chrisvoncsefalvay/vaers-outcomes huggingface dataset:
joint pain; joint pain,  "especially in my shoulders, neck and hip"; hurting; a little stronger than it is normally; headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2023US136212_NS (Novartis).  An 84-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol lowering treatments" (unspecified if ongoing); "joint pain" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; NECK PAIN (non-serious), outcome "unknown", described as "joint pain,  "especially in my shoulders, neck and hip""; PAIN (non-serious), outcome "unknown", described as "hurting"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "a little stronger than it is normally"; HEADACHE (non-serious), outcome "unknown", described as "headaches".  Clinical course: Patient reported she has had two treatments thus far and she still has trouble with "hurting" and having "joint pain". Patient stated she usually has joint pain with all Cholesterol lowering treatments and with this treatment, she has joint pain, "especially in my shoulders, neck and hip". Patient initially stated, "I don't know that it's increased", then stated she feels like it's "a little stronger than it is normally" right after she gets the shot. Patient stated she also has headaches but believes this is from the Covid shot as she states these began for her after taking the Covid shot and she does not know if it's been impacted by this treatment but will take notice of this after the next treatment. Patient has not yet had lab work, but it will be in the next month or so. Patient will also have 6 months checkup around the same time as her next treatment. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Coughing-wheezing-itching in lungs when coughing-tightness in chest.
This spontaneous report as received from a 67 year old female patient referred to herself. On an unspecified date in October 2012, the patient was vaccinated with a dose of ZOSTAVAX (subcutaneous, one injection, strength, lot#, dose/frequency and duration were unspecified). Patient experienced a lingering pain in her arm at the injection site, "ongoing since October 2012". Patient had sought unspecified medication. No lab diagnostics studies were performed and not treatment was given for the event. The outcome was reported as not recovered. Additional information has been requested.
RT. DELTOID.  REDNESS AND SWELLING, MILD ITCHING AT INJECTION SITE.
PATIENT REPORTS REDNESS AND SWELLING AROUND THE INJECTION SITE WITH THE REDNESS RUNNING DOWN THE ARM. SHE ALSO REPORTS SEVERE HEADACHE AT THIS TIME  FOR 24 HOURS SHE HAD EXTREME CHILLS AND FATIGUE.
angioedema, treated with solu-medrol 125mg/2ml IM injection, patient experienced some relief at time of discharge
At site of Varivax injection developed a week later an inflammatous indurated 1 cm lesion and centered pustule with  before or  with sites,  rash all over. 10/23/06 Received medical records from PCP which reveal patient seen in clinic 10/3/06 w/dx: acute flare up of chronic eczema x 2 days, worst on legs. Vomited & nauseated. Exam revealed warmth & swelling of bilateral LEs from knee to ankles.  Tx w/triamcinalone, moisturizers, atarax & prednisone.  Also given vax that visit.  Next note is for 10/18 for severe eczema, probable staph infection & scalded skin syndrome.  Presented with painful blisters on both hands x 1 day after having been recently hospitalized on 10/10 for eczema flare up.  Referred to rheumatology clinic for lupus w/u.  Blisters were fluid filled on palms with redness & warmth extending up the arms & edema of LEs & hands.  Entire trunk covere with fine erythematous macpap rash.   Varivax injection site with erythematous base pustular lesion with umbilication. Dx at that visit was: cellulitis, probable staph aureus; eczema severe; and varivax vaccine reaction.  She was admitted to hospital that day & consults with dermatology & rheumatology were requested. 12/4/06 Received medical records from hospital which reveal pateint admitted 10/8-10/10/06 for itchy rash & was noted to be globally edematous.  Thought to be atopic dermatitis exacerbation or diffuse erythoderma possiblya drug reaction (Keflex she was on for UTI).  Treated w/steroids & derm consult & rheum consults were done.   Final Dx: Eczema, exacerbation. Readmitted to hospital 10/18-10/23/06 for rash & blisters on hands as well as skin peeling on LEs.  Also had UTI 3 wks prior to admit & pleuritic rash on both calves which resolved but began with edema from ankles to face.  Finished steroids on 10/16. Noted to have vesicular rash on back, face, chest & wrists.  There was diffuse erythema of feet, legs & hands.  A different bolus rash was noted on palms & multiple denuded areas on both feet.  Rheum, Derm & ID consults revealed dx: erythroderma, bullae, acneiform & vesicles highly suggestive of varicella & staph or strep toxin production and perhaps vaccine strain varicella mild.  Started on anti virals & antibiotics & placed in isolation.   Final Dx: likely toxin mediated dermatitis.
has a headache; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 19May2021, this case now contains all required information to be considered valid.  This is a spontaneous report a contactable consumer (patient) from a Pfizer- sponsored program.  A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation; palbociclib (IBRANCE), via an unspecified route of administration from an unspecified date to an unspecified date, at 100 mg (frequency unknown) for breast cancer female (C50.211) . The patient medical history and concomitant medications were not reported. The patient experienced headache on an unspecified date after covid-19 shot.  The action taken in response to the events for palbociclib was unknown. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Case number PHEH2013US022858 is an initial spontaneous report received from a consumer on 30 Oct 2013. This report refers to an adult female patient whose age was not reported. Her medical history included sickness due to shingles for over a year which was continuing and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on an unknown date (reported as a week ago). On an unknown date after vaccination (about a week ago), she started experiencing adverse reactions. She stated that she felt like she was dying. She reported that doctor refused to see her since she hasn't been there in over a year. She was not eating and was throwing up and had bad muscle aches. She was very tired and could not do anything. She felt like she was working for 6 months. She was running a fever also, but not very high. She had bacteria in the blood stream. She felt like someone had beat her up and her knees in the front were swollen. She was not able to walk anywhere. She had soreness and could hardly get out of bed. The outcome of the event was reported as unknown. No further information was provided.
Injection Site Redness; Discomfort at injection site; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received the 1st dose of FluLaval Quadrivalent .5 ml. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced injection site erythema and injection site discomfort. On an unknown date, the outcome of the injection site erythema and injection site discomfort were unknown.   It was unknown if the reporter considered the injection site erythema and injection site discomfort to be related to FluLaval Quadrivalent.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced redness and discomfort at injection site. The reporter consented to follow up. This is 1 of the 5 linked cases reported by the same reporter.
Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Tingling in left arm where vaccine administered. Tingling/pain in arm dissipated with OTC pain meds. Chest pain/tightness started on left side and has moved to directly under sternum. No shortness of breath. She experiences acute pain in chest area that comes and goes. Not alleviated by OTC pain meds. Patient was advised to go to Urgent Care to get looked at. She will call back when she gets out urgent care.
At 05/01 about 2:10 AM I woke up suddenly  and I felt so nervousness and  with kind of panic than I realize  that my pulse  on the left hand bit so fast.when I checked my blood pressure I got 180/108 /132 where my normal is 87-95/65-73/60-70
Metallic taste in mouth, started to cough, red eyes and watery drainage, sore throat.  Saw acute care and they told them to use Benadryl and other otc products.
Area where T-DAP given (left deltoid) area red, swollen with tender - advised warm soaks - Keflex 500 mg BID x 7 day.
Sinus tachycardia probably related to immunologic reaction to COVID-19 vaccination. He started experiencing tachypalpitations about 30 minutes after receiving Johnson & Johnson COVID-19 vaccine. He reports having associated low- grade fever, chills, and myalgias. He was noted to have elevated lactate levels which resolved on follow-up labs.
Patient expressed that she was nervous during  the shot. About 5-6 minutes after, patient was on the ground supported by parents (no injuries from fall) appearing sweaty with clammy hands, and with slurred speech and looking pale. I made sure she was not itchy anywhere and airway was not affected in anyway; and treated the episode as syncope.  I let the patient elevate her legs in sitting position on the ground. A few minutes later patient recovered. Stayed in the pharmacy for 30 minutes to monitor. Ambulance was offered but parents refused. Gatorade given.
was sick/clarified as flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (was sick/clarified as flu like symptoms) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Relapsing-remitting multiple sclerosis, Sulfonamide allergy and Drug allergy (Dilaudid). Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced INFLUENZA LIKE ILLNESS (was sick/clarified as flu like symptoms). In April 2021, INFLUENZA LIKE ILLNESS (was sick/clarified as flu like symptoms) had resolved. The patient received first vaccine on 16-Mar-2021 and had no symptoms then 28 days later had second vaccine on 13-Apr-2021 and was sick (clarified as flu like symptoms) for 48 hours from 10 am to 2 the next morning. No treatment information was provided.   This case was linked to MOD-2022-621237 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2022: Follow up received included no new information.
Patient experienced chills/temperature, redness from shoulder to elbow, hard lump, swelling, and warmth at injection and also sore joints. Symptoms started soon after injection
The Monday I  had blood test it was normal and progesterone was little low. I started miscarrying on Wed on 3/27. My estimated date of delivery would have been mid Nov. 2021.
Woke up to red rash across throat and right collarbone.  Not itchy, no other symptoms.
Very sore around injection site; numbness in 3 fingers of injected arm; elevated blood sugar; loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Right on 15Feb2021 12:45 (Lot Number: EL9266) at single dose for Covid-19 immunization.  Medical history included Diabetes, Heart failure, COPD, High B/P, known allergies: yes. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9262) on 25Jan2021 12:45 AM in right arm for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other unspecified medications in two weeks. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient experienced very sore around injection site, numbness in 3 fingers of injected arm, elevated blood sugar, loss of appetite all reported as non-serious on 16Feb2021 06:00 with outcome of recovering. No treatment was received.
Contact dermatitis on my back and forehead. I had a rash, itchiness like an eczema look. I went to a physician who prescribed prednisone and topical creams. I went to a dermatologist who prescribed a stronger topical cream. I went to an allergist who tested for about 80 different chemicals that I might be allergic to. None of them were found in my daily life.
Erythema & induration w/in 10 min of injection. Swelling of tongue after 15 minutes.
No adverse event.  Expired HPV immunization given.  Re-given 7 days later.
Irregular menstrual cycles: 19 days cycle on Dec 8-26 43 days on Dec 27-February 7
Several hundred red spots, some with dark red center, a few with raised "dew drop" center, tired, lack of appetite.
The next day after vaccination, I felt some round seals on my neck.  It feels like a cyst.  I think there are only 3 of them.  I try not to touch as I feel pain when pressed.  It is located on the lower left side of the neck, near the collarbone.
Pruritis of upper extremities followed by urticarial rash [both immunizations given in deltoids].
Swollen lymph node on right jaw directly in front of the ear, same side of body as vaccination.
Patient came in next month (23 days) and told us if we needed to report side effect, we said yes - that night of the shot patient experienced strong headache, temp > 103.5, and chills -> all symptoms gone by morning -> except chills also next day.
This spontaneous report was received from a nurse referring to an unspecified patient of approximately 21-years-old of unknown gender. The patient's medical history, concomitant therapies, concurrent conditions, historical drugs or allergies were not reported. On 26-NOV-2018, the patient was vaccinated with an expired dose of VAQTA injection, 50 / 1.0 units per milliliters (U/ml) lot number N028743, expiry date 30-NOV-2018 (dose, route and frequency were not reported) for prophylaxis. No adverse effects were reported.
Nausea - sick to stomach. Can't lift small items. Dizzy, hot, tired, weakness, loss of appetite, back pain, chills, constant pain in right arm on going.
patient wanting to receive second shot 45 days after first shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient wanting to receive second shot 45 days after first shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient wanting to receive second shot 45 days after first shot). On 04-Mar-2021, PRODUCT DOSE OMISSION ISSUE (patient wanting to receive second shot 45 days after first shot) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant and Treatment details were provided.
3 hours after the injunction I received a severe low back pain. The pain lasted 2 and a half hours. I didn?t take any thing for it. I just went away.
After MMR given slightly red at site, no other problems until 5/14/03 7:00 AM arm at site became red, warm and tender to touch. No fever, no seizures, no N/V.
Reddened and dry "rash" began left posterior shoulder which spread up left side of neck to right side of neck.
suffering from Neuropathy; Have not been able to sleep; First dose on 19Jan2021, second dose on 19Aug2021; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (BNT162B2), second single dose via an unspecified route of administration, administered in Arm Left on 19Aug2021 12:00 (Batch/Lot number was not reported) for covid-19 immunisation at age of 60-year-old. The patient previously received first dose of bnt162b2 on 19Jan2021 at 13:00 at age of 59-year-old for Covid-19 Immunisation in left arm. Medical history included multiple myeloma. Concomitant medication included bortezomib (VELCADE). There were no known allergies. The patient had no COVID prior vaccination. No COVID tested post vaccination. The patient had Pfizer Booster vaccine administered on 19Aug2021 than on same day had a bortezomib Infusion within 24 hours, patient had been suffering from neuropathy on 19Aug2021 at 16:00. Patient went to emergency room with pain and currently taking gabapentin and unable to control pain. Patient had not been able to sleep in days due to pain in feet and hands. The event neuropathy resulted in emergency room/department or urgent care and hospitalization. Outcome of the event neuropathy was not recovered, of the other event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Had both Pfizer-BioNTech vaccines and the booster and tested positive with a home test today; Sleep apnea; Had both Pfizer-BioNTech vaccines and the booster and tested positive with a home test today; Had both Pfizer-BioNTech vaccines and the booster and tested positive with a home test today; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 62 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Dec2021, outcome "unknown" and all described as "Had both Pfizer-BioNTech vaccines and the booster and tested positive with a home test today"; SLEEP APNOEA SYNDROME (non-serious), outcome "unknown", described as "Sleep apnea". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) positive, notes: tested positive with a home test today. Therapeutic measures were taken as a result of sleep apnoea syndrome, patient was using cpap for sleep apnea.  The lot number for bnt162b2 was not provided and will be requested during follow up.
On 24 I had sinus and watery eyes. I went to ER because I was congested and coughing.
PAINFUL ARMPITS; REDNESS IN ARMPITS; RASH UNDER BOTH ARMPITS; This spontaneous report received from a patient concerned a 19 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. patient took 180mg of otc allergy medication. 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 20-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAY-2021, the subject experienced painful armpits. On 21-MAY-2021, the subject experienced redness in armpits. On 21-MAY-2021, the subject experienced rash under both armpits. On 22-MAY-2021, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from painful armpits, and had not recovered from rash under both armpits, and redness in armpits. This report was non-serious.
Squalene in Anthrax vaccine has caused the reaction; Spontaneous report received on 02DEC2020 from P?zer.  A healthcare professional reported regarding a male consumer to whom "squalene in anthrax vaccine has caused the reaction" (PT: Vaccination complication). The healthcare professional was inquiring if COVID-19 mRNA vaccine (BNT162) had squalene in it. The patient was exposed to squalene in his career with anthrax vaccine and it was documented that there was squalene in that vaccine that had caused the reaction to him. The outcome of the reported event was unknown at the time of report.  Company Comment: It was reported that squalene in anthrax vaccine has caused the reaction (vaccination complication) in a consumer who received presumably BioThrax. Further information of the event is limited. Squalene is an adjuvant used in several vaccinations, and considering the case information the causality of vaccination complication is assessed as related.; Sender's Comments: It was reported that squalene in anthrax vaccine has caused the reaction (vaccination complication) in a consumer who received presumably BioThrax. Further information of the event is limited. Squalene is an adjuvant used in several vaccinations, and considering the case information the causality of vaccination complication is assessed as related.
Information has been received from a physician concerning a 61 year old female patient. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On 19-SEP-2016 (reporter as "ten days ago"), the patient was vaccinated with an unspecified dose of ZOSTAVAX 19400 PFU, via subcutaneous route (dosage schedule, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant medications were not provided. On 24-SEP-2016, the patient experienced rash on her chest and arms that was painful and burning (rash and thermal burn), and also had "some blistering" but no fever. The reporter stated that her primary doctor prescribed VALTREX and she took 3 doses, one daily by mouth. On an unknown date in September 2016, the patient also had an unspecified type of biopsy, but the results were not provided. At the time of reporting, the outcome of thermal burn, rash and blister was reported as recovering. The relatedness between the events and therapy with ZOSTAVAX was not reported. No product quality complaint was involved. Additional information has been requested.