chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Temperature of 104 F after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temperature of 104 F after 1st dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040b21a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient was hospitalised for a week.) in January 2021.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Temperature of 104 F after 1st dose). At the time of the report, PYREXIA (Temperature of 104 F after 1st dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications were not reported.
Nausea, headache, lethargic, muscle aches, mild chills, that lasted 11 hrs.
Coughing, no other sypmtoms. No trouble breathing. Cough resolved with Benadryl.
Patient called 3/28/22 to report arm was still sore from vaccine back in November, states now hurting up into shoulder area. Patient was advised of otc medications such as tylenol and ibuprofen to treat soreness but was encouraged to reach out to dr for evaluation to make sure soreness from vaccine back in November as pharmacy cannot diagnose
Patient claims she was very tired and arm ached. She said she didn't "feel right" so she went to bed early. She got up in the middle of the night (does not know what time) and tried to stand up. She fell and hit her head on the dresser on the way down. She didn't feel well the next morning and spent most of the day in bed.
Tachycardia; chest swelling; This spontaneous case was reported by a pharmacist and describes the occurrence of TACHYCARDIA (Tachycardia) and SWELLING (chest swelling) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (Tachycardia) and SWELLING (chest swelling). At the time of the report, TACHYCARDIA (Tachycardia) and SWELLING (chest swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
I developed a red, raised, itchy area approximately 2 inches diameter at the site of injection.
Diagnosed with chickenpox (post vaccination), treated with Acyclovir, approximately 30 lesions.
Started experiencing multiple events of tachycardia, heart palpitations, and received multiple a-fib ECG reading from smart watch within days of receiving fist vaccine dose which led to multiple ER visits. Was directed to where a Holter monitor for 21 days which captured multiple PVCs. Prescribed beta blockers to treat PVCs. No prior history of heart issues or PVCs before.
developed chest tightness and shortness of breath this AM, saw PCP, given motrin which relieved the pain
Chest pain, tiredness and fast breathing, sometimes I feel like I'm going to faint.
11/30/17: Patient presented to the hospital ER with tingling and numbness in both hands and legs, pain in lower back and down back of legs, stiff hands, ankles, and hips. BP was 200/100's, nausea/vomiting, CT brain showed area of hypoattenuation within the right parietal lobe that extends to the cortex, was started on nicardipine drip. 12/1/17: Lumbar puncture and intubation - patient unable to lift legs/arms, using accessory muscles, voice barely audible. IVIG therapy started. 12/3/17: Awake, attempting to talk; flaccid 0/5, able to move head, tracks examiner. IVIG continued 12/4/7: Pupils fixed and dilated, no corneal reflexes, weak gag, unresponsive on no sedation.
mild Shingles outbreak on right leg 1 month following first 2 vaccines and 2 months following the 3rd vaccine; 3rd vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Nov2021 (Lot number: FE3592) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "migraines" (unspecified if ongoing); "cervical disc disease" (unspecified if ongoing); "chronic Muscle spasm" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: Ek5730, Location of injection: Arm Left, Route of Administration: Intramuscular, mild Shingles outbreak on right leg 1 month following first 2 vaccines), administration date: 31Dec2020, when the patient was 49 years old, for Covid-19 immunization, reaction(s): "mild Shingles"; Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: El8982, Location of injection: Arm Left, Route of Administration: Intramuscular, mild Shingles outbreak on right leg 1 month following first 2 vaccines), administration date: 21Jan2021, when the patient was 49 years old, for Covid-19 immunization, reaction(s): "mild Shingles". The following information was reported: IMMUNISATION (non-serious) with onset 03Nov2021, outcome "unknown", described as "3rd vaccine"; HERPES ZOSTER (non-serious) with onset Jan2022, outcome "not recovered", described as "mild Shingles outbreak on right leg 1 month following first 2 vaccines and 2 months following the 3rd vaccine". The event "mild shingles outbreak on right leg 1 month following first 2 vaccines and 2 months following the 3rd vaccine" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of herpes zoster.  Additional information: mild Shingles outbreak on right leg 1 month following first 2 vaccines and 2 months following the 3rd vaccine. There is no history of shingles outbreak in the past until receipt of this vaccine. Ae treatment: Acyclovir, than valacyclovir. Ae resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. The patient did not receive other vaccine in four weeks. The patient did not have covid prior vaccination and not tested post vaccination. Patient did not have any known allergies.
normally have migraines and this has triggered one; feels like a full on flu; Plus a bump on my arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "migraine" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 immunization, reaction(s): "The first dose had side effects"; Bnt162b2 (Dose: 2), for Covid-19 Immunization, reaction(s): "the second dose gave me covid arm". The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "normally have migraines and this has triggered one"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "feels like a full on flu"; PAPULE (non-serious), outcome "unknown", described as "Plus a bump on my arm".  Additional information: The third was giving patient what feels like a really bad flu plus triggered a migraine requiring medication. Patient was really happy that patient was not going to die of Covid-19.  The lot number for vaccine [BNT162B2] was not provided and will be requested during follow-up.
Sudden onset of severe spasm of low back muscles. Rendered me unable to walk without assistance.
I had COVID-19 back in July of 2022. I had pulmonary embolisms in my lungs that gave me issues with my breathing. I went to the ER and the saw scarring in my lungs and send it was signs and causes from long COVID-19 giving people pneumonia shortly after. I am still having issues with breathing; my PCP says it's most likely caused by the scarring.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, an unspecified number of patients were vaccinated with GARDASIL (route, dose, lot # and expiration date were not reported). It was reported that GARDASIL was improperly stored and the temperature excursion was found to be unsupported with in-house stability data. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Starting 08/18/2022, I noticed a bright red spot on the right elbow on the outer part of my arm. My elbow became real swollen and sore. As the day went on, it became very hot. I tried to make an appointment with my PCP but they were closed. I went to urgent care that day and they diagnosed me with cellulitis. They sent me home with cephalexin and I took that over the weekend. However, my arm didn't appear to get better. On 08/22/2022, I called my PCP and got to see my dr. right away. I was told I had cellulitis, given more antibiotics and told to take more frequently. Also, I was told to get an x-ray at the hospital. I have not heard the results of that yet. Today (08/24/2022) is the first day that I have noticed its not as red/swollen and not as warm.
several cowerkers had side effects after vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (several cowerkers had side effects after vaccination) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (several cowerkers had side effects after vaccination). At the time of the report, ADVERSE EVENT (several cowerkers had side effects after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.        Information about concomitant medications was not reported. No treatment information as provided. This case was linked to MOD21-049967 (E2B Linked Report).   This case was linked to MOD21-049967 (E2B Linked Report).; Sender's Comments:  MOD21-049967:
Mother reports had small, red, warm area at back of right arm that client reported as "itchy", has progressed to 10cm in diameter and remains red in color and warm to touch.  Client reports remains "itchy" as well but this has been alleviated with use of Benadryl given to client by parent. Medical director in house when client returned for report, prescription for Cephalexin 500mg (#21) 1 tab po three times daily for 7 days provided also to prevent possible infection.
Dose 2-  Severe Gastrointestinal discomfort, inducing nausea Neurological effects - headache, disassociation
12/16/2020 @7:00pm caller started feeling flush with hives and nausea.  Caller took Ibuprofen and next day got relief.
Patient received the vaccine on 4/2/22. There are no reported adverse reactions but vaccine expired on 4/1/22. We are waiting for manufacturer to research and contact us if we need to administer another dosage.
Approximately one week after injection, I noticed a rash on my upper chest, inner upper thighs, under arms, full length.  Itchiness.  Another week later, (two weeks after the shot)I called the doctor's office, spoke to a nurse. Rash & slight itchy sensation continues, mainly on chest......may be subsiding.  Seemingly no other adverse effects.  She suggested that I do get the second shot.
Max/low temperature reached: Negative 0.2C Duration out of labelled range: 96 Hours with no adverse event; Initial information was received on 17-Oct-2023 regarding an unsolicited non-valid non-serious case received from a other health professional.  This case is linked to cases 2023SA322724(CLUSTER) and 2023SA324260(CLUSTER).  This case involves temperature excursion with max/low temperature reached: negative 0.2c duration out of labelled range: 96 hours was administered with no adverse event with influenza quadrival A-B high dose HV vaccine [fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect influenza quadrival A-B high dose HV vaccine via unknown route in unknown administration site for Immunization (strength, formulation ,batch, dose and expiry date: unknown) max/low temperature reached: negative 0.2c duration out of labelled range: 96 hours was administered to patient with no adverse event (poor quality product administered) (latency same day). Information on the batch number was requested  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event poor quality product administered  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report as received from a physician refers to a 70 years old female patient. Pertinent medical history was none. Allergic reaction included hives for chocolate. On 23-JUL-2012, the patient was vaccinated with 0.65 milliliter (ml) ZOSTAVAX. Lot number was 671775/0466AE and expiration date was 28-FEB-2013. Other suspect therapies included PNEUMOVAX 23 on 23-JUL-2012. Concomitant medications included aspirin, FOSAMAX and PEPCID. Approximately on 25-JUL-2012 (reported as 2 days after vaccination), the patient experienced nodule in her deltoid area of injection. On 25-JUL-2012, the patient had called the physician's office to report the same and was told by the physician over the telephone to apply a warm compress and to take BENADRYL and ADVIL if needed. Later the patient never called back and on an unspecified date had recovered from the event. On 12-SEP-2012, the patient reported that she went numb and tingly on the right side for which she went to the emergency room. On an unspecified date in September 2012, laboratory tests were performed which included MRI which showed demyelination of C2 area. Lumbar test and other unspecified tests were performed and the results were pending. The patient was treated with steroid and was responding to the treatment. On an unspecified date the patient was hospitalized. The outcome of the event of she went numb and tingly on the right side was reported as recovering/resolving. The patient's events were considered to be disabling by the reporter. Additional information has been requested.
Received immunization on am of 10/19. Hives each cheek and left arm on pm of 10/20.  Arm red and inflamed.  History of hives with Augmentin at age 6-8 months. Treated with application of cortisone cream.  Hives resolved.
w/in 15min of vax pt presented to ER;passed out;ER working dx syncope;parents thinks had a sz-like episode;recovered;
Information was received from a female consumer of unknown age with asthma, drug hypersensitivity and allergies. The patient's medical history included chemotherapy and reaction to chemotherapy (not specified). Approximately in 2011 the patient was vaccinated with PNEUMOVAX 23. The patient reported that "24 hours after getting the vaccine", she experienced her arm swollen with redness and a minor itch for a "number of days." The patient reported this was her second pneumonia vaccine in 15 years and she had not reaction with the first one. The pt self medicated with BENADRYL and ice. The outcome of arm swollen, minor itch and redness was reported as recovered/resolved. Additional information is not expected.
8:33 am, 1/17/2021, 10 min after being vaccinated, patient began complaining of chest pain.  Patient has extensive cardiac history but did not have acute pain until after vaccination.  Client was released by EMS with wife, to home.
Spots in vision; This is a spontaneous report from a non-contactable consumer (patient). An elderly female patient of unspecified age received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via an unspecified route of administration on 10Mar2021 08:30 (at an unspecified age) at 2nd dose, single dose for COVID-19 immunisation. Medical history included neurological conditions associated with neck/back, and the patient was getting physical therapy for this. It was unknown if patient has known allergies. The patient was not pregnant at the time of vaccination. Concomitant medications included methylphenidate hydrochloride (RITALIN), meloxicam, hydroxychloroquine sulfate (PLAQUENIL), and calcium (reported as calcium supplements). Historical vaccination included first dose of BNT162B2 (lot number: unknown) received on an unspecified date for COVID-19 immunisation. On 10Mar2021 14:30, the patient experienced spots in vision. The patient received no treatment for the event. The patient had no COVID prior vaccination, has not tested for COVID post vaccination, and had no other vaccines in four weeks. The patient was vaccinated in a school or student health clinic. Outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
1-2 days after MMRV, pt. had vesicular rash on face, trunk and extremities. 3 days after had fever 39-40 C, cough, and congestion. Bacitracin for vesicles that ruptured. Ibuprofen PRN fever.
Spiked a fever the within 24 hours. Started developing cysts near back of head/neck.  Developed cyst in neck and throat is sore.
This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX with an associated reaction of herpes zoster (received ZOSTAVAX previously on an unknown date and had shingles 5 times since receiving ZOSTAVAX). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however it could be 71 or 72 years. In 2018, the patient received her second dose of SHINGRIX and developed a fever of over 100 degrees F. This case has been linked with US2018151138 and US2018151144, reported by same reporter.
received only one dose August 2021; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received first dose in August 2021).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 8-Aug-2022 Reporter's comment: A pharmacist reported that a patient received only one dose of Twinrix on August 2021. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting the patient had not received the second dose of Twinrix yet, which led to incomplete course of vaccination. This case was linked with US2022116443,reported by same reporter.; Sender's Comments:  US-GSK-US2022116443:Same repoter
Fever that started around 12 hours after injection, soreness of injection site, followed by body chills and aches.
Tingly lips, chest tightness, feeling faint and sluggish, metallic taste and smell, pressure behind the eye.
Feelings of vertigo three weeks after receiving vaccination. These feelings of the room spinning and nausea are ongoing. But do not happen all day or even everyday. It happens often, but not daily.
Patient complained of feeling lightheaded, fast heartrate, and hot/cold sweat.  Vitals were:  BP 132/80, pulse 89, O2 98%, respiration 14, temp 97.8.  Patient advised to drink her soda and eat her food she had with her.  Patient felt better after 2 minutes, monitored additional 15 minutes.  Advised to see PCP if symptoms persist.  Patient cleared.
Throat tightness, chest pains, tingling all over body, headaches Immediate reaction treated with Benadryl and PEPCID injection Hospitalisation with a subsequent PEPCID injections, 10mg Claratin, 125mg Prednisone (1500), 2nd Prednisone at 2000, potassium chloride 20m at 2242.  Following morning followed up with PEPCID at 0545, Claritin 10mg 0545, zenax when I returned the hospital after being discharged.  Went back as I was experiencing chest pains and very flushed and red in the face.
red, flushed, hot, tender  cheeks, face; noticed after removing face mask in car.  This was  not noticed at vaccination facility because face was covered with protective mask. Pain in both eyes continued for several hours following.
Date of shot-03/26/21 Lower left lip twitching-03/27/21 Today is 04/03/21- still twitching. It could be   2 minutes from the last twitch or an hour. It is unpredictable when this happens. It has been a week and 1 day and it is still happening.
patient didnot have allergy but experience  side effect wich is listed in vis handout  wich is nausea, headache, body ache redness on the site of injection
Erythema and swelling around the injection site with some induration. About 4 cm in diameter.
Patient received Hepatitis B vaccine on 11/4/05.  Immediately felt pain to left arm.  Over the next few weeks pain did not go away. In the last 3-4 days symptoms progressed to numbness, tingling in arm and hand.  Coolness to left hand with swelling of joints and discoloration (purple) in fingers.  Swelling has increased.  Range of motion to left arm is limited.  Physical Therapy started.
This case was reported by a consumer via call center representative and described the occurrence of nausea in a 76-year-old female patient who received SHINGRIX. Concomitant products PNEUMOVAX. On 16th May 2018, the patient received SHINGRIX .5 ml. On 17th May 2018, 1 days after receiving SHINGRIX, the patient experienced nausea, pain, fever, dizziness and weakness. On an unknown, the outcome of the nausea, pain, fever, dizziness and weakness were recovering/resolving. The reporter considered the nausea, pain, fever, dizziness and weakness to be almost certainly related to SHINGRIX. Additional details were reported as follows: The reporter was GlaxoSmithKline employee reporting about her mother's experience. On 16th May 2018, the patient also received PNEUMOVAX concomitantly. The reporter had limited information regarding her mother experience.