chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician's assistant refers to a male patient of unknown age. The concurrent condition, medical history and concomitant medications were unknown. On an unknown date, the patient was vaccinated with GARDASIL dose 1 (route and lot details unspecified). Six months later the patient was then administered with GARDASIL 9 (route and lot details unspecified) as the second dose of the series. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
My body hurt; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (My body hurt) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (My body hurt). At the time of the report, MYALGIA (My body hurt) outcome was unknown.            No information regarding concomitant medications provided. No information regarding treatment medications provided.
About 3 hours after injection patient started to notice symptoms she has swelling at injection site, area is warm and painful. Swelling lump measured to be 9.5cm X 9.5cm at 1:20 PM. She was given TYLENOL 1,000 gm and Loratadine 10 mg. She was given an ice pack to apply to site. It is 2 PM and still in our office not much improvement has been seen at this time.
vaccination failure; shingles; 3-5 small blisters; injected arm became very red; swollen and raised; feeling pain; itching on her left scapula; painful to touch; Drug dose administration interval too long; Fever and was "in bed for 5 days; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 18th June 2018, the patient received the 1st dose of Shingrix. On 14th March 2019, the patient received the 2nd dose of Shingrix. On 14th March 2019, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In July 2019, the patient experienced pain, pruritus and tenderness. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister, injection site erythema, injection site swelling and fever. On an unknown date, the outcome of the vaccination failure, shingles, blister, pain, pruritus, tenderness and drug dose administration interval too long were unknown and the outcome of the injection site erythema, injection site swelling and fever were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blister, pain, pruritus, tenderness, injection site erythema, injection site swelling and fever to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles, blister, pain, pruritus and tenderness to be related to Shingrix.  Additrional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix was administered on right arm and the patient reported having much milder symptoms. She knew that she had received a vaccine but the symptoms were not nearly as bad. In mid-July 2019, the patient reported feeling pain and itching on her left scapula that became worse and worse and also painful to touch or if anything touched it.  The patient had 3-5 small blisters developed and broke out in that area and the patient, who was also a physician, suspected shingles. The patient was consulted with an infectious disease provider who diagnosed her with shingles. The reporter was consented to follow up.
This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Extremely sick), PAIN (hurt everywhere/Pain), COUGH (coughing), PYREXIA (fever) and CHILLS (chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939202) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by reporter.  Concomitant products included GLIPIZIDE, ATORVASTATIN, HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN HCTZ), PANTOPRAZOLE and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Extremely sick), PAIN (hurt everywhere/Pain), COUGH (coughing), PYREXIA (fever), CHILLS (chills) and HEADACHE (very bad headache). At the time of the report, ILLNESS (Extremely sick), PAIN (hurt everywhere/Pain), COUGH (coughing), PYREXIA (fever), CHILLS (chills) and HEADACHE (very bad headache) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided by reporter.
arm was a little swollen for 2-3 days; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was a little swollen for 2-3 days) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020821A and 024320A) for COVID-19 vaccination.     The patient never had COVID positive test or COVID diagnosis. The patient did not receive any other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Soap allergy, Alcohol allergy, Iron deficiency anemia (recent change in status was worsening), Renal impairment (22 percent; recent change in status was worsening), Solitary kidney (one kidney, 70 years old (kidney bled out or wasn't born with left kidney - worked 60%); recent change in status was worsening), Blood pressure abnormal and Blood cholesterol abnormal. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PERIPHERAL SWELLING (arm was a little swollen for 2-3 days). In April 2021, PERIPHERAL SWELLING (arm was a little swollen for 2-3 days) had resolved.            Concomitant medication of the patient also included unspecified blood pressure pills, unspecified vitamin and tumeric.  No treatment information was provided by the reporter.  In September 2021, the patient underwent cardiac stent (which was postponed from March 2021) and change in status for this condition was mentioned as improvement.  On 26-Nov-2021, the patient received the booster dose of Moderna COVID-19 vaccine at a dose of 0.25 mL (Lot number: 013F21A). After receiving the booster dose, now the patient was getting iron shots for kidney at a frequency of every other week (last got 2 weeks ago, i.e., 01-Apr-2022).
Vomiting and diarrhea, decreased po intake, no fever. Evaluated in ED on 8/28/2010, dx'd with intussusception which required surgical reduction and incidental appendectomy and repair of umbilical hernia.
Fever; chills; nausea; sweating; SOB; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 17-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jun2021 17:30 (Batch/Lot number: unknown) at the age of 17 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Product: COVID 19, Lot unknown: True, Lot unknown reason: Unable to locate or read the details, Administration date: 17May2021, Administration time: 05:30 PM, Dose number: 1, Vaccine location: Left arm), administration date: 17May2021, when the patient was 17 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 15Jun2021 20:00, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 15Jun2021 20:00, outcome "not recovered", described as "chills"; NAUSEA (non-serious) with onset 15Jun2021 20:00, outcome "not recovered", described as "nausea"; HYPERHIDROSIS (non-serious) with onset 15Jun2021 20:00, outcome "not recovered", described as "sweating"; DYSPNOEA (non-serious) with onset 15Jun2021 20:00, outcome "not recovered", described as "SOB". Therapeutic measures were not taken as a result of pyrexia, chills, nausea, hyperhidrosis, dyspnoea.  Additional information: The patient did not receive any other vaccine in four weeks of covid-19 vaccine. The patient received other medications (unspecified) within two weeks of covid vaccine. The patient was neither diagnosed with covid prior vaccination, nor been tested for covid post vaccination. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
10/10/2011 1:45 PM ED provider note impression was allergic reaction - flu vaccine. Pt was treated with CIPRO MEDROL and BENADRYL IV, 1 L normal saline, advised to f/u with pcp for further eval of allergic reaction, stop taking flu shots. TC to pt. Reports that she is feeling well today. All sx reported 10/7/11 have completely resolved. Says that when she arrived 10/7/11 had also developed "the shakes" and was vomiting. Pt advised to f/u with, MD. Pt says she will f/u with provider at next ofv, will call sooner with any further questions or concerns. 10/10/2011 9:39 AM Addendum shows pt arrived at ED approx 5:05pm. 10/11/2011 2:21 PM Addendum TC from pt. Concerned that she is having reaction to flu shot given today around 1pm; EMR shows high dose flu vaccine given 10/7/11. About 10 min before phone call, approx 4:20pm, pt began having increasing heart rate, increased rate of breathing, "just doesn't feel right". Feels like sx are continuing to get worse. Throat feels a little tight and had begun to have slight cough. Slightly dizzy. Denies any itching or rash. Pt has had flu vaccine in the past without any problems, but this is first time receiving high dose flu vaccine. Strongly advised pt to go to ED immediately. Pt is agreeable, does not want to call ambulance, says her husband can drive her to ED, thinks she can get there in about 15 min. Advised pt if she cannot leave immediately, should call 911; sx have worsened significantly in 10min period of time. Pt agreeable.
itchy left eye beginning one hour after vaccination chills the day after vaccination mild cough the day after vaccination extreme fatigue for 36 hours swollen puffy left eye the day after vaccination, still currently experiencing more that 40hrs after vaccination
Case number PHEH2014US024972, is an initial spontaneous report from a nurse received on 09 DEC 2014. This report refers to a 51 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 145701) intramuscularly at a dose of 0.5 ml on 04 NOV 2014. The  nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 OCT 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration (incorrect storage of drug).
According to the patient, the rash erupted yesterday morning but thinks that it is spreading. This morning patient noted small lesion in right inner canthus and on eyelid margin. Patient was treated with Valtrex 1g TID x 7 days.
Develops rash at injection site. Erythema with small ~ 2 cm area vesicular appearing lesions.
4 minutes after receiving the first Pfizer vaccine shot, I felt a wave of tingling heat pass down through my body. My only pain the first day or so was a sore arm and shoulder. Within 2 days, I noticed increasing joint pain, foggy brain, and mild headaches. I also noticed a circular rash on my vaccinated arm, not at the injection site. Symptoms increased. By day 6 the joint pain was unbearable. I was treated with doxycline for potential Lyme, though I tested negative. I also took Ibuprofren for the pain for a few days. Since then, the symptoms have continually increased, and have restricted my activities. After the first 2 weeks, I could still "loosen up" all the joints, which popped loudly - even toes and fingers, but especially ankles, knees, hips, shoulders and upper spine and neck. Then followed a month of more constant pain, and numbness and tingling in my right hand and across upper back. Headaches and upper back pain kept increasing. Sleep affected, with joint pain beginning each afternoon 4-5 p.m., climaxing around 3-4 a.m. 5/27, 2 months after the Pfizer vaccine shot, the right side of my head suddenly went numb. Vision and hearing impaired in the right side also. At the periphery of the numbness, intense itching, that slowly spread from the epicenter of the numbness. A drooping feeling in the right cheek, jaw pain. Nausea. Numbness slowly abated after 2 hours. By the next morning, the right side of my face itched, one small spot at a time. Itching remains in spots all over my body, 2 days later. 7/18 - symptoms are still increasing in number and strength- numbness on the tip of my tongue and lower lip. Jaw pain and metallic taste in my mouth, extreme neck/shoulder pain, foggy brain, internal tingling and electrical-feeling vibration in muscles, heart palpitations, high blood pressure, popping joints, weakness, shortness of breath.  These sensations diminish in the morning, then increase as each day goes on, and are very distracting and painful by each evening. I am unable to work a full day, or exercise as I used to before the vaccine.
I have chill first then body ache but its mild; I have chill first then body ache but its mild; This is a spontaneous report from a contactable healthcare professional (patient). This 38-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 15May2021 at 10:15 (at the age of 38-years-old) as a single dose for COVID-19 immunization. Medical history included allergies to certain type of antibiotic medicines. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included metronidazole from an unknown date for an unknown indication. The patient previously received dose 1 of BNT162B2 (lot number EW0164) on 24Apr2021 at 10:15 as a single dose in the left arm for COVID-19 immunization. On 16May2021 at 13:00 the patient had chill first then body ache but it was mild. The patient did not receive any treatment for the events. The outcomes of chill and body ache were recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
I have always had very regular me trial cycles, every 26 days. After receiving the vaccine, I did not have a cycle in May. I had one in early June, beginning on the 7th. Then I had no cycle at all until August 23rd. I have no signs or symptoms of early menopause and no family history of menopause. I was diagnosed with cysts on both ovaries in June, again, with no family history or personal history of this issue. I feel there may be a possible link to the vaccination I received.
Extreme dizziness  Diarrhea  Dry heaves Tingling in arms and legs Extremely weak Chills and hot  Husband cared for me.   Spoke to nurse at my doctor?s office.   Water. Eventually bland food.   Condition improving.  She told me to go to ER if extreme dizziness recurs.
This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (mistakenly given a full 0.5 mL dose instead of a half dose) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (mistakenly given a full 0.5 mL dose instead of a half dose). At the time of the report, ACCIDENTAL OVERDOSE (mistakenly given a full 0.5 mL dose instead of a half dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient is not immunocompromised. No concomitant medication were provided. No treatment details were provided. Reporter did not allow further contact.
Presented to ER with subsequent admission two days after receiving second dose of COVID 19 vaccine with Lactic Acidosis/Sepsis.  She was hospitalized for 4 days
Sometime after the vaccination, the pt developed a raised erythematous reaction at the site of the JE-VAX injection.
Swelling, redness, itchiness, warm to touch day following ZOSTAVAX. No rxn at flu vaccine site. Improvement 12/22 - 3 days following.
Pt developed fever of 102-103 and an injection site reaction characterized by a large knot, redness and warmth. Pt favored left leg while walking. Reportedly, pt recovered from this experience. As of 2/14/00, no further info was available. This case is closed.
11/20/22 presents to ED for "altered mental status". PMHx of "HFpEF,  ETOH abuse, mood disorder, COPD, CVA, HTN and thyroid disorder"
joint pain; Chills; body aches; This is a spontaneous report from a contactable other hcp.  A 28-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/lot number: EK5730, intramuscular in the right arm,  from 06Jan2021 16:15 to 06Jan2021 16:15 at a single dose for covid-19 immunization. The patient medical history was not reported. Historical vaccine included BNT162B2 on 17Dec2020. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. On 07Jan2021 12:00, the patient experienced joint pain, chills and body aches. The outcome of events was recovering. No treatment was received due to events.  No follow-up attempts possible. No further information expected. Information on the batch number has been obtained.
Season received the Pfizer-BioNTech COVID 19 vaccine today at 8:30 and scheduled for 30 minute wait time because of prior history of anaphylaxis (non-vaccine).  Within a few minutes she developed light-headedness and dizziness, these symptoms continued to worsen so she notified our nurse who was observing post-vaccine patients.  She was promptly wheeled to our anaphylaxis room at 8:50 and placed in semi-Trendelenburg position. In addition to light-headedness and dizziness. she reported mild neck tightness and throat fullness.  She had facial flushing and conjunctival injection with some tearing.  She was monitored for Vital Signs and Oxygen Saturation.  Within 20 minutes her symptoms progressed to chest heaviness, increased effort to take a breath and shortness of breath.  She was mildly tachycardic with HR 96, though did not become hypotensive, B/P was 140/92.  She had no gastrointestinal symptoms.  She was anxious and "did not feel right", but did not report "impending doom". At 9:05 Epinephrine 1:1000, 0.3mL was administered IM, upper-outer thigh.  Symptoms began improving within 8 to 10 minutes and were mostly gone by 9:20. At 9:17 she was given Diphenhydramine Solution 25mg, Famotidine 20mg, Prednisone 20mg.   Her vital signs and Oxygen Saturation remained stable. (see flow sheet) Patient was monitored by an RN for 2 hours in our anaphylaxis room, on monitors, full crash cart present.
headaches; shoulder pain; feeling lousy; This case was reported by a pharmacist via call center representative and described the occurrence of headache in an unknown number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, shoulder pain and feeling bad. On an unknown date, the outcome of the headache, shoulder pain and feeling bad were unknown.   It was unknown if the reporter considered the headache, shoulder pain and feeling bad to be related to Shingrix.  Additional details were provided as follows: This case was reported by the reporter on behalf of for his neighborhood. The patients had been complaining about bad headaches, shoulder pain and felt lousy following Shingrix administration. They were really laid up. The reporter did not consent to follow-up.
Hospitalization with COVID-19 following COVID-19 vaccination. Vaccinated with Moderna COVID-19 vaccination on 2/3/2021 and 3/4/2021.
This spontaneous report was received from a Registered Nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, (lot # L004014, expiration date 04-MAR-2017), (lot # L007560, expiration date 15-JUN-2017) and (lot # L011846, expiration date 16-JUN-2017), doses, routes and anatomical locations were not provided. No concomitant medications were reported. No adverse effects reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Rash on right buttock, 1" from injection site noted 08/18, persists. Lethargic, no fever until 08/20. While being fed through g-tube, seized for 3 minutes. She was taken to ER where fever was 103.5. No further seizing. When she was release 5 hours later, her temperature was still fluctuating between 104 to 105 on Tylenol/Motrin. No fever since 08/22.
Swelling, redness and pruritus.  Marked induration/erythema entire left upper arm.
Pt call hospital call center on 5/26/21  c/o Shortness of breath, rapid heartbeat and weakness started 2 days ago. Patient stated received covid vaccine 2nd dose 5/22/2021 which she received at outside pharmacy. Pt advised to go to ED but she declined. ED education were reiterated to patient.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 15-MAY-2013, the patient was inoculated with the ZOSTAVAX for its intended purpose: the prevention of shingles (dose, route, and lot # not provided). The patient did not have a shingles outbreak until 21-OCT-2016, in addition to chronic pain, rash and lesions to various parts of 'his' (patient is a female) body. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, the patient suffered permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX. Shingles outbreak was considered to be disabling. Additional information has been requested.