chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccination site swelling; raised rash; Hives were uncomfortable; Hives were itchy; Deltoid muscle blew up with hives; Soreness at injection site; Redness at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE DISCOMFORT (Hives were uncomfortable), VACCINATION SITE PRURITUS (Hives were itchy), VACCINATION SITE URTICARIA (Deltoid muscle blew up with hives), VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Celiac sprue on 02-Jan-2004 and Hashimoto's thyroiditis on 07-Jan-2003. Concurrent medical conditions included Cosmetic allergy (Juvaderm cosmotic face filler. facial redness & swelling requiring oral steroid and antibiotic.) since 10-Jan-2015, Fruit allergy (Hives, itching.) since 2010 and Cosmetic allergy (Dermatitis entire scalp requiring topical steroids) since 19-Jan-2018.   On 11-Jan-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). On 19-Jan-2021, the patient experienced VACCINATION SITE DISCOMFORT (Hives were uncomfortable), VACCINATION SITE PRURITUS (Hives were itchy) and VACCINATION SITE URTICARIA (Deltoid muscle blew up with hives). 19-Jan-2021, the patient experienced VACCINATION SITE RASH (raised rash). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) on 18-Jan-2021 for Adverse event, at a dose of 1 dosage form; EPINEPHRINE for Adverse event, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. On 13-Jan-2021, VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) had resolved. On 21-Jan-2021, VACCINATION SITE DISCOMFORT (Hives were uncomfortable), VACCINATION SITE PRURITUS (Hives were itchy), VACCINATION SITE URTICARIA (Deltoid muscle blew up with hives) and VACCINATION SITE RASH (raised rash) had resolved. At the time of the report, VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient stated Yes for the question - Was the adverse event most likely caused by mRNA-1273?   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Significant follow up Appended
Extra Dose; Fever; did not want to move/Fatigue; This case was reported by a consumer via call center representative and described the occurrence of fever in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 24th January 2019) and Shingrix (2nd dose received in 24th May 2019).   In August 2019, the patient received the 3rd dose of Shingrix (intramuscular). In August 2019, not applicable after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the patient experienced fever and fatigue. On an unknown date, the outcome of the fever and fatigue were resolved with sequelae and the outcome of the extra dose administered was unknown.   The reporter considered the fever to be related to Shingrix. It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details were reported as follows: The reporter was the daughter and patient was the mother.  The patient lives with the reporter. The reporter states that her mother did not speak English very well and that she received a third dose of Shingrix, which led to extra dose administered.  The reporter did not know the exact. The reporter did not have the lot number for any of the doses.  The reporter said all three doses were given at the same pharmacy.  The reporter states that all three were given intramuscularly.  The reporter also stated that after the 3rd shot of Shingrix her mother had a fever and was fatigued for 2 days.  She said she did not want to move.  The reporter consented to follow up.
needing to sleep; sore left arm at the injection site,; chills; some muscle aches; This spontaneous case was reported by an other health care professional and describes the occurrence of SLEEP DISORDER (needing to sleep), VACCINATION SITE PAIN (sore left arm at the injection site,), CHILLS (chills) and MYALGIA (some muscle aches) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced SLEEP DISORDER (needing to sleep), VACCINATION SITE PAIN (sore left arm at the injection site,), CHILLS (chills) and MYALGIA (some muscle aches). At the time of the report, SLEEP DISORDER (needing to sleep), VACCINATION SITE PAIN (sore left arm at the injection site,), CHILLS (chills) and MYALGIA (some muscle aches) 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 medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-409964 (Patient Link).
1. Since 2nd does of Vaccine, my monthly menstrual cycle has become longer.  It is now and has been 12 days long since 2nd dose of vaccine. 2. Since March of last year (2021), I have had skin issues that have required steroid creams and daily zyrtec dose. 3. I developed a dense mass of breast tissue in my left breast (non-cancerous).
Patient complains of heart fluttering since given Moderna Covid vaccine on 4-15-21
He got his vaccine, the first reaction was early yesterday afternoon was his arm hurting him, which is similar to other COVID vaccines.  Then starting early evening through last night, through the night he got terrible side effects of chills, pains in the right side of his neck, below his ear and would keep coming and going.  Then, besides the chills had incredible fatigue (nothing like the other vaccines), and then he had really bad constipation (not a normal issue for him).  He took something for that, and then switched to diarrhea, and he could not sleep last night.  He laid in bed all night, never slept.  He got up and drank some chamomile tea and still did not sleep.  He had very bad chills, thermostat at 71, took extra blankets out and wore flannel shirt.  The pain is what bothered him that went from his ear down about 3-4".  He took some Advil which did not help much, but a heating pad did help him.   He is feeling good now.  He has never been that sick in his life.    His other vaccines were all the same, fatigue but not bad, but said that this one was bad.
Initial and follow-up information has been received from a medical assistant concerning a 17 year old female who from 01-JUL-2008 was vaccinated IM with a first dose of GARDASIL (Lot# 660553/0070X) and a second dose of GARDASIL (Lot#660616/0570X). After the first and second dose the patient developed rash and one week after the second dose was given the patient developed hives. The patient had sought medical attention, spoke to medical assistant. At the time of report the patient had recovered but the third dose had not been given. Additional information is not expected.
Lymph nodes were swollen; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 09:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included Sjogren's disease. The patient had a known allergy to sulfa (sulfonamide). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydroxychloroquine (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN); both for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 13Apr2021, the patient reported that she went for a diagnostic mammogram and ultrasound screening 5 days following the second shot and was informed that her lymph nodes were swollen, likely due to the vaccine. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lymph nodes swollen was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Pt. states that after receiving the 3rd dose of Moderna 01/07/2022, started experiencing symptoms that evening of fever (101.7 lasting 01/11/2022), chills, muscle aches, fatigue, and nausea. No noted Primary visit/communications. Symptoms have subsided after 72hrs.
Hard lump under skin 3cm medial from injection site. 3.6 cm x 4.1 cm red, itchy, painful to touch, warm to touch; Hard lump under skin 3cm medial from injection site. 3.6 cm x 4.1 cm red, itchy, painful to touch, warm to touch; Hard lump under skin 3cm medial from injection site. 3.6 cm x 4.1 cm red, itchy, painful to touch, warm to touch; Hard lump under skin 3cm medial from injection site. 3.6 cm x 4.1 cm red, itchy, painful to touch, warm to touch; Hard lump under skin 3cm medial from injection site. 3.6 cm x 4.1 cm red, itchy, painful to touch, warm to touch; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 27Oct2021 at 19:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included levonorgestrel (MIRENA IUD), vaccinium macrocarpon fruit (THERACRAN ONE), probiotic (MANUFACTURER UNKNOWN) and multivitamin (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: PAA173696) via an unspecified route of administration in the left arm on 06Oct2021 at 19:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Oct2021 at 11:00, the patient experienced hard lump under skin 3 cm medial from injection site, 3.6 cm x 4.1 cm, red, itchy, painful and warm to touch. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hard lump under skin 3 cm medial from injection site, 3.6 cm x 4.1 cm red, itchy, painful and warm to touch was not resolved at the time of this report.
Left upper arm weakness experienced while exercising. Patient could not lift left arm above head. Diagnosed with Acute Brachial Neuritis by primary care physician.  12/02/09 Office visit for DOS 09/28/09. DX: Muscle weakness, brachia neuritis or radiculitis. Pt c/o muscle weakness in upper limbs.  Review of systems: negative.  tx: bystolic. Pt scheduled for follow up visit in 1 mo.
DTaP and IPOL given right deltoid 7/2/07 AM. By 7/2/07 PM mother noted swelling of right arm from shoulder to elbow. Redness and warmth developed by Tuesday 7/3. Mother took child to Doctor on 7/5. Pt saw NP who gave client PO antibiotic per mom.
off label use; Drug use in unapproved population; fever today; sweating; chills; This is a spontaneous report from a Pfizer sponsored program via a non-contactable consumer or other non-healthcare professional (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 12Apr2021 as dose 1, single for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient has a fever that day, sweating, and chills. She was also breastfeeding. She reported adverse event online. The outcome of all the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Moderate persistent asthma with acute exacerbation - She was treated with IV lasix, steroids and broncholdilators wit clinical improvement and is feeling ready to discharge back to her group home on a slow steroid taper. She never required supplemental oxygen. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Vaccine 1/6; on 1/14 had a red, raised bump at the injection site which was itchy
11:30 shot. 12:00pm 96%sp02, nausea, double vision, 50mg Benadryl. 12:01pm 130/84mmHg, 12:07 strong nausea. 12:11pm trying to throw up, but cant, double vision still there. 12:15pm blurred vision, double vision. 12:20pm 143/83mmHg. 12:21pm 93%sp02, 69bpm. 12:42pm, blurred vision gone, still double vision. Called doctor for follow-up instructions.
Headache, NauseaVomiting, Palpitations, chills, injection site pain, redness, swelling used Tylenol Narrative: resolved 2/4  Other Relevant History:
Breakthrough case admission after 4 vaccines  Pfizer 2/19/21 Lot# En6200;  Pfizer 3/12/21 Lot# EN6207;  Pfizer 10/03/2021 Lot# FF2588;  Pfizer 4/24/22 Lot# FJ4989
Patient came in with mother/family. Patient had two Moderna vaccines with documentation provided to nurse. Mother stated the entire family received the Moderna vaccine and would not like to mix and match. Nurse did note year of birth appropriate for 18 but incorrect math, patient 17 years and 10 months.
Case previously recorded as MA2009-4189. Initial report received from a physician on 12 Nov 2009: A one year infant was inadvertently administered a dose of S-OIV FLUVIRIN (batch no 102045P1) on 10 NOV 2009. No adverse reaction occurred. Reference No: MA2009-4189.
I had the vaccine and at 2 o clock in the morning I woke with excruciating pain it felt like I broke both my legs and they swelled, more the right one than the left, I could barely walk, Tylenol did not help, the swelling got worse for over a week, the pain was the same for over a week, I still have some pain but the swelling is still there.  I did not go into Urgent care until a week because I was at work and my left leg was swollen and discolored and my heart rate.  They drew my blood checked my heart rate which was in the high 90s and jumped to 163. They did not know what was going on but did not think it was a blood clot so they sent me home. They did not prescribed any medications.
Grand mal seizure x 1. Petit mal seizure x 2. Received ZOSTAVAX 12-17-12. Above seizures 12-31-12. No prior h/o seizure.
There was no adverse event. This patient was given Pfizer vaccine #1 on 1/15/21. Pfizer lot # EL3249. She was then given a Moderna  COVID vaccine for her second dose on 2/08/21. There are several safeguards in place to ensure the same brand of vaccine is given for first and second doses. The hospital is looking into this vaccination error to ensure this does not happen again. The patient did not have her vaccination card with her for her second dose.
w/in 24-36hr fatigue, nausea, diarrhea, 6-7 days temp 101.3, extreme fatigue;
2 minute seizure. Temp 104. Admitted overnight to local hospital for observation. Discharged in the am on 10/14/2010.
Headache, neck ache, dizziness, hot and red skin.  From about 15 minutes after injection lasting for 3 hours.
Chills; fever; body and muscle aches; body and muscle aches; fatigue; This is a spontaneous report from a contactable nurse (patient). A 47-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 08Jan2021 16:45 (04:45 PM) at a single dose for COVID vaccine. There was no medical history. The patient had no known allergies. Concomitant medications were not reported. The patient previously had his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at a single dose for COVID vaccine. He had no other vaccine in four weeks. The patient experienced chills, fever, body and muscle aches, fatigue, all on 09Jan2021 08: 00 AM. Treatment was not received for the events. The patient had no COVID prior to vaccination and did not have COVID tested post vaccination. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Non-demarcated erythema, warmth, and tenderness at the injection site and right axillary lymph nodes without edema.
Patient was given first dose and was in waiting area for observation.  About ten minutes after his shot our vaccine coordinator alerted me that he was having a reaction. When I went out to the patient his eyes were open but he was staring blankly. His father was shaking him and waving his hand in front of his face and asking him if he was okay and the patient was not responding. I also tried to get the patient to respond and he did not. Since the patient was not responsive to any questions we called 911. While waiting on the paramedics to arrive the patient came around and started to answer some simple questions. He was clammy and sweating and he threw up one time. When the paramedics arrived they took over. They checked all the patients vital signs  and were with him for about 15 or 20 minutes assessing him. The patient walked out of the store on his own and was not taken by ambulance.   I called the patient around 3:10pm to check on him and I spoke with him and he said he was doing fine.
Swelling, tenderness, blotchy redness at site of Hep B vaccination. Patient complained of a severe headache and malaise. Vaccine was given on Monday, headache symptom lasted through Thursday night. As of Friday morning, swelling and tenderness was starting to subside and redness started to disappear by Thursday morning.
5/16/2021:  3pm-5pm Extreme nausea, almost passed out several times within the course of 2 hours.  5/17/2021:  8:30am  red rash on front of thighs with extreme itchiness took Benadryl and symptom resolved in 30 minutes roughly.  7pm noticed 10+ bruise-like bruises on legs. Bruises are still visible
Periorbital edema for 2 weeks that started 6 days after vaccination. Primary doctor referred me to allergist. Tinnitus in right ear started about 5 months after vaccination. 4 dose was administered on 06/29/2022 at allergist office. Started with 10% of the dose and developed an allergic reaction within 10 minutes. Doctor ordered a subcutaneous test and confirmed a positive reaction to the vaccine. Tinnitus aggravated after 06/29 and noticed some hearing loss. Audiogram conducted 07/20/2022. ENT confirmed 07/26/2022 sudden sensorineural hearing loss in right ear.
No adverse event; HCP states that they administered 16 shots to patients after their expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor. No concomitant medication was reported.  Suspect product dosage text was reported as unknown. The intact cartons of 0.5 ml of were initially stored in the refrigerator and the thaw dates were the same as administration dates as 01-Sep-2022 ,25-Aug-2022, 04-Aug-2022, 26-Jul-2022 and 19-Jul-2022. The vial did not undergo any temperature excursions. No treatment medication was reported. This case is reported for patient 11 out of 16 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-739796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739796:Master case
soreness and redness at place of injection, itchy at arm and shoulder, swelled lymph node on left, achy muscles all over,  stuffy nose
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Feb2021 as dose 1, single (Lot number: EI9267), in left arm, on 04Mar2021 as dose 2, single (Lot number: EN6202), in left arm, on 18Aug2021 as dose 3 (booster), single (Lot number: FC3181), in left arm and on 30Mar2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthropathy" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing); "Allergy to Eggplant" (unspecified if ongoing); "Allergy to Kiwi" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient did not receive any other medication in 2 weeks. The patient received anti-viral treatment with Paxlovid from 24Feb2023 to 01Mar2023. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300099732 Same patient, different product, different event;