chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Facial swelling; Neck swelling; Generalized Itching; This case was reported by a physician via call center representative and described the occurrence of facial swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. On 27th September 2019, 7 days after receiving Shingrix, the patient experienced facial swelling, neck swelling and generalized pruritus. On an unknown date, the outcome of the facial swelling, neck swelling and generalized pruritus were unknown.   It was unknown if the reporter considered the facial swelling, neck swelling and generalized pruritus to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient developed swelling in face and neck and generalized itching about a week after first Shingrix dose. The reporter disconnected the chat prior to providing any additional patient details. The reporter did not consent to follow-up.
Patient and his wife came to our pharmacy to receive their bivalent Moderna boosters. One syringe was drawn from the correct bivalent vial and the second was drawn incorrectly from a monovalent Moderna vial. After review of video footage, we could not determine which patient received the incorrect monovalent dose. The patients were notified. No adverse events to report. We are in contact with Moderna and the CDC to determine if re-vaccinating with the bivalent dose in 2 months is appropriate.
Sore arm-2days , headache -current  on and off , light sensitivity 2 days
Patient's right arm, which is where PNEUMOVAX 23 was administered, swelled, turned red, and was hot to the touch. Pt also had difficulty moving this arm.
Severe body aches, lightheaded, pressure on chest, dizziness, headache, sluggishness, odd bowel movements starting within 8 hours.
Cough; Sore throat; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat) and RHINORRHOEA (Runny nose) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 081A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat) and RHINORRHOEA (Runny nose). At the time of the report, COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat) and RHINORRHOEA (Runny nose) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
The day following vaccination, pt. experience fever and flu like symptoms for 24 - 36 hours. Injection arm was red, warm, and swollen x 1 wk.
Dizziness, Headache, Arthralgia, Fever, chills, dizziness, fatigue Narrative:
Nov. 2 severe headaches began....other neurological symptoms followed...now developed essential tremors and myoclonus.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 01Apr2021 as dose 2, single (Lot number: ER8734), in left arm and on 03Nov2021 as dose 3, (booster), single (Lot number: GG2593) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM, start date: Mar2020; BUPROPION, start date: Aug2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: After testing negative (home antigen test) on Day 5,; Positive, notes: on Day 10 I tested positive again,; Positive, notes: It is now Day 13 and I am still positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient received other medication in 2weeks. The patient was treated with Paxlovid from 01Jul2022 to 05Jul2022 for COVID-19. Adverse event: After testing negative (home antigen test) on Day 5, on Day 10 I tested positive again, and began to have symptoms again. Congestion, fatigue, fever. It is now Day 13 and I am still positive and with symptoms.  No follow-up attempts are possible. No further information is expected.
30 minutes after first Covid jab she experienced tachycardia, tingling in neck and chest. Her legs gave out when she got home and she felt unwell for the rest of the day, but recovered.  Second Covid jab was on 4/11/21 and she felt her throat close up afterwards. Numbness in toes, feet, thighs and hand, felt tingling in throat, tongue and face. She took prednisone taper and experienced hip and knee pain, then took ibuprofen, which caused chest discomfort. Since then she has lost 8# because of dryness in throat and tightness in throat when she tries to swallow or eat. Feels short of breath although pulse ox readings have been normal. Fatigue and light-headedness with some reduced hearing and tinnitus.  Symptoms are gradually improving after visits to primary care, neurologist and cardiologist. Still experiences heart pounding when she stands up first thing in the morning and light-headedness. Also experiences heart pounding when she eats. Sometimes pounding in the middle of the night that wake her up from sleep. Tingling in arms and legs continues.
Patient briefly felt dizzy and nauseous after the vaccine and developed a red quarter dollar sized red spot at injection site.
January 24, 2023 I experienced a very strong scratchy on Tuesday and on Wednesday night when I cough my chest would hurt and by Friday the chest pains were severe. By Sunday after I started to feel better, went to my Dr. on Monday and my lungs were clear. No prescription needed by Tuesday I was worse again. I was tested for Covid-19, Flu, and RSV and they were all negative.
Hives appeared on Dec. 27th, spread all over body, extremely itchy. Itchiness of hands, scalp, ears, eyes). Particularly bad in areas that were rubbed by clothing or were warm. Went to urgent care and got a 6 day taper pack of prednisone, told to follow up with primary care physician if not resolved in 3 days. Not resolved, so visit primary care where I am diagnosed with  dermatographic urticaria and cholinergic urticaria. Taking 1 tablet of 10mg cetirizine daily with 1 tablet of 25 mg hydroxyzine at bedtime. Experienced heartburn on the first day after starting antihistamines which I have never experienced before and, based on my research, appears to be connected (self-treated with tums). Itchiness was much better after starting the antihistamines, but dermatographia and sensitivity to heat remains. Went to a dermatologist who confirmed the diagnosis and recommends up to 4 cetirizine a day with hydroxyzine only as needed as well as steroid creams for the itchiness. No known allergies, nothing new had been added to my environment- I eliminated common allergies from my environment- switched detergents, stopped using fragrances, use sensitive soap, didn't eat eggs, dairy, etc. but did not resolve my symptoms. Was told by both doctors that they are not studying the vaccine but cannot say for sure it was the booster but that it is possible- my primary care had seen someone else with a bad skin reaction ask after their booster. Please take this seriously. I believe in science and the vaccines but this is connected- I have joined a group with as of today 4,000 people and growing that all are pro-vaccine but had the same reaction as me all around a week after receiving the vaccine (mostly Moderna, mostly after the booster) and are sharing visits they've had with immunologists and allergists who are confirming that they are seeing many many people with this reaction after the boosters and that it is starting to be studied.
This spontaneous case was reported by a consumer and describes the occurrence of LEPROSY (Patient said it looks like he has leprosy) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Psoriasis. On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jun-2021, the patient experienced BURNING SENSATION (burning), PSORIASIS (psoriasis/patient had flare up of psoriasis and rashes all over his scalp), HAEMORRHAGE (Bleeding), SCAB (extreme crust tightening on the scalp.), BLISTER (blister), RASH VESICULAR (blistering rash), PRURITUS (itching), RASH ERYTHEMATOUS (Red rash) and VACCINATION SITE PAIN (little sore arm). On an unknown date, the patient experienced LEPROSY (Patient said it looks like he has leprosy) (seriousness criterion medically significant), FEELING ABNORMAL (like someone was pulling on his head) and ERYTHEMA (red marks in the opposite side of the elbow where the hand bends). The patient was treated with HYDROCORTISONE at a dose of 2.5 mg; FLUOCINOLONE ACETONIDE (topical) at a dose of 0.01 %; TRIAMCINOLONE ACETONIDE at an unspecified dose and frequency and SELENIUM SULFIDE (SELSUN BLUE) at a dose of 1 dosage form. At the time of the report, LEPROSY (Patient said it looks like he has leprosy) and PSORIASIS (psoriasis/patient had flare up of psoriasis and rashes all over his scalp) outcome was unknown and BURNING SENSATION (burning), HAEMORRHAGE (Bleeding), SCAB (extreme crust tightening on the scalp.), BLISTER (blister), FEELING ABNORMAL (like someone was pulling on his head), RASH VESICULAR (blistering rash), ERYTHEMA (red marks in the opposite side of the elbow where the hand bends), PRURITUS (itching), RASH ERYTHEMATOUS (Red rash) and VACCINATION SITE PAIN (little sore arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not provided. On 30-Jun-2021, the patient reported that the reaction had subsided with the use of steroidal creams and oils. On 09-Jul-2021, the patient reported that he had had flare up of psoriasis and rashes all over his scalp and mentioned that it looked like he had leprosy. This case was linked to MOD-2021-207737. Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up information received included treatment information and outcome of the event. On 09-Jul-2021: Additional information received included additional event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Immediately after vaccine administered. pt stood up and c/o metalic taste in mouth and tongue/mouth/lips being numb. Remained alert and able to talk. No difficulty breathing. MD called. Monitored. No further complications and patient recovered and numbness went away within 10 minutes. No edema.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 21-JUL-2018, the patient was vaccinated with one dose of improperly stored VARIVAX lot # N035940, expiration date 21-JUL-2018, for prophylaxis (route of administration was not reported). Temperature of storage was reported as: -14 Celsius degrees to -10 Celsius degrees, time frame 1 hour. There was no previous temperature excursion. Digital data logger was involved. No adverse effect reported.
Patient called the pharmacy she had to go to the dr and had and mri done, she was diagnosed with bursitis and tendonosis from dr. She explained that right after her shot the next am she experience intense burning pains.
Information regarding a case in litigation was received from a lawyer, a female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 25-SEP-2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). "Shortly after" receiving the ZOSTAVAX vaccine, the patient suffered a painful rash on her scalp and was diagnosed with shingles. The patient continued to suffer from pain and/or burning sensations in her scalp following the outbreak requiring additional care and treatment. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experienced mental and emotional distress due the resulting physical limitations and the seriousness of the patient's condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of live, physical impairment and injury. As a direct and proximate result of ZOSTAVAX, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the shingles was considered to be not recovered. Shingles was considered to be disabling. Additional information has been requested.
Patient was vaccinated with Pneumococcal pneumonia vaccine at 10:51 AM, patient developed selling and redness in the left upper arm (vaccination site).
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (arm pain for about 3-4 days), migraine headache, back pain (back pain and neck pain, pretty severe), neck pain (back pain and neck pain, pretty severe) and decreased mobility (she couldn't hardly move) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Mar 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced pain in extremity (arm pain for about 3-4 days), migraine headache, back pain (back pain and neck pain, pretty severe), neck pain (back pain and neck pain, pretty severe), decreased mobility (she couldn't hardly move), chills (shivers) and pyrexia (mild temperature at 98). At the time of the report, pain in extremity (arm pain for about 3-4 days), migraine headache, back pain (back pain and neck pain, pretty severe), neck pain (back pain and neck pain, pretty severe), decreased mobility (she couldn't hardly move), chills (shivers) and pyrexia (mild temperature at 98) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant medications and treatment details not reported.
No adverse vaccine event - patient admitted to the adult care unit on 11/4/21 with COVID pneumonia after receiving 2 doses of Moderna vaccine.  Per doctor's admission note  Patient with intermittently increased oxygen needs. Was on 1L at home, appears to be requiring 2L while inpatient.  Also treated for pneumonia in ED, received 1 g ceftriaxone. Given baseline oxygen needs and potential to worsen, will admit for close monitoring of respiratory status. -Remdesivir, X 5 days 11/4-11/8 -Dexamethasone X 10 days 11/4-11/13 -Ceftriaxone/azithromycin X 3 days for community-acquired pneumonia given consolidation in right upper lung -Wean O2 as tolerated back to baseline home needs -Encourage.  Rheumatic heart disease: Stable, not currently active while inpatient
I had server out break of HSV 1  for 10 days ,  low grade fever 99.  and anti-viral  Vancylerver, Tylerol and Advil
spine pain; headache; light headed; Temp of 105; This is a spontaneous report from a contactable consumer, the patient, via the Pfizer-sponsored program. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021, reported as between 16:00-17:00, (at an unspecified age) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 20Jan2021, the patient experienced spine pain, headache, lightheadedness and a temperature of 105 (units not provided). The patient was treated for the events, reportedly he took an ibuprofen (ADVIL) the morning of 21Jan2021 and coffee throughout the day. The clinical outcome of spine pain, headache, lightheadedness and a temperature of 105 was unknown.  Information on the lot/batch number has been requested.
Pt. states that after receiving the 1st dose of High-Dose Influenza vaccine 10/15/2021, started experiencing symptoms 10/165/2021 of fever 101.4, fatigue, and right side of the upper back pain. Symptoms have subsided, No noted Primary visit/communications. (Received Phizer Booster 09/13/2021)
no adverse effect; administered improperly stored vaccine; This spontaneous report was received from a medical assistant referring to refers to a 2-month-old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 30-SEP-2019, the patient was inadvertently administered improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R026541 with expiration date: 11-JUL-2020) (strength, exact dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced a temperature excursion of 51.62 degrees Fahrenheit for 10 hours. It was reported that digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There were no adverse effects reported. No product quality complaint (PQC) was involved.  This is one of the several reports received from the same reporter.
The patient presented to the ED on 3/11/2021 with fatigue for a few weeks, and recent abdomen pain. The patient was found to be hyponatremic and there was also evidence of a CVA on MRI findings.
This is in follow-up to report(s): previously submitted on 7/16/2008. Information has been received from a licensed practical nurse (LPN) concerning an approximately 14 year old female student with stollosis and hypermobility syndrome, drug reactions or allergies who on 19-JUN-2007 was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL vaccine (yeast) (Lot #657737/0522U). On the same day the patient also received secondary suspect  hepatitis A virus vaccine inactivated (MSD) (Lot #657306/0360U). it was previously reported that the patient also received a dose of varicella virus vaccine live (Merck). On 20-JUN-2007 the patient had a fever of 104F. Subsequently the patient recovered from fever. On 20-JUN-2008 the patient was in office for the second dose of GARDASIL vaccine (yeast) and hepatitis V virus vaccine inactiviated. The patient did not seek medical attention. Additional information is not expected.
Injection site was swollen and tender to touch from Thursday until Sunday, then subsided. On Thursday, injection area began to itch. Then large area surrounding site became firm.  No pain. Size approximately that of human palm.
Pt. presented two days after injection with swelling, erythema, warmth and tenderness at injection site. Tx plan: continue BENADRYL, hydrocortisone cream and cool compress, monitor.
Extreme body Aches that lasted 3 days and started about 10 hours after the injection, Milder body aches after that that lasted 6 days, so a total of 9 days.  All my muscles were trembling/twitching, this started 7-8 hours after the vaccine and lasted several hours even after taking Tylenol and Advil.  chills that lasted 3 days, no fever, joint pain that lasted 3 days. Shortness of breath after taking showers, this would last a few hours after and require me to use my rescue inhaler. This would be abnormal for me as I don't normally become short of breath during or after taking a shower.   Arm pain with 2 in x 2 inch swelling just above the injection site.  9 days out and I still have a red , raised  bump at the site of the vaccination. At day 9 post injection, I am still very tired and take several naps everyday. I have not been to work in a week. I normally work 10 hour days with no problems of fatigue. Of note, I did not have any reaction other than mild arm pain at the injection site with the first vaccine that I got on 1/20/2021.
My heart rate got up to 132 beats per minute; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (My heart rate got up to 132 beats per minute) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included Anxiety since an unknown date and Hypertension since an unknown date. Previously administered products included for an unreported indication: TETANUS TOXOID.    On 24-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 24-Mar-2021, the patient experienced HEART RATE INCREASED (My heart rate got up to 132 beats per minute). The patient was treated with ALPRAZOLAM (XANAX) for Anxiety, at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (My heart rate got up to 132 beats per minute) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.  High blood pressure medication for hypertension. Xanax for chronic anxiety disorder     Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: No specific follow-up information recorded.
The evening of the injection right arm swollen, red and painful. Continues to be swollen on 7/2/04.
Patient and patient dad came in for COVID booster. Stated DOB and age 2x to 2 staff members. After found out patient and dad both lied about age to get adult Pfizer booster. Patient previously lied to pharmacy for first two shots, but said "correct" DOB of a year later to us. Thought suspicious but surprised patient lied so well.
May 4th 2015, vaccine was administered to me 5/5/2015 at 4am I woke with pain and swelling over my entire body, some places were worst than other body parts, pain was mostly in my muscles.
Presented with AMS x1 day; + covid in ED: CT with bilat pneumonitis suggestive of covid PNA; Labs: D dimer 5.36; CRP 5.51, Ferritin 980; Tx: Maxipime, Singulair, Zinc; Initially on room air, up to 3 LPM supplemental o2; back to room air by d/c
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender.  The patient's medical history and drug reactions / allergies were not reported. On 05-SEP-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # N012614, expiration date: 16-MAR-2018, for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT) lot # N015478, expiration date: 28-SEP-2019. No adverse events were reported. Administered vaccines experienced a temperature excursion of 17.4F for a time frame of 1 hour and 48 minutes. There was no previous temperature excursion. Data logger was reported as "Yes".  This is one of two cases received from the same reporter.; Sender's Comments: US-009507513-1709USA013482:
Patient was inadvertently given expired vaccine (expired 3-25-22).  Patient was informed of this and then clinic offered to redo the dose.  Patient refused.