chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lymphadenopathy; A Literature Non-Study report,  was received from a physician concerning a 72 year old male patient who developed Lymphadenopathy/Lymphadenopathy.  The patient's medical history included Mantel cell lymphoma, completion of chemotherapy with complete metabolic response to the therapy 10 months prior to immunization with mRNA-1273. Concomitant product use was not provided by the reporter.  Prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of Covid-19 infection.  After receiving a dose of  mRNA-1273, (onset date and time not provided), the patient developed Lymphadenopathy.  Treatment information was not provided.   According to the literature abstract, two days following the patient's immunization, he underwent a FDG PET/CT examination.   Per report abstract,  "Series follow up FDG PET/CT scans have been negative for lymphoma".  "Current FDG PET/CT scan showed a new cluster of subcentimeter left axillary lymphadenopathy with avid FDG uptake.  There was also focal FDG uptake in the left upper arm deltoid muscle and adjacent subcutaneous soft tissue, with no other abnormal FDG avid lesion or suspicious CT image findings".  Action taken with mRNA-1273 in response to the event was unknown.  The event, Lymphadenopathy, outcome was considered unknown.; Reporter's Comments: This case concerns a 72-year-old male with PMH of Mantel cell lymphoma S/P chemotherapy with complete metabolic response, who had a serious unexpected event of lymphadenopathy, with FDG PET/CT 2 days after first dose mRNA-1273 showing new cluster left axillary and upper arm deltoid muscle nodes. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Six hours after the vaccine, patient developed a severe headache, temperature to 102 F, diarrhea and abdominal cramps.   Slowy resolving symptoms 36 hours after onset with symptomatic treatment and clear liquid diet.
"Covid Arm" (Red welt, itching, beginning 8 days after vaccination)
have had 5 of my wife's friends who had miscarriages; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABORTION SPONTANEOUS (medically significant), outcome "unknown", described as "have had 5 of my wife's friends who had miscarriages". Clinical course includes, As per call with reporter: Reporter thinks the real world data right now, rather than just the data from Pfizer and early on, I mean, there its-its awful, is just awful Murry, what they saw. Reporter started referring to a document that was regarding breast feeding and pregnant women. Reporter spoke for a while and then summarized and asked about information regarding breastfeeding and pregnancy with the Pfizer COVID19 vaccine. He mentioned both he and his wife are not vaccinated. Early on, Reporter had 5 of his wife friends who had miscarriages. They had the COVID vaccine. All of their friends who had no COVID vaccine had a normal, healthy baby. So 5 out of 5 that were vaccinated had miscarriages in their third trimester and then-well one had a still born birth so he guessed that's 4 out of 5. No doctor linked any of that to the COVID vaccine and all those doctors-all those women were told, cause we actually we're in the same church and they- there obviously were very mentally upset-but all their doctors, OBGYN, all of them recommended that they get the COVID vaccine because they were told that 'your baby is gonna get COVID or you could get COVID during it and your baby would die reporter meant, they didn't give any data and that scared those women into getting the shot. They didn't provide anything. So any questions that were asked, they said 'no you have to, you need to get it. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200677408 mother/baby case
10/14 Client called and c/o sore arm, redness at injection site. Client instructed to place warm compress to site 4x a day to (R) arm. 2/6/15 telephoned to report continued pain and request VAERS report be filed.
small bump reaction in my arm; small bump reaction around my eyes; small bump reaction in my head; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (small bump reaction in my arm), EYE SWELLING (small bump reaction around my eyes) and SWELLING (small bump reaction in my head) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 013A21A) for COVID-19 vaccination.     Concomitant products included SALBUTAMOL SULFATE (PROAIR HFA), ROFLUMILAST (DALIRESP), LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D), PREDNISOLONE (PREDNERSONE), GABAPENTIN, CHIMAPHILA UMBELLATA, APAP;CODEINE, (6S)-5-METHYLTETRAHYDROFOLATE;BETAINE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;VITAMIN B12 NOS;ZINC, ASCORBIC ACID (VITAMIIN C), CALCIUM, COLECALCIFEROL (CALCIUM +D3) and POTASSIUM for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (small bump reaction in my arm), EYE SWELLING (small bump reaction around my eyes) and SWELLING (small bump reaction in my head). At the time of the report, PERIPHERAL SWELLING (small bump reaction in my arm), EYE SWELLING (small bump reaction around my eyes) and SWELLING (small bump reaction in my head) outcome was unknown.            Treatment information was not provided. Lab details were not provided.   This case was linked to MOD-2021-265823 (Patient Link).
The cyst swelled with fluid. It was a fluid filled sack. I had gone into the doctor office about this to my 2nd dose already, and had an ultrasound and a CT scan, with and without contrast. For the 3rd it was just a no contrast CT scan. Also was given an ultrasound. Told this was normal for the vaccines by my doctor and that it was not grown, just filled with fluid. The swelling has not gone down at all.
Upper lip started feeling tingly at approximately 8:00pm on Saturday 03/06; 29 hours after I was administered the second dose. By approximately two hours later nearly the entire upper lip is swollen.
Pain at sight, hard and swollen around the area of sight, itchiness, area is still swollen today
No additional AE; VARIVAX was administered to patient with temperature excursion; This spontaneous report was received from a nurse prescriber and refers to 11 year old female patient. No illness at time of vaccine. No significant past medical history. The patient also received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and meningococcal vaccine a/c/y/w conj (crm197) (MENVEO).   On 10-MAR-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter (lot # W008712, has been verified to be a valid lot number, expiration date reported and upon internal validation established as 14-MAR-2024), administered for prophylaxis (anatomical location, and route of administration were not reported) (Product storage error). Temperature excursion as following: 15.7 Fahrenheit (F) for 0 hours 20 minutes. No adverse events related to vaccination.   This is one of six reports received from the same reporter.
severe chills / after my first vaccine; body aches after my first vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills and general body pain. On an unknown date, the outcome of the chills and general body pain were unknown.   It was unknown if the reporter considered the chills and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe chills and body aches after 1st dose. For tolerance of 2nd dose of Shingrix, refer case US2020AMR221115.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR221115:same reporetr
routine test for covid positive after trauma ( fall from bed at a nursing home)  no covid symptoms, 10/31/2021
post menopausal vaginal bleeding; vaginal hemorrhage; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 14Apr2021 as 2nd dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 24Mar2021 for COVID-19 immunization. Patient stated she had already reported this, did not confirm a reference, did not provide her age or prescribing physician's information. She asked if there were reports of "post menopausal vaginal bleeding or vaginal hemorrhage". She received Pfizer-BioNTech COVID-19 Vaccine. She stated "I found it reported online, I researched it, post menopausal vaginal bleeding/ vaginal hemorrhage. I'm in a terrible situation." The outcome of the events was unknown.   Information on the lot/batch number has been requested.
A report was received from a health care professional on 12/15/03 concerning an 18 month old male vaccinee who inadvertently received Fluvirin vaccine on an unspecified day in October 2003. On an unspecified day in October 2003 the vaccinee was administered Fluvirin. No adverse events were reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
hearing loss; This initial spontaneous report was received from a lawyer on 11-JAN-2021, regarding a case in litigation and refers to a patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. In or around 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dosage regimen information was not reported) for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the patient suffered hearing loss. As a direct and proximate result of vaccination, the patient's symptoms have resulted in physical limitations not present to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. The patient sustained severe and permanent personal injuries. Further as a tragic consequence of vaccination, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life and physical impairment and injury.  At the time of the report, the outcome of deafness was as not recovered. The reporter considered deafness to be related to Zoster Vaccine Live (ZOSTAVAX). The reporter considered this case as serious due to patient's disabling conditions. Upon internal review, deafness was considered to be medically significant.
Plattlets dropped from 96 K/mcl to 10 K/mcl  Pumonary Embolish requiring ER and Hospitalization
A 13 month old healthy girl developed red, papular rash with vesicles from head to toe which started on 9/2/01. She was seen in my office and she had about 30-40. She was not ill, not pruritic and had no URI symptoms or fevers.
Arm didn't feel right; Spot was itching; Soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness of arm), LIMB DISCOMFORT (Arm didn't feel right) and PRURITUS (Spot was itching) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0BL20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness of arm). On an unknown date, the patient experienced LIMB DISCOMFORT (Arm didn't feel right) and PRURITUS (Spot was itching). At the time of the report, VACCINATION SITE PAIN (Soreness of arm), LIMB DISCOMFORT (Arm didn't feel right) and PRURITUS (Spot was itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Event outcome and additional events updated
hip pain/shoulder pain; Neck pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (hip pain/shoulder pain) and NECK PAIN (Neck pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (hip pain/shoulder pain) and NECK PAIN (Neck pain). At the time of the report, ARTHRALGIA (hip pain/shoulder pain) and NECK PAIN (Neck pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment Information was provided.  The patient had hip, shoulder and neck pain and believes it was from the Modrna vaccine.
No additional AEs; temperature excursion for VARIVAX; This spontaneous report was received from an office manager and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On an unknown date, varicella virus vaccine live (oka/merck) (VARIVAX) injection (1 dosage form, lot #W025277, expiration date: 10-AUG-2024) was underwent a temperature excursion of minus 22.3degree Fahrenheit (F) for 1 hour 9 minutes. No previous temperature excursion.  On 02-MAY-2023, the improperly stored vaccine was administered to patient for prophylaxis (strength and route were not provided) (product storage error). No additional adverse events (AEs).
Chills, fever, vomiting diarrhea. Painful bones for 12 hours.
Pt  received first dose on 07/20/2023. Pt  asked for second dose on 08/24/2023 and was given . It was given before the full two month wait  for second dose Shingrix.
Nausea; dizziness; Pfizer Bivalent Dose Number: 1; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Nov2022 as dose 1 (bivalent), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 06Nov2022, outcome "unknown", described as "Pfizer Bivalent Dose Number: 1"; NAUSEA (non-serious) with onset 07Nov2022, outcome "not recovered"; DIZZINESS (non-serious) with onset 07Nov2022, outcome "not recovered". Therapeutic measures were not taken as a result of nausea, dizziness.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
t105 R @ 1AM-did not dec APAP & sponging seen PMD; Also had period of staring spell @ 230 or 3AM did not have grand mal sz;
Soreness at the injection site; right leg feels achy; feeling very tired and a little nauseous.
I had symptoms of headache, sinus congestion and drainage. I went to urgent care and got positive COVID-19 test. I was prescribed steroids, cough medicine, and had a steroid shot. These symptoms lasted for approximately 7 days. It was a mild case like a sinus infection.
Menstruation irregularity. Severe abdominal cramping. Menstruation cycle prior was consistent to every 28-30 day cycles & after second Covid Moderna vaccine have not received a period since. As todays date have not had a period in 73 days!
Congestion of nasal sinus Contact with and (suspected) exposure to covid-19 nausea, vomiting, and diarrhea
sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN (sore) in a 64-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-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 an unknown date, the patient experienced PAIN (sore). At the time of the report, PAIN (sore) outcome was unknown.            Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-654236, US-MODERNATX, INC.-MOD-2022-654320, US-MODERNATX, INC.-MOD-2022-654324 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654236:MOD22-025207 (Wife's case) US-MODERNATX, INC.-MOD-2022-654320:Wife's case US-MODERNATX, INC.-MOD-2022-654324:Wife's case
The 1st reaction was on 8/13/01 with vomiting, red and flushed face, legs and arms and lethargy which lasted 45 minutes. The 2nd reaction was on 11/14/01, post vax of Comvax and Varivax, with lethargy and broke out in hives which lasted over an hour. Gave him 1/4 tsp of Benadryl.
1000 recvd inj @ work-some redness-no heat @ inj site-round small red bumps (4 @ shot area-5 on forearm rt arm) (2-3 bumps on lt arm); no itching;
patient had received an expired IMOVAX vaccination with no reported adverse event; Initial information was received on 30-Jun-2021 regarding an unsolicited valid  non-serious case from a nurse.  This case involves a 23-year-old female patient received an expired dose of RABIES (HDC) VACCINE [IMOVAX RABIES] (expired product administered).  Medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.  On 30-Jun-2021, the patient received a first dose of 1 ml suspect RABIES (HDC) VACCINE (lot R1C71) which was expired on 30-Apr-2021 via intramuscular route in the right deltoid for unknown indication (expired product administered).  It was an actual medication error due to expired vaccine used. (latency: same day).  It was reported that, nurse calling to report a patient had received an expired IMOVAX vaccination. She wants to know if she can get another IMOVAX on the same day. Upon transfer, nurse also asked if the repeat dose could be given in the left deltoid, since the expired dose was given in the right deltoid.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt recv vax 19APR96 & 23JAN97 pt devel greater than 50 full-blown chickenpox that were generalized, but were more numerous on lower extremities;this was reported to be an active case of varicella;
On 05/25/21 at 03:23PM patient received the Janssen Vaccine Covid-19 and 10 minutes post administration she had 2  anxiety induced seizure (pseudo-seizures).  The first seizure lasted about 2 minutes, followed by a second seizure that lasted approximately 30 seconds. The patient stated she's gotten anxiety induced seizures in the past, but never after a shot administration. She was fine for 10 minutes, then said she felt a seizure onset. We lowered her and placed her flat on the ground. Her heart rate was around 100bpm and blood pressure 140/90. The paramedics came to the scene and took patient to  Hospital to get checked out.
One hour after receiving the flu vaccine, face became hot and throat felt like it was tightening. Voice became hoarse, became chilled and began to shake. Vital signs taken and were normal. Given 25mg BENADRYL by mouth.
11/14/05 Got both shots in left arm at 10 am. 11/15/05 Left shoulder sore and inflamed, fever 100.5 degrees F, nausea. 11/16/05 Inflammation and swelling of left arm spreading down past elbow. 11/16/05 Went to ER at 5 pm. 11/16/05 9 pm treatment apply cold packs to reduce swelling and inflammation. Take Cephalexin 500mg, Zyrtec 10mg; Methyl prednisolone 4 mg as prescribed. 11/17/05 Follow up with PCP 11:15 am continue treatment as above. MD wasn't sure if condition was reaction to vaccine or bacterial infection of ski. Wrote prescriptions to treat both possibilities.
received a second dose of Arexvy today; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 76-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 75BS5, expiry date 28-JAN-2025) for prophylaxis.   Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY).   On 27-OCT-2023, the patient received the 2nd dose of Arexvy. On 27-OCT-2023, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: received a second dose of Arexvy today). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 27-Oct-2023 The registered pharmacist reported that the patient received first dose of Arexvy a little over 2 months ago in August. The reporter consented to follow-up. This is 1 of 2 inked patients reported by the same reporter for different patient. The patient received second dose of Arexvy on the day of reporting, which led to extra dose administered.; Sender's Comments:  US-GSK-US2023149471:2nd patient
This spontaneous prospective pregnancy report was received from a physician referring to a 21 year old female patient. She was allergic to penicillin (manufacturer, date, and reaction unknown). Patient had no concomitant medication nor medical history. The patient became pregnant with last menstrual period (LMP) of 13-SEP-2016 and estimated due date (EDD) of 20-JUN-2017. On 16-FEB-2017, the patient was vaccinated with VARIVAX (dose and frequency unknown; lot # M023383, expiry date: 11-MAY-2018; route: subcutaneous) in error to prevent chickenpox. No known adverse effects. Additional information has been requested.
Patient received Pfizer covid vaccine 05/29/2021 AND 06/19/2021 admitted to floor bed covid positive 08/28/2021
My arm has been in dire pain for 10 days. I do not have range of motion and cannot lift arm or hold heavy objects. No OTC pain medication helps. I cannot sleep because of the pain.