chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching at the site of injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A male patient received pf-06928316 (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Neomycin, reaction(s): "Drug allergy: neomycin". The following information was reported: VACCINATION SITE PRURITUS (non-serious) with onset Sep2023, outcome "unknown", described as "Itching at the site of injection".  Additional information: Itching at the site of injection started on Thursday. The patient is allergic to neomycin but was told not in the shot.  The information on the batch/lot number for pf-06928316, pf-06928316  has been requested and will be submitted if and when received.
Severe chills; Fevers went up to 103 deg. F; Postural hypotension; faintness and lightheadedness; Headache; administered with dose 3 or booster shot; This is a spontaneous report from a contactable pharmacist (patient). A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: FF2590; Expiration date was not reported), via an unspecified route of administration in the left arm on 16Oct2021 03:00 PM (at the age of 55-years-old) as dose 3 (booster), single for COVID-19 immunisation. The facility where the most recent COVID-19 vaccine was administered was at a pharmacy or drug store. The patient has no relevant medical history. Concomitant medication included influenza vaccine (FLU) via unspecified route of administration in the left arm on 05Oct2021 as single dose for influenza immunization. The patient was previously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 21Jan2021 (at the age of 54-years-old; Lot number: El1283; Expiration date was not reported) as dose 2, single and on 31Dec2020 (at the age of 54-years-old; Lot number: Ej1685; Expiration date was not reported) as dose 1, single, both via an unspecified route of administration in the left arm and for COVID-19 immunisation. It was reported that the patient did not have any reaction to the first 2 Pfizer-BioNTech vaccines. The patient previously took Aspirin and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 16Oct2021 03:00 PM, the patient was administered with dose 3 or booster shot of BNT162B2. On 17Oct2021 03:00 AM, 12 hrs after the booster shot, the patient experienced severe chills, fevers went up to 103 degrees Fahrenheit, postural hypotension leading to faintness and lightheadedness lasting 48hrs and headache lasting 72 hrs. Fevers lasted 3 days despite acetaminophen and ibuprofen round the clock. Events were reported as non-serious by the reporter. Treatment with acetaminophen and ibuprofen round the clock was taken for event fevers went up to 103 degrees Fahrenheit and no treatment was taken for the other events. The outcome of event severe chills was recovered on an unspecified date in Oct2021, outcome of event fevers went up to 103 degrees Fahrenheit was recovered on 20Oct2021, outcome of events postural hypotension leading to faintness and lightheadedness was recovered on 19Oct2021 03:00 AM and outcome of event headache was recovered on 20Oct2021 03:00 AM.
Patient returned to the pharmacy the next day with a large, raised, red, swollen area on left arm around the vaccination site. It was approximately 7 inches in size. She reported the area was itchy and warm to the touch. She also reported pain from site and it radiated into the neck. She had already taken acetaminophen for the pain and pharmacist advised her to take diphenhydramine for the itching and swelling. She was also referred to her primary care physician for further care.
Patient reported; headache, vomiting, fever, chilled, red swollen arm at injection site; warm to the touch;
No additional adverse events were reported; The healthcare worker reported that a patient received improperly stored vaccine.  The patient received only one dose but the healthcare worker did not specify which actual lot the patient received.  No additional AEs were reported, no further inform; This spontaneous report has been received from a health care professional, concerning a 6-months-old patient of unknown gender.  The patients' medical history, concurrent conditions, concomitant medications, previous drug allergies, and reactions were not provided.  On 25-AUG-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), once, for prophylaxis, the reported did not specify which lot number received it could be either the (lot number W004504 has been verified to be valid; expiration reported and established as 16-JUN-2023, or lot number W002562 has been verified to be valid; expiration reported and established as 12-OCT-2023) (dosage, vaccination scheme, and route of administration were not provided) (product storage error). The patient received only one dose.   The administered dose of the vaccine was stored at a temperature of 11.3 degrees Celsius (C), during a time frame of 34 minutes. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA001469:MSD
hives on the upper arm, stomach, back and upper thighs/  red welts; red welts; skin drying; little bumps; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on the upper arm, stomach, back and upper thighs/  red welts), ERYTHEMA (red welts), DRY SKIN (skin drying) and RASH (little bumps) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included Colon cancer since an unknown date. Concomitant products included INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (NOVOLIN 30/70), PIOGLITAZONE, LISINOPRIL, ATENOLOL, AMLODIPINE BESYLATE, POTASSIUM CHLORIDE, FUROSEMIDE, ALLOPURINOL and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives on the upper arm, stomach, back and upper thighs/  red welts), ERYTHEMA (red welts), DRY SKIN (skin drying) and RASH (little bumps). At the time of the report, URTICARIA (hives on the upper arm, stomach, back and upper thighs/  red welts), ERYTHEMA (red welts), DRY SKIN (skin drying) and RASH (little bumps) 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.   Patient treatment information was not provided.
Ten hours after the vaccination was given, the customer's arm was swollen, hot, and sore at the vaccination site. She called me at pharmacy and asked what to do. I told her to put ice on it. And go see a doctor if it wasn't better the next day. On 11/3/17 patient went to an urgent care facility. The doctor there gave her a cortisone shot of some type. I called her in the evening on 11/3/17. She told me it wasn't any better, actually worse. The swelling seemed to be going down her arm. I told her to go to a doctor. On 11/4/17, patient went to her own doctor. The doctor said it was vaccine induced cellulitis. The doctor gave her a prescription for azithromycin to be taken 2 times a day. She did not fill it at this pharmacy, so I do not know the dosage or days supply. I phoned patient at 6pm on 11/4/17 and told me that her arm was very hot and swollen, with the cellulitis. The doctor told her that a very small percentage of people get a vaccine induced cellulitis from PNEUMOVAX 23. On 11/6/17 I called patient again to check on her. She said it had been improving while on the antibiotic.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 13May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "Auto-immune disorder" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Allergy: Sulfa" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Morphine, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: No other medication in 2 weeks.   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 the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Local redness, no swelling, no abscess. Positive tender with palpation. Full range of motion. No anaphylaxis. No respiratory symptoms.
Administered influenza vaccine on 1/12/18 pt started seeing bruise, swelling on (L) deltoid. Swollen 35 mm painful, itching. No discharge, no fever. Patient feels malaise.
she had breakthrough bleeding; menstrual spotting; she was not supposed to get her period for another week or two.; This is a spontaneous report from a contactable consumer (patient). A 19-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 19 years of age), via an unspecified route of administration, administered in arm left on 09Mar2021 (Batch/Lot Number: EN6203) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included contraception from an unknown date and unknown if ongoing. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LARIN FE) taken for contraception, start and stop date were not reported. It was reported that the patient received her first dose of Pfizer-Biontech Covid19 vaccine 09Mar2021. She mentioned that almost immediately afterward she had breakthrough bleeding and now she has a "full blown period" even though she was on the pill.  She wanted to know whether this has been reported, and if she should be concerned. She added that she got the Covid vaccine on Tuesday 9Mar2021, and since then she has been having a lot of menstrual spotting, she was not supposed to get her period for another week or two. This started almost immediately after she got the vaccine about an hour or two after on the same day. She was unsure if this could be a side effect of the vaccine. Stated it had progressively gotten worse and was now a full blown period. Stated she does not typically have any breakthrough bleeding. The outcome of the events was not recovered.
Very painful at injection site. I could not move my left arm without severe pain. My arm could not be moved for 2 days. I also became very ill the day after with flu-like symptoms.
Monday night I started getting pretty fatigued and my arm was tired, and the next morning I woke up with body aches, headaches and joint pain. The next morning I had fevers and chills, so I took a tylenol and I started feeling better. This morning I had a bump at the injection site and it's very tender to the touch. I'm currently icing it. The injection site is a little warm
Day after vaccination, I had a fever of 101.7 and chills. I expected those.  About 3 days after vaccination I started experiencing joint  pain. At first I thought maybe it was just that I had made myself sore with physical activity, but the joint pain has never completely resolved and is something that I have never experienced before. I am a veterinarian, and the symptoms that I am experiencing are consistent with a poly arthritis. The pain reduces with a anti-inflammatory but never goes away completely. Also I am experiencing joint swelling and fluid accumulation, I have never had such symptoms before. I other effect, my menstrual period was over 3 weeks late. I realize that I am of an age that menopause could start, but I had been extremely regular up to that point, had not had intercourse in over 1 year, and my family history is that of women who go into menopause in their early 50's.
Case number PHEH2014US024787, is an initial spontaneous report received from a nurse received on 09 Dec 2014. This report refers to a female patient of an unknown age. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1411401) intramuscularly on 04 Dec 2014. On the same day, after vaccination, the patient experienced cellulitis around the injection site. The patient consulted physician and was taking antibiotics. The outcome, seriousness and causality of the event were not reported. Seriousness assessment of cellulitis around the injection site was upgraded based on the NVS-IMS list.
On 10/10/08, left arm at injection site was noted to be quite red and with swelling of an area about the size of an egg.  Area somewhat  tender to the touch, but arm otherwise symptom pain.  Injection site ("where needle went in") visible.  Redness became "purple-red" and discoloration and swelling began to subside 1 day later.  No systemic symptoms.
10 year old patient was given pfizer dose instead of pfizer dose. Pt was evaluated for 20 minutes with no adverse reactions noted. Followed up with mother of patient on 12 July 2022 who reported that the patient is okay.
This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. On 5th September 2018, the patient received SHINGRIX. On 5th September 2018, unknown after receiving SHINGRIX, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. In September 2018, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On Wednesday, 5th September 2018, the patient was administered only the adjuvant component of SHINGRIX, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Less than a week after receiving SHINGRIX, the patient experienced flu-like symptoms. The healthcare professional was in the car and did not have additional information.
lymph nodes around my groin area start swelling up; It is kind of gets hard but it is hurt and it is point down now/I kind of lost function of my 'sored'; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "lymph nodes around my groin area start swelling up"; PAIN (non-serious), outcome "unknown", described as "It is kind of gets hard but it is hurt and it is point down now/I kind of lost function of my 'sored'".  Additional information: It was stated, the 2 weeks after patient got the second vaccine shot. It was the lymph nodes around patient groin area start swelling up and patient kind of lost function of patient 'sored' (Further clarification unknown hence not captured). It was kind of gets hard but it was hurt and it was point down now."  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected
Red raised pimply rash on stomach and his right eye puffy / itchy. He took Benadryl with minimal relief from the itching. Today he has the rash on upper extremities and torso which continues to be very itchy. He denies any difficulty breathing, dizziness, headache or any other symptoms.
Had IZ on 2/18/00. Next day had blotchy, hot to touch rash from head to knees, later spread to feet. Palms of hands and soles of feet were itching and face was red and swollen. Gave Benadryl and next day rash was gone.
fever; weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: pfizer 4176) intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Epstein barr virus", start date: 03May2019, stop date: 10May2019, notes: Pertinent details: hospitalized 5 days (Name) hospital; "sciatica", start date: Feb2010, stop date: 03Aug2010, notes: Pertinent details: spinal injection; "vagina haemorrhage", start date: 1982, stop date: 1994, notes: Pertinent details: hysterectomy Dr (name withheld) 1996; "Miscarriage", start date: 1979, stop date: 1979; "hysterectomy", start date: 1996 (unspecified if ongoing), notes: Pertinent details: hysterectomy Dr (name withheld)  1996. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 22Jan2021, outcome "unknown", described as "fever"; ASTHENIA (non-serious) with onset 22Jan2021, outcome "unknown", described as "weakness". Therapeutic measures were taken as a result of pyrexia, asthenia.  Additional information: Prior vaccinations: None. Therapeutic measures were taken as a result of pyrexia, asthenia includes Tylenol
Initial information received on 15-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient (age and gender not reported) who was vaccinated with DTaP/IPV portion only, not reconstituted with ACTHIB of PENTACEL (batch number, expiry date, route and site of administration were not reported) on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to Inappropriate reconstitution technique. No adverse event 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 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. Documents held by sender: none.
102 fever for 5 days following injection with around the clock Tylenol, severe pain to the point of not being able to walk for 1 day after the injection, arm swelling and rash about the size of a baseball that started on 1/25/21 responded to Benadryl after a day and a half, severe headache that is still lingering, WBC count <2 as of 1/25/21.
Ill for 36 hours post vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ILLNESS (non-serious) with onset 13Oct2023 at 19:00, outcome "recovered" (Oct2023), described as "Ill for 36 hours post vaccination". Therapeutic measures were not taken as a result of illness.  Additional information: Patient denied taking other medication in two weeks or for any other vaccine in four weeks. Patient denied for covid tested prior or post vaccination.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
1 month of pain close to injection site, with reduced ROM, tenderness to palpation.
Severe shoulder pain, painful to touch, hard & swollen 24-48hours after injection- Treated with Tylenol, Ibuprofen, CDB oil, Ice. resolved to soreness 48-72 hours Delayed injection site rash 10 days after first dose
Came down with an outbreak of Herpes Zoster.  Given Acyclovir 800mg tid for 10 days and Gabapentin 100mg bid for 10 days
monovalent vaccine given as booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 WRONG PRODUCT ADMINISTERED (monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (monovalent vaccine given as booster).    No concomitant drug were reported.   It was reported that the caller was the office manager. She had a situation. She found out that they could not give the Moderna as a booster starting 31-Aug-2022, but she administered 15 monovalent doses as boosters. She called public health, who said there was no harm in it. She was also told to call VAERS. She was told that the booster that they received did not cover omicron, so they would need to be revaccinated with the bivalent later.  No treatment drug were reported.