chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Prescribed Paxlovid after vaccination; Prescribed Paxlovid after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 12Jan2021 at 06:30 as dose 4 (booster), single (Lot number: El3249) at the age of 66 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Prescribed Paxlovid after vaccination". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received treatment with Paxlovid for covid-19. start date: 06Jun2022.  No follow-up attempts are possible. No further information is expected.
A non-serious spontaneous report of "we gave expired H1N1 to several patients" was received from a registered nurse/health professional concerning a 6-year-old male out of 17 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. The original expiration date was 12-Feb-2010, that had been changed to 15-Jan-2010. On 20-Jan-2010, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered recovered.
A non-serious report of tested positive for influenza B with symptom of 104 fever has been received from a health professional concerning a four-year-old female subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. The patient's medical history was not reported. The patient did not use any concomitant medications. The patient received FLUMIST intranasally on 19-Oct-2010. On 21-Oct-2010, the patient returned to the clinic with fever of 104 Fahrenheit and tested positive for Influenza B. The patient was treated with Oseltamivir. The events resolved on an unknown date.
Narrative: Headache, myalgia, CoughWheeze, Pain at injection site and left shoulder and back; chills sore throat, nasal congestion
Dose # 1 - started with fatigue that evening, and two days later, woke up with swollen glands in the left side of my neck, and above clavical.  Dose #2 - started with fatigue, severe chills later that evening. Woke up with high fever (103.3), chills, muscle aches, severe headache, nausea - lasted 24 hours or so.   Swollen glands never went down, they just feel like they've spread.  The glands  above my clavicle are the most annoying.  Pulls when I move my head
16 hours after my second shot, I woke up with some nausea.  I went to the bathroom, did not vomit, however in the middle of urinating I collapsed on the floor, couldn't walk, couldn't form full sentences, started sweating profusely, had to crawl back to my bed, and my pulse was through the roof.  I almost went to the ER, but the episode subsided within 15 minutes.   When I tried to fall back asleep, it felt like I was blacking out and not drifting asleep.  The next day, I experienced the typical flu like symptoms.  Followed by 4 days of normalcy.  On the 4th day, while working, I experienced a sharp 3 second "electric shock" feeling in my left side of my chest.   On the 5th day, I already had previously scheduled an appointment with my primary for a physical.  I told her about my episode; she took an EKG which yielded normal results.  Lab work also looked ok.  On the 6th day, I started feeling some more nausea and fatigue.  On the 7th day, the vertigo intensified tenfold, and the room was spinning.  That's when I started experiencing the following symptoms:  ? More nausea. ? Dizzy spells that come and go, especially after eating. ? Persistent periodic electric shock feeling in my left chest.  It?s dull but annoying.  And just when I think it?s gone for good, another 1 second shock happens. ? Left arm is  weak - the entire arm. ? When I try to sleep, the left side of my head feels as though I?m blacking out when I start drifting.  It almost feels like I?m getting anesthesia or something like that.  But just the left side. ? Basically the left side of my body (I got the jab in my left arm) from the waist up just feels off. ? One of my arms is numb when I wake up until I shake it out.  It?s not one particular arm. ? Energy levels are low.  Especially when I wake up and start moving around.  On the 8th day, I went to the ER thinking  perhaps it was a heart attack.  Nothing - EKG was again normal and lab work was normal.  The doctor told me it's all in my head - anxiety.  However, I'm not anxious and I'm a very level headed individual.    It's now day 12 and I feel overall awful.  I can't concentrate on anything.  I'm not thinking clearly and forgetting simple things.  The dull feeling and electric shocks on my left side continue.  I've never felt this bad before.  I'm a healthy 34 year old that exercises regularly, has never smoked or done drugs, rarely drinks alcohol, and eats generally very healthy.  If given a second chance I would not take the covid shot.  I am praying this goes away.
fatigue; chills; mild persistent headache (checked but, no fever); severe arm soreness at injection site/could not lift arm; severe arm soreness at injection site/could not lift arm; This is a spontaneous report from a contactable healthcare professional (patient). A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration at right arm on 08Jan2021 at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The patient had no allergies to medications, food, or other products. Concomitant medications included ethinylestradiol, levonorgestrel (ALESSE) for birth control, ascorbic acid, biotin, boron citrate, calcium pantothenate, calcium phosphate, choline bitartrate, chromium picolinate, colecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, inositol nicotinate, potassium iodide, pyridoxine hydrochloride, retinol palmitate (VITAFUSION WOMEN'S) and cetirizine. The patient previously received BNT162B2 (COVID Pfizer) first dose in Dec2020 for COVID-19 immunization. On 09Jan2021, the patient experienced fatigue, chills, mild persistent headache (checked but, no fever), severe arm soreness at injection site and could not lift arm. Symptoms began about 12 hours after vaccination. The patient did not receive treatment for the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovered in Jan2021.   Information on the lot/batch number has been requested.
Swelling and redness and injection site night after injection. Taken to ER and referred to DR. Admitted for cellulitis. Discharged the next day (5/4/07) with IV antibiotics. 07/02/2007 MR received for overnight hospitalization for L deltoid injection site redness, swelling, and pain.  PE remarkable for a 10x15 cm oval area of edema, firmness, warmth, erythema, and tenderness of the L deltoid. Txd with abx and ice. Final DX:  Cellulitis of the arm- due to adverse reaction of immunization.
Pt states on 10/20/19 that they are experiencing a sore neck beginning on Friday. Pt reports no other symptoms. Pt reports uncertainty if it is related to the 2 vaccinations that they received.
Case number PHHY2014US037836, is an initial literature report received on 21 Mar 2014. In this article, the author mentioned about the events after influenza vaccination for a 04-year-old girl. She had a known history of peanut, tree nut and shellfish allergy. She had pollen-food allergy syndrome from melons and bananas. She avoided gummy candies and other foods containing gelatin because she disliked them. Her vaccination history included vaccination with influenza vaccine at 03 years of her age and experienced shortness of breath and tightness of the chest (see case: PHHY2014US035991). She was vaccinated with influenza vaccine (not specified seasonal or pandemic, manufacturer and batch number: not reported, so conservatively coded as Influenza vaccine INN) on an unknown date. On an unknown date, immediately after vaccination she experienced shortness of breath and tightness of the chest. The outcome and seriousness of the events were not reported.
She received two doses of Pfizer COVID vaccines on 8/3/2021 and 08/24/2021. On 5/17/22, she presented to the ED at Facility with 10 days onset of rhinitis, dry cough, sore throat, wheezing. Upon ED evaluation, she had temp of 100.3 and tested positive COVID PCR, and she was admitted to the hospital on the same day for medical management. She received Azithromycin, Ceftriaxone, and steroids. She was discharged home with stable condition on 5/19/22.
C/O heart palpitations started minutes after vaccination. EMS was called. VS B_ 110/70, SaO2 97, P 87. She was assessed and refused EMS
arm soreness; altered menses  Narrative: employee states: she experienced a sore arm for approx. 72 hours additionally, menses was delayed by approx. 14 days from anticipated start of cycle
Missed heart beats 3 days after receiving vaccine. EKG - March 10, 2021 Patch on chest to monitor heart rhythm for 14 days - began on March 11, 2021
Gave patient shot in (L) deltoid. Upon pressing plunger, influenza squirted out of syringe all over patient and myself. Retracted syringe and regave new dose with new syringe in (R) deltoid. Pt came to me 12-4-07, states sores in area where vaccinated x 2 days then 7 days later muscle weakness, aches in both arms (shoulder to elbow, no fault). Lasted until MD visit 12-3-07 and was prescribed Naproxen and better but not gone.
This case was reported by a healthcare professional at a dialysis clinic and described the occurrence of HEPATITIS B antigen positive in a 52-year-old male subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).  Concurrent medical conditions included diabetes. On 23 February 2008 in the afternoon, the subject received unspecified dose of ENGERIX B (40 mcg, unknown, right arm).  On 26 February 2008, 3 days after vaccination with ENGERIX B, the subject tested positive for the HEPATITIS B antigen.  At the time of reporting the outcome of the event was unspecified.
This spontaneous report was received from a registered nurse and refers to a 7 year old male patient. The patient's concurrent conditions and medical history were not reported. Stock of vaccine was received on 11-AUG-2016. On 04-NOV-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M018636 with expiration date of 12-JUL-2017 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (DILUENT MRK) for prophylaxis. No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 37 days. It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA013888:
Within 2 hours of injection, site began to turn red and swell. Swelling continued to grow for 48 hours before decrease. Red, warm to the touch, pain, itchiness.
Measles-like rash on face, trunk (front and back), legs. and arms. Noticed first thing in the morning of Nov. 18 and still present on Nov 19
This spontaneous case reported by a nurse, describes the occurrence of polymenorrhea (my sister got the Moderna COVID-19 shot & it has shortened her menstrual cycle) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 1, 2021, patient experienced polymenorrhea (my sister got the Moderna COVID-19 shot & it has shortened her menstrual cycle). At the time of the report, polymenorrhea (my sister got the Moderna COVID-19 shot & it has shortened her menstrual cycle) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that no adverse reactions were reported by any patients.  No treatment medication was provided.
ARM WAS VERY SORE; NO APPETITE; COULD FEEL MEDICINE GO IN; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included scleroderma, esophageal disorder, problems swallowing, raynaud in hands, allergy of dairy products, and alcohol consumer.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included esomeprazole magnesium for esophageal disorder, and nifedipine for raynaud in hands.  On 09-APR-2021, the subject experienced no appetite. On 09-APR-2021, the subject experienced could feel medicine go in. On 10-APR-2021, the subject experienced arm was very sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could feel medicine go in, had not recovered from arm was very sore, and the outcome of no appetite was not reported. This report was non-serious. This case, from the same reporter is linked to 20210420295.
Rash after 2nd injection on same arm.  Rash is at site of first injection, approximately 4 inches diameter.  Lump at site of first injection after 2nd injection into same arm.
Extreme muscle aches and joint pain throughout the entire body which started in the evening. I did not sleep well with the pain with not being able to lay on my sides as my arms would go numb and I hurt terribly the next day until the afternoon when I took two Advils.
A report was received from a consumer on 1/20/04 concerning a 2.5 year old female vaccinee who inadvertently received 0.25ml Fluvirin on an unspecified date in December 2003 and on 1/9/04 inadvertently received a booster vaccine of 0.25ml Fluvirin. On an unspecified date in December 2003, the vaccinee inadvertently received 0.25ml Fluvirin and on 1/9/04 inadvertently received a booster vaccine of 0.25ml Fluvirin. At the time of the report no adverse events had been reported. Update 2/23/04: Follow up information received received from a health care professional indicated that the vaccinee received Fluzone on 12/5/03 instead of Fluvirin as previously recorded. The vaccinee did not have experience any adverse reactions. No follow up pending.
Mild loss of smell. Also mild fatigue, injection site soreness. The symptoms were gone the next day. I hadn?t heard of loss of smell as a side effect so I thought it might be of interest. I was cooking and food smelled so off I was throwing it away. Then I remembered the vaccination and I stuck my nose in an onion and couldn?t smell it. Some smells were still present. It affected my ability to taste my dinner but it was probably just the smell component.
immunization should have been administered subcutaneously. in error, pharmacist administered immunization intramuscularly. spoke with Merck vaccine information, they indicated that the response is unlikely to vary if subQ was given IM and it is not recommended to redose the vaccine. patient was made aware and is not concerned. counseled on possible side effects including soreness and fever.
This case was reported by a healthcare professional and described the occurrence of hepatitis B surface antigen positive in a female subject of unspecified age who was vaccinated with ENGERIX B, (GlaxoSmithKline).  The subject's medical history included hemodialysis and renal failure.  On an unspecified date the subject received unspecified dose of ENGERIX B (40 mcg, unknown).  Two days after vaccination with ENGERIX B, the subject experienced hepatitis B surface antigen positive.  The blood was tested because the subject had a possible exposure incident after she received ENGERIX-B.  The reporter believed the the positive hepatitis B surface antigen may be a false positive from the ENGERIX-B but she is not certain.  Medical attention was not required.  At the time of reporting the outcome of the event was unspecified.  Follow-up information was received on 17 December 2007, via nurse, who provided additional demographic information on the subject.  The nurse considered the events related to ENGERIX B.  The nurse also suggested the hepatitis B surface antigen positive was associated with the subject's blood drawn two days after vaccination with ENGERIX B.  The nurse reported the events resolved.
10MAR94 given Hep B vax; 13MAr93 shivering & crying; 14MAR94 weakness of legs & shaking of hands-pain in legs dx GBS; barely able to stand; c/o discomfort, fatigued; HR140; also dx viral synd; shivering; unable to bear weight;
Chief Complaint   DKA , Covid pneumonia  History of Present Illness     74-year-old female with PMH of ESRD on HD MWF, T2DM, HLD, HTN presents to the ED complaining of shortness of breath of 3 days duration.   Patient reports having increased shortness of breath for the last 3 days, per patient her  Her granddaughter is a nurse and tested her for Covid yesterday on 12/11 which was positive so she came to the hospital today. Apart from the patient is also complaining of polyuria and polydipsia for the last 2 days, patient mentions she did not take her insulin yesterday because of being tired. Patient denies any new fever, productive cough, hemoptysis, chills, any change in bowel or urine habits. Patient also on hemodialysis and reports missing her last Monday appointment but has been to Wednesday and Friday.   In the ED patient was hypotensive with a blood pressure of 84/53, labs remarkable for glucose of 731, potassium of 7.1, bicarb of 11, anion gap of 34, pH of 7.17. Sodium is 128 however when corrected is 140. Patient given 1 L of normal saline, started on Levophed, started on insulin drip per DKA protocol, chest x-ray consistent with Covid pneumonia.
Information has been received from a licensed practical nurse concerning a college-aged male who in approximately 2003 was vaccinated with a dose of Varivax. In approximately May 2006 the patient had a varicella titer drawn that did not show seroconversion. The varicella IgG titer came back as equivocal. No other symptoms were noted. Unspecified medical attention was sought. No other information was available. There was no product quality complaint. Additional information has been requested.
Patient immediately felt ache in arm where shot was given. Participant indicated she'd recently had spinal surgery but Dr gave the OK to get flu shot.  She took Advil and 3 hours later reported pain was gone.
fluzone hd qiv experience a temperature excursion which was not covered by the extended stability data with no reported adverse event; fluzone hd qiv was administered to a patient after experiencing a temperature excursion with no reported adverse event; Initial information received on 05-Oct-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves 85 years old female patient who was administered vaccine Influenza Quadrival A-B High dose HV vaccine [Fluzone High-Dose Quadrivalent] after experiencing a temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Oct-2023, the patient received 0.7 ml dose (frequency: once) of suspect Influenza Quadrival A-B High Dose HV vaccine of lot UT8150CA and expiry: 30-Jun-2024 via intramuscular route in the right deltoid for immunization.  On an unknown date, it was reported that the suspect Influenza Quadrival A-B High Dose HV vaccine experience a temperature excursion which was not covered by the extended stability data with no reported adverse event (product storage error) (unknown latency).  On 04-Oct-2023, the patient was administered Influenza Quadrival A-B High Dose HV vaccine (Fluzone HD QIV) after experiencing a temperature excursion with no reported adverse event (poor quality product administered) (latency: same day).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both events.   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 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.