chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented with a one day history of arm soreness at the injection site of the vaccine. On exam, the pt had erythema and edema over the deltoid with a single hive near the injection site. The patient was given acetaminophen, ibuprofen, and diphenhydramine and her symptoms improved.
Patient hospitalized for COVID-19 on 5/16/2021 (COVID PCR test positive 5/16/2021), currently still hospitalized; received Pfizer COVID-19 vaccines on 4/5/21 and 4/27/21
This spontaneous report was received from a registered nurse, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and allergies were not reported. On 21-JUN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX, lot number M046004 with expiration date 18-NOV-2018, for prophylaxis (dose, frequency, route of administration, and anatomical location were not reported), which was reconstituted with properly stored STERILE DILUENT, lot number M044950 with expiration date 30-MAY-2019. No adverse events were reported.  The vaccine was exposed to a temperature of 6 to 14 degree Fahrenheit for 60 minutes; the digital data logger was involved. A previous temperature excursion was of 6 to 14 degree Fahrenheit for 180 minutes. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1706USA010264: US-009507513-1707USA000673.
experienced fever after first dose; This is a spontaneous report from Pfizer-sponsored program  CEP 159558. A male contactable consumer reported for himself who received that BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on 13APR2021 dose 1 single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication was not reported. Unknowingly patient had possible exposure to Covid 10Apr2021. On an unknown date after vaccination patient experienced fever. Outcome of the events was unknown.  Information regarding lot/batch number has been requested.
This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient. A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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 had no relevant medical history and no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 24Dec2022 to 30Dec2022. Then the patient had rebound symptoms on 31Dec2022 once she stopped Paxlovid. No treatment was received.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drugs BNT162B2 and BNT162b2, BNT162b2 omi ba.4-5 cannot be excluded. The case will be reassessed once new information is available.
Because of past allergic reactions in past, took a 25mg tablet of BENADRYL before dose 5. Received Flu vaccine along with Moderna dose 5 at the same time; Started feeling itchy and nauseous at 03:15; at 3:40 my lips and tongue started swelling and I started to have overwhelming chest pressure. Was already near pharmacy so I went back. I told the Pharmacist that I had an allergic reaction to dose 1. He sat with me and gave me a 4 ounce dose of BENADRYL. However, I forgot to mention that I'm allergic to red dye and my throat started closing. It was the cherry flavor and I'm allergic to red dye. I stayed 45 minutes for observation. I drank a lot of water per Pharmacist and took another BENADRYL 25mg, tablet. I started to feel better and went home; I had to take BENADRYL every 4 hours or I'd start feeling hot itchy again. I was afraid to sleep for too long. The next day on 09/17/2022 I started having a headache, diarrhea and congestion. I was able to stop taking BENADRYL on 09/18/2022.
pt recvd vax & pt's friend devel genital herpes & the reporter was concerned about a poss relationship to the vax;No further details were provided;
Approximately 3-4 hours post vax the pt felt warm and flush to the point of passing out, was nauseous and vomited (or almost vomited). As of 10/13/2000, the outcome of the events is unknown.
headache; hot spot inche below injection site; hot spot 1 inch below injection site; This case was reported by a consumer via call center representative and described the occurrence of headache in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced headache, skin warm and rash. On an unknown date, the outcome of the headache, skin warm and rash were recovered/resolved.   It was unknown if the reporter considered the headache, skin warm and rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported.  The patient enquired about the difference between the first and second dose of Shingrix. It was confirmed that there was no difference between the 2 doses. Patient pharmacy mistakenly thought that it was second dose and not the first. The patient had reaction that lasted for 4 days. The patient got headache first then about 24 hours later there was a hot spot 1 inch below the injection site. The patient would talk to physician about getting the second one.
Headache, Fever, ACHINESS; FLUSHED Narrative:  Other Relevant History:
RED RING AROUND THE SITE; WARM, PAIN ON SITE; ICTCHINESS; NO TROUBLE BREATHING OR ITCHY THROAT.
Extreme nausea; cyclic vomiting; Muscular cramps in feet, legs, torso; Combination ofsweats and chills; Renal failure; This spontaneous case was reported by a consumer and describes the occurrence of RENAL FAILURE (Renal failure), NAUSEA (Extreme nausea), CYCLIC VOMITING SYNDROME (cyclic vomiting), MUSCLE SPASMS (Muscular cramps in feet, legs, torso) and COLD SWEAT (Combination ofsweats and chills) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cannabinoid hyperemesis syndrome.   On 27-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 27-Aug-2021, the patient experienced RENAL FAILURE (Renal failure) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced NAUSEA (Extreme nausea) (seriousness criterion hospitalization), CYCLIC VOMITING SYNDROME (cyclic vomiting) (seriousness criterion hospitalization), MUSCLE SPASMS (Muscular cramps in feet, legs, torso) (seriousness criterion hospitalization) and COLD SWEAT (Combination ofsweats and chills) (seriousness criterion hospitalization). At the time of the report, RENAL FAILURE (Renal failure) was resolving and NAUSEA (Extreme nausea), CYCLIC VOMITING SYNDROME (cyclic vomiting), MUSCLE SPASMS (Muscular cramps in feet, legs, torso) and COLD SWEAT (Combination ofsweats and chills) outcome was unknown.            No concomitant medication details were reported. No treatment information was reported.  Company Comment:  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.; Sender'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.
Severe weakness of lower legs with pain and swelling, persisting by improved 3 months later and further evaluation include MRI pending.  Onset of persistent severe hoarseness.
MMR given at 12 mos and inadvertently repeated at 15 mos of age
redness; soreness; rash; I  also had severe bloating and gas for 3 days; I  also had/ gas for 3 days; This case was reported by a consumer via interactive digital media and described the occurrence of erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema, pain, rash, bloating and gas. On an unknown date, the outcome of the erythema, pain, rash, bloating and gas were recovered/resolved.   It was unknown if the reporter considered the erythema, pain, rash, bloating and gas to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The patient had received Shingrix and experienced redness, soreness, rash and also had severe bloating and gas for 3 days. The patient was fine at the time of reporting. The patient enquired if the symptoms were connected to Shingrix vaccination.
On 10/30, DTaP4 and HepA1 administered IM L thigh. Pt left clinic in good condition. On 11/1, parent/child RTC with L thigh cellulitis. Pt treated by same provider with course of Keflex.
got the flu from a flu shot; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case from a non-healthcare professional (patient's parent) via social media.  This case is linked to case 2020SA297294.  This case involves an adult female patient with an unknown age who got the flu from a flu shot (influenza), while she received vaccine Influenza Vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, reporter stated that daughter got the flu from a flu shot (influenza) (Unknown latency) following the administration of Influenza Vaccine.  Details of laboratory data were not reported.  Action taken was not applicable.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
per Spanish interpreter, pt had Pfizer vaccine, the 2nd dose on the 29th  foot swollen and has hand tingling sx started on  the  31rst, sx  still present  but improved  vaccine given at marlin stadium  lot number  ew0153 first vaccine on may 8th  no reaction
fever, headache, congestion, muscle pain, chills, back pain, and nausea.   600mg ibuprofen   have not resolved yet
I95.9 HYPOTENSION 11/5/2022 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE I95.9 HYPOTENSION 11/5/2022 PRESSURE ULCER OF SACRUM, UNSPECIFIED STAGE
Pinkish area of my face/Pink patches on face, hairline.; Hives on neck; This spontaneous case was reported by a nurse and describes the occurrence of SKIN DISCOLOURATION (Pinkish area of my face/Pink patches on face, hairline.) and URTICARIA (Hives on neck) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Perimenopause (they attribute a lot of things to hormonal changes.).   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced SKIN DISCOLOURATION (Pinkish area of my face/Pink patches on face, hairline.) and URTICARIA (Hives on neck). At the time of the report, SKIN DISCOLOURATION (Pinkish area of my face/Pink patches on face, hairline.) and URTICARIA (Hives on neck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications was reported. It was reported that events caused by immune system and vaccine and it was not specified caused by 2nd dose or not.   This case was linked to MOD-2022-516211 (Patient Link).
Headache; can't walk/he needs a walker; tired; lazy; hiccups; This is a spontaneous report from a contactable consumer (Reporter's dad). A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported, Expiry Date: Unknown), dose 1 via an unspecified route of administration, administered in Arm on an unspecified date as a DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included diabetes mellitus reported as Diabetes; he has Diabetes, hypertension; High Blood Pressure and he had Brain Stroke (Medical History) 3 years ago, cerebrovascular accident (Brain Stroke) all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No other Prior vaccinations (within 4 weeks). On an unspecified date, the patient experienced headache, can't walk/he need a walker, tired, lazy and hiccups. Reporter stated, I am reporting about my family member. He is my dad (patient) and he took (received) the (first dose) shot 10 day ago but I think he is having side effects from the shot and I don't know if that's normal. Reporter said, he (patient) had a headache, he can't walk, he can stand but he can't walk, so he needs a walker, hiccups and headache don't go away. He was tired, lazy. They didn't ask for any conditions and he either didn't say that he has Diabetes, High Blood Pressure and he had Brain Stroke (Medical History) 3 years ago. None of that was asked when he went to get the shot, so I am worried about him. Event start date was reported as, it was day after he took the shot like it was "10" (not clarified) days ago. Reporter stated anatomical site of vaccination as it was in his arm (Further not clarified). Reporter stated, I am not sure about that second shot. Reporter stated, "He only takes medications for Diabetes and High Blood Pressure, he only takes his "injection" (further not clarified) for his diabetes." Treatment received for the event reported as, no, he didn't take any medicine. Outcome of the headache was not recovered whereas, rest of the events were unknown.  Information on the Batch/Lot number has been requested.
Rash appeared on face, 1 hour, post vax. Was given on 7/29/00 and then spread over body. No itching, no fever, no hives. Rash stayed the same for 3 days.
patient states today that she has had muscle pain since receiving vaccine in august (has been 8 months). she was concerned because the pharmacist asked if "it hurt". patient flinched and bone was hit (which is normal) given patient's size.
15 minutes after injection, subject had weird taste in mouth, tongue got tingly, nauseated, BP increased 40 points.
Pt with LOC with jerky movements of bilateral arms and legs, eyes rolled upward. Regained consciousness in 5-6 seconds. Pt placed at bedrest and monitored for >1hr prior to discharge. No meds given.
I received 1st dose of Moderna vaccine in a left arm on April 21,2021. I have a previous bcg scar on the same arm. After getting Moderna 1 under bcg scar after 8 days I developed local reaction at Vaccine administration site without any associated symptoms with mild swelling at vaccine site separate from bcg scar. Scar is still present.
This is a previously health 8-month-old boy with a 2-week history of runny nose and cough without fever. Three days prior to admission he developed a fever which has been a T-max of 103. He was seen in the emergency department at his referring hospital two days prior to this admission at which point he was diagnosed with bilateral otitis media. Labs were not drawn at that time. He was started on azithromycin orally for which he had received two doses when he returned to the emergency department last night due to persistent fever and irritability. At that point his bulging fontanelle was noticed and he was empirically given a dose of IM ceftriaxone 100 mg hg. Note that a lumbar puncture was attempted and yielded only a few drops of apparently bloody CSF. It is unclear to me in talking with the lab whether this was actually received by the lab. A blood culture was obtained and that is pending. Finally a urine culture was obtained, but the lab also does not have this specimen. The patient was then transported by a team originating from that hospital. He had an 10 in place as both peripheral and central access were unsuccessful. 1/6/09-records received for DOS 11/22/08-12/29/08-DC DX: Streptococcus meningitis. Streptococcus Bacteremia.admitted with C/O two week history of rhinorrhea and cough and 3 day histoy of fever to 103. Bilateral otitis media 2 days prior to admission. Irritability. Bulging fontanelles.
Patient felt lightheaded, sweaty and nauseous. He vomited about 5 minutes after I gave him the vaccination. Had some chills  but felt better after 20 minutes.
I caught COVID-19 from a close friend. I had a very mild case but was prescribed PAXLOVID. After finishing the prescription, I caught COVID-19 again but it was a mild case again.
I had heart complication all day.  I went to urgent care, they said it is because of the vaccination and it would go away.  The next day it went away, then it came back.  I came back different.  My heart was beating really fast. I called 911, they took me to the ER.  They did chest x-ray, EKG, and Covid-19.  My EKG shown sinus rhyme tacha. They got me medication. They told me to follow up with a cardiologist.   I had to get back to the ER.  They did the same test.  My EVC came back as TVC.  I see the cardiologist tomorrow.  (Wants to know how to get the vaccination out of the body).
This spontaneous report was received from a nurse via company representative, referring to a currently 14 year old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. The patient did not have any drugs allergies. In approximately March 2016 (reported as "2 years ago"), when the patient was 12 year old, the patient was vaccinated with GARDASIL 9 for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported). On unspecified dates, the patient received unspecified doses of GARDASIL 9. On an unspecified date (reported as "on a later unspecified date"), the patient developed mononucleosis after receiving a dose of GARDASIL 9. On an unknown date, the patient was sick for 6 months (adverse event). The patient sought medical attention and received treatment. On an unknown date, a liver test was performed (results not provided). At the time of reporting, the outcome of mononucleosis and adverse event was recovered on an unknown date. Additionally, the causality assessment between mononucleosis and adverse event with GARDASIL 9 was not provided.
Patient received complete Pfizer COVID vaccination series with first dose received on 22 February 2021, second dose received on 19 March 2021, and booster received on 01 December 2021. Tested positive for COVID via home test which was confirmed with testing completed per the Emergency Department on 05 December 2021.
Heart Palpitations; rapid heart rate; irregular heart beat; dizziness;  After 2nd vaccine (Lot #010A21A - Modetma - experienced more & longer symptoms. In hospital-  discovered pulmonary embolism; treated for all & treatments still ongoing.
pt states she started to feel weird shortly after receiving vaccine.  She also reported tingling in lip.  We closely monitored. Checked bp  which was normal.  Lip tingling subsided shortly after showing.  Pt felt tired and "brain fog".  RPh sat w her for 15 minutes.  Symptoms subsided.
Information has been received from a physician concerning a parent of a pediatric patient (WAES# 0605USA05216) who was vaccinated with a dose of Varivax. Subsequently the parent developed herpes zoster while their child was experiencing breakthrough varicella. There was no product quality complaint involved. Additional information has been requested.
Pain at injection site one hour after vaccine,  bad headache, pain in arms and legs, 102 degree fever,  periodic stomach cramps.
first twenty four hours it's really painful. It diminishes after that; This case was reported by a consumer via media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and in first twenty four hours its really painful and it diminishes after that. In two or in less than six months the patient needs to get second shot.
no adverse effect; Incorrect product storage; This spontaneous report was received from a medical assistant and refers to currently 4 year old patient of unknown gender. The concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (dose, frequency and route were not reported) (lot # N029878, expiry date: 22-APR-2019) in the left arm for prophylaxis. The measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) vaccines were reconstituted with properly stored vials of sterile diluent. No adverse events were reported. No product quality complaint was involved.   The measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) underwent temperature excursion (stored at 15 degree Fahrenheit (°F) to 46°F) for 49 minutes. Digital data logger was involved. There was no previous temperature excursion reported.  This is one of several reports received from the same reporter.
Arm started itching, 6 days after the second dose.  Before arm had been slightly sore and tender.  It was warm to the touch.  An area about 4-5 inches in diameter was red below where the injection was.
Immediate Lethargy. Low Grade Fever 101 for Three Hours. Increased Tiredness. Fussiness. Protruding Tongue. Second day and still remaining symptoms: Fussiness. Protruding Tongue. Trouble Bearing Weight. Loss of cooing and vocalizing. Child was extremely vocal and interactive at 3 months. Tongue protruding and very little communication. Still maintaining eye contact, but definitely a difference.
Began with low grade night fevers 8/20- 8/24. Arthritic pain began 8/21 and continued through 8/23. Upper abdominal pain concentrated to right upper quadrant began 8/23 and continues. Responded to PCP office 8/24 for blood work and assessment.