chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Headache; Vaccination site swelling; injection site redness; This spontaneous case was reported by an other caregiver and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE ERYTHEMA (injection site redness) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE ERYTHEMA (injection site redness). At the time of the report, PYREXIA, HEADACHE, VACCINATION SITE SWELLING, and VACCINATION SITE ERYTHEMA (injection site redness) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Pyrexia: 98 degree - 102 degree (High) Fever.         No concomitant medication was reported.  No treatment medication was reported.
I fell asleep; Terrible headache; Sore throat; fatigue; felt like someone was stabbing me in the ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "I fell asleep"; HEADACHE (non-serious), outcome "unknown", described as "Terrible headache"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Sore throat"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; EAR DISORDER (non-serious), outcome "unknown", described as "felt like someone was stabbing me in the ear".  Additional information: Patient received first covid vaccine on Monday. On Tuesday patient felt asleep on the floor of the class for a half an hour while the kids were at recess. By Wednesday patient had a terrible headache, sore throat, fatigue and it felt like someone was stabbing in the ear. Patient concern is should patient get the second vaccine if the symptoms of the first are so bad.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash, Onset: 2 days ago. The problem is worse. Location is left leg. The patient describes the rash as itchy. Associated symptoms include diarrhea, fever and painful rash. Pertinent negatives include cough, nausea and vomiting. Additional information: Child had flu shot at left anterior thigh 2 d ago. Immediate redness, now red spot is larger and hot. Tried BENADRYL cream without any help. Spot is itchy. Diarrhea yesterday. IZ, Pt is UTD, Assessment/Plan.
9:30 am November 7, 2018 - - 17 hours after vaccines a fever of 103.3; Accompanied with chills, body aches, difficulty breathing. Major pain in right arm. Advil would take down the fever for a few hours and it will rise back. 9:00 am November 8, 2018 -- 41 hours after vaccine fever of 102.3. Blood pressure 80/50. Heart rate 110-130. Diagnosed at emergency room with Sepsis and Sepsis treatment started.  Chest X-ray clean. Urine clean. Blood White cells 19.9 x 1000. Slight discoloration and major pain in right arm. November 9, 2018 Blood White cells 24 x 1000 Major infection / Edima in the right arm.
large mildly erythematous area of skin over right deltoid the day after injection, mildly warm, non-tender, no  pain, patient complained of itchiness
Fatigue; Waking up every night with cold sweats; Waking up every night with cold sweats; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07May2021 at 16:30 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Medical history included obesity. The patient had no known allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included salbutamol (ALBUTEROL INHALER), cetirizine hydrochloride (ZYRTEC ALLERGY) and omeprazole (MANUFACTURER UNKNOWN); all for unspecified indications from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Apr2021 at 16:15 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. On 07May2021 at 21:00, the patient experienced fatigue and waking up every night with cold sweats. On 11May2021, four days after the shot, patient was still experiencing fatigue and waking up every night with cold sweats. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fatigue and waking up every night with cold sweats were not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Full body aches; Nausea; Vomiting; Fever; Fatigue; Headache; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12May2021 at 14:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included atomoxetine hydrochloride (STRATTERA) for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 11Apr2021 at 11:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 13May2021 at 03:00 the patient experienced full body aches, nausea, vomiting, fever, fatigue and headache. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events full body aches, nausea, vomiting, fever, fatigue and headache were resolving at the time of report.  No follow-up attempts are required, information about lot/batch number cannot be obtained. No further information is expected.
Initially 1 day of flu-like sx's. Then on 4/26 she had "left kidney pain". On 4/17 a burning redness and swelling of her legs bilaterally which worsened and she became unable to walk secondary to pain and swelling. Also reported shortness of breath. The rash was initially wheals spreading up legs with pain, burning and allodyina to light touch. It then spread to arms bilaterally.  She admitted to Medical Center and discharged with dx of urticarial rash with petechiae. I saw her 4/19 with painful palpable purpura, significant diffuse joint pain, puffiness on all 4 extremities and starting to appear on abdomen. Areas on legs where condition originally started had began clearing. Likely Henoch Shonlein Purpura.
This is a spontaneous report from a Pfizer Sponsored Program. A contactable 34-year-old female consumer (Patient) reported that: Who received dose 1 (Lot number and expiry date was not reported) via an unspecified route of administration on 13Aug2021 as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter, and her husband was a 38-year-old male consumer, both are on speaker phone, they received their first doses of the Pfizer COVID-19 Vaccine. Comirnaty on 13Aug2021 and about a week after their first doses they both tested positive for COVID-19. They were due for their second dose on 03Sep2021. The reporter would like to know if it was safe to receive their second dose since they tested positive for COVID-19 after receiving their first dose. Reporter husband, on speaker, asked if it is still recommended to receive the second dose or if the antibodies from having a COVID-19 infection after the first dose would provide enough protection. Outcome of the event was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Vaccine given at approximately 9:10 am , at 10:00 am Patient report dizziness as she was walking out of clinic to car in parking lot. Patient brought back to clinic exam room at 10:05 am, patient report feeling dizzy, tired an sleepy.  Vital signs taken: blood pressure 114/77 mmHg, heart rate 82 bmp, pulse oximeter 98% on room air, capillary glucose was 123.  Patient sat in exam room for 20 minutes, symptoms resolved and patient able to ambulate with her daughter back to the car in parking lot.  Patient report that she has been fasting for religious reason and the last time she had anything to eat or drink was 4 am this morning and she has been awake since that time.
Tdap given 1-23-08 when Td should have been given.  Last Tdap was given 1-22-07.  Td #1 8-2-06, Tdap #2 1-22-07.
shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number h2pe2, expiry date 19th May 2023) for prophylaxis.   On 23rd June 2022, the patient received the 1st dose of Shingrix. On 4th October 2022, 103 days after receiving Shingrix, the patient experienced shingles. The patient was treated with antivirals nos. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 11-Oct-2022 Reporter's comment: The pharmacist reported that the patient received the first dose of Shingrix on 23rd June 2022 and approximately on 4th October 2022 (exact date was not recorded by pharmacist) started with shingle symptoms.  The pharmacist mentioned that the patient was taking antiviral medication at that moment (for shingles).  The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up.
Stiffness in right side of face along with twitching and tearing in the right eye. This is similar to the Bel?s Palsy case I had in April 2021 after receiving the J & J Covid vaccine on 03/06/2021. However, the present symptoms are at a lesser scale.
Urticarial/Papular rash to arms, chest, abdomen, back, face within 4hrs of administration of Hep B #2.  No SOB, dyspnea, fever.  Patient did have less severe, similar reaction with Hep B#1 1 mo ago, but did not report it.
rash and urticaria. rash resolved within a week  urticaria remains for approximately 30 minutes per incident and is reproducible through any friction on skin. unresponsive to antihistamines.
This spontaneous report as received from a registered nurse refers to an 11 year old female patient with no drug reactions/allergies. On an unspecified date approximately in February-2014, reported as about two months ago the patient received the first dose of GARDASIL 1 single shot on the left arm (lot number and expiration date were not reported). Concomitant therapies included two other unspecified vaccines in right arm. On an unspecified date approximately in February-2014, after receiving her initial dose of GARDASIL the patient experienced bruising and swelling of the injected arm, and had an itchy rash from naval to face, a fever and malaise for approximately 4 days. This event was discovered when the patient went back for her second dose of first dose of GARDASIL at which time it was determined that she would not be continuing with the dosing regimen. Therapy with first dose of GARDASIL was discontinued at the time of the report and was reintroduced. The patient was recovered from the events at the time of the report. The patient did not sought for medical attention and did not received treatment for the events. No lab diagnostics were performed. Additional information is not expected.
59 yo male with PMH gout, depression, PTSD, cervical radiculopathy and myopia reported that he developed a "light rash" 10 days after receiving his first covid19 vaccine dose. Rash lasted for 2 days. He described as itchy. Patient reported this ADR on 2/17/2021 when he was scheduled for his second dose of vaccine, pt wished to get his second dose of covid19 vaccine. Both times, vaccines were administered without complication. Pt did not have ADR during observation period.
Bumped L hand then got large hematoma, with resilient paresthesia on 2/11/07 hematoma resolved, paresthesia persisted. "ETS", 2/07 current pain posterior scalp, 3/1/7 current painful groin and R thigh pain (moderate - severe). Pt seeing her primary MD and scheduled for EMG for hands and legs.
did not receive 3rd primary series dose; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not receive 3rd primary series dose) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not receive 3rd primary series dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not receive 3rd primary series dose) outcome was unknown.            No concomitant medication reported. No treatment information was provided.  Patient reported that he was immunocompromised. Patient reported he had received two Moderna primary series doses and two Moderna booster doses. The patient stated his last booster dose was 4 or 5 months ago. The exact dates of administration and lot numbers were not provided.   This case was linked to MOD-2022-607774 (Patient Link).
Sore throat, cough. Diagnosed as viral upper respiratory infection. Treated with Tessalon cough pearls, albuterol inhaler, dextromethorphan, guaifenesin, codeine cough syrup.
Tested positive after getting the first dose; diagnosed with COVID; Tested positive after getting the first dose; diagnosed with COVID; This is a spontaneous report received from a contactable consumer or other non-health care professional. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single and a second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated, i got a caller was here on hold. He was in a hurry cause i was talking to earlier but she was no longer responding. The main concern here was that the caller just like to report a patient who tested positive after getting the first dose, diagnosed with COVID on unknown date. I would, I should be closing right now so I need answers for my questions please. While paraphrasing the concern, Reporter stated, I am not reporting. My question was what would be right time to pick the second dose. While paraphrasing, Reporter stated, She got the second dose and may be like and may like week or 10 days after she goes diagnosed with COVID. The events assessed as serious (medically significant). The patient underwent lab tests and procedures which included sars-cov-2 test: positive on unknown date. The outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.
Patient had limited range of motion in vaccinated arm, and patient described notable pain the day after receiving the vaccination. However, the pain and stiffness worsened and lasted much longer than normal and patient reported that she was still suffering on 10/30/2018 and noted a doctor visit was required. Pain has lasted 2 weeks now and patient is still suffering from pain and she cannot lift her arm above her head.
Supraventricular Tachycardia; This case was reported by a other health professional via sales rep and described the occurrence of supraventricular tachycardia in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced supraventricular tachycardia. On an unknown date, the outcome of the supraventricular tachycardia was unknown.   It was unknown if the reporter considered the supraventricular tachycardia to be related to Shingrix.  Additional details were provided as follows: The reporter stated that patient experienced  supraventricular tachycardia. The reporter stated that oncologist following the patient. The reporter consented to follow up. For tolerance to 2nd dose of Shingrix, refer case US2019AMR192595.
Began to experience Body chills followed by a Low grade fever (approx 100 degrees).  These symptoms developed the next morning around 10:00am and lasted approximately 12 hours.  Extreme fatigue accompanied the fever, however, the fatigue lasted longer (approximately 48 hours). Soreness at the injection site also began the morning after receiving the vaccine. The soreness lasted for 48 hours and  was more extreme than any other shot I?ve received in my bicep.  None of these symptoms were disabling; however the fatigue did prohibit me from participating in my normal daily activities.
Soft mass/ bump on his right lower anterior part thigh 1-2 weeks after receiving MMRV and PCV-13 on that thigh.
woke up in the middle of the night with clenching teeth, myalgias today, facial numbness on the right with mild facial drooping noted with puffing of cheeks and smile
Some shots have given patient the not unexpected warmth and redness at the shot site. What is unusual is that he subsequently developed hyper pigmentation where the redness was that lingers for several weeks to months. Interesting he has had similar reactions to minor cellulitis.
A patient received three doses of the Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of OFF LABEL USE (A patient received three doses of the Moderna COVID-19 vaccine) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A, 003B21A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Aug-2021, the patient experienced OFF LABEL USE (A patient received three doses of the Moderna COVID-19 vaccine). On 04-Aug-2021, OFF LABEL USE (A patient received three doses of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided.  Action taken with mRNA-1273 in response to the event was not applicable.  The nurse practitioner explained that the patient lied and or misrepresented having received the Moderna COVID-19 vaccine earlier at another facility, but her medical records indicate that he did indeed receive a total of 3 doses.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received  and it contains no new information On 30-Sep-2021: Follow up received on 01 oct 2021 contains non- significant information .
Following you vaccination nausea, dizziness, and migraine.  These persisted, and still happen occasionally. Started once a day and now is every few days.
About 3 weeks after the vaccine I started to experience significant pain in my shouldes, hips and pelvic girdle. Within a couple of days the pain was severe and I had very little mobility. I thought I might have strained something but by May 24th it was obviously not the case. I tried to manage the symptoms with aleve with no results. I was finally able to see the doctor around July 7th after over a month of suffering. Given my symptoms she diagnosed me with Polymyalgia Rheumatica (PMR) and started me on prednisone. I also had blood work done specific to PMR with no significant findings and the Dr. Told me that it doesn't always show up in blood work. The prednisone provided relief quickly. She referred me to a rheumatologist and they confirmed the diagnosis given my symptoms and response to prednisone. Still on prednisone and am now down to 8mg a day but drawing down past that has been difficult because the symptoms come back.
Red, raised, itchy bump at the insertion site that is warm to the touch. I am now over 48 hours since getting the vaccination.; Red, raised, itchy bump at the insertion site that is warm to the touch. I am now over 48 hours since getting the vaccination.; Red, raised, itchy bump at the insertion site that is warm to the touch. I am now over 48 hours since getting the vaccination.; Red, raised, itchy bump at the insertion site that is warm to the touch. I am now over 48 hours since getting the vaccination.; This is a spontaneous report from a non-contactable nurse who reported for herself. A 40-year-old female patient received first single dose of BNT162B2 (Pfizer/BioNTech Covid-19 vaccine, Lot number: EL0140) intramuscularly at right arm at 10:00 AM on 29Dec2020 for Covid-19 immunization. The patient received the vaccine in hospital. The patient had a history of hypothyroidism and had known allergies to sulfa. Concomitant medications in two weeks included Levothyroxine, amlodipine, losartan, drospirenone, ethinylestradiol betadex clathrate (YAZ), tizanadine, montelukast sodium (SINGULAIR), terbinafine (LAMISIL), cetirizine hydrochloride (Zyrtec). At 12:00PM on 29Dec2020, the patient developed red, raised, itchy bump at the insertion site that was warm to the touch. No treatment was received. The events had not resolved at the time of reporting. The reporter considered the events were non-serious.  No follow-up attempts are possible. No further information is expected.
05/14/2021 @ 19:15- Tightness in chest and difficulty breathing. Called doctor who prescribed prednisone.
redness & swelling around site 13 1/2cm x 10cm fever up to 102;
Fever, migraine, chills, exhaustion, body aches, blurry vision in and off for 2 days