chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives; Swollen Eyes; Chills; tchy Sensation - Near Injection Site; Swelling - Near Injection Site; Redness - Near Injection Site; Rash - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), EYE SWELLING (Swollen Eyes), INJECTION SITE PRURITUS (tchy Sensation - Near Injection Site), INJECTION SITE SWELLING (Swelling - Near Injection Site) and INJECTION SITE ERYTHEMA (Redness - Near Injection Site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced INJECTION SITE PRURITUS (tchy Sensation - Near Injection Site), INJECTION SITE SWELLING (Swelling - Near Injection Site), INJECTION SITE ERYTHEMA (Redness - Near Injection Site) and INJECTION SITE RASH (Rash - Near Injection Site). On 22-Feb-2021, the patient experienced URTICARIA (Hives), EYE SWELLING (Swollen Eyes) and CHILLS (Chills). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 16-Feb-2021, INJECTION SITE PRURITUS (tchy Sensation - Near Injection Site), INJECTION SITE SWELLING (Swelling - Near Injection Site), INJECTION SITE ERYTHEMA (Redness - Near Injection Site) and INJECTION SITE RASH (Rash - Near Injection Site) had resolved. At the time of the report, URTICARIA (Hives), EYE SWELLING (Swollen Eyes) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Developed "knots in both legs where you gave the shots". Over the next 2 weeks, she had a fever, "off and on". The highest temperature was 102F. She then developed "little bumps" on her face and it spread to her legs and arms. The "rash" developed and turned red in the last couple of days. Hasn't been seen by a doctor yet. Referred to clinic and has appt at 14:15 on 5/14/01. On 5/17/01, telephone call to mother reports seen by physician and rash was believed to be related to heat. "knots" should go down.
localized redness, itching, swelling & pain @ inj site;cool pack to site;claritin given;
Vaccinated at 2:34 pm; pt returned at 3:20 pm with cc: hot, light headedness; BP measured at 3:25 pm = 135/90 mmHg; BP at 3:35 pm = 134/92 AOX3; Rph noted hands were shaking; denied airway constriction; no swelling at injection site. Pt requested to 911 ambulance to ER; No tx at ER pt was released by 7:10 pm; 6/27/13 f/u fine.
AE none. Pt was given expired vaccine. Expired 6/12. Pt. reported no adverse events and was revaccinated 9/25/12.
Broke out in hive and a rash, throat swelled, eyes swelled, problems with heart and lungs and sinus issues really bad... lasted over 3 months and still having some effects.
No Additional AE/PQC; patient was inadvertently given a dose of ROTATEQ after it suffered a TE; This spontaneous report has been received from an office manager and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 29-AUG-2023, the patient was inadvertently vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter (mL) after it had suffered a temperature excursion (product storage error) (lot #number 938977 has been determined to be valid for rotavirus vaccine, live, oral, pentavalent (ROTATEQ), with an expiration date established as 30-APR-2024), administered for prophylaxis (strength, and route of administration were not provided). The temperature excursion had a timeframe of 36 minutes at a temperature on 50 degrees Fahrenheit (F). No additional adverse events were reported.
High Fever 11/17/2009 PCP records for 10/28/2009, patient with c/o's sore throat and fever. Tx: ABX and Tamiflu. Dx Flu syndrome
Date removed from freezer 8/9/22 . Thaw expiration date 9/8/22 @1100. Dose administered 9/19/22. Doses administered after 30 day thaw expiration. Moderna was contacted for assessment of vaccine activity for both doses. Based on the assessment vaccine maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration per Moderna.   No adverse effect reported
c/o body aching with hot and cold feelings since yesterday evening and nasal drainage and diarrhea. Left arm and shoulder tender and painful. Small reddened area, size of quarter, over left arm injection site. No swollen nodes at neck/axilla area.
throat tightness; This is a spontaneous report from a non-contactable other healthcare professional. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number HE9899, intramuscular Right arm (right deltoid muscle) from 18Dec2020 12:45 to 18Dec2020 12:45 as single dose for COVID-19 immunization. Medical history included mild anxiety. The patient's concomitant medications were not reported. Patient was given the Pfizer vaccination in the right deltoid muscle. During her 15-minute waiting period after the injection, the patient began to experience throat tightness. She denied rash, hives, difficulty breathing, hoarseness, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. Review of Systems Constitutional: Negative for activity change, appetite change and fever. HENT: Negative for congestion, facial swelling, rhinorrhea and trouble swallowing. Initially with some throat tightness. Resolved within 10 min Respiratory: Negative for cough and shortness of breath. Neurological: Negative for dizziness, weakness, light-headedness and headaches. The outcome of the event was recovered on 18Dec2020.  No follow-up attempts are possible, information about batch number cannot be obtained.
Patient received TDAP vaccine on 4/19/2018 during office visit. On 4/20/2018 the patient noticed a large lump where the vaccine was administered. She was seen on 4/24/2018 for another office visit. The lump was reported as painful, hot, and increasing in size. Warm compresses and cold compresses offered no relief.
patient states started to fill itchiness and discomfort on 3/14/20 (4 days after injection). Went to md office today (3/16/20) and was diagnosed with active shingles. patient was prescribed valacyclovir 1 gram tid #21
Information has been received from a consumer concerning herself with a history of infectious mononucleosis two years ago and seasonal allergies who on 21-NOV-2007 was vaccinated with her first dose of Gardasil. Concomitant therapy included LOESTRIN. On 10-JAN-2008 the patient was vaccinated with her second dose of Gardasil. After receiving the second dose in January 2008, the patient experienced scab at the injection site and scabs on her torso. The patient's scab at the injection site and scabs on her torso persisted. She indicated she did not have any adverse events after the first dose. The patient gives permission to contact her physician. Additional information has been requested.
Severe muscle pain, lack of mobility in arm unable to lift arm in an upward or outward direction, hives for two days treated with Benadryl.  Receiving Physical Therapy and pain control for arm referred to a neurologist suspect brachial neuritis.
On Thursday, March 11th, 2021 approximately 3:10 pm, Patient received his first dose of Moderna Vaccine (Lot number: 003A21A) in his left deltoid  Patient received the Moderna Vaccine. After which he sat in the designated medical observation area for 15 minutes. Approximately five minutes later around 3:15 pm, Patient experienced syncope, fell out of his chair, hit the left side of his forehead on the ground. Due to the fall, he experienced a mild abrasion on the left side of his forehead, which led to bleeding.  The Physician?s Assistant rushed to aid Patient who was lying on the ground in a supine position. Emergency Medical Services (EMS) - Fire Department and ambulance were called immediately and approximately five minutes later EMS arrived. During the time frame prior to EMS arrival, the Physician?s Assistant asked numerous questions to Patient to assess his condition. She asked Patient if he could breathe and he responded ?yes?. She asked Patient  if he was short of breath and he responded ?no?. She asked Patient if he felt like his throat was closing and he responded ?no?. At this point, an Epinephrine pen was not used.  Patient was alert and the Orient x 4 questions were asked [(1) Who are you? (2) Where are you? (3) What is the date and time? (4) What just happened to you?]. Patient also denied head pain, neck pain, nausea or chest pain. Staff performed a limited neuro-exam and was deemed within normal limits. Patients Glasgow Coma Scale score was 15 Patient  mentioned that he has a phobia of needles and something like this has happened before when he was ?young?. Patient initially did not want an ambulance to be called. It was explained to him that it might be in his best interest to call EMS due to syncope and abrasion on his forehead due to the fall. Patient also mentioned that he only consumed two cookies and coffee for that day.  When the EMS arrived (about 5 firefighters), they interviewed him and performed a blood pressure test. His sitting blood pressure was 130/82. One of the firefighters assessed his spine and Patient denied cervical, thoracic, and lumbar tenderness or pain. The firefighter assessed Patient's glucose level, which was a bit difficult to obtain in the first initial efforts, with the glucometer reading ?error?. The firefighters eventually were able to obtain a reading on Patient's glucose and it read 86. Patient was able to stand on his own, and a second blood pressure test was performed; his standing blood pressure reading was 145/89.  EMS gave Patient gauze to address his head wound Patient initially refused to go to the hospital, but per EMS protocol, fluids needed to be administered. Patient entered the ambulance and was taken to the hospital by EMS.
Feeling weak; Tired; This is a spontaneous received report from a contactable consumer. A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0173, Pfizer NTEC), via an unspecified route of administration on 06May2021 in arm left in the morning at unknown time after 09:00 as 2nd dose, single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included minerals nos, vitamins nos (CENTRUM A TO ZINC) taken for supplementation therapy, start and stop date were not reported. The patient previously took first dose of BNT162B2 (Lot: EW0153) on 07Apr2020 at around 10:00 the Left arm for COVID-19 immunisation. Patient reports experienced feeling weak on 08May2021 and tired since then on May2021.  She wants to know if we have reports of the tiredness lasting this long, as she said most people she knows only reported 3 days of fatigue. She stated she had seen her HCP yesterday. The patient who called to report feeling weak after the second dose of the Pfizer Covid Vaccine. Event was still ongoing. Onset date approximate initially she felt good on 06May2021, but by 08May2021 she had onset of feeling weak time of onset unknown 09May2021 she felt weaker. She still was feeling weak and reported outcome as persistent, about the same. She was administered a B12 shot yesterday in the doctor's office and thought she would feel good, but today she still feels the same, feeling weak. B12 shot: Lot/NDC/Expiry: Unknown, product administered in the doctor's office. She went to her doctor who referred her to Pfizer. She asked if there have been any other reports of feeling weak after the Pfizer Covid Vaccine and why she had no problems with the first dose of Pfizer Covid Vaccine, but feeling weak after the second Pfizer Covid Vaccine. Dosage previously discontinued/treatment completed. Patient took Pfizer Covid Vaccine because everybody else got it. Second dose completed prescribed therapy. The patient underwent lab tests and procedures which included blood test: unknown on 02Jun2021. Therapeutic measures were taken as a result of feeling weak. The outcome of the event feeling weak was reported not recovered and the event tired was reported as unknown.  Description of Product Complaint: Consumer was the patient who called to report adverse event of feeling weak after Pfizer Covid Vaccine. During report mentioned that she was administered a B12 shot yesterday in the doctor's office and thought she would feel good, but today she still feels the same, feeling weak. B12 shot: Lot/NDC/Expiry: Unknown, product administered in the doctor's office.
Metal mouth directly after injection as well as tingling, and numbness in checks. The numbness took a couple days to wear off.
Patient complains of redness, itching and swelling at injection site that has progressively worsened since receiving vaccine. Patient states redness and swelling have a diameter of two inches at injection site. Narrative: Patient complains of redness, itching and swelling at injection site that has progressively worsened since receiving vaccine over one week ago. Patient states there is a two inch diameter of redness and swelling at injection site and itching has worsened. Patient advised to see primary care provider if symptoms continue to worsen and do not resolve.
I had been notified the day before that I had been exposed by a family member to COVID. I woke up the next morning and had a scratchy throat. I thought I better get tested to make sure. I got tested at about 11:30AM and as the day progressed, I started to get really tired. My nose was stuffy. I was notified at 07:00PM that night of the 31st that I tested positive on the rapid test. I also had PCR test as well that same day. On the next day, I received those results at 04:30PM and they came back positive. I ran a temperature of 102.5. Stuffy nose and dull headache across my forehead. I had a cough, but it was every once in a while. I felt more like my allergies were bad instead of COVID, except the temperature. I drank a lot of fluids and stayed in bed until Thursday. Thursday, I had no temperature and Friday as well. Still had the runny nose. I'm fine now. I get tired but I feel fine.
Sore Arm; arm swollen to the size of half a tennis ball and itchy; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), PERIPHERAL SWELLING (arm swollen to the size of half a tennis ball and itchy) and PRURITUS (Itchy) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 027A21A) for COVID-19 vaccination.     The patient's past medical history included Biceps tenodesis (metal pins in his arm at place of surgery). Concomitant products included CHOLESTEROL and EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (DESCOVY) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm), PERIPHERAL SWELLING (arm swollen to the size of half a tennis ball and itchy) and PRURITUS (Itchy). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Sore Arm), PERIPHERAL SWELLING (arm swollen to the size of half a tennis ball and itchy) and PRURITUS (Itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication includes OTC sinus medicine   This case was linked to US-MODERNATX, INC.-MOD-2021-059750 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received on 11-MAY-2021 and contains no significant information On 07-Aug-2021: Insignificant follow up is received, contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-059750:Linked to 2nd dose
I signed up to receive my first dose of Pfizer covid vaccine for 12/3/21 0700 at Hospital . Later that day I was notified by the pharmacist at Hospital that the nurse accidentally gave me an overdose from the vial as it was not diluted / reconstituted beforehand and that the vial contained 6 doses .  I experienced tingling to my upper lip area that day and then developed headache , body aches and difficulty walking that evening as I felt weak . I developed chest pain and palpitations / tachycardia that prompted me to seek urgent care that night . I was evaluated in an emergency department where I received IV fluids , Tylenol a chest X-ray and ct scan of chest as I had an elevated D Dimer lab and persistent tachycardia / chest pain .  I also had an elevated WBC. I have since required outpatient cardiac 24 monitor for palpitations and increased heart rate episodes . I spoke with the pharmacist at hospital  , again today 12/16/21 who informed me that the dose was not diluted before the nurse received the vial from the pharmacy department and that it is believed the nurse did draw 0.3ml of an undiluted amount from the vial which would more likely be more equal to 4 doses received  instead of all 6 .
A delayed cutaneous hypersensitivity reaction at injection site.  Redness on whole area of deltoid accompanied by itching.  No actual wheal present.  Currently still have some redness about half of the area.  Some on/off itching at times.  Did not take antihistimine.
Petechial rash, platelets decreased 30,000. Diagnosed with ITP and given Helmet.
Extreme joint pain, back, legs, neck... Headaches Very large swollen lymph nodes under are where shot was given.
received vaccine friday afternoon saturday started feeling extremely dizzy and weak,  difficulty walking sunday unable to walk, blood pressure high, tremors called 911
Information was received from a nurse referring to an unknown number of unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On unspecified dates, the patients were administered doses of improperly stored PROQUAD injection, recombinant human albumin (rHA)/human serum albumin (HSA) (lot# M046943, expiration date 27-MAY-2018; lot# M049122, expiration date 13-JUN-2018) (Strength, dose, frequency, anatomical location and route were not reported) for prophylaxis. The concomitant therapy included sterile diluent which was used to reconstitute PROQUAD injection, was stored properly. The vaccines were exposed to 6 to 14 Fahrenheit degree (F) for 1.5 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects was reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA012152: US-009507513-1707USA012415: US-009507513-1707USA012416: US-009507513-1707USA012418: US-009507513-1707USA012419.
RECEIVED VACCINE 01/22/2021.  SORENESS AND TENDERNESS FOR FIRST FEW DAYS.  ON FRIDAY, 01/29/2021, SITE OF VACCINE WAS ITCHY.  BY SATURDAY MORNING SITE OF VACCINE WAS RED AND RAISED.  ITCHINESS PERSISTED SINCE FRIDAY. REDNESS SPREAD TO LARGER AREA. PROVIDING INFORMATION FOR PURPOSE OF DOCUMENTATION.
I experienced few days later I stated getting very itchy skin, all over my body. I would occasionally have hives usually on my neck and face and sometimes in my shoulders. When I would scratch myself I would develop red whelps. My eyelids felt weird and bit swollen and also felt my blood was having like an allergic reaction. I went to see my allergist and the did a series of allergy tests but the results were invalid because my skin was hypersensitive. I continue with my symptoms today. My doctor also recommended an antihistamine (ALLEGRA medication) four times a day but now I am down taking it two times a day. I do have a follow up appointment with my allergist on 11/11/2022. I also have never had a reaction like this before along with taking a flu shot vaccine.
temperature excursion; No additional AEs; This spontaneous report was received from a registered nurse and refers to an 18-month-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 06-DEC-2022, the patient was vaccinated with improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W006595, expiration date: 10-OCT-2024, administered intramuscularly for prophylaxis (dose and strength were not provided); pneumococcal vaccine conj (PCV B) lot #FN5555, expiration date: 31-JUL-2024, administered intramuscularly (dose, strength, formulation, and indication were not provided); hepatitis a vaccine inact (HAVRIX), unk, lot #94H52, expiration date: 30-APR-2023, administered intramuscularly (strength, formulation, and indication were not provided); and  diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) lot #Y4259, expiration date: 03-MAR-2024, administered intramuscularly (dose, strength, formulation, and indication were not provided) (product storage error).  On an unknown date, before the administration, the vaccines underwent temperature excursion for unknown period of time. There was no adverse event reported.  The reporter considered temperature excursion to be not related to suspect vaccines.; Sender's Comments:  US-009507513-2212USA007828: US-009507513-2212USA007829: US-009507513-2212USA007830: US-009507513-2212USA007831: US-009507513-2212USA007832: US-009507513-2212USA007833: US-009507513-2212USA007834: US-009507513-2212USA007835: US-009507513-2212USA007836: US-009507513-2212USA007837: US-009507513-2212USA003061:
on the first day around 4pm i got tired, sleepy, legs feel weak, a little chillness.  Went to bed before 5:30. the next morning i was still sleepy could hardly move. some body ache and headache from the back of my head to front. third day still a little weak but not like day 1&2.
Patient contacted pharmacy on 1/14/22, she reported ongoing side effects following vaccination 9 days ago.  She indicated that about 3 to 4 hours after her injection she started getting side effects that included significant headache and pain that radiated toward the neck and spine.  This has continued.  She indicated that she has had feelings of lightheadness and dizziness.  She indicated that she has had feelings of tingling in all 4 extremities since the booster shot.  Patient was calling to know more about what people have experienced and if it was a normal reaction and what would be next coarse of action.  Rph indicated that since it was ongoing and of concern to patient that it was not getting better that rph would advise to be seen by medical provider
Pt vaccinated with Typhoid/Influenza at approx 1255PM on 13OCT90 presented in the ER @1655 on 13OCT90 BP 98/60, pulse 132, resp 24, temp 102.4, nausea, vomiting, myalgia & arthralgia.
Fever, onset about 9 PM, lasting until about 5 AM; body aches; overall fatigue a couple hours prior to fever onset. No symptoms after fever besides muscle stiffness at injection site, which resolved in about 1 week.