chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash all over arms legs chest and back and hands began on hands first, very itchy. Slight sore throat negative strep culture (-) mono test normal CBC Pt put on PCN at school rash resolved one day later
approx 11.5 hours after vaccine had headache, myalgia, shakes and chills with hot flashes, insomnia and nausea
This case was reported by a nurse and described the occurrence of injection site cellulitis in a 4 year old female pt who received DTAP (Infanrix) for prophylaxis. On 07/15/03, the pt received the 5th dose of Infanrix (Lot# DTPA596A2).  On the same date, she also received an injection of IPV. On 07/16/03, 1 day post-immunization, the pt developed redness and swelling at the Infanrix injection site, which "extended down the arm". The pt was seen by the physician who made a diagnosis of injection site cellulitis and prescribed an unspecified antibiotic. The injection site cellulitis began to respond after two days of therapy, and resolved after an unspecified period of time. The reporter considered the event to be related to vaccination with Infanrix.
I had been freezing all evening after the shot.  Went to bed as usual for the night.  Woke up about 1 am which is normal for me.  I was still freezing.  Got up to go to the bathroom as I normally do.  While sitting on the toilet, I started shaking violently - not just regular shivers.  This was scary.  Violent jerking from the waist up - head, arms, torso.  I could not control it.  Eventually it stopped.  I put on warmer clothes and climbed back into bed.  Eventually I warmed up and went to sleep.  Other minor side effects were same as the first vaccine - sore and tender around the injection sight and slight headache.
Myalgia - akinesia - pain to upper body weakness reported arms and legs more last night. Somewhat better this am - able to get OOB today.
cold; Cannot take deep breath; Headache; Mild Fever; Chill; aches and pains, body aches; Left Arm sore and Hurting; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), DYSPNOEA (Cannot take deep breath), PAIN IN EXTREMITY (Left Arm sore and Hurting), HEADACHE (Headache) and CHILLS (Chill) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) 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 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Left Arm sore and Hurting), CHILLS (Chill) and MYALGIA (aches and pains, body aches). On 17-Mar-2021, the patient experienced NASOPHARYNGITIS (cold), DYSPNOEA (Cannot take deep breath), HEADACHE (Headache) and PYREXIA (Mild Fever). The patient was treated with PARACETAMOL (TYLENOL) on 12-Mar-2021 for Pain in arm, at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (cold), DYSPNOEA (Cannot take deep breath), PAIN IN EXTREMITY (Left Arm sore and Hurting), HEADACHE (Headache), CHILLS (Chill), MYALGIA (aches and pains, body aches) and PYREXIA (Mild Fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  The patient reported on 12-Mar-2021, she experienced chill, aches and pains, headache, arm sore and hurting. Patient took Tylenol and felt better. On 17-Mar-2021, she experienced chills, body ache, headache, mild fever, cannot take deep breath and cold coming feeling. Patient took Tylenol.
Sore throat, congestion, sneezing, coughing, mucous production, body aches, fatigue, headache, lasted 3 days, cough persistent for 24 days
Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 30 years old female patient who experienced rash on her face (only her face), the day after that the skin got dry while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U6260BA via unknown route in the left deltoid. On an unknown date, the patient developed a non-serious she got a rash on her face (only her face) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious the day after that the skin got dry and was peeling following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious the day after that the skin got dry and was peeling following the administration of INFLUENZA QUADRIVAL A-B VACCINE. (Other relevant tests included No lab data). Final diagnosis was the day after that the skin got dry and was peeling, the day after that the skin got dry and was peeling and she got a rash on her face (only her face). No corrective treatment was received. The patient outcome is reported as Recovered/Resolved on an unknown date for she got a rash on her face (only her face), as Recovered/Resolved on an unknown date for the day after that the skin got dry and was peeling and as Recovered/Resolved on an unknown date for the day after that the skin got dry and was peeling. List of documents held by sender: none.
RT THIGH REDNESS, SWELLING, "KNOT" ON THIGH. ABOUT 3/4 INCH WIDE.
Shoulder area around injection site was swollen, inflamed, itchy and very warm to touch. My doctor looked at it and prescribed Z-pac antibiotic as he thought it might be infected. While the symptoms subsided a bit, they did not go away until after the antibiotic was used up. Since then I have had much loss of strength in both arms while trying to use them reaching above my head. I have to push my left arm up with my right hand to get dishes off the second shelf in the cupboard. The doctor then took blood samples and did a urine analysis but found nothing. He sent me to the ER to have a CT scan of the abdomin and IV fluids. While there they took more blood samples and found nothing. I am also having lower back pains
Initial R arm pain.  Migrated to bicep and diagnosed with R bicep tendonitis.
Fever=101.1 Body aches  Chills I took two Tylenol  twice
pt recv vax & exp soreness & heat @ inj site, devel redness @ the inj site & exp muscle aches to a point where could not lift arms;
Initially had body aches, then headache, then high body temperature and difficulty breathing.  I felt better Thursday morning but gradually felt worst.  About 1600, my temp was 102.4.  I went to hospital and they told me I had a viral infection. They gave me both Tylenol eq and Motrin eq to break the fever. Over the next 5 days, I have switched between cold, normal and hot. My temperature has gone from 97.5 (normal for me) to 101.4.  I have had night sweats 4 of the 5 nights. I still feel unwell.
Information has been received from a registered nurse concerning two patients who were vaccinated with Rotateq PO (dose not reported). The nurse reported that two patients who had received Rotateq subsequently developed blood in their stool. Upon internal review blood in the stool was determined to be an other important medical event. Additional information has been requested to obtain patient identifiers.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Pt has PMH significant for Multiple Myeloma, Chronic Kidney Disease, Hypertension, and Hyperlipidemia. No information regarding patient death.
Second dose of Moderna administered at 8:30 AM.  10 hours post vaccination marked the onset of chills and body aches.  11-12 hours post vaccination, fever started.  Patient took ibuprofen (800 mg) and fever started to come down 2.5 hours later.  Body aches, joint pain, and injection site pain persisted throughout the night without relief.  24 hours post vaccination body aches and injection site pain continued, and fever returned.  Fever reduced with ibuprofen. 48 hours post vaccination, remaining side effects included injection site pain and fatigue.
The patient developed red splotches of varying sizes, some with purple in the middle, suddenly appearing 7 days post vax. The patient is alert and slightly irritable.  On 07/19/2001 the patient saw a pediatrician and was diagnosed with hives. The patient was treated with Periactin.
Patient felt lightheaded and dizzy immediately post vaccination. Observed patient for 30 minutes after which she felt better and left on her own.
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with GARDASIL or with GARDASIL 9 (unidentified Merck hpv vaccine administered; lot #, expiry date, dose, route of administration and anatomical location were not reported). On an unknown date, following the administration of unidentified Merck hpv vaccine, the patient experienced syncope. The outcome of syncope was unknown. The relatedness between the event of syncope and unidentified Merck hpy vaccine was not reported. Additional information has been requested.
The injection site started to itch, the next day the area was red, and there was a bump under the skin and the skin was warm to the touch.  I went to my doctor who diagnosed me with Cellulitis.  I am taking cephalexin 3x/day for seven days.   I was told that it is perfectly fine to receive the 2nd dose of the vaccine that the cellulitis was not caused by the vaccine itself but rather by bacteria getting under my skin when the shot was given.
Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild
pt came in lobby today stating to nurse that he has had brain fog ever since he got his COVID shot, stated to nurse that he has been in a fog and saw his private MD who said they couldn't find anything wrong. MD ordering MRI. Stays tired. Had covid disease in January.
Information has been received from a physician concerning a female patient who was vaccinated intramuscularly with 0.5 ml dose of GARDASIL. Concomitant therapy included HAVRIX. The patient developed a fever 2 days after she received the vaccine. The fever lasted 2 days. After the fever went back down, she had "swelling in her legs". The patient sought unspecified medical attention. Additional information has been requested.
Pt was diagnosed with cellulitis left upper extremity, adverse effect of vaccine, shingrix on 8/14/2019
Extreme lethargy, chills, headache, extreme muscle pain and weakness. Shaky when standing over a min or two. Nausea, swollen arm and pain fingers to surrounding top of arm area (breast, neck, shoulder)
No immediate reaction after DTaP on Day 1. Day 2 localized swelling of left thigh, warm to touch, afebrile, no restriction of limb movement, no crying behavior. Day 3, brought to health department by aunt per mom, swelling subsided, to contact private physician.
Information has been received from a nurse practitioner concerning a 21 year old black female with allergies to guaifenesin (ROBITUSSIN) and doxycycline who on 20-Mar-2007 was vaccinated IM, into the right deltoid, with a first dose of Gardasil (lot #654702/0011U).  On 20-Mar-2007, the patient experienced pain at the injection site.  The pain lasted for 1 week and then on 27-Mar-2007, the patient resolved without treatment.  On 16-Aug-2007 the patient was vaccinated IM, into the right deltoid with a second dose of Gardasil.  On 16-Aug-2007, the patient developed a sore muscle and arm at and around the site of injection.  On 23-Aug-2007, the patient recovered.  No further information is available.
This spontaneous report was received from an administrator, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications were not reported. On 03-FEB-2017, the patient was vaccinated with an improperly stored dose of VAQTA intramuscularly, with lot # M047658 and expiration date on 28-OCT-2017 for prophylaxis. It was stated by the reported that, VAQTA was exposed to a temperature of 34 °F, for a 2 hours and 12 minutes time frame. Additionally, the vaccine was not involved in any previous temperature excursions and data logger was involved.  It was also reported, that no adverse effects were suffered and that no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA007052:
Patient admitted to Hospital with worsening shortness or breath, hypoxic at home. COVID positive 9/7/21
pt presents to the ED for sore throat, chills and dizziness that he attributes to the second dose of the Moderna vaccine which he received on 29Jun2021 at 1400.
Breakthrough case admission after 2 vaccines Moderna 2/3/21 lot# 031L20A;  Moderna 3/3/21 Lot# 030A21A
This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Jan2022 09:37 (Lot number: FJ1620) at the age of 41 years as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), administration date: 29Apr2021, for COVID-19 immunization; Bnt162b2 (Dose: 02, Vaccine Name: COVID-19, Manufacturer: Pfizer, Batch/Lot#: FJ1620, Route: IM, Anatomical Site of Injection: L arm), administration date: 20May2021, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "fever"; FATIGUE (non-serious), outcome "recovered", described as "fatigue"; PAIN (non-serious), outcome "recovered", described as "body aches"; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 04Jan2022 09:37, outcome "unknown", PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome "unknown" and all described as "administered to a patient after several days when it must be administered within 6 hours". Therapeutic measures were not taken as a result of poor quality product administered. Additional event: The patient provide information to the physician when she presented to the office for her daughter's routine visit regarding the reported adverse event(s) with the use of the product. The Pfizer product had a causal effect to the adverse event (s), possible normal expected side effect vs from expired vaccine. Reporter was not willing to be contacted again by Pfizer on the reported adverse event (s). The events did not result in doctor office or urgent care. Vaccines reconstituted and stored in syringe on 31Dec2021. Nurse did not read label on syringe that showed the date and administered the dose on 04Jan2022. She said she didn't recall a label on it and thought it was just drawn up. The Nurse "didn't see" an expiration date and has been reminded to never administer a vaccine without a label. The patient and mother both experienced fever, fatigue, and body aches that they didn't experienced with previous doses. Both recovered without a need to seek medical attention. Follow-up attempts are completed. No further information is expected. Follow-up (07Mar2022): This is a spontaneous follow-up report from a contactable Nurse. This Nurse reported in response to HCP letter sent that included: Updated information included: New Reporter added, Patient Initials and Age added, Historical Vaccines, Vaccine details added, Vaccination facility details added, Event Onset date and Treatment updated, New events added. Follow-up attempts are completed. No further information is expected.
6 x6 area of redness, swelling, pain and itching. Onset several hours post injection. Local reaction only. No anaphylaxis.
Post vax, the vaccinee's legs became progressively more sore and achy. He noted that the soreness is primarily between the hip and knee in both legs and has become progressively worse with each injection. At some point, the events required a doctor's visit. No treatment has been given.
Her jaw hurt for 3 days; Her sinuses hurt for 3 days; The left side of her neck numbed up/ the left side of her face numbed up; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (The left side of her neck numbed up/ the left side of her face numbed up), PAIN IN JAW (Her jaw hurt for 3 days) and SINUS PAIN (Her sinuses hurt for 3 days) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced HYPOAESTHESIA (The left side of her neck numbed up/ the left side of her face numbed up). On 04-Aug-2021, the patient experienced PAIN IN JAW (Her jaw hurt for 3 days) and SINUS PAIN (Her sinuses hurt for 3 days). On 04-Aug-2021, HYPOAESTHESIA (The left side of her neck numbed up/ the left side of her face numbed up) had resolved. In August 2021, PAIN IN JAW (Her jaw hurt for 3 days) and SINUS PAIN (Her sinuses hurt for 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.   No treatment medications were reported.
Felt lightheaded and diaphoretic.  Given juice and crackers.  No juice or crackers...no difficulty breathing.  Patient felt better.  VS WNL>  Lightheadedness resolved.  Only had 1 egg for breakfast - counseled patient on eating meal.
4NOV93 c/o pain in  shins-onset 1NOV93 sharp shooting on ambulation; rt knee swollen, non tender onset 3NOV93; suggested have MD check for cause & call clinic;
PT VACCINATED WITH MMR DEVELOPED IMMEDIATE SWELLING OF THROAT NUMBNESS OF LIPS & HANDS. SCARLET COLOR OF FACE & CHEST. HOARSNESS
pt recvd vax;devel localized rxn of erythema & swelling from elbow to inject site on deltoid;exp fever 101 for 2 days & enlarged axillary lymph node;seen by MD & tx w/ atbs;
symptoms such as myocarditis; occasional and random rapid heart beats along with shortness of breath; occasional and random rapid heart beats along with shortness of breath; This is a spontaneous report from a contactable consumer, the patient. This consumer reported similar events for herself and another one patient. This is 1st of 2 reports. A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot unknown, second dose) solution for injection intramuscular in left arm on 20Feb2021 at 12:00 (at the age of 72-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included hypertension, blood pressure was usually 120/80 or within 5 numbers of those numbers. The patient had no known allergies. Concomitant medications included lisinopril for hypertension, estradiol (ESTRACE), levothyroxine, fluoxetine hydrochloride (PROZAC), and vitamin B complex (B COMPLETE). Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination on 30Jan2021 with no adverse effect reported (no side effects in the following days). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 29May2021 at 12:00, the patient began experiencing occasional and random rapid heartbeats along with shortness of breath. It seemed to be symptoms such as myocarditis (29May2021 at 12:00). The events resulted in doctor or other healthcare professional office/clinic visit. The patient took ibuprofen when experienced the rapid heartbeat. No treatment was provided for the events myocarditis and shortness of breath. The outcome of the events rapid heartbeats and shortness of breath was recovered on 22Jul2021. The outcome of the event myocarditis was recovering. The patient was not tested for Covid post vaccination.  The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow up.
Headache, Myalgia & Tachycardia Narrative: Continues to have prolonged Tachycardia.
This spontaneous report as received from a pharmacist via company representative refers to a 70 year old male patient. Approximately in October 2013 (2 months ago), the patient was vaccinated with ZOSTAVAX (Lot number, expiry date, route and dose unknown) for vaccination. On unspecified dates within a week of administration of ZOSTAVAX, patient developed rash at his elbow and covered an unspecified area up his arms. It was reported that patient visited pharmacist and no treatment was given for rash. On an unspecified date, patient recovered from rash after a week adverse effect began. The outcome of rashes started at his elbow and covered an unspecified area up his arms was reported as recovered/resolved. No further information provided. This case # 1312USA011728 is linked to case # 1312USA010015 via same reporter link. Additional information is not expected.