chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of numbness of hand and arm in a 27-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included allergy to amoxicillin and asthma. Concurrent medications included ADVAIR, SINGULAIR, PRO-AIR, Omeprazole and CLARITIN. On 10 October 2011 at 12:00 the subject received a dose of FLULAVAL (.5 ml, unknown route, right arm). On 10 October 2011, 45 minutes after vaccination with FLULAVAL, the subject experienced numbness of right hand and right arm, tingling in the right arm and right hand, dysphagia and nausea. The healthcare professional considered the events were disabling. At the time of reporting the numbness of right hand and right arm was unresolved and the outcome of the other events was unspecified. The healthcare professional considered the events were probably related to vaccination with FLULAVAL.
This is an initial spontaneous report by a contactable consumer. A male infant (age unknown) received PREVNAR on an unknown date. Relevant medical history and concomitant medications were unknown. On an unknown date (two and half days after immunization), the patient experienced vomiting after he had solids in his stomach. It was noted that they thought that the symptoms were due to stomach and intestinal inflammation. Relevant laboratory data was unknown. At the time of report the clinical outcome of the events was unknown. Follow-up (10MAR2011): Follow-up attempts completed. No further information is needed.
left foot toe bruise, petechia in feet and lower legs by the next day. thrombocytopenia diagnosed on CBC collected 3/27/21
High fever, severe swelling upper arm and shoulder, cellulitis at injection site and facial shingles breakout.
Patient is 16 years of age and was given the Moderna shot which was indicated for 18 and over.  Patient was scheduled for Pfizer vaccine and was given Moderna mistakenly.  Per the patient and her mother, there were no adverse reactions, patient felt fine and still wanted to receive her 2nd vaccine.  Patient and parents were notified of the mistake by hospital risk management and they agreed to bring patient in to receive her 2nd Moderna vaccine at the 28 day mark.  There were no issues.
Chills; Not feeling good; Diarrhea; Didn't feel like eating; Arm was sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 89-year-old female patient received BNT162b2 (BNT162B2), on 13Jul2022 as dose 4 (booster), single (Lot number: FP4554, Expiration Date: 31Oct2022) at the age of 89 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: EP6955), administration date: 22Mar2021, when the patient was 88-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Lot Number: 5EL1016), administration date: 14Apr2021, when the patient was 88-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot Number: FJ110112.R), administration date: 15Dec2021, when the patient was 89-year-old, for COVID-19 Immunization; Shingles (With the shingles shot she had a very sore arm for a few days. The first one was at the end of Feb.), administration date: Feb2022, for Immunization, reaction(s): "sore arm"; Shingles (With the shingles shot she had a very sore arm for a few days. The 2nd one was at the end of May), administration date: May2022, for Immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 14Jul2022, outcome "recovered" (Jul2022), described as "Arm was sore"; CHILLS (non-serious) with onset 14Jul2022, outcome "recovered" (Jul2022); DIARRHOEA (non-serious) with onset 14Jul2022, outcome "recovered" (Jul2022), described as "Diarrhea"; DECREASED APPETITE (non-serious) with onset 14Jul2022, outcome "recovered" (Jul2022), described as "Didn't feel like eating"; MALAISE (non-serious) with onset 14Jul2022, outcome "recovered" (Jul2022), described as "Not feeling good".  Additional information: It was reported that the events happened the before day and it has all resolved now (as of report). The patient did not receive any vaccination within the last 4 weeks. There was no family medical history. No relevant lab tests were done. The patient had no other conditions and medical history.
No additional AE reported; Patient was administered expired GARDASIL 9; This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.   On 26-MAY-2022, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot #T026954, expiration date: 13-APR-2022, administered for prophylaxis (strength, dose, frequencyand route of administration were not provided)(expired product administered). No additional adverse events were reported. The vaccine did not undergone any previous temperature excursion.
Pain in heart area, extreme cold within 1 hour of injection, erratic heartbeat, heaviness in chest, EKG done in ER, on 10-31-22 with abnormal rhythm, heart enzyme tests normal, Echocardiogram done 11-8-22 at Hospital, results show enlarged heart and Pericardial Effusion. Other symptoms in days following vaccine, severe headache, eyes blurred and foggy, severe tinnitus, extreme nausea with vomiting and diarrhea for 1 week, legs stopped working correctly and had severe tremoring, upper arms and shoulders severe tremoring, loss of bladder control.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding an unknown age (previously reported as child), female patient with no pertinent medical history reported. On 18-MAR-2013 the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Pt recv vax on 4/24/99; 2 hr post vax pt exp continuous crying x 10 hr
Skin Reactions  after each vaccine.   After fist COVID vaccine my skin blistered , then healed.  After SECOND vaccine my skin blistered up again but this time the blisters popped.  Then the blisters repeatedly reappeared and spread over a larger area.  It was painful burning and itching.  After 3rd COVID vaccine, the blisters spread even more, my skin is cracking, skin is flaking off/easily rubbed off.  I do not have full use of my hand any longer.
My daughter is having Vitiligo and it is increasing from Feb 20th . We noticed in March and went to doctor . It is increasing  since then more. We see it from the pictures before and after..
Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and CHILLS (Chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 00?6/4C21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included PHENOBARBITAL (PHENOBARBITONE COX), TOPIRAMATE (TOPAMAX) and PRAVASTATIN for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced HEADACHE (Headache) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   This case was linked to MOD-2021-098691 (Patient Link).
(Covid Arm) A delayed localized reaction. A 2" round itchy, red, inflamed, warm to the touch and hard underneath reaction at injection spot. The nurse practitioner prescribed Triamcinolone Acetonide Cream twice daily.
Patient received J&J vaccine , was told to wait 15 min for observation. Patient felt dizzy and asked for a cup of water. Patient passed out right after for about a min. Myself and my staff pharmacist who was helping me tried to make the patient gain conscious. Patient came back right away with full memory, no head injuries, Patient refused ambulance and any medical assistance. patient was given 3 gatorade drinks and fruit snacks, was also asked to perform leg and hand muscle contractions to help stabilize the blood pressure. Patient was asked to stay 30 min for more observation, Patient felt better and was able to walk away when 30 min were up. . Patient was thankful for the attention he got .
initial rxn scarlet flushing, base of neck & upper chest;sores in mouth & sore throat secondary rxn:2 1/2hr later flu like sx;3rd stage 3-4 hr later large 3-3 1/2 wheal devel around inj site;4th stage 12hr later flu, h/a;swell inj site;ache
The HCP administered an expired Moderna Vaccine to the patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The HCP administered an expired Moderna Vaccine to the patient) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The HCP administered an expired Moderna Vaccine to the patient). On 15-Jan-2021, EXPIRED PRODUCT ADMINISTERED (The HCP administered an expired Moderna Vaccine to the patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications details were provided. No Treatment Medications details were provided.   This case was linked to MOD-2021-366988, MOD-2021-367774 (Patient Link).
Shoulder pain that has not gone away since the day after injection. Reduced range of motion in left shoulder, difficulty lifting arm. Pain radiating up to neck from injection site.
This spontaneous report was received from a healthcare worker referring to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patients received improperly stored PROQUAD lot # N012616 expired on 18-OCT-2018 for prophylaxis (strength, dose and route of administration were not reported). The sterile diluent (manufacturer unknown) used to reconstitute the vaccine was properly stored. No adverse effect was reported. The vaccines were stored at 6.3°F for 20 minutes. Previous temperature excursions reported were: 5.4°F for 10 minutes, 5.4°F for 10 minutes, 5.7°F for 10 minutes, 5.4°F for 20 minutes, 5.5°F for 20 minutes, 5.4°F for 10 minutes, 5.5°F for 10 minutes, 5.4°F for 20 minutes, 6.4°F for 1 hour, 5.9°F for 40 minutes and 5.7°F for 10 minutes. It was reported that the call was because of a data logger. This is one of two cases received from the same reporter. Sender's Comments: US-009507513-1708USA011980.
Lower digestive upset and loose stools 3:30 am; Mild nausea 3:30 am-12 pm; Headache 6 am - 6 pm (resolved 6 pm with acetaminophen); Lethargy 6 am - 6 am next day; Muscle pain at vaccine site (continuing 36 hrs post-shot).
My supervisor conveyed by telephone 01/13/05 that on 01/12/05, the daughter reported, having her mother experience local redness and swelling at site. Today 01/13/05 daughter reported symptoms subsided.
Low back pain; Whole body aches; No energy; Flu like symptoms, but no fever; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN0205) via an unspecified route of administration in the left arm on 02Mar2021 at 11:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included familial hypercholesterolemia, cardiovascular disorder, arthritis, Hashimoto's disease, attention deficit disorder and hypertension. The patient had known allergies (unspecified 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 COVID-19 vaccine. The patient received other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an unspecified route of administration in the left arm on 08Feb2021 at 11:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. On 02Mar2021 at 18:30, the patient experienced low back pain, whole body aches, no energy, flu like symptoms, but no fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events low back pain, whole body aches, no energy, flu like symptoms, but no fever were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
fever; Sore arm; Swollen arm; . This case was reported by a consumer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st December 2020, the patient received the 2nd dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced fever, pain in arm and swelling arm. On an unknown date, the outcome of the fever, pain in arm and swelling arm were not recovered/not resolved.   It was unknown if the reporter considered the fever, pain in arm and swelling arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that patient received the 2nd dose of Shingrix and experinced fever, sore arm and arm swelling. Patient asked regarding how long the side effects such as fever generally last.
Itchy blisters on arms and legs; very swollen face, swollen lips, swollen tongue
One Shingles Blister which itched beginning 2 days after 2nd SHINGRIX injection (May 24, 2018). I have photo. Husband is neurologist. I first thought it could be melanoma which runs in my family so made appointment with plastic surgeon for biopsy May 30. By May 29, 2018, 7 days after the vaccination, it looked like one large blister, rather than a melanoma. The biopsy on May 30, 2018 came back negative. When I showed the photo later to my dermatologist, he confirmed that it was a shingles blister. I also have a photo of the blister from May 29, 2018, 7 days after the 2nd Shingles vaccination. Also, on the first SHINGRIX vaccination, I just had a little soreness at the site. When I had the 2nd vaccination, 61 days after the first, I had large pink swollen arm, flu like symptoms AND the 1 shingles blister which was completely gone by 2 weeks or so. The blister was also on the site of what I call a "barnacle which is a seborrheic keratosis or age spot".
Puffy eyes, fever over 102, nasal congestion, sore throat, sneezing.  Appeared like a bad cold/flu.  All symptoms cleared within 24 hours.
Headache, Fever, Diarrhea, Fatigue, chills, arm feels heavy Narrative:
felt some liquid drip down his shoulder; felt some liquid drip down his shoulder; nurse said she measured a little extra; patient couldn't be certain he received the correct amount; nurse said she measured a little extra; patient couldn't be certain he received the correct amount; Fever; Malaise; Body aches; This is a spontaneous report from a contactable pharmacist (patient himself) via a regulatory authority. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 21Feb2021 at 07:00 at the age of 42 years old (Batch/Lot number and Expiration date were unknown) as dose 2, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the workplace clinic. Relevant medical history indicated that the patient was diagnosed with COVID-19 prior to vaccination on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient had no family medical history relevant to the adverse events (AEs). Concomitant medication received within 2 weeks of vaccination included omeprazole (PROTONIX) taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date (Batch/Lot number and Expiration date were unknown) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. At the time of administration on 21Feb2021 at 07:00, the patient felt some liquid drip down his shoulder. The nurse said she measured a little extra; the patient couldn't be certain he received the correct amount. At night on 21Feb2021, the patient experienced fever, malaise, and body aches, which were considered non-serious. The patient further stated that he did not report an overdose with the Covid vaccine. He just felt a little drop on his shoulder and he was now wondering if the nurse dropped some of the product, but he cannot know. The patient was not taking any treatment and did not require any visit to the emergency room (ER) or physician's office for the events "fever, malaise and body aches." The patient had no relevant tests. The patient did not receive any treatment for the adverse events. The patient was not recovered from fever, malaise, and body aches at the time of the report.  Follow-up attempts are completed. No further information is expected.
Started having lain in right home on 4/15/2021. On 4/16/2021 complained more about right hip, said feels like he got hit by a truck, and that he felt like he was starting to get a cold. Then he died the night of 4/16/2021.
Pfizer dose given as booster, Moderna was given as dose 1 and dose 2. Not documented on questionnaire, patient requested Pfizer,. No adverse reaction.
Felt lethargic night of adm.; 4 days later pt noted rash w/difficulty raising arm; again felt lethargic w/inc pain; Seen in ER-afebrile, diarrhea x 3 days.
First visit PCP office 8/9/06 vomiting, headache and stomach x 1 day. Diagnosis viral syndrome, headache, abdominal pain, medications: none. Seen at medical center ER 8/10/06 earache started on 8/10/06 am. Diagnosis Otitis media. Treatment Auralgan and Zithromax. Seen at medical center ER 8/14/06 abdominal and flank pain, painful urination and vomiting. Morphine given in ER. Seen at medical center ER 8/15/06 lethargic, weak, low grade fever, and unable to get out of bed and walk. Developed these symptoms on 8/15/06. Diagnosis encephalitis. He was transferred to another Hospital. Patient died on 8/21/06. Autopsy revealed acute hemorrhagic leukoencephalitis (Hurst disease), a rare, fulminant form of acute disseminated encephalomyelitis. The cause of death was likely acute disseminated encephalomyelitis secondary to prominent cytokine release prompted from a prior infection, which ultimately let to development of early DIC and multi organ system failure. 01/16/07-records received and reviewed from Med Ctr.  ER visits 8/14/06 and 8/16/06.  DX on 8/16/06- meningoencephalitis, cerebral edema. 02/09/07-records received and reviewed from another Hospital for DOS 8/15-8/21/06 DC DX: Cerebral edema basal ganglia edema with right sided thalamic edema in a vascular distribution antiphospholipid antibody positive Presented to ER with persistent vomiting times 10 days leading to ataxia and altered mental status. On transfer to another Hospital he was intubated for a Glasgow Coma Score of 8 Hospital course included antimicrobial therapy and steroids.  Developed hydrocephalus and an EVD was placed and subsequently lost all cranial nerve function and was noted on hospital day 6 to be breathing only slightly on the ventilator, also had renal insufficiency of unknown etiology with a rising creatinine. Hypertensive episode with bradycardia and expired.  Neuro exam: pupils 2mm and nonreactive to light on left side and 3-2mm and nonreactive to light on right side. Doll eye sign negative. No response to deep pain stimulation. Deep tendon reflexes 0-1 plus. Babinski sign negative. Clonus negative. Gag reflex negative. Funduscopic exam shows obvious papillary edema on right side, left eye was unable to be examined due to small size. Intermittent spontaneous movement of right arm. no movement of left arm.
Arm was red, itched, burned, raised welts within hours of injection. 4 days later, the symptoms have lessened but are still present.
Pt is an employee. Five minutes after she got her Fluarix inj. she started to have rash on the injection site then funny feeling. Started to cough then went to clinic she started to wheeze with eyelids became swollen. Dr. was notified treated with 50 mg IM Benadryl and x1 dose of Albuterol inhalation.
pt recv vax 2AUG96 & 5AUG96 pt exp a varicella-like rash w/12-15 vesicles on the arms & abd, h/a, & fatigue;
Area was hot; Area was red; Area was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Area was hot), VACCINATION SITE ERYTHEMA (Area was red) and VACCINATION SITE PAIN (Area was sore) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 020B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021 at 5:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced VACCINATION SITE WARMTH (Area was hot), VACCINATION SITE ERYTHEMA (Area was red) and VACCINATION SITE PAIN (Area was sore). On 11-Jun-2021, VACCINATION SITE WARMTH (Area was hot), VACCINATION SITE ERYTHEMA (Area was red) and VACCINATION SITE PAIN (Area was sore) had resolved.            No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up received included no new significant information.