chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness from neck to ear; Swelling from neck to ear; This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th January 2023, the patient received Shingrix. In January 2023, unknown after receiving Shingrix, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were unknown.   It was unknown if the reporter considered the erythema and swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 30-JAN-2023 Reporter's Comments: Pharmacist left message on afterhours VM box. Reporter reported that she administered a Shingrix vaccine on last Thursday and the patient reported today (on the day of reporting) that she experienced redness and swelling all the way from her neck to her ear. At the time of adverse report no additional details regarding Shingrix lot and expiration date or patient demographics available. The reporter consented to follow up.
This spontaneous report as received from a medical assistant refers to a 18 month old patient. On 20-JAN-2014 the patient was vaccinated with expired MMR II dose 2. The reporter reported of alleged mix where 3 expired MMR II vials with lot 1508AA and expiration date: 09/23/2013, were found in a sealed multi-vial carton of 10 vials for MMR II with lot 0648AE expiration date: 03/27/2014 but no adverse effect was reported. Additional information has been requested.
Pt presented to office with redness and swelling at DTaP site and varicella like lesions around site at VARIVAX.
In the first two months of 1999, I received my first three Anthrax shots. On May 30, 1999 I went to the medical facility complaining of blisters that appeared on the skin in various spots and turned into itchy, dry patches of the skin. The problem had been going on for about a month when I went to medical. They gave me Benadryl for the itching and a topical cream for the patches of dry sky. On June 22, 1999, I was back in medical because the condition had worsened; they were guessing that it might be Eczema. Due to the fact that we were on our six month cruise, medical did not have the facilities or the expertise to diagnose me or care for me. I was told that I would need to wait till I could see a dermatologist. They gave me Keri lotion and some topical creams told hold me over. On July 29, 1999, I received my fourth Anthrax shot. My skin never healed during this period of time. On September 20, 1999, six days before we were due back, I again ended up in medical. My skin was so bad that I could not stand it. I would scratch so bad I would bleed through my uniforms. Medical again gave me Benadryl for the itching and some moisturizers. I was then given a referral to Hospital. I saw a dermatologist on October 20, 1999. She put me on Prednisone, which had helped while I was on the medication however when I stopped taking the medication I had a severe break out. I then received Temovate, a topical steroid, moisturizer, and medicine for the itching. The dry patches of skin were now covering 50 percent of my body. From my scalp all the way down my legs. The medications unfortunately did not help. I saw a dermatologist that had recently taken over for the first dermatologist I saw, She took over November 16, 1999. She gave me new moisturizer, more Temovate, and Atarax for the itching. I was then started on the light box treatment, which was the highest medical protocol treatment available. That had little effect on my skin. The dermatologist diagnosed nummular eczema. I had a follow up appointment with the dermatologist on November 30, 1999. Since there was no real improvements in my skin she ordered a patch test, which is an allergy test. The skin on my back was so bad that they could not do the test right away, it was delayed until the week of January 3, 2000. When the results came back I was slightly allergic to Formaldehyde and Quaternium 15. Formaldehyde is the Anthrax shot along with many other vaccines. I was not to take any more vaccines containing Formaldehyde.  I had another follow up appt with the dermatologist on January 24, 2000. The condition of my skin had deteriorated. The same medications were prescribed now the dermatologist wants to do a biopsy. On February 16, 2000 the biopsy was performed, results were all negative. I was again put on Prednisone. She saw me again on March 7, 2000. The Prednisone had worked slightly but when I went off of it my skin has a major flare up again. On March 14, 2000 I was put on Prednisone again. With the same results as the last time. Up until now there has been no improvements with my skin.
Expired antigen powder administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) (batch number 92C34, expiry date 4th June 2022) and (batch number 9G44C, expiry date 23rd September 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 20-SEP-2022 Reporter's comment: The pharmacy student reported that a dose of Shingrix antigen powder given to the patient and it was already expired. The reporter reported that lot number (9G44C) and expiration date (23rd September 2022) for adjuvant suspension. The reporter did not consent to follow up. Additional Supportive Information: The use of Shingrix dose, which was already expired on 4th June 2022, which led to expired vaccine used.
RECORDS INDICATE THAT CLIENT RECEIVED J&J COVID VACCINE ON 4/12/2021 AT  PRIOR TO RECEIVING THIS J&J DOSE 06/18/2021.
Injection site reaction; red, warm to the touch with small "lump" at injection site. No treatment at time of reporting.
The patient felt dizzy when after the vaccine was administered and then fainted.  The patient was given crackers and juice and recovered on their own.
Eryhema Multiforme Minor - Information has been received from a physician concerning a 15 month old caucasian female with sinusitus and otitis media at the time of vaccination who on 05-May-2000 was vaccinated with a second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) SC in the right lower thigh.  On 07-May-2000 the patient began a ten day course of amoxicillin trihydrate, On 15-May-2000 the patient experienced an erythematous rash consistant with erythema multiform.  She also experienced a fever.  she was seen in the clinic on 16-May-2000 and 17-May-2000 and was started on cetirizine dihydrochloride (Zyrtec).  diphenhyramine HCL (Benadryl).  and reassura.  subsequently, the patient recovered.  No further information is available.
Less than one hour post vax, the pt experienced dyspnea and chest pain which lasted three hours and then resolved. Lymerix was discontinued. An ECG taken on 07/06/2000 showed ST elevations (NR: none). A cardiac evaluation yielded no cardiac disease. The reporting physician stated that the event could be associated with the pts anxiety disorder. As of 12/12/2000 the outcome of the event is recovered without complications.
I began experiencing dermatographism about 10 days after receiving the booster. It has now been several months and I still experience symptoms. I take Zyrtec everyday which lessens them, but they still appear and get worse of Zyrtec is not taken. I have experienced a tightened feeling in my throat, tender armpits (swollen lymph nodes).
On 4/5/2021 Patient had swelling of left side of his chest area.  No pain noted. He went to urgent care and was evaluated. He was advised to take Ibuprofen and apply ice to area x 1 week, , which he did. On 4/9/2021 left side became swollen in abdominal area no pain.  He went to Hospital ER and was diagnosed with Soft Tissue Swelling. He was advised to apply ice to area but he should not take any more Ibuprofen. He was advised to check with Health Department to see if he needed to take the 2nd dose. At this time patient stated he did not have a doctor/physician. Side effects of the vaccine was explained to him.
Extreme muscle pain/soreness; swelling in entire left arm and upper left back/shoulder; Tingling in entire left arm from shoulder to fingertips; Decreased mobility; headaches; stomach pain; diarrhea; tiredness/fatigue; This is a spontaneous report from a contactable consumer (Patient). A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EW0167), dose 2 via an unspecified route of administration, administered in Left arm on 05May2021 11:30 as dose2, single for COVID-19 immunisation. Medical history included irritable bowel syndrome (Other medical history: Ibs-C, chronic constipation, slow transit , constipation) and Known allergies: Sulfa meds, SSRIs, Iodine. There were no concomitant medications. The patient previously took iodine and experienced allergy. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EW0153), dose 1 via an unspecified route of administration, administered in Left arm on 06Apr2021 03:00 as dose1, single for COVID-19 immunization. On 05May2021, the patient experienced extreme muscle pain/soreness, swelling in entire left arm and upper left back/shoulder, tingling in entire left arm from shoulder to fingertips, decreased mobility, headaches, stomach pain, diarrhea and tiredness/fatigue. The patient had an emergency room visit due to this event. Patient was treated with unspecified pain medications, muscle relaxants, steroids and physical therapy as a therapeutic measure of all the events. The outcome of all the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Information has been received from a physician concerning a female with who was vaccinated with Gardasil (Lot # not provided).  Concomitant therapy included MENACTRA and hepatitis A virus vaccine (unspecified).  Per the reporter, 1 day post-vaccination the patient experienced an entire body rash, swollen lips and swollen feet.  The patient sought unspecified medical attention.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/14/2008. Additional information received from B-form (31-Mar-2008): The patient was vaccinated IM in the right arm with the first dose of GARDASIL vaccine (lot#: reported as 1448U) on 15-FEB-2008. On 17-FEB-2008, the patient experienced hives, swollen hands, feet and lower lip. Additional information has been requested
Hello, actually reporting a great side effect. My dermatologist recommended the Gardacil vaccine for my plantar warts (feet, legs, hands) that I'd been battling for 15 yrs. You have no idea what I went through. With an immune deficiency, "freezing" & "over the counter" remedies didn't touch the warts. I did so many step therapies that didn't work, culminating in laser surgery, and then a 14 month extremely painful process at the teaching institution. I spent thousand in copays, parking tickets, gas & tolls, etc. Finally got rid of the wart on my toe only to have warts come back with a vengeance spreading up & down my legs and hands. I had at least 40 wards. I did not hold out much hope for Gardacil. I received 3 doses. After a year, just saw a different dermatologist and she said I had ZERO warts. I am beyond thrilled. Hope this can help other battling warts.
Within two days of receiving the vaccine, my long standing Tinnitus (over 20 years), became much worse (louder).  I waited close to a year for the symptoms to fade, but they have not.  I checked with my primary care physician to make sure there was no underlying reason, such as high blood pressure, that my tinnitus had changed.  My blood pressure was not a concern, however, I did have a good bit of wax buildup in both ears.  I saw an ENT who removed the wax and told me that other than a small amount of hearing loss at the 4k to 6k range, my hearing was normal.  Since having the wax removed, my level of tinnitus has not improved.
Severe muscle pain in arm, severe headache, dizziness, nausea, chills, "brain pain"
ringing in her head and it was like somebody answer the phone; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER2613) via an unspecified route of administration in Arm Right on 18Mar2021 (at the age of 80 years old) as single for COVID-19 immunisation. The patient medical history was not reported as no. The patient's received no concomitant medications. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6205; Expiration Date: Jun2021) via an unspecified route of administration in Arm Right on 24Feb2021 (at the age of 80 years old) as single for COVID-19 immunisation. The patient experienced ringing in her head and it was like somebody answer the phone on 19Mar2021. Reporter stated, the first dose was nothing, no sore arm or nothing. she confirms the ringing in her head occurred after the second dose. She confirms it was very slight and then it went away by noon of 20Mar2021. Outcome of the event was recovered on 20Mar2021.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received on 10-JUL-2015 from a healthcare worker via company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL (dose, frequency and route were not reported). On an unknown date, the patient experienced serious cardiovascular effects. The reporter stated that the patient was an athlete and runs track and on an unknown date, experienced fainting and collapses. On an unknown date, the patient sought medical attention and was currently taking treatment in clinic. Action taken with GARDASIL was unknown. The outcome of the events was unknown. The reporter did not provide the causality between the event and the suspect therapy. Upon internal review, the events cardiovascular effects and collapse were determined to be medically significant. Additional information is not expected as the reported does not wish to be contacted.
When I arrived home around 5pm I felt dizzy and had a headache. When I woke up 6:00 AM the symptoms were still there.  I took Advil at 8:00 AM for the headache.  Around noon the symptoms seem to get worse and I became flush.  My body feels very warm and I feel like my skin is burning all over.  I took more Advil at 2 PM to try to get rid of the headache.  It is 2:30 PM my symptoms have not subsided.
Really bad case of diarrhea/worst case of diarrhea he has ever had; Shrunk to about 5'10''; This is a spontaneous report from a contactable consumer (patient). A 93-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 25Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 25Jan2021, after the first dose of vaccination, the patient had a really bad case of diarrhea, and mentioned that it was the worst case of diarrhea he has ever had. In Jan2021, the patient had shrunk to about 5'10". The outcome of the events, 'diarrhea' and 'shrunk to about 5'10"', was unknown.  Information on the lot/batch number has been requested.
PT C/O NUMBNESS  AND TINGLING ON HER LT HAND,HER CELL PHONE FELL OUT OF HER HAND. PT OBS.V/S 99%O2 SAT,PULSE 83,BP103/66 ; EDUCATE PT TO MOVE HER HAND AND SHOULDER; ANOTHER CHECK MADE,PT STATES FEELING BETTER AND WAS SENT HOME.
dizziness; pounding of the heart; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (dizziness) and PALPITATIONS (pounding of the heart) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced DIZZINESS (dizziness) and PALPITATIONS (pounding of the heart). At the time of the report, DIZZINESS (dizziness) and PALPITATIONS (pounding of the heart) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
UNKNOWN MEDICAL IN THE PARKING LOT AT THE MASS VACCINATION CLINIC. PATIENT WAS FOUND BY A BYSTANDER ON THE GROUND AFTER HE RECEIVED HIS SHOT. MEDICAL ON SCENE RESPONDED AND FOUND PATIENT IN  CARDIAC ARREST. CPR AND ACTIVATION OF 911 EMERGENCY MEDICAL SERVICES AT 11:59. ON SCENE PATIENT RECEIVED CPR, THEN PLACED ON A LUCAS DEVICE, DEFIBRILLATION X2(VFIB) AND PLACED A KINGS TUBE TO SECURE THE AIRWAY. ROSC ON SCENE, CODE 3 TO CARDIAC CENTER. PATIENT CURRENTLY IN THE ICU AT HOSPITAL.
slight swelling of face near eyes; faster heartbeat than normal; redness on one side of tongue; nausea; feeling a bit of tightness in the throat; tightness in the chest; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 25Feb2021 at 15:30 (at the age of 62-year-old) as unknown, single dose for COVID-19 immunisation. Medical history included diabetes type II, allergies to nuts and cefzil. Concomitant medications included clindamycin HCL, citalopram, rosuvastatin and pioglitazone hydrochloride (PIOGLIT). The patient did not receive any other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient did not test COVID post vaccination. On 26Feb2021 at 03:00, the patient experienced slight swelling of face near eyes, faster heartbeat than normal, redness on one side of tongue, nausea, feeling a bit of tightness in the throat and tightness in the chest. The patient stated none of the symptoms were stopping her from working. The patient took some Benadryl and feeling a bit better. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Never been sick more than twice in last 40 years. All of a sudden have blood clot and resultant pulmonary embolisms. In excellent health with no other conditions.   Just my belief it is vaccine related and hospital staff agreed.
Received TDAP 3/6/09. Within 1-2 days developed fever of 102, body aches tender arm & hard bump the size of a coin where injection given.
I am getting hives; It is just itchy, a little bit itchy not much; Raised & hard bumps; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6206), dose 1 via an unspecified route of administration on 10Mar2021 as single dose for covid-19 immunisation. Medical history included rheumatoid arthritis. Concomitant medication(s) included Xeljanz XR (TOFACITINIB CITRATE), Nabumetone: 750 mg, Metformin XR (METFORMIN) 750 mg, Glipizide: 2.5mg, Losartan, Chlorthalidone: 25 mg, Omeprazole: 40 mg daily all for unspecified indication from unknown date. The patient underwent lab tests and procedures which included haemoglobin on 01Mar2021 with unknown results. It was reported that on 11Mar2021, patient experienced getting hives, it is just itchy, a little bit itchy not much on 11Mar2021. She also reported the following day she broke out in scattered hives described as itching, raised & hard bumps. Patient is asking if it's possible to experience the same symptoms on the second vaccine. Outcome of event getting hives was not recovered while others was unknown  No follow-up attempts are possible. information on lot/batch number cannot be requested.
Period of lightheadedness several minutes following dosing and reported to staff at clinic. Headache and pain at injection site began at 8:00PM that day. On 1/21, progressive head pain (migraine-like) throughout day (which was not relieved with OTC NSAIDS) and progressive fatigue. Mild chills and malaise started around 6:00PM. Headache continued throughout evening and woke me up at 4:00AM. Runny nose at that time also. Pain was relieved with an OTC sinus medication. Headache stopped around 11:00AM on 1/23. as did injection site pain. Sinus med (Advil sinus) worked on the headache.
Terrible muscle pain in left leg. Same side as hip replacement surgery in August. Pain was so severe couldn't slept. After 5 days, went to ER. Prescribed oxycodone. Later went to orthopedic surgeon. Surgeon prescribed steroid. Stopped taking oxycodone  because it was causing terrible stomach pain. Steroid finally eliminated pain and allowed her to sleep.
Moderna COVID-19 Vaccine EUA Headache, fever of 101 after Tylenol, light headed, muscle aches. Lasted about 12 hours
Pt started experiencing pain around 6pm on 6-29-15. Pt call office around 3:30pm  reporting pain, swelling and redness. Assessment of area presented with redness, heat area from acromion process to elbow, 5mm induration over deltoid muscle. Take ibuprofen to decrease inflammation.
Over 65 influenza vaccine: within 24 hours had breakout of acne and dry peeling skin on face. Symptoms seem to subside, then on day 10 eyes watering. Followed by swollen glands, low fever, severe congestion, burning eyes and sinuses, nasal drainage. Obtained relief with old expired penicillin, each day better. Recovery in process.
Information has been received from a physician concerning a 2 year old male who was vaccinated in the thigh with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live. Subsequently the patient experienced a rash across the injection site on his thigh. Unspecified medical attention was sought. The patient was treated with Benadryl and his rash improved. At the time of the report, the patient was recovering. There was no product quality complaint involved. Additional information has been requested. The patient's rash was considered to be an other important medical event. (OMIC)
7 days p/MMR intense pain in feet x 3 days, tingling & numbness in hands x 3 days; joint pain w/achyness since immun given; sl disorientation; still having joint pain;
Sore arm; Feeling tired; Headache like type of feeling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (Feeling tired) and HEADACHE (Headache like type of feeling) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (Feeling tired) and HEADACHE (Headache like type of feeling). At the time of the report, PAIN IN EXTREMITY (Sore arm), FATIGUE (Feeling tired) and HEADACHE (Headache like type of feeling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment and concomitant medications were reported.
Invalid Dose of Flumist given- Vaccine for ages 2 and older, given to child 6 months.