chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received SHINGRIX for prophylaxis.  Concomitant products included rivaroxaban (Xarelto). On 2nd July 2018 15:30, the patient received the 1st dose of SHINGRIX (intramuscular) 50 mcg/mg. On 2nd July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and difficulty sleeping. On 3rd July 2018, the patient experienced cold feet. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the difficulty sleeping was not reported and the outcome of the cold feet was not recovered/not resolved. It was unknown if the reporter considered the injection site pain, difficulty sleeping and cold feet to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient stated that he started experiencing cold feet in both of his legs approximately 1 to 2 days after getting the SHINGRIX vaccine. Legs were not cold to touch but they felt cold for the patient. It has became more noticeable since the past 2 days from the date of this report. The patient also experienced pain at the injection site within one day of getting the vaccine, and was not able to sleep on the side of the arm due to pain. At the time of this report, the patient recovering from the pain.
Patient reported extreme pain at the time of injection followed by lasting nerve pain in her arm for over one week.
Case number PHEH2014US020168 is an initial spontaneous report received from a pharmacist on 06 OCT 2014. This report refers to an adult patient of an unspecified gender. Past medical history and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with an expired FLUVIRIN 2014/2015 (batch number: 1310301) intramuscularly. No adverse events were reported following this medication error (expired vaccine used).
a very strong headache/a generalized headache, in all the head; This spontaneous case was reported by a health care professional and describes the occurrence of HEADACHE (a very strong headache/a generalized headache, in all the head) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024W20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Hypertension, Diabetes and Cholesterol.    On 23-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 HEADACHE (a very strong headache/a generalized headache, in all the head). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (a very strong headache/a generalized headache, in all the head) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: (Inconclusive) normal. On an unknown date, Oxygen saturation: % (Inconclusive) normal.     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.   Concomitant medications for blood pressure, cholesterol, stomach, diabetes and for sleep. (Information not provided)
Awoke next morning with left wrist swelling and pain. Pain has persisted all day today despite trying ibuprofen and Ace wrap.
low grade fever; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on 25Feb2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that before the vaccination, she had a Rapid and PCT test. The Rapid test came back negative, but on Friday (26Feb2021) morning, Caller was informed of a positive PCR test from a phone call. On 27Feb2021, she had a low grade fever for 2 days after receiving the first dose. Potential AE documented after call (Clinically significant underlying condition). The patient is scheduled for her second dose on 16Mar2021. The patient was asking if she should still proceed with the second dose of the vaccine. She is still not feeling well on the schedule of the 2nd shot, "can I still take the vaccine" Caller seeking guidance on the scheduling of the second vaccine. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Nauseous; Weak; Really unwell; Tired; Muscle aches; Headache; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: CN5318, via an unspecified route of administration at right arm on 29Jan2021 09:00 at a single dose for COVID-19 immunisation. Medical history was not reported. Historical vaccine included first dose of BNT162B2 on an unspecified date. There were no concomitant medications. On 29Jan2021, at 7 pm, the patient was nauseous and weak. At 9 pm, the patient was really unwell, tired, headache, muscle aches and nausea. She slept all Friday night, all day Saturday. Late around Sunday was finally able to get out of bed. Asked if she should see a doctor. The patient was still nauseous and weak. The outcome of the events nausea and weak was not recovered. The outcome of other events was unknown.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: patient was given vaccine, during observation period fainted in her chair. patient was brought to the floor and legs were elevated. patient awakened and felt dizzy and had mild flushing. patient was given water, sat down for about 15-20 minutes until full recovery. patient left with no further issues.
bursitis in shoulder; arm pain at injection site on left arm; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Batch/lot number: EJ1685, Expiry date: Mar2021) via an unspecified route in the left arm on 28Jan2021 (age at vaccination: 50-year-old) as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 28Jan2021, patient experienced arm pain at injection site on left arm. Her arm hurt the normal amount for a couple of days, states day after day it got worse and worse until she couldn't use it. States just now she was looking at the paper they gave her and wanted to call to report this. Patient went to the doctor, was diagnosed with bursitis in shoulder, treating with steriods. The clinical outcome of arm pain at injection site on left arm was not recovered/not resolved and bursitis in shoulder was unknown.  Follow-up attempts completed. No further information expected.
severe glaucoma; Intermittent itching, numbness around my left eye & down cheek; Intermittent itching, numbness around my left eye & down cheek; Visual field defect; Intermittent itching, numbness around my left eye & down cheek; Intermittent itching, numbness around my left eye & down cheek; This is a spontaneous report from a contactable consumer.  A non-pregnant 71-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EM9810), via an unspecified route of administration in the right arm on 05Feb2021 at 15:30 at 71-years-old at a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the bnt162b2 administration. Medical history included controlled blood pressure high (HBP) from an unknown date and unknown if ongoing, glaucoma from an unknown date and unknown if ongoing; "known allergies: comparing." Concomitant medications included unspecified medications taken for an unspecified indication from an unspecified date to an unspecified date; within two weeks of the vaccination. On 08Feb2021 at 07:30, the patient experienced: severe glaucoma (medically significant), intermittent itching, numbness around my left eye & down cheek (non-serious), visual field defect (non-serious); with no treatment received.  The clinical outcome of the events was not recovered. The patient was not tested for COVID prior to the vaccination and post vaccination.
Patient experienced "Covid arm". Pain and swelling that onset about a week after administration.  She experienced heat sensation, itching, redness.
Patient should have received Pfizer Bivalent, however, the Pfizer monovalent was administered.  Pharmacist was working on 1/8/23 when she noticed that monovalent and bivalent Pfizer vaccines were mixed in the same basket.  She compared lot numbers for vaccines administered from 12/28/22 (when the monovalent box was opened) through 1/8/23 and discovered this error.
SARS COV-19 INFECTION.  CONGESTION, RUNNY NOSE, SORE THROAT.
Initial report received on 29 May 2009 from a health care professional. A 58 year old male patient received DECAVAC intramuscularly in the left deltoid (lot number U2590AA) on 28 April 2009. A few days after the vaccination, the patient complained of soreness, pain in the left arm which got progressively worse. he reported having some paralysis in the left arm. Black spots appeared on his left leg and abdomen. He experienced loss of sleep for two nights. He was unable to work due to arm paralysis for two days. He was seen in the emergency room, however the diagnosis, treatment, and recovery status were all unknown. No further information was provided. List of Documents held by Sender: None.
Soreness Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness Near Injection Site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness Near Injection Site). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain, at an unspecified dose and frequency. On 13-Jan-2021, VACCINATION SITE PAIN (Soreness Near Injection Site) 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 relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This arm c/o pain. Redness noted left upper arm swollen (dia 2 cm compared to right arm at 20 cm) 5cm dia erythema firm, hot tender in between injection sits RX Benadryl Ibuprofen Keflex.
Rash coming up in the inside of his upper leg; chills; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash coming up in the inside of his upper leg) and CHILLS (chills) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included OLMESARTAN MEDOXOMIL and ATORVASTATIN CALCIUM for an unknown indication.   On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced RASH (Rash coming up in the inside of his upper leg) and CHILLS (chills). At the time of the report, RASH (Rash coming up in the inside of his upper leg) and CHILLS (chills) had resolved.            Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Added outcome of event.
On 11/05/2003, child had upper respiratory infection with runny nose.  This AM, awoke in bed next to mom, very hot, then had seizure.  In ER temperature was 103-gave Tylenol and Advil and IVF.  Discharge alert and awake-will recheck in ER 11/07/2003.
Information has been received from a registered nurse concerning a 4 year old male who was vaccinated with a dose of MMR II. The mother of the patient said he had a "severe reaction" after receiving MMR II. The patient sought unspecified medical attention. The patient's outcome was unknown. Additional information has been requested.
Low grade fever the next day at 100.2 Took Liquid Tylenol at 30ml
Systemic: Anaphylaxis-Severe, Systemic: Hives across neck and face-Mild; symptoms lasted 0 days
3MAY95 2 hr p/inj c/o h/a, eye pain, gait unsteady, BP inc 200/110; site of inj red & warm; vision affected; 4MAY95 grand mal sz; 5MAY95 gradually improving;
Pain at the injection site/Tenderness at the injection site (left arm); muscle pain; joint pain; headaches; migraine; neck pain "like snapping a rubber band"; a pain in the face nerve like "bell palsy" which caused a brief 20 second paralysis but was not a bell palsy; a redness on the muscle area/a red line around the arm; Swelling; fatigue; chills; Feels a very nasty taste when is gargling and brushing the teeth.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site/Tenderness at the injection site (left arm)), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headaches) and MIGRAINE (migraine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site/Tenderness at the injection site (left arm)), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headaches), MIGRAINE (migraine), NECK PAIN (neck pain "like snapping a rubber band"), FACIAL PAIN (a pain in the face nerve like "bell palsy" which caused a brief 20 second paralysis but was not a bell palsy), ERYTHEMA (a redness on the muscle area/a red line around the arm), SWELLING (Swelling), FATIGUE (fatigue), CHILLS (chills) and TASTE DISORDER (Feels a very nasty taste when is gargling and brushing the teeth.). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site/Tenderness at the injection site (left arm)), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headaches), MIGRAINE (migraine), NECK PAIN (neck pain "like snapping a rubber band"), FACIAL PAIN (a pain in the face nerve like "bell palsy" which caused a brief 20 second paralysis but was not a bell palsy), ERYTHEMA (a redness on the muscle area/a red line around the arm), SWELLING (Swelling), FATIGUE (fatigue), CHILLS (chills) and TASTE DISORDER (Feels a very nasty taste when is gargling and brushing the teeth.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and Treatment medications were not provided by reporter.
THE PT WAS ADMINISTERED THE VACCINE.  SHE THEN GOT UP FROM THE CHAIR TO MOVE TO OUR WAITING AREA AND FAINTED (VASOVAGAL SYNCOPE).  SHE ALMOST IMMEDIATELY GOT BACK UP.  NO INJURIES REPORTED
Incorrect Moderna COVID vaccine was given - "Pink Cap" rather than "Blue Cap" for 1st dose. Patient had no adverse reactions. Informed parent to bring child in to repeat dose asap.
On 3/30/21 admitted to hosp. With possible stroke. Left side not functions. Received Prompt Care ER Transport admitted to hospital Recovered left side with 10 days therapy, full recovery w/o w/c. Possible Myocarditus 4/29/21 chkup for Macular Degen Received Dye Injection Violent Reaction - Tremors Chest shoulder pain Admitted to ER Complete chkup. No complications Possible Pericarditus Extreme loss of Balance Following to date 10/29
Patient received TD vaccine on 2/12/07 around 4:00 pm. She woke up on 2/13/07 6:00 am feeling ill. She has 101.0 fever, headache, chills, aching all over.
Right arm soreness, Stomach bug and exhaustion for 3 days after the 1st dose of the vaccination.
every time gets a flu shot, get sick; Initial information regarding an unsolicited valid non-serious social media case was received from a non-healthcare professional (parent of patient) via Social media on 17-Nov-2020.  This case involved an adult male patient of an unknown age who every time gets a flu shot, got sick (Illness), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by an unknown manufacturer (lot number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), it was reported that every time patient got a flu shot, patient got sick (Illness).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown.  There will be no information available on the batch number for this case.
Woke up early the night of the shot with severe pain in left are below shoulder where shot was given. My arm has been painful to move..I thought would eventually go away but never did. Three weeks later still very painful and makes my job even more painful to do. It's a continual ache and hard to move.
Exocrine Pancreatic Insufficiency likely auto-immune, occurred following Covid RNA shots.
Breakthrough case admission after 4 vaccines  Moderna 1/4/21 Lot# 039K20A;  Modern 2/1/21 Lot# 012L20A;  MOderna 11/10/21 Lot# 013F21A;  Moderna 4/27/22 Lot# 056A22A
right shoulder pain; pins and needles sensation in her arm; muscle pain; stiffness in her shoulders; stiffness in her wrists and hips; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included scoliosis.   In September 2022, the patient received the 1st dose of Shingrix (intramuscular). In September 2022, 1 day after receiving Shingrix, the patient experienced muscle pain, stiffness shoulder and stiffness hip. On an unknown date, the patient experienced shoulder pain and pins and needles. On an unknown date, the outcome of the muscle pain, stiffness shoulder, stiffness hip and shoulder pain were not recovered/not resolved and the outcome of the pins and needles were recovered/resolved.   It was unknown if the reporter considered the muscle pain, stiffness shoulder, stiffness hip, shoulder pain and pins and needles to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-OCT-2022 Reporter's comment: The patient self-reported this case. The patient received her first Shingrix dose about one month ago into unknown arm and one day after she developed muscle pain and stiffness in her shoulders, wrists and hips (adverse events pain and stiffness was not recovered).  The patient mentioned she woke up one morning to right shoulder pain and pins and needles sensation in her right arm. The events pins and needles sensation was recovered.  The patient had not taken anything to treat the pain.  The patient had not yet seen her doctor. If the pain continued she planned to have a Lyme Disease test. The reporter had nothing else to report. The reporter did not consent to follow-up.
Information has been received from a 34 year old patient registered nurse with allergies to IMITREX, COMPAZINE, MACROBID, for the Pregnancy Registry for GARDASIL. The patient stated that on 21-MAY-2009 she was supposed to receive RHOGAM and inadvertently received a first dose of GARDASIL (lot # 1702X). The vaccination was painful. Concomitant medications on the same day included RHOGAM. The nurse stated that the error was immediately recognized that the patient receive GARDASIL instead of RHOGAM, it was a medication error and not product confusion. At the time of reporting, 29 weeks gestation and the pregnancy was normal. Her last menstrual period was 31-OCT-2008 and her EDD was 07-AUG-2009. A follow-up appointment was scheduled with the physician. Additional information has been requested.
HCP administered to 5 patients vaccines after 30 days the vaccines were on the fridge, 3 patients on 10FEB2022 (1 Booster dose and 2 primary doses); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP administered to 5 patients vaccines after 30 days the vaccines were on the fridge, 3 patients on 10FEB2022 (1 Booster dose and 2 primary doses)) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2022 at 9:42 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Feb-2022 at 9:42 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP administered to 5 patients vaccines after 30 days the vaccines were on the fridge, 3 patients on 10FEB2022 (1 Booster dose and 2 primary doses)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP administered to 5 patients vaccines after 30 days the vaccines were on the fridge, 3 patients on 10FEB2022 (1 Booster dose and 2 primary doses)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication and treatment information was reported. HCP stated that they received a box of vials on 7-Jan-2022. There was one vial which was used after 30 days being in the fridge (30 days were on 6-Feb-2022) and they administered Moderna COVID-19 vaccine to 5 patients. HCP stated that she does not have the personal information of those patients. The vaccines were administered in the pharmacy: 3 patients on 10-Feb-2022 (1 Booster dose and 2 primary doses) and 2 patients on 9-Feb-2022 (1 booster and 1 primary dose ).  On 10-Feb-2022 the patients received the vaccine one hours after first puncture and on 9-Feb-2022 the patients received the vaccine almost 3 hours since the first punctured. HCP stated that there is no temperature excursion during the administration of that vial (the vials were in the fridge). Patient had no allergy to medications, food and other products. Patient received vaccine 4 days after use by date, and stated that patient experienced no adverse side effects from vaccine.   This case was linked to MOD-2022-480648 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Feb-2022: Follow up received on 11-FEB-2022 Contains non Significant information On 01-Mar-2022: Significant follow up appended- reporter added, patient details added, Product details added,Narrative updated.