chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Administered vaccine after the 30 day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jan-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered vaccine after the 30 day beyond use date).    This case contains information for the 3rd of 4 child patients described by the reporter. No concomitant information was reported. No symptoms reported. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704265 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704265:Master case - 1st adult
Flu vaccine administered 9/16 - Subseq. Acute pain for 1 week at inj. site. Thereafter worsening pain in (L) arm and limited R.O.M. Misdiagnosed by family Dr. and properly diagnosed by Orth. surgeon after x-ray and MRI. -Cortisone inj. and PT.
Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.
This spontaneous report as received from Register Nurse refers to unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with M-M-R II (dose, strength, frequency and lot number were not reported), which on 27-FEB-2015 were exposed to a temperature excursion of 50.0 degrees F for 48 minutes. No adverse experience were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a LPN concerning a 12 month old white female with eczema and no known allergies or other medical history who on 10/22/03 at 10:30AM was vaccinated in the right arm with a first dose of varicella virus vaccine live (Lot # 645579/0440N). Concomitant therapy that day at 10:30AM included a first dose of MMRII (Lot # 641627/0666N) administered in the left thigh, a dose of Prevnar (Batch # 493266) administered in the left thigh, and a first dose of Fluzone (Batch # L11097AA) administered in the right thigh. On 10/29/03 the pt developed a rash with blisters on her legs, arms and abdomen. Some of the blistered were raised. The child was also noted to have a low grade fever. The outcome was reported as recovered. There were no relevant diagnostic tests or lab data. The reporter also reported another pt's adverse experience (WAES # 0311USA01477).  No further information is expected.
Symptoms:  Still experiencing swollen and tender lymph nodes on/around neck/collar bone area after two months, either side or both at a time.  Mild fever, sore throat, loss of appetite, fatigue, irritability, and headaches.
Ten days of fever within two weeks of vaccine associated with antibiotic treatment for Rapid Strep + test and an intermittent/wandering macular/follicular rash. Pediatric ID rec. VAERS report.
pt recvd vax;noticed decline in ability beginning w/ period p/ flu shot;petechia on legs,large bruises,cont nasal blood seepage;ITP dx mar94;5 hospitalizations w/ steroids gamma immune,decadrone P tx;platelet count responsive to decadrone;
None stated. Medical Records received on 12/07/2004 states cardiopulmonary arrest and hyperglycemia. 12/14/04 Autopsy report received states COD as cardiorespiratory failure & acute bilateral pneumonitis.
A report was received from a health care professional on 11/24/03 concerning a 37 year old female vaccinee who was inadvertently administered frozen Fluvirin vaccine on an unspecified date. On an unknown date, the vaccinee inadvertently received Fluvirin, which had been left adjacent to a freezer compartment and was subsequently frozen. The vaccinee will be advised to receive Fluvirin again in 3 weeks time. It was not reported if the vaccinee had experienced any adverse reaction. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Patient noted on 5/13/14 arm soreness with movement - (L) upper arm. Then noted red and tender nodule under the skin. Punctuate at (L) deltoid noted. Exam on 5/15/14 revealed sl red, tender, well circumscribed nodule. Recommended warm compresses and treated with AUGMENTIN 875 twice a day for 10 days.
Spot is red; Spot is itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Spot is red) and PRURITUS (Spot is itchy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 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 ERYTHEMA (Spot is red) and PRURITUS (Spot is itchy). At the time of the report, ERYTHEMA (Spot is red) and PRURITUS (Spot is itchy) outcome was unknown.
Information has been received from a registered nurse concerning a 30 year old female patient with no pertinent medical history and no drug allergies who on 20-APR-2011, was vaccinated with a dose of MUMPSVAX (route not reported) (lot number 659616/0188X, Exp. January 2010) expirated. There was a mix of medication in a carton of MMR II. 10x10 carton of MMR II contained one vial of MUMPSVAX. The MUMPSVAX vial had a teal color, the MMR II was very similar, almost exactly the same. The nurse reported that the patient who received the vaccine had not been checked on status and to made her aware of this issue. The patient did not seek medical attention. There was no treatment for the event and no laboratories were performed. At the time of the report the outcome of the patient was unknown. Product quality complaint was involved. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received SHINGRIX. Concomitant products included Aspirin, Atorvastatin, lisinopril and Metformin. On 15th February 2018, the patient received the 1st dose of SHINGRIX. On 15th February 2018, 4 hrs after receiving SHINGRIX, the patient experienced injection site pain, general body pain and influenza. The patient was treated with ADVIL. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the general body pain was recovering/resolving and the outcome of the influenza was unknown. The reporter considered the injection site pain and general body pain to be related to SHINGRIX. It was unknown if the reporter considered the influenza to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine at approximately 2:00 pm in left arm. Four to 5 hours later the patient felt injection site soreness and took ADVIL. The patient woke up at 5:00 am with total body aches. He said he felt like he had the flu. He thought the body aches presented while he was sleeping and were so bad by 5:00 am that it woke him up. He took ADVIL. He felt much better now than he did this morning.
Initial unsolicited report received from a nurse on 2 June 2016. This case involves a four-year-old male patient who was vaccinated with fifth dose of DAPTACEL (batch number: C4756AA, expiration date: 11 June 2017, dose and route not reported) in the right arm, fourth dose of (IPOL) (batch number: L1442-1, expiration date: 15 September 2017, dose and route not reported) in the right arm and second dose of PROQUAD (Manufacturer: Merck, batch number: M002053, expiration date, dose and route not reported) in the left arm on 31 May 2016. Patients Illness at time of vaccination was reported as Sick for 3 days before well check up, temperature of 100 with red eyes and nasal congestion. Pre-existing physician diagnosed allergies, birth defects, medical conditions was not provided. Any other vaccinations within 4 weeks of vaccinations was reported as none. Concomitant medication was not reported. On 31 May 2016 in the night, same day post vaccination, the patient had fever (104 degree Celsius). On 01 June 2016, one day post vaccination, the patient had right eye redness with discharge. On an unspecified date, post vaccination, the patient experienced right arm swollen and red, warm to touch, measured 6X8mm. It was reported that patient was not tested for cellulitis. The patient required ER or doctor visit. Laboratory data was not reported. The patient received corrective treatment with Augmentin preventatively for both arm. On an unspecified date, the patient was recovered from the events. List of documents held by sender: none.
ON CALL NOTE 5:45 pm. Patients reports fever to 101.5, headache, stiff neck, severe arm pain over the past few hours. She received Tdap vaccine yesterday. I advised ER evaluation for above symptoms and fever.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 76-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020). On 7th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 7th May 2018, several hours after receiving SHINGRIX, the patient experienced injection site rash, headache, injection site pain, injection site swelling and nausea. The patient was treated with NORCO. On an unknown date, the outcome of the injection site rash was not recovered/not resolved and the outcome of the headache, injection site pain, injection site swelling and nausea were recovered/resolved. The reporter considered the injection site rash, headache, injection site pain, injection site swelling and nausea to be possibly related to SHINGRIX. Additional details were provided as follows: The health care professional reported that the patient experienced rash, bumps, and swelling 1 and 1/2 inches below the injection site after receiving SHINGRIX. The patient also experienced headache, nausea, and pain where the rash was located and there was swelling at the injection site. The patient started to experience these effects a few hours after receiving the dose of SHINGRIX. The patient did not have a doctor visit but did take NORCO for the pain because it was so bad. Most of the adverse affects had resolved except the rash and bumps below the injection site.
burning throat, coughing up phlem, nasal congestion, watering eyes over about 5 days;
Little tingling in the front of my palm; Metal taste in my mouth; My whole arm on my left and stuff is whole sore; Little nauseous; Frustrating; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported he/she had the vaccine yesterday and wanted to know if the symptoms were of allergic reactions or if it's normal. Patient would like to know he/she should get the second shot. The patient experienced a little tingling in the front of his/her palm, metal taste in mouth, his/her whole arm on my left and stuff was whole sore, and little nauseous on an unspecified date. He/she asked if they got to hear the side effects as it was so frustrating. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Cough, roughly 2 weeks, Muscle spasms/cramps, 1 week. Tylenol taken to relieve pain. Stomach flu, 1 week, immediately after the cramps subsided, Imodium and BRAT diet. UTI, 1 week, due to dehydration from the stomach flu, 5 days of Bactrim (antibiotic).
The vaccinee was not immunocompromised. On an unspecified date, the vaccinee received a 3rd dose of Engerix-B (lot ENG5213A2; expiry 11/23/02). At that time, the vaccinee received 2 injections of the 10 mcg pediatric formulation to provide the adult dose of 20 mcg. Subsequently, the vaccinee's antibody titer against Hep-B surface antigen (HBsAg) was found to be "too low". As of 4/4/02, the outcome of the event was unknown.
Headache, Muscle Ache, Sore in the arm, mild fever. Took Tylenol to control fever.
Had Flu Quadrivalent MDV .5 ml (L) upper arm on 10/3/15 - on day 3 after vaccine his (L) arm was swollen, itchy and warm to touch, mild redness of skin.
Fever 101; Chills; Diarrhea; Vomiting; Dizzy; Weak; Muscle aches; Injection redness; Injection hot to touch; Injection soreness; Exhaustion; Headache; .Profuse sweating; Lack of hunger; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old, non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Jun2021 at 10:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications within two weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 18May2021 at 12:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 06Jun2021 at 10:00, the patient experienced fever 101, chills, diarrhea, vomiting, dizzy, weak, muscle aches, injection redness, injection hot to touch, injection soreness, exhaustion, headache, profuse sweating and lack of hunger. On the same day, the patient underwent body temperature test and the result was 101 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were 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 fever 101, chills, diarrhea, vomiting, dizzy, weak, muscle aches, injection redness, injection hot to touch, injection soreness, exhaustion, headache, profuse sweating and lack of hunger were not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Day 1: redness at injection site. Day 2: awoke with bad headache, fatigue, aches. Took 400 Motrin po. That evening, had chills, sweating. Day 3: night chills and sweating again. Day 5: noticed large red patches (non-tender, non-pruritic) on upper left arm. Day 6: came to clinic. Patches measure 14cm x 10 cm,and 10cm x 7 cm on upper left arm. No adenopathy.
3 hours after covid injection patient presented with significant swelling in armpit and lymph nodes on side of administration and significant pain in all lymph nodes.  Patient felt symptoms improve gradually except for the left armpit swelling.  Patient called in sick to work the next day due to arm discomfort and brain fog.  Physician said the swelling can take a week or so to go down.  Patient advised to take Naproxen and Acetaminophen around the clock.
Information has been received from a medical assistant concerning a 5 year old caucasian female with environmental allergies who on 10/03/97 was vaccinated with the first dose of Varivax SC in the right arm. The patient at the time of vaccination was seen in the doctor's office with a rash on buttocks. On 02/19/02 at 11:15 am the patient developed a varicella-like rash. The patient had a rash on her back and legs to following exposure to chicken pox two weeks prior. On 02/22/02 it was reported that it has been 3 days since the patient was seen and there had been no calls received with complications, to date. It was noted that the patient was not hospitalized and that she did not have an adverse event following prior vaccinations. Additional information has been requested.
Hives and itching under arms, on upper and lower arms, hands, on back and buttocks, starting roughly 24 hours after. Has mostly subsided by 12/3/2021, but slight symptoms have continued to this point . Hives have mostly faded but are still slightly present but itching is more infrequent.
Extreme pain in left side of back below ribs, prescribed a pain medication Myalgia swelling in feet and legs bleeding in left eye conjunctiva hemorrhage I was tested by blood urine and CT of Aorta and nothing was found to be the cause of the pain or bleeding except the blood pressure was elevated.  I told Doctor I had the covid shot and began experiencing the symptoms the next day.  I took all my medications and did not have a problem with the pressure.  She could find no physical outside of covid cause and sent me home the next morning.Symptoms began 3/27/21 and I was in the ER by 6pm on 3/29/21 and stayed until 3/30/21.
Elbow and breast she is still experiencing cellulitis in these areas; Experienced a fever of 101 degrees fahrenheit; This spontaneous case was reported by a health care professional and describes the occurrence of CELLULITIS (Elbow and breast she is still experiencing cellulitis in these areas) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PREDNISONE for an unknown indication.   On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CELLULITIS (Elbow and breast she is still experiencing cellulitis in these areas) (seriousness criterion medically significant) and PYREXIA (Experienced a fever of 101 degrees fahrenheit). At the time of the report, CELLULITIS (Elbow and breast she is still experiencing cellulitis in these areas) and PYREXIA (Experienced a fever of 101 degrees fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 101 (Inconclusive) 101 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment for the event included the patient went through two rounds of antibiotic treatment. On 20 Apr 2021, the patient was started on prednisone.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  Company comment: 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.  However, Further information has been requested.   This case was linked to US-MODERNATX, INC.-MOD-2021-081503, US-MODERNATX, INC.-MOD-2021-081647 (Linked Report).; 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.  However, Further information has been requested. US-MODERNATX, INC.-MOD-2021-081503: US-MODERNATX, INC.-MOD-2021-081647:
Headache, Myalgia,  chills, fatigue Narrative:  Other Relevant History:
Slight fever; tiredness; loss of appetite; muscle aches 24 hours after vaccine; symptoms lasted 2 days
Information has been received from a lawyer regarding a case in litigation concerning an approximately 85 year old male. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On and unknown date in 2015, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). In March 2017, the patient was treated by a health care provider for the following injury resulting from his use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to himself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
vesicular rash, which was diagnosed as severe herpes zoster or shingles; The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age or gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided.   In 2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, strength, administration route, anatomical location, lot number and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles at a clinic.The reporter stated that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2015, the patient was treated in a health center, for the onset of a vesicular rash, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles. The patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages.