chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 65-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020). On 4th May 2018, the patient received the 1st dose of SHINGRIX. On 4th May 2018, less than a day after receiving SHINGRIX, the patient experienced headache and fever. In May 2018, the patient experienced pustular rash, pain in arm, erythematous rash and blister. On an unknown date, the outcome of the headaches was recovering/resolving and the outcome of the fever was recovered/resolved and the outcome of the pustular rash was unchanged and the outcome of the pain in arm, erythematous rash and blister were unknown. It was unknown if the reporter considered the headache, fever, pustular rash, pain in arm, erythematous rash and blister to be related to SHINGRIX. Additional information was received as follows: The pharmacist reported that the patient experienced headache and low-grade fever, in the same evening on the day of vaccination. The fever lasted a few days and had resolved but the headache has improved. After 2 days, the patient also developed a pustular rash. Less than a week, the pustular rash initially presented as red and over the course of two days turned into blisters or pustules. The body temperature was recorded as 100 degree F. The reporter stated that the patient had not been able to see her physician regarding this events but she intended to do so. The reporter stated that the patient returned from country on 26th April 2018. The pharmacist was not aware of any medical intervention taken because of patient's experiences.
Potential COVID breakthrough. I had the vaccine on May 26th at 5PM and then went home. Felt fine that day. Also had the Hep B same time. Woke up in the morning with muscle soreness, tired and achy. I ran a couple of errands with my brother and came home. Later that day/Saturday I got a potential exposure notification from the previous week. I rode the commuter bus and only came in contact with 3 people from my office that day. Must have been someone on the commuter bus. Called the nurse on 5/29 for advice. Both of my at home COVID Tests were negative. Nurse stated my symptoms were probably not COVID but instead just reactions to both vaccines. Fevers and chills and nasal congestion continues as well as tickle in the back of my throat. I had a very sore throat for the first 36 hours.
About 8 hours after immunization, patient noted fever up to 104 degrees (oral), chills and headache. Also note "red rash" at immunization site. Sx improving using Tylenol.
After receiving the second vaccine dose, a tingling and numbness sensation started in my right arm and then spread to my face (the right cheek).  The tingling sensation has now spread to my entire fac; After receiving the second vaccine dose, a tingling and numbness sensation started in my right arm and then spread to my face (the right cheek).  The tingling sensation has now spread to my entire fac; After receiving the second vaccine dose, a tingling and numbness sensation started in my right arm and then spread to my face (the right cheek).  The tingling sensation has now spread to my entire fac; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Apr2021 12:30 (Lot number: EW 0172) at the age of 36 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CETIRIZINE HYDROCHLORIDE taken for seasonal allergy. Vaccination history included: Bnt162b2 (COVID 19, Brand: Pfizer , Lot number: ER8737, Administration time: 12:30 PM, Vaccine location: Right arm, Dose number 1), administration date: 05Apr2021, when the patient was 36 years old, for COVID-19 immunization. The following information was reported: MUSCULAR WEAKNESS (non-serious), PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 26Apr2021 13:30, outcome "not recovered" and all described as "After receiving the second vaccine dose, a tingling and numbness sensation started in my right arm and then spread to my face (the right cheek).  The tingling sensation has now spread to my entire fac". The event "after receiving the second vaccine dose, a tingling and numbness sensation started in my right arm and then spread to my face (the right cheek).  the tingling sensation has now spread to my entire fac", "after receiving the second vaccine dose, a tingling and numbness sensation started in my right arm and then spread to my face (the right cheek).  the tingling sensation has now spread to my entire fac" and "after receiving the second vaccine dose, a tingling and numbness sensation started in my right arm and then spread to my face (the right cheek).  the tingling sensation has now spread to my entire fac" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of muscular weakness, paraesthesia, hypoaesthesia.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Within 2 weeks of vaccination, she received Cetirizine Hydrochloride (for seasonal allergy). Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Patient experienced rapid heart rate, high enough she sought medical attention at an emergency dept the day following her covid immunization. After a round of tests, provider informed patient it was likely a reaction to the covid immunization she received.  Symptoms have resolved since then.
Fainted at point of vaccine, which is normal for me. However, since the vaccine I have experienced constant headache, nausea, weakness, and fatigue.
Pruritic erythematous wheal at left inferior temple 20 mins post Typhoid immunization. Urticaia.
Underage patient accidentally given shingrix / patient is 47 years old; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 47-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional details were provided as follows: The reporter stated that, an underage patient accidentally given Shingrix, which led to inappropriate age at vaccine administration. The patient wanted to continue with Shingrix series so the reporter asked if that was acceptable. No further information available. The patient consented to follow up
Body shaking and aches 5 hours after vaccine, fever started 6 hours after vaccine, along with headache and inability to sleep, fever lasted for almost 36 hours, nausea which led to vomiting 16-17 hours after vaccine, vomiting off and on for the next 8 hours, 3 days later and still have headache and some dizziness and brain fog and some moments of nausea, day 2 had some itching on legs, day 3 and still don?t feel back to normal
Lightheaded/dizziness 3 days; Causing nauseous-ness; Headache behind eyes; Very tired; This is a spontaneous report from a non-contactable consumer, the patient. A 65-year-old (estimated age) non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 01Apr2021 at 08:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and sulfa allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 01Apr2021 at 13:30, the patient experienced lightheaded/dizziness for 3 days, nauseousness for 1st day, headache behind eyes and the patient was very tired. These symptoms lasted for more than 3 days and in 3rd day became much less. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache behind eyes, nauseousness for 1st day and the patient was very tired, was recovered on an unknown date in Apr2021 and lightheaded/dizziness for 3 days was recovered on 04Apr2021.  No follow-up attempts are possible. No further information is expected.
15 wks pregnant due date 9-21-21, symptoms included fever, nausea, vomiting, rapid heartbeat, insomnia, muscle aches, sore arm, very tired.
Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM injection for Pulmonary arterial hypertension.    Concurrent medical conditions included Primary pulmonary hypertension. Concomitant products included TADALAFIL (ALYQ) and AMBRISENTAN (LETAIRIS) for an unknown indication.   On 18-Jun-2019, the patient started TREPROSTINIL SODIUM (Intravenous) .052 microgram/kilogram. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore). At the time of the report, PAIN IN EXTREMITY (Arm was sore) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable No treatment drugs were reported
Guillain Barre syndrome symptoms 10 days after flu shot. Leading to hospitalization and continued upper extremity weakness.
Meningococcal MCV4 Lot # U3433AA - Exp. 08/02/11 vaccine administered 8/10/11, 8 days after expiration date. Dose not re-administered.
Information has been received from a physician referring to a female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug allergies/reactions were not reported. On 15-APR-2019, the patient was vaccinated with her first dose of GARDASIL 9 (route, dose, lot# and expiration date unknown) for HPV prevention. On the same day, after the injection of GARDASIL 9, the patient experienced an injection site reaction of redness, swelling and pain. The outcome of the events was unknown and the causality assessments were not provided.
Redness, warmth, and swelling at injection site with red streak to Axilla. Patient was seen by his primary care doctor who prescribed Dicloxacillin
Above patient was given DTAP at R deltoid on 2/13/06, now presented: local swelling and erythema and warmth to back. Patient evaluated and given Benadryl. Prescription and instructions for oral compress.
This spontaneous report was received from a medical assistant, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On unspecified dates, the patients were orally vaccinated with an improperly stored dose of ROTATEQ (dose and frequency were not reported) lot # M038846 with expiration date of 26-APR-2018, for prophylaxis. The temperature of the ROTATEQ was between 47 °F and 77 °F for a time frame of 16 hours. No previous temperature excursion occurred, and no data logger was involved. No adverse effects were reported. This is one of three reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA003118: US-009507513-1705USA007814:
Fifteen minutes after receiving the second dose of the vaccine, patient felt hot all over, flushed.  She also complained of nausea and dizziness.  She laid down on a cot and drank some water.  After 10 minutes, the hot feeling was gone, she stated she was hungry and was going home.
Nose bleeds after 2nd Pfizer vaccine continued every other day for 10 days
Patient was afebrile and presented for a well-child visit. Approx. 15 minutes after receiving vaccines patient spiked a fever of 102.0 and had localized heat to the injection area of the left thigh. Mother reports a fine raised rash under bottom lip as well. This was not visualized by RN and is gone at time of completing this report.
On March 10, 2022, three (3) weeks after receiving the Moderna booster shot I started feeling very sick to my stomach (nauseous and had diarrhea).  I also had a migraine.  I had absolutely no energy at all and that night I wet the bed.  The next day,  the symptoms got increasingly worse and while I was sitting on my couch I noticed that I had lost all control of my bowels.  There was no feeling at all.  This happened for three (3) days straight.  Ever since March 10, I have had no energy at all, my stomach has been very ?shakey?, I have had vertigo, horrific headaches, pain on both sides of my head and in my ears, my mood has been very low and I have cancelled any appointments that I have had because I don?t want to even leave my house at all.  My body hurts all of the time.
Swollen liver; Swollen kidney; She did not receive the 2nd dose between day 25-35 of getting the 1st dose; Bronchitis; This spontaneous case was reported by an other health care professional and describes the occurrence of BRONCHITIS (Bronchitis), HEPATOMEGALY (Swollen liver), KIDNEY ENLARGEMENT (Swollen kidney) and PRODUCT DOSE OMISSION ISSUE (She did not receive the 2nd dose between day 25-35 of getting the 1st dose) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced BRONCHITIS (Bronchitis). On an unknown date, the patient experienced HEPATOMEGALY (Swollen liver), KIDNEY ENLARGEMENT (Swollen kidney) and PRODUCT DOSE OMISSION ISSUE (She did not receive the 2nd dose between day 25-35 of getting the 1st dose). At the time of the report, BRONCHITIS (Bronchitis), HEPATOMEGALY (Swollen liver), KIDNEY ENLARGEMENT (Swollen kidney) and PRODUCT DOSE OMISSION ISSUE (She did not receive the 2nd dose between day 25-35 of getting the 1st dose) 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.   Patient's doctor recommended not to get second dose until all the symptoms subside. Patient has taken an ultrasound for swollen liver and kidney whose results were not reported. No concomitant product was reported. Treatment information was not provided.
The patient had a local skin reaction (large, pear-shaped red and raised rash on her right arm near the injection site) that developed 7 days after getting her initial Moderna Covid vaccine on 19Jan2021. The patient reported the rash was improving at her appointment on 29 Jan 2021. Denied systemic symptoms.
Patient developed chest pain 02 SEP 2003.  Admitted to clinic 02SEP 2003, ruled out for MI, diagnosed with MYOCARDITIS, dischared 03 SEP 2003. He has been without symptoms ever since.  He Will repeat ECG in 1 week and 1 month.
Post vax pt developed pain at the injection site. No further info was available at the date of this report. This is 1 of 3 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune-23. Manufacturer's Comment: The reporter indicated that 4 pts developed an injection site reaction; however, only 3 are presently identifiable. An addtl report will be generated when identifying info is provided. Follow-up info recvd 4/3/01 from MD indicated that the pt recovered.
Swollen area about 4-1/2 inches by 2-1/2 inches. Warm to the touch and hard. Unable to move arm without immense pain. Around 5:30 PM flu symptoms kicked in: fever, chills, body aches, horrible headache, no appetite, and constantly nodding asleep. Hard to wake up the next morning. Area of swelling doubled but flu symptoms subsided a little. Still no appetite. Saw doctor on 4/17 @ 4:15. Prescribed clindamycin 150mg 4 times a day and a topical 2 times a day. If no better in 2 days then go to the ER for antibiotics thru IV. Recheck on 4/21 @ 11:20. After taking 3 doses of antibiotics on 4/18 the swelling is still spreading.
Severe fatigue and muscle weakness.  Caused enough concern for patient to go to Emergency Room 4/14.  ER found no known medical reason for fatigue and muscle weakness and sent patient home.  Patient returned to ER 4/17, again with no diagnosis.
Hospitalized 11/27/2021-still admitted currently; COVID-19 positive 11/27/2021; fully vaccinated  CHIEF COMPLAINT: Weakness  Assessment/Plan   ASSESSMENT/PLAN: Sepsis due to other etiology Assessment & Plan Febrile at 38.1, tachycardia, and tachypnea on admission Procalcitonin was 1.17 Unknown source at this time. CT abdomen/pelvis without direct cause.CXR without infiltrates/consolidations Question possible port infection/blood stream infection UA negative Blood culture pending Continue Zosyn and will add Vanco (day 1).   COVID-19 Assessment & Plan Currently room air Has been fully vaccinated for COVID-19 with Moderna Will not start dexamethasone or remdesivir at this time due to lack of symptoms and room air Patient may be eligible for Monoclonal antibodies Date of Symptom onset:11/23/21 Date of positive COVID-19 test:11/27/21 CXR:  No pulmonary infiltrates Current oxygen requirement: SpO2: 91 %   room air CRP: No results found for requested labs within last 720 hours.  D-dimer: No results found for requested labs within last 720 hours. Empiric antibiotics: vanco and zosyn DVT prophylaxis: Lovenox SCDs Daily CBC w/diff, CMP, CRP, D-Dimer Progress Note 12/1/2021: ASSESSMENT / PLAN: * Weakness Assessment & Plan Will plan for PT/OT. Appreciate recommendations Suspect secondary to COVID-19 and/or other infectious causes   Diarrhea Assessment & Plan Patient has had intermittent watery diarrhea with multiple episodes after previous chemotherapy Patient is C difficile negative.  Etiology is probably related to chemotherapy or COVID-19 infection  Give Imodium as needed for ongoing loose stools  Hypokalemia Assessment & Plan Likely secondary to diarrhea Continued hypokalemia despite supplementation  Continue with supplementation Repeat BMP this evening and in the morning  COVID-19 Assessment & Plan Currently room air, Has been fully vaccinated for COVID-19 with Moderna.  No hypoxia, no indication for dexamethasone/remdesivir.            -monoclonal antibody therapy (casirivimab/imdevimab) given          -monitor hypoxia for progression CM note 12/1/2021: Plan Discharge Coordination/Progress: Pt plans to discharge home with family
pt recv vax in AM 9OCT97 & around 4AM awakened w/sweating & nausea, 1hr fever, muscle aching in arm;consulted pmd & adm to hosp;d/c 11OCT;
Pt had reaction on right thigh about 5 mm not raised just red, went down the next day. Left thigh just had a small bruise the size of a small fingernail.
rash on arm where flu shot given; I got sick; could not breathe out of nose, had to breathe out of mouth; Initial and additional information received on 21-Oct-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case is linked to cases 2020SA298526 and 2020SA298571.  This case involves a patient of an unknown demographic who experienced rash on arm where flu shot given (rash), got sick (illness) and could not breathe out of nose, had to breathe out of mouth (Mouth breathing), when received INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious rash on arm where flu shot given (rash), got sick (illness) and could not breathe out of nose, had to breathe out of mouth (Mouth breathing) (Unknown latency) following the administration of INFLUENZA VACCINE.  It was not reported if the patient received a corrective treatment.  The outcome of events was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Aches and pain all over body, Headache, fatigue and joint pain. Just  happened.
ED visit for delusions of parasitosis. Treated and released. ED to hospital visit 6 days later for Acute systolic congestive heart failure. Cardiac Catheterization completed 3/9:  Left and right heart cath showed moderate non-obstructive coronary artery disease with normal filling pressures.            Per Cardiology recommendation:                                    -Start Crestor 20 mg daily                       -Start Aspirin 81 mg daily ED visits and hospital admission within 6 weeks of receiving the COVID vaccine.
Patient immediately felt pale and lightheaded after dose 2. Recovered quickly over 10 minutes. Discharged home after 20 min additional obs.
Approx 12 hrs after vac developed a temp 102.4(A) w/Tylenol. Next day vomiting, diarrhea along w/fever continued the next 4 days. Generalized red rash appeared on 12JAN. Seen by MD he questions whether this could be a possible HIB reaction.
It happened approx. 6 weeks ago I started experiencing pain in my back. I sought medical care and I was given pain medication. Blood work indicated abnormal enzymes, a CT scan showed tumors in my pancreas and liver.