chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Loss/Changed- Taste; Loss/Changed- Smell; Redness at injection site; Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Loss/Changed- Taste), PAROSMIA (Loss/Changed- Smell), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L0A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). On 27-Jan-2021, the patient experienced TASTE DISORDER (Loss/Changed- Taste) and PAROSMIA (Loss/Changed- Smell). At the time of the report, TASTE DISORDER (Loss/Changed- Taste) and PAROSMIA (Loss/Changed- Smell) outcome was unknown and VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
The day after the vaccine my right hip locked up. It was very stiff and sore and there was a sharp pain while going from standing to sitting and in the sitting position. It was a very sharp pain that was shooting down my leg and it wrapped around my hip. It was a constant pain. I also had a little soreness in my neck and shoulders and it lasted two days. I went to see my chiropractor the next afternoon. It was better after that visit and it is still a little stiff after two weeks. I took Ibuprofen as needed since then.
Chills, body aches, nausea (no vomiting), severe fatigue lasting 12-18 hours
She received the vaccine in her left deltoid.  He upper arm became very sore and swollen shortly after the vaccination. Then five days after the vaccination she developed a tender supraclavicular 2.5 cm lymph node.  She has not had any other symptoms of illness.  She has not had fevers, chills, night sweats, or other adenopathy.  She does not have hepatosplenomegally.  Otherwise she seems to be in her usual state of good health.
This spontaneous report was received from a nurse and refers to unspecified number of patients of unknown age and gender. No medical history, current conditions and concomitant therapies were reported. The nurse reported that on unknown dates unspecified number of doses of improperly stored (Merck) VARIVAX (lot # L003775, expiration date: 02-APR-2017 and lot # J014407, expiration date: 13-NOV-2015) had been administered to unspecified number of patients. No adverse effects reported. Additional information is not expected, as the reporter did not wish for any further contact.
Swelling and pain in armpit; Swelling and pain on collarbone; Swelling in armpit and on collarbone; Soreness; Tiredness; Stiffness in right arm; injection site swelling; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE SWELLING (injection site swelling), MUSCULOSKELETAL STIFFNESS (Stiffness in right arm), FATIGUE (Tiredness), PAIN (Soreness) and AXILLARY PAIN (Swelling and pain in armpit) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE SWELLING (injection site swelling) and MUSCULOSKELETAL STIFFNESS (Stiffness in right arm). On 08-Feb-2021, the patient experienced FATIGUE (Tiredness) and PAIN (Soreness). On 09-Feb-2021, the patient experienced AXILLARY PAIN (Swelling and pain in armpit) and BONE PAIN (Swelling and pain on collarbone). 09-Feb-2021, the patient experienced SWELLING (Swelling in armpit and on collarbone). The patient was treated with PARACETAMOL (TYLENOL) in February 2021 for Adverse event, at a dose of UNK dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) in February 2021 for Adverse event, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE SWELLING (injection site swelling), MUSCULOSKELETAL STIFFNESS (Stiffness in right arm), FATIGUE (Tiredness), PAIN (Soreness), AXILLARY PAIN (Swelling and pain in armpit), BONE PAIN (Swelling and pain on collarbone) and SWELLING (Swelling in armpit and on collarbone) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. It was reported that 6 hours after vaccination, the patient had injection site swelling and stiffness in right arm.   This case was linked to MOD-2021-031080 (Patient Link).
10 days s/p vaccination, I developed severe headache.  Seen in urgent care and diagnosed with bilateral ear infection and acute sinusitis. Treated with antibiotics and medrol dose pack. Sxs persisted Upon completion. Seen by ENT today and thought to be migraine triggered by vaccine. No history of migraines .
Case number PHEH2014US015199 is an initial spontaneous report received from a consumer (patient) on 28 Jul 2014. This report refers to a female patient of unknown age. Her medical history and concomitant medication were not reported. She was vaccinated with the first dose of RABAVERT (batch number: not reported) via intramuscular route on 23 Jul 2014. She was also taking sulfamethoxazole and trimethoprim (unknown manufacturer) via unknown route at unknown dose for bacterial infection from an unknown date. She stated that soon after receiving the vaccine, she began to feel lightheaded and experienced a headache. She also experienced a numb sensation on the tongue and swelling of the tongue around this time. The patient recovered from headache and lightheadedness within a day. Outcome for numb sensation on the tongue and swelling of the tongue was reported as condition improving. The reporter was not sure whether RABAVERT or the antibacterial drugs have contributed to the events. The seriousness was not reported.
TWO DAYS AFTER IMMUNIZATOIN LEFT SHOULDER (MUSCULAR) PAIN AGGRAVATES PT. WHEN HE TURNS HIS HEAD AND IT RESTRICTS MOTION WHEN TRING TO LOOK LEFT.  PT. RECEIVED IMMUNIZATION IN HIS LEFT ARM.  PAIN PRESISTS HAS NOT SUBSIDED.
Well child check (12 month) 10/18/16, received, PCV13, MMR, Varicella, Hep A Developed rash on belly today (10/29/16) Afeb.
Patient became lightheaded and was not able to hear or see and was unable to respond appropriately to questions.  Patient was laid on her back and began to recover. 911 was called and they responded. Her BP, HR and Oxygen levels were WNL when the EMT squad came.
Information has been received from a Licensed Practical Nurse concerning a 9 week old male patient with "none" drug allergies or reactions and who had diarrhea "the day before the vaccine was administered" (on 24-MAR-2011). On 25-MAR-2011, the patient was vaccinated orally with the first 2 ml dose of ROTATEQ (Lot#669084/1653Z, expiration date unspecified). Concomitant therapy included ACTHIB and TRIPEDIA administered on the same day. The nurse reported that "a few hours later" after the patient was vaccinated, he experienced vomiting. On 25-MAR-2011, the patient was taken to the emergency room and was admitted to the hospital. It was reported that the patient's stool was positive for Rotavirus but no blood noted; the patient also had "numerous unnamed tests" performed in the hospital (results not provided). As treatment the patient received Intravenous fluids (unspecified). On 27-MAR-2011 the patient was discharged from the hospital. On 28-MAR-2011 the patient went to the physician office for follow up. At the time of the report the patient was recovering. The reporter considered vomiting and stool was positive for Rotavirus as other important medical events. The reporter did not consider the events as disabling or life threatening. The reporter felt that vomiting and the stool was positive for Rotavirus were not related to therapy with ROTATEQ. Additional information has been requested.
SWELLING AND FEVER AT SITE. RING CIRCLING AROUND ARM. PT STATED FLU LIKE FEELINGS.
Approx 6 weeks after patient received flu vaccine patient c/o soreness left upper arm. Came to Health dept. No tenderness, bruising or knot noted. Client then went to his pvt MD. X-rays were taken of left arm, came out neg. Returned to Health dept. still c/o left arm pain.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about concomitant medication and medical history was not provided. On an unknown date, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX23 (injection, lot # L014458, expiration date 11-FEB-2017, 1 dose, frequency unknown) intramuscularly for prophylaxis. No adverse effects reported. Additional information has been requested.
Immediately after administration of vaccine pt began to feel nauseous and became diaphoretic. Pt laid her head on table and continued to feel nauseous, lightheaded, and sweaty.  0822 BP72/52, HR42, SpO2 97% 0825 laid pt supine on floor per her request 0828 BP70/48, HR56, SpO2 97% EMS called 0830 BP68/46, HR50, SpO285% 0833 BP80/52, HR61, SpO292% 0835 HR48 EMS arrived and assumed care 0900 EMS reported pt recovered and sent home via private vehicle
Discharge Provider: MD Primary Care Provider: MD Admission Date: 2/9/2023 Discharge Date: Feb 13, 2023  PRESENTING PROBLEM: Palpitations  Dizziness Hyponatremia  Generalized weakness  COVID-19 COVID-19 virus infection   HOSPITAL COURSE: 84 year-old female with a medical history of HTN. She came to the ER for dizziness and heart palpitations.   In the ER CBC was unremarkable. CMP with hyponatremia of 129. COVID POSITIVE. EKG NSR without ischemic changes. CXR negative.   Patient stayed in hospital for approximately 4 days.   Patient was given normal saline for her hyponatremia.  This had shown improvement and had remained to be stable off IV fluids around 130's.    Her TSH had been checked for her complaints of palpitations and this was elevated with normal free T4.  Recommended that TSH be checked in 6 weeks.   Her COVID-19 infection.  Patient has been monitored.  Lovenox given for DVT prophylaxis.  She was also given total of 3 doses of remdesivir with her liver function monitored.   Chest CT was performed  to evaluate the questionable lesion seen on chest x-ray.  This showed oval mass in the right lung apex and smaller lesion in the left lung apex that may represent benign or malignant process and that follow-up imaging recommended for there was no available prior imaging for comparison.   Patient had remained stable throughout hospital stay.  PTOT evaluation completed and recommended home with assist.   Patient was discharged home in stable after completion of 3 doses of remdesivir.
PATIENT EXPERIENCED NEUROPATHY PAIN RADIATING UP RIGHT ARM AND INTO NECK.
Aprox 24 hrs after vaccine I had extreme pain in my left upper jaw tooth rear tooth, I mean extreme like the tooth was dying , then headachy on the left side of my head, and then extreme tiredness!  The tooth pain has reduced to a mild pain but still hard to eat, the extreme tiredness has lessened a little buy today the 21st  it is still there!
3 SPOTS ON LUNG IN CAT SCAN / THE LUMPS IN LUNG; BREAKING OUT INTO GOOSEBUMPS; DRIPPING SWEAT; FEELING DIZZY; FEELING HOT; FEVER; NAUSEA; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's past medical history included: kidney with cancer, adrenal gland issue, and left kidney removal. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the patient experienced dripping sweat. On 09-APR-2021, the patient experienced feeling dizzy. On 09-APR-2021, the patient experienced feeling hot. On 09-APR-2021, the patient experienced fever. On 09-APR-2021, the patient experienced nausea. On JUN-2021, Laboratory data included: Computerised tomogram (NR: not provided) normal. On 09-JUL-2021, Laboratory data included: Computerised tomogram (NR: not provided) the lumps/spots in the lung. On 25-JUL-2021, the patient experienced 3 spots on lung in CAT scan / the lumps in lung. On 25-JUL-2021, the patient experienced breaking out into goosebumps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from  3 spots on lung in CAT scan / the lumps in lung, nausea, breaking out into goosebumps, dripping sweat, feeling dizzy, feeling hot, and fever. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Felt like having a stroke; Rash on the injection site/rough, not raised, rectangular area probably 4x4 inches large, creeping down to her elbow, very uncomfortable, bruised and feeling hot, crimson red in color.; Rash on the injection site/rough, not raised, rectangular area probably 4x4 inches large, creeping down to her elbow, very uncomfortable, bruised and feeling hot, crimson red in color.; Feet and joint problem. Burning on her feet, flaring joints and toes, a lot of discomfort; She had feet and joint problem; a lot of discomfort; Rash on the injection site/rough, not raised, rectangular area probably 4x4 inches large, creeping down to her elbow, very uncomfortable, bruised and feeling hot, crimson red in color.; This is a spontaneous report from a contactable consumer. This 57-year-old female consumer (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 31Aug2021 as dose 2, single for COVID-19 immunization. The medical history of the patient included right knee and left ankle reconstruction (partial allograft) in the past 13 months, 2 strokes in the past, overall 17 surgeries over the last 20 years, history of PTSD with ongoing therapy and was immunocompromised. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 30Jul2021 as dose 1, single for COVID-19 immunization. On an unknown date the patient experienced rash on the injection site. It was described as rough, not raised, rectangular area probably 4x4 inches large, creeping down to her elbow, very uncomfortable, bruised and feeling hot, crimson red in color. She had feet and joint problem. Burning on her feet, flaring joints and toes, a lot of discomfort and felt like having a stroke. Caller even mentioned asking for her insurance company for a home support due to the event. Caller also reported that she came to the pharmacy she had her shot and they said that they did not find anything similar to the event she reported. Caller wanted to know on how she can check if she is allergic to the vaccine. The outcome of events was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
patient received vaccination. upon leaving immunization room, patient fainted. patient recovered and was observed for 30 minutes afterwards. mom took patient to er as a precaution to have patient checked out
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 04-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Stopped menstrual cycle; This is a spontaneous report from a contactable consumer (patient). A 47-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 18Mar2021 00:15 (at the age of 47-years-old) as dose number unknown, single for covid-19 immunization. Medical history included fibromyalgia, spondylolisthesis, cervicalgia, cervical spondylosis, lumbar canal stenosis, chronic constipation, insomnia from an unknown date and unknown if ongoing. Concomitant medications included cyclobenzaprine; duloxetine; linaclotide (LINZESS); losartan.  The patient previously took lyrica and experienced allergy. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. On 18Mar2021, the patient experienced stopped menstrual cycle. The patient visited physician office for the adverse event. Therapeutic measures were taken as a result of adverse event was blood tests. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Modern a COVID-19 Vaccine EUA Several days after receiving the shot, my arm has been very itchy at the injection site. Today  is one week since my vaccination and it is still itchy. It's seems to be getting a little worse and not better.
Hospitalization for Sepsis due to UTI from chronic indwelling Foley catheter and COVID-19 infection on dates 5/3/2023- 5/13/2023. Treated with dexamethasone, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
My hair is falling in large amounts. Which before the vaccine i never had that problem. When i wash my hair i need to sweep the bathtub. Daily i have to constantly be removing hair from my shoulders.
bad headache with first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 13:50 (Lot number: EN6203) at the age of 76 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hip replacenent" (unspecified if ongoing), notes: Additional Information for Other Conditions: 4 years ago First right then 2 months later left; "knee replacenent" (unspecified if ongoing), notes: Additional Information for Other Conditions: 6 years ago both 2 months apart. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 25Feb2021, outcome "recovered" (26Feb2021), described as "bad headache with first dose". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller received the first dose of the Covid-19 vaccine on 25Feb2021. She experienced bad headaches. She received the second dose on 17Mar2021. She had a CT scan that showed a blood clot in her lower abdominal area. She would have another CT scan on 06May. She is not sure what they would do because the nerves are wrapped around it. No other products. Patient had no other medical History (including any illness at time of vaccination). Family Medical History Relevant to AE(s): None.  No follow-up attempts are possible. No further information is expected.
no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-APR-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R002086, expiry date 22-APR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
The patient fainted post vaccination. He did not come to immediately and EMS was called as a precaution and the patient was assessed and found to be fine. The patient states this is common for him.
presenting the hospital ED for shortness of breath. Patient diagnosed Covid positive in outpatient setting. Patient reports progressive symptoms including body aches, nausea, decreased appetite, shortness of breath. Patient hypoxic on EMS arrival. 74% on room air
Report  fatigue, fever and headache the next day after receiving vaccine. Treatment: Tylenol and urgent care visit.  Outcome: did not interfere with ADLs, tested for COVID at urgent care which was negative. Able to return to work on 2/15/21.
The day after her first Moderna COVID-19 shot (3/14/2021) she developed groin pain that lasted for about 2 days before going away, but then on 3/16/2021 she developed Chest Pain in her mid-chest and associated shortness of breath which did not go away, so she went to the emergency room on 3/17/2021 and was diagnosed with a Pulmonary Embolism. (I assume the groin pain was cause by a blood clot in her upper leg that moved up into her lungs.)
Pt developed headaches several weeks after her vaccine.  She was working out and  developed severe Headache and was seen in the ER.  She was diagnosed with Idiopathic Intracranial Hypertension.
Received tetanus booster (TD VACCINE) on 3/19/07 in the right arm.  The needle went in easy, but the serum stung going in.  There was no swelling or redness at any time.  Arm became increasingly sore on a daily basis until deep pain immobilized the arm.  A phone call was made to the Clinic and patient was told to take 600 mg of Ibuprophen every 4 hours for a week.  Patient finally went into the office again on 03-28-07. Ms. Smith-Leach determined that it was a "frozen" muscle and gave patient a supply of sample muscle relaxers and demonstrated two exercises for regaining mobility.  The muscle slowly started an "unfreezing" process. At this writing (04-02-07), most of the pain is gone and most of the mobility is back but not all.
Other complications following immunization, not elsewhere classified, initial encounter on 2022-02-24.
Rash; shingles; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and HERPES ZOSTER (shingles) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history.).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced RASH (Rash) and HERPES ZOSTER (shingles). At the time of the report, RASH (Rash) and HERPES ZOSTER (shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were given  treatment information was provided as Valacyclovir
Patient was 4 year, 11 months old at time of vaccination. When child came back with parent for 2nd dose, this was caught/identified. The child had no adverse effects. Only reporting since patient was not > 5 years old at time of vaccination. Parent was told to bring child back after 12/11/21, when they are 5 years old.