant for paroxysmal atrial fibrillation status post ablation anticoagulated on Coumadin, history of CVA, iron deficiency anemia, cecum AV malformation, hyperlipidemia, mild aortic stenosis, CHF LVEF 40%, coronary artery disease status post stenting and pulmonary fibrosis on 2 L oxygen. She presented to ED with complaints of increased shortness of breath for the past week.  Shortness of breath is present with exertion but at rest on occasion.  She reports a productive cough with yellowish sputum production.  She has had decreased appetite and oral intake.  No fevers, chills or body aches. Patient reports tachycardia but has discontinued her sotalol due to side effects that she read on the bottle. No chest pain. Denies nausea or vomiting.   Patient is hypotensive in ER 89/52 and hypoxic on room air at 89%, supplemental oxygen was applied with improvement oxygen saturations.  Patient was noted to be in atrial fibrillation with RVR at a rate of 169. She was given diltiazem 10 mg IV.  IV fluid resuscitation was given with NS 0.9% 2 L. Subtherapeutic INR 1.7.  Leukocytosis 19.09. Normocytic anemia HGB 9.4.  Lactic acidosis 3.0.  ProBNP 90807. chest x-ray showed extensive interstitial changes consistent with known pulmonary fibrosis.  Perihilar areas of consolidation similar to prior CT could be overlying infection/pneumonia. She received Decadron 10 mg, magnesium sulfate 2 g and was started on Levaquin in ED.  4/16/22: Patient is a 76-year-old female who was admitted to the hospital secondary to increasing shortness of breath for the last 1 week prior to arrival.  Along with this the patient had a productive cough and had some decreased appetite and decreased oral intake.  There had been some tachycardia initially but her sotalol was discontinued due to some side effects.  Patient was hypotensive in the emergency room and was hypoxic on room air and 89%.  Heart rates were in the 160-170 range and the patient is known to have atrial fibrillation.  Patient did receive IV of diltiazem along with IV fluids.  Patient went on to test positive for COVID and was treated appropriately for this with IV remdesivir, vitamin-C, vitamin-D and zinc.  On the morning of 04/16/2022 the patient was back to her regular 2 L of oxygen via nasal cannula and was feeling noticeably better.  Patient was enquiring and asking about discharge. Patient appears to be medically stable for discharge as long as she has close follow-up with her primary care provider as well as ongoing follow-up with her pulmonologist due to her history of pulmonary fibrosis. Patient is in agreement with this approach.  We discussed reviewed her vital signs, laboratory studies, current medications and overall plan of care as well as the plan for follow-up.
Patient had nausea and vomiting 4 times on 1/20/21, 2 times on 1/21/21, 1 time on 1/22/21. Patient also experiencing constipation.
Received dose one of vaccine, did not have any initial reaction. Stated usually pre-medicates for vaccines, but did not this time due to recommendation of not doing so with this vaccine. One hour post vaccination, developed cognitive changes- deer in the headlight, unable to think/process information, lasting 4-5 hours. Later that evening, extreme fatigue. Resting respirations labored >20/min lasted most of the night along with chills with no fever x 3days. Dizziness with LOUD ringing in R ear started around 1-2am and lasted one week. Pain in joints/muscles of jaw.  Next day both ears were hurting inside (eardrum, middle ear) x1week. HR elevated up to 135 bpm walking to bathroom x 2 days post vaccination. Felt sick/wiped out post vaccine for 3-4 days with no energy with muscle aches/stiffness.
The day after my 2nd vaccine, I started with muscle weakness and could hardly walk. It seemed to improve, but started with increased pain in my hands. After a month, I started having leg pain and weakness in both thighs, hip where I had my previous hip surgery, and both shoulders where I could not raise my arms ( I also had surgery on one shoulder years ago). Wrist weakness and both hands to the point I  could barely close them and could not grip  onto anything. This started gradually and increasingly became worse over time. It has not gone away. I have been evaluated by rheumatology and all lab tests are negative. My doctor is now prescribing steroids which is the only thing that will help and when I have tried to stop them, the pain and weakness comes back within a day. I am now on a daily dose to prevent this which is also increasing my blood sugar. I continue to have the same problems with no one area getting better.
24 hours after injection  Pain at injection site   Chills  Body Aches Headache Fatigue
Hip, lower back, and leg pain. Unable to transition from laying to standing or sitting to standing without extreme pain.