chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen lymph nodes end to the arm; breast swelling; The initial case was missing the following minimum criteria: Unidentifiable patient. Upon receipt of follow-up information on 02Nov2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 47-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes end to the arm"; BREAST SWELLING (non-serious), outcome "unknown". Additional information: The patient isn't the reporter. Caller is a pharmacist. Pharmacist stated "So, my common, would be question is can Prevnar 20 shot cause like swollen lymph nodes end to the arm and like swelling of the breast. I don't know if any of this?" (Further clarification unknown if administered to any patient). Caller asked for the possible side effects of prevnar 20 after administration. Caller clarified that she has a patient with unknown history of pnuemococcal vaccine who experienced "swollen lymph nodes on the arm, under the arm, swelling on the breast on the right side."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dry itchy skin.  Swollen limbs.  Skin peeling.  Redness.  On both arms.  Behind kneecap.  Between legs.  On shoulders, neck, and chest region.
This spontaneous report as received from a healthcare worker refers to an unspecified patients of unspecified age and gender. The patients concurrent conditions and medical history was not reported. The healthcare worker reported that, on an unspecified dates, an unspecified number of unspecified patients were administered with improperly stored doses of MMR II (therapy type unspecified) with lot# L026550 and expiration dates: 16-JUL-2017 and with lot # L005290 with expiration date: 17-FEB-2017; (strength, dose number, dosage and route unspecified). The vaccine was exposed to temperature of 10.1 C for time frame of 1 hour, there was no previous temperature excursion. No adverse effect was reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Diffuse papular rash throughout body and pruritic. No additional symptoms. Rx'd Atarax 25mg po tid prn for pruritus. Will follow.
Woke up will chills around 3AM which lasted till about 11AM. Drank a bunch of water and slept on/off till about 6PM due to fatigue. Got out of bed and the the fatigue mostly settled by 11PM. Felt mostly okay the next morning.
Mild rash in the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovered/resolved.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient that received the first dose of Shingrix a month ago, experienced mild rash in the injection site for 2 days. The reporter consented to follow up.
pt was sitting p/shot c/o feeling SOB & congested more so than before the shot; localized urticaria around site
I had a strong immune response to the second dose (fatigue, fever and body aches) for over 48hrs. Within 72 hrs of the second vaccine, I developed tinnitus in both ears.
Per patient red blotches appeared on 12/08/2017, no itchiness, no burning. Patient start taking Benadryl, blotches starting to fade out.
Red from shoulder to elbow, hot, hard, swollen and painful for about 3 days.
Within two hours of ingesting a single tablet/capsule, experienced severe stomach cramping which lasted the entire morning until an analgesic was taken (ADVIL 400mg). Rested for the remainder of the day Reports that abdominal cramping remained upon awakening the following morning.  Continues to rest; no additional medication taken thus far and no additional medical follow up sought to date.
This spontaneous report was received from a registered nurse referring to a patient of currently 14 years age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of (Merck) VARIVAX with lot # L034368, expiry date 08-SEP-2017; dose, route of administration and anatomical location not reported). The doses of (Merck) VARIVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a 73 year old male patient referring to himself. The patient's drug reactions/allergies included ROCEPHIN. The patient's concurrent conditions and pertinent medical history were not provided. In approximately 2009 (reported as 6-7 years ago), the patient was vaccinated with ZOSTAVAX (subcutaneous; dose, lot # and expiration date were unknown). The patient stated that right after receipt of the vaccine he developed a mild rash in his ears. The rash was not immediately identified as shingles. The rash in the patient's ears eventually spread to other areas of his face on both sides, and was accompanied by Bell's Palsy. The rash was later confirmed to be shingles. The patient explained that he had developed intermittent breakouts of shingles on his face since receipt of the vaccine, which had been occurring for the last 6 years and occur approximately every 6 months, and take approximately 4 months to recover from it. The patient was being treated with unspecified antiviral medications. The patient was not recovered at this time, as the breakouts continually occur. The patient visited physician for medical attention. Unspecified lab tests were performed (result not provided). The causality was not provided. Upon internal review, Bell's Palsy was considered to be medically significant. Additional information has been requested.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX dose 1, (dose, lot # and expiry date unknown). On 21-MAY-2012, the patient was vaccinated with improperly stored VARIVAX dose 2 (dose unknown), from lot # 671861/1907AA with expiry date of 05-DEC-2013. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Redness; Small Rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE RASH (Small Rash) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE RASH (Small Rash). On 09-Jan-2021, VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE RASH (Small Rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       ICE used as treatment therapy.
22 or so hours after my vaccination I had a 100 degree fever (I'm usually 97.7) , headaches, painful joint and muscle aches, nausea, extreme fatigue, dizziness. I experienced these same responses for my first 2 Pfizer vaccines and 1st Moderna booster. After this 2nd Pfizer booster I also had a constant urge to urinate for several hours, with no increase in my normal water consumption. My pelvic floor was aching and the urination was burning for the first couple hours. 24 hours after the onset of symptoms I am only experiencing fatigue. These were adverse reactions, but not too extreme and I wasn't overly worried. A friend encouraged me to report for research.
chills; headache; nausea; muscle aches; mild temp; Atrial fib for 1 hour; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular, administered in arm left on 18Jan2021 12:00 as a single dose for covid-19 immunisation. Medical history included bone disorder, plague prevention, cardiac disorder, sleep disorder, pancreatic disorder from an unknown date to 2015 which was stable, supraventricular tachycardia, and osteoporosis. Concomitant medications included ergocalciferol (VIT D) taken for bone disorder from an unspecified start date and ongoing; calcium (CALCIUM) taken for bone disorder from an unspecified start date and ongoing; rosuvastatin calcium (CRESTOR OD) taken for plague from an unspecified start date and ongoing; metoprolol succinate taken for cardiac disorder from Oct2019 and ongoing; zolpidem taken for sleep aid when needed from an unspecified start date and ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH 9899) on 29Dec2020 05:15 PM (at the age of 71-years-old), intramuscular on the left arm for Covid-19 immunization. On 20Jan2021, the patient experienced chills, headache, nausea, muscle aches, and mild temp. On an unspecified date in 2021, it was reported that the patient had Atrial fib for 1 hour as recorded on apple watch at 01:00 am and required visit to Physician Office. Treatment was Eliquis  5 mg twice a day. The patient underwent lab tests and procedures which included body electrocardiogram: 1 hour of Afib continuously beginning 01:05-02:10 AM on 02Jan2021. Comments: ECG in office at 09:00 or holder Zis: No continues AF but at her shot run of irritability. The outcome of the event Atrial fibrillation was unknown while recovered on 20Jan2021 for the rest of the events.   Information on the lot/batch number has been requested.
Pt started to get red swelling on (R) deltoid yesterday. Positive warm, positive pain, positive red & swelling.
Metal taste in tongue 15 minutes after injection; Itchy eyes; Itchy skin; Runny nose; Nausea; caffeine-like mental excitedness mixed with body feeling very heavy; caffeine-like mental excitedness mixed with body feeling very heavy; This is a spontaneous report from a non-contactable consumer, the patient. A female patient of unknown age received 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. Medical history included allergy to red wine. Concomitant medications were not reported. The patient previously took TYLENOL and BENADRYL on unknown date for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in 2021, the patient experienced metal taste in tongue 15 minutes after injection, itchy eyes, itchy skin, runny nose, nausea, caffeine-like mental excitedness mixed with body feeling very heavy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events metal taste in tongue 15 minutes after injection, itchy eyes, itchy skin, runny nose, nausea, caffeine-like mental excitedness mixed with body feeling very heavy was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
86-year-old male past medical history hypertension, high cholesterol, CLL pulmonary embolism, pleural effusion who is here for evaluation of shortness of breath the patient had this morning and altered mental state present for the last 5 days.  Patient tested positive for COVID 1 week ago he was initially started on Medrol Dosepak that was switched to dexamethasone.  Patient also took couple doses of Augmentin that was discontinued after patient received monoclonal antibody infusion on Friday.  Since Friday patient has had hard time sleeping at night time.  Patient's family states the patient appears to be more confused from time to time.  Patient lives independently and is self-sufficient.  Patient has had cough since Tuesday which has been improving.  This morning patient complained of shortness of breath the patient states currently has resolved.  Patient has been able to tolerate oral intake.  Patient has been able to ambulate without any difficulty.  Patient is on Eliquis a given pulmonary embolism 1 year ago.  Patient's family also noted increasing lower extremity edema.  Patient has been compliant with all his medications.  Patient has not required any oxygen.  Patient received full COVID vaccinations did not receive booster.
Narrative:  1st Moderna COVID Vaccine: 9/2/2021 2nd Monderna COVID Vaccine: 9/30/2021 Tested positive for COVID: 12/17/2021 received one treatment of Etesevimab & Bamlanivimab 12/20/21 patient admitted for impatient stay 12/22/21 - 12/23/2021
Flu; Initial information received on 08-Jan-2023 regarding an unsolicited valid non-serious case received from a non-healthcare professional via social media.  This case involves a male patient of unknown age who experienced flu after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient had received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, route, formulation, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination (immunization).  On an unknown date, the patient developed flu (influenza) (latency: unknown) following the administration of influenza vaccine.  It was reported, "My boyfriend got the flu shot and it gave him the flu. And then he gave it to me."  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.   At time of reporting, the outcome was Unknown for the event.
Arm soreness; fever of 101; chills; headache; This is a spontaneous report from a Non-contactable consumer. A 30-years-old non-Pregnant female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL3247), via an unspecified route of administration on 17Feb2021 at 13:45 administered in Arm Left as a single dose for COVID-19 immunization at Workplace clinic. The patient had received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; batch/Lot Number not provided), via an unspecified route of administration on 27Jan2021 at 13:45 administered in Arm Left as a single dose for COVID-19 immunization at Workplace clinic. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies. On 18Feb2021 at 12:15 AM, the patient experienced Arm soreness, fever of 101, chills and headache. Therapeutic measures were taken as a result of arm soreness (pain in extremity), fever of 101 (pyrexia), chills (chills), headache (headache) and treatment included Ibuprofen.The outcome of the events was recovered on an unknown date.  No follow-up attempts are possible. No further information is expected.
Tinnitus in right ear started just days after receiving the Pfizer booster.  The tinnitus has become progressively worst, lasting most of the day, every day.  I never had this problem before.  I do not have high blood pressure or any other medical issues. I am normal weight. I received the first two Pfizer vaccines at the clinic  on 19 Mar 2021 and 9 Apr 2021. The booster I received at the pharmacy locally.  I received a flu vaccine in early Oct 2021 (don't recall the date) at the same clinic.  I never had any adverse reactions to the flu vaccine in all my years of getting it.
1 of 3 pts who presented w/herpes zoster following vax; pt recvd vax & about a month later, presented in office w/c/o rash, low back pain & restlessness @ noc; pt recovered;
falling, unable to get up, weakness, lack of energy, ghost look in eyes,shaking, no treatment
A non-serious spontaneous report of administration of expired FLUMIST was received from a physician concerning a 34-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 13-Dec-2011, the patient received expired FLUMIST. The product expired on 20-NOv-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Information has been received from a physician concerning a 64 year old female who was vaccinated with one dose of varicella zoster virus vaccine live. Subsequently the patient developed chickenpox. No information was provided regarding the number of lesions. The patient had an "Emergency Visit".  It was reported that at the time of the report the patient had not recovered. There was no product quality complaint involved.  No further information is available.
Patient brought in by Mother to ED, presenting with a bruise to the right thigh that occurred 1 week ago.  Patient's mother stated that she received vaccines on February 24 to both of her thighs.  Patient's mother states that she has been constipated.  She states that she took her off of formula.  She also states that she has been having blood in her stool.  Patient's mother states that she has noticed mucousy blood only after straining due to constipation.
chickenpox; Vaccine exposure via breast milk; Secondary transmission to the Non-vaccinated person who develops the disease; This spontaneous report was received from a physician and refers to a 5-week-old female patient. The concurrent conditions included meningomyelocele and hydrocephalus. The patient's concomitant medications conditions included vancomycin and acyclovir.  On 12-DEC-2020, the patient's mother was vaccinated post partum with varicella virus vaccine live (oka/merck)(VARIVAX)in left upper right arm ( lot # 279202867, dose and expiration date were not reported) since it was determined, that she was seronegative for varicella virus vaccine (for prophylaxis). The physician reported that the mother was not sure if she had chicken pox in the past and there were no available medical records for the mother. The physician also stated that there was no known recent exposure to VZV and confirmed that the mother did not develop an injection site reaction or rash post-vaccination. An immnunological work-up was not performed for the mother. It was reported that on 12-JAN-2021, the patient developed diffuse distribution of vesicles. The physician reported that the baby's rash specimen was collected on 14-JAN-2021, which was approximately 8 hours after acyclovir treatment began. The polymerase chain reaction (PCR) sample was tested on 15-JAN-2021 and revealed the vaccine strain (it was also reported that the infant developed chickenpox 30 days post maternal vaccination). The physician reported that the baby had been breastfeeding until the infant developed the rash(Vaccine exposure via breast milk). The infant had more that 20 diffuse lesions on her trunk, legs, arms, face She reported that the baby was treated with acyclovir for a total of seven days and reported that the baby was currently "doing well." The physician also stated that an immunological work-up for the baby was performed and the results were pending. The outcome of varicella and secondary transmission was not reported.  The causal relationship between varicella, secondary transmission and varicella virus vaccine live (oka/merck)(VARIVAX ) was not provided.  This is one of the two linked reports of mother and child (the mother's case # 2101USA008318).; Sender's Comments:  US-009507513-2101USA008318:
Developed slight jaundice (yellow skin and eyes a week after hep b shot); persisted for about one month.
By 8 pm had chills, fever (did not take temp), pain from neck to lower back worse than usual chronic pain. Urination frequency increased and becasue of pain in back it.
Pt recvd 2 doses of Engerix-B & exp no reaction following the 1st dose; exp pain & a lesion @ the inject site following 2nd dose;
Was recommended to get the Bexsero; received his first dose on January 7,2019 and second dose on Oct 30, 2019; This case was reported by a consumer via call center representative and described the occurrence of off label use in a 86-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   The patient's past medical history included pancreatic cancer (in January 2018 (for pancreatic cancer)) and splenectomy.   On 7th January 2019, the patient received the 1st dose of Bexsero. On 30th October 2019, the patient received the 2nd dose of Bexsero. On an unknown date, unknown after receiving Bexsero and Bexsero, the patient experienced off label use and inappropriate age at vaccine administration. On an unknown date, the outcome of the off label use and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The patient was recommended to get the Bexsero in the hospital which led to off label use and inappropriate age at vaccine administration. The follow up consent was granted.
Enlarged lymph node in shot arm. Itching around shot 7 days after first moderna shot
Nausea, joint pain, fever, chills, fatigue.  2 days duration
The patient and her husband came in for first Moderna shot. Patient received dose of Moderna on 04/27/2021 at about 640 am. Per patient, after receiving the shot, she went to see her pain mamagement doctor. She was not given any shots at the doctor's office just medications; However, around 1030 am, she started having anaphylactic reaction including throat closing, severe rash/itch, and difficulty breathing. She has never had any allergies to any other IMZ. Per patient, her husband used a pack of epipen as directed, took benadryl and headed to the ER.  At the ER, she was given steroids and monitored for a while before being released. She has been asked to not receive second dose of Moderna. Also, she has not yet reported to V-safe. Per patient, her husband will come back for the second shot.