chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case involves a 25 years old female patient who experienced lymph node increased to size of lemon, feeling of tiredness, body aches, not feeling well, left arm became sore and swollen lymph node under arm while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ELASOMERAN (MODERNA COVID-19 VACCINE) for Prophylactic vaccination. On 26-Dec-2021, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination. On 27-DEC-2021 the patient developed a non-serious lymph node increased to size of lemon (condition aggravated) 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On 27-DEC-2021 the patient developed a non-serious feeling of tiredness (fatigue) 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On 27-DEC-2021 the patient developed a non-serious body aches (pain) 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On 27-DEC-2021 the patient developed a non-serious event "not feeling well "(malaise) 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On 27-DEC-2021 the patient developed a non-serious left arm became sore (tenderness) 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On 27-DEC-2021 the patient developed a non-serious swollen lymph node under arm (lymphadenopathy) 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) was not applicable. It was not reported if the patient received a corrective treatment for the events (lymph node increased to size of lemon, feeling of tiredness, body aches, not feeling well, left arm became sore, swollen lymph node under arm). At time of reporting, the outcome was Not Recovered / Not Resolved for the event lymph node increased to size of lemon, was Not Recovered / Not Resolved for the event feeling of tiredness, was Not Recovered / Not Resolved for the event body aches, was Not Recovered / Not Resolved for the event not feeling well, was Not Recovered / Not Resolved for the event left arm became sore and was Not Recovered / Not Resolved for the event swollen lymph node under arm.
States initial flu like symptoms, lasting less than 24 hours. She states bruising at site and continued pain. She states numbness and tingling from shoulder to fingers from administration site (left arm) began 10/05/2012. Immunization was given 09/14/2012. States she was seen at Occ. Health on 09/26/2012, provider stated they felt a small bump at site.
This spontaneous report was received from a physician and refers to 11-year-old male patient. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (strength, dose, frequency, route of administration, lot # and expiration date were not provided) for prophylaxis. On an unknown date, after receiving the GARDASIL 9, the patient experienced axillary lymphadenitis. The outcome of axillary lymphadenitis was reported as recovered in one week. The relatedness between axillary lymphadenitis and GARDASIL 9 was not reported. On 11-JUN-2018, follow-up information was received from a physician. On 29-JAN-2018, the patient was vaccinated with the first dose of MENACTRA. On 19-FEB-2018, the patient was vaccinated with a first dose of GARDASIL 9 1 dose, lot # N020353, expiration date: 28-APR-2020 in left deltoid. On 21-FEB-2018 (also reported as within 48 hours), the patient developed a peanut size lymph node, mild tenderness in left axilla and above mid left clavicle. No fever, no local swelling or redness on site injection was reported. The physician also reported that the patient developed a peanut size firm mildly tender swelling in left axilla and just above mid left clavicle. Swelling was mobile with no overlying redness or warmth. The patient was given ibuprofen for 3 days and advised to be observed for fever worsening. On 05-MAR-2018, the patient was seen at physician office and it was reported that swelling was stable. On 16-APR-2018, the patient again was seen at physician office and it was reported that swelling completely resolved.
Dizziness, Headache, Myalgia & Diarrhea Narrative:  Vaccinated in the morning 12/20. Fell asleep early due to fatigue. Woke up not feeling well: headache, body aches, dizzy. Unable to go to work that day. By Tuesday able to return to work though experiencing loose stools.
DEVELOP REDNESS AND PAIN AT INJECTION SITE.  TREATING W/COMPRESSES,NSAIDS
doses administered after excursion; No adverse event; Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 37-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    Concomitant medications details were not reported by the reporter.  Reportedly, Pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. the excursion was found out in an audit and all the vaccines were viable.  Treatment details were not reported by the reporter.
Arm was red and warm below injection site; Arm was red and warm below injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm was red and warm below injection site) and VACCINATION SITE ERYTHEMA (Arm was red and warm below injection site) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L2A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (High Blood Pressure) since 1978 and Hypercholesterolemia (Cholesterol). Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN + HIDROCLOROTIAZIDA) for Blood pressure high, FISH OIL and MONASCUS PURPUREUS, NICOTINAMIDE, PHYTOSTEROLS NOS (RED YEAST RICE WITH PLANT STEROLS) for Hypercholesterolemia, ACETYLSALICYLIC ACID (ASPIRIN 81) and VITAMIN D3 for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Arm was red and warm below injection site) and VACCINATION SITE ERYTHEMA (Arm was red and warm below injection site). On 22-Feb-2021, VACCINATION SITE WARMTH (Arm was red and warm below injection site) and VACCINATION SITE ERYTHEMA (Arm was red and warm below injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE WARMTH (Arm was red and warm below injection site) and VACCINATION SITE ERYTHEMA (Arm was red and warm below injection site) to be possibly related.    Treatment information was not provided.   This case was linked to MOD-2021-033610 (Patient Link).
Redness spreading with pustules which as stop and pain radiating to back. Pain and fever remains of and on.
This spontaneous report was received from a physician via a company representative and refers to a 60 year old male patient with remission for renal cell carcinoma. There was no information about the patient's concomitant therapies, drug reactions or allergies provided. On 19-AUG-2016, the patient was vaccinated with PNEUMOVAX 23 lot # M018766 with an expiration date: 15-OCT-2017, one shot, once, intramuscularly. On 20-AUG-2016, reported also as the day after administration of PNEUMOVAX 23, the patient experienced rash and his temperature rose to "102.5 (unit of measurement unspecified). The patient sought medical attention and had to go to an unspecified hospital. The patient's white blood cell count test was 22,000 (unit of measurement unspecified) and he was diagnosed with cellulitis. He was treated with unspecified "intravenous (IV) antibiotics". It was unspecified how long the patient stayed at the hospital. The outcome of cellulitis was reported as recovered. (On an unknown date in August 2016). The relatedness between the event and PNEUMOVAX 23 was not reported. The reporter believed that event could be life threatening, if left untreated. Upon internal review cellulitis was determined to be medically significant. Additional information has been requested.
right thigh redness, swelling, tenderness after PCV7. Treated with warm compress, ibuprofen
I previously reported an event in 2021. I developed heart block after my second Moderna dose in 2021. After my Moderna vaccine (9/21/22) I started to have NSVT events((approx 11/22) on my pacemaker report. My MRI on 02/20/23 shows inflammation consistent with cardiac sarcoidosis. My PET scan on 03/14/23 shows inflammation consistent with cardiac sarcoidosis.  I am now being treated for the condition by a HCP.
fever; 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 PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.            No concomitant medication iwere not provided No treatment medication information were not provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Reporter did not allow further contact
Vesicular rash on trunk in 2 days. Erythema around injection site (about 6 cm diam).
Cannot reach behind my back with left arm, cannot carry a purse with my left arm, cannot lean on left arm, slight pain from shoulder to elbow most of time, rolling over in sleep to left side and awakened with pain.
Localized reaction to either HPV or Meningococcal. Suspect reaction to the preservatives in the vaccine.
lymph node under arm left arm swollen, left side gums imflamed and left eye eyelid imflamed.
Allergic reaction, suffered from a drug allergy to the Flumist /swollen eyes & face, difficulty breathing, chest pain, nose burning.
Early Symptoms of the Flu with the 2nd shot, Body aches, chills, aches  which resolved Now  I have unexplained dizziness and Eyes sometimes go in and out of focus.  which has not resolved
Swollen right thigh with inflammation and knot; Excessive crying up to 3 days after; PREVNAR and Hib given.
On the day of vaccine,  02/25/2021, slight soreness less that 24 hrs in duration with no swelling.  No further discomfort of symptoms after 24 hrs.  A week later, on 03/05/2021,  developed itching and swelling with nodules under skin at vaccine site.  Increased swelling, itching and tingling with redness, approximately 2 inch by 4 inch oval area around vaccination site.  On 03/06/21 the swelling seems to be decreasing; however, itching and some redness is still present at the site.  No  other symptoms.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 14-NOV-2015 at time- 19:05, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.2 and 2.6 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Covid shortness of breath. Patient states that she was diagnosed with Covid on Thursday. Patient states she was admitted and discharged on Saturday. Patient states that she is going to get antibiotic infusion therapy when they stated that she was saturating in the mid 80s and then had outside oxygen ordered. Patient states today she has worsening dyspnea. Patient states she is vaccinated. Patient lost taste and smell. Patient was saturating 77% on room air and 90% on nonrebreather, patient was placed on high flow nasal cannula.
The night following vaccine administration (30 hours post shot), experienced head congestion, fogginess.  (Patient had experienced expected side effects of fatigue and tiredness throughout the day following administration.)   Patient took tylenol pm.  Approximately 1-2 hours after taking, when patient sat up experienced nose bleed.  Nose bled for approximately  five minutes.  Following  putting pressure on nose and cold water, bleeding  stopped.  No further occurrences of nose bleeding.  All other symptoms o fatigue were gone by following morning.
Pt was given 2nd dose around 1:10 pm and about 10 minutes later started feeling lightheaded and shaky.  We got her water and wet cloth for her head and moved her to our vaccination room. Her heart rate was up and she continued to feel lightheaded.  She didn't want us to call anyone at first, but changed her mind so we called 911.  They arrived and checked her out and took her to hospital.
no protective antibody levels; received a fourth dose; This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 66-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis, HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B, the 3rd dose of Engerix B, the 2nd dose of Engerix B and the 1st dose of Engerix B. On an unknown date, 3 years after receiving Engerix B and unknown after receiving Engerix B, Engerix B and Engerix B, the patient experienced therapy non-responder and extra dose administered. On an unknown date, the outcome of the therapy non-responder and extra dose administered were unknown.  Additional information was provided as follows: The age at vaccination was not reported. The patient received three doses of Engerix-B (unspecified date) and in 2017 a fourth booster dose. This patient was tested for protective antibodies three years after the booster dose and the results came back as no protective antibody levels. The reporter consented to follow up.
-Near complete loss of menstrual cycle first month after vaccine, two months later lighter but closer to normal---doctor checked hormone numbers and confirmed all looked good and likely not likely to hormone level decline  -Mollescum or bumps/lessions primarily on face. Haven't had any skin issues at all and zero acne for 13 years...went to Dermatologist who confirmed it wasn't acne and believed it was likely immune response to the vaccine given the first one popped up the day after 1ts vaccine
Recvd vaccine 10-1-10. Started running fever. Same cough and congestion 10-2-10. Some fever still on 10-3 adv clinic of problems 10-6. Pt adv she was better wanted this reported.
DATE OF EVENT: MAY 2021 Pt got toe infection(cellulitis) and heart problems after his 2nd dose of moderna covid 19 vaccine. He was hospitalized for 4 days for the cellulitis. He now has swollen lymp node for which he has surgery scheduled on 8/18/21.
"99-"03- anthrax vaccine #1-#6- "no problems" 6/22/04- anthrax booster- "few days after" developed myalgias and fatigue- legs "gave out" at times and noticed "difficulty writing" due to hand weakness
got flu; Initial information was received on 12-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who got flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, dosage, strength, lot number and expiration date: unknown) via unknown route in unknown administration site as prophylactic vaccination. There will be no information available on the batch number for this case.  On an unknown date the patient developed a non-serious event "got flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, "Reported Adverse Event Information: The case received from Social media Product Name: Product name was not provided. Since this is a public post on the Sanofi flu shot we are assuming the consumer is referring to the Sanofi flu vaccine. Author/Reporter Comment: I got the flu shot and got flu. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available".  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got flu).  At time of reporting, the outcome was Unknown for the event got flu.
pt recv vax NOV95 & w/in 3 days pt exp elevated BP to 190/100;13NOV95 pt MD inc the dosage of med;pt elevated BP persisted;
This spontaneous report as received from registered nurse refers to another nurse's grandchild of unknown age and gender who lives in another state. On an unknown date, previously patient was administered MMR II and VARIVAX (Merck) (dose number, dose unit, lot # and expiry date, route unknown) separately. On 27-DEC-2013 the patient was vaccinated with expired dose of PROQUAD (Merck) first dose (dose unit, lot # and expiry date, route unknown) for prophylactic vaccination by an unspecified provider in another state. Concomitant therapies included MMR II and VARIVAX (Merck). It was reported that the dose of PROQUAD (Merck) was the first dose of PROQUAD (Merck), but not the first dose of MMR II and VARIVAX (Merck). The nurse asked for follow-up for a safety report. No adverse event reported. The outcome of expired dose of PROQUAD was administered and no adverse event was unknown. No other information to report. Additional information has been requested.
Patient states that she has have 3 COVID vaccinations. unknown manufacturer and dates. Pt is now hospitalized with COVID-19.
Status Epilepticus (40 minutes GTC), no documented fevers prior to, during or after event, but had mild URI symptoms, normal CBC, SMA-7 and PE 6hrs post and discharged home from ED. Seizure was 9 days after vaccines (MMR, Varicella, DTAP, PCV, and influenza).  Patient also had history of complex febrile seizure 10 days after vaccines in May of 2011, (Pentacel, PCV, Rotavirus) given and complex febrile seizure was 10 days later (30 min long), also had URI/fever during this seizure.
Vaccine given 2/8/11. Pt experienced redness, swelling & pain (moderate to severe) Ibuprofen 800mg TID PRN cool compresses.
10-9-07 area achy and red - encouraged to not rub area, let us know if increased redness, itching, warmth. Pt called approx 1 1/2 hour after and reported decreased redness, still tender to touch. 10-11-07 pt called stated lump size of tangerine and redness on 10-10-07, decreased swelling and redness, cont to be tender.
side effects; 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 ADVERSE DRUG REACTION (side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     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(s). On an unknown date, the patient experienced ADVERSE DRUG REACTION (side effects). At the time of the report, ADVERSE DRUG REACTION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No  concomitant medical  provided by the reporter. No treatment information provided by the reporter.
Adult male felt unwell overnight, headache and body pains.  Next morning at 9 am he felt dizzy and fainted, was unresponsive for 10-20 seconds.
pt recv vax 1DEC94 & was adm to hosp on 14NOV95 w/pneumonia;this is one of two pt from this site to devel pneumonia p/vax;
A report has been received from a Health Professional concerning a 15 year old, female subject, who had been receiving FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 14-Jan-2014. The patient received expired FLUMIST on 14-jan-2014. The outcome of the event of RECEIVED EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
I had a couple of heart palpitations the first 5 mins, the next 2 hours I could feel  my heart beating but wasn't irregular, I took a shower I realized I had a rash on my arms and thighs (front), did not hurt or itch,  pinprick bumps, it felt like sandpaper. I had facial flushing, felt hot and turned red, I took pepcid and benydryl, I went to sleep because that was the end of my shift . The rash stuck around for 1.5 weeks for the rash to go away . I woke up 6 hours after and  felt fine I only had the rash and I went to occumed to document my symptoms and everything was fine after that