chrisvoncsefalvay/vaers-outcomes huggingface dataset:
autoimmune disease has gone; Mild Skin issue; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (autoimmune disease has gone) and SKIN DISORDER (Mild Skin issue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included Joint pain (Recovered after the administration of vaccine), Tiredness (Recovered after the administration  of vaccine) and Lupus syndrome (Patient suffered from lupus 3-4 years ago.). Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (autoimmune disease has gone) and SKIN DISORDER (Mild Skin issue). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (autoimmune disease has gone) had resolved and SKIN DISORDER (Mild Skin issue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) autoimmune disease has gone..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included cultural pre and probiotics.   Medical history includes lupus which is recovered after the administration of vaccine. patient tested highly positive for lupus in April 2020. patient lab data included she received the results for blood work that her autoimmune disease has gone. The patient pre-existing medical condition include lupus, 3-4 years ago had really bad sickness and her doctor thought that could have thrown her into autoimmune situation but said she was never diagnosed medically having autoimmune disease. patient had c-difficile about 3 years ago and after the c-difficile was treated she had health issues up until 2 weeks after the 1st moderna coronavirus vaccine.  Treatment information was not provided.   This case was linked to MOD-2021-215828 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow-up received on 30-JUL-2021 contain  Patient Demographics added and concomitant medications have been provided.
15mm area on (R) thigh at injection site; red and hot, but not tender. 8 days later, the area is still 10cm x 10cm & bluish discoloration. Pt. was treated with KEFLEX on 6.13.11 for reaction.
Patient received vaccines 4/27/15 approx. 4:30 PM. She went to the school nurse yesterday and was advised to call the Health Dept. The back of her (R) arm is swollen "4 inches long" with a depth of 1/2 to 1 inch. It was red and puffy. After ADVIL and a cold compress, she was feeling better.
VACCINE ADMINISTERED WAS IN THE FRIDGE MORE THAN 30 DAYS AS  RECOMMENDED BY THE MANUFACTURER
** Medication error WITHOUT adverse drug reaction.   A 12-year-old patient came in for their 1st dose. Received the 5-11yr Pfizer dose (10mcg/0.2mL) instead of 12 yrs and older Pfizer dose (30mccg/0.3mL).   Followed recommendation from the CDC Administration Errors and Deviations and Pfizer medical line: If a patient between 12-17 got 5-11 yrs formulation (10mcg/0.2mL) as the first dose, do not repeat dose. Instead, administer the 12yrs and older formulation (30mcg/0.3mL) 21 days after the last dose to complete the primary series.
appears that he has hypoglycemia; thought he was going to die after getting second vaccine; when he exerts himself or stands up sensation of headaches; feels tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPOGLYCAEMIA (appears that he has hypoglycemia), VACCINATION COMPLICATION (thought he was going to die after getting second vaccine), HEADACHE (when he exerts himself or stands up sensation of headaches) and FATIGUE (feels tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOGLYCAEMIA (appears that he has hypoglycemia), VACCINATION COMPLICATION (thought he was going to die after getting second vaccine), HEADACHE (when he exerts himself or stands up sensation of headaches) and FATIGUE (feels tired). At the time of the report, HYPOGLYCAEMIA (appears that he has hypoglycemia), HEADACHE (when he exerts himself or stands up sensation of headaches) and FATIGUE (feels tired) had not resolved and VACCINATION COMPLICATION (thought he was going to die after getting second vaccine) outcome was unknown.            Concomitant medications include Prostate medication.  Treatment medication was not provided by the reporter.  Patient has an appointment with an Endocrinologist in November.
This spontaneous report was received from a Licensed Vocational Nurse referring to 8 unspecified patients of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 07-NOV-2017,  08-NOV-2017, 09-NOV-2017 and 10-NOV-2017, the patients were vaccinated with improperly stored VARIVAX lot # M046924 and expiration date on 28-NOV-2018 (dose and route of administration were not reported) for prophylaxis; which was reconstituted with sterile diluent (MRK) lot # N001534 and expiry date on 30-JUL-2019. The doses of VARIVAX were exposed to a temperature excursion of 19 degrees Fahrenheit (°F) during a time frame of 2 hours 20 minutes, which was detected by the data logger. Previous temperature excursion was reported as 17.1°F for 2 hours 10 minutes and 6.4 °F for 25 minutes. No adverse events were reported. Follow up information has been received from the nurse on 16-NOV-2017. The reporter stated that on unspecified dates an unspecified number of patients were inadvertently vaccinated with improperly stored VARIVAX lot # M046924 and expiration date on 28-NOV-2018 (dose and route of administration were not reported) for prophylaxis; which was reconstituted with sterile diluent (MRK) (lot # and expiration date unknown). The doses of VARIVAX were exposed to a temperature excursion of 6 degrees °F to 14 degrees °F during a time frame of 1 hours 20 minutes and 15 °F to 46 °F for 20 minutes which was not detected by the data logger. There was a previous temperature excursions reported as 6 °F to 14 °F for 12 hours and 30 minutes; and 15 °F to 46 °F for 1 hour and 30 minutes. No adverse events were reported.
Pain at injection site. Pain in arm and shoulder which received the shot. Fatigue, nausea, vomiting, fever (102), unable to sleep.
I tested positive for COVID-19 on 6/6/22. I had body aches, chills, fever, sore throat, cough, fatigue, shortness of breath, chest pains,  and migraines. This started on 6/3/22 and I am still dealing with the symptoms at this time.
pt recv vax 7APR97 & 18APR97 pt exp a very mild rash w/one blister on hand;the child did not have a fever;
chills; sweating; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and HYPERHIDROSIS (sweating) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002021A and 028PL1A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced CHILLS (chills) and HYPERHIDROSIS (sweating). At the time of the report, CHILLS (chills) and HYPERHIDROSIS (sweating) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Pyrexia: 101.6 f (Inconclusive) Fever of 101.6 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.
Patient did not suffer adverse effect however syringe attached to the needle did come apart causing the vaccine dose to spill down his arm. I had to give another dose of vaccine- he did not get any of the vaccine at all the first time. The hub that attached to the needle broke when pressure was applied.
Vial administered was stored outside recommended temperature. First puncture was 6/23/21 @ 256pm Unable to contact patient - only phone number on file has a busy signal
The evening of the vaccination his left deltoid became swollen. The next morning swelling was from left shoulder to elbow, red and painful. He was seen at the emergency room and was determined to be a DTaP reaction.
Child was lethargic, not acting right, very agitated. Overflowing her diapers for several days. Taken to the hospital and diagnosed with type one diabetes.
10/3/19  4:10 am  woke with fever (99), chills, shivering, pain at injection site 10/3/19 6:30 pm  fever (100.4), shivering; right hip pain w/sciatic nerve irritation, pain at injection site 10/4/19 All day general malaise, fatigue, pain at injection site, redness below injection site 10/5/19 Riding in car - motion sickness, pain and redness at/near injection site
Shingles Narrative: 53yo man received first dose of COVID-19 vaccine (pfizer) on 3/19. On or about 4/1 patient started developing a painful rash on the forehead. He went to a ER on 4/4 and was diagnosed with shingles. Treated as outpatient with oral acyclovir. Patient without evidence of shingle vaccine.
Rash on arm started at injection site 6 days after injection and still continues on day 8. Rash is 1.5 inch diameter circle of red hives/rash
fever to 103 x 48 hrs; measle appearing eruption trunk-extending to extremities & face-macular;
pt recv vax & exp pain, swelling, redness & area was hot to touch from shoulder to elbow @ the inj site w/in 48hr of inj;
Constant Headaches (over left eye). Pain in left arm, loss of hearing in left ear and ringing in left ear. left jaw locking (has stopped after 2 months)
diarrhea. one the day after vaccine Stomach gurgling when eating or drinking day 2...worse when lying down Day 4 upper Stomach discomfort/Pain minor Day 5 increased pain burning sensation Day 14 still persistent
Fully vaccinated patient tested positive for COVID-19 on 9/6/21 and admitted to hospital for supportive care.
lab on 5NOV98 CBC platelet count of zero;pt adm to hosp;27OCT98 recv vax;
Severe redness, swollen arm, 101 fever, muscle aches throughout body. Nausea.
Patient received COVID-19 Moderna Bivalent 6 months - 5 years (dark pink cap with yellow label) 0.2 ml as dose #1 instead of receiving COVID-19 Moderna Bivalent 6 months - 5 years (dark blue cap with grey label) 0.25 ml
2 shots in lt arm; lt arm-swollen, hard, lumpy, bruised, red-size of twentyy five cents piece;
per death certificate, pt died at home of COVID; doctor who signed death certificate did not have any death related records per their fax;
Information has been received from a registered nurse, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 28 year old female patient with hypertension, anxiety, hypothyroidism, hypercholesterolaemia, no drug reactions or allergies and a history of 18-19 week gestation pregnancy loss possibly in 2009, who on 21-OCT-2010 was vaccinated with a dose of VARIVAX (Merck) (lot # and expire date not reported), intramuscularly. Concomitant therapy included SYNTHROID (also reported as SNYTHROID) and methyldopa (manufacturer unknown). On 05-NOV-2010, the patient was one week late for her menses and had a positive serum pregnancy test. She had one week of gestation. Her last menstrual period was approximately in September 2010 and estimate delivery date is in approximately June 2011. The patient sought medical attention in the office. Follow up information had been received from a register nurse concerning the patient who on 21-OCT-2010 was vaccinated with the first dose of VARIVAX (Merck) (lot # and expire date not reported). On 03-OCT-2010 and 07-DEC-2010, the patient had 2 sets of varicella titers done and the results of both showed negative. The nurse also verified the patient's LMP was 01-OCT-2010 and her EDD was 09-JUL-2011. On 21-JUN-2011, the patient delivered a healthy  baby boy via C-section. The baby was delivered by C-section due to breech presentation (WAES# 1011USA00857 B1). There was no complication reported with the delivery and the baby boy had no congenital anomalies. Her gestational age of neonate was 37/2. The baby's weight was 6 pounds, 12 oz. Length and H.C. information was not available. C-section due to breech presentation was considered to be an other important medical event. No additional information is available.
Patient phoned pharmacy on 2/3/2022 at 12:45 pm stating that he had an allergic reaction to the 2nd dose he received the day before. Patient states he had hives under arms. Patient states he took Allegra and Pepcid to alleviate side effects.
sore arm; cervical chain lymph nodes swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and LYMPHADENOPATHY (cervical chain lymph nodes swollen) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028120A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and LYMPHADENOPATHY (cervical chain lymph nodes swollen). On 28-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, LYMPHADENOPATHY (cervical chain lymph nodes swollen) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient stated using concomitant medication of eye drops.
Patient reported tightness in throat, lightheadedness,  and cough after the 15 minute observation period. Patient was given Benadryl and symptoms improved in 15-20 minutes.
I woke up in the middle of the night, my heart was beating very hard. I felt like my heart was going to explode. I was sweating excessively. My left arm hurt tremendously. My armpit swelled up and a swollen lymph node formed under my armpit. It was very hard. My joints, muscles, head, and skull hurt badly. I couldn't go back to sleep. I had hot flashes. My period came two days after my 2nd dose, even though it wasn't supposed to arrive around that time. My period was extremely heavy. Also, my veins in my arms are very pronounced and raised. Currently, I have frequent chest pains, I get light-headed, and my heart continues to beat really fast. Two fingers on my right hand have become numb and its painful. I still break out into full body sweats, and I have a headache all the time. I feel dizzy a lot. I am extremely fatigued all the time. I still deal with muscle and joint pain. When I went to the Emergency Room, I would pass out whenever my blood was drawn. I'm not able to physically do a lot of things like I did before the vaccine.
I had lab work done for an insurance physical and I had an elevated in my liver function so I stopped drinking alcohol and taking meds like Tylenol. I repeated 6 months later and the liver function test was still high if not higher. I also had an abnormal blood test that stated possible elevated heart function. That test was repeated and came back normal. I am to have an ultrasound of my liver to monitor it.
Patient stated that Right after she received Pfizer vaccine she experienced her heart racing and heart palpitations after that lasted for four months.
Arm was sore; Rash is on both arms, sides and back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) and RASH (Rash is on both arms, sides and back) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) 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) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced RASH (Rash is on both arms, sides and back). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore). At the time of the report, PAIN IN EXTREMITY (Arm was sore) and RASH (Rash is on both arms, sides and back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported. Patient had not used anything to treat his symptoms.
Bad Reaction to Shot, Vaccination complication; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (Bad Reaction to Shot, Vaccination complication) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TIPIRACIL HYDROCHLORIDE, TRIFLURIDINE (LONSURF) for Malignant neoplasm of colon.    Concurrent medical conditions included Malignant neoplasm of colon and Allergic reaction to drug. Concomitant products included PROBIOTIC [BIFIDOBACTERIUM BIFIDUM;BIFIDOBACTERIUM LACTIS;BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS], MULTIVITAMIN [VITAMINS NOS], DOCUSATE SODIUM (COLACE), LISINOPRIL and REGORAFENIB (STIVARGA) for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and TIPIRACIL HYDROCHLORIDE, TRIFLURIDINE (LONSURF) (Oral) 45 milligram twice a day. On an unknown date, the patient experienced VACCINATION COMPLICATION (Bad Reaction to Shot, Vaccination complication) (seriousness criterion hospitalization). At the time of the report, VACCINATION COMPLICATION (Bad Reaction to Shot, Vaccination complication) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Company comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Rt. arm rash, itching at the injection site.  Pain and swelling under armpit and rt. chest area on rt. side (injection side), no treatment given at this time, Pain continues will see MD.  Pain noted under armpit when lying on that side. Visible swelling of armpit and rt. chest area present.
Baby had all of his 8-week shots administered. He developed a nodule on the left upper thigh that has remained for over a year. The doctor was unwilling to give us the vaccine information and said any injection can cause a long-standing skin nodule.
A non-serious spontaneous report of administration of expired FLUMIST was received from a physician concerning a five-year-old patient. Neither relevant medical history nor concomitant medications have been reported for these patients. The product expired on 11-Dec-2011. The patient received the expired FLUMIST on 12-Dec-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 18-Apr-2012 and incorporated into the narrative: Patient's demographics, lot #, suspect drug information and no late occurring adverse event.
Fever and nausea beginning in the evening after administration, improved, then onset 2 days after administration of chest pain.  Presented to emergency room and subsequently admitted with diagnosis of pericarditis.  Symptoms resolved within a few hours of treatment with Colchicine
acute onset of daily headache that started on 11/6/23, involved left side of head and face, associated with numbness and tingling in face and head, some tearing of the eye on left. Has persisted. Has seen multiple doctors including primary care and neurologist and has 2nd opinion with another neurologist in near future. Has been tried on multiple medications and remains on medications  (steroids, verapamil, NSAID, Emgality, topiramate)
TIREDNESS; SKIN PAIN; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's past medical history included heart attack, and smoker, and concurrent conditions included type 2 diabetes mellitus, allergy to vodka, and immune to pain relievers.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288 expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, Laboratory data included: Pain scale (NR: not provided) 3 on a 1-10 scale, 7 out of 10. On 10-JUN-2021, the subject experienced skin pain. On 12-JUN-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiredness, and skin pain. This report was non-serious.
Mild body aches, dizziness, low-grade fever (99.4), headache.  Body aches started about 20 hours after dose, followed by dizziness and fever.  Headache lingered the longest.  All resolved approximately 30 hours after dose.
Severe headache and dizziness, low-grade fever, general malaise occurring within a half-hour of receiving 2nd dose of Gardasil vaccination.
Thrombocytopenia, liver cysts, adrenal adenoma , severe fatigue since vax, muscle aches severe since vax
Fainted and fell in bathroom. Woke up to dog licking her face on the ground and hit a hard trash can on chest when fell. Was feeling dizzy with blurred vision during the day. Headache and blurred vision next day also.
pt recv vax & w/in 5 days pt devel arthritic pain in hands, hips & knees;consulted MD;Ibuprofen prescribed which provided only mild relief;treating MD to r/o Lupus;pt states arthritis sx worsening, having difficulty walking & writing