chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I took first dose of COVID- 19 (Pfizer) September 9, 2021 @ 3:30pm.  Around 4:00pm to 4:30pm I started having an allergic reaction. With-in a hour span I started itching on my thighs, arms, chest, back, face, ears and eyes. I called the health care professional that gave me the vaccination and explained that I was severely itching. She advised me to go back to clinic and get a steroid injection to stop the allergic reaction.  I got the steroid injection around 5:10pm.  My symptoms started to slowly stop after getting the steroid injection but it took a couple of hours for all the itching to completely stop.  On October 4, 2021 around 3:45pm I went to my doctors appointment with my primary care physician and explained that I had an allergic reaction to the first vaccination and he advised me to report this occurs to the CDC.
Patient became lethargic, extremely tired, unable to care well for self.  Patient had no appetite, refused most food and spent many hours simply sitting in her chair.  She felt that she was having a heart attack and called 911 using her emergency response button on 2/21/2021.  Doctors indicated that the patient's life was in serious danger, but because of age they were hesitant to try to remove the clot pressing on her heart.  She was only allowed to go back home because we utilized Hospice.  When asked about her life expectancy, we were told she could die any minute or might live a few more months, but that she was not expected to live much longer.  SHE WAS IN GOOD HEALTH PRIOR TO THE IMMUNIZATION!
Information has been received from a pharmacist concerning a pt who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647660/0945N). Subsequently the pt developed redness, swelling and pain at and around the injection site. The pt was seen at their local ER and was released. Unspecified medical attention was sought. There was no product quality complaint involved.  The reported indicated that several pt's (WAES # 0403USA00248) had similar experiences following exposure to pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
I previously had cervical fusion on 10/23/2020 and have been healing  since then. I received the shot on a Friday Morning. I woke about 11-12pm with my surgical sight burning and hot pain. I took my pain medication but it didn't touch it. After about 3-4 hours in which I took another pain pill, a muscle relaxant and a sleep pill, the pain and burning subsided. The site was then sore along with my left arm where I received the site. Today 4/13/2021 is the first day I feel good.
2 day progressive erythema, induration and warmth with axillary nodal tenderness.
Itching all over my body right after I received the first vaccine. Now I am itching on a regular basis.
Fever; Chills; Headache; Body ache; This is a spontaneous report from contactable physician (patient) via Pfizer Sales Representative.   This 27-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on unknown date for COVID-19 immunization. No relevant medical history and concomitant medications were provided. On unknown date, the patient developed fever, chills, headache and body ache. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Case number PHEH2016US023389 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 48 year old patient whose gender was not specified. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in the left arm on 01 Dec 2015. It was reported that the patient received FLUVIRIN that had temperature excursion. The patient did not experience any adverse events following vaccination.
Numbness of left arm going into left side of face. Since resolved May of 2022 had blood clots and heart swelling, and multiple blood transusions at Hospital.
Full Body aches, headache, extreme body chills, and extremely tired.  Slept a great deal .  Lasted 24 hours.
dont feel good; This is a spontaneous report received from a contactable reporter(s) (Consumer), Program ID:. The reporter is the patient. A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "dont feel good". Additional information: It was reported that the patient dont feel good and she was asking how far apart she should take the COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A report was received from a health care professional on 12/8/03 concerning an unknown number of children of unspecified sex and less than 4 years of age who inadvertently received Fluvirin on an unknown date. On an unknown date, an unspecified number of children less than 4 years of age inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
lethargy, muscle weakness, inc somnolence, ataxia;Annual follow-up provides no additional data.
red blotches on both of my feet/ blotches on my toes/ blotches up my heel/ feet have red spots on them/ my feet look terrible; feet are itching; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red blotches on both of my feet/ blotches on my toes/ blotches up my heel/ feet have red spots on them/ my feet look terrible) and PRURITUS (feet are itching) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (red blotches on both of my feet/ blotches on my toes/ blotches up my heel/ feet have red spots on them/ my feet look terrible) and PRURITUS (feet are itching). At the time of the report, RASH MACULAR (red blotches on both of my feet/ blotches on my toes/ blotches up my heel/ feet have red spots on them/ my feet look terrible) and PRURITUS (feet are itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.
Patient received dose 1 of the pediatric Pfizer COVID vaccine (lot FK5127) in her left deltoid at approximately 1100. At 1142, patient reported tingling from her left shoulder down her arm. PHN and RN responded. PHN assessed neurologic function: grip strength weak on left side, responsive to soft stimuli bilaterally on upper extremities. Patient's mother reported the patient had no medical history, took no medications, and had allergies to seasonal allergens and mosquito bites. At 1142, vital signs: O2 100%, pulse 100, blood pressure 128/88, respirations 20. PHN offered Benadryl, patient's mother consented, patient took Benadryl 25mg oral solution at 1155. Patient ate crackers and drank water provided by site. PHN educated on remaining for 30min monitoring from time of report of symptoms, to follow up with provider, and ER precautions. At 1200, vital signs: O2 99%, pulse 100, respirations 18, blood pressure 118/76. Patient reported symptoms improving, less tingling, left grip strength still weak. At 1215, vital signs: O2 99%, pulse 100, respirations 20, blood pressure 124/78. Patient reported symptoms continuing to improve, left grip strength remained weak. At 1218, patient left walking with steady gait.
A rash on the inner thighs/A rash on the right arm; Soreness at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of RASH (A rash on the inner thighs/A rash on the right arm) and INJECTION SITE PAIN (Soreness at the site of injection) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced RASH (A rash on the inner thighs/A rash on the right arm) and INJECTION SITE PAIN (Soreness at the site of injection). At the time of the report, RASH (A rash on the inner thighs/A rash on the right arm) and INJECTION SITE PAIN (Soreness at the site of injection) had not resolved. Not Provided          Action taken with mRNA-1273 in response to the events was not Applicable.  No concomitant and treatment medication were provided
Rebound symptoms and positive COVID test 3 days after finishing treatment; Rebound symptoms and positive COVID test 3 days after finishing treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 21May2022 as dose 4 (booster), single (Lot number: Fk9896) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster) single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Rebound symptoms and positive COVID test 3 days after finishing treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (17Jul2022) Positive, notes: Rebound symptoms and positive COVID test 3 days after finishing treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient did not receive any other medication in 2 weeks.  No follow up attempts are possible. No further information is expected.
I had to sleep all day the day after the injection.   I think more should be said that people may have to plan on not being able to go to work the day after.
01/30/22 presents to EC ED for "Breathing Problem". PMHx of "acid reflux, prediabetes, gout, hypertension"
This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 15-month-old male patient who received BOOSTRIX (batch number 472S7, expiry date 3rd April 2016). On 17 November 2014, the patient received BOOSTRIX .5 ml. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. Additional information received: LPN reports that 15 month-old male inadvertently received BOOSTRIX instead of INFANRIX for 4th DTaP dose. Maladministration was human error of new employee to peds. Maladministration AE. This case is one of the 2 cases reported by the same reporter for the same vaccine.
Left upper arm with edema/ erythema over 10 x 10cm area left upper arm. Mild tenderness. Afebrile.
Four days following administration of the patient's second dose of Shingrix, we were made aware that the vaccine was deemed "not viable" due to a temperature excursion that occurred earlier in the week.  The patient doesn't recall experiencing any adverse effects immediately following vaccination.  The patient reports experiencing diarrhea from April 18-22, and April 24th.  She attributes this to a  keto diet that she has recently adopted.  Recently she has been experiencing sinus infection symptoms, which she attributes to allergies from pollen.
discharge of blood from penis; heart wanted to race or skip a beat/experienced arrhythmia and rapid heart beating; felt fatigued and felt like he was ready to go to sleep; This spontaneous case was reported by a consumer and describes the occurrence of PENILE HAEMORRHAGE (discharge of blood from penis) and ARRHYTHMIA (heart wanted to race or skip a beat/experienced arrhythmia and rapid heart beating) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arrhythmia and Cardiac ablation.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PENILE HAEMORRHAGE (discharge of blood from penis) (seriousness criterion medically significant), ARRHYTHMIA (heart wanted to race or skip a beat/experienced arrhythmia and rapid heart beating) (seriousness criterion medically significant) and FATIGUE (felt fatigued and felt like he was ready to go to sleep). On 12-Mar-2021, FATIGUE (felt fatigued and felt like he was ready to go to sleep) had resolved. At the time of the report, PENILE HAEMORRHAGE (discharge of blood from penis) outcome was unknown and ARRHYTHMIA (heart wanted to race or skip a beat/experienced arrhythmia and rapid heart beating) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
As I wiped client's left arm off with alcohol, she started to lean to the right and said that she was going to pass out. I stopped what I was doing and supported her in a seated position in the chair and called for assistance. The cot was immediately brought into the workup room and fellow Imms Nurse helped me stand-by assist her to lie down on the cot. The client was able to support herself the entire time she was standing. We elevated her feet. She was able to hold conversation and never lost consciousness. While she was lying down we discussed some incidents that she has had in the past. She states that she "had seizures all through college but it's been a long time". I asked when she last remembers having a seizure and she said that she had one as recently as one month ago "after doing a cardio workout". She said that she lost consciousness with her arms and legs "flailing" at the gym, "but I could hear everybody talking to me the whole time". There apparently was a nurse who witnessed this event and told her to see a cardiologist because her "pulse would stop for 5-10 seconds then speed up real fast", with this cycle repeating. She states that she did see a cardiologist and wore a Holter Monitor last week and that "they couldn't find anything...no pulse issues on the monitor". Cardiology said that she doesn't need follow-up with them. I inquired about the seizures during her college years and she said that she was taken to the ER each time but they "couldn't figure out why", just that she'd had a seizure and to come back if it happened again. She continued explaining that she can "always taste when this is going to happen...like there's a metal taste in my mouth and I know its coming". I asked if she had that taste now and she stated that she had it right as I wiped her arm off and it lasted until we gave her juice (so for about 10 minutes during today's visit). I administered her TWINRIX injection while she was lying on the cot. She remained talkative and even put her feet up on the counter of the workup room. She tolerated the shot without further incident and brought herself to a seated position on the cot within two minutes of getting the shot. After sitting there for about a minute she stood on her own and walked to the chair. I had her sit there for 2-3 minutes and checked her BP 100/60, pulse regular and strong at 88 bpm. She denied having the "metallic taste" in her mouth and stated that she was "OK to leave", but that she planned to sit in her car for about 10-15 minutes before driving home. She surmises that these episodes are brought on by stress and states that she's been diagnosed with seizures as well as vasovagal syndrome. She did not write any diagnoses nor history on her consent form today or previous consents from this year. She left in stable condition at 16:05.
Area erythema around injection site that measures 11cm x 8cm. No systemic symptoms.
8 hours after the injection I got a severe pain in my lower spine, not muscular but spinal then I got chills and began to shake, became very cold ( I usually run hot), I did not have a fever. My hands and feet then felt ice cold, almost as if they were immersed in an ice bucket.  I had my husband feel them and he said they were not cold at all, I realized at that pint that they felt cold because my hands and feet were numb.
Blood sugar rose from baseline of 120mg/dl to 216mg/dl one day after first dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood sugar rose from baseline of 120mg/dl to 216mg/dl one day after first dose of vaccine) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Asthma and Type 2 diabetes mellitus. Concomitant products included METFORMIN and GLIPIZIDE for Diabetes.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced BLOOD GLUCOSE INCREASED (Blood sugar rose from baseline of 120mg/dl to 216mg/dl one day after first dose of vaccine). At the time of the report, BLOOD GLUCOSE INCREASED (Blood sugar rose from baseline of 120mg/dl to 216mg/dl one day after first dose of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Warm transfer from customer service, customer service case number 00110071. Patient took first dose of the Moderna COVID-19 vaccine yesterday 11Mar2021 in left upper arm and today 12Mar2021 his blood sugar rose from base line of about 120mg/dl to 216mg/dl. He is a known type 2 diabetes mellitus patient with a well controlled blood sugar. His blood sugar is controlled with pills only. He does not use insulin. He wanted to know if we had any information from our clinical trials on a correlation between blood sugar and the moderna vaccine.
A full untouched 10 dose Moderna COVID-19 vaccine only having enough for four doses which were administered to four patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT PACKAGING QUANTITY ISSUE (A full untouched 10 dose Moderna COVID-19 vaccine only having enough for four doses which were administered to four patients) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced PRODUCT PACKAGING QUANTITY ISSUE (A full untouched 10 dose Moderna COVID-19 vaccine only having enough for four doses which were administered to four patients). On 26-Aug-2021, PRODUCT PACKAGING QUANTITY ISSUE (A full untouched 10 dose Moderna COVID-19 vaccine only having enough for four doses which were administered to four patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter stated that they were not sure of what exactly occurred as the facility was sent a sealed vial and only 4 doses were contained within it. There were no doses withdrawn from the vial at their pharmacy and therefore she do not believe that the patients received expired product.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: New event-product packaging issue added.
Systemic: Lymph Node Swelling-Medium, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: Knot at injection site. Left arm, middle pinky numb & loss of sensation for top knukle (inch from top knuckle to finger tip). Sensation has still not returned. Contemplating seeking medical attention.
fever; chills; malaise; This is a spontaneous report from a contactable consumer (patient, self-reported).  A 48-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 12Apr2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Apr2021, after second dose of BNT162b2 vaccine (week of 4/12/21), patient experienced fever, chills, malaise for 24 hours and symptoms resolved. Event took place after use of product. Outcome of the events was recovered on an unspecified date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
C/o left arm pain after injection. Denies numbness, SOA, dizzy. Patient has full ROM, equal grips, brisk cap refill. VSS. Patient states ok to return to class after being evaluated and monitored 30 min.
Received below vaccines about 1600 on 11/15/05, was on day 9/10 of Amoxicillin for sinusitis. Symptoms had resolved. 12 hours later, developed hives, low grade temp, and 1 loose stool. (Diffuse erythematous plaques with central white papule - face, trunk, and extremities). Treated with Benadryl. No wheezing/hypotension. Hives lasted 72 hours.
Reports two hours after vaccination began having arm pain which progressed to full body aches, muscle spasms, muscle pain/tenderness, fatigue the following day. Was seen in the ED on 8/29/21; received 2 L NS in ED, KCL 40 mEq PO x1, and plan was to continue NS with KCL supp however patient went home early due to impending storm. She continued to feel poorly. Followed up with PCP (me) with continued complaints; labs repeated, not improved, patient now complaining of rigidity; was sent back to ER for further management.
Approx 3 hrs post vax mom took pt to ER; c/o inc temp, seen by MD, ER temp 103.3 R; dx rxn to immun vs viral synd;