chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Joint pain; Muscle pain; More hot flashes than usual; Red area underneath the injection site; Arm was sore; A spontaneous report was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced joint pain, muscle pain, more hot flashes than usual, red area underneath the injection site and sore arm.  The patient's medical history included hot flashes. Relevant concomitant medications included Estrogen for hot flashes(since 20 years).  On 14 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 013L20A) intramuscularly on her left arm, for prophylaxis of COVID-19 infection.  On 14 Jan 2021, the patient experienced sore arm and lasted for few days. On an unknown date,she also started to have joint andcmuscle pain. She stated that she usually had hot flashes, but that approximately a week and a half later from getting the vaccine, she seemed to have a lot more and that feeling lasted for a couple of days. Also, underneath the injection site, there was a little red area. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event(s) joint pain, muscle pain, more hot flashes than usual, red area underneath the injection site and sore arm were Unknown.; 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.
arm was sore/felt achy; hives got worse after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY and CONDITION AGGRAVATED (hives got worse after second dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, VITAMIN D3 and BIOTIN for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 PAIN IN EXTREMITY and CONDITION AGGRAVATED (hives got worse after second dose). The patient was treated with ZYRTEC at an unspecified dose and frequency; HYDROXYZINE at a dose of 25 milligram and METHYLPREDNISOLONE at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY and CONDITION AGGRAVATED (hives got worse after second dose) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Patient received 3rd dose, booster Moderna.  Within 30 seconds , patient felt very hot and diaphoretic, tunnel vision and nauseated.  Patient transported from chair to wheelchair, then to gurney.  Vitals signs taken:  BP: 112/69, heart rate 18, O2 sat 97%, temp: 36.7.  Patient symptoms started to subside upon lying on gurney for 5 to 10 minutes. Patient given apple juice and tolerated it well.  VS taken again upon sitting up.  BP: 113/71, heart rate 18, O2 sat 96-97%.   Patient verbalized feeling  better.  Patient symptoms subsided after 40 minutes of observation. Patient able to walk out of the clinic without any problems.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Vaccine received post its 30 days Expiry date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine received post its 30 days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022 at 9:03 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Mar-2022 at 9:03 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine received post its 30 days Expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine received post its 30 days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Vaccine administration time was given as 31-Mar-2022 09:03:13.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-542869 (Patient Link).
Information has been received from a health professional concerning a 17 year old female who on 16-FEB-2008 was vaccinated by injection with her first dose of GARDASIL (lot number unspecified). On 16-Apr-2007 the patient was vaccinated by injection with her second dose of GARDASIL (lot number unspecified). On 05-Mar-2008, the patient was vaccinated by injection with her third dose of GARDASIL (lot number unspecified). On 03-Apr-2008 the patient was vaccinated by injection with her fourth dose of GARDASIL (lot number unspecified). The patient experienced headaches after receiving four doses. Lot numbers were not provided. No additional information was provided. The patient sought unspecified medical attention . Additional information has been requested.
Per mother, patient became stiff and then had generalized tonic/clonic activity for 1 minute. Was limp afterwards. Second episode lasted few minutes. Fever prior to seizure activity. Taken to ED; temp 102.3. No further episodes at ED; acted normally. Discharged home.
9/5/07-Pt came into immunizations for Anthrax #3 immunization.  In my routine screening questions before giving an immunization pt. stated he had been hospitalized on 8/12/07 with an inflammation of the lining around his heart and was admitted to the Cornary Care Unit for 3 days.  He stated to me that approx. 7 to 8 days after his smallpox immunization he began to have shortness of breath and trouble breathing when he exercised.  These sypmptoms continued to worsen as the days progressed and he went to E.R. on 8/12/07.  He said they did all knds of lab tests, E.K.G., Echocardiogram, medicines and admitted him to an inpatient unit.  He said his blood test showed he had an inflammation of his heart muscle.  The M.D. called it pericarditis.  Pt was placed on low dose molecular weight heparin, low dose aspirin therapy and Indocin 25 mgm-po-tid while he was and in patient. Pt discharged on 8/14/07 with discharge instructions to continue Indocin 25 mgm-po-tid for 5 days.  Pt states he feels really good now.  09/10/2007 MR received for DOS 8/12-14/2007 for D/C DX of Chest Pain, probable Pericarditis and abnormal Troponin I Level. Pt presented to ER with a several day hx of substernal chest pain with radiation to the neck which is exertion related.  Shortness of breath and tingling of the arms also occur with minimal activity.  PE WNL. Treated with Indocin.
injection site pain; injection site swelling/induration distal to the injections site; injection site erythema; asthenia; fatigue; myalgia; ecchymosis distal to the injection site.
Injection site rash, induration, erythema, pain. Redness started 2 days after injection, other symptoms started 4 days after injection along with headache.
At the time of the call it was "1 year and 3 months" after the scheduled time for her third dose; No additional AE information reported. No  reported; This spontaneous report as received from an unknown age female patient concerning herself. There was no information about the patient's medical history, concurrent conditions or concomitant medication. On an unknown dates, the patient was vaccinated with a first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), 0 .5 milliliter for prophylaxis (route of administration, lot number and expiration date were not reported).  At the time of the call it was "1 year and 3 months" after the scheduled time for her third dose, but she had not received it yet. She was supposed to have received her third dose in June 2020. No additional adverse event information reported
Patient experienced nausea chills aches fever 101 starting 4 hours post vaccination and resolved within 48 hours also sore arm.
Within 15-minutes of vaccination, the patient reported that she was short of breath and having difficulty breathing. EMS evaluated the patient on-site. The patient is currently prescribed albuterol for a history of breathing issues. EMS placed patient on 8lpm oxygen and administered 2.5mg inhalation albuterol treatment. Patient refused transport.
Arthritic pain in the toes, hips, thumb, elbow/ elbow pain/ thumb pain; Soreness in his chest muscle; wrist stiff; Arm began to swell; Limited arm movement; Burning at the injection site; This case was reported by a consumer via and described the occurrence of injection site burning in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included viral arthritis.   On 25th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 26th September 2020, 1 days after receiving Shingrix, the patient experienced injection site burning. On 29th September 2020, the patient experienced swelling arm, mobility decreased and stiff joint. On 9th October 2020, the patient experienced arthritic pains and musculoskeletal chest pain. On an unknown date, the outcome of the injection site burning, swelling arm, arthritic pains and stiff joint were recovered/resolved and the outcome of the mobility decreased was unknown and the outcome of the musculoskeletal chest pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site burning, swelling arm, mobility decreased, arthritic pains, musculoskeletal chest pain and stiff joint to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for himself. The patient received Shingrix on left arm. Four days after receiving Shingrix, the patient's right arm began to swell, wrist stiff and had limited arm movement. Two weeks after receiving Shingrix, the patient experienced arthritic pain in the toes, hips, thumb, elbow and soreness in his chest muscle. No other address available at time of report. The reporter consented to follow up. The patient noted that he had emailed this information to GSK, but no report or patient name could be found. He reported getting an email back with case 01469077. It was not known if this was reported prior to day of reporting.
This case was reported by a consumer via call center representative and described the occurrence of palpitation in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (1st dose received on an unknown date, for tolerance refer case US2018GSK182297). Concurrent medical conditions included cold sores lip (when exposed to shingles). On 29th September 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced palpitation, cold sores lip and adverse event. On an unknown date, the outcome of the palpitation, cold sores lip and adverse event were unknown. It was unknown if the reporter considered the palpitation, cold sores lip and adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on the last Saturday, from the date of reporting and it gave all of the common side effects, in addition heart palpitations and a large cold sore on the patient's upper lip. The patient did see the potential for heart palpitations, but not cold sores. The patient thought that the formation of cold sores was a potential side effect of Shingles vaccine. This case is one of the 3 cases reported by the same reporter.
5 hrs p/vax pt turned white, lips were blue, went limp; then shivered & startled/jerked p/immun was alert w/some gagging sounds & 40mins of moaning; w/in an hrs these events repeated 100 temp;
Patient's wife reported on 4-29-10 that the day after he received injection that the site was red, swollen, itching and patient had "light" fever. He wasn't treated by a doctor.
Severe chills, severe headache, severe leg pain, weakness, fever went from 99.0 to 105.5 with in 30 min, double vision.
HOT FLASHES; SHOOTING PAIN IN DIFFERENT AREAS; BLURRY VISION AND CANNOT READ AT CERTAIN DISTANCE; BLOOD VESSELS BENEATH  BOTH KNEES AND FEET (LEFT LEG APPEARS WORSE THAN RIGHT LEG); PURPLE-LIKE VEINS; TINGLING IN BOTH THE LEGS/ TINGLING IN HANDS; ITCHING OF RIGHT AND LEFT LEGS; COLD SWEATS; DISORIENTED; BURNING OF RIGHT AND LEFT LEGS/ BURNING SENSATION IN BOTH ARMS; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's past medical history included: tick bite, and concurrent conditions included: cigarette smoker, alcohol user, alpha-gal allergy, and sulfa allergy, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 21-SEP-2021) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride for allergy. On 06-AUG-2021, the patient experienced burning of right and left legs/ burning sensation in both arms. On 06-AUG-2021, the patient experienced disoriented. On 06-AUG-2021, the patient experienced itching of right and left legs. On 06-AUG-2021, the patient experienced cold sweats. Treatment medications included: diphenhydramine hydrochloride. On 16-AUG-2021, the patient experienced blood vessels beneath both knees and feet (left leg appears worse than right leg). On 16-AUG-2021, the patient experienced purple-like veins. On 16-AUG-2021, the patient experienced tingling in both the legs/ tingling in hands. Laboratory data included: Blood test (NR: not provided) not reported, and Ultrasound scan (NR: not provided) no clots in legs. On 17-AUG-2021, the patient experienced blurry vision and cannot read at certain distance. On 18-AUG-2021, the patient experienced hot flashes. On 18-AUG-2021, the patient experienced shooting pain in different areas. Laboratory data included: Pain scale (NR: not provided) 7 out of 10. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from disoriented, and cold sweats on 06-AUG-2021, had not recovered from burning of right and left legs/ burning sensation in both arms, blood vessels beneath both knees and feet (left leg appears worse than right leg), blurry vision and cannot read at certain distance, hot flashes, itching of right and left legs, and tingling in both the legs/ tingling in hands, and the outcome of shooting pain in different areas and purple-like veins was not reported. This report was non-serious.
Diffuse rash, scratchy, swollen throat, and chest pain -> to ER given BENADRYL & Prednise f/u on 10/7 at clinic.
Information has been received from a healthcare worker referring to a 6 month old patient of unknown gender. Concurrent conditions and medical history of the patient were not reported. On 24-FEB-2016 the patient was vaccinated with an expired dose of ROTATEQ (lot # K005394, expiry date: 23-FEB-2016) orally. Other suspect and concomitant therapies were not reported. No adverse experience has been reported. Additional information has been requested.
Chills, nausea and headache at 9pm, fever at 10pm peaking at 107.1° at 4am, blood pressure peaking at 216 over 103 at 8am. Fever persisted 41 hours, headache persisted 38 hours, nausea persisted 34 hours.
Had an immediate and severe allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Had an immediate and severe allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ALLERGY TO VACCINE (Had an immediate and severe allergic reaction). In 2021, ALLERGY TO VACCINE (Had an immediate and severe allergic reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. It was reported that patient started treatment of the moderna vaccine a year and a half ago. It was reported that patient had an immediate and severe allergic reaction after Moderna shot and suffered for 2 months. No treatment medications were reported.
over 10 days pt had stuffy nose & then devel a cough; 3 to 4 days prior to death became febrile; had poor suckle 15JAN94 was noted to be dusky in crib; pt was picked up, cried out & then stopped breathing;
Redness 8 x 9.5 cm firm raised center 2 x 2 cm started 1-30-10
triouble breathing; itchy throat that progressed to a little cough; itchy throat that progressed to a little cough; body aches; fever; covid at the time of the first dose; headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid at the time of the first dose), THROAT IRRITATION (itchy throat that progressed to a little cough), COUGH (itchy throat that progressed to a little cough), PAIN (body aches) and DYSPNOEA (triouble breathing) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    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 COVID-19 (covid at the time of the first dose) and HEADACHE (headache). On 12-Jan-2021, the patient experienced THROAT IRRITATION (itchy throat that progressed to a little cough), COUGH (itchy throat that progressed to a little cough), PAIN (body aches) and PYREXIA (fever). On an unknown date, the patient experienced DYSPNOEA (triouble breathing). At the time of the report, COVID-19 (covid at the time of the first dose), THROAT IRRITATION (itchy throat that progressed to a little cough), COUGH (itchy throat that progressed to a little cough), PAIN (body aches), DYSPNOEA (triouble breathing), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided Treatment medication includes Z-PAK, albuterol pump
Severe swelling with redness over most of left upper arm from shoulder to elbow.  Warm to the touch & painful.  Child did not alert mother to situation until late in the evening 8/26 & mother took child to ER where child was given an antibiotic & pain medication prescriptions.
Patient had severe hives covering 90% of her body on Nov. 13.  She went to Health Services on campus.  Got Benadryl.  By midnight hives were so bad we took her to Hospital.  Given steriods.  Strep test came back negative.
reported headache, sore throat, nausea on 5/16/22- tested positive for covid, molecular test same day.
Notes:received Covid Vaccine on 1/16/2021 ,  received flu shot on 9/11 , s/s symptoms started 9/14/2021 ,now having  nasal congestion , runny nose , loss of smell and head ache . tested 9/21, resulted 9/21 /21, positive for covid , Patient advised on policy of staying on Quarantine for 10 days on symptom onset till 9/24 and to call back on 9/24 with release from DOH and resolution of symptoms and for RTW clearance .Patient requesting retesting and has a test scheduled at airport today and patient insisted on having the test done there .
While in California, on June 12, 2022, I noticed a cough during my walk that morning and began started wearing a mask.  Home test on June 12 and negative.  The next morning I was really fatigued.  The food that I tried to eat didn't taste good.  Monday morning I had a fever of 101.5.  I just felt like trash.  I still had the cough.  I tested again and I was positive for COVID-19.  I called the advice nurse and they sent a nurse to my home.  They tested me again and I was positive.  They did not prescribe anything.  I had been taking my previous 800 milligram ibuprofen.  I had quite a bit of nasal congestion and chest congestion.  My symptoms seemed to dissipate around June 18th.
Device issue; Injection site burning; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE ISSUE (Device issue) and INJECTION SITE PAIN (Injection site burning) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Drug allergy.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jul-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 22-Jul-2022, the patient experienced DEVICE ISSUE (Device issue) and INJECTION SITE PAIN (Injection site burning). On 22-Jul-2022, DEVICE ISSUE (Device issue) and INJECTION SITE PAIN (Injection site burning) had resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine trial.  No concomitant drugs taken by the patient.  Moderna vaccine was taken 1 in once for all doses.  It was reported that patient had burned skin when humira pen misfire.  No treatment information was provided.   This case was linked to MOD-2022-617503 (Patient Link).   Reporter did not allow further contact
Onset red mark on arm (noted by husband). Induration 36x38mm, erythema 50x50mm L arm.
Hard knot, red, itchy. Treatment - ice topically and oral BENADRYL.
(1) Hardness under the injection site/four inch large (red, swollen and) hardness under the injection site (LLT: Injection site induration, PT: injection site (induration), 10/05/2014 to, Outcome is Not Recovered/Not Resolved. (2) Redness at the injection site/four inch large red (swollen and hardness) under the injection site (LLT: Injection site redness, PT: Injection site erythema), 10/05/2014 to, Outcome is Not Recovered/Not Resolved. (3) Swelling at the injection site/ Four inch large (red) swollen (and hardness) under the injection site (LLT: Injection site swelling, PT: Injection site swelling), 10/05/2014 to, Outcome is not Recovered/Not Resolved.
Information has been received from a respiratory therapist concerning a 60 year old male with a penicillin allergy who on 07-AUG-2007 was vaccinated with PNEUMOVAX 23. Concomitant therapy included metformin, niacin, HYDRODIURIL (manufacturer unknown), CRESTOR, AVAPRO, CELEBREX and VICODIN. Subsequently the patient experienced a large area on his arm that was red and puffy. The patient also had a low grade temperature, nausea, sweats and chills. Unspecified medical attention was sought. At the time of the report the patient had not recovered. Additional information has been requested.