chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; 14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15-MAY-2023 to 10-JUN-2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15-MAY-2023 to 10-JUN-2023.) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15-MAY-2023 to 10-JUN-2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15-MAY-2023 to 10-JUN-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15-MAY-2023 to 10-JUN-2023.).    Concomitant medication was not provided. Suspect product dosage text was reported as unknown. It was reported that 14 doses of the Moderna COVID-19 vaccines were administered after the 30 day BUD between 15-MAY-2023 to 10-JUN-2023. Treatment information was not reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-732456 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732456:Master case
Headache, Sedation, Myalgia, Arthralgia, Fever, chills and fatigue. pain at injection site Narrative:
Patient's (R) arm started itching around 1200. At 1500, patient came to clinic with small hives on bilateral arms, chest and back. Patient had taken 50mg BENADRYL at 1430. Patient was given 0.3mg Epi 1:1000 IM (R) thigh. Patient observed for 30 minutes, itching stopped, redness receded, hives decreased. Patient left clinic. Patient does receive allergy injections weekly.
Symptoms started approximately 6 hours after injection. Felt chills, night sweats, headache, body ache.
15 days after injection, arm became swollen, itchy, and had a rash.  Fingers also exhibited same symptoms on both hands.  This is the second day of the reaction, so I do not know how long it will last. Symptoms have neither improved or worsened in the past 48 hours.
Excessive amniotic fluid, polyhydramnios. Resolved on it's own. Delivery 01/24/2022, Birth weight: 6lb 15oz.
7YR OLD WAS MISTAKENLY GIVEN A HPV VACCINE, NO AFTER SYMPTOMS
The patient initially weaned off the ventilator but then developed an episode of sepsis and never was able to tolerate significant weaning subsequently.  He had an event desaturation on trach collar on 05/17.  Chest x-ray showed mucus plugging left lung.  Despite aggressive percussive therapy, he left lung remained atelectatic.  Bronchoscopy was performed the morning of 5/18.  The mucus plug was removed and he had temporary improvement in his oxygenation.  However he became profoundly hypotensive requiring pressor therapy.  Multiple attempts were made to obtain labs without success.  Broad-spectrum antibiotics were initiated.  Discussions were held with his parents and siblings.  They understood his severity of illness and elected to change his code status to DNR/active.  He he became pulseless despite maximal ventilator support and pressor therapy and expired with family present.
This spontaneous report as received from a registered nurse referring to multiple patients of unknown age and gender. No pertinent medical history, concurrent conditions or drug allergies were reported. On unspecified dates, multiple unspecified patients received improperly stored VAQTA lot # M003011, expiry date : 15-NOV-2017 (dosing details not reported). No concomitant medications were reported. No adverse effects were reported. Temperature/time frame: 30.2 F for 56.47 hours. There was no previous temperature excursion. The call was due to data logger. There was no product quality complaint reported. This is one of the three reports from the same reporter source (1701USA003860 and 1701USA003747). Additional information has been requested. Sender's Comments: US-009507513-1701USA003747: US-009507513-1701USA003860.
90% of the vaccine leaked onto arm/ Did not get a full second dose; A spontaneous report was received from a  Consumer concerning a 28-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 90% of the vaccine leaked onto arm/ Did not get a full second dose (incomplete dose administered).    The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14Jan2021 the patient received first dose of the Moderna Covid-19 vaccine (2:30PM). It was administered on her left arm prophylaxis of COVID-19 infection with unknown dose and route of administration. Lot number 011L20A, unknown expiration date.  On 11Feb2021, the patient had her 2nd dose of the Moderna Covid-19 vaccine (3:00PM) at a local hospital. She had it on her left arm with unknown route of administration. Lot number 0B2L20A, expiration date was unknown.  During the administration of the 2nd dose, the 90% of the vaccine leaked on to her arm.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event was resolved on 11 Feb 2021.; Reporter's Comments: This is a case of 28-year-old female patient who was administered second dose of mRNA-1273 vaccine and experienced 90% of the vaccine leaked on to arm (incomplete dose administered) Lot #: 11L20A. There was no associated adverse event reported for the event of incomplete dose administered.
PATIENT CAME IN FOR A BIVALENT DOSE AND WAS INADVERTANTLY GIVEN A MONOVALENT DOSE. PATIENT WAS ADVISED TO WAIT TWO MONTHS AND RETURN FOR THE BIVALENT DOSE.
Left part of her face started to feel "numbish"; Red, hot, and itchy at the injection site; Red, hot, and itchy at the injection site; Red, hot, and itchy at the injection site; Tiredness; Swelling/Arm became swollen; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), VACCINATION SITE SWELLING (Swelling/Arm became swollen), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE ERYTHEMA (Red, hot, and itchy at the injection site) and VACCINATION SITE WARMTH (Red, hot, and itchy at the injection site) in a 46-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.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced FATIGUE (Tiredness), VACCINATION SITE SWELLING (Swelling/Arm became swollen) and VACCINATION SITE PAIN (Pain at the injection site). On 07-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red, hot, and itchy at the injection site), VACCINATION SITE WARMTH (Red, hot, and itchy at the injection site) and VACCINATION SITE PRURITUS (Red, hot, and itchy at the injection site). On 15-Jan-2021, the patient experienced HYPOAESTHESIA (Left part of her face started to feel "numbish"). At the time of the report, FATIGUE (Tiredness), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE ERYTHEMA (Red, hot, and itchy at the injection site), VACCINATION SITE WARMTH (Red, hot, and itchy at the injection site) and VACCINATION SITE PRURITUS (Red, hot, and itchy at the injection site) outcome was unknown, VACCINATION SITE SWELLING (Swelling/Arm became swollen) had resolved and HYPOAESTHESIA (Left part of her face started to feel "numbish") was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  Treatment medication included antibiotics for 5 days.
On 7/2/99, post vax, she experienced joint swelling and increased arthritic pain. Her knees and hands became swollen and she had difficulty walking due to pain. Also, she could not move her right hand which was very swollen. On 7/9/99, she misjudged a step and fell on a sidewalk skinning her hand, knees, and elbow.
Pt was administered expired Pfizer vaccine. Initial manufacturer's expiration date was 09/30/21, expiration date based on vaccine's transport date from freezer to refrigerator was 07/03/21. Vaccine was administered after this date on 07/06/21. Pt did not have an adverse reaction to vaccine in clinic.
Reproducible persistent arthralgias after the anthrax vaccine 1 and 3.
No additional AE reported.; a 25 year old female patient was administered PROQUAD on 22JUL2022.; This spontaneous report was received from nurse via company representative and refers to a 25-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-JUL-2022, 25-year-old female patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (albumin status, strength, dose. lot #, expiry date, route of administration, and anatomical location were not provided) for prophylaxis (product administered to patient of inappropriate age). No additional information provided.
PT PRESENTED TO ER WITH INCONSOLABLE CRYING AND VOMITING, LOSS OF APPETITE, DECREASED URINE OUTPUT, FEVER AND MUCOID BLOODY STOOL IN ER. WAS HAVING COUGH CONGESTION FOR 3 DAYS. ULTRASOUND DONE SUGGESTED INTUSUSSCEPTION. CONTRAST ENEMA WAS DONE.
Pt presented at Pharmacy on )5/28/2021 with for Astra Zenica vaccine given 1st dose 04/07/2021 Lot # NA0079 received Pfizer shot and wished to complete Pfizer series for cross border travel which he did on 06/24/2021 lot # EW0181 .... Pt reported Rheumatoid arthritis flareup on both thumbs and severely painful Trigger finger post 1st and 2nd Pfizer shots on 8/21/2021
t102;head & chest congestion;green tinged mucous;SOB;chills;
T6 transverse myelitis. Patient developed thoracic banding pain and left lower extremity numbness and weakness on 9/17/22, 6 days after getting Pfizer vaccine on 9/11. Imaging showed spinal cord edema consistent with transverse myelitis.
Patient received 1st dose of Moderna at age 16 through a clinic provider office.  No adverse outcome. No side effects.  Patient missed her 2nd dose appointment and called the clinic main Vaccine Clinic to reschedule.  Case discussed with clinic CMO and per CDC guidelines patient will be offered 2nd dose of Moderna to complete series.  Will be considered as off label use. Patient will be counselled on events prior to 2nd dose administration.
Left thigh swelled to size of softball, really red, warm to touch that lasted 4 days before swelling started to go down.
NO redness; 1st dose gave just sore arm; This spontaneous case was reported by a consumer and describes the occurrence of NO ADVERSE EVENT (NO redness) and VACCINATION SITE PAIN (1st dose gave just sore arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L2/(Z)0/(O)A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE PAIN (1st dose gave just sore arm). On an unknown date, the patient experienced NO ADVERSE EVENT (NO redness). On 18-Jan-2021, VACCINATION SITE PAIN (1st dose gave just sore arm) had resolved. At the time of the report, NO ADVERSE EVENT (NO redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.   This case was linked to MOD-2021-057481 (Patient Link).
Headache & Myalgia Narrative: day 1 and 2- pain/ discomfort injection site day 1: ha ; chills; day 2 - fatigue ; ha ;
The day of the vaccine, no symptoms Day 2: fever, chills, and soreness in arm upon waking.  By noon I had more pain and redness in the right upper arm.  Took Aleve for pain Day 3: Woke up in more pain, redness on my right upper arm was now bigger and raised up with defined edges.  Wrapped from the front of the arm to the back. Went to the ED after discussing my symptoms with a 24 Hours RN Hotline.  I had a huge hived area. Was given Dexamethasone and Tylenol and sent home to rest. Day 4  Arm still redden and sore.  Pain is resolving.  Will follow up with Primary Monday or Tuesday
Ongoing hospitalization began 9/18 with generalized weakness and myalgias. Given fluids, antibiotics,oxygen 2 L
Seconds after the shot was administered the right side of my face felt numb and as seconds passed it felt as though the right side of my face was drooping (think Bells Palsy).  My "shot buddy" was there and I asked her if my face was drooping and she said yes.  The symptoms slowly decreased but to this day I still can feel the muscles in that area of my face pulling downward.
Patient called the pharmacy with complaints of a burning sensation in the arm that has lasted for over a week.  She also mentioned redness that has progressed to the underarm area.
Got covid after first dose of the covid-19 vaccine; Got covid after first dose of the covid-19 vaccine; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: CN6200), via an unspecified route of administration on 03Mar2021 as single dose for COVID-19 immunisation. Medical history included diabetes mellitus from 2016 and ongoing. The patient's concomitant medications were not reported. On 11Mar2021, the patient experienced got covid after first dose of the COVID-19 vaccine. The patient states she was due for her second dose of Pfizer COVID-19 vaccine on 24Mar2021 and wants to know if she should get the second dose even though she has antibodies now, has not gotten second dose scheduled for 24Mar2021. The patient states symptoms started on 11Mar2021 and she tested positive on 15Mar2021. She clarified that she only had one test, then she stated she had a rapid test and the 3 day test and the rapid was negative and the 3 day test was positive. She states only cough medicine but that was it. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Mild soreness at injection site, continuing more than 24 hours. It does not interfere with my functioning. Pain rating is 1/10 (with 10 being severe).
The area are red and a little edema in the area of the left deltoid. The patient was oriented about how manage the area when vaccine was adminsitered to put ice in the area. Prescription was given and patient as evaluated by the doctor.
Coagulopathy, prescription medication Presents to the vascular clinic on 8/13/21, as referred by Dr., for evaluation of aortic thrombus after receiving the Moderna COVID vaccine. Patient reports being "pretty healthy" prior to this recent reaction to the COVID vaccine, with a past medical history of HTN, HLD, and BPH. He is a worker and has a history of being very active; he has never had any lower extremity claudication, rest pain, or swelling in the past. Patient received the Moderna COVID vaccine on 1/11/21, and reports having leg weakness 2 days later, and by the 3rd day, he could not get out of bed and had difficulty walking. He had bilateral lower extremity pain (L>R)  With left leg swelling, and shortly afterward was diagnosed with a left ilio-femoral deep vein thrombosis, which was treated with Eliquis therapy for 3 months and compression socks. The Eliquis is now discontinued and the left leg swelling has resolved, however the patient continues to have bilateral lower extremity weakness, and aortic thrombus was suspected. Patient was ordered to have a CTA chest and arterial doppler studies with a hypercoagulable work-up. Imaging studies demonstrated bilateral ABI of 0.3 (previously palpable pedal pulses), and CTA demonstrates a mass-like consolidation at the right lower lobe with intraluminal filling defect of the pulmonary artery branch, and thrombus formation of the proximal abdominal aorta. Since receiving the first Moderna COVID vaccine, patient has developed left ilio-femoral DVT, aortic thrombus, and possible pulmonary embolism. He was advised against receiving the second dose. Today, Patient ambulates with a cane, and has severe bilateral lower extremity claudication. He is unable to be active as a worker since receiving the vaccine.
5 days following the HPV vaccine patient experienced skin irritation on face, neck, and back. Pt. went to emergency room 4/12/07 and treated for allergic reaction with prednisone and benadryl.  Pt. did not fill prescription and rash became worse so pt. came to doctor's office 4/13/07 and prescribed longer course of prednisone over 10 days and benadryl.  At 4/13/07 visit, pt. had wheals over neck, back, bilateral cheeks, forehead and facial swelling. Pt. has been recommended to not receive further doses of HPV vaccine.
SWELLING AT INJECTION SITE SPREADING TO WRIST AND HAND.  LOW GRADE FEVER PAINFUL AREA.  PRESCRIBED TWO (2) ANTIBACTERIALS. CEPHALEXIN 500MG & SMZ/TMP DS 800-160MG FOR 10 DAYS.
Symptoms started on 4/29  Diarrhea. 4/30 - congestion and sore throat. 5/2- Body aches, lethargy, and chills. All symptoms lasted until 5/8, except diarrhea which persists.
This case was reported in a literature article and described the occurrence of anaphylaxis in a 14-year-old female subject who received Flu seasonal TIV Dresden. This cases refers to patient 11 in the literature article. Concurrent medical conditions included asthma. Historical conditions included allergic conjunctivitis and rhinitis. On an unknown date, 2 hrs after receiving Flu seasonal TIV Dresden, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included wheezing and vomiting. The subject was treated with antihistamine and Bronchodilator. The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included wheezing (recovered/resolved) and vomiting (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, wheezing and vomiting may have been caused by Flu seasonal TIV Dresden. Additional information was provided: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 14-year-old female patient who had received an unspecified trivalent influenza vaccine (manufacturer unknown). The patient was a female. The subject's medical history included atopic disease with asthma and allergic conjunctivitis and rhinitis. No further information on the patient's concurrent medical conditions, medical or family history, or concomitant medication was provided.  On an unspecified date, between the 1st of January of 2009 and the 31st of December of 2011, the patient received an unspecified dose of an unspecified trivalent influenza vaccine (dosage unknown; administration route and site unspecified; batch number not provided). On an unspecified date, 2 hours after the vaccination, the patient developed wheeze and vomiting. This was classified as anaphylaxis by the paediatrician. According to the authors the case was considered as Brighton level 2 and setting of initial evaluation was clinic. The patient was treated by oral antihistamine and bronchodilators. At the time of reporting the outcome of the events was recovered. This event was classified as vaccine related according to the authors. The authors concluded that "Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case is 1 of the 28 valid cases reported in the same literature article.
Patient presented to ED after her GI specialist referred her for an abnormal hgb level. Patient reported fatigue for past several days but denied any abdominal symptoms or symptoms of bleeding. In the ED, patient's hgb was found to be 5.2. Pt received blood transfusion and was treated with protonix. She underwent an endoscopy and a colonoscopy. Pt was discharged to follow up with GI and PCP
Case number PHEH2014US007348, is an initial spontaneous report received from a consumer on 10 APR 2014, with a follow-up received from consumer on 29 APR 2014. This report refers to a 14-year-old female patient. Her medical history and concomitant medications were not reported. It was reported that this patient under 18-years of age was inadvertently administered a dose of FLUCELVAX (batch number: not reported) on an unknown date. She neither did not see any pediatrician nor follow up for the treatment of the FLUCELVAX she received. She did not exhibit any side effects or symptoms following the maladministration (inappropriate age at vaccine administration).   Follow up received from consumer on 29 APR 2014. Updated reporter comment (she neither did not see any pediatrician nor follow up for the treatment of the flu shot she received. She did not exhibit any side effects or symptoms following the maladministration).   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 29 APR 2014. Th BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
SIDE EFFECTS; This spontaneous report received from a patient via a company representative from social media  concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
Within 48 hours patient had hives, irritability, vomiting & difficulty breathing.  Was taken to ER.  Kept for observation & breathing challenges for 8 hrs.
On 08/10/2000 or 08/11/2000 patient developed chicken pox on genitals, legs and arms which was described as an itchy rash with an unknown number of lesions. The patient sought unspecified medical attention. On 08/21/2000 the patient recovered. Also reported was the patient's sibling who was vaccinated and received similar events. Follow up information from a RN reported that in an unspecified date the patient recovered. No further information is available.
Mother stated patient had an increase in seizure activity after administration (pt has hx of seizures) mother just notified clinic today (6/21/14).