chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash (papules) on both arms, feet, back.  Swollen lymph nodes (swelling resolved after two days).  Referred to dermatologist for evaluation and confirmation on rash.
COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Batch/Lot number: unknown), on 12Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 29Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 23Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Apr2022, outcome "recovered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (Jul2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: Treatment of COVID-19; (15Jul2023) Negative, notes: tested negative 7 days after starting paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid and recovered from COVID quickly and tested negative 7 days after starting paxlovid.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of the subject product cannot be excluded for suspected LOE.  There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.,Linked Report(s) : US-PFIZER INC-202300257232 Same patient different drug/events;
Tested positive for COVID after receiving the first two doses of the MODERNA vaccine. I got the antibody infusion four days after I tested positive.
Patient complained of arm being really sore, itchy, red and warm to the touch. No complaints of respiratory difficulty. Patient's wife placed hydrocortisone cream on the area on 01/24/2010 which helped the redness, warmth and itchiness disappear.
This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Very bad headache 5 or 6 days after the vaccine) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Very bad headache 5 or 6 days after the vaccine). At the time of the report, HEADACHE (Very bad headache 5 or 6 days after the vaccine) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received on 24-MAY-2021: Event outcome updated and denied for further follow up.
had DT vax @ approx 11AM on 27NOV95;approx 11PM 27NOV95 exp uncontrollable generalized shaking & chills;c/o both arms being sore lasted 2 hrs;APAP given; shaking & chills;
5 inch rash below the vaccination site; Bump underneath the  vaccination site; Redness at the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (5 inch rash below the vaccination site), VACCINATION SITE SWELLING (Bump underneath the  vaccination site) and VACCINATION SITE ERYTHEMA (Redness at the vaccination site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced VACCINATION SITE RASH (5 inch rash below the vaccination site), VACCINATION SITE SWELLING (Bump underneath the  vaccination site) and VACCINATION SITE ERYTHEMA (Redness at the vaccination site). The patient was treated with TRAMADOL for Adverse event, at a dose of 15 mg. At the time of the report, VACCINATION SITE RASH (5 inch rash below the vaccination site), VACCINATION SITE SWELLING (Bump underneath the  vaccination site) and VACCINATION SITE ERYTHEMA (Redness at the vaccination site) outcome was unknown.            Concomitant drugs were not reported.
Developed sever case of shingles and prolonged post hepatic neuroglia and muscle weakness and pain.
Nurse reports patient has red, swollen right arm that is warm to the touch. The reaction has been unresponsive to oral BENADRYL nor hydrocortisone cream. The nurse will be sending the patient to her doctor.
Clinician forced needle below deltoid muscle. I DON'T RECALL EXACT TIME. MY 2 KIDS WERE WITH ME. I REMEMBER THINKING IT SHOULDN'T HAVE TO BE FORCED WHEN INJECTED. (I AM A NURSE). BUT AFTER THAT I DIDN'T GIVE IT MUCH THOUGHT UNTIL MY ARM DISCOMFORT/PAIN WAS STILL PRESENT 3 MOS AFTER. I WAS ALSO BEGINNING TO EXPERIENCE WIDE-SPREAD BODY ACHES, MOSTLY AT NIGHT, BUT THEY ARE BAD ENOUGH THAT I HAVE DIFFICULTY SLEEPING AND NEED TO TAKE MEDICATION. I SAY A BACK SPECIALIST BECAUSE MY BACK AND NECK STARTED TO HURT AT THE SAME TIME AS THE BODY ACHES STARTED. WAS TOLD I HAD PROGRESSIVE DEGENERATIVE DISK DISEASE WHICH WAS THE FIRST I EVER ENCOUNTER ANY BACK DISCOMFORT. ORTHOPEDIST COULDN'T EXPLAIN THE THROBBING WIDESPREAD BODY ACHES. I THEN SAW A RHEUMATOLOGIST WHO DX THE "AUTOIMMUNE INFLAMMATORY PROCESS". I HAVE NOT BEEN ABLE TO RETURN TO MY PREINJECTION WORKOUT PROGRAM; I EXPERIENCE CONSTANT THROBBING ACHES/PAINS -MOSTLY AT NIGHT. EXERCISE EXACERBATES IT. TO SEE RHEUMATOLOGIST FOR FOLLOW-UP ON OCTOBER 6.
Patient received Pfizer COVID #1 on 2/1/2021 with Lot EL3247. Patient then received Pfizer COVID #2 on 2/25/2021 with Lot EN6202. Patient reports nasal congestion since 4/12/2021 with associated headache. Denies fever, sore throat or cough. Patient  has also developed loss of taste and smell. patient reports her boyfriend was positive for COVID  earlier in the month. Patient arrived to our facility today and was tested for COVID using PCR.
Arthritis Pain; Neuropathic Pain; I still have enlarged underarm lymph nodes.; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis Pain), NEURALGIA (Neuropathic Pain) and LYMPHADENOPATHY (I still have enlarged underarm lymph nodes.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis since 01-Dec-2020 and Neuropathic pain since 01-Dec-2020.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Arthritis Pain), NEURALGIA (Neuropathic Pain) and LYMPHADENOPATHY (I still have enlarged underarm lymph nodes.). At the time of the report, ARTHRITIS (Arthritis Pain) and NEURALGIA (Neuropathic Pain) was resolving and LYMPHADENOPATHY (I still have enlarged underarm lymph nodes.) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received contains added event - Lymphadenopathy and updated outcome from not recovered to recovering
Morning after vaccine (2/12/2022) patient woke up with severe myalgias and a high fever of 101.8 degrees F. Her arm was red, swollen, and sore at injection site. The next day on 2/13/2022 patient's arm became hard, red, warm to touch down towards her bicep. She still had a fever of 99.5 degrees F. Over the next couple of days her arm continued to be hard, red, warm to touch and also developed fluid under the skin. On 2/16/2022 the patient also experienced hypertension (150's/90's) which is very unusual for her. She went to the urgent care where they confirmed her HTN. Patient reached out to us on 2/17/22 and was feeling better but arm was still sore/red/swollen.
Patient arrived at clinic and was registered and screened prior to vaccination; however, it was not captured that the patient was outside of the EUA authorized age group to receive the Moderna COVID-19 vaccine. Patient received first dose of Moderna COVID-19 vaccine at age 16 without any issue post-vaccination. Moderna Medical Information consulted for recommendations for dose given outside of authorized age range. Confirmed that second dose should be administered at 28 days out for this 16 year old patient. This will be considered off label use. Patient and family notified; patient has been scheduled for dose 2 in the series on 5/5/21.
Narrative: Patient received vaccine on 03/31/2021; upon follow-up call with nurse the patient reported increased heart rate, fever, dyspnea, and headache the  evening of the vaccine. The symptoms lasted 2 days and had no symptoms at time  of follow-up. Patient did not report taking any medications for symptoms.
Narrative: Fully vaccinated, COVID positive on preadmission for EVAR on 09/16/2022. Patient was asymptomatic.
Another intradermal vaccination from that same vial; Case reference number US-BN-2022-003940 is a spontaneous case report initially received on 07-Oct-2022 from a nurse via Communications (reference number: USBAV22-1658) and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown), at an unknown dose and site of administration, administered intradermally, for unknown indication. The patient was vaccinated with the vial that was already used a week before (explicitly coded as 'intradermal injection').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  The case is linked with US-BN-2022-003939 (same reporter).  Additional information received from Bavarian Nordic on 10-Oct-2022 included the local BN case ID.; Reporter's Comments: A patient of unknown demographics was vaccinated with Jynneos, at unknown dose and site of administration, for unknown indication, administered intradermally (considered as intradermal injection). Injection is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Jynneos. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with Jynneos, at unknown dose and site of administration, for unknown indication, administered intradermally (considered as intradermal injection). Injection is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Jynneos. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
pt states 1-1 1/2 days p/vax pt exp pain, & muscle weakness from lt neck down to below lt elbow-last couple of days has exp pain in lt rib, underarm area;
Narrative:  Patient received Moderna covid #1 on 3/23/21 and #2 on 4/20/21. On 5/18/21, he received an injection of haloperidol decanoate 100mg for schizoaffective disorder with depression. No other scanned records from that time to his date of death recorded as 5/4/21. He does have a note entered that states cause of death as suicide by firearm. Time from second vaccine to date of death was 34 days.
This spontaneous report as received from a physician via NOVARTIS refers to a 63 years old patient who on an unknown date was vaccinated with live ZOSTAVAX (dose, route, frequency and lot number not provided). On an unknown date, the patient experienced reaction, bump and redness within 30 minutes at injection site (left arm), itchiness, swollen upper arm, red rash over the next day, pain and itchiness. No treatment information was reported. The outcome of reaction, bump and redness within 30 minutes at injection site (left arm), itchiness, swollen upper arm, red rash over the next day, pain and itchiness were unknown. The relatedness for reaction, bump ad redness within 30 minutes at injection site (left arm), itchiness, swollen upper arm, red rash over the next day, pain and itchiness was unknown for live ZOSTAVAX. Additional information has been requested.
Both thighs were tender; prolonged, hard crying soon after receiving immunizations. Gave infant Tylenol concentrated gtts 0.6 ml every 4 hours. Pt improved, legs no longer tender, no more crying, resolved 10-13-05.
No Adverse Event; 2nd primary dose given on day 21; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd primary dose given on day 21) and NO ADVERSE EVENT (No Adverse Event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Aug-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd primary dose given on day 21). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd primary dose given on day 21) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.            Patient was Pediatric.  No concomitant medications was provided. No treatment medications was provided.   Reporter did not allow further contact
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 82 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Child received a 2nd dose of FluMist and should have only received 1 dose, due to age. No treatment. Spoke with child's father who stated child was coughing after adverse event, but symptoms have resolved. No other signs or symptoms noted. Reported adverse event.
Took Vivotif every day instead of every other day; Spontaneous report received on 21FEB2020.  A nurse reported that a consumer "took Vivotif every day instead of every other day" (PT: Inappropriate schedule of product administration). The consumer was receiving Vivotif for immunisation. It was reported that the consumer had taken Vivotif every day instead of every other day. The consumer will be travelling on 05MAR2020 as a one time visit. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took Vivotif every day instead of every other day (Inappropriate schedule of product administration). Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took Vivotif every day instead of every other day (Inappropriate schedule of product administration). Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.
Case number PHHY2011US29455 is an initial spontaneous report received from a health care professional on 04 Apr 2011. This report refers to a 15 years old female patient. She was given only the Men CYW-135 liquid vaccine component of MENVEO vaccine (batch number unknown) intramuscularly on 09 Mar 2011. No other adverse reaction was reported.
injection site is red; injection site is swollen; injection site is painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site is red), VACCINATION SITE SWELLING (injection site is swollen) and VACCINATION SITE PAIN (injection site is painful) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A, 046B21A and 041H21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Wellbutrin allergy), Depression and Atrial fibrillation. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), BREXPIPRAZOLE (REXULTI), CLONAZEPAM (KLONOPIN), DILTIAZEM HYDROCHLORIDE (DILT-XR), METOPROLOL SUCCINATE, LOSARTAN, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), SIMVASTATIN and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site is red), VACCINATION SITE SWELLING (injection site is swollen) and VACCINATION SITE PAIN (injection site is painful). At the time of the report, VACCINATION SITE ERYTHEMA (injection site is red), VACCINATION SITE SWELLING (injection site is swollen) and VACCINATION SITE PAIN (injection site is painful) outcome was unknown.            It was reported that patient neither diagnosed nor tested positive for COVID-19. No other vaccines was administered within 1 month prior to Moderna COVID-19 vaccine.  The patient had gone to the Emergency Room three times since January 2022. The Emergency Room could not find anything that was causing the welts and the black and blue mark at the injection.  Treatment medications were not reported.
Headache, fever, erythema multiforme and cold sweats. Cephalexin 500 mg QID, ibuprofen 600 mg QID.
Inconsolable crying greater than a 3 hour period.  Mom called after hours (PNP and reported crying approximately 10 pm.  ? Pertussis reaction.  No treatment given.
Swelling at injection site and surrounding area size of a golf ball Hot to touch Sore Has a knot in arm
Pt's wife called back saying that the patient was experiencing severe arthralgia and myalgia and was lethargic. This is the patient's first flu vaccine in a number of years and I presumed it might be due to the adjuvant. I instructed the patient to take OTC medications for the pain and I will follow up at 24 hours.
I tested positive for COVID-19 on 12/4/22. I had a terrible sore throat, a low-grade fever, fatigue, and a slight cough. Also, I had severe pain in my feet. This lasted for about 5 days. I contacted my doctor and was prescribed 5 days worth of PAXLOVID. I couldn't tell if PAXLOVID helped or not. I am feeling much better now.
fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 5-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 5 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, on 19Oct2022 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (Dose 3, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 27Oct2022, outcome "recovering", described as "fever". Therapeutic measures were not taken as a result of pyrexia.  Additional information: Report is about COVID vaccine. Dose received: More than 3. Patient received other vaccine in four weeks (flu). No other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
nine days after the first Pfizer shot wanted to know is it really weird to have a headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "nine days after the first Pfizer shot wanted to know is it really weird to have a headache".  Additional information: Stated that nine days after the first Pfizer shot wanted to know is it really weird to had a headache. Reporter details: Stated that she worked as nursing assistant. Stated that she worked in pharmaceutical and medical sales. Email address captured as provided.  Follow-up attempts completed. No further information is expected.
Around 7 minutes after receiving COVID19 injection, patient started experiencing adverse reactions: throat closure sensation, cool,  skin,clammy, bradycardia . Adrernalin 0.3mg was adminstered @ 2:39pm. EMS was on scene at 0241. Patient transferred @ 3:06 TO ER at Hospital.