chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received SHINGRIX. Previously administered products included Shingles vaccine (In 2016). On 17th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a month after receiving SHINGRIX, the patient experienced muscle soreness, influenza like illness and malaise. On 17th May 2018, the patient experienced injection site erythema and injection site swelling. The patient was treated with Aspirin (Baby), CRESTOR and SYNTHROID. On an unknown date, the outcome of the injection site erythema, injection site swelling, muscle soreness, influenza like illness and malaise were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, muscle soreness, influenza like illness and malaise to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The local injection site reaction started within a few hours of administration. The flu, malaise, etc started several hours later and lasted approximately 48 hours. The local injection site reactions lasted for 5 days. The picture of patients arm was taken on day 4 since I was concerned it hadn't gone away. The patient was not hospitalized. This case has been linked with US2018GSK102763, reported by the same reporter.
lips are full of fever blisters; fever; swelling; redness; swelling above the left breast; shoulder bone has a knot of fluid; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), ERYTHEMA (redness), SWELLING (swelling above the left breast), OEDEMA (shoulder bone has a knot of fluid) and LIP BLISTER (lips are full of fever blisters) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (In December 2020). Concomitant products included DIGOXIN, CARVEDILOL, DABIGATRAN and LOSARTAN for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced SWELLING (swelling), ERYTHEMA (redness), SWELLING (swelling above the left breast), OEDEMA (shoulder bone has a knot of fluid) and PYREXIA (fever). On 01-Apr-2021, the patient experienced LIP BLISTER (lips are full of fever blisters). At the time of the report, SWELLING (swelling), ERYTHEMA (redness), SWELLING (swelling above the left breast), OEDEMA (shoulder bone has a knot of fluid) and LIP BLISTER (lips are full of fever blisters) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    No treatment information was provided.   Reporter did not allow further contact
Patient developed periorbital type vesicular lesions that were felt to be possibly herpes zoster at 3 years of age.  She was given IV antibiotics in the hospital. She was treated with amoxicillin and the acyclovir.  No discharge or visual problems were noted. There is no pain.
Pain at injection site that lasted 48 hours. Fatigue that started 36 hours after injection, and lasted 5 weeks.
after receiving the second dose it was more painful than his first dose; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) received from Pfizer Sponsored Program. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced after receiving the second dose it was more painful than his first dose. Side effects were negligible for him. Caller said after receiving the second dose it was more painful than his first dose. He was calling about the Pfizer COVID 19 vaccine. He wants to know if he still needs to take the booster shot. Caller stated he was concerned about the delta virus because it is running rampant in country. The side effects were negligible for him. He has been getting vaccines since he was a child. He has to hang up his nephew was calling him. The clinical outcome of the events was reported as unknown.  This lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Pt had a positive COVID test at Medical Center on 1/18/22; to ED on 1/25/22 with generalized weakness, nausea, vomiting, cough in the setting of COVID 19; dc'd to home with Dexamethasone; pt passed away at home on 2/1/22
some body aches; Arm hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced general body pain (Verbatim: some body aches) and pain in arm (Verbatim: Arm hurt). The outcome of the general body pain and pain in arm were not reported.   It was unknown if the reporter considered the general body pain and pain in arm to be related to Shingles vaccine.  It was unknown if the company considered the general body pain and pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-JUL-2023 This case was reported by a patient via interactive digital media. The patient just received his/her shingles injection.  The patient's arm hurt a bit and some body aches but he/she would take that over the shingles pain. The follow up would not possible as no contact details were available.
headache; This case was reported by a consumer and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th August 2019, the patient received Shingrix. On 11th August 2019, 1 days after receiving Shingrix, the patient experienced headache. The patient was treated with sumatriptan succinate (Imitrex). 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 case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication.  The patient did not have a migraine for a long time but had the shingles shot last Saturday and had suffered from headache since Sunday. The patient finally took imitrex last night but still had remnants of a headache.  The patient enquired could this all be connected to the shot or just coincidental. The reporter did not give permission to follow up.
pt recvd vax 21APR93 10AM & 4PM 21APR93 t103 w/APAP accompanied by unconsolable crying, high pitched scream; 10PM pc to MD t105.2 MD prescribed advil; 22APR93 pt seems alert & comfortable;
Moderate pain at injection site. Fever <101.5 degrees. Redness - infection at injection site. Muscle pain treatment. Treatment: 50 mg PREDNISONE 1 X daily for 5 days. 50 mg BENADRYL 4 X daily.
This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient. A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Nov2021 at 11:00 AM as dose 2, single (Batch/Lot number: unknown) at the age of 42 years, in right arm for covid-19 immunization. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: LEVOTHYROXIN. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right, Vaccine Administration Time: 11:00 AM), administration date: 21Sep2021, when the patient was 42-year-old, for COVID-19 immunization.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 09Nov2021 at 11:00, outcome "unknown", described as "Dose 1: 21Sep2021; Dose 2: 09Nov2021"; PLANTAR FASCIITIS (non-serious) with onset 01Dec2021, outcome "not recovered", described as "Severe Plantar fasciitis". The event "severe plantar fasciitis" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of plantar fasciitis. Additional information: Event was treated with Ultrasound therapy and scrapping. The patient received no other vaccination in four weeks. The patient had no known allergies. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
swelling of tongue and mouth; swelling of tongue and mouth; Trouble swallowing normally; dizzy; seeing stars; This is a spontaneous report from a contactable consumer (the patient).  A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL8982), via an unspecified route of administration in the left arm on 21Jan2021 (at the age of 70-years-old) as a single dose for COVID-19 immunization. Medical history included allergies when growing up: food allergies, allergic to pollens, allergic to iodine. The patient took allergy shots for years. The patient did not have trouble very often anymore. The patient stated she was healthy. The patient did not have COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included: clarithromycin (CLARITIN). The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 21Jan2021, the patient experienced a little swelling of tongue and mouth, trouble swallowing normally, and dizzy and seeing stars. For treatment of these events, the patient took diphenhydramine hydrochloride (BENADRYL). The clinical outcome a little swelling of tongue and mouth, trouble swallowing normally, and dizzy and seeing stars was recovered on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
3 days of fever, tmax 103.  The day following highest fever, broke out in rash to entire trunk and face.  Loss of appetite for the week following start of illness (1 week post vaccination).  Loss of balance and weakness in legs on day 11 post vaccination.
I had vaccination on 09/17/2022. I started to experience a headache congestion and feeling like coming down with a cold on 11/04/2022. I tested COVID-19 negative on 11/04/2022. On 11/06/2022 my head was pounding with nausea, vomiting, exhaustion. I tested COVID-19 positive on 11/06/2022. I had not been able to eat till 12/2023 and lost weight down to 100lbs. I have not recovered as of 03/20/2023. I have not made any follow up appointments.
02/10/10 700pm pt starting itching, developed intermittent, migratory hives, lasting 15 - 20 minutes. Pt has used BENADRYL and CALADRYL lotion with little short term relief. Pt has L/m with liver HCP requiring evaluation and treatment.
Elevated temperature of 103 deg F approx 18 hrs post immunization. Fever continued during day 2/19/03 but was relieved w/Tylenol. Private MD examined PT on 2/19 - found no earache, sore throat or any other signs of infections.
3 days post vax, the pt developed progressive bilateral leg weakness, fever and cough. 5 days post vax, she developed paraplegia and sensory impairment to the T6-T7 level (pin prick, light touch, temperature). The pt was treated with IV steroids and discharged to a long-term care facility without any improvement on 12/11/01. Pt with PHH sign for MS and an episode of acute transverse myelitis and paraplegia.
13APR92 pt recvd 1st dose of Engerix-B; 1030-11AM devel sweating & difficulty breathing;
6cm x 6cm red area on upper right arm.  Complaint of pain when touched.  Site felt hot.  Mother took child to ER and was given Keflex IV.
pt received a booster dose 15 days too early. He was only 5.5 mos out.
Patient reported that events started the evening of the vaccination, with redness, swelling, and pain at and around the injection site, including shooting pain down his arm and tingling sensation in the fingers. He came in to the pharmacy on 11/9/18 saying the pain was still present around the injection site, with lessening redness and swelling to the right of the injection site. He said it was not itchy or hot, but still painful. He had tried using ice on it, but didn't get any relief from that. He was going to try diphenhydramine today when he left.
stomach burning for about a little over a month. Have various test such as CTScan, blood labs, stool samples etc
Information has been received on 31-OCT-2018 from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider, a pharmacist, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2017, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 24-NOV-2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered.  Additional information has been requested.
Days after developed hard, red, swollen and itching bump. Read on internet that this reflects ?COVID arm?.
4JUN98 mom states child brought to MD 4JUN98 for rash on head, spread to forehead, back of head, neck; MD felt it was allergic rxn to vax;pt given DPH;3JUN98 tiny bumps, no fever, malaise, cough, today has spread;bronchiolitis;
Herpes Zoster; Products liability: manufacturing defect/defective design; Information has been received regarding a case in litigation from a lawyer and refers to a currently 89-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On an unspecified date in 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) injection (dose, route of administration, lot number and expiration date were not reported) for long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by the physician due to the event. The patient claimed damages as a result of: Injury to themselves; Loss of consortium; Loss of services; Economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; loss of consortium; punitive damages. The outcome of the events was not provided.  The reporter consider the event of herpes zoster to be related to the suspected vaccine. The causality between the product quality issue and zoster vaccine live (ZOSTAVAX) was nor provided.
Patient received pfizer vaccine on 5/28/21 and 6/18/21. Presented to ER on 6/22/22 and found to be COVID positive. who came to emergency initially due to  nausea, vomiting and some complaint of shortness of breath.  She was admitted  on June 22nd.  She was diagnosed to have problem with COVID-19 positive test,  chest x-ray showing congestive heart failure. On admission, patient had need for oxygen, which improved immediately after  treatment.Patient progressively improved with diuresis.  She was treated with steroids.   Did not require any other COVID medication. Discharged on 6/25/22
Information has been received from a physician concerning a 42 year old male surgeon with no allergies or medical history who on 22-SEP-2008 was vaccinated subcutaneously in the left arm with a "suspected" 0.5 ml second dose of MMR II (lot # 656428/0203U). Concomitant therapy included a dose of tuberculin purified protein derivative in the right arm. Five days later, on 27-SEP-2008, the patient developed malaise, tiredness and possibly fever. On 29-SEP-2008 the patient developed soreness and achiness up and down triceps of his left arm. Unspecified medical attention was received in the physician's office. The patient is taking 1600 mg of ibuprofen daily. A complete blood count was drawn and the results are pending. The patient was reported as not recovered from malaise, tiredness, possibly fever and soreness and achiness up and down triceps of left arm. The reporter stated since the patient was a surgeon there was some mild disability. A product quality complaint was not involved. Additional information was received from the health care provider that the patient experienced no congestion or other viral symptoms and reported having low energy. On "Monday" the patient had chills and a painful mass-like area around the injection site. The patient reported feeling slightly sick to his stomach at some point. The patient treated himself with LEVAQUIN. The reporting health care provider suspected myalgia. The patient's triceps were slightly warm, tense, with no mass felt, but "mass" appeared to be traveling down the arm and extending. The patient's skin appeared normal with no joint symptoms reported. Additional information has been requested.
Dizziness, Equilibrium was off.  This started within an hour of the vaccine and lasted 24 hours.  Had to take the following day off of work.  Also, burning in the chest  ( like heartburn) lasted 48 hours.
Hives in different places on the body. Swelling of knees, hands, and feet.
Extreme arm pain, lip swelling,  extreme nauseas, bad weakness, extreme head ache, excessive tremors shaking uncontrollably, hands were really cold, high heart rate, took 2 ibuprofen 400mg total
Cellulitis due to vaccinia vaccination with lymphangitis and drainage. No systemic symptoms. 1cm lymphadenopathy.
About 5 hours after my vaccine, I experienced right arm soreness, I could not eat anything, very nauseous and my stomach was super sick. I went to the hospital because I felt I was going to throw up and I had to hold on to my stomach, felt a stabbing sensation to my stomach and the pain was unbearable. They performed an ultrasound of the abdomen and a CT scan of the abdomen. I also had an endoscopy performed after my 2nd vaccine. I had a biopsy of my stomach and I am pending results.
onset with severe headache the day after 2nd injection, arrived to the ED and CT and MRI showed possible cerebral infarct.  patient has ataxia and lateral weakness.  admitted to ICU
After given her 1st COVID vaccine patient started sweating, c/o dizziness and lightheadedness then passed out.
pt recv vax 30OCT95 & that evening pt temp became elevated to 102;pt was delirious, had a dec appetite & felt debilitated;pt also c/o gen aching & pain in the inj arm,tx w/heating pad;1NOV95 pt fever broke & began to feel better;
Chills; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9267) via unspecified route of administration in the left arm on 12Feb2021 at 11:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included hoshimotos disease, blood pressure high and osteopenia. The patient had a known allergy to penicillin. The patient concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN), telmisartan (MANUFACTURER UNKNOWN) and Metoprolol succinate (TOPROL-XL) received within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3247) via unspecified route of administration in the left arm on 22Jan2021 at 11:00 (at the age of 72-years-old) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 15Feb2021, the patient experienced chills 2 days after the second vaccination with 2 hours of duration and had it for every two to three days since last 7 weeks approximately and sometimes more than once a day/ night. On 10Mar2021, the patient underwent COVID-19 test (nasal swab) and the result was negative. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of chills. The clinical outcome of the event chills was not recovered.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of VAQTA (strength, dose, route of administration, lot number and expiration date were not reported) for prophylaxis, however no adverse effects were reported. It was reported that the vaccine were exposed to temperature of 11 centigrade degrees (°C) (9 °C to 25 °C) for a time frame of 1 hour and 5 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA012144: US-009507513-1704USA012143: US-009507513-1704USA003984: US-009507513-1704USA012142:
Patient complained of dizziness and feeling of something in her throat. She felt the need to clear her throat.