chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itching; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 14Jan2021, it was reported that Spouse is having intense itching since taking vaccine today. States she has taken Tylenol and pain killers but to no effect. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Lt deltoid cellulitis, arm swollen, red hot to touch and itching. Treated with Augmentin and Benadryl.
Macular rash that developed within 24 hrs of application. T max 100.4 F, pt doing well feeding adequately.
Patient said he developed sores and redness inside of mouth and on lips and around lips. He said it was tender to the touch.
Moderna COVID-19 Vaccine EUA: during follow-up clinic visit patient reports experiencing facial swelling and symptoms similar to seasonal allergies after vaccination. Patient went to emergency department, received steroids, and was discharged. Symptoms resolved and did not return.
For two days low grade fever, severe muscle aches, fatigue, chills, mild cough and congestion.
pt recv vax;w/in 3 mins, became pale & limp;diaphoretic;given caffeine & sugar, came around w/in 5-7mins";
Sharp shooting pains in torso and head, slight numbness in finger - next 10 days progressed to whole body, went to E.R. in hospital. Had all types of tests conducted per patient. Labs CT scan and MRI all came out normal, had shot on 10-12-10 - No problems until 10-18-10 (upon which she went to ER). Called pharmacy on 11-12-10.
Shot on Tue-Oct. 9 approx. 11:30 am; next morning weakness (10-10-07), achy muscles, H/A, fever 101 deg, chills, denies chest congetion, c/o head congestion, fatigue, diarrhea started 10/15/07 with abd cramps. Began to feel better on 10/20/07.
Information has been received from a pharmacist referring to a currently 23 year old female patient who was not pregnant. No other relevant medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an initial dose of (Merck) VARIVAX (lot#, expiration date, dose and route not reported). In May 2012 the patient was vaccinated with a "booster" dose of (Merck) VARIVAX (lot#, expiration date and route not reported). On unknown dates the patient presented with "severe mental hallucinations, problems with her ability with thinking, disorientation and panic attacks" after receiving the "booster" dose of (Merck) VARIVAX. The patient had a Magnetic Resonance Imaging (MRI) on an unknown date and was found to have her "grey matter affected". The patient went to the doctor to seek medical attention. The patient's mother reported that the patient was recovered on an unspecified date and had no further effects. Causality assessment was not reported. Additional information has been requested.
I started getting symptoms but did not test positive to COVID-19. Both my daughter and husband tested positive. I took PAXLOVID for 5 days and was feeling better then on the 19th I spiked a fever then tested and I was positive. I still have sniffles and congestion today.
This medically confirmed spontaneous report (initial receipt: 08-Oct-2012) concerns a female patient, who experienced itching after receiving flu vaccine (manufacturer, brand name and lot number were not provided) recently (date unspecified). The event outcome was not reported.
neck pain sore swollen throat- muscle relaxer  prednisone symptons much better today 04/8/2021
Patient presented approximately 72 hours after receiving vaccination with complaint of erythema and tenderness at injection site as well as surrounding area. Patient also reported fever as high as 102, 24 hours after injection was received. On exam, right arm significantly erythematous, superior to injection approximately 5 x 5 cm, inferior to injection site approximately =10 x 13 cm, tenderness appreciated at injection site but not as tender surrounding site. No warmth appreciated. Treatment included BENADRYL Q6H, prednisone 20 mg BID x 5 days, cool compresses, ibuprofen PRN. Patient was already taking ZYRTEC OTC. (Patient hesitant to use BENADRYL 2/2 agitation).
Recent problem with cellulitis of leg prior to receiving 2nd Lymerix. Two days after vaccination, developed fever and confusion. Taken to ED, cultured and given IV fluid. Started on antibiotics.
pt recv vax 27FEB96 & 12MAR96 pt exp a gen rash w/50 lesions & flu-like sx;lab eval revealed a negative varicella titer;
Feel dizzy when I get out of bed in the morning. I also feel dizzy when I exercise.
Patient developed swelling in the arm and face (especially lips) a few hours after vaccination. Patient used ice and ibuprofen to help reduce the swelling.
Delayed soreness, swelling, redness, and itching, about 3 inches in diameter around the injection site.
Hospitalization for acute hypoxic respiratory issues due to COVID-19 on dates 9/29/22-10/2/22.  Treated with dexamethasone, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Painful to lift arms above the head; Joint pain; Fatigue; Muscle pain; Low grade fever of 98.1; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful to lift arms above the head), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), MYALGIA (Muscle pain) and PYREXIA (Low grade fever of 98.1) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (Painful to lift arms above the head), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), MYALGIA (Muscle pain) and PYREXIA (Low grade fever of 98.1). At the time of the report, PAIN IN EXTREMITY (Painful to lift arms above the head), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), MYALGIA (Muscle pain) and PYREXIA (Low grade fever of 98.1) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 98.1 (Inconclusive) 98.1.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
By evening the same day of injection the injection site became increasingly tender to the touch. The second night, the left arm hurt to move at all and kept patient up most of the night. However, was resolved the following day. Intense migraine  Headache every day since
About 15 days after receiving first vaccine I developed what I thought was a rash.  It turned out to be guttate psoriasis, which is a different form of psoriasis than I previously suffered from.   Saw a dermatologist after both vaccine injections and treated with a course of oral steriods.  When it came back after the second round of steriods, we began treatment with Otezla 30mg 2x/day.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 14Apr2021 at 16:00 as dose 1, single (Lot number: EE0164), in right arm, on 05May2021 at 16:00 as dose 2, single (Lot number: EW0179), in right arm and on 23Nov2021 at 16:30 as dose 3, single (Lot number: FH8020) at the age of 44 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Mild anemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 04Oct2023 to 09Oct2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300328715 Same reporter/patient, different drug, different event.;
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Hypertension-Mild, Systemic: Tachycardia-Mild, Additional Details: pt immediately felt short of breath and felt his heart beating fast. I called 911 and paramedics responded, determined he was not having an anaphylactic reaction and advised him to go home and take it easy and call again if he experienced more symptoms. He improved markedly within minutes.
EXTRA DOSE ADMINISTERED; This spontaneous report received from a physician concerned a 63 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021, and dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-MAY-2021, the subject experienced extra dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of extra dose administered was not reported. This report was non-serious.
L upper arm redness/swelling/warmth/pain stated after previous injection in same deltoid musc. pain extending to L forearm and L axilla and L chest wall.
Child given 0.25 ml of infant covid while managing noticed vaccine & dosage was incorrect. Verbal explanation to nurse, provider and child's parent given. Explained child will get remaining of the dosage before leaving mom understand. Administered vaccine.
She got really sick and started throwing up; She got really sick and started throwing up; Rash; This is a spontaneous report from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on 24Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 24Jul2021, the patient got a rash right away and then, patient got really sick and started throwing up. The outcome of events was unknown.  Information on lot/ batch number has been requested.
This spontaneous report as received from a physician via field representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot # and dosage regimen unspecified). The reporter stated that he had a question concerning a possible side effect of GARDASIL in a patient. No further information was provided at this time. Additional information has been requested.
mom reported that pt exp a sharp pain just below the rib cage approx 10 hr p/taking first oral typhoid pill;pain subsided p/approx 5hr;the sharp pain then returned;approx 5 hr p/taking second oral typhoid pill;
feeling a bit achy; her arms hurting; having a little cough; earache; she is stressed out; This is a spontaneous report received from a contactable nurse and a consumer (patient). An 81-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date at 81 years old (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications included tofacitinib citrate (XELJANZ) from Feb2021 and ongoing. Patient reported feeling a bit achy and her arms hurting after taking her first dose of the covid-19 vaccine. Patient also reported having a little cough and ear ache. Patient stated this happened when she was stressed out. The adverse events were non-serious. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever, runny nose, malaise, rash down side of the arm of the injection site. Muscle pain at injection site.
Started with temple pain then started having pain behind both my eyes.  Tried taking Tylenol without relief.  Continued to have the temple headache and pain behind eyes, then the morning of 1/31/2020 felt like throat was swollen and lymph nodes on neck were swollen and had a mild earache.  All symptoms subsided the morning of 1/2/2021.
SHE WAS GIVEN A WEEK EARLIER THAN HER EXPECTED DATE FOR HER SECOND SHOT
patient's in for booster dose of Moderna around 09:37 am.  Approximately 10 to 15 min after received the vaccination, she  complained itching sensation on both palms and itching/burning sensation of bilateral face. no swelling or difficulty breathing or difficulty swallowing or shortness of breath or rash or hives. Patient spoke in full and clear sentences without distress.  at 1010 am  119/83; pulse 73 . she took. Benadryl 25 mg and rested in chair. she reported symptoms slightly improving at 1040 am. she took another dose of Benaryl 25 mg. husband drove her home. 1:32 pm, called patient who reported symptoms were subsided.
LETHARGY DECREASED MOBILITY DECREASE IN APPETITE CONFUSION DAYTIME LETHARGY INSOMNIA VERTIGO NAUSEA VOMITING VISION DISTURBANCE
Mother called and states that after leaving health unit approximately 30 minutes after shots, daughter had SOB, tingling and passed out for a few seconds while in the car drive home.  Mother called her doctor who told her that it was probably anxiety because she is fearful of needles.  Mom states child is doing fine now.
A day after receiving the booster my body started to itch.  I took a dose of Clariton and the itching stopped.  Felt fine rest of day and that night. Two days later (Sunday morning ), I woke up with my chest, my stomach, my back, and joint areas on my arms and legs were bright red.   This happened after 1st vaccination too but not when I had second and third shots.  8 hours later, it is still red, but not as severe as it had been earlier in the day.
Patient has MS and takes immunosuppressive medication. He receive Moderna vaccinations on 3/22/21 and 4/20/21 and subsequent antibody levels were undetectable.  It was decided to receive the Pfizer series due to that lack of response to Moderna.
Erroneous dosage was given. This was a multi-dose vial. But the nurse just drew up all the contents (without diluting it) and then administered the entire contents in the injection.  She was not aware that this was a multi-dose vial.
fever of 101.8; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd November 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. In November 2022, less than a week after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-NOV-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The reporter reported that his/her son got a dose of Bexsero vaccine yesterday (the day before reporting) and the patient had a fever of 101.8 degree Fahrenheit.  Follow-up would not possible as no contact details were available.
Autoimmune-type disorder. Fever, joint pain, diffuse swelling.  4/6/09 Received chiropractor medical records of 11/14/2008. FINAL DX: sciatica, DJD, kyphosis acquired, cervical & thoracic segmental/somatic dysfunction Records reveal patient experienced fever, body & joint pain, fatigue x 3 wks.  S/S temporarily relieved by NSAIDs.  Patient states had gone to bed 3 wks prior & awoken in night w/fever, then developed body & joint pain & fatigue.  Had been unable to exercise & had been taking oral antibiotic.  6/15/09 Received vaccine & PCP medical records of 7/16-11/8/2008. FINAL DX: Rhinitis, fever, healed fibular fracture. Records reveal patient experienced fever, post nasal drip, nasal congestion, allergic rhinitis. Rhinorrhea, sneezing. Aching pain right ankle. Tenderness, swelling deformity, right distal fibula. Edema - feet.   ICD-9 Codes 477.9 Rhinitis, allergic cause unspec. 729.5 Pain in limb 780.60 Fever NOS 823.81 Fx closed fibula NOS.
No adverse reaction, however the patient was given an additional dose that was not necessary.  It would appear that the patient has had 7 DTaP doses to date. And additional dose of IPV
This patient scheduled an appointment for a booster online. When she came in, I asked for her immunization card, which she did not have. I printed her records from the state that showed all of her vaccinations for Covid were given in 2021. After the immunization, she started talking about her last dose being in January. I told her I thought she was incorrect and all of her vaccinations were given in 2021. She said no, she got one this year with her flu shot on January 10, 2023. Subsequently, she was given a booster dose too soon. No adverse reactions were reported as I checked on her the next day.
Pfizer vaccine vial was incorrectly diluted with 1.6ml of sterile 0.9%sodium chloride instead of 1.8ml. Pt was injected with 0.3ml of diluted vaccine. Vaccine administrator was informed of vaccine dilution error as soon as error was realized (after vaccine was administered). Patient was stable after administration and left clinic after observation. Clinic manager and supervising MD were notified on same day. I was advised to report event to VAERS and ERS per manager. Patient was not contacted for status follow-up per manager recommendation on 4/30.
MOTHER CALLED THIS AM TO REPORT THAT LAST EVENING CHILD'S LIPS AND LEFT SIDE OF FACE STARTED TO SWELL.  THE LEFT DELTOID WHERE INJECTION WAS GIVEN BECAME VERY HARD AND RED.  MOTHER ADMINISTERED 3 TSP OF BENADRYL OTC AND CALLED THE ER.  THEY ADVISED MONITORING AND CALLING MD OFFICE IN AM.  THIS AM LIP AND FACE STILL SWOLLEN AND INJECTION SITE STILL RED AND HARD.  MORE BENADRYL WAS ADMINISTERED THIS AM.  WRITER ADVISED MOTHER TO CONTACT MD'S OFFICE TO SEEK ADVICE ON FURTHER TREATMENT
The Shift Lead heard items fall on floor on the hardware aisle.. she went over and found the patient passed out and she approached him and had him walk over to the pharmacy area and sit in a chair and then she came and got a Pharmacist (myself). I ran out to the waiting area and found the patient having a seizure in the chair..I immediately told pharmacy staff to call 911 and then our soon to be Pharmacist, pending passage of boards in August, grab an Epi-Pen out of the immunization room and immediately told patient we are going to give you an Epi-pen..patient  then stopped seizing.. at this point we talked to him to find out his health history and how he was currently feeling and was waiting on EMS to arrive. we wanted to place him on the floor with legs elevated but then EMS arrived and took over. Per EMS his blood pressure and heart rate were very low and they wanted to take him to Hospital. Patient is on the way to Hospital
Dose was given on 11/10/2021.  On 1/1/2022, I was diagnosed as having COVID.  In February, 2022, I was diagnosed as having AFIB with shortness of breath.  On 2/23/2022, I had a cardiac ablation to correct the AFIB.  I continue to have shortness of breath.
Patient vasovagaled in waiting room while scheduling second doses of vaccines. Patient did hit right side of head on countertop, next to eye. Patient had a slight bruise next to eye before leaving.  Patient was checked over by MD in the waiting room while remaining on the floor with a cool compress on her neck. Vitals were rechecked two times in the waiting room to verify that they were getting better. Patient also given a bottle of water. Patient's mother was brought in to the office to accompany patient down to the car who was brought down to the car in a wheelchair by a nurse.
I woke up the next morning with a large sore on the inside of my right leg, much like a boil.  I called my doctor and texted him pictures of the sore.  He prescribed an antibiotic.  After 3 -4 days of the antibiotic, the sore began to heal.  I've never had anything like it in my life.
Starting early June 2021, 2 months post vaccination, muscle aches and stiffness began in left arm and right leg.  By August, pain & stiffness  dramatically increased.  Saw my Dr who ran full panel blood screen w/all test in normal range.  Pain and stiffness continued to worsen so that by early October it was difficult to walk and lift arms above shoulder height.  Right leg/left shoulder pain was constant and debilitating.  Tested for Lyme w/negative results.  Treated w/2 weeks of Doxycycline with no positive effects.  Personal research matched symptoms to Polymyalgia Rheumatica  (PMR).  Reran full panel blood test plus Sed Rate and C-Reactive protein tests.  Both Sed Rate and C-Reactive came back positive.  Other parts of full panel also out of range.  Started treatment with Prednisone 11/09/2021.  Within days pain and stiffness abated to point of able to function.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concomitant medications or drug reactions/allergies. On 25-JAN-2019, the patient was vaccinated with LIQUID PEDVAXHIB, subcutaneous for prophylaxis (dose, lot number and expiration date were not reported) diluted with the sterile diluent (lot number and expiration date were not reported) of M-M-R II for prophylaxis (dose, route of administration, lot number and expiration date were not reported) (product preparation error). The nurse stated the reason for the confusion was the LIQUID PEDVAXHIB was in a bag with M-M-R II written on the front by the facility (interchange of vaccine products). The nurse also reported, the patient had received three doses (each on a separate unspecified date) of LIQUID PEDVAXHIB (inappropriate schedule of product administration). The outcome of all the aforementioned events was not provided.
03/17/2021 soreness of the left arm later in the afternoon, and still till this day. Pressingly later in April 2021 I started noticing I could not lift anything heavy with my left arm. I cannot raise my left arm to normal daily activities like I used to be able to. During my physical on 04/22/2021 I told my doctor about my lose of range of motion. I still have the loss of range of motion. I began PT but only went a few times and it only worsen it. These days of muscle pain and joint pain are apotheotic.