chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Golf ball size swelling on jaw line below her ear; same pain after the second shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (same pain after the second shot) and SWELLING (Golf ball size swelling on jaw line below her ear) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PAIN (same pain after the second shot). On 07-Apr-2021, the patient experienced SWELLING (Golf ball size swelling on jaw line below her ear). At the time of the report, PAIN (same pain after the second shot) and SWELLING (Golf ball size swelling on jaw line below her ear) outcome was unknown.            No concomitant medication reported.  Treatment for the event include paracetamol.  Action taken with mRNA-1273 in response to the events was not applicable.
The second shot produced flu-like aches with additional joint stiffness and headache at the top of the head within 12 hours.   After the second dose, I took a Tylenol and went to bed at about 9:30PM, but continued symptoms lasted until 18 hours after onset.  I took a second Tylenol at approximately 4PM and recovered by 8PM.
Administered out of approved age range. Vaccine approved for 18 years and older. Patient was 17 years old at the time of vaccination.
Patient developed varicella (chickenpox) infection after second dose of varicella vaccine (administered 10/21/21) Doctor diagnosed this patient with chickenpox at his Office appointment on 11/17/21. Nursing staff called Infection Control for notification during this visit. Patient was seen in Emergency Department on 11/12/2021. Notes indicate that the patient has a rash all over his body. States this began 3 days ago. Started on arms and face - few on his thorax and his legs. Mother reports patient itches them ESP when sleeping. Mother states that she just got over shingles and the patient's father have COVID.
I have spontaneously had the meniscus in both knees and the tendon in my left elbow tear. I've had GI issues and was found to have fatty liver. There have been no changes to routine exercise medications. The only difference was the vaccine.
No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report was received from a medical assistant and an other non-health care professional referring to a 1-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. No illness at time of vaccination nor vaccine within 4 weeks prior to vaccination date was reported.  On 23-MAR-2022, the temperature excursion occurred of varicella virus vaccine live (oka/merck) (VARIVAX). The storage temperature was -14 degree Celsius up to -10 degree Celsius for 3 hours and -10 degree Celsius up to 8 degree Celsius for 1 hour 30 minutes. There was no previous temperature excursion. The temperature excursion occurred as a result of a reading from a digital data logger. On 04-APR-2022, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection by a healthcare professional for prophylaxis (subcutaneous, lot #U025790, expiration date: 19-AUG-2023; strength and dose were not provided) (product storage error). No additional adverse event (no adverse event) was reported. After administration, the reporter contacted company and verified the viability of vaccine. The vaccine was not available for return or evaluation because it was given to the patient.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2205USA008004: US-009507513-2204USA009330:
her left leg has a hand sized area numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (her left leg has a hand sized area numb) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced HYPOAESTHESIA (her left leg has a hand sized area numb). At the time of the report, HYPOAESTHESIA (her left leg has a hand sized area numb) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Patient presented for 2nd Moderna Vaccine on 4.19.2021.  She did not have her vaccination card with her. Moderna was administered.  When patient got home, she looked at her vaccination card and had received Pfizer for her 1st does.  When discussing with the patient, she stated that she thought she signed up for Moderna for 1st vaccine and assumed that is what she had received.  No adverse affects noted at this time.  Paitnet informed to call us if she experienced any adverse symptoms.  Patient also informed per CDC guidelines to not get another Covid vaccine.  Nurse took patient at her word that was to receive her 2nd Moderna Vaccine.
at 3 months old developed rotavirus and was subsequently hospitalized; Indication: Prevention of Rotavirus; the patient should not of received the ROT ATEQ vaccine because the mother of the patient was on Humira while pregnant; because the mother of the patient was on Humira while pregnant; This spontaneous report refers to a 2-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally, 2 ml once (formulation, strength,lot # and expiration date were not reported) for prevention of rotavirus. On an unknown date (but about 1 month later as the patient was 3-months-old), the patient developed rotavirus and was subsequently hospitalized. The patient should not received the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) because the mother of the patient was on adalimumab (HUMIRA) while pregnant (foetal exposure during pregnancy, product use issue). On an unknown date, the unspecified treatment was given to the patient. The outcome of the events was not reported. The causality between the event of drug ineffective and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was assessed to be related. The causality assessment between the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and the event of rotavirus infection was not provided.
HEADACHE; FEVER; CHILLS; ACHES; FATIGUE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced aches. On 06-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever, chills, aches and fatigue was not reported. This report was non-serious.
Light headed, tight chest, rapid pulse B/P 112/78, HR 84 regular, 99% ox sat. Refused 911 transport to ER. Friend transported her to ER.
Within 12 hours of vaccine became dizzy and was extremely dizzy. She could not walk.
Approximately 18 hours post injection I began running a fever with severe body aches and headache. 24 hours after onset of initial symptoms, I developed diarrhea. 72 hours after injection, I noted a large painful lymph node in the axilla of the injection side. Fever and malaise continue in addition to cough and chest tightness
I got the booster on Friday the usual pain on my left arm started, then the fever, Saturday pain in the back, waist, Abdomen, with fever, ends at 6:00pm after I took the Tylenol, next morning Sunday, nothing more than the pain in the shot spot, and then I start feel something strange in my right arm from the back side like a burn not a pain , when i touch it, went up to the shoulder and get down to the back of the shoulder. Monday  woke up with pain in my left shoulder as well, which is the arm I got the shot in.
Swollen glands under arm, proceeded to swell through 7/14 down arm further to side around the serratus anterior; also pain at injection site.
Information has been received from a physician concerning a female (age unknown), who, on an unspecified date, was vaccinated with a dose of Gardasil.  Subsequently the patient "had alot of anxiety and passed out."  At the time of the report, the patient's outcome was unknown.  Additional information is not expected.
Acutely short of breath several hours after flu vaccine. Brought to emergency room from home. Found to have angioedema. Nasally intubated for airway protection. Treated with steroids. Extubated approx. 2 days later.
AFTER THE VACCINE, SHE FELT HER TONGUE WAS ITCHY. ON SITE EMS/PHYSICAN RESPONDED.  SHE WAS EVALUATED AND GIVE DIPHENHYDRAMINE 25MG CAPSULE.  VITALS BELOW. SHE REFUSED TO GO TO THE HOSPITAL.
Husband called pharmacy evening of 10/26/16 stating she had red, hot, itchy, swollen (half golfball size) area around injection site. Pt appeared at pharmacy around 11:30 am 10/27, stating itching subsides w Benadryl and area has not worsed. swelling has reduced somewhat.
One week after my vaccination I developed itching and hives like rash. Every day it continued to get bigger. Itching stopped after two days. Rash kept on increasing in size for one week.  It increased to 4 x 6?. Itching periodically. After one week it seems to be lightening up and not increasing. This is now day eight.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in an unspecified number of adult patients who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm, swelling arm and erythema of extremities. On an unknown date, the outcome of the pain in arm, swelling arm and erythema of extremities were recovered/resolved. It was unknown if the reporter considered the pain in arm, swelling arm and erythema of extremities to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable for this report. The healthcare professional reported that multiple patients experienced mild to moderate soreness of the arm, redness and swelling. The adverse events lasted for a couple of days. The reporter did not wish to share any patient or vaccine information. The healthcare professional stated that all patients that reported these side effects did fully recover from them.
Seriousness criteria other medically significant (OMIC). Initial report received on 5/11/2006 from a health care professional. An 89 year old male patient with an unknown medical history, had received an influenza vaccine in the right deltoid on an unspecified day in Sept 2005. the trade name, manufacturer, lot number, and route of administration were not reported. Within a week of receiving the influenza vaccine, the patient developed right shoulder pain and was unable to move his arm. He required medical evaluation, and was treated with steroid injections. Per the reporter the patients influenza vaccination was administered with a 25g one inch needle and may have been administered higher up on the deltoid near the shoulder joint than in the recommended area of the deltoid muscle. At the time of this report, the patient was in rehabilitation and the range of motion in his right arm was improving. The reporter stated that another patient experienced the same reaction following vaccination, but may have only received pneumococcal vaccine. No patient identification or other details were provided for this second patient.
Patient took one capsule every day for 3 days starting May 6, 7, 8.
Presented to the ER on 8/31/21 complaints of shortness of breath apparently was recently is treated with Levaquin for a lung infection along with steroids which he completed approximately week ago.  He also does complain of some fevers, intermittent cough, body aches, malaise, lack of act diet.  No nausea vomiting abdominal pain.  Patient does use 2 L of oxygen at night.  He has received both doses of the moderna vaccine.   Evaluation in the ED did reveal a temperature of 97.3 pulse 90 BP was 156/73, in the ED was noted to be desaturating into the high 80s therefore was placed on 2 L of oxygen currently saturating in the high 90s.  His workup was essentially unremarkable apart from COVID being positive influenza negative procalcitonin negative ABG did reveal a pH of 7.417 PO2 was 63.1 pCO2 40.9 white count 6.53 chest x-ray did reveal left pneumonectomy otherwise no other acute infiltrates. He was found to be mildly hypoxemic in the ED.  Was placed on 2 L of oxygen.  Currently comfortable.  Will be admitted as an inpatient, expected length of stay likely greater than 2 midnights. Will start antibiotic therapy, Decadron, remdesivir.  Found to have elevated D-dimer, CTA chest did not reveal any pulmonary embolism.  Patient was found to have DVT in his left tibial venous distribution.  Started on Eliquis. Patient gradually started to feel better and it started requiring baselines oxygen and was discharged home.
Possible SIDS. Mother found infant at 06:57 on 5/9/01, lying prone in his crib (stiff and cold). Paramedics responded to 911 call and pronounced the death. No trauma or injury found. Information obtained from Sheriff-Coroner's initial death report. Unable to contact mother. On 8/9/01, dx received from Deputy Coroner of blunt force traumatic injuries of torso.
Mild fatigue, muscle soreness within 2 hour following booster. After awaking from a 1 hour nap at 6pm, left arm sore and hurt to put pressure on. Around 7pm hot flashes and chills occured until the next morning. Overall worsened full body soreness. Difficulty sleeping due to arm discomfort, soreness, and body temperature fluxuation. 1 500mg tylenol taken at 11 pm which made sleeping easier.   Next day, 12/4, felt mild lightheadedness and fatigue persisted for the day.  Fatigue continued 12/5 but largely diminished
Patient reported that her arm began hurting the evening of vaccine administration.  It was red and itchy and warm.  She put ice on it. Then she put heat on it.  The redness began to spread and get worse so she went to the ER. The ER told her it was an allergic reaction and gave her IV steroids, antihistamine and PEPCID.  She was prescribed a course of BENADRYL, prednisone, and PEPCID at discharge.
On 1/11/02, had cough and wheeze and then severe wheeze. Taken to ER and O2 Sats 89%. Was treated with albuterol nebs X 3 and Sats increased to 91%. Parents declined admission. By 1/11/02, all symptoms gone. Treated for 3 days with prednisolone and Zithromax.
Within 24 hours developed swelling, slight pain. Then increasing edema developed, induration at injection site and red line edge around upper arm.
Vaccine remained in the freezer past the recommended guidelines (14 days). Once discovered, Pfizer was contacted but did not have stability data to support acceptability of the product greater than 31 days in the freezer. All patients that were administered vaccine past 31 days were contacted and given an option to be re-vaccinated based on their doctor'S recommendation or health expert guidance.
Information has been received from a physician who in 1981 was vaccinated with a dose of pneumococcal vaccine 14 polyvalent. Subsequently, the physician developed a sore arm. It was noted that the physician, "did not want to report adverse event for his sore arm, said no big deal". Unspecified medical attention was sought. Further information is expected.
Headache (migraine-like) post shingles vaccination undergoing treatment by physician for headache since 7/2012.
Client presents to clinic for covid booster. Brings vax card that has one dose of Pfizer administered 03/10/2021. Review state immunization registries and find one dose of Moderna adminsted 02/28/2021. Review health information exchange and find the 02/28/2021 Moderna and 03/10/2021 Pfizer documented. Client states he was not aware of receiving two different manufacturer products. Clinician reporting event now is not aware if the event was reported at the time of administration so is retrospectively reporting.
had highfever to 104.3, ten had 2 shot seizures on evening p/shots;
sever with cellulitis; after sever itching requiring steroids and antibiotics; Hypersensitivity reaction on Right skin; hives on neck; systemic effects with vesicles forming on backs of hands; This is a spontaneous report from a contactable physician.   A 39-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 04Jan2021 (Batch/Lot Number: Ek4n6) as 2ND DOSE, SINGLE (at the age of 39 years) for covid-19 immunisation.  The patient took dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot Eh9899 with unspecified expiration date on 17Dec2020 in the right arm as 1ST DOSE SINGLE (at the age of 39 years) for COVID-19 immunisation.  The patient did not have COVID prior vaccination. The patient has no known allergies.  The patient medical history was not reported.     The patient had no other vaccine other than BNT162B2 in four weeks. There were no concomitant medications.  The patient experienced sever with cellulitis (medically significant) on 06Jan2021 with outcome of recovering, hypersensitivity reaction on right skin on 06Jan2021 with outcome of recovering, sever itching requiring steroids and antibiotics on 06Jan2021 with outcome of recovering, hives on neck on 06Jan2021 with outcome of recovering.  Additionally, the patient experiences systemic effects with vesicles forming on backs of hands on 06Jan2021 with outcome of recovering.   Therapeutic measures were taken as a result of sever with cellulitis, hypersensitivity reaction on right skin, hives on neck, and sever itching requiring steroids and antibiotics. The patient was not tested for COVID post vaccination.; Sender's Comments: Based on chronological connection to the vaccine causality between events sever cellulitis and severe pruritus and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Mother stated patient's arm was itchy and swollen from top of shoulder to elbow, swollen like twice the size, red, hot and itchy. They gave him Benadryl and Motrin and the next day she thought he had less symptoms but was maybe more swollen. Mother was following up with pediatrician
Severe vertigo like episode requiring emergency room visit. Medicated with meclizine x2 and zofran with no relief of symptoms. Attempted Brandt-Daroff maneuver with no relief of symptoms. Medicated with valium with no relief. Medicated with IV Bendadryl, IV Toradol, and IV Reglan with moderate relief.
Patient received DTAP #4 in left deltoid on 11/24/2003.  That evening, patient starting having redness, warmth in left upper extremity.  From 11/24-11/26 (when patient was seen at PMD), patient with increased warmth, erythema, pruritis.  In clinic, patients temperature: 100 rectally F.  Heart rate: 130; Respiratory Rate: 20-25.  Patient given Keflex.
9 hours after vaccine, was confused for an hour.  Then sudden chill, then blacked out for a few seconds, confused for another 30.  minutes.   EMTs checks signs -- normal.
Multiple sclerosis exacerbation secondary to Pneumovax vaccine.  As per annual follow up report: excacerbation of MS immediately after administration of Pneumovax, characterized by more dysesthesia, extreme unsteadiness in feet, difficulty with balance and weakness in legs as well as numenss and tingling.
On day 8 my injection site became raised, hard, red, hot, et half-dollar in size. I applied ice to the area that day. Within 3 days it was completely gone. It did not hurt unless I touched it.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 14:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 67 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient did not receive any Other medication in 2weeks. Covid -19 was treated with Anti-viral (COVID 19 Treatment - Brand Pfizer) from 19Nov2022 to 23Nov2022.  No follow-up attempts are possible. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness/dizziness), EPISTAXIS (Bloody nose), RHINORRHOEA (Nose dripping), INJECTION SITE PAIN (injection arm became sore) and MYALGIA (Body aches) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 10A02A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced INJECTION SITE PAIN (injection arm became sore) and MYALGIA (Body aches). On 02-Mar-2021, the patient experienced DIZZINESS (Light headedness/dizziness) and HEADACHE (Strange headaches). On 08-Mar-2021, the patient experienced EPISTAXIS (Bloody nose) and RHINORRHOEA (Nose dripping). At the time of the report, DIZZINESS (Light headedness/dizziness), EPISTAXIS (Bloody nose), RHINORRHOEA (Nose dripping), INJECTION SITE PAIN (injection arm became sore), MYALGIA (Body aches) and HEADACHE (Strange headaches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications included Anti-anxiety and Anti-depressant medications. The patient used ice packs to treat the sore arm and body aches, and peppermint oil for the headaches and dizziness.