chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 73 years old female patient who didn't get the full dose as she had a hard time getting the needle on the syringe and if fell off during injection, while she received vaccine TYPHIM VI. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-Aug-2018, the patient received a single dose of suspect TYPHIM VI lot NIK81, expiry date- 19-Oct-2019 via unknown route in unknown administration site. It was a case of actual medication error due to vaccine underdose and syringe issue. (Other relevant tests included no lab data.) Final diagnosis was she had a hard time getting the needle on the syringe and if fell off during injection and the patient didn't get the full dose. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for she had a hard time getting the needle on the syringe and if fell off during injection and as Not Applicable for the patient didn't get the full dose. 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 and Module VI of the 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.
This serious initial spontaneous case, was received on 01-Jun-2017, reported by other health professional (registered nurse) and concerns students in an academic campus, who all received flu vaccine. This case deals with thirteenth of 23 reports. From 03-Oct-2016 to 04-Oct-2016, 176 students were vaccinated with FLUCELVAX in the total of 258 students in the campus. In the spring of 2017, an outbreak of the flu occurred and lasted for approximately 10 days. The reporter stated that, from 13-Apr-2017 to 18-Apr-2017, they treated 22 students with flu and among them 5 students had the vaccine on campus. In the beginning of 18-Apr-2017, they treated another 23 students with flu symptoms and only 3 of those had not received the flu vaccine. The students were tested positive for influenza A via rapid flu test with nasopharyngeal swab. This case concerns 18-years-old patient of unspecified gender. On 03-Oct-2016, the patient received FLUCELVAX QIV (dose, route of administration and anatomical location: not reported, batch number: 185888, expiration date: 31-May-2017). On 18-Apr-2017, the patient was tested positive for influenza A via rapid flu test with nasopharyngeal swab (characterized as vaccination failure). Based on the investigation performed, it can be concluded that FLUCELVAX 185888 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the LOE complaint was the result of the Fill Finish or Bulk manufacturing process and no trends were identified for the batch number 185888, or any other FLUCELVAX QIV batches from the 2016-2017 FLUCELVAX commercial season. Therefore no internal root cause could be confirmed. Outcome of influenza A virus infection and vaccination failure was not reported. The reporter stated that, the students received flu vaccine had less severe symptoms than those who had not received the flu vaccine. Batch review report (number 1022277) received from quality assurance department on 29-Jul-2017: QA investigation results were updated. Narrative amended accordingly. Non-significant case correction received on 10-Aug-2017: The narrative was corrected.
Narrative:  Patient received Pfizer COVID-19 vaccination on 2/20/21 and 3/10/21. He presented to hospital regarding left leg swelling, US venous duplex and vascular surgery consulted. Patient diagnosed with left leg occlusive thrombus from popliteal vein and started on rivaroxaban. Of note, patient also has history of heterozygous Factor V Leiden mutation.
he has not received his 2nd vaccine; threw up; left arm tingling; began coughing quite a bit; ongoing intermittent stomach aches; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (left arm tingling), COUGH (began coughing quite a bit), ABDOMINAL PAIN UPPER (ongoing intermittent stomach aches), PRODUCT DOSE OMISSION ISSUE (he has not received his 2nd vaccine) and VOMITING (threw up) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced PARAESTHESIA (left arm tingling), COUGH (began coughing quite a bit), ABDOMINAL PAIN UPPER (ongoing intermittent stomach aches) and VOMITING (threw up). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (he has not received his 2nd vaccine). At the time of the report, PARAESTHESIA (left arm tingling), COUGH (began coughing quite a bit), ABDOMINAL PAIN UPPER (ongoing intermittent stomach aches), PRODUCT DOSE OMISSION ISSUE (he has not received his 2nd vaccine) and VOMITING (threw up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not provided.   The patient's arm started tingling and he began coughing quite a bit. He threw up everything that he ate and felt somewhat better after this. He had ongoing intermittent stomach aches ever since then.  During the patient's follow up call on 01-Jul-2021 the patient reported his adverse events from the first vaccine has resolved and stated adverse events finally went away after a month. Patient stated he is doing fine now and declined any further need for follow up. Patient advised he has not received his 2nd vaccine because he is moving. Patient plans on getting the 2nd once he is moved.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Updated events outcome and added information from follow-up call.
Hives/itching/significant swelling that started several weeks after the vaccine and has continued intermittently for the past 1.5 years; while I didn't initially connect this to the vaccine, it flared significantly after receiving a booster (within hours) (Pfizer FJ8762, administered 1/6/22), and again (and worse than ever) when I contracted COVID in May 2022, such that there seems to be a clear connection. OTC allergy medication and topical steroids reduce symptoms but don't prevent flares.   I also experienced ~4 months of amenorrhea after receiving the 2nd shot, but that resolved and did not recur.
ever 101 1/2, chills, muscle aches, headache, fatigue, very sore arm, very red
PATIENT WAS SEEN AT THE EMERGENCY ROOM OF HOSPITAL, NO FURTHER SYMPTOMS REPORTED, PATIENT WAS REFERRED TO FOR NEUROLOGY FOLLOWUP.
Got what appeared to be a blister type reaction with large area of redness around injection site. Had pictures on her phone. Advised to see PCP before we would give second dose. May have been a hive around injection.
Continually muscle aches and soreness in my left arm after 5 weeks.  I am not sure what kind of flu shot I received.  My arm has been sore enough that I continually notice when do minor activity.  I have not gone to a doctor for this issue.
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 at 10:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 35 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: "Salmon allergy" (unspecified if ongoing). Concomitant medication(s) included: SUDAFED 12 HOUR, start date: 01Mar2023, stop date: 03Mar2023. Past drug history included: Sulfa, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "recovered"; COVID-19 (medically significant), outcome "recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid taken from 01Mar2023 to 06Mar2023 as treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300109069 same patient, different drug and event.;
taste the medicine in her mouth; Tongue became tingly; Arm was sore and achy; A spontaneous report was received from a consumer concerning a 52-year-old female patient who experienced arm was sore and achy, taste the medicine in her mouth, and tongue became tingly.   The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 (lot: unknown) for prophylaxis of COVID-19 infection in the right arm on 27 Dec 2020.   On 27 Dec 2020, the patient's arm was sore and achy, taste the medicine in her mouth, tongue became tingly.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, arm was sore and achy, was resolved on 29 Dec 2020.  The outcome of the events, taste the medicine in her mouth, and tongue became tingly, was resolving.; Reporter'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.
About 12 days after the vaccine I broke out in an itchy rash and hives. My grandmother experienced a very similar Event after receiving her Covid booster, which led me to draw the connection.  I am now on my 3rd day of this persistent, uncomfortable rash and hives, which are moving around my body (torso, neck, legs, back, and now face).   I have never had hives or a rash like this previously. I will visit my primary care doctor this week.
nausea, fever, aches, numbness in hands;pounding heart, dizziness, vomiting;took a full wk to recover;all sx were severe;
Information has been received from a RN concerning an 11 yr old Asian female student who on 10Jul95 was vaccinated with the first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 01Jun05 the pt experienced a varicella outbreak. It was noted that the pt recovered. No date was specified. No additional information is expected.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51-year-old male patient received BNT162b2 (BNT162B2), on 01Feb2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 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: "Asthma" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Azithromycin, reaction(s): "Known allergies: azithromycin"; Citrus, reaction(s): "known allergies: citrus", notes: known allergies: citrus. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (07Jun2022) positive, notes: tested instantly positive on Tuesday 07Jun; (08Jun2022) Positive, notes: tested instantly positive on Tuesday 07Jun and Tuesday 08Jun. Therapeutic measures were taken as a result of drug ineffective, Covid-19.The patient was treated with Paxlovid from 30May2022 to 03Jun2022 for the treatment of COVID-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received second dose of Pfizer COVID19 vaccine and within 1-2 minutes after administering the vaccine the patient informed me that they could not breathe and felt that their chest was tight. I asked the patient to please take a seat and I would come out to evaluate them and they said they could not sit and did not want to. I took an EPIPEN out of the emergency kit to have on hand when I was with him incase he progressed. I asked the technician to call paramedics because he was not getting better within a couple minutes of standing with him and when I did the patient left the pharmacy and left the grocery store. I did follow the patient to their car as they would not stop walking away. They said they would drive themselves to the emergency room and would not come back inside of the store. At this point the patient was talking with no signs of throat closure or progressive difficulty breathing. I observed the patient's face and neck and there were no visible rash/hives. At this point the patient left on their own and would not come back inside of the store and I informed him of their risks by leaving. The paramedics showed up after the patient had left. No intervention was given and no therapy was given to the patient.
A non-serious spontaneous report of pneumonia has been received from a consumer, patient's mother, concerning a 41-month-old female subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 50 months of age for FLUMIST. The patient's medical history included asthma. The patient received FLUMIST on 01-Sep-2009. The patient experienced pneumonia on 21-Sep-2009 and 11-Jan-2010. She was not hospitalized, but was treated as an outpatient. The patient is currently with symptoms. The outcome of the event of pneumonia with the onset date of 21-Sep-2009 was unknown. The pneumonia with the onset date of 11-Jan-2010 was ongoing. This is in follow-up to report(s) previously submitted: Lot number is not available. Additional information was received on 18-May-2010 and incorporated into the narrative: Event details, onset date changed from 21-Sep-2009 to 18-Sep-2009, treatment medications and chest x-ray.
patient was possibly given 6 doses of undiluted pfzier.   chest pain headache chills arm red and swollen
During the second Vaccination it was painful receiving the shot compared to the first one. Months later the pain was still there in the injection area and my arm started to feel heavy and weak at night. As time went on it became difficult to perform everyday activities because of the weakness feeling. During the night the pain became unbearable, so I contacted my physician, and she ordered an Xray and physical therapy to start. Meanwhile I started taking Tylenol or Aleve to subside the pain to get rest.
Within one hour of receiving the FIRST SHINGRIX injection, I had a red ring around my arm at the injection site. Three weeks later I started breaking out in red rashes on my upper torso, shoulders, neck, arm, buttocks and around my waist. This has continued on a daily basis ever since. I have been back to Dr, who prescribed Steroids for 4 days and then Claritin. I also saw my Dermatologist, Dr. who prescribed Allegra and Benadryl, both of which I am still taking. I have NOT had the SECOND SHINGRIX injections! These red rashes start as a burning sensation before they develop into the actual rash.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Concurrent condition and medical history were not reported. On an unspecified date, the patients were vaccinated with improperly stored doses of MMR II (albumin status: rHA) (lot # K003806, expiration date 13-MAR-2016; Lot # K024036, expiration date 26-NOV-2015; Lot # K018990, expiration date 15-NOV-2015) (Strength, route and dose were not reported). Concomitant medications were reported. This is one of several reports from the same source. Additional information has been requested.
Nonstop, heavy menstrual bleeding. Ongoing. Severe cramping.  Nonstop headaches that sometimes turn to migraines. (Never had a headache in my life.) Tic. Popping ears constantly and involuntarily.
pt recv vax 15AUG96 430PM & about 8PM pt was nursing & mom noticed was shaking & shivering all over x 1min;pt became pale, lethargic;mom called MD & was seen in the office then transported to ER;
Shortness of breath, heart palpitations, vertigo/dizziness, phantom body pains appearing and disappearing in various places, occasional itching sensation, numbness, brain fog, double-vision, extreme tiredness. Symptoms tapered off over 3-5 days. Similar experience with 2nd vaccine but less pronounced with a shorter timeframe, tapering off after 2-3 days. Strongest side effects after first vaccine, symptoms did not become noticeable until a couple of hours after it was administered, increasing next 24 hours before lessening over time. Basically identical to long covid symptoms but lasting only for a few days after vaccinations and not before.
Rash developed at vaccine site within 24 hrs spreading for 3 days. Area became red, hot, hard and very itchy. No treatment given. Pt con'ts with a slight rash, afebrile during reaction and has no tenderness.
Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6203) via an unspecified route of administration in right arm on 18Mar2021 at 13:15 (at the age of 50-year-old), as a single dose for COVID-19 immunisation. Medical history included raynaud's disease. Patient was allergic to amoxicillin and penicillin. Concomitant medication received within two weeks of vaccination included multi vitamins from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6203), via an unspecified route of administration in left arm on 25Feb2021 at 15:00 (at the age of 50-years-old), as a single dose for COVID-19 immunisation.  Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 at 18:00, patient experienced fatigue. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of fatigue was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Now has bone pain; Hard to eat; Joint pain in jaw and teeth; Joint pain in jaw and teeth; Fever; Allergic reaction; Hives all over the body; Difficulty breathing; Swollen lips; Swollen eyes; Numbness in hands and feet; Numbness in hands and feet; Felt very dizzy; Was out of it; Massive stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), URTICARIA (Hives all over the body), DYSPNOEA (Difficulty breathing), LIP SWELLING (Swollen lips) and EYE SWELLING (Swollen eyes) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Nickel sensitivity and Allergy to metals (Lithium). Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction), URTICARIA (Hives all over the body), DYSPNOEA (Difficulty breathing), LIP SWELLING (Swollen lips), EYE SWELLING (Swollen eyes), the first episode of HYPOAESTHESIA (Numbness in hands and feet), the second episode of HYPOAESTHESIA (Numbness in hands and feet), DIZZINESS (Felt very dizzy), FEELING ABNORMAL (Was out of it) and ABDOMINAL PAIN UPPER (Massive stomach pain). On an unknown date, the patient experienced BONE PAIN (Now has bone pain), PYREXIA (Fever), MASTICATION DISORDER (Hard to eat), PAIN IN JAW (Joint pain in jaw and teeth) and TOOTHACHE (Joint pain in jaw and teeth). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, PSEUDOEPHEDRINE (BENADRYL CHILDREN [DEXTROMETHORPHAN HYDROBROMIDE;DIPHENHYDRAMINE HYDROCHLORIDE;PSEUDOEPHEDRINE]) at an unspecified dose and frequency; PREDNISONE for Stomach pain, at an unspecified dose and frequency and HYDROCODONE for Stomach pain, at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Allergic reaction), URTICARIA (Hives all over the body), DYSPNOEA (Difficulty breathing), LIP SWELLING (Swollen lips), EYE SWELLING (Swollen eyes) and the last episode of HYPOAESTHESIA (Numbness in hands and feet) had not resolved and DIZZINESS (Felt very dizzy), FEELING ABNORMAL (Was out of it), ABDOMINAL PAIN UPPER (Massive stomach pain), BONE PAIN (Now has bone pain), PYREXIA (Fever), MASTICATION DISORDER (Hard to eat), PAIN IN JAW (Joint pain in jaw and teeth) and TOOTHACHE (Joint pain in jaw and teeth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient stated that she could not afford to go to the ER.
Dizzy; This is a spontaneous report from a contactable consumer. This consumer (patient) reported.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, Expiry Date: Unknown), via an unspecified route of administration on 2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient just took the vaccine that day (yesterday) and the patient was wondering what the different side effects were and do they have a 'black box label' (Clarification unknown) and what should the patient do if something was like 'talking about the' nausea it did or something because the patient experienced felt dizzy earlier on an unspecified date in 2021. The patient concern was about the different 'black box label'. The patient had already asked the questions, and this was concerning self then and the patient took the vaccine, questioned whether she would get the COVID or not. The patient was unclear about that question. The patient just did not want to die on that medicine. The patient questioned the side effect of catching COVID while taking it. The patient questioned if the vaccine caused hearing loss. Outcome of the event dizzy was reported as Unknown at this time of the report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.