chrisvoncsefalvay/vaers-outcomes huggingface dataset:
reports that they believe expired IPOL was administered to a patient with no reported adverse event; Initial information received on 27-Mar-2023 regarding an unsolicited valid  non-serious case received from an other health professional.  This case involves an unknown age and gender patient to whom an expired IPV (VERO) [IPOL] vaccine was administered with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) , concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect IPV (VERO), suspension for injection (lot U1A452M , expiry date: 12-Feb-2023) (With unknown strength, route and at unknown administration site) for prophylactic vaccination (immunization).  On an unknown date reporter reported that that an expired ipol was administered to a patient with no reported adverse event(expired product administered) (same day latency).  No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the guideliens. 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.
allergic reaction; patient did not receive the second dose of the vaccine; traumatized by this event; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (allergic reaction) in a female patient of an unknown age 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 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction) (seriousness criterion hospitalization), PRODUCT DOSE OMISSION ISSUE (patient did not receive the second dose of the vaccine) and EMOTIONAL DISTRESS (traumatized by this event). The patient was treated with EPINEPHRINE for Adverse reaction, at a dose of 5 Epi-Pens. At the time of the report, HYPERSENSITIVITY (allergic reaction) and PRODUCT DOSE OMISSION ISSUE (patient did not receive the second dose of the vaccine) had resolved and EMOTIONAL DISTRESS (traumatized by this event) outcome was unknown.            Concomitant product use was not provided by the reporter.  The father of the patient reported his daughter ended up in the intensive care unit for 2 days on unknown dates. The father stated that while hospitalized, the daughter was treated with  epinephrine "needed 5 epi-pens before it was over with". The father states that his daughter (the patient) was ok now. His daughter was very traumatized by this event and it was difficult for her to talk about it.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This report also refers to a case of product dose omission issue for mRNA-1273, lot # unknown, with no associated AEs.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This report also refers to a case of product dose omission issue for mRNA-1273, lot # unknown, with no associated AEs.
Red area 70 MM across on upper arm.  30 mm area inside larger area is raised somewhat.   Hot to touch.  Burning sensation.   Patient has no fever. No itching.
febrile with severe vomiting, diagnosis was pancreatitis, treatment was/is bland diet with anti-emetics.  symptoms are still recurring.
lump at unspecified injection site; This spontaneous report was received from a nurse practitioner via company representative regarding a 12-year-old female patient. The patient had no pertinent medical history, drug reactions or allergies. The patient did not receive any concomitant medications. On an unknown date, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route, lot # and expiry date) for prevention of human papillomavirus/ prophylaxis. On an unknown date 48 hours after receiving therapy, the patient developed an unspecified "lump" at the unspecified injection site (injection site mass). The patient did not seek medial attention and also did not receive any treatment drugs. There was no cancer or overdose associated. There was no product quality complaint. The outcome of injection site mass was unknown. Causality assessment was not provided.
Raised rash occurred on injection arm from injection site downward to elbow. Rash is clearing and no longer raised as of date of reaction reporting.
15 days post vax pt experienced mild chickenpox with small red papules. The lesions continued to evolve over the next week and the pd had developed over 1000 lesions and vesicles on the trunk, chest, arms, face, legs and scalp by the time of the report. Some of the lesions had begun to scab over. The pt also experienced itching and a fever of 100F.
N/A- Vaccine Administration Error- Patient was given a dose of the Pfizer Bivalent Booster after the BUD.
pt recv vax 2FEB97 & the day p/vax pt noted a hardened area & inflammation @ the inj site;arm was too sore to allow pt to sleep & had reduced ROM in the arm;pt recv cold/hot tx & the sx lessened;
Patient received INLFUENZA injection in her left arm. She is stating she has had continued pain since she received injection.
Following vaccination with two doses of Pfizer COVID-19 vaccine in third trimester of pregnancy (unremarkable pregnancy), baby was diagnosed with stage IV Wilms tumor with lung mets at just 1yr of age, with genetic 1q addition. No family history of pediatric cancer (only thyroid cancer of grandmother). Kidney removed; undergoing chemo/radiation.
Pt devel redness & warmth covering a large area ("size of an orange") @ inject site w/in 48 hrs of receiving Td;
Extreme exhaustion/weakness, headaches almost daily, tingling or hollowness of extremities, muscle pain, fainting/dizziness/ flu like symptoms frequently, labored breathing (hard to take deep breath), blood pressure bottoms out, transient global amnesia.
fever (102.6F), nausea/vomiting, body aches, headache; worst at 18hrs after receiving 2nd dose, resolved roughly 24hrs after onset
Since 2nd shot on 2/15/2021 I have been experiencing worsening sleeplessness.  First it wasn't every night. For the 5 nights I had one night I actually slept well - I took Lunesta. Last night I tried 3mg melatonin- fell asleep but woke up after 2 hrs, read for 3, then "twiliight slept" , maybe actually dosing off a little.  This is very unusual for me. What can I do ? Will my normal routine return?
Face pain especially jaw bones, headache, sharp shooting pain in right abdomen, icy cold, foot cramps, extremely loud and fast heartbeat for about seven hours followed by moderately loud but still very fast heartbeat for several more hours, urination approximately every half hour throughout the night resulting dehydration.
Sore throat/ thought the sore throat was gone through the night but it wasn't; Has felt really sick; Sweats; Congestion; No energy/ up and down all night; Chills; This spontaneous case was reported by a physician assistant and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat/ thought the sore throat was gone through the night but it wasn't), ILLNESS (Has felt really sick), HYPERHIDROSIS (Sweats), NASAL CONGESTION (Congestion) and ASTHENIA (No energy/ up and down all night) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A, 011A21A and 0251202A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Contrast media allergy (CT contrast), Allergy to arthropod sting (Wasps) and Depression. Concomitant products included BUPROPION HYDROBROMIDE (APLENZIN) for Depression, CALCIUM LEVOMEFOLATE (METHYL FOLATE [CALCIUM LEVOMEFOLATE]) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022, the patient experienced OROPHARYNGEAL PAIN (Sore throat/ thought the sore throat was gone through the night but it wasn't), ILLNESS (Has felt really sick), HYPERHIDROSIS (Sweats), NASAL CONGESTION (Congestion), ASTHENIA (No energy/ up and down all night) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat/ thought the sore throat was gone through the night but it wasn't) had not resolved and ILLNESS (Has felt really sick), HYPERHIDROSIS (Sweats), NASAL CONGESTION (Congestion), ASTHENIA (No energy/ up and down all night) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that she was not feeling better at the time of report.
I had a bump in my neck and shoulder for like 2 or 3 years prior to the vaccine. It never bothered me. I had the vaccine on 01/14/2021 and a week later, 01/21/2021 the bump became sore and tender. The bump was removed on 02/04/2021 and it was benign.
Redness, Swelling, and vesicles around injection site of Varicella vaccine (SQ).
had diarrhea badly, 6-7 bowel movements a day; injection site stiffness; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 14Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported, "I received my first dose on Thursday 14Jan2021 and then the next morning I had diarrhea badly, 6-7 bowel movements a day, and injection site stiffness. Should I get the second dose?" Outcome of the events was unknown.   Information on the lot/batch number has been requested.
DVT in left leg, below the knee.  Pain in left calf at the end of July, early August for 3-5 days.  Swelling of left ankle around 9/4-5, strong pain in bottom of foot 9/9 onwards.  Visit to orthopedic surgeon 9/10 in the morning with x-rays done and ordered ultrasounds and MRI Ultrasound performed 9/10 in the afternoon, revealing blood clot, and sent to ER for treatment.  Started Eliquis 9/10 in the evening  Swelling and pain subsided within about one week.  No obvious cause for DVT. Currently undergoing further testing to determine potential cause, while continuing treatment with Eliquis.
Within 24 hours post vax, pt developed an injection site reaction characterized by soreness and swelling.  One week later, he developed a pruritic rash and a burning sensation in his eyes and ears.
Patient received a Johnson & Johnson Covid vaccine 51 minutes passed the 6 hour expiration time. My pharmacy intern had just arrived to work and I handed him the baggie with the vial and the paper which stated the storage information and expiration time written on it directly from the refrigerator. Since I did not look at the paper directly or draw up the dose myself I personally did not realize the vial had expired. Patient has been called and a voicemail has been left with no reply. Patient has not reported any adverse reactions. We have spoken with the manufacture and they stated they have no data from studies on use beyond the 6 hour window. When asked about re-vaccination they stated to use professional judgement.
Uncontrolable shaking, bad headache, blood shot eyes, very fast heartbeat that felt like it was fluttering.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX, subcutaneous (dosing regimen unspecified). No concomitant therapy was reported. On an unknown date after vaccination with a dose of ZOSTAVAX experienced shingles. The outcome of shingles is unknown. Causality assessment was not reported. There was no product quality complaint involved. Additional information has been requested.
Expired dose was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 44-year-old female patient who received HAV (Havrix) (batch number e9g4e, expiry date 29th December 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th February 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 7th February 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022021663  Additional details were provided as follows: The case was reported by the clinical supervisor. The patient was inadvertedley administrated an expired dose of Havrix, which led to expired vaccine used. No further events were reported. The reporter wanted to know if there was information on potential side effects.  The reporter was advised that, they had limited information as there was no data on use of expired vaccines. Provided Medical Information number for the Healthcare professional to contact and obtain more information. The reporter did not consent to follow up. Note: The batch number was captured as per the follow up source document.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022021663:Same reporter.
Information has been received from a consumer concerning a patient who was vaccinated with a dose of PNEUMOVAX 23 (lot #662018/1332X). Subsequently the patient experienced an unknown reaction that resulted in the patient being hospitalized for an unknown length of time (location unspecified). At the time of reporting, the outcome was unknown. The patient sought medical attention via visiting physician going to hospital. No further information is available.
about 3 hours later I had this big knot over from my injection its about 2 inches long and it's like a big roll; this knot came up from the injection site and it's real hot and its real hard and its real red; this knot came up from the injection site and it's real hot and its real hard and its real red; this knot came up from the injection site and it's real hot and its real hard and its real red; This is a spontaneous report from a contactable consumer, the patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 2 via an unspecified route of administration on 17Mar2021 10:30 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), dose 1 via an unspecified route of administration on 24Feb2021 as a single dose for covid-19 immunization. On 17Mar2021, the patient experienced "about 3 hours later I had this big knot over from my injection its about 2 inches long and it's like a big roll it's about happening and it's big rod and this knot came up from the injection site and it's real hot and its real hard and its real red". Outcome of the event was unknown. No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Heavy fatigue, headache, some dizziness,  very sore arm ( swollen. Hot ,red circle surrounding injection site) Symptoms lasted 3 days with the exception of dizziness.
received liquid portion only; received liquid portion only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA660A, expiry date February 2023) for prophylaxis.   On 25th July 2022, the patient received Menveo. On 25th July 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 29-Jul-2022 Reporter's comment: A nurse reported that a patient received the liquid portion of Menveo only. The reporter stated the expiration date was February 2023 (she did not had an exact date). The reporter did not had the patient's details but consented to follow-up via email. Additional supportive information: The patient received the liquid portion of Menveo only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
got a flu shot and still got influenza; Initial information received on 31-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves Adult and unknown gender patient who got a flu shot and still got influenza after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (form, strength, dose, frequency, site, route: unknown, with an unknown batch number and expiry date: unknown) for prophylactic vaccination (Immunisation)  On an unknown date the patient got a flu shot and still got influenza (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Reportedly "Got a flu shot and still got Influenza"   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event
Woke up morning after immunization with sensation of itching. By 11/18/2011 face was swollen, erythematous, itching. Doctor diagnosed allergic reaction. Returned to doctor on 11/21/2011 with full body rash, peeling skin on face and hands. Per patient, doctor diagnosed Stevens-Johnson reaction.
I'm still testing positive on the at-home test; I'm still testing positive on the at-home test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "sleep anxiety" (unspecified if ongoing), notes: sleep anxiety; "Lymphoma" (unspecified if ongoing); "herniated discs" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "reflux" (unspecified if ongoing), notes: reflux; "migrain" (unspecified if ongoing); "penicillin" (unspecified if ongoing); "sulfa" (unspecified if ongoing). Concomitant medication(s) included: PROZAC; NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]; GABAPENTIN; KLONOPIN. Past drug history included: Quinalones/floxacins, reaction(s): "Allergies: Quinolones", notes: known allergies quinalones/floxacins; Floxacin, reaction(s): "Allergies: floxacins", notes: known allergies quinalones/floxacins.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "I'm still testing positive on the at-home test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: I'm still testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Awoke that night needing to throw up and had difficulty walking, a very dangerous situation, felt so ill, fell asleep sitting in chair in bathroom could not get to toilet. Very weak and felt horrible.
rash, roughly 3" x 2"; raised, red, hot to touch, very itchy; appeared almost exactly two weeks after getting first dose of Moderna
Leaving the vaccination site I felt fatigued. About 4.5 hours following the vaccine, I experienced extreme nausea and vomiting, dizziness, cough and stuffy nose.
Pfizer COVID Vaccine Dose 1 given past the recommendation timeframe of 6-hours.   No adverse side effects by the patient after given dose 1.
No adverse event; A dose of Moderna Covid-19 vaccine, Bivalent vaccine was given 2 days beyond BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine, Bivalent vaccine was given 2 days beyond BUD) and NO ADVERSE EVENT (No adverse event) in a 34-year-old 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. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 20-Jan-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. On 20-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine, Bivalent vaccine was given 2 days beyond BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine, Bivalent vaccine was given 2 days beyond BUD) 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 (A dose of Moderna Covid-19 vaccine, Bivalent vaccine was given 2 days beyond BUD).    Concomitant product use was not provided by the reporter.  A dose of Moderna Covid-19 vaccine, Bivalent vaccine was given 2 days beyond BUD.  Treatment information was not provided.