chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Warm to the touch Injection Site; Hard to the touch Injection Site; Itching Injection Site; Sore Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm to the touch Injection Site), INJECTION SITE INDURATION (Hard to the touch Injection Site), INJECTION SITE PRURITUS (Itching Injection Site) and INJECTION SITE PAIN (Sore Injection Site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 14-Apr-2021, the patient experienced INJECTION SITE PAIN (Sore Injection Site). On 23-Apr-2021, the patient experienced INJECTION SITE WARMTH (Warm to the touch Injection Site), INJECTION SITE INDURATION (Hard to the touch Injection Site) and INJECTION SITE PRURITUS (Itching Injection Site). On 16-Apr-2021, INJECTION SITE PAIN (Sore Injection Site) had resolved. At the time of the report, INJECTION SITE WARMTH (Warm to the touch Injection Site), INJECTION SITE INDURATION (Hard to the touch Injection Site) and INJECTION SITE PRURITUS (Itching Injection Site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was given. No laboratory details was given. No treatment information was given.
Simple febrile seizure.  Patient with a generalized seizure lasting 2 minutes 1 day after receiving MMR and Varivax vaccines.  Patient's fever following seizure was found to be 105. Patient evaluated in the emergency department.
lethargy, crying, pale & limp for a few seconds, temp 100.8 R;tx APAP, manifestations neuro; probable ADR, severity mild mechanism could be pharm, allergic, idios or unknown;dx r/o idiosyncratic rxn to DTP;
After patient recieved his third dose of the Pfizer Covid vaccine the patient started having  palpatations and left sided chest pain and a head ache
Started with pain at injection site, in the upper arm, got worse over time, numbness down the arm, at some points, with tingling to the fingers, swelling onset, more pain, right upper part of the body began to hurt the evening of 11/4, glands began to hurt on the right side, throat began to feel weird this morning 11/5/15..took Benadryl, severe headache onset, cannot move arm to good today fingers feel very stiff, obvious swelling, discolored injection site, lighter than usual barely able to dress myself.
the patient experienced no symptoms; 6 month old patient received a thrid dose of PEDVAX HIB; This spontaneous report was received from a medical assistant referring to a 6 month old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On 13-FEB-2020, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # S021457 (verified to be a valid lot number), expiration date reported and established as 03-MAR-2022, for prophylaxis. The patient experienced no symptoms.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Additional Details: Patient stated they felt nausous and about to faint. Thwe pharmacist was able to get to the patient before they passed out with no injuries. Emergency services was called and paramedics showed up. Pt was responsive after 30 seconds and was given water and orange juice and felt better afterwards. Patient was dizyy and sweating and they stated they couldnt hear anything. Patient felt normal after a few minutes.
very fair skinned. rash at injection site with itch. 30 mg BENADRYL PO
approx 5 mins p/shot pt became pale & clammy; placed in step mom's lap w/feet in air p/about 5 mins-color had returned; pt felt fine; no nausea or pain anywhere; pt did not loose consciousness @ anytime;
Information has been received from a pharmacist regarding a patient of unknown age and gender. There was no pertinent medical history, drug reactions/allergies or concomitant medication reported. On 11-MAR-2016, the patient was vaccinated with one dose of PNEUMOVAX 23 (lot# L024118 with expiration date of 26-MAR-2017), intramuscularly (dose was not reported), which were stored at 80 F for 12 hours. The vaccines did not have previous temperature excursion. No adverse effects reported. Additional information is not expected as no consent was provided.
Dizzy, nausea, felt warm. BP 171/114 (pulse 100), then 151/93. 98% O2 sat. Given juice, water, and rested.
skin bumps all over her body; Itching rash; had an allergic reaction hypersensitivity/ sneezing; This spontaneous case was reported by a patient and describes the occurrence of SNEEZING (had an allergic reaction hypersensitivity/ sneezing), SKIN MASS (skin bumps all over her body) and RASH PRURITIC (Itching rash) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product DUPILUMAB solution for injection for Atopic dermatitis.    Previously administered products included for Atopic dermatitis: DUPILUMAB (Solution for injection Dose: 300 mg Frequency: QOW Route: Subcutaneous On 16 Oct 2020, the patient took dupilumab at a loading dose of 600 mg followed by maintenance dose of 300 mg every other week since 30 Oct 2020.) in August 2020, DUPILUMAB in August 2020 and DUPILUMAB in August 2020. Past adverse reactions to the above products included Drug use for unapproved dosing regimen with DUPILUMAB; Incomplete dose administered with DUPILUMAB; and Intentionally missed dose with DUPILUMAB. Concurrent medical conditions included Visual impairment.   On 30-Oct-2020, the patient started DUPILUMAB (Subcutaneous) 300 milligram every two weeks. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced SNEEZING (had an allergic reaction hypersensitivity/ sneezing). On an unknown date, the patient experienced SKIN MASS (skin bumps all over her body) and RASH PRURITIC (Itching rash). At the time of the report, SNEEZING (had an allergic reaction hypersensitivity/ sneezing), SKIN MASS (skin bumps all over her body) and RASH PRURITIC (Itching rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's past medical history, concomitant treatment(s) and family history were not provided.  No concomitant medications were reported. No lab test was reported.  Reported itching returned because she has not received any injection due to insurance issues and product use issue (nurse asked consumer if on the same day she was injected twice, she said no, she was injected one injection two weeks apart) and only took one syringe 300 mg instead of 600 for the loading dose.  It was reported by the patient that two to three days after the doctor injected her in the office her itching went away and she was very happy with dupilumab, but then the itching returned on Sunday that was on 04-0ct-2020 (pruritus, latency: approximately 1 month few days) because she had not received an injection since Aug-2020 due to insurance issues.  Nurse reported since 30Dec2020 being her last dose there has been a lapse in her therapy due to PAP approval then restarted on 08Mar2021. She received her second vaccine on 29Mar2021.  It was not reported if the patient received a corrective treatment for the events.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
20JAN93 pt recvd vax on 21JAN93 pt c/o pain & tenderness in lt arm; pt had firm red lump which was red & warm w/edema the size of mom palm; 22JAN93 arm became red & hot from the lt shoulder to the elbow; pos allergic reaction given DPH;
Information has been received from the authors of a published literature article concerning a 4 month old male with a neuro-degenerative disease of unknown etiology who on an unspecified date was vaccinated with his first dose of HIB conjugate vaccine. There was no concomitant medication. Subsequently, the patient presented to the clinic with a 1 week history of cough and watery diarrhea and 1 day history of fever to 40 degrees C. Chest radiograph revealed bilateral pneumonia. The patient was hospitalized. He was treated with IV cefuroxime. Blood culture grew H. influenzae type a. The patient became afebrile after 2 days of antibiotic therapy and was discharged in his baseline state of health. The patient subsequently died of unspecified complications of his underlying neuro-degenerative disease. No further information is available. A copy of the published article is attached as further documentation of the patient's experience.
Pfizer-BionTech COVID 19 Vaccine EUA. Received injection one in right upper arm. One hour later started to experience some nausea and mild headache. Within several hours later, headache throbbing, nausea worsening with vomiting. Eight hours later, right arm throbbing, pain going up and down arm. Hand and fingers throbbing. Pain in back of head, neck and down back into right hip. Nothing relieved pain or nausea. Tried ice packs, cool rags, motrin, tylenol, maxalt, zofran. 24 hours later, still have symptoms, not as violent, but pain and throbbing continue and unable to eat or drink anything.
This spontaneous report as received from a other health professional (registered nurse) refers to a unspecified number of patients of unknown age. Current conditions and medical history was not reported. Since 05-NOV-2014, patient were administered with VAQTA injection (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On 05-NOV-2014, VAQTA vaccine was exposed to temperature (9 degree for 6 hours) out of the recommended range and administered to unspecified patients. It was reported that the nurse was not aware of any adverse effects. At the time of this report, the excursion has not ended. It was reported to nurse that as per stability assessment data, VAQTA would not be adversely affected by this specific temperature excursion. Product quality complaint was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
diarrhea; extreme dry mouth; loss of taste; brain fog; fatigue; sharp stomach pains; bloating; reflux; intermittent laryngitis; This is spontaneous report from a contactable consumer (patient) reported for herself. A 59-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0150, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 02Apr2021 at 14:15 pm (age at vaccination was 59 years) as dose 2, single for COVID-19 immunization. The patient's medical history included high cholesterol from an unknown date. Concomitant medications included fenofibrate, ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) and progesterone all taken for an unspecified indication. The patient previously took tetanus and experienced known allergy to it. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6206, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 12Mar2021 at 16:15 pm (age at vaccination was 59 years) as dose 1, single for COVID-19 immunization and 3 days after 1st dose, the patient experienced stomach pains, bloating, diarrhea, headache & dry mouth w/loss of taste which lasted for 13 days. The facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 04Apr2021, 2 days after 2nd dose, the patient experienced extreme dry mouth, loss of taste, brain fog, fatigue, sharp stomach pains, bloating, reflux, diarrhea, intermittent laryngitis, still had the symptoms. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab test which included COVID test (nasal swab): negative on 09Apr2021, MRI (Magnetic resonance imaging) and abdominal ultrasound with unknown results on an unspecified date. The patient received treatment for the events. The patient had a restricted diet. The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Immediate extreme pain in the injection site. Subsided slightly within the first 15 minutes. As the day went on, started feeling more soreness and headache. By 7 pm that night, I was extremely fatigued and nauseated. Pain very bad in my arm that night to where I could not sleep. Each day that has gone on, I have had worsening fatigue, headaches, and an increase in my heart rate, and a decrease in my blood pressure. I've had an increase in brain fog and an increase in sleep issues. The pain in my arm went away after 4 or 5 days.
4" X 3" raised, red area, tender to touch over "biceps" of left arm which lasted 5 days.
Cried a "screaming" cry for over 4 hrs w/ redness & swelling of inject site lt thigh w/more & louder crying when mom applied warm compress;
tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable consumer (patient's wife) via a Pfizer-sponsored program. This consumer reported similar events for two patients. This is the second of two reports.  A 46-year-old male patient (consumer's husband) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on 25Feb2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer's husband (patient) received the first dose the same time as her and he has Covid as well. The consumer (wife) and her husband (patient) received the covid vaccine at the end of Feb. Then recently tested positive for covid (in 2021), wanted to know when they will be able to receive the second dose of the vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) :PFIZER-2021275214 same reporter/product/events, different patient
After receiving the shot, Patient went to the restroom.  He felt dizzy, wobbled a little, got back his balance, and as he walked out of the restroom, lost his balance and passed out.  He fell to the ground and possibly fell onto a nearby cart.  He quickly regained consciousness, but was clammy and pale.  He split his lip and is very sore throughout his body.  After sitting for several minutes, drinking water and drinking a berry smoothie, color came back to his face and he was coherent, able to carry on a conversation.  He mentioned that he hadn't eaten after breakfast.  The pharmacist administering the vaccine reported that he was nervous prior to getting the shot.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On approximately 15-OCT-2015 (date estimated based on "one week ago"), the patient was vaccinated with the first dose of pneumococcal vaccine (manufacturer unknown), (dose, route of administration, injection site, lot number and expiration date were not reported). On approximately 22-OCT-2015 (date estimated based on "one week later"), the patient received the second dose of pneumococcal vaccine (manufacturer unknown), (dose, route of administration, injection site, lot number and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
OBSTRUCTIVE SLEEP APNEA 3/8/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Erythemic patch (10 x 7.5 cm) on upper (R) arm circumferentially. Warm to touch. Does not itch. Takes Ranitidine 150mg twice daily for GERD.
Tested positive for Covid 2/12/22. Presented with N/V, headache, chills, and fevers. Workup in the ER noted sepsis likely due to urinary source and she was admitted for further workup.Treated with antibiotics and dexamethasone.
Plaintiff was diagnosed with Shingles by her primary care physician; Information has been received regarding a case in litigation, referring to a female pt of unknown age. Information regarding the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. In or about September 2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles. In or around October of 2018, the pt presented to the physician's office with complaints of a rash on her right lower leg. The pt was diagnosed with shingles by her primary care physician. The shingles outbreak lasted several weeks and resulted in skin discoloration. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of defendants' conduct, the pt has incurred and would continue to incur medical expenses and other economic harm as a direct result of zoster vaccine live (ZOSTAVAX).At the time of the report, the outcome of herpes zoster was considered as not recovered. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).     The event was determined to be serious due to disability criteria.
No additional AE's/PQC's.; temperature excursion for VARlVAX.; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 09-FEB-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # T020652 was confirmed to be valid, with expiration date 16-JUN-2022(exact dose, vaccine schedule, route of administration and anatomical location were not provided) for prophylaxis.   The multiple temperature excursions were below -13 Celsius degrees (C) (-13.9 C) for 45 hours. There were no previous excursions reported. The digital data logger was involved. No adverse effects were reported.  This is one of the several reports from the same reporter.; Sender's Comments:  US-009507513-2103USA003180:
SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 SYMPTOMS; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight was 189 pounds, and height was 68 inches. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported with frequency 1 total, dose administered at right arm on 11-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-JUL-2021, the patient only felt like he had Covid coded to (suspected covid-19 symptoms) all over again but it resolved in 24 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 symptoms on 12-JUL-2021, and the outcome of suspected clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210728143-COVID-19 VACCINE AD26.COV2.S- suspected clinical vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
In the middle of the night after my vaccine, my left thumb started to lock into place. I saw a doctor on 3/22/2023 who suspected trigger finger and ordered an x-ray, and made a referral to occupational therapy for assessment. I attended 5 OT appointments for the thumb until I could see the hand specialist. Trigger thumb was confirmed. On 5/8/2023 at my appointment with the hand specialist, I received a cortisone injection in the thumb. On 5/23/2023 I had my final OT appointment, with much improvement in my thumb. After the vaccine I did have joint pain in ankles, knees, elbows for about 5-6 days.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. Information regarding pertinent medical history, drug reactions, allergies and concomitant therapies was not provided. On 18-JAN-2017, the patient was inadvertently  vaccinated with and expired dose of PNEUMOVAX23, (strength, route of administration, dose, and frequency were not provided), lot # L012215, expiration date 13-JAN-2017 for prophylaxis. No adverse effect was reported nor product quality complaint was not involved. Additional information has been requested.
loss of taste; swollen glands underneath jaw; prickling feeling; tingling feeling; itchiness; soreness in am of injection; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling feeling), PARAESTHESIA (prickling feeling), AGEUSIA (loss of taste), VACCINATION SITE PRURITUS (itchiness) and LYMPHADENOPATHY (swollen glands underneath jaw) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 1. On 19-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness) and VACCINATION SITE PAIN (soreness in am of injection). On 20-Mar-2021, the patient experienced PARAESTHESIA (tingling feeling). On 21-Mar-2021, the patient experienced PARAESTHESIA (prickling feeling). On 22-Mar-2021, the patient experienced AGEUSIA (loss of taste) and LYMPHADENOPATHY (swollen glands underneath jaw). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (tingling feeling), PARAESTHESIA (prickling feeling), AGEUSIA (loss of taste), VACCINATION SITE PRURITUS (itchiness), LYMPHADENOPATHY (swollen glands underneath jaw) and VACCINATION SITE PAIN (soreness in am of injection) outcome was unknown.            Concomitant medication were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Age at Vaccination added. No adverse event removed as relevant history. Second dose regimen information was added. Lower level term changed from Pruritus to vaccination site pruritus. Action taken, dechallenge and rechallenge was updated to not applicable. On 18-Aug-2021: Follow up received contains no new information added.