chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 63 year old female with sulfonamide and codeine allergies who was vaccinated subcutaneously with a 0.5 ml dose of PNEUMOVAX 23 vaccine at the end of 2004 or beginning of 2005. On 19-APR-2010 the patient was vaccinated with another 0.5 ml dose of PNEUMOVAX 23 vaccine (lot # 665400/1315Y, SC, exp. 19-MAY-2011). On 23-APR-2010 the patient called the office regarding an injection site reaction. Her symptoms included itching, swelling and pain that went down her arm. The patient was told to treat the area with ice and over-the counter anti inflammatories. Her symptoms lasted for 1 or 2 weeks. At the time of the report, the patient had recovered on unspecified dates. The patient thought injection site itching, swelling and pain were disabling. Additional information has been requested.
TC from grandmother reports grandson received vaccinations on 10/22/07. (L) arm is red/sore and warm to touch (from armpit area to almost elbow); fever, decreased appetite and increased sleepiness. Taking to MD at hospital
Developed post-vaccinal brachial neuritis, with partial paralysis of the hand and severe pain, ten days after a deltoid injection of the current trivalent flu vaccine.
24hr p/vax pt felt tired; 3 days later started w/neck aches & pruritus;wrist & arm swelling up to elbow;lt arm achiness yesterday;h/a started on 20OCT97;18OCT97 stiffness of all joints;swelling cont @ lt wrist & thumb;
About 26 hours after shot my hands began to itch and 27 hours after shot my tongue swelled. Hands had stopped itching.  All Urgent Cares closed on Sunday evening.  Talked to a pharmacist and was advised to take Benadryl.  Took 2 pills every 4 hours for a total of 6 pills.  Tongue returned to normal size within 4 hours of first 2 pills.  Contacted my internist the next morning (Monday).  Since reaction had reversed, I did not visit doctor office.
Headache; missed her second dose; COVID arm went down her elbow; Nauseous; Deep pain in the vaccine area intermittently; Felt dizzy; Her head was feeling funny; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 17-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt dizzy), FEELING ABNORMAL (Her head was feeling funny), PRODUCT DOSE OMISSION ISSUE (missed her second dose), ARTHRALGIA (COVID arm went down her elbow) and NAUSEA (Nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DIZZINESS (Felt dizzy), FEELING ABNORMAL (Her head was feeling funny), NAUSEA (Nauseous) and VACCINATION SITE PAIN (Deep pain in the vaccine area intermittently). On 27-Mar-2021, the patient experienced ARTHRALGIA (COVID arm went down her elbow). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed her second dose) and HEADACHE (Headache). The patient was treated with HYDROCORTISONE at a dose of 1 dosage form. On 03-Apr-2021, ARTHRALGIA (COVID arm went down her elbow) had resolved. At the time of the report, DIZZINESS (Felt dizzy), FEELING ABNORMAL (Her head was feeling funny), NAUSEA (Nauseous), VACCINATION SITE PAIN (Deep pain in the vaccine area intermittently) and HEADACHE (Headache) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (missed her second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  .   Reporter did not allow further contact
"Covid Arm"....Itching, Swelling, Warm to the touch, Pink in color on white skin, Swollen area is kind of solid in nature under the skin. Size of area is about 2" across, 3" in length. Location of swelling is at injection site.  Injection site is not in the center, but slightly higher than center of the swollen area.
Blood shot eyes with white puss coming out of the corner of my eyes.  low grade fever with the shakes.  Extreme fatigue with no appetite.  All activity very difficult - laid in bed.
A report was received from a health professional on 10/11/2002, concerning a 23 year old female vaccinee who experienced an injection site reaction approximately 30 minutes after receiving Fluvirin on 07/10/02. She experienced a red, hot, itchy injection site swelling. There was insufficient information to determine the reporter's causality assessment. 5 other vaccinees vaccinated at the same time with the same batch, had the same reaction. See PJP20020497, PJP200200501, PJP200200502, PJP200200503 and PJP200200504. Update (1) 12/10/02: A report was received from a health care professional, the injection site reaction had resolved at the time of the report.
104.2 degree fever, full body convulsions, migraine, tunnel vision, hallucinations, nausea - lasting over 16 hours
The injection site real red - swollen and very painful. I went to my Dr and he put me on Benadryl for about a week.
Full body rash that looks like a mix between hives and measles. Very itchy, red, and irritated. Steriod shot on 4/27/21, did not do anything for the rash.  Started taking 4 Allegra a day, stay out of the sun, heat, no sweating, etc....  on 5/3/21  by Dermatologist and Biopsy sent off.
On 1/30/23 at 1336 Patient received the incorrect formulation of covid vaccine, He received 5-11year pfizer covid bi-valent(not diluted) 0.3ml, instead of a 12+ pfizer bi-valent booster. Patient tolerated dose well and had no adverse reactions. Parent was notified per Dr of vaccine given.
From the second day I have had persistent and continuous vaginal bleeding lasting three weeks. Upon receiving the second from that moment I continue with persistent and continuous vaginal bleeding. Appearance of multiple bruises (hematomas) in different parts of the body, even with just scratching my skin, blood stains come out.
Approximately 12 hours after receiving the Moderna Covid -19 vaccine, I began to experience extreme nausea, fever of 102,  headache, shortness of breath, tachycardia (Resting heart rate was mid 150's), vertigo, and seeing spots like I was going to black out which has never happened to me before. I expected an immune response from the vaccine, but not one this extreme. I went to my local ER where I needed IV fluids and benadryl to bring my pulse down. It has now been about 48 hours since I went to the hospital and I am still very nauseous and weak. I have had to miss two (possibly three) days of work due to this reaction to the vaccine.
Covid19 breakthrough.  1st vaccine received on 05/29/2021.  74 y/o PMHx of AFIB, CVA, HTN, HLD, Hypothyroidism, Type 2 DM, sacral decub, cholecystitis, klebsiella UTI presents to ED via EMS with c/o SOB, cough and fevers.  EMS found pt with room air sat of 90% and placed on O2 at 2L NC.  CT chest-multifocal PNA, low grade temps.  Pt started on IV ABX, Steroids and Remdesivir.
Healthy male who received anthrax #3 (FAV570A), JEV #1 (NOV 17M64E) MCV4P (SKB AmV7054A) YF  (V1680AA) vaccines on 04 JAN 2019 . He denies any immediate adverse symptoms suggestive of IgE reaction (immediate urticaria, oral, face throat or tongue swelling CP, dyspnea cough, n/v). He states 1-2 days later he experienced onset of a pruritic generalized dermatitis affecting all extremities, face and torso. He stated the lesions will come and go, were raised and has photos. It lasted about a week and he was treated with steroid. Ever since then he has outbreaks, with sites started on his chest wall under his axilla. He has symptom relief with atarax 25 mgs 1 daily, but if he stops it, within 1-2 days get pruritus followed by the dermatitis.
Breakthrough COVID-19 infection. Pt received Pfizer on 02/26/2021, 03/29/2021, and 11/12/2021
little sore arm but not enough to complain; itching in stomach front upper part / itching arm / really itching all over body, even on her butt; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itching in stomach front upper part / itching arm / really itching all over body, even on her butt) and VACCINATION SITE PAIN (little sore arm but not enough to complain) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PRURITUS (itching in stomach front upper part / itching arm / really itching all over body, even on her butt). On 14-Mar-2021, the patient experienced VACCINATION SITE PAIN (little sore arm but not enough to complain). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) in March 2021 for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (itching in stomach front upper part / itching arm / really itching all over body, even on her butt) and VACCINATION SITE PAIN (little sore arm but not enough to complain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment for the event included Benadryl, which did not relieve her symptoms. The patient sought medical attention at Urgent Care and she was recommended 24 hour allergy relief but that didn't help. The patient went to doctor who prescribed "Hydrocondis" lotion.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Event outcome updated
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an adult male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 09-MAR-2017, the patient was inoculated with ZOSTAVAX at a medical office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unspecified date, the patient was treated at the same medical office for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Local reaction (soreness/redness/itching swelling at injection site  told to put ice (10/26/19) & Tylenol/go to urgent care 10/27/19 10/27/19 - went to urgent care given prednisone  Thamanolone cream 10/28/19 - spoke to patient. Arm still hurts a little Patient has headache. Swelling has gone down  but still a little itchy.
About two weeks after dose two I woke in the middle of the night with pain and pressure in my bladder.  I went to the doctor and diagnosed with UTI.  I was prescribed Cipro and after this round of prescription I still was not better.  I was referred to urologist and prescribed a different antibiotic.  After this round I still was not better.  I was prescribed a third type of antibiotic and it took two rounds before my UTI was cleared up.  I was diagnosed with Interstitial Cystitis.  I treat with diet changes, hydration and AZO when the symptoms first begin, and Premarin cream.
One day following my Pfizer booster vaccination (dose 3 overall), I noticed that the lymph node below my left arm (the arm used for vaccination) was very swollen and tender to the touch.
On Wednesday, March 31, 2021 client received her first dose of Pfizer COVID vaccine (LOT # ER8737, EXP 7/2021) at approximately 11:12am. While in Observation Area, patient reported to EMTs on site she felt a sensation of "dizziness and pressure on chest" at 11:35am and vitals were taken by EMT. Vitals at 11:35pm: HR: 85bpm, 02 sat: 97%. Lead PHN was alerted and vitals were taken again at 11:40am. Vitals: BP: 120/70. Client was walked over and seated on the anti-gravity chair with a bottle of water. Vitals at 11:50am: BP: 122/74, HR: 90, 02 sat: 98%. Vitals continued to improve and client stated the "pressure on chest and dizziness" was completely gone 20 minutes later. Reassessment of vitals were were offered at 12:30pm but were refused by client. Client was observed for an additional 30 minutes in Observation area. Patient was alert and oriented x4 during entire interaction. No further interventions indicated. Client was educated by Lead RN & EMT on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to sign-up on mobile reporting app. Client left vaccination site at approximately 1:00pm with a steady gait.
Swollen lymph node, left side, less than 1 cm, above collarbone
per patient report:  "103.5 fever with heart rate of 100-120s.   Farmer's Lung activated with profound coughing.  O2 sats went transiently low to 85 but mostly 91-92%. Became very unsteady on feet, requiring support of walls, furnishings and counters. Horrible chiari headache with bad nausea Neuropathy in BLE flared, legs were buzzing and I was getting intense spasms of bilateral feet and ankles that made it hard to use them. Visual decline Passed out twice cold in the bathroom [found myself in bathroom, when "I came to"] In bed for 3 days except to use the restroom and make tea. Could not attend to any other ADLs. Injection site red from shoulder to elbow, swollen and itchy with axillary lymph swelling". Symptoms
Vaccine was administered after the beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the beyond use date after the thaw process) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.  The patient did not report any adverse reactions after the administration of vaccine.  Vaccine number 1 NDC code was reported as 80777-0273-99.
Muscle ache; Headache; Chills; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle ache), HEADACHE (Headache), CHILLS (Chills) and ASTHENIA (Weakness) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced MYALGIA (Muscle ache), HEADACHE (Headache), CHILLS (Chills) and ASTHENIA (Weakness). At the time of the report, MYALGIA (Muscle ache), HEADACHE (Headache), CHILLS (Chills) and ASTHENIA (Weakness) outcome was unknown.            no concomitant medications are provided. treatment to the events not provided.  patient want to know whether it is advisable to go for the second dose, given these symptoms. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Having to poop around every 4 hours for around 40 hours.  Not really diarrhea but just getting rid of everything in the colon.   When all the poop & even the liquid was gone, just blood would come out.  Also feelings of not enjoying anything (didn't like to do things that are fun).
This is weird but I'm not too worried. I got the Covid booster on Monday in my left arm. I felt a weird pain in my thumb, kind of like arthritis. It felt like the joint in my thumb was stiff. So when I held a cup with coffee it felt like the cup was heavy but only to my thumb.  Yesterday I had a headache on the right side of my head and Motrin helped. I had good energy until lunch time then was tired for about an hour and a half. My thumb felt better but my left armpit felt bruised. It felt like I had an irritated hair follicle in my armpit. I needed a second dose of Motrin in the afternoon because the headache was back. By the time I got home at 9:30 PM I looked at my armpit and didn?t see any redness but my lymph nodes were definitely inflamed.   Today I have a headache again but not enough pain for Motrin. It feels like a blood pressure cuff is on my left arm and pumped up but not too tight and my arm feels heavy and when I lift it it all the way up it hurts.
injection given in the right arm and a couple days later she starting having some itching on her arm and there was a bright red 50 cent size mark on her skin along with some swelling. Patient also noted some blistering and today one of the blisters popped  No treatment provided as of now
30-year-old female complained of chest tightness 15 mins after receiving the first dose of the vaccine. She reported her only history is environmental allergies. She was assessed and monitored by NP, EMT and paramedic. BP - 115/89, HR - 90, RESP - 26, O2SAT - 97%.
My neck felt warm and fuzzy; My neck felt warm and fuzzy; Oddly pleasant/I felt... high; Some arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jul2021 13:00 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "anaplasmosis" (unspecified if ongoing), notes: I, unknowingly, lived with anaplasmosis (a tick borne illness) for several years. Concomitant medication(s) included: PRAZOSIN; TOPIRAMATE; BUPROPION. The following information was reported: FEELING HOT (non-serious), MUSCULOSKELETAL DISCOMFORT (non-serious) all with onset 2021, outcome "not recovered" and all described as "My neck felt warm and fuzzy"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "not recovered", described as "Oddly pleasant/I felt... high"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "Some arm pain". Therapeutic measures were not taken as a result of feeling hot, musculoskeletal discomfort, feeling abnormal, pain in extremity.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no known allergies. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Other medications the patient received within 2 weeks of vaccination: Clonidinramelteon.   The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Temperature excursion of Unopened IPOL at 24.4 F for 13 hours with no reported adverse event; Initial information received on 07-Jul-2022 regarding an unsolicited valid non-serious case received from health professional. GMI number: 01180402   This case involves report of temperature excursion of unopened IPV (VERO) [IPOL] at 24.4 f for 13 hours with no reported adverse event while receiving vaccine.  This case is linked to case 2022SA271987(Tenivac).   On an unknown date, temperature excursion of unopened: ipol (lot UIA451M and expiry date: 28-FEB-2023) at 24.4 f for 13 hours with no reported adverse event (product storage error).  It was reported that Caller was reporting a temperature excursion. The cause of the temperature excursion was unknown. Caller is requesting stability information on these products.  Confirmed with caller that products were not administered to any patients post temperature excursion This situation is reported as a medication error due to temperature excursion exceeded the stability data documented in the local labelling and additional supporting stability data the cause of the excursion was unknown.    Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.     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 the guidelines. 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.
Site: Itching at Injection Site-Severe, Systemic: Pins and Needles/Numbness in the arm -Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
I have all of the reactions; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient had all of the reaction and was in bed. The patient did not want to provide other details.