chrisvoncsefalvay/vaers-outcomes huggingface dataset:
odd reaction; hives in her upper body; hives in her back; hives in her neck; body aches; feeling kind headache; upper left arm started swollen; lump; very itching; all body itching; chest rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (all body itching), NONSPECIFIC REACTION (odd reaction), PERIPHERAL SWELLING (upper left arm started swollen), MASS (lump) and PRURITUS (very itching) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.     On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced RASH (chest rash). On 20-Feb-2021, the patient experienced PRURITUS (all body itching). On 25-Feb-2021, the patient experienced PERIPHERAL SWELLING (upper left arm started swollen), MASS (lump) and PRURITUS (very itching). On 26-Feb-2021, the patient experienced URTICARIA (hives in her upper body), URTICARIA (hives in her back), URTICARIA (hives in her neck), MYALGIA (body aches) and HEADACHE (feeling kind headache). On an unknown date, the patient experienced NONSPECIFIC REACTION (odd reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, PRURITUS (all body itching), NONSPECIFIC REACTION (odd reaction), PERIPHERAL SWELLING (upper left arm started swollen), MASS (lump), PRURITUS (very itching), URTICARIA (hives in her upper body), URTICARIA (hives in her back), URTICARIA (hives in her neck), RASH (chest rash), MYALGIA (body aches) and HEADACHE (feeling kind headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were supplements, blood pressure medications: Hydrochlorothiazide 25 mg and diuretic for blood pressure.
Radiating pain from joints. Extreme fatigue Lightheadedness Not able to continue giving lecture
Narrative:  66yo patient with PMH: Hyperlipidemia (SCT 55822004) Open injury, ulnar nerve (SCT 212265003) Neuropathy (SCT 386033004) Abusive emotional relationship with spouse (SCT 102901007) Tobacco dependence, continuous (SCT 1918Leukopenia (SCT 84828003) Thrombocytopenia (SCT 302215000) Depression (SCT 35489007) DM - Diabetes mellitus (SCT 73211009) Benign essential hypertension (SCT 1201005) Hypertriglyceridemia (SCT 302870006) - PHypothyroid (SCT 40930008) - Unspecified acquired hypothyroidism (ICD-10-CM E03.9) Back pain (SCT 161891005) - Backache, unArthritis (SCT 3723001) - Unspecified arthropathy, site unspecified (ICD-9-CM 716.90) Insomnia (SCT 193462001) - Insomnia, unsGastroesophageal reflux disease (SCT 235595009) - Esophageal reflux (ICD-10-CM K21.9) with Primary care and Mental health died on 11/13/2021 at unknow location and unknow cause of death. Pt had received covid vaccines on 3/3/21 & 3/31/21. Unable to assess if vaccines contributed to death but likely did not given long length of time from vaccine administration.
Very large, red, itchy, and warm to touch area on upper arm around injection site.  I contacted the pharmacy where I received the vaccine and was told to make sure it didn?t expand. I was advised to report it as it was considered an allergic reaction. My wife drew a line around the area and the redness extended well past the border. We marked the new boarder and the area expanded again.  I took a dose of Benadryl  and the area stopped expanding.  After several days the redness started to resolve but it still has not completely gone away.
Little soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little soreness) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031120A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Cholesterol.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (Little soreness). At the time of the report, PAIN IN EXTREMITY (Little soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications also included high blood pressure medication and cholesterol medication. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-066997 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-066997:Second dose
Abscess in the back.; This spontaneous case was reported by a consumer and describes the occurrence of SUBCUTANEOUS ABSCESS (Abscess in the back.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Nov-2021, the patient experienced SUBCUTANEOUS ABSCESS (Abscess in the back.). The patient was treated with DOXYCYCLINE for Back abscess, at a dose of bid, for a week. At the time of the report, SUBCUTANEOUS ABSCESS (Abscess in the back.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not provided.
Information has been received from a registered nurse concerning a 21 year old female patient with a penicillin allergy who on 27-Apr-2007, was vaccinated IM with first 0.5 ml dose of GARDASIL. On 26-Dec-3007, the patient received her third dose of the vaccine. The patient is pregnant. Unspecified medical attention was sought at the time of this report. Follow up information was received from the registered nurse who reported that in March 2008 , the ultrasound was normal at 29 6/7 weeks from her last menstrual period, the patient had preterm labor. the patient was treated with BETAMETHASONE on 21-May- 2008. The patient also had nifedipine. On 23- May- 2008 the patient took INDOMETHACIN. On 15-Jul-2008 the patient gave birth to a live born male APGAR=9/9. She was 39 1/7 weeks from her last menstrual period. The infant was reported to be normal and there were no congenital anomalies or other complications. Additional information is not expected.
I received the Moderna vaccine on Dec 28th at 12:15 pm.  I was feeling fine at the time.  At 6:30 pm on the 28th I started to have a severe headache and chills.  Through the night of the 28th and into the 29th,  I developed a fever of 101.7 before I took Tylenol.  I called my dr that said alternate Ibuprofen and Tylenol every 4 hours.  By the 3rd hour each time my fever would climb back to 101.7 and would never be lower than 100.3. On the 29th, I had a severe headache, severe joint pain to the point I could barely turn in pain, severe chills, severe muscle aches, very weak to the point I had to be helped to the bathroom, no appetite, dizziness, some confusion, very weak and felt at times I could not walk as the day progressed (maybe weakness).  My fever and other symptoms continued through the night.  I saw the dr. on the 30th - severe headache, fevers without Ibuprofen 101.3-101.7, severe muscle aches, severe joint pain throughout, dizziness, sore throat, chills.  I started on steroids and continued with Ibuprofen and had chills and drenching chills, slight shortness of breath that continued through the night, fever of 100.3, dizziness, sore throat, severe headache, severe muscle and joint pain.  On the 31st, I have a fever of 100, some chills, severe joint pain, muscle aches, very bad headache, increasing very sore throat and now losing my voice and severe headache.  I was home throughout the holiday with just my children, no visitors, no activities outside the home.  Children are home schooled.  Masks and visors worn at work, all visitors and staff wear masks.  Groceries are no-touch pick up.  No known exposures  Symptoms after vaccine were worse than actual covid, had to miss work and still feel very bad. Was unable to care for my children and barely able to care for myself after the vaccine, unlike when I had covid - I could still function.  Unsure if I should have waited longer to receive the vaccine than right after I was just feeling better.  Feeling very ill again with symptoms
Excursion information: total time out of range is 2 days with a minimum 9.2C and maximum 28.3 C with no adverse event; Initial information received on 29-Apr-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 3 month old and unknown gender patient who received diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel] which was involved in excursion information: total time out of range is 2 days with a minimum 9.2c and maximum 28.3c with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (lot number not reported and expiry date: 10-Sep-2022) via unknown route in unknown administration site as prophylactic vaccination. There will be no information on batch number for this case.  On an unknown date the patient developed a non-serious "excursion information: total time out of range is 2 days with a minimum 9.2c and maximum 28.3 c with no adverse event (product storage error)".   It was reported "HCP emailed patient information in regards to a previous temperature excursion case, see case 01078729 for additional details. Excursion information is listed below: 17Oct2021: total time out of range is 2 days with a minimum of 9.2C and maximum of 28.3C reported. 19Oct2021 @ 1:15pm: total time out of range is 30 minutes with a minimum of 12.3C and maximum of 15.6C reported. 19Oct2021 @ 2:25pm: total time out of range is 1 hour with a minimum of negative 1.8C and maximum of 1.8C reported. Additional Description of event Adverse events: Administered. No additional information provided."  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event excursion information: total time out of range is 2 days with a minimum 9.2c and maximum 28.3 c with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated with one dose of 0.65 ml live ZOSTAVAX (Subcutaneous, lot number unknown) on 30-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. The patient is scheduled to receive an unspecified corticosteroid shot (manufacturer unknown) on an unspecified date for a knee issue. The pharmacist noted that she doesn't know if the corticosteroid shot was scheduled before or after live ZOSTAVAX vaccination, but she doesn't suspect it is due to the ZOSTAVAX vaccination. The outcome of knee issue is unknown. Additional information is not expected.
Progressive local reaction.  12 cm area of redness, warmth and induration surrounding injection site.
Information has been received from a nurse concerning a currently 74 year old male patient who on 14-SEP-2010 was vaccinated with a 0.5ml dose of PNEUMOVAX 23 (667136/0499Z) into his arm. Subsequently the patient experienced swelling of the injection site and arm. No medical attention was sought. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
2nd shot yesterday-now fever; 2nd shot yesterday-now body aches /sore; nausea; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, general body pain and nausea. On an unknown date, the outcome of the fever, general body pain and nausea were unknown.   It was unknown if the reporter considered the fever, general body pain and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccinae indication. The reporter stated that, after vaccination had fever, general body pain and nausea. For the tolerence of 2nd dose refer case US2020AMR047393, reported by same reporter for the same patient.
Patient presented to ED on 08/08/2021 with difficulty breathing with h/o DM, renal transplant.  She was covid positive on presentation.  Patient had severe SOB with exertion, placed on oxygen with NC.  Patient also c/o productive cough.  Chest xray in ED was consistent with cardiomegaly and bilateral infiltrates with small pleural effusion.  The patient was admitted on supplemental oxygen which was escalated to high-flow nasal cannula, continued to worsen and required mechanical ventilation and intubation on 08/17/2021.  She was on mechanical ventilation, the patient continued to decline.  ICU course was complicated by streptococcus bacteremia and lower GI bleed which resolved with supportive transfusions and surveillance.  On 09/07/2021, patient had multiple cardiac arrests and subsequently died.
After the administration, patient reported feeling tired. next day around 10Am she woke up with flu like symptoms body aches, chills, fever, redness and swelling. Also her arm had a massive swollen hard band around most of her arm around the injection area. The flu like symptoms lasted 2 whole days. Patient got some relief with Advil as the treatment. Patient had similar reaction with the first shot, minus the swollen band around her arm.
Nausus; Headaches; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausus), HEADACHE (Headaches) and VOMITING (Vomiting) 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.   On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausus), HEADACHE (Headaches) and VOMITING (Vomiting). At the time of the report, NAUSEA (Nausus), HEADACHE (Headaches) and VOMITING (Vomiting) outcome was unknown.            No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
After patient received the vaccine, next morning after waking up, found abrasion on the inner side of her arm, it is red, and part of it is dark red, looks like scab.
This case was reported by a consumer via call center representative and described the occurrence of pain in a 65-year-old female patient who received SHINGRIX. Previously administered products included SHINGRIX (1st dose, no reaction experienced). Concurrent medical conditions included leukemia (diagnosed in 2012). Concomitant products included Aspirin, CRESTOR and vitamin D. On 30th May 2018 01:00, the patient received the 2nd dose of SHINGRIX. On 30th May 2018 08:00, 7 hrs after receiving SHINGRIX, the patient experienced pain, shivering, vomiting and headache. On 31st May 2018, the patient experienced fever. On an unknown date, the outcome of the pain, shivering, vomiting, headache and fever were not recovered/not resolved. The reporter considered the pain, shivering, vomiting, headache and fever to be related to SHINGRIX. Additional information was reported as follows: The patient received the dose of SHINGRIX at her doctor's office. The patient reported that around 8 pm on the evening of vaccination, she experienced severe achiness, bad headache, throwing up, shivering and on the morning of reporting day she had fever (1 day after vaccination). The patient declined to provide prescriber or practice demographics where she received the injection. The patient had denied permission to contact their physician.
Initial misuse report received from a healthcare professional on 25 July 2013. A 15-year-old patient (no other information was provided regarding the patient) had received DAPTACEL instead of ADACEL. No adverse event was reported. Documents held by sender: None.
Spinal Migraine; Leg weakness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Spinal Migraine) and MUSCULAR WEAKNESS (Leg weakness) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Spinal Migraine) and MUSCULAR WEAKNESS (Leg weakness). At the time of the report, MIGRAINE (Spinal Migraine) and MUSCULAR WEAKNESS (Leg weakness) outcome was unknown.            No concomitant medication reported.  No treatment medication reported.
pt recv vax & exp a rash on chest & abd;ER or MD visit was required;sx subsided;10AUG96 exp a full body rash; sx subsided;
bad headache; body hurts; been in bed; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (bad headache), MYALGIA (body hurts) and MOBILITY DECREASED (been in bed) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (bad headache), MYALGIA (body hurts) and MOBILITY DECREASED (been in bed). At the time of the report, HEADACHE (bad headache), MYALGIA (body hurts) and MOBILITY DECREASED (been in bed) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Shortness of breath, intermittent chest pain and palpitations (PVC's).   I am an RN and I used my Watch to determine the  EKG. I went to the doctor for the PVC's, wore a heart monitor, which showed same.   However I did not put it together until it was determined that heart inflammation was a problem with the MRNA vaccines.   I believe that is what I had, however we did not do an echo.   I suffered with these pvcs and sob until May 27th when it all stopped.
3:15: C/O of tightness to throat, stated he has allergies and did not take medication for today. States has Phlegm. B/p132/77, 101, 96%, H20 given.  3:05 Continued to monitor, states is feeling better after hydration. Will continue to monitor for additional 30 minutes.  3:30 122/79, PULSE 104, 02 sat remains at 96%, continued to feel better. 3:45 pt. left facility on own no further c/o, encouraged f/u with doctor.
During school, patient became very fatigued, achy, and sore. He went to bed at 7:20pm he was so tired.
Patient got a fever the following night and 6 days later got a rash, with some vomiting.
5 minutes after: Face tingly Then, sore and tongue tingly for 16 hours, headache x3 days, hard time swallowing,  sore throat about 24 hrs, extreme fatigue and chills
vial underwent temperature excursions; vaccinated someone two days after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated someone two days after the expiration date) and PRODUCT TEMPERATURE EXCURSION ISSUE (vial underwent temperature excursions) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated someone two days after the expiration date). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vial underwent temperature excursions). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccinated someone two days after the expiration date) and PRODUCT TEMPERATURE EXCURSION ISSUE (vial underwent temperature excursions) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  On an unknown date, the vial undergo temperature excursions.  On 15-Jul-2022, the vial was initially stored in the refrigerator.  The patient received 4 doses were (2 boosters and 2 second boosters).  No treatment drug details was reported.
Pt. given flumist.  Pt. stated felt fiine.  Amb. to reception area of clinic - told receptionist she wasn't feeling well - receptionist went to to get writer.  Writer immediately went to pt. finding her face down on floor.  Pt. turned onto back, alert but dazed, vitals stable - Pt. quickly alert and oriented.  Moved by w/c to bed.  Eating/drinking.  12:29pm Pt. left clinic amb. per self.  (Pt. had an approx. 3 cm. abrasing to (R) temple - seen by provider.)
KNOCKED OUT; ACHES; RESTLESSNESS; RAPID HEART RATE; CHILLS; EXTREME FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced knocked out, aches, restlessness, rapid heart rate, chills, and extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from knocked out, chills, aches, restlessness, rapid heart rate, and extreme fatigue. This report was non-serious.
BLOOD PRESSURE DROPPED REAL LOW , THEN ALSO HAD PAIN IN MY CHEST AND HARD TO BREATH
Patient came in on 12-20-12 at 3:30 pm with 4 x 4 redness & 3 x 4 whelp on left deltoid after receiving vaccines on 12-18-12. No pain with movement or touch. Mom instructed to give BENADRYL, apply cool compress, and give TYLENOL. Told to return to clinic or call if worsens or new sx.
Nurse drew up 0.4% Sodium Chloride solution from the ActHIB immunization box and mixed with the Dtap and IPV component from the Pentacel box. Sanofi was consulted. Health Department consulted. Expert Physcian said that DTap and IPV is considered a valid dose. Plan is to give HIB for completion of the Pentacel. Pt arrived on 6/17/2022 and received ActHIB.