chrisvoncsefalvay/vaers-outcomes huggingface dataset:
started feeling very ill/very sick; could not eat anything and was only able to swallow water; freezing alternating with feeling very hot; most of my arm was red and painful to touch; most of my arm was red and painful to touch; Nausea; body ache; very tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (started feeling very ill/very sick), DYSPHAGIA (could not eat anything and was only able to swallow water), FEELING OF BODY TEMPERATURE CHANGE (freezing alternating with feeling very hot), PAIN IN EXTREMITY (most of my arm was red and painful to touch) and ERYTHEMA (most of my arm was red and painful to touch) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced MALAISE (started feeling very ill/very sick), DYSPHAGIA (could not eat anything and was only able to swallow water), FEELING OF BODY TEMPERATURE CHANGE (freezing alternating with feeling very hot), PAIN IN EXTREMITY (most of my arm was red and painful to touch), ERYTHEMA (most of my arm was red and painful to touch), NAUSEA (Nausea), MYALGIA (body ache) and FATIGUE (very tired). At the time of the report, MALAISE (started feeling very ill/very sick), NAUSEA (Nausea) and FATIGUE (very tired) had not resolved and DYSPHAGIA (could not eat anything and was only able to swallow water), FEELING OF BODY TEMPERATURE CHANGE (freezing alternating with feeling very hot), PAIN IN EXTREMITY (most of my arm was red and painful to touch), ERYTHEMA (most of my arm was red and painful to touch) and MYALGIA (body ache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Dec-2020, SARS-CoV-2 test: (Positive) She did not have a bad case and recovered from it..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medications were reported.
Extreme arm pain beyond normal muscle soreness that felt like an open cut more than muscle pain. Strong chills that last 4 hours through the night and unable to get warm. Feverish for 8 hours. Migraine for 14 hours with sensitivity to light and sound.
This case was considered medically important (OMIC). Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a male pt who developed autism. The pt received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose. Additional suspect medication included Hib Titer vaccine (haemophilus b conjugate vaccine (diphtheria crm197 protein conjugate) injection). Concomitant medication were not reported. A mother reported that her son is autistic and has declined further details.
It was reported to this writer that immediately following the administration of the vaccine, the patient reported to the vaccinator that he was feeling dizzy. He did state that he had not eaten prior to the appointment. It was observed that the patient had 3 brief syncopal episodes. EMS was on the scene to assess patient. The vital signs that EMS obtained were WNL. Patient declined water and juice. Patient was free to leave following assessment by EMS.
TDAP GIVEN @ APPROXIMATELY 11:30. BEGAN ITCHING WITH FINE RED RAISED RASH BEGINNING ON NECK. AND SPREADING TO CHEST, BACK, THEN ARMS AND LEGS AND FACE OVER 24 HOUR PERIOD
Headache chill, face numb, face swollen, diarrhea, fatigue Narrative:
Neurological symptoms: weakness/tired feeling in arms and legs, tiredness in jaw muscles when chewing, stiffness in  facial muscles, nerve pain in hands and in legs, sluggish tongue and resulting biting of tongue, brief period of numbness in upper lip and nose.
sore arm from first vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 16Mar2021 (Lot number: EP7534) at the age of 82 years 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: PAIN IN EXTREMITY (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "sore arm from first vaccine". Therapeutic measures were taken as a result of pain in extremity.  No follow-up attempts are possible. No further information is expected.
Itchy Injection Site; Red Injection Site Size of a Quarter; Pain Injection Site; Burning Injection Site; Swollen Injection Site; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site Size of a Quarter), VACCINATION SITE PAIN (Pain Injection Site), VACCINATION SITE PAIN (Burning Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history reported).    On 25-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site Size of a Quarter), VACCINATION SITE PAIN (Pain Injection Site), VACCINATION SITE PAIN (Burning Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site), HEADACHE (Headache) and CHILLS (Chills). On 27-Apr-2021, HEADACHE (Headache) and CHILLS (Chills) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site Size of a Quarter), VACCINATION SITE PAIN (Pain Injection Site), VACCINATION SITE PAIN (Burning Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site) outcome was unknown.            No concomitant medications were provided. No treatment drugs were reported. She also updated that on 06April2021 she delivered a healthy Boy (8 Lbs. & 4 Oz) and is Breastfeeding.   This case was linked to MOD-2021-095716 (Parent-Child Link). This case was linked to MOD-2021-060886 (Patient Link).   See case MOD-2021-095716 for details regarding the child case.
This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 74-year-old, elderly patient of an unspecified gender. It was report that, the FLUAD TIV vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 30-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250802, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805527 was crossed linked to original case 201804863 due to same reporter.
This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on 06Nov2017 at single dose for pneumonia. The patient's medical history and concomitant medications were not reported. The patient had swelling that was the size of a baseball, at the site on unspecified date. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
Postherpetic neuralgia; Shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not reported. In or around 11-MAY-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, injection anatomical location or route of administration were not provided) as routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On approximately 13-MAY-2015 (reported as "2 days after vaccination"), the patient suffered a severe rash characterized by blistering along with pain, redness and swelling across the left breast and back. She was diagnosed with shingles and postherpetic neuralgia. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), her symptoms had resulted in physical limitations not present prior to vaccination. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of vaccination, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, 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. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The herpes zoster and postherpetic neuralgia were considered disabling events.
Patient did not have any adverse events. The immunization was given outside of suggested age range. Patient was 17 years and 8 months at time of immunization.
redness and swelling around the injection site. Redness was the size of a gold ball. Swelling - moderate. Some itching as well - mild Noticed above around 5-6 days after the vaccination.  Went away about 24-36hrs after i first noticed it
Headache, Myalgia, CHANGE IN VISION, RIGHT ARM SORENESS Narrative:
Pt developed redness over mid-thing day after administration. 10x10cm area on leg became stiff, red, warm, seemed to move after 3 days.
On 4/16, I was unable to move my muscles weren?t working. I was in a lot of pain that over the counter meds couldn?t help. I had severe migraines. For 4/17, I have shortness of breath and slight chest pain. My voice is going in and out I?m losing it.
Patient received J&J on 4/13/21. Found to be COVID positive on 1/6/22. Presented to our ER on 1/25/22. Was previously at another hospital from 1/6-1/17/22 due to acute pulmonary edema secondary to having missed hemodialysis days with COVID pneumonia superimposed bacterial pneumonia. SHe was then sent 1/17/22. Facility was not set up for the patient so she came to our ER on 1/25/22.  The patient is on home O2 at 6 L of oxygen.  When she arrived  here, she was a little bit confused. She has now completed a course  of oral corticosteroids for her COVID infection.  When I saw the patient she  does complain of still having a cough with occasional yellowish sputum.  She  is quite awake and alert and oriented x3 almost.  She was able to tell me her  name, where she was, she was only off by a year, since she told me it was  2021. Since she received COVID19 medications at other hospital, she got vit D and vitamin C at our hospital. Discharged on 1/29/22
flu; Initial information received on 23-Nov-2020 regarding an unsolicited valid non-serious case from a consumer via Social media.  This case involves an Adult female patient who experienced flu (influenza), while she received INFLUENZA VACCINE [INFLUENZA VACCINE].  Medical history, medical treatment, vaccination and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, after started vaccine, the patient's relative reported that the patient was sickest ever saw when she got the flu (influenza), a week after she got the flu shot.  No laboratory data was provided.  Final diagnosis was influenza.   It was not reported if the patient received a corrective treatment.  The outcome was reported as Unknown for flu.
This spontaneous report as received from a healthcare worker, certified medical assistant (C.M.A) refers to a patient of unknown age and gender. In approximately November 2011 reported as about 2 years ago the patient was vaccinated with the first dose of GARDASIL, injection (strength, dose, lot number and expiration date not provided). In approximately November 2012 reported as about 1 year ago the patient was vaccinated with the second dose of GARDASIL injection (strength, dose, lot number and expiration date not provided). On 15-NOV-2013 the patient came to office to receive the 3rd dose of GARDASIL. No  adverse effect was reported. Additional information has been requested.
High blood pressure; Dizziness; Fatigue; Chills; A spontaneous report was received from a healthcare professional concerning a 80 years old, male patient who experienced fatigue/PT: fatigue, chills/PT: chills, dizziness/PT: dizziness and high blood pressure/PT: hypertension.   The patient's medical history included COVID-19 since an unknown date in Jul 2020 and double pneumonia since an unknown date.  Products known to have been used by the patient, within two weeks prior to the event, included Allopurinol 300 mg, Levothyroxine 88 mg, Amlodipine 10 mg, Potassium 99 mg, Vitamin B12 250 mg, Zinc 50 mg, Vitamin C 500 mg, Tamsulosin Hel .4 mg and Finasteride 5 mg all since an unknown date for an unknown indication.  On 07 Jan 2021, prior to the onset of the symptoms, the patient received their first/second (not specified) of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.    The patient experienced fatigue, chills, dizziness as well as high blood pressure all since 07 Jan 2021.  Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events fatigue, chills, dizziness as well as high blood pressure were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
I had a light case of the COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I had a light case of the COVID) in an elderly female patient 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 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 COVID-19 (I had a light case of the COVID). At the time of the report, COVID-19 (I had a light case of the COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 2400 (High) 2400.         No Concomitant product use was reported.  The patient had two Moderna shots and then they had a light case of the COVID. When the patient cheeked their antibodies checked, they were 2400. The patient wanted to check when the antibodies had to get down to before the booster shot.  No treatment information was provided.  Company comment This is a regulatory case concerning a 76-year-old female patient with no medical history reported, who experienced the non- serious event of special interest of COVID-19. The event occurred approximately on an unknown date after the second dose of mRNA-1273 (vaccination dates unknown). The rechallenge was assessed as not applicable as the AEs occurred after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Although referred that COVID-19 is diagnosed being fully vaccinated, the information regarding the vaccination dates is incomplete so lack of efficacy situation cannot be properly assessed.; Sender's Comments: This is a regulatory case concerning a 76-year-old female patient with no medical history reported, who experienced the non- serious event of special interest of COVID-19. The event occurred approximately on an unknown date after the second dose of mRNA-1273 (vaccination dates unknown). The rechallenge was assessed as not applicable as the AEs occurred after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Although referred that COVID-19 is diagnosed being fully vaccinated, the information regarding the vaccination dates is incomplete so lack of efficacy situation cannot be properly assessed.
Every time I stood up, my heart rate went up into the 120's and I felt an intense pressure in my chest. I felt like I couldn't breathe. All day that day I has also experienced feeling hot but I never got a fever. The chest pressure last for a few hours every time I tried to get up. I had a couple of minor episodes over the next 2 days where my heart rate went into the 120's and I felt slightly short of breath but no pressure.
About 15 minutes after leaving the doctor and receiving her 18 month I believe MMR vaccine, my child began projectile vomiting, and her fever spiked to 102. Her fever did come down but stayed at 99-101 for the next 2 or so days, her doctor said this was normal, but the projectile vomiting & inconsolable crying for a half hour after, didn't seem normal. A friend gave me the link to report, after her second reaction last night, to another vaccine.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 13-FEB-2017, the patient was vaccinated with improperly stored dose of M-M-R II (lot# L049314 with expiration date 03-DEC-2017; site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
hypersensitivity reaction; hives; looked like contact dermatitis; This case was reported by a physician via call center representative and described the occurrence of hypersensitivity reaction in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 10 days after receiving Shingrix, the patient experienced hypersensitivity reaction, hives and contact dermatitis. The patient was treated with prednisone. On an unknown date, the outcome of the hypersensitivity reaction, hives and contact dermatitis were recovering/resolving.   It was unknown if the reporter considered the hypersensitivity reaction, hives and contact dermatitis to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reaction initially looked like contact dermatitis, then hives. It became widespread and severe so a biopsy was performed that showed it was a hypersensitivity reaction.  The patient took a couple courses of prednisone. It was at the time of reporting a couple months since he was first seen in the office and the reaction has improved a lot.  The emergency room visit required to the patient.      Lab Comments: Biopsy was performed on unknown date and that showed it was a hypersensitivity reaction
Sunday after Saturday night vaccination I woke up with Headache, fever was 101.8, chills ,muscle aches, very tired- spent day on couch sleeping-next day Monday I still have slight fever 98.9 but am feeling better.  NOTE : Sunday at around 5;00 I had to take Excedrin tension headache 1 tab  This got rid of my headache !
Patient has history of fainting with needles. Patient started to feel lightheaded then fainted about 5 minutes after receiving the vaccine.
Information has been received from a doctor of osteopathy concerning a 60 day old male patient who on an unspecified date was orally vaccinated with 2 mL of the first dose of ROTATEQ (Lot # and expiration not reported). On an unspecified date the patient had projectile vomit. Patient did not seek medical attention. No treatment was given for this adverse event. On an unspecified date the patient recovered. Follow up information was received from the doctor of osteopathy who reported that he recommended a consult with a gastrointestinal (GI) specialist for the patient and ordered a liver function test and rotavirus test but the patient did not follow up with the GI specialist and did not have the tests performed. Additional information has been requested.
3in area of pink with diffuse border, very mild swelling at site of Kinrix injection: dx-> Localized Rxn LA
Information has been received from a licensed practical nurse concerning a 41 year old male. The pt was potential exposed to Hep B during surgery and was vaccinated with Hep B. The pt reported no adverse effects following the first vaccination. In August of 1998 shortly after the second vaccination, the pt telephoned the medical center and reported that he was feeling sick, he experienced dizziness, chest pain, numbness in his left arm and the left side of his face and terrible arm sensation. He was sent to the ER but was not admitted. The pt felt the symptoms were related to hep b vaccine. Follow up information received from a nurse on 4/5/99 noted that the pt telephoned the medical center and reported that his chest pain had persisted and also he experienced ringing in his ears. The pt indicated that the hospital believed there was an association between his symptoms and Hep b vaccine. As cited by the pt,
Chills  at bed time. Restless sleep and  woke up with back pain and body aches ( like the flu).  No fever presented. I took 2. Tylenol but had no effect. Finally at 12pm I had 1  500mg  Anaprox
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 25-JUN-2013, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J00495 and expiry date: 14-APR-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.