chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchiness on the injection site; arm was sore for 2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itchiness on the injection site) and PAIN IN EXTREMITY (arm was sore for 2 weeks) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. not have the card) for COVID-19 vaccination.     Concomitant products included IBUPROFEN from 01-Feb-2021 to an unknown date for Toothache, METOPROLOL, AMLODIPINE, ATORVASTATIN and CLOPIDOGREL for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced INJECTION SITE PRURITUS (itchiness on the injection site). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore for 2 weeks). At the time of the report, INJECTION SITE PRURITUS (itchiness on the injection site) and PAIN IN EXTREMITY (arm was sore for 2 weeks) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: TCR Form attachedphone number provided was added. Email provided was added.
Right deltoid area red and swollen - deltoid diameter approximately 22.5cm. After 3 doses of Ibuprofen and BENADRYL, redness and swelling almost completely resolved.
Itching at site of injection spread to entire upper arm then to body this lasted about 2 days.  Then have muscle aches and pains.  Feel feverish and sore throat.
Fever of 105, vomiting, loss of appetite, pain, sleeplessness.
Abdominal pain, back pain, lethargy, extreme weakness, no appetite, fevers, tremor in hands, inability to stand or walk. Patient was hospitalized 3 times so far since this vaccine was administered.  Endless tests have shown little except continuous elevated WBC, sed rate and CRP blood past 6 weeks, MRI of brain and spine showed white matter lesions consistent with ADEM and possible transverse myelitis.
Tenderness localized with movement at the site at 12 hours noticed with significant swelling, firm raised area with defined border 4.5 by 3.5 cm, width by length, heat, and redness.  Site of swelling is 4 fingers width below the Deltoid at the Subcutaneous region of the lateral Left Arm in the region of the Bicep. Itching began on day 6.  Applied Ice to the site over time and tenderness now limited to moderate palpation, redness, swelling, heat reduced from moderate to mild with continued Ice Application.  Border region reduced to 3 by 3.5 cm width to length.
This spontaneous report as received from a Registered Nurse who reported that improperly stored GARDASIL may have been administered (demographics and number of doses unspecified) since 20-JAN-2014 (case opened on 07-FEB-2014), no administration was reported during the call). No adverse event reported. GARDASIL was exposed to temperatures of 32.2 F for 17 hours. The product would not be adversely affected by this specific temperature excursion. Additional information is not expected.
High fever 104+ seizures and not eating.  She was admitted to the hospital.  The next time she got vaccines she had seizures and high fevers too.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown demographics. No concurrent condition, medical history or allergy/drug reactions were reported. The nurse reported that on an unspecified date, an unspecified number of patients were administered improperly stored doses of PNEUMOVAX 23 injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Vertigo that is transient. Particularly vulnerable when laying down or moving in bed. It will occasionally occur midday with a change in position of my head (I am a dentist, so this is a fairly common movement.)
Severe pain in my arm and it wont let me get no sleep sometimes arm gets weak and bruising hasn't gone away.
I went into Atrial fibrillation.  I went yesterday to the hospital (Hospital).  They did a cardioversion.  Then they sent me home.
HIGH PITCH CRYING HOURS AFTER VACCINE, THE CRYING GOT WORST AS DAYS WENT BY, MY BABY WAS A CALM AND HAPPY LITTLE GIRL BEFORE THE VACCINES. SEVERE STARTLENESS TO ANY NOISE, LOSS OF APPETITE. BEFORE VACCINE, SHE WOULD TRY CRAWLING AND COOING A LOT, WEEKS AFTER VACCINE, SHE STOP BOTH. JAN 4TH, 2007 PATIENT WAS DIAGNOSED WITH SPASTIC DIPLIGIA AND CEREBARAL PALSY. PATIENT NEVER RECIEVED ANY MORE SHOTS AFTER HER 2 MOS.  02/16/2007 MR received from pediatrician including WCC from birth, date of vaccine as well as multiple acute care visits and well-child checks. Vax. received at 2 month well-child check (WCC) on 3/15/2006. Acute care visit 4/5/06 for URI and Right otitis media. Acute care visit 6/18/06 for AGE. 6 month WCC with parental c/o child being fussy. Vaccines refused. Impression: Bilateral Otitis Media. Acute care visit 8/26/06 for Right Otitis Media. Acute care visit 8/30/06 for c/o rash. Impression: Left Otitis Media, Roseola. Acute care visit 11/1/06 for parental c/o baby not sitting or crawling. PE: DTR's 3-4+. Impression: Spastic Diplegia, slow weight gain.  Neuro consult. Acute care visit 11/16/06 Impression: Feeding problem, DD (devlopmental delay) Acute care visit 12/4/06 Impression: URI, cough. Failure to Thrive (h/o Spastic Diplegia). 12 month WCC in 1/07 followed by 2 acute care visits for BOM/Bronchiolitis, and Diarrhea. /pc 02/21/2007 MR received from Neurologist.  Motor exam shows relative axial hypotonia and spasticity of the legs bilaterally with increased reflexes. Otherwise WNL.  Impression:  Positive paraplegia, 4 month cerebral palsy. MD recommended child resume immunizations as there is no contraindication for using immunizations in this child.
Reported to us that patient was diagnosed with GBS at Medical Center via phone call from MD 10/16/2018.
Cellulitis, left thigh with redness and warmth. Had fever for 1 day, post vax, then developed 6cm X 8cm region of erythema over left anterior thigh. Keflex started on 9/13/00. Admitted 9/14/00 for IV Claforan. He had marked swelling of left thigh and increased induration. He was having obvious discomfort in the thigh. He was also treated with warm moist packs to the left thigh, ibuprofen and Tylenol with codeine elixir for refractory pain. He was discharged home on Suprax and ibuprofen with follow-up on 9/18/00.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 09-APR-2018, the patient was vaccinated with improperly stored PROQUAD (dosing details were not reported) (lot # N028444, expiry date: 09-APR-2019) for prophylaxis the vaccine was administered with properly stored sterile diluent (MERCK). The vaccine was stored at a temperature of  14 degree Celsius to -10 Celsius (-9.9 degree Celsius) for 17 hours and 11 minutes. No previous temperature excursions reported. No adverse effects reported. No product quality complaint involved. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1804USA007886.
Patient wore a cloth mask.  Medical assistant and I wore loop mask.  Patient received second Moderna 3 days ago.  Patient started to experience swelling in left supraclavicular area and lower area of neck as well as rash in that area and back of neck.  Patient also reports feeling of tightness and swelling under her arm.  Injection site area warm and swollen and left upper deltoid.   Rash This is a new problem. The current episode started in the past 7 days (2 days). The problem has been gradually worsening since onset. The affected locations include the left arm, left shoulder and neck. The rash is characterized by redness. Associated with: Maternal COVID-19 vaccine. Associated symptoms include fatigue. Pertinent negatives include no congestion, cough, diarrhea, fever, joint pain, rhinorrhea, shortness of breath, sore throat or vomiting. (Positive for swelling and tightness under her left arm and armpit, Negative for shortness of breath, tightness of throat swelling of tongue) Past treatments include nothing. The treatment provided no relief. There is no history of allergies, asthma or eczema.      The following portions of the patient's history were reviewed and updated as appropriate: allergies, current medications, past family history, past medical history, past social history, past surgical history and problem list.   Review of Systems Constitutional: Positive for fatigue. Negative for chills and fever. HENT: Negative for congestion, rhinorrhea, sore throat and voice change.   Respiratory: Negative for cough, chest tightness, shortness of breath, wheezing and stridor.   Cardiovascular: Negative for chest pain. Gastrointestinal: Negative for diarrhea, nausea and vomiting. Musculoskeletal: Negative for arthralgias, joint pain, myalgias and neck pain (swelliing).       Left upper arm and deltoid at area of injection red, warm, swollen  Skin: Positive for rash (neck anterior and posterior, as well as swelling in the supraclavicular area). Neurological: Negative for dizziness and headaches. Psychiatric/Behavioral: Negative for sleep disturbance.  All other systems reviewed and are negative.
flu like; sweats chills; sweats chills; fever; vomiting; extreme tiredness; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 09Aug2021, this case now contains all required information to be considered valid.  This is a spontaneous report from two contactable consumers (patient's wife and patient). A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in deltoid right on 02Feb2021 08:45 (Batch/Lot Number: EL9265) as single dose for covid-19 immunisation. Patient age at vaccination was 76-year-old. Medical history included blood pressure, cholesterol and COPD (chronic obstructive pulmonary disease). Concomitant medications included lisinopril taken for blood pressure from an unspecified start date to 22May2021; pravastatin taken for cholesterol from an unspecified start date to 21May2021; salbutamol sulfate (PROAIR HFA) taken for chronic obstructive pulmonary disease from an unspecified start date to 22May2021. After 1st dose, withheld the evening of vaccine (02Feb2021) his s/s were flu like, sweats chills, fever, vomiting lasting 2-3days with extreme tiredness. Did not go to urgent care even the requested by family. Outcome of s/s were flu like was unknown. Outcome of extreme tiredness was not resolved. Outcome of other events was resolved in 2021.  Follow-up attempts are completed. No further information is expected.
itching; swelling in the size of a lemon; redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (swelling in the size of a lemon) and VACCINATION SITE ERYTHEMA (redness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (swelling in the size of a lemon) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (swelling in the size of a lemon) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by reporter. Treatment medication not reported.   This case was linked to MOD-2021-044150, MOD-2021-044135 (Patient Link).
Lightheadedness, felt like he was going to black out, he did not faint. He was evaluated by a MD and due to the distance of his drive home was advised to go to ER via ambulance. Seen in ER- no chest pain, nausea, or vomiting. He did have some diaphoresis. Has a history of vasovagal syncope associated with needles. Seen and released without further interventions.
syncope and briefly passed out a few minutes after vaccines administered.  Client laid on exam table and given juice.
7 days of secretory diarrhea, abdominal pain and nausea 5 pound weight loss due to inability to eat/drink regularly
Swelling at the injection site with fever in the skin, raised red hives. Severe headache lasting 48 hours. Nausea and desire to throw up, although I did not.
Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 22-OCT-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L008031 with expiration date of 03-AUG-2016; strength, dosage and frequency unspecified) orally. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I had a fever reaching up to 104 F. I took Ibuprofen and Tylenol to drop it along with applying wet towels to my forehead and armpits. My fever increased to 104 F 4 times.   Vomiting: After the first two fever spikes, I woke up feeling no fever. But, all of a sudden I vomited 5 times.   I have had tiredness, muscle pain, and a really strong headache.
No adverse event; Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    In January 2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2023, the patient experienced WRONG PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster).    This case contains information of patient 09th out of 20 reported patients.  No concomitant product reported by reporter.  Moderna monovalent vaccine was administered to approximately 20 patients from 11-Jan-2023 to 21-Jan-2023, instead of the Moderna bivalent booster.  No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704234 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704234:Master
daughter had pertussis vaccine at 18 months in 1987 and had sz; since then had occasional sz through 1991; now has severe rheumatoid arthritis and immune;
Patient's caretaker, called today on 08/09/21 to request us to submit a report that patient passed away on June 17th due to major stroke, which is believed to be linked to the Janssen Covid Vaccine.
This is a prospective pregnancy case. This 32-year-old female subject was enrolled in a study. The subject received DTPa vaccine (intramuscular) on 25th June 2014. Concomitant products included Prenatal Vitamin. The subject's last menstrual period was on 26th November 2013 and estimated date of delivery was 2nd September 2014. The subject received Tdap vaccine at week 30 of the pregnancy and during the third trimester of pregnancy. On 25th June 2014, an unknown time after receiving Tdap vaccine the subject developed vaccine exposure during pregnancy (Non-serious). Additional event(s) included live birth. The outcome of vaccine exposure during pregnancy was not applicable. The outcome(s) of the additional event(s) included live birth (unknown). The pregnancy resulted in a live neonate with no apparent congenital anomaly. On 3rd September 2014 after 40 weeks and 1 day, the subject gave birth to a male neonate via vaginal delivery. The neonate weight 3635 grams (8lbs 0oz) at birth. APGAR scores were 9 and 10. It was unknown if the investigator considered the vaccine exposure during pregnancy and live birth to be related to Tdap vaccine.
I got the Moderna booster on the afternoon of the 18th of January 2022, after having the J&J vaccine in April 2021.  On the morning of January 19th, 2022 at approximately 6am I got up to do my normal morning chores and ended up stopping as I started to sweat profusely and  felt light headed.  I ended up  feeling like I was going to have diarrhea so went into the bathroom, called for my husband who was  sleeping and the next thing  I know I woke up with him asking if I  was ok.  I had passed  out and in the process evacuated my bowels  onto the floor as well.  I didn't feel I needed to go to the ER  as I was 1) trying to not get Covid and 2) had  means to monitor my vitals here and keep hydration going for the day.  I'm still feeling the effects of it all, the normal expected chills, headache and fever came about 3hrs after passing out and they lasted until the middle of the night on the 19th.
Her husband got complete numbness from his shoulder to his neck and jaw; it could be a heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administered in arm, administration date 26May2021 (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: HYPOAESTHESIA (non-serious), outcome "unknown", described as "Her husband got complete numbness from his shoulder to his neck and jaw"; ANXIETY (non-serious), outcome "unknown", described as "it could be a heart attack".  Additional information: Caller is not sure who to talk to. She called the CDC, and they couldn't give her information. Her and her husband got the first dose of the COVID vaccine on 26May2021. It had been like 99 days since their first day. They didn't get the second vaccine. They were both scared to get the second dose because of everything they heard about the second dose. Her husband got complete numbness from his shoulder to his neck and jaw. He said it was like the dentist gave him Novocain. It didn't wear off for 5 hours. They called his doctor and she said to call # that it could be a heart attack. Then, in regards to her getting the vaccine, she has a history of autoimmune disorders. She had a heart issue which developed after the COVID vaccine. They are now putting her on a 24 hour heart monitor. They are both scared because COVID is getting worse. They want to know if it is it too late to get the second dose 99 days apart. Her husband is really worried. They gave her vaccine high up in her arm. Her husband got his way lower than hers. She honestly didn't get side effects. Her arm didn't hurt. She did get headaches a couple of days out. They were pretty bad. She also has IBS issues. Her digestive issues got worse. She doesn't know if it was because of the vaccine or because of stress. She doesn't want to do a report. She would just like more information on the second dose. She needs to decide if she is getting the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: added event "Impending doom". Sender's Comments: Linked Report(s) : US-PFIZER INC-202101145230 similar report from same reporter;US-PFIZER INC-202101176377 similar report from same reporter.
This spontaneous report was received from an office manager referring to a 14 year old female patient. The patients' concurrent condition. medical history and past drug history were unknown. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route, lot number and expiration date were not provided). On 20-APR-2016, the patient was vaccinated with the second dose of GARDASIL 9 (lot # L018351; expiration date 11-AUG-2017) (dose and route were not provided). Concomitant therapies were unknown. The primary reporter stated that the second dose of GARDASIL 9 underwent a previously supported temperature excursion. It was unknown if there was any relevant tests performed. At the time of the report, it was unknown if the patient continued with the last dose of GARDASIL 9. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse referring to a patient of unknown age and gender on 20-OCT-2017. There was no information about patient's concurrent conditions, medical history or concomitant medications. On 13-SEP-2017, the patient was vaccinated with improperly stored VARIVAX lot # N012131 and expiration date of 17-APR-2019, (route of administration and anatomical location were not reported) for prophylaxis, reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (lot # unknown), The vaccines were stored in the range of 6 Farenheit degrees to 14 Farenheit degrees for 3 hours and 40 minutes. No previous temperature excursion was reported. The patient did not experience any adverse events. Digital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA007342: US-009507513-1710USA014743: US-009507513-1710USA014744: US-009507513-1710USA014745: US-009507513-1710USA014747: US-009507513-1710USA014748: US-009507513-1710USA014749:
Returned to clinic area after 15 minutes with SOB and loss of voice. Had administered albuterol prior to coming in room. 911 called. Administered .3 cc epinephrine. Right arm after tourniquet placed above injection site left arm. Felt better 2 minutes later. EMS arrived and took pt to hospital.
Information has been received from a mother of triplets who reported that two of her triplets have received the second dose of varicella virus vaccine live and have experienced low grade and persistent fevers that spike at night. This report is concerning one of the triplets, a 7 year old female with no known medical history or allergies who on 26-Jan-2007 was vaccinated with varicella virus vaccine live  (Oka/Merck) in her arm. (unknown which arm or specific route). There was no concomitant medication. On 02-FEB-2007 or 03-FEB-2007 the patient experienced a low grade fever. The highest the fever has been was 101-102 degrees F. the child had also experienced chills and can't get warm. The fevers have been going on for 18 to 19 days now. On 22-FEB-2007, the patient underwent laboratory evaluation which included a CBC and Lyme disease test (results not provided). Additional information has been requested. The sister's experience following vaccination is discussed in WAES #0702USA04015.