chrisvoncsefalvay/vaers-outcomes huggingface dataset:
7 days after receipt of Varicella (second dose), MMR #2, DTaP #5, and IPV #4, patient developed fever (Max 102.5 Axillary) and approximately 10 discrete scattered, non-pruritic, maculopapular rash on neck, chest, trunk, belt-line, bilateral thighs, and right arm.  Mild headache and stomachache two days ago.  Good appetite.  Sleeping well.  No behavior changes.  No seizure-like activity.    Tx.  Motrin/Tylenol for fever. Avoid contact with individuals susceptible to varicella.
Moderna vaccine were inadvertently given past the vaccine beyonduse-date (i.e. past 30 days at fridge temperature) of 9/5/21; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine were inadvertently given past the vaccine beyonduse-date (i.e. past 30 days at fridge temperature) of 9/5/21) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine were inadvertently given past the vaccine beyonduse-date (i.e. past 30 days at fridge temperature) of 9/5/21). On 07-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine were inadvertently given past the vaccine beyonduse-date (i.e. past 30 days at fridge temperature) of 9/5/21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.   Treatment information was not provided.    This case was linked to MOD-2021-320876 (Patient Link).
After my shot in my arm (right arm) I had no adverse affects after the shot until the next morning my arm was very sore and the muscle was swollen. It was very tender to the touch. About 3:00 that afternoon I noticed that the area that was swollen was now covered in a bright red rash, and it was very tender. And it was approximately 2x2 and it spread over the next few hours until it about 4x4 and it was bright red. But it wasn't exactly on the spot where she stuck the needle in. It was about an inch over from the injection site. That was on Friday. On Saturday it was still there, and it spread about 2 inches more on Saturday. On Sunday it continued to spread to about 6x4. Yesterday the pain started going away and the swelling went down, and the redness went way down. Today the pain is about the same as yesterday, and the redness is almost gone and there's about 2 inches of the redness still.
Red; blotchy rash on back, front, neck, upper arms .  Itchy
Blacked out and passed out completely; Next morning, around 6:30am, I woke up feeling dizzy; Morning after second dose, my temperature was 99.3degF; Breast pain on my left side which has been there for a while after the second shot; Felt so dehydrated after the second shot; My head felt a little muddled; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Blacked out and passed out completely) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced FEELING ABNORMAL (My head felt a little muddled), BREAST PAIN (Breast pain on my left side which has been there for a while after the second shot) and DEHYDRATION (Felt so dehydrated after the second shot). On 10-Apr-2021, the patient experienced PYREXIA (Morning after second dose, my temperature was 99.3degF). On 10-Apr-2021 at 6:30 AM, the patient experienced DIZZINESS (Next morning, around 6:30am, I woke up feeling dizzy). On 10-Apr-2021 at 9:45 AM, the patient experienced LOSS OF CONSCIOUSNESS (Blacked out and passed out completely) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Blacked out and passed out completely) had resolved, FEELING ABNORMAL (My head felt a little muddled), BREAST PAIN (Breast pain on my left side which has been there for a while after the second shot) and DEHYDRATION (Felt so dehydrated after the second shot) had not resolved and DIZZINESS (Next morning, around 6:30am, I woke up feeling dizzy) and PYREXIA (Morning after second dose, my temperature was 99.3degF) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Physical examination: normal.         On 10-Apr-2021, the patient blacked out and passed out completely. She gained consciousness as her family members were carrying her. Her regular body temperature is 97.6degF. The patient felt so dehydrated after the second shot that her son had to keep on giving her water every 15 minutes. The patient took Tylenol for the symptoms. The patient also had physical examination with her gynecologist before first shot and it was normal.   This case was linked to MOD-2021-089609 (Patient Link).; 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.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received BOOSTRIX (batch number JT494, expiry date 3rd April 2016). Concomitant products included PREVNAR. On 20th November 2015, the patient received BOOSTRIX (intramuscular) .5 ml. In November 2015, less than a week after receiving BOOSTRIX, the patient experienced injection site pain, injected limb mobility decreased and stiffness. On an unknown date, the outcome of the injection site pain and stiffness were recovered/not resolved and the outcome of the injected limb mobility decreased was unknown. The reporter considered the injection site pain, injected limb mobility decreased and stiffness to be related to BOOSTRIX. Additional details provided were as follows: On 20th November 2015, at 11:47 am, the patient received a dose of BOOSTRIX in her left deltoid. In November 2015, less than a week after vaccination, the patient complained of soreness, stiffness and decreased range of motion in her left arm. Also the patient was not able to dress properly due to the events. On the same day, the patient also concomitantly received a dose of PREVENAR in her right deltoid.
Scattered papular, sl. vesicular lesions scattered back, chest, abd, and prox extremities.
Hot, swollen and reddened upper arm. Pt seen by primary care physician. Received Solu Medrol 40mg IM and antihistamines (Zyrted) 1/d x 5 days.
Moderna for 6 month to 4 years diluted. Patient had no reactions. No medical treatment needed.
Had vaccine at 4:30 on on 3/29/21 and the next morning I noticed that I could not lift my head up off of the pillow to sit up. I had to roll to the side to get up. Also, I noticed that I could not lay down from a sitting position without my head flopping backward.  My symptoms began to resolve on the eighth day post vaccine. I went to a neurologist and had an MRI which was normal. He ordered bloodwork which I have not done yet.
Pediatric dose to an adult patient; administration of a pediatric Engerix-B vaccine to a 58 year old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 58-year-old female patient who received HBV (Engerix B pediatric) (batch number CM294, expiry date 19-APR-2024) for prophylaxis.   On 23-AUG-2023, the patient received Engerix B pediatric. On 23-AUG-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Pediatric dose to an adult patient) and adult use of a child product (Verbatim: administration of a pediatric Engerix-B vaccine to a 58 year old patient).  The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt date: 23-AUG-2023 A healthcare professional HCP reported that the administration of a pediatric Engerix-B vaccine to a 58 year old patient which led to underdose and adult use of a child product.  The HCP wanted to know how to proceed with this patient.  The reporter consented to follow up.
This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a 50-year-old female patient who received SHINGRIX. On 6th February 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 6th February 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and pain in arm. On 13th February 2018, the patient experienced erythematous rash and pruritus. On an unknown date, the outcome of the injection site pain, pain in arm, erythematous rash and pruritus were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, pain in arm, erythematous rash and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 50 or 51 year old. The patient experienced arm hurt and was sore at the injection site (unknown deltoid) and 7 days after receiving SHINGRIX, experienced red rash on her chest and arm and itching on her chest and arm. Limited information was provided by the sales representative from the registered pharmacist.   It was unknown if the reporter considered the injection site pain, pain in arm, erythematous rash and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 50 or 51 year old. The patient experienced arm hurt and was sore at the injection site (unknown deltoid) and 7 days after receiving SHINGRIX, experienced red rash on her chest and arm and itching on her chest and arm. Limited information was provided by the sales representative from the registered pharmacist.
BODY TEMPERATURE GET LOW; CHILLS; HEADACHE; NAUSEA; DRUG USE VIA UNAPPROVED ADMINISTRATION ROUTE; OFF-LABEL USE; TIREDNESS; MUSCLE PAIN INCLUDING CHEST AND BACK; STOMACH ACHE; DIARRHOEA; BODY ACHES; SORE THROAT; This spontaneous report received from a patient concerned a 41 year old female. The patient's weight was 158 pounds, and height was 62 inches. The patient's past medical history included rash, vomiting, nauseas, pass out, and tachycardia, and concurrent conditions included non-alcohol user, non-smoker, latex allergy, clindamycin allergy, and hydrocodone allergy, and other pre-existing medical conditions included the patient had no history of drug abuse. the patient did not have acute illness 30 days prior to vaccination. the patient did not have significant family history of diseases or hospitalizations. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, administered on 12-MAR-2021 18:45 to left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced stomach ache. On MAR-2021, the subject experienced diarrhea. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced sore throat. On MAR-2021, the subject experienced tiredness. On MAR-2021, the subject experienced muscle pain including chest and back. On 12-MAR-2021 18:45, the subject experienced drug use via unapproved administration route. On 12-MAR-2021 18:45, the subject experienced off-label use. On 12-MAR-2021 18:55, the subject experienced body temperature get low. On 12-MAR-2021 18:55, the subject experienced chills. On 12-MAR-2021 18:55, the subject experienced headache. On 12-MAR-2021 18:55, the subject experienced nausea. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Done, COVID-19 PCR test (NR: not provided) Negative, Negative, Negative, Urine analysis (NR: not provided) Done, and X-ray (NR: not provided) Done. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nausea, chills, and body temperature get low, and the outcome of stomach ache, diarrhea, sore throat, tiredness, muscle pain including chest and back, body aches, drug use via unapproved administration route and off-label use was not reported. This report was non-serious.
Mild ringing in both ears 2 days after first vaccine shot, which decreased as fatigue feeling decreased. Mild ringing in both ears that began  the night of the 2nd day after second shot. Ringing decreased and stopped in the left ear and increased to a very loud ringing in only the right ear. I went to see a general medicine doctor, then an Ear, Nose and Throat doctor. She had a hearing test conducted that showed hearing loss in my right ear. The ENT has me scheduled to an MRI today. I went to the MRI, but could not continue because of an increased feeling of dizziness, faintness and severe nausea. I am scheduling an open MRI.
On 09/15/2022 I received my Covid-19 vaccine. On 02/14/2023 I started having nasal congestion. The next day I tested positive for Covid-19. After reaching out to my doctor I was prescribed Paxlovid.  I am also experiencing irregular heart beats and symptoms are ongoing.
Patient was in office for vaccine appointment on 04/16/2023. Patient should have received Moderna monovalent vaccine (0.25 mL/25 µg) as first dose, but nurse inadvertently given Pfizer monovalent vaccine (0.2 mL/10 µg) in stead Moderna monovalent vaccine to patient. Patient's mother was informed of error immediately. Mother reported patient currently doing well. Mild tenderness at injection site, denied other active complaints. Encouraged to use warm compress and monitor for other symptoms. Contacted with CDC's COVID resource department for future covid dosing and schedule, as per representative, patient no needs to repeat the dose. No indication to stop continue with the series of the COVID vaccine.
Dizziness, SkinRash, UrticariaPruritus, Fatigue Narrative:
Severe pain throughout entire body the first night, especially in the brain. I am not sure I would have survived had I not taken the THC gummies preemptively. Extreme nausea the next day, but I had to work anyway.
Sore throat/hoarseness started 2 days post vaccine. Productive cough, 100 degree fever, fatigue, elevated blood sugar.  Treated with ibuprofen & hydration
her right breast and right side has been bothering her/breast began to hurt; her right breast and right side has been bothering her/breast began to hurt; She states she can't sleep with it, can't do nothing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 26Feb2021 08:10 (Batch/Lot number: unknown) at the age of 85 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: has had this condition for years; "Diabetic" (unspecified if ongoing), notes: diagnosed about 20 years. The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (First dose, Lot: Unknown, Expiry date: Unknown , Route: Intramuscular injection , Anatomical location: Left arm), administration date: 04Feb2021, for COVID-19 immunisation. The following information was reported: BREAST PAIN (non-serious), PAIN (non-serious) all with onset Mar2021, outcome "unknown" and all described as "her right breast and right side has been bothering her/breast began to hurt"; INSOMNIA (non-serious) with onset Mar2021, outcome "unknown", described as "She states she can't sleep with it, can't do nothing". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had no prior vaccinations (within 4 weeks). Clinical course: She received the second vaccine on 26Feb2021, but she mostly had been having problems this week. Her right breast and right side had been bothering her. She broke out all under arm only on the right side. She did not know where it came from. Her breast has been bothering her ever since she had the shot. She clarified her breast began to hurt and she cannot wear a bra anymore. Both times, she had worn a sports bra and the other kind of bra, she had not been able to keep them on. She stated she cannot sleep with it, cannot do nothing. She thought the pain goes away and comes back. Sometimes, it hurts real bad. The events did not result to emergency room or physician office visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt here with concerns about leg pain. Had bexsero immunization on 7/20/23. Did get this in her left thigh (per her request). States can't remember if it was the same day or the day after but wanted to go out but felt lightheaded and just didn't feel well. Did also have a little fever and had left thigh pain. Did lay in bed the next day. 2 days later, got an itchy rash to the back side of her left leg - started on calf but also reports rash was on the same place on the right side. Did use an OTC cream and that made it better. Rash only lasted a day. Leg continues to hurt and still has a lump where the shot was given. Admits she has been working out quite a bit - lifting/running/ect.. Doesn't think it has gotten any better. Has taken some ibuprofen - usually before bed because she lays on her stomach.
headache and pain at injection site; headache and pain at injection site; This is a spontaneous report from a contactable Other HCP via Pfizer Sales Representative.  A male patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache and pain at injection site on an unspecified date with outcome of recovered.  No follow-up attempts are possible. No further information expected; Information about batch/lot number cannot be obtained.
Injection site swelling (deltoid) followed by severe elbow edema and erythema.
Patient received vaccine at local pharmacy, 10 minutes after administration developed respiratory symptoms and syncope. Given Epi at site.
Isolated lesion on right thigh that is raised oval, red, and painful. Relevant recent history: had a varicella in that location 12 days ago.
This spontaneous report as received from a certified medical assistant refers to 9 adult patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were inadvertently vaccinated with pediatric doses of RECOMBIVAX HB injection (dose, route of administration, lot# and expiry date were not reported). The medical assistant stated that the patients completed RECOMBIVAX HV series with three does of pediatric formulation (dates unspecified). There were no concomitant therapies reported. No adverse effect was reported. There was no product quality complaint involved. This is one of two reports received from the same reporter.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender (patient identifier: 7715394). On an unspecified date the unspecified patient were administered RECOMBIVAX HB (Lot# H010380, expired date: 18-NOV-2014) dose, frequency, route and location unspecified was stored improperly (first exposed to 9C for 30 minutes and then exposed to 8.3C for 1 hour). No adverse effects reported. This is one of several reports received from the same reproter. Additional information has been requested.
PT c/o chest pain and heaviness with severe headache with nausea. Vaccination site scabbing and WNL. Admitted to area hospital and cardiac w/u neg rx'd motrin ans asprin
Patient reported muscle pain/tightness in her legs only. Starting AM of 8/22/08. Upon speaking with her again on 8/25/08, she noticed that her conditioned had improved, and felt the residual pain was due to standing for a long period of time on 08/24/08.
pt found by parents AM not breathing, pale, warm; lips were blue & sl stiff; CPR was begun; monitor showed asystole; In ER found to be cold, stiff; extremities showed poor peripheral perfusion & no cap refill; SIDS;
Pt recvd vax 10JUN92 between 9AM & 11AM pt c/o sore lt arm, t101; listless; mom gave APAP s&s subsided by 12JUN92 PM;
Became ill roughly 3 weeks post vaccine with chronic headaches, chest pain (likely myocarditis), fatigue, brain fog, heart palpitations , exercise intolerance. Symptoms have lasted nearly 6 weeks
52 yo F with multiple allergies with history of anaphylaxis to flu vaccine, history of rebound anaphylaxis, psoriatic arthritis non-erosive, fibromyalgia, psoriasis (BSA 15%) and other comorbidies had been weaned down on her steroids in anticipation of Covid19 vaccination series.  1st Covid19 vaccination was given 9/29 at 1530 in the left deltoid (Lot # 30145BA).  Per her allergist, she was to be observed for 2hours.  She started feeling bad ~1630.  Developed facial swelling along with midsternal, sharp stabbing chest pain.  Hives developed around her chest and neck along with urticaria.  Symptoms also associated with shortness of breath and nausea, but no vomiting, diarrhea, abdominal pain, fever and sats were WNL.  EMS was called.  SBP 200's.  Treated with 2 doses of epinephrine, first epinephrine was 0.3mg IM given at around 1739.  Second was 0.5mg IM.  The patient reported some improvement of her symptoms after the epinephrine doses, but she still had some mild chest pain and swelling.  Received in ED.   Treated with famotidine 20mg IV at 1941 and prednisone 40mg po at 1941.  EKG WNL.  Troponin <6 at 3hr with symptoms less than 3hrs.  Patient kept for observation overnight.  Lactate went from 4.4 to 3.3 and back to 3.8 then down to 1.9.  Elevated lactate thought to be due to epinephrine.  No signs of hypoperfusion.  Patient c/o of her anaphylaxis returning ~0200 9/30 however no physical findings so anxiety treated with lorazepam 0.25mg which was effective.  Patient discharged 9/30.
Hours after my first covid vaccine I got a very bad headache and my back muscles started aching extremely bad. I took ibuprofen in hopes that it would ease my symptoms but it did not help at all. Today is March 4, 2022 and I have had the same type of headache every single day since my first dose. That is 122 days of what now my neurologist says are migraines. I had never in my life experienced a migraine before. My neurologist has put me on several migraine medications with no success, physical therapy for migraines with no success and also  therapy with no success. Our next step is injectables and I am praying that it helps. Not only am I experiencing daily migraines, I am experiencing hair loss and memory loss/brain fog. The memory loss/brain fog is so bad that my colleagues have noticed it multiple times and asked if I was ok.