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 79-year-old female patient who received SHINGRIX for prophylactic. Concomitant products included Co Q10 and simvastatin. On 17th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site lump and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site lump and injection site erythema were recovered/resolved. The reporter considered the injection site pain, injection site swelling, injection site lump and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: This case was not previously reported to anyone. The patient stated that, after getting her SHINGRIX vaccine in right arm, she had redness, swelling and pain to touch at the injection site. The patient stated there was a lump at the injection site that traveled down to her elbow. The patient stated that, all the symptoms lasted 4 to 5 days. The patient had denied permission to contact their physician. The patient stated, the pharmacy mailed her a letter after her vaccines stating if she had any reaction she should call GlaxoSmithKline and report it. The patient did not have any additional information including street number, or name of pharmacist who administered the vaccine.
Pt had a seizure, early AM, and was taken to ER. Admitted to ICU then transferred to Pediatrics.
Diagnosis of disseminated shingles. Burning, nerve pain 6 inches below left axillary that 2 days later developed painful and itchy red dots and pustules. These also developed across upper chest bilaterally and right side of neck. This occurred 7 days status post ALIF Lumbar Fusion L5 - S1 and 18 days post Covid 19 Moderna vaccine #1. Symptoms dissipated within 3 weeks.
Pt became itchy within 1 hr of vaccine started taking Benadryl, Tylenol, develops fever chills body aches that night. Continued home medications. Woke up day 2 with severe rash on trunk swelling in left side of neck clavicle area swollen glands in arm pit and neck. Still taking Benadryl and Tylenol increased heart rate rash mining to neck. Went to er. Hr 140's bp 158/96 spo2 96. Medicated with more Benadryl IV steroids and Pepcid. Monitored sent home with all medications listed plus Epi pen. Benadryl increased to q4 50 mg after soft tissue next swelling and top lip tingling. Pt continues to be on medications listed with minimal relief of symptoms.
Pain; Discomfort; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), DISCOMFORT (Discomfort) and CHILLS (Chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain), DISCOMFORT (Discomfort) and CHILLS (Chills). At the time of the report, PAIN (Pain), DISCOMFORT (Discomfort) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
pt devel baseball size hives on both thighs, then moved to calves, arms, face, chest & back;tx w/DPH;
Eight days after I received the shot, my arm has started to feel itchy, red and hot. It hurts to touch and feels swollen
The day of vaccine devlp'd fever, chills, GERD sxm & next day devlpd rash at inj. site. Rash is now abating. Other sym resolved after 2 days. Still with faint erythema of left arm.
it was rpt fr pt who in approx 1996 was vax & subsequently the pt exp a fever & one red mark.
vomiting continuously for 3 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 21Mar2021 12:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious) with onset 22Mar2021, outcome "recovered" (22Mar2021 03:00), described as "vomiting continuously for 3 hours".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Diarrhea; Her arm hurt really bad; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 29EY3, expiry date 28-JUN-2024) for prophylaxis.   Concurrent medical conditions included allergy (Cephalexin, Morphine, Codeine and Sulfa albendazole). Concomitant products included alprazolam.   On 01-JUN-2023, the patient received the 1st dose of Shingrix (right deltoid). On 01-JUN-2023, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: Her arm hurt really bad). On an unknown date, the patient experienced diarrhea (Verbatim: Diarrhea).  The outcome of the pain in arm was resolved (duration 3 days) and the outcome of the diarrhea was not resolved.   The reporter considered the pain in arm and diarrhea to be possibly related to Shingrix.     The company considered the pain in arm and diarrhea to be possibly related to Shingrix.   Additional Information: GSK Receipt Date: 31-AUG-2023 The patient was self-reported this case. The reporter reported that she received Shingrix vaccine and on same day she experienced arm hurt really bad for 3 days. The patient experienced diarrhea before receiving 2nd dose of Shingrix vaccine. The reporter consented to follow up.   Follow information received on 05-OCT-2023 It was reported that patient received 2nd dose on 30th August 2023 on left deltoid with batch number 7L777 and expiry date 22 August 2025. The patient had allergies with Cephalexin which caused GI upset and diarrhea, Morphine which caused itching, Codeine which caused nausea, vomiting and Sulfa albendazole which caused nausea, vomiting. It was reported that the clinic was unaware of the adverse events occurred after 1st dose. Summary of changes: Patient tab, product tab, event tab and narrative was updated.; Sender's Comments:  US-GSK-US2023AMR122939:
This spontaneous report was received from a healthcare professional refers to multiple unspecified patients of unknown age and gender. No medical history and concomitant medications were reported. On an unknown date the patients were vaccinated with GARDASIL (Lot# K007828, expiry: 02-MAR-2017 and lot# K007264, expiry: 02-MAR-2017) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Numbness of arm, at 6:25 am next morning, went to doctors office, took Tylenol.
This spontaneous report as received from licensed vocational nurse (LVN) refers to a 14 month old patient of unknown gender. No information regarding current condition, medical history or drug allergies were reported. Approximately on 20-MAR-2015 (also reported as today) the patient was vaccinated with VARIVAX (Merck) injection (strength, dose number and route was unknown) with lot # J002618 which was expired on 01-MAR-2015. No adverse effect was reported. The outcome of event was unknown. No further information was provided. Additional information is not expected.
This is a serious post marketed study case from a physician in the USA involving paroxysmal hemicrania. The reporter causality is possibly related to FluMist. A 48 year old female patient received FluMist on 11/3/04. On 11/6/04, the patient developed left side headache radiating to the left jaw. She was given Septra which was later changed to Augmentin. She was also given multiple pain medications, including Vicodin, Relafen, Nasal spray, Percocet and morphine, all of which did not relieve her. A CT scan of the head and sinuses done on 11/22/04 showed sinus mucosa disease and small air-fluid in right frontal sinus. The patient was hospitalized on 11/25/04. MRI and MRA of the brain done on 11/26/04 was essentially normal. Her chemistries, CBC and sedimentation rate were also normal. A neurologist was consulted and diagnosed her with paroxysmal hemicrania with overlapping symptoms of migraine. The patient was given Indocin, to which she responded. On 11/27/04, patient's condition was stable and improved and was discharged home to follow up as an outpatient. Previous medications being taken by the patient include Verapamil, Levothroid, Lovastatin, and Prilosec for gastric reflux. The patient has not yet recovered. The reporter determined the events to be possibly related to FluMist vaccination. 27 Jul 05, the patient recovered from all events except for hypoaesthesia. Complete information for this case submitted to VARES on 03 Aug 05 as a 15 Day expedited report in accordance with 21 CFR 600. 80- BT
She did not think she received the full dose/the bandage was quite moist; A spontaneous report was received from a pharmacist for a 56 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and it was reported that the patient did not think that she received the full dose/the bandage was quite moist.  The patient's medical history was not provided. No concomitant product use was reported.  On 19 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 007M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.   On 19 Feb 2021, a week after administration of the vaccine, the pharmacist was made aware that the bandage was moist and the patient thought that full dose of vaccine was not administered. The patient's doctor recommended the patient to get second dose of vaccine. Treatment information was not applicable.  Action taken with mRNA-1273 was unknown.  The outcome of the event, the patient did not think that the patient received the full dose/the bandage was quite moist was considered as resolved.; Reporter's Comments: This report refers to a case of Product administration error  Underdose  for mRNA-1273, lot # 007M20A with no associated Adverse Events.
Chest pain; longer and stronger for the second one; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 (Lot number: ER8736) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart palpitations" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing). Concomitant medication(s) included: LATANOPROST taken for glaucoma. Past drug history included: Ampicillin, reaction(s): "drug allergy". Vaccination history included: Bnt162b2 (First dose, Lot: ER8734, Location: left upper arm or shoulder), administration date: 08Apr2021, when the patient was 59 years old, for Covid-19 Immunization, reaction(s): "Chest pain", "left breast pain", "sharp pain, like pleuritic pain, especially on inhalation". The following information was reported: CHEST PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "Chest pain; longer and stronger for the second one". The event "chest pain; longer and stronger for the second one" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chest pain. Additional information: The patient also took vitamins as concomitant therapy. The patient had a reaction to shot number one and shot number two of the Pfizer,  shot number two had a much more 'exacerbated' reaction. There was no any other vaccine shortly before the vaccination, within 4 weeks. The patient went into the Emergency Room, they ruled out Pulmonary embolism and sent the patient on her way.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021549918 same patient, vaccine different dose, similar AE
Client presented to clinic on 11/19/2018 for a seasonal flu shot. Vaccine administered and client observed for 15 minutes before leaving clinic. Client reports on 12/21/2018 that he felt "sick" for a few days after the vaccine was given and noticed a week later some twitching and numbness in hand and feet. Went to see his PCP and was referred to a neurologist. Client went to neurologist and was diagnosed with Guillain-Barre. Has been instructed by his PCP to not receive any more seasonal flu vaccines.
Patient stopped by pharmacy on 11/18/19 to discuss getting the second Shingrix vaccine. During the discussion, she reported having hives on her neck the following morning after the vaccine. She took Benadryl, and they improved. She did not seek medical treatment and is still  indecisive as to whether she will get the second dose.
apr89 pt vax hepta B. 7-10 days after pt devel lymphadenopathy. remitted spontaneously.
The client complained of being itchy while waiting in 30-minute wait area after injection of the COVID19 vaccine. Her itchiness and rash did not get better with time. She was transported to the hospital for a possible allergic reaction to the vaccine (Moderna Dose #1, Lot 043B21A, exp 10/03/2021.
Information has been received from a physician, via a company representative, concerning a male pt age unknown, with unknown medical history and unknown drug reactions/allergies, who on an unspecified date was vaccinated route unknown, with a dose of Pneumococcal 23v polysaccharide vaccine (lot known). The physician reported that the day after the injection the pt experienced a case of breakthrough. The physician also reported that there has been about two other cases that are nearly identical. Unspecified medical attention was sought. No product quality complaint was involved. The outcome was reported as unknown. Additional information has been requested.
Approximately 10 hours after receiving my second shot of Shingix on April 17, 2023 I began feeling the typical symptoms one often feels after a vaccination. Lethargy, weakness. I expected this because this is what I felt after receiving the first shot. However, after about 2 days these symptoms worsened. I felt completely fatigued to the point of exhaustion, also aches and pains, feverish, and pronounced Tinnitus.
Paramedic assessed patient.  Pt stated head felt heavy, light-headed.  Vitals, HR 89, BP 142/93, respiratory 18.  Patient monitored and was stable to leave upon expired observation timeframe.
Fatigue, 11 cm x 7 cm area on upper (R) bicep of erythema & warmth.
Pt experienced redness, heat and swelling on the arm vaccinated w PNEUMOVAX. Advised to use cool compresses, antihistamines and closely monitor. If worsens to call office back. No signs of cellulitis.
Fatigue for several days, very mild rash, followed by dizziness and disorientation/unsteadiness on day 8
Atrial fibrillation diagnosed on 4/14/2021; asymptomatic; treated with electrical cardioversion on 06/24/2021;  verified normal rhythm on 07/22/2021
5 mins post vaccination pt c/o dizziness and periorbital area swelling. Vitals: @10:50 BP 140/92, HR 74, O2SAT 99% -- > @10:56 140/94, 83, 100% -- > 11:13 130/86, 73, 99% -- > 1123 120/82, 72, 100% Pt was given 25mg PO Benadryl @11:05AM.  Swelling and dizziness improved.  Pt denies SOB.  Pt stable and released from the vaccination site.  Pt returned to onsite residence via wheelchair.  Pt verbalized understanding to call 911 or seek assistance if symptoms persist or worsen.
PATIENT STATED THAT SHE HAD SHAKING MOVEMENT; VITALS WERE TAKEN AND STABLE.
Swelling of about 2x2 cm. with mild redness over the ant right thigh.
Pt. had adverse reaction after receiving typhoid vaccine (left arm) and anthrax booster (right arm). Thursday 11/4/2021 evening , Friday 11/5/2021 all-day, and Saturday 11/6/2021 morning had the following symptoms: chills, body aches, fever, headaches, muscle aches, and bruising (right arm).  Treatment was ibuprofen Saturday 11/6/2021 at 0630.
Pt had a 6 cm large reaction on right deltoid, also complained of a headache and swollen arm.
Initial swelling and redness after shot lessened within a few days; a few days later, however, pain, swelling and large area of redness appeared
Fever; Headache; Vomiting; Patient received dose 3; Patient received dose 3; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 17Sep2021 at 08:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medication. The patient previously received first dose of COVID-19 VACCINE (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and also second dose of COVID-19 VACCINE (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 18Sep2021 at 02:00 the patient experienced fever, headache, and vomiting. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with ondansetron (ZOFRAN), paracetamol (TYLENOL), and famotidine (PEPCID). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, headache, and vomiting was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arthralgia limited ROM of left shoulder for 6 months Narrative: Patient ROM is improving but is still decreased. No pain with movement of shoulder.
Little tiny bumps on neck then throughout the days is covered with the bumps all over body. Bumps started on January 15th and he is covered in them up until this day (January 27th, 2010).
02/09/21 1900: Nausea, vomiting, hives. 02/09/21 2200 - fever, chills, muscle and joint pain.  02/10/21 0700 - local injection site reaction (redness, swelling, warm). Symptoms still present 02/11/21 at 0600
Patient had MMRV on 1/31/19 then developed viral exanthem on 2/10/19.
Passed 128 days from first dose; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Passed 128 days from first dose) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Passed 128 days from first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Passed 128 days from first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
gout in the left lower big toe joint area / appeared on 3/4/2021 and is ongoing; sharp excruciating pain; is debilitating; and he can not walk.; shoulder pain; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd March 2021, the patient received the 1st dose of Shingrix (intramuscular). On 3rd March 2021, less than a day after receiving Shingrix, the patient experienced shoulder pain. On 4th March 2021, the patient experienced gout and pain. In March 2021, the patient experienced debility and unable to walk. On an unknown date, the outcome of the shoulder pain was recovered/resolved and the outcome of the gout, pain, debility and unable to walk were not recovered/not resolved.   It was unknown if the reporter considered the shoulder pain, gout, pain, debility and unable to walk to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The patient experienced shoulder pain. The shoulder pain lasted and resolved in two to three days. One day after vaccination, the patient experienced gout and pain. The patient also reported gout in the left lower big toe joint area. He described the gout as a sharp excruciating pain. He states that the gout appeared on 4th March 2021 and was ongoing.  Less than a week after vaccination, the patient experienced debility and unable to walk. The patient stated that this gout was debilitating and he could not walk. He reported that he had not changed his diet.  The reporter consented to follow up
I never had complications after my Pfizer injections, but in October 2022, I began experiencing involuntary jerking of the head. At the time this developed, I was still dealing with extreme fatigue that had begun in August 2022. After I developed the head jerking, I decided to quit all of my medications, including my supplements. On 1/7/2022, I saw my PCP, who tested me for COVID-19 antibodies, and none were detected. By the late afternoon of 1/10/2022, though, I was sick with a breakthrough case of COVID-19. On 1/20/2022, I underwent an MRI at a local medical center and the result was normal. On 3/9/2022, I underwent an EEG at the clinic; again, the result was normal. On 3/14/2022, I saw a neurologist, who ordered 22 lab tests, 16 vials of blood, and a 24-hour urinalysis. The results to all of the tests were normal, except for one. I am not sure which test it was, as I have yet to speak to the doctor about it. The neurologist also ordered a 3-day EEG, which I am due to undergo on 4/12/2022. Although nothing is conclusive at this point, the neurologist suspects post-COVID brain damage. Also, when I began battling fatigue in August 2021, I underwent a blood test then. The test results showed elevated liver enzyme levels, but when I underwent a subsequent liver ultrasound, no abnormalities were found.