chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vertigo; Sluggishness; Chills; Fever; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (Vertigo), SLUGGISHNESS (Sluggishness), CHILLS (Chills) and PYREXIA (Fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013220A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Vertigo (Had vertigo two times before around 2010 ago and got treated) and Epley procedure (Had Epley procedure done at an ENT doctor's office.). Concurrent medical conditions included Drug allergy (Celebrex). Concomitant products included CALCITRIOL from 03-Jan-2018 to an unknown date for Vitamin D deficiency.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced SLUGGISHNESS (Sluggishness), CHILLS (Chills) and PYREXIA (Fever). On 06-Mar-2021, the patient experienced VERTIGO (Vertigo). On 09-Mar-2021, VERTIGO (Vertigo) had resolved. At the time of the report, SLUGGISHNESS (Sluggishness), CHILLS (Chills) and PYREXIA (Fever) had resolved.            The patient was fine with the first dose of vaccination but post second dose experienced the events. She was curious whether it was related to vaccine or was just coincidental.  The patient had not tested positive for COVID 19 and had no acute or chronic illnesses at the time of vaccination. She had trouble getting out of bed because of vertigo. It was reported as Benign Paroxysmal Positional Vertigo and lasted for a day or two.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: Follow up received on 11 Jul 2021. The medical history information, concomitant medication and event onset date, stop date, outcome of the event vertigo were updated.
EXACERBATION OF SHINGLES; itchy nose got worse; pain right side of face got worse; "hematoma" left side face; itchy nose and pain in face got worse; had shingles prior to getting Shingrix, received the vaccine; This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles, nasal itching and pain localized.   On 10th May 2022, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced shingles, nasal itching, facial pain, hematoma, condition aggravated and off label use. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the shingles, hematoma and condition aggravated were not recovered/not resolved and the outcome of the nasal itching, facial pain and off label use were unknown.   It was unknown if the reporter considered the shingles, nasal itching, facial pain, hematoma and condition aggravated to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-JUN-2022 Reporter's Comments: The patient self-reported this case. The patient knowingly had shingles prior to getting Shingrix. The patient stated the itchy nose and pain in the left side of his face got worse after the vaccine. The reporter stated that he went to health care professional and was diagnosed with shingle s and was given Valacyclovir to take for a week. The patient still had a hematome on left side of face. The reporter did not consented to follow-up.
Pain in left arm at injection site. Day after shot large swollen and painful rash that is raised. Noticed when I woke up that next morning on May 20, 2021
Right arm swelling and pain increasing in intensity from 1 day post vaccine adm. Seen by NP from clinic.
HAVING ELEVATED HEART RATE (100 BEATS PER MINUTE AND UP TO 138 BEATS PER MINUTE WHILE RESTING); TROUBLE BREATHING; SICK TO WORK MID DAY; This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with mrna 1273 for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and batch number: 1822811 expiry: UNKNOWN) dose was not reported, administered on 25-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-OCT-2021, the patient experienced having elevated heart rate (100 beats per minute and up to 138 beats per minute while resting). On 26-OCT-2021, the patient experienced trouble breathing. On 26-OCT-2021, the patient experienced sick to work mid day. Laboratory data included: Heart rate (NR: not provided) 100 beats per minute (elevated), 138 beats per minute while resting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from having elevated heart rate (100 beats per minute and up to 138 beats per minute while resting), and trouble breathing, and the outcome of sick to work mid day was not reported. This report was non-serious.
pr recv vax & w/in 24 hr p/vax pt cried inconsolably for 8 hr, & devel a t102 to 103; pt given APAP;
Arm pain; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  An adult female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), in Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Sep2023, outcome "unknown", described as "Arm pain". It was unknown if therapeutic measures were taken as a result of pain in extremity. Additional information: Vaccine location: Deltoid  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
ultrasound revealed blood clots at right leg; Swollen ankle and foot after 5-6 days of first dose; Swollen ankle and foot after 5-6 days of first dose; This is a spontaneous report from a contactable consumer reported for herself. A 73-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 20Jan2021 11:00 at single dose for COVID-19 immunisation. The patient was vaccinated in nursing home/senior living facility. Medical history included high blood pressure, monitored for lymph node growth. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included high blood pressure medication and clonazepam. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swollen ankle and foot on 25Jan2021 12:00 AM after 5-6 days of first dose, ultrasound revealed blood clots at right leg. Doctor ordered to take apixaban (ELIQUIS) immediately during second week. The events resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Left axillary adenopathy - improved in 3 days Left facial weakness consistent with Bell's palsy - mild to moderate; started on prednisone and Valtrex
Patient had syncopal episode almost immediately following administration of the Menactra vaccine. The child fainted and landed on the floor and was unconscious for almost 1 minute. The child had headache for several hours and felt dizzy for several hours as well.
extreme fatigue,sore guns,canker sores,loss of appetite,diarrhea, rectal bleeding, no smell, no taste, extreme thirst rash on front of both legs and both arms,night sweats, runny nose
Starting one week after injection I experienced rampant high blood pressure and adrenaline rushes.  Starting on 3/20/21 my blood pressure began to increase. By 3/22/2021, a nurse appointment showed that it was exceedingly high, so high that they would not let me leave the doctors office.  On 03/25/201, I visited the Emergency Room due to stoke-level readings from my home BP monitor. They brought me in for regular BP checks, while seated and lying down, on both arms. They also performed BP checks while I was lying down in a dark room, with a machine that checked it automatically every few minutes. The doctors prescribed a full pill of Hydrochlorothiazide, but it did not work. After a couple of weeks, they added Linsopril and the issue resolved approximately 5 weeks after the first COV-19 vaccination.
No Adverse Event; Patient received a dose from a vial that was punctured a week ago; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose from a vial that was punctured a week ago) and NO ADVERSE EVENT (No Adverse Event) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7166B) for COVID-19 prophylaxis.     Concurrent medical conditions included GERD, Dementia and Bradycardia.    On 04-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 04-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a dose from a vial that was punctured a week ago). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a dose from a vial that was punctured a week ago) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received a dose from a vial that was punctured a week ago).    No concomitant medication details was reported. No other vaccine received 4 weeks prior to COVID-19 vaccine. No treatment medication details was reported.
12/22/2020 Chills, body aches, fever 103.00 fever --  overnight fever unable to break 104.7 fever with Tylenol and Ibuprofen. Morning no change in temperature 104.7 no change  -- ER Clinic Visit, XRAY-results: pneumonia , Covid test - positive; medications prescribed : 5day Z-pack
This spontaneous case reported by a consumer, describes the occurrence of increased blood sugar levels in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 018B21A) for COVID-19 immunization. Concurrent medical conditions included diabetes. On Mar 24, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Most recent follow-up information incorporated: On May 12, 2021: Non-significant follow-up received on May 12, 2021.
Patient receive expired vaccine on 03/12/21 due to temperature excusion. Manufacterer advised to repeat dose. Final valid dose was issued 03/19/21. This was patient's second dose. First valid dose was given 02/19/21.
Received second hep B vaccination 04/22/02, developed "itching" Wednesday 04/24/02, increased itching through Friday 04/26/02 when he allegedly developed hives. He reports a pharmacist advised him to take Benadryl; which reportedly helped a little. "They g away" but then "spread." Client advised to see physician immediately/
Intense pain at injection site/ injection site very sore; Bleeding at injection site; went through 4 layers of muscle/ paused while injecting/ dose incorrectly given; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2022, the patient received the 1st dose of Shingrix. On 30th August 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site hemorrhage and wrong technique in product usage process. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site hemorrhage was recovered/resolved and the outcome of the wrong technique in product usage process was unknown.   It was unknown if the reporter considered the injection site pain and injection site hemorrhage to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's Comment:  The patient stated that the vaccine was administered incorrectly, the patient was felt as though needle went deeper than it should and went through or 4 layers of muscle before being administered.  The healthcare professional who administered dose paused as they were injecting the dose as oppose to sticking it straight in, as had been the case of all her vaccines administered. The patient reported that after received shingrix vaccine, she experienced intense pain at the injection site and informed their was bleeding from the injection site while dose had being administering, the patient did not saw the blood as they did not look while the vaccine administered, so the patient did not knew how much it bled. The healthcare professional inquired as to whether they had took any medication such as Tylenol prior to receiving dose, the patient stated she did not received. The patient stated the bleeding ceased once they returned home and removed bandage and she barley being able too see the injection site once they arrived at home and believed that it could not had bled much, based on small amount of blood on bandage. The patient stated the injection site was very sore on the day of reporting. The reporter consented to follow up. Additional supportive information: The Shingrix vaccine was administered incorrectly to the patient, which led to wrong technique in product usage process.
i have a headache today; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2020, the patient received the 1st dose of Shingrix. On 30th July 2020, 1 days after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix the day before reporting and experienced headache on reporting date.
I started having pain in my arm/shoulder a few hours after the vaccine was given, this had happened before but only lasted for a day or so. The evening of the day I received the vaccine the injection site began to itch. It also felt very hot around the area that the vaccine was given. The itch lasted through the next night and for a couple of days. The area that was hot around the vaccine lasted for a day or so. I then began to experience pain when sleeping on my left side, which is the side the vaccine was given in. I had to at one point in the night move my left arm with my right arm because it was too painful and I was unable to move it when I went to roll over to my right side during the night. I have since found it increasingly difficult to pull my sheets or blanket over myself with that arm and I am not able to sleep on it. I also have difficulty and pain when I raise my shoulder or try certain ranges of motion. I have never had shoulder pain, surgery, or any injuries prior. The pain in my arm/shoulder have not gotten any better over the past 9 days and is seemingly getting a bit worse. I have included the below information about my shot which I found on my patient portal through my doctors office. Influenza 3+ yo IM NDC 49281062778 Influenza 0.5mL 9y-64y Dose: .5 Date administered: 09/13/2017 Administration Site: Left Deltoid.
Client c/o dizziness, weakness and near syncope.  VS at 1137: 120/60, 82 HR, 16R, A&Ox3.  1145 no change and ambulance called.  1210 client refused medical advice.
Hx asthma.  Pt c/o tightness in chest as with asthma.
Pt had left post/vax & went to class, when she became very weak & dizzy, her arms & legs weak, transported per rescue squad to hospital. Tx'd w/glucose & anti-nausea med, also had asthma attack in ER. Has been on diet.
approx 3 hrs following admin of 2nd set of immun pt devel an unusual high pitch cry for 45 mins & unconsolable for 1 1/2 hrs;
Memory got all confused; Not walking right; Horrible headache; Got sick; Could not walk; Very weak/extremely weak; Could not lift himself up; Could barely move; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick), GAIT INABILITY (Could not walk), ASTHENIA (Very weak/extremely weak), LIMB DISCOMFORT (Could not lift himself up) and HYPOKINESIA (Could barely move) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   Concurrent medical conditions included Diabetes, Blood pressure high and Heart disease, unspecified.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, the patient experienced ILLNESS (Got sick), GAIT INABILITY (Could not walk), ASTHENIA (Very weak/extremely weak), LIMB DISCOMFORT (Could not lift himself up) and HYPOKINESIA (Could barely move). On 25-Sep-2021, the patient experienced HEADACHE (Horrible headache). On 26-Sep-2021, the patient experienced GAIT DISTURBANCE (Not walking right). On 27-Sep-2021, the patient experienced CONFUSIONAL STATE (Memory got all confused). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK, 2 Tylenols. At the time of the report, ILLNESS (Got sick), GAIT INABILITY (Could not walk), ASTHENIA (Very weak/extremely weak), LIMB DISCOMFORT (Could not lift himself up), HYPOKINESIA (Could barely move), GAIT DISTURBANCE (Not walking right), CONFUSIONAL STATE (Memory got all confused) and HEADACHE (Horrible headache) outcome was unknown.      Reporter stated that the patient takes medication for a heart condition, diabetes and high blood pressure and stated that they are not sure whether the patient is immunocompromised.   This case was linked to MOD-2021-333558 (Patient Link).
Moderna 3/31/21, 4/29/21. Positive on 12/15/22
This spontaneous report as received from a medical assitant, refers to a currently 14 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored GARDASIL 9,  (which had a lot # of N022728 and an expiration date of 31-MAY-2020; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion since an unknown date: 49 F for 9 days. Reportedly, there had been no previous temperature excusions and the aformentioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA006354:
pain/arm pain; shakiness of left arm; This is a spontaneous report from a contactable pharmacist. A 31-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 27Mar2021 on the left arm as single dose for COVID-19 immunization. Medical history included irregular menses, low thyroid, high prolactin. No allergies to medications, food, or other products. There were no concomitant medications, no other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient did not test for COVID-19. On 27Mar2021, patient experienced pain and shakiness of left arm within a few minutes after the shot. The shakiness lasted for about 15 minutes then went away. The arm pain lasted for about 1 day then stopped. There was no treatment received for the adverse event. The outcome of events was recovered on unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient is 14  years old and received a Moderna vaccine at a school based vaccination clinic. He reported no adverse reaction.
This spontaneous report has been received from a health professional concerning 2 patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On 04-AUG-2015, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K006960, exp. date 19-FEB-2017 and Lot # L004741, exp. date on 04-MAR-2017) (dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
About 2 hours after getting the vaccine I developed a severe pain at the site where I got my shot (left arm). It was extremely painful. I was not able to move my arm. The pain was located with in 8" from the shot site. It was sharp pain especially when I tried to move my left arm. I had trouble sleeping. I'm in my second day and the arm is better but very sore and I can't lift it up.
PATIENT CALLED AND STATED SHE WAS HAVING AND EPISODE OF FLUSHING IN THE FACE. CONFIRMED THAT NO SWELLING OR TINGLING SENSATION WAS PRESENT IN THE MOUTH OR THROAT. SUGGESTED SHE TAKE BENADRYL AT THE MOMENT AND CALL IF SHE NOTICES ANY WORSENING SYMPTOMS.
pt devel several vessicles on rt thing-mom didn't report it or bring him back until 17 days later-they were quite extensive by this time; down to rt calf & up to abdo w/one; Augmentin given & then DPH in ER 22OCT
Information has been received from a pharmacist referring to a patient of unknown age and gender. Pertinent medical history and drug allergies were not provided. On an unspecified date, the patient was vaccinated with RECOMBIVAX HB (route, strength, dose, lot#, expire date and frequency were unknown) for dose 2 within 48 hours after the dose 1 for prophylaxis (Inappropriate schedule of vaccine administered). Concomitant medication was not provided. No adverse effect reported. The outcome of inappropriate schedule of drug administration was unknown. Causality was not reported. Additional information has been requested.
This patient's mother describes 10 hours of crying after immunization given. The left thigh was very tender and caused crying when touched. She gave him Tylenol. The baby would not eat". The mom reported lump a the Comvax injection site. Could be felt 1 month later, now resolved.