chrisvoncsefalvay/vaers-outcomes huggingface dataset:
seizure; This spontaneous social media report was received from a patient's mother referring a 20-year-old female patient. The patient's pertinent medical history, concurrent conditions, allergies/drug reactions and concomitant medications were not reported. On an unknown date (reported as when the patient was 12-year-old), the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, dosing schedule, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date, immediately after vaccination the patient experienced seizure. The outcome of the event was unknown. The causality assessment between the event and suspect therapy was not reported.  Upon internal review, the event seizure was determined to be medically significant.  This is one of the two reports.; Sender's Comments:  US-009507513-2002USA002370:
She had a fever all night long and the soft spot on her head was very swollen this morning. Difficult breathing also.
Systemic: Dizziness / Lightheadness-Medium, Additional Details: developed syncope, fell over in store
Pt felt jittery, dizzy, shakey and vomited 1 hour post vaccine. Developed itchy throat, itchy skin, erythema and blotching bilat. arms.  Diaphoretic. No resp. Sxs.  Injection site tender warm and edematous.  Pt had also increased her dose of VYVANCE from 30 to 50mg at 10:30 same morning.
Headache, rash, muscle and bone pain, severe foot pain, back pain, burning eyes, and itching. Severe cramp in the feet and legs
Patient stated he had pain in the muscle during after receiving the injection. He thought it was the normal muscle soreness associated with receiving a an injection. It has continued to last for 3 weeks at this time and OTC ibuprofen does not help. He stated the pain was localized to the deltoid and did not radiate down the entire arm. He has not seen a medical doctor at this time.
10 x 11 induration, redness severe pain started in 4 hours more severity in 12 hours. resolving spontaneously 2 days later with slight itch. no systemic symptom no fever
side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (side effects). At the time of the report, ADVERSE REACTION (side effects) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
4X2 WELT AT INJECTION SITE, PAINFUL KNOT AT INJECTION SITE
?Moderna COVID-19 Vaccine EUA Headache, fatigue, chills, weakness, dizziness, fever and R shoulder soreness. Last for about 18 hrs. soreness lasted 3 days
Information has been received from a pharmacist concerning a patient who on 26-MAR-2010 was vaccinated SC with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck). There were no adverse events reported. All telephone attempts to contact the reporter have been unsuccessful. Additional information has been received from a nurse indicated she had the form and would fax it to our company after she filled it out. Follow-up information has been received from a registered nurse concerning the 60 year old female patient with no illness at time of vaccination and LIPITOR allergy caused muscle ache and left breast mass, depression, colonic polyp and skin rash who on 26-MAR-2010 at 09:30 was vaccinated SC into the left deltoid with the first dose of VARIVAX (Merck) (Lot# 665583/1207Y) and vaccinated SC in the right arm with the first dose of ZOSTAVAX (Merck) (Lot# 664444/0722Y) at a community Health Center. The patient had no adverse event. Additional information is not expected.
Six days after pfizer shot #1, I noticed that my little finger and ring finger had no strength on the arm with the shot.  I also had arm. pain since the shot as well on that arm.
Moderna bivalent booster shots to two patients that was stored beyond the storage condition / vaccine was stored 35 days in refrigerator/ vaccine was not disposed after the 30 days storage period in the refrigerator; received the Bivalent booster dose on 17Feb2023; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Moderna bivalent booster shots to two patients that was stored beyond the storage condition / vaccine was stored 35 days in refrigerator/ vaccine was not disposed after the 30 days storage period in the refrigerator), EXPIRED PRODUCT ADMINISTERED (received the Bivalent booster dose on 17Feb2023) and NO ADVERSE EVENT (no adverse event) in an adult 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. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna bivalent booster shots to two patients that was stored beyond the storage condition / vaccine was stored 35 days in refrigerator/ vaccine was not disposed after the 30 days storage period in the refrigerator), EXPIRED PRODUCT ADMINISTERED (received the Bivalent booster dose on 17Feb2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT STORAGE ERROR (Moderna bivalent booster shots to two patients that was stored beyond the storage condition / vaccine was stored 35 days in refrigerator/ vaccine was not disposed after the 30 days storage period in the refrigerator), EXPIRED PRODUCT ADMINISTERED (received the Bivalent booster dose on 17Feb2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (Moderna bivalent booster shots to two patients that was stored beyond the storage condition / vaccine was stored 35 days in refrigerator/ vaccine was not disposed after the 30 days storage period in the refrigerator) and EXPIRED PRODUCT ADMINISTERED (received the Bivalent booster dose on 17Feb2023).    No concomitant medication information was reported. Suspect dosage text was reported as Initial Booster. Pharmacist administered the Moderna bivalent booster shots to two patients that was stored beyond the storage condition. Vaccine was stored 35 days in refrigerator. Pharmacist mentioned that vaccine was not disposed after the 30 days storage period in the refrigerator. No treatment medication information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-711138 ( Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-711138:patient administered on 15Feb2023
Starting 11/4/07 Injection site became red and inflammed, Primary doctor gave her cephalexin 500mg 1qid for ten days
Initial unsolicited report received from a nurse on 22-May-2018. This case involves a patient (age and gender not reported) who was vaccinated with an expired vaccine of MENACTRA (batch number, expiry date: 12-MAR-2018, dose, dose in series, route and site of administration were not reported) on an unknown date. Medical history and concomitant medication not reported. It was a case of actual medication error due to Expired vaccine used. It was unknown whether adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Tiredness/very tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness/very tired) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Tiredness/very tired). At the time of the report, FATIGUE (Tiredness/very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Patient got co-suspect Humira in solution for injection in pre-filled pen.  No concomitant medication was reported by reporter.  Patient got Moderna booster on an unknown date.  The reporter causality for the event with respect to Humira was reasonable possibility.  No treatment medication was reported by reporter.
9/20 at 2:45pm at HCF.  Pt received a Pfizer #1 dose IM Lot Number FD 8448.  The vaccine was mixed at 2:15pm as per protocol.  At 3:05, Pt notified the student volunteer that she was having a itchiness in throat and around face. I arrived.  She explained that she has history of allergy and followed by an allergist. She takes Singular daily  and Benadryl as needed. She has an Epi-Pen and knows how to use.   She drove to herself to the COVID-19 vaccine clinic.  On assessment, no difficulty breathing, no stridor, able to talk with ease.  Escorted (walked) to another area of the clinic for privacy and observation.   Underneath the face mask, the client had a fine red rash in a butterfly shape over the cheeks and slight red in the forehead.  She stated that she was itchy on the tongue, no airway restriction, speech not affected. Based on assessment, I administered 25mg of Benadryl IM followed by 30 minute observation.   Benadryl 25mg administered in right deltoid..  Observed client for signs of increased symptoms. Rash became almost pink in color and faded toward the check line. No signs of distressed, syncope.  At 3:20  client walked outside of clinic area to parking lot to retrieve laptop.  Client spoke to on personal cell phone.   At 3:40 discussed dismissal options and giving an additional 25 mg of Benadryl.  Client elected to go home and contact provider.  Reinforced client to continue taking Benadryl every 6 hours.   Instructed client to see medical attention with primary care provider or urgent care if symptoms persist.  Client left at 3:42.
Lung collapsed due to atelectasis, from a strong immune response. Oxygen sat 83% temperature 103.2. HR 157.
Injection site became red, itchy, firm, and hot a week after vaccine. This lasted 2-3 days then turned into what looks like a bruise without pain.  Faint bruising still there two weeks later.
Red raised rash both arms from elbows to hands 3 hours after H1N1 nasal mist. Resolved by morning. Advised mom if rash returns-give BENADRYL and contact our office.
Treatment of COVID-19; Treatment of COVID-19; Dose Number: 4 Moderna; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 at 17:30 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Jan2021 at 10:00 as dose 1, single (Lot number: EM9899), in left arm, on 26Jan2021 at 10:00 as dose 2, single (Lot number: EL1283), in left arm, on 17Aug2021 at 09:00 as dose 3 (booster), single (Lot number: FC3181), in left arm and on 28Jul2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Dec2021 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "GERD" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "NASH" (unspecified if ongoing); "insomnia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Clindamycin, reaction(s): "Allergy", notes: Known allergies: Clindamycin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Dec2021, outcome "unknown", described as "Dose Number: 4 Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccines to interchange of vaccine products, COVID-19 and drug ineffectiveness cannot be ruled out.
She got her vaccine, she had the initial soreness in the shoulder where she had the shot, which lasted all day.  Then she went to bed, and slept on the left side, so when she woke up he tried to get her up and she told her husband that her legs were not working, could not move her legs.  She went to the doctor after that and nobody explain what had happened to her.  She did not get her booster since they she did not get an explanation from what had happened.   She has improved some, she is able to get up but she cannot walk yet.   She can sit up, and he she cannot walk to the bathroom so her husband has to assist her with that too.  She was able to care for herself prior to the vaccine.  She was doing gardening and things prior to that.   Since being bedridden she has lost about 60-70# since the vaccine from being bedridden.  She has not been able to walk well since the vaccine.  They met with a NP yesterday and they are going to give her home health care to give her PT.
Patient received Pfizer  covid vaccine 1 week early vs the correct 3 weeks in between doses. No none side effects were reported in result of the early administration of the covid vaccine 1 week early.
Confusion, Dizziness, Sedation, Fever & NauseaVomiting Narrative: Employee c/o needing to go home after vaccination due to inability to focus on work. She is clinical pharmacist. She c/o being dizzy,light headed, vertigo,loss of concentration,fever,chills, H.A. and nausea.
COVID 19 Treatment; COVID 19 Treatment; BNT61b2 (dose 1 and dose 2) and Moderna (dose 3 and dose 4 and dose 5); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6199), in left arm and on 26Mar2021 as dose 2, single (Lot number: ER8727) at the age of 57 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Sep2021 as dose 3 (booster), single (Lot number: 048F21A), in left arm, on 18Apr2022 as dose 4 (booster), single (Lot number: 001M21A), in left arm and on 11Oct2022 at 15:00 as dose 5 (booster), single (Lot number: 057F22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "bronchiectasis" (unspecified if ongoing); "constipation" (unspecified if ongoing). Concomitant medication(s) included: TRULANCE, start date: Sep2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Sep2021, outcome "unknown", described as "BNT61b2 (dose 1 and dose 2) and Moderna (dose 3 and dose 4 and dose 5)"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Nov2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: testing positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Anti-viral details, Product=COVID 19 Treatment, brand=Pfizer, Paxlovid, treatment start date=04Nov2022, Treatment stop date=10Nov2022. Patient reported she is on day 11. 02Nov2022 was my first day of symptoms. Although she improved after taking Paxlovid, she have never stopped having symptoms. She continue to sneeze, have extra snot and phlegm, sometimes cough, sometimes ear pressure, and She is still testing positive. Today is the first day her symptoms were a little increased but no new symptoms.
Case number PHEH2015US018176, is an initial spontaneous report from a pharmacist received on 15 Sep 2015. This report refers to a 16 years old female patient. Medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with FLUCELVAX (batch number: 173906) intramuscularly on 14 Sep 2015. No adverse event was reported.
49-year-old patient with history of hypertension, family history of DVT, presents back to the emergency room with complaints of left flank pain. Earlier in the day she was diagnosed with left renal infarct. Patient also has abnormal EKG. Renal infarct?earlier in the day the patient underwent a CT angiogram of the abdomen that showed patent renal arteries. Mechanism appears to be thromboembolic. Cannot rule out in situ thrombosis. We will proceed with a hypercoagulable work-up to include prothrombin gene mutation, protein C, protein S, Antithrombin III, factor V Leiden, lupus anticoagulant, antiphospholipid antibody panel. Patient will be started on anticoagulation with subu Lovenox and daily aspirin 325 mg daily. Symptomatic treatment will be given with IV Dilaudid and Zofran. Hypertension?uncontrolled? we will start Nitropaste Coreg and lisinopril?titrate as needed?monitor creatinine  Abnormal EKG findings?patient reports an episode of severe nausea and chest tightness on Saturday?she could have had a myocardial infarction vs unstable angina that day?wil will proceed with telemetry monitoring and serial troponins. We will check an echocardiogram in the morning. Currently patient does not have chest pain. She has had an exercise stress test in 2018 -but she could not achieve target heart rate.  Patient reports that she has received the COVID 19 vaccine including a booster 1 month ago  History of ashtma? continue daily inhaler?Advair substitution per hospital protocol  History tobacco abuse?she reports that she quit 4 years ago
Patient came to pharmacy to recieve the third in a series of Gardasil Shots.  She confirmed she had no ill responses from her first two shots (I had asked her as I had not given the first two shots).  I administered the vaccination, applied a bandaid to the injection site, and massaged the site briefly.  We stood there for a few minutes, so I could observe the patient, talking about her work.  After a few minutes she started to rub her arm, I asked her if it was bothering her more then the first two shots, and she said yes, that it was stinging a little more then the first two.  Her eyes began to flutter so I grabbed her by her wrists.  She begain to buckle at the knees and was falling towards the counter.  I caught her head with my forearms, then she went completly limp.  She then went backwards as she landed in a sitting position.  i tried to lay her out softly but lost my grip, falling the rest of the way and hitting the back of her head on the floor.  We raised her feet and called 911.  She had normal breaths and pulse until emergancy help arrived a few minutes later.  She came to and was coherent shortly after she had passed out.
Patient received immunization. A few minutes after, had lightheadedness and arm soreness/tingling. She stayed for the full thirty minutes and had no further problems. Blood pressure was within normal limits. When patient returned with boyfriend for his second COVID-19 shot 3 weeks later on 11/5/2021, she said she had lingering effects starting the day after administration including severe vertigo, occasional shortness of breath and intermittent numbness of extremities. When reported, patient said she went to the ER on 10/16/2021 for the vertigo but decided against it because of the wait. 'Rest was the only thing that would help anyway.' When patient was called 11/9/2021, she confirmed no chance of pregnancy and continued episodes of shortness of breath but unknown if due to asthma (patient has no primary care provider).
Vomited < 15min post receiving MMR, then developed allergic rash on trunk, face, neck, gave Benadryl and observed for approximately 1 hr, rash disappeared.
Started with slight tingling feeling in my fingers. Then I became tired and starting shivering aggressively. Then got the chills pretty bad as I laid down to go to bed. Became really sore all over.  Couldn?t stay asleep for more than an hour. Later in the night I started sweating and felt really hot. Also became quite thirsty. During the entire night I also had horrible dreams. After about 5am things started improving. Had some light sensitivity in the morning for a shot bit. By noon I was almost back to 100%
Itchiness on forehead and feet; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer.), for Covid-19 Immunization. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "Itchiness on forehead and feet".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial misuse report received from healthcare professional on 21 October 2013. The cases were received on 21 March 2014. The patient received intramuscular dose of FLUZONE but most amount of vaccine ran down (no further information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Fainted, convulsed, woke up incoherent and threw up repeatedly. Occured approximately 15 minutes after receiving vaccine.
Pt reported headache and dizziness after vaccines were administered.  Pt was advised to sit down for 15 minutes.  Pts BP was taken  and pt was given a Pedialyte Popsicle .  After 15 minutes pt reported feeling better and BP was taken again.  Pt able to ambulate safely and without assistance. Nurse walked pt to Clinic front door to make sure pt was okay .
Approximately a few days after shot was given a red bump appeared on arm. It was slightly raised and mildly itchy. It scabbed over. Wore off then returned. It is still there 3 weeks after vaccine
12 hours after second dose experience of severe chills, fatigue, night sweats, nausea lasted for over 28 hours.
T 101.2, runny nose-blood tinged, rash around eyes, back, stomach macular-papular rash, trunk and neck blanches.