chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a female patient who at an unknown date was vaccinated with the second dose of Gardasil. Subsequently the patient experienced mastitis. It was unknown whether or not this patient had this experience was with the first dose. Unknown medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
The pt experienced a quarter sized knot on the pt's left thigh that was hot to the touch with redness around the area. The child felt hot and was very irritable. The pt was given Motrin and was playful as usual on the following day.
pt recvd vax & 50mins p/vax exp numbness & tingling in hand & lips;sx were treated w/ice & an oral anti-inflammatory;sx lasted for approx 3hrs;
No adverse event reported from giving extra doses of MMR (3 doses) IPV (5 doses) or from giving Tdap early (age age 10 yrs).
The patient was given the first Prevnar vaccine on 01/23/2001 and developed hives 5 days post vax, lasting 1 1/2 days. The same occurred on 04/24/2001 when the patient was given the second Prevnar vaccine. The patient was treated with Benadryl.
I had a very, very, sore arm again. This is day 3 and its better but my arm has hurt so badly its been hard to use the last couple days. Day 1; I felt the same as I did after dose 1, fatigue and kind of light headed and dizzy. Woke up yesterday feeling the same and thought it was maybe lack of sleep because I kept rolling onto my left arm. But then the fever kicked in and I had the chills for about 2 hours. I couldn't seem to get warm. I had a pounding headache all day that Tylenol and Motrin wouldn't take away. I was very fatigued all day. Later in the day I became very hot and could not seem to cool off. I also had a sore throat and my body was slightly achy but that could of been from not sleeping well or sleeping weird due to my arm hurting. I woke up this morning with just being tired and my arm is still sore but even that is feeling much better. I didn't even feel the need to take pain reliever for that like I had been since I got my vaccine.
I broke out in a rash ( chest - neck - arms - legs - back) with extreme itching; I broke out in a rash ( chest - neck - arms - legs - back) with extreme itching; Face was swollen (eyes - lips -ears); Face was swollen (eyes - lips -ears); Face was swollen (eyes - lips -ears); Face was swollen (eyes - lips -ears); This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Apr2021 10:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Facility type vaccine was Pharmacy or Drug Store. There was no other vaccine in four weeks nor other medications in two weeks. The patient broke out in a rash (chest - neck - arms - legs - back) with extreme itching, face was swollen (eyes - lips - ears). Patient went to the hospital and was given IV drip with Benadryl - steroids for treatment. Patient was then sent home but the rash and itching still persist. He then went to my doctor and was given 2 shots of steroids and Prednisone 10mg. The events onset date was reported as 16Apr2021 16:00. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The outcome of events was recovering. Patient had no COVID prior vaccination nor tested COVID post vaccination. No known allergies.  Information on the lot/ batch number has been requested.
I did not know this was her 5th dose until 8/5/2022. Before giving COVID-19 vaccine, I asked for her vaccine card, which she provided only showing Moderna vaccine. I called her today. I asked her if she knew she received 7 shots of the COVID-19 vaccine. She answered yes. I asked her why she did not shown me a vaccine card for Pfizer COVID-19 vaccine. She stated she got the Moderna vaccine before, which is why she only showed me the Moderna vaccine card.
Dizziness, shortness of breath minutes after injection. Each day continued dizziness, nausea, vomiting, diarrhea, intermittent hives, full body skin flushing, itching
Felt a very heavy heartbeat, felt a heavy mass in the chest side of hears for 3-4 days to a degree that some nights could not sleep and had to turn to right side often to alleviate inner chest pain.  The heavy heart feel sloly dissipated after about a week or two. After about 2 -3  days of 2nd Pfizer shot - started to feel lightheadedness and pulsating headache in the frontal areas of forehead.  This pulsating pain would come and go and continued for about a month. after about 2 weeks it was continuous throughout the day with some relief after a night sleep.  This pain often kept me from falling asleep for hours. At the same time I noticed that I started to experience increased ringing in my ears,  I had been experiencing tinnitus for years and used to the slight ringing noise but this was different.  Sometimes ringing noise would increase to the degree - I could not able to hear others around me.  after a month of headaches and increased ringing noise my doctor recommended to take blood pressure medication, which helped relief my headache.  I still have heavy ringing noise I did not experience prior to the vaccination.
Significant localized reaction to DT shot with 6cm inudrated erythema l/arm and 2cm nodule at injection site, continuing to be bothersome.
injection site pain; Headache; Mucscle and joint pain; Mucscle and joint pain; chills; feeling unwell; swollen Lymph nodes; This is a spontaneous report from a contactable consumer (patient).   A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Enu2v2), via an unspecified route of administration, administered in Arm Left on 02Mar2021 01:45 (at the age of 76 year old) as dose 2, single for COVID-19 immunisation.  Medical history included Celiac disease/gluten Free . Concomitant medications included atorvastatin (LIPITOR); amlodipine; losartan, hydrocodone, all taken for an unspecified indication. The patient was not pregnant at the time of vaccination. Prior vaccination, the patient was not diagnosed with COVID and did not receive other vaccines in four weeks. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EM9809, via an unspecified route of administration in left arm,  on 08Feb2021 11:45 (at the age of 76 year old), as single dose for COVID-19 immunization. On 03Mar2021, patient experienced injection site pain, headache, muscles and joint pain, chills, feeling unwell and swollen lymph nodes. Since the vaccination patient had not been tested for COVID. No treatment was received in response to the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Patient is a 33 y.o. male who received the Moderna Covid-19 Vaccine, mRNA-1273 (PF) 100 mcg/0.5 mL IM Susp, Lot 044A21A on 3/15/2021. The patient experienced the following reaction(s) during the immediate of observation: 3:06pm Patient c/o itchiness to bilateral arms. Patient reports feeling anxious and lightheaded s/t fears of needles prior to coming in. Patient arm color appeared within normal limits. No swelling noted to face or mouth. Denies shortness or breath or difficulty breathing. Patient was treated/managed as follows:  3:07pm VS BP 132/88, HR 83, RR 18, O2 sat 99% on room air. Reports feeling better. 3:17pm VS BP 128/90, HR 74, RR 18, O2 sat 99% on room air. Patient reports symptoms have improved. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. 3:45pm Escorted to car by RN.
cold feeling in her left arm; a little chest pain that eventually subsided/excruciating pain in her chest; excruciating pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE COLDNESS (cold feeling in her left arm), CHEST PAIN (a little chest pain that eventually subsided/excruciating pain in her chest) and PAIN IN EXTREMITY (excruciating pain in her arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Brain damage (the brain damage causes her not to be able to remember things.) and Liver, cancer of (she had liver cancer (HCC) two years ago that required surgery of her liver and gallbladder.) in 2019. Concurrent medical conditions included Shellfish allergy, Fruit allergy (strawberries, peach, mango, and dragon fruit), Penicillin allergy (antibiotic cillins), Drug allergy (Cipro,), Allergy to antibiotic, Drug allergy, Drug allergy (,), Drug allergy (fentanyl) and Drug allergy (acetaminophen). Concomitant products included LISINOPRIL and ASCORBIC ACID, BIOFLAVONOIDS NOS, HESPERIDIN, MALPIGHIA GLABRA, ROSA CANINA, RUTOSIDE (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS;HESPERIDIN;MALPIGHIA GLABRA;ROSA CANINA;RUTOSIDE]) for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced VACCINATION SITE COLDNESS (cold feeling in her left arm), CHEST PAIN (a little chest pain that eventually subsided/excruciating pain in her chest) and PAIN IN EXTREMITY (excruciating pain in her arm). At the time of the report, VACCINATION SITE COLDNESS (cold feeling in her left arm), CHEST PAIN (a little chest pain that eventually subsided/excruciating pain in her chest) and PAIN IN EXTREMITY (excruciating pain in her arm) outcome was unknown.            No treatment received. The patient had  little chest pain that eventually subsided. The chest pain lasted a few hours. On 02-Dec-2021, The patient experienced excruciating pain in her chest and arm. The pain stopped and then it hit again currently experiencing chest pain.   This case was linked to MOD-2021-403801, MOD-2021-403813 (Patient Link).
Irritable for one week. 3 spots on face (mom thought insect bite). Cries nonstop when putting down. No local reaction.
Patient started to ?feel his heartbeat more rapidly?, felt lightheaded, and felt some dizziness. Patient was given ice to apply to himself and laid down on the ground with limbs in the air to increase circulation to core. Patient was then brought to a room for provider review  and given juice. After a short time patient felt normal and was discharged home.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 20-AUG-2014 the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (dose and route were not reported, lot # J009827, expiration date 10-AUG-2014). No adverse effects were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
had an extra powder left / not sure if just liquid cyw / was administered / what would happen / if they administered only the cyw component; had an extra powder left / not sure if just liquid cyw / was administered / what would happen / if they administered only the cyw component; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that in office had an extra powder left with Menveo in their box and reporter not sure this was just liquid CYW of Menveo vaccine was administered by patient which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter said that in same office they had drawn up a CYW and were about to mix with A' component, but the patient decided then not to get the vaccine. The reporter wanted to know that what would happened and if there was any information from GSK if patient administered only the CYW component. No other information provided by reporter. The reporter told if they found out vaccine was administered to a patient they would report information.
HIGH FEVER 104.5; CELLULITIS; SYSTEMIC INFECTION; LETHARGIC, REDNESS, CHILLS, SEVERE BODY PAIN, SWELLING, INCREASED WHITE BLOOD COUNT (X3 NORMAL) ALL WITHING 24 HOURS.  WENT TO THE ER THE SECOND DAY WITH INCREASED SYMPTOMS.  ADMITTED TO HOSPITAL.
No adverse effects were reported. The patient received a fourth dose incorrectly. The patient and the LTCF did not make the administering pharmacist aware that she had already received a third dose 11-5-21 at a hospital setting.  The LTCF and the patient's doctor were both contacted.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patiens were vaccinated with (Oka/Merck) VARIVAX. Dose, route, lot number and expiration date were not reported. NO co-suspect and concomitant therapies were reported. The nurse reported that (Oka/Merck) VARIVAX vials also had been exposed to temperature excursion and improperly stored (Oka/Merck) VARIVAX doses had been administered. Nurse stated that since the excursions, 6 doses of (Oka/Merck) VARIVAX had been administered. No adverse effects reported.  This is one of two reports from the same source (other case # 1406USA011997). Additional information has been requested.
Localized swelling, warmth, inflammation, tenderness at site of injection (at left deltoid).  4 x 5cm area of swelling and erythema.
Pain in injection left arm site 2 hrs after injection. Pain lasted for 48 hours. On the third day after the injection, I developed swollen lymph node under left armpit.
Muscle cramp at the site injection/Intractable neck cramp the last 8 days post shot; Muscle cramp at the site injection; This is a spontaneous report from a non-contactable pharmacist.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Dec2020 (ten days before 04Jan2021) at single dose for covid-19 immunization. Vaccine location was arm. The patient medical history and concomitant medications were not reported. The patient experienced muscle cramps and intractable neck cramp the last 8 days post shot in Jan2021. The shot was given ten days ago and after 08 days of time intent Muscle cramp at the site injection would be proximal to the shot injection site of the basically trapezius muscle and external emasculate muscle. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # R000301, Expiry date: 29-AUG-2020) for prophylaxis (route and anatomical location were not reported). No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 20 degrees Farenheit for 5 days.  There was no previous temperature excursion. The call was due to data logger. This is one of the two reports from the same reporter. Sender's Comments:  US-009507513-1808USA008205.
pt recv vax & a couple of days post vax pt exp a rash under both arms;rash resolved in 3-5 days;
6" x 4" warmth and erythema upper rt arm with several fluid filled blisters.
Three months after the second vaccine, sever skin irritation would occur everyday around 7pm, on both arms and stomach area. At six month, i had symptom of subacute thyroiditis.  both sides of my throat.  it lasted 2 months of time.  I only took OTC ibuprofen for the entire 2 months.
Initial information received on 25-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse via phone. This case is linked to case 2018SA206110. This case involves a 17 years old female patient who was exposed to vaccine MENACTRA while pregnant, patient was seven weeks pregnant. The date of last menstrual period was reported as 26-May-2018. The estimated due date is 02-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines given. On 18-Jul-2018, the patient received a 0.5 ml third dose of suspect MENACTRA (lot U5948AB, frequency once, expiry date 03 July 2019) in the left deltoid, Patient had previously received MENACTRA in May 2012 and then again in Dec 2017 but it was found that Dec 2017 dose invalid due to excursion affecting vaccine. It was an actual medication error due to vaccine exposure during pregnancy, Extra dose administered and Incorrect product storage. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender- none.
Pretty strong dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Pretty strong dizziness) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS, HYALURONIC ACID and AMINOACIDS for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced DIZZINESS (Pretty strong dizziness). At the time of the report, DIZZINESS (Pretty strong dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medication included supplement chasteberry. The patient did not receive any treatment medication.
Patient developed a rash at injection site as well as on her arms, chest and back exactly 2 weeks after vaccine given. The rash looked like a classic chicken pox rash.  Rash was dry and crusted 5 days later.
high grade fever 104.8 w/difficulty of walking;dec PO feedings;lethargic & apparently in pain when turning head to hosp;LP done to r/o meningitis;tx IV decadron & ceftriaxone;
Pt was admitted to hospital 5/2 w/ acute onset of DVT/PE (had her COVID vax on 4/29 and 4/8).  On further history, she was feeling some chest tightness in mid-April, so may have started in between the two doses.  Not sure if it's related - pt also has MGUS which may be the cause of her hypercoagulable state, but felt I should do my due diligence and report it given the temporal relation to her vaccines.
mom reported pt lt arm, red, hot & swollen;advised cool compresses & APAP for pain;no fever;17SEP97 lt deltoid red, hot, & swollen-induration measured 3 inches by 3 1/2 inches;blisters were bandaid;arm sore & hurts;
Caller states that he had a hard time sleeping; right arm was painful at the vaccine site; Fever; Headache; Body aches; Dizziness; Cold symptoms; This is a spontaneous report from a contactable consumer. A 53-year-old male patient started to receive pneumococcal 13-val conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration from an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient stated he had what felt like cold symptoms and then in the late afternoon of 30Sep2020, he started to experience fever which got to around 104 but he's not sure of the accuracy, he had a headache, body aches and dizziness. It was reported that his wife is a nurse and she told him that this symptoms are common with vaccines so she advised him to take Tylenol. Caller states that the fever subsided, but then when the Tylenol wore off he had body aches again but the fever was much less compared to Wednesday afternoon. It was also reported that the patient had a hard time sleeping and he did not get up to take more Tylenol because he was unable to get out of bed due to the body aches. Caller reports that he took more Tylenol this morning and his body aches went away. It was also reported that the patient had a hard time lifting his right arm where the Prevnar vaccine was given and further stated that the right arm was painful at the vaccine site. The outcome of the event fever was recovering, recovered on an unspecified date for body aches while unknown for the other event.  No follow-up attempts are needed. No further information is expected.
"Within the 15 minute wait time I became nauseous and felt pain go down my arm to my fingertips.  I had someone with me so I took it.  The pain stopped right after it started.  I was just tired with a very sore arm the rest of the day. During the night I got up to go to the kitchen and I became disoriented and couldn't find my way back to the bedroom.  I woke up on the floor with my forehead about my eye hurting from hitting something on the way down.  It is now 7:38am on 11/10/21 and so far I just feel week and a little unsteady but doing fine."
injection site pain, full arm pain with swelling and more intense pain in the arm pit and upper chest on left side. Forearm is hard and warm to the touch and also has pain with pain to touch.
Breakthrough infection. First symptoms detected upon waking at 7am on 6/1/2022 (sore throat). Mild headache occurred later in the day. On 6/2/2022 (10 am) went in to local testing center for rapid test, it came back negative. PCR test was given immediately. Received positive result on 6/4/2022. Symptoms worsened the evening of 6/2/22 with increased headache, body aches, low grade fever (99.0*F, my typical is 96.4*F with our thermometer). Some clearing of chest congestion (thick mucus). Sinus drainage was clear and mild to moderate in volume. Required Tylenol to sleep. 6/3/2022: headache intensity dropped, body aches became less intense/frequent. Only an occasional need to clear chest. Inhaled steam using vaporizer. Drank lots of fluids plus electrolytes. Able to sleep without Tylenol 6/4/2022: Headache intensity dropped further. Body aches gone by end of the day. Still an occasional need to clear chest of mucus. Began drinking a cup of horehound tea before bed in addition to the electrolyte hydration routine. Received positive PCR test results 6/5/2022: Headache gone. Body aches did not return. Occasional need to clear chest of mucus. Maintaining Tea, steam, and electrolyte routine. 6/6/2022: Similar to 6/5 but feel like I have my normal amount of energy--likely due to improved sleep.