chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious, spontaneous report of administration of expired product, vomiting and diarrhea was received from a nurse in concerning a 33-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 year to 59 months of age for FLUMIST.  Neither relevant medical history nor concomitant medication has been reported for this patient.  The patient received expired FLUMIST intranasal on 23-Dec-2008 for Flu Vaccination.  The lot of FLUMIST expired 18-Dec-2008.  The patient began vomiting and diarrhea the morning of 06-Jan-2009.  The patient was without fever, was not taken to the emergency room and did not receiver any treatment other than fluids.  The patients sibling experienced similar events of vomiting and diarrhea over the same time period which required a visit to the emergency room, reference case MEDI-0007733.  As of 09-Jan-2009 the events resolved. based on the results of the investigation , the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring durin the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 09-Apr-2009 that included the results of a root cause investigation of the medication error.
Fever 100F beginning at 3pm, muscle aches,  joint pain, fatigue, migraine
On 1/23/2021 in the night I noticed in the vaccine site I noticed it was red, hot to the touch, itchy and it was like a ball of 3-4in diameter. I took Benadryl that same night by the next morning it was gone.
Left deltoid: increased warmth and erythematous and edema. Treatment with cephalexin 500mg PO BID for 10 days. Ibuprofen 800mg PO BID for 15 days.
Unable to write as normal next day Mental decline and unable to care for herself Hospitalized 2 weeks later for dehydration Noticed reddened and painful R arm down to elbow Now back in hospital 5/18/21 with unresponsiveness, UTI and dehyration
6cm x 8cm red, erythematous skin over (L) deltoid area where PREVNAR given. Min. tender to palpation. No skin breakdown.
Vaccinated shoulder swelling. Loss of ability to move arm upwards above waist height. Pain upon waking day after vaccination.
almost the full content of the vial was dropped down, Do not know how much was administered to the patient; needle was not properly attached; A spontaneous report was received from a pharmacist  concerning a 72 year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced needle was not properly attached and so almost the full content of the vial was dropped down, it sprayed out too fast and the amount of vaccine administered to the patient was unknown.  The patient's medical history was not provided. Concomitant product use was unknown.   On an unknown date, the patient received his first of two planned doses of mRNA-1273 (Batch number: unknown). On 18-FEB-2021, the patient received his second of two planned doses of mRNA-1273 (Batch number: 024M20A) intramuscularly in right arm for prophylaxis of COVID-19 infection.  While administering the vaccine, the nurse noticed the needle was not properly attached and so almost the full content of the vial was dropped down. It sprayed out too fast and the nurse did not know how much was administered to the patient.  Action taken with the drug in response to the events is not applicable.  The outcomes of the events were considered resolved.; Reporter's Comments: This report refers to a case of 'needle was not properly attached' and almost the full content of the vial was dropped down, Do not know how much was administered to the patient' for mRNA-1273 (lot# 024M20A) with no associated adverse events.
started uncontrollable crying-over 12 hrs; threw up all food- ate; T104; could not be consoled;
One week after receiving my second dose of Pfizer, I had a stroke and was hospitalized. I received my dose 02/26 and had a stroke on 03/03. I now have to take a baby aspirin daily and a treatment for low testosterone. After my stroke I developed pneumonia and became very ill. I now have a pace maker installed as well.
Pain at injection site, fever, fatigue, body aches. Injection site pain started at 2 hours. Fever started at 21 hours an lasted 20 hours.
PATIENT HAD 5 CM RED AREA WHERE VACCINE ADMINISTERED. ON 6/4 HAD PROGRESSED TO RAISED WHEAL 9-10 CM ACROSS AND RAISED. PATIENT THEN VISITED DOCTOR'S OFFICE.
Extreme pain in upper left arm. Next day I could hardly move arm. Unable to lift, hold, or do anything. Clammy hold steering wheel, cant drive, cant pull clothes on, cant hold coffee cup. Arm barely moves and is in constant throbbing pain. Ppain so bad I am crying and have not sleep for three nights.
asthmatic symptoms; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 26Mar2021 as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history of the patient were not reported. On 28Mar2021, patient experienced asthmatic symptoms afterward first vaccine. Patient would like to know if it was okay to take cortisone. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
About an hour after the shot my face felt flushed and itchy. When I looked in the mirror I saw raised, bumpy rash on both cheeks, left for than right side, on both ears. I took benadryl and tylenol - for my itch and generalized malaise. Next morning rash spread to my neck and left antecubital. Rash on my arm continues to spread and is as itchy as poison ivy.
Tachycardia, Heart rate went as high as 160 / heart started rising; Dizziness / started getting little dizzy; Weakness; Throwing up; Fever; Chills; Body aches; Hands started shaking; This is a spontaneous report received from a contactable nurse (patient).   A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, in the left arm, on 29Aug2021, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On 29Aug2021, she experienced tachycardia, her heart rate went as high as 160 (her heart started rising). On the same date, on 29Aug2021, she also experienced little dizzy, weakness, throwing up, fever, chills, body aches and her hands started shaking. Patient reported that didn't had any problem before the vaccine and it started about 30 minutes after the vaccine. Clinical outcome of the adverse events was unknown at time of this report. Treatment: she took her topiramate (TROKENDI) last night (further clarification unknown).  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
I got the injection in upper left sholder.  The next day I had a bit of pain. The second day the pain was down my arm. At the same time the second day I had a feeling of Fatigue and a bad headache.  I felt like I had the flu.    The forth and fifth day I was feeling very Lethargic and slept a bunch.   I also had pain in my somach.  I started to feel better about day 6.
Headache, Nausea, lethargy, increased heart rate, muscle pain, chills, loss of appetite,  and sleepiness
Subconjuctival Hemmorage. Patient referred to Ophthalmology. In conversation with Ophthalmologist did not think this event was connected with vaccine.
Vaccine administered 24 days post Beyond Use Date; Product Storage Error; Product temperature excursion issue; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 24 days post Beyond Use Date), PRODUCT STORAGE ERROR (Product Storage Error), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) 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. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Nov-2022, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 24 days post Beyond Use Date), PRODUCT STORAGE ERROR (Product Storage Error), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 24 days post Beyond Use Date), PRODUCT STORAGE ERROR (Product Storage Error), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine administered 24 days post Beyond Use Date), PRODUCT STORAGE ERROR (Product Storage Error) and PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue).    No concomitant medication was reported. It was reported that vaccine administered 24 days post Beyond Use Date. There was an excursion where Moderna product was stored in the fridge and experienced multiple cold excursions and was punctured 24 days post Beyond Use Date. Data shows the vaccine was below 36F for a total of 1 hour. The minimum temperature reached was 35.4F.  Lot 083B22A was delivered and placed in the freezer 30-Aug-22. Lot 083B22A was relocated to the fridge on9-Sep-22. Vial was punctured on 15-nov-22 at 12:09 PM EST. This was the only puncture for this vial and it was damaged out 15-nov-22 at 9 PM EST. Vaccine was only administered once on 15-nov-22 at 12:09 PM EST. No treatment medication was reported.
Chills began first around 6:30PM, shortly followed by a fever, both these symptoms lasted until at least midnight, when I fell asleep. A headache started around 8:30 PM and persisted through the night. Body/muscle aches were felt the same time duration as the chills and fever. Nausea was felt briefly between about 8PM and 9PM. No medicine was taken, and I did not call a healthcare provider. The following morning I woke up soaked in sweat, but all the symptoms from the night prior were gone. I was just tired all day.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 30th September 2018, the patient received the 1st dose of SHINGRIX. On 30th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The batch number was unknown. The patient experienced injection site soreness after 1st dose of SHINGRIX. The case is linked to case US2019020218, reported by same reporter.
Body aches, low grade fever, swelling of lips, mainly lower, juvaderm lip filler. Tenderness, tingling in lips. No other swelling elsewhere.
The patient was hot, pale, near syncope, weak and nauseated. HR was 54, RA 94%, 94/80. Patient felt better when lying down. The patient didn't want a drink or a snack.
Information has been received from a physician referring to unspecified patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was unspecified. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot # L005295, expiration date 17-AUG-2016; lot # L014401, expiration date 23-OCT-2016, dose and route unknown). The vaccine was supported until labeled expiry. There was no previous excursion. It was reported due to data logger. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Immediately after receiving injection he felt faint. Unresponsive less than 30 seconds. After arousing he felt sweaty and weak. He was placed prone with feet elevated and cool cloth to head. Pulse 72, BP 134/90.
Information has been received through the Merck pregnancy registry from a licensed practical nurse concerning an 18 year old female smoker with a penicillin allergy who on 09-NOV-2006 was vaccinated in the left buttocks with the first dose of GARDASIL (Lot #653735/0688F).  Concomitant therapy included NUVARING, LOESTRIN 24 FE and prenatal vitamins (unspecified).  On 04-JAN-2007, the patient was vaccinated in the right gluteal with the second dose of GARDASIL (Lot #655765/1425F).  It was reported that the patient was pregnant, after receiving the vaccine.  Her last menstrual period was reported as 13-MAR-2007 and estimated due date 18-DEC-2007.  On an unspecified date in 2007, the patient had the following infections or illnesses during pregnancy gestational diabetes mellitus and anemia.  On 07-MAY-2007, an ultrasound was performed results reported were 7 6/7 IUG which confirmed the pregnancy.  On 20-JUL-2007, a pregnancy quad screen and ultrasound were performed results were within normal limits.  On 29-SEP-2007, 1 hour glucose "HcH" was performed results were not reported.  On 18-OCT-2007, an ultrasound was performed results were within normal limits.  On 03-DEC-2007, an ultrasound was performed results were within normal limits.  On 17-DEC-2007 (39 4/7 weeks gestation), it was reported that the patient delivered a normal healthy baby girl, weight 7lbs 8 oz and Apgar score was 8/9.  No congenital anomalies, complications or abnormalities were reported.  The seriousness and outcome of the GDMA and anemia were not reported.  Additional information is not expected.
Didn't feel good; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 06-Nov-2022 Reporter's comment: This case was reported by a patient via  interactive digital media. The patient did not felt good after the first dose.  The patient told them that he/she had every side effect. Additional Supportive Information: Follow-up would not be possible as no contact details were available.
Nausea, muscle pain, joint pain, hoarseness- all started within 2 hours of vaccine. 5 hours after vaccine I had muscle contractions, like I couldn't stop having to stretch and couldn't stop- very strange! Next day fatigue, nausea, aches and I could not lift the arm that the vaccine was given due to terrible pain at my shoulder, on the fourth day after the vaccine, I am able to lift my right arm without to much pain. On the 2nd day (Saturday) I broke out into hives on my stomach and back and that is still going on and I am very itchy still.
started on 12/6/21 (2.5days after booster vaccination) with fatigue most of day; duration approx. 8hours progressed to nausea; duration approx. 2hrs  followed by intense dizziness (unable to see things not moving with open eyes); duration approx. 30-60mins climax was throwing up/vomit; 1 occurrence. dizziness continued for short period after
Patient reports noticing some red itchy bumps presenting below her buttocks and behind her knees the morning after vaccination. She initially thought that they were bug bites, but as the day progressed, more spots appeared. They are not painful, just itchy and patient describes them as small and thinks they are hives. Patient was advised to continue monitoring reaction and to seek treatment at a local urgent care or PCP for evaluation.
Pt has itchy throat and was nauseated. Gave EPIPEN and called 911. Ambulance took her to hospital. She received IV BENADRYL and prednisone tablet. She is ok but still weak.
Few hours after immunization became dizzy.  Later develped headache, neck and body pain, nausea and diffus myalgias, Temp of 104F. Seen as out pt. 4/23& and 4/25/25, received IV fluids and IBuprofen and hydroco. Became afebrill with resolution of myolgias by 4/28.  Still has fatigue.
Mother reports infants left upper thigh is warm, swollen and reddened. Sl. fever. Reports infant is irritable. Mother reports right thigh has a knot at injection site.
broke her left wrist/arm is in a cast; This spontaneous case was reported by a consumer and describes the occurrence of JOINT INJURY (broke her left wrist/arm is in a cast) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced JOINT INJURY (broke her left wrist/arm is in a cast). At the time of the report, JOINT INJURY (broke her left wrist/arm is in a cast) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatments medication was reported.
Swelling at area of site around 6pm, and then on the following day noticed redness at injection site followed by more redness and circular lesions at around 8pm 10/26/2010 on both interior and medial thighs.
I felt fine just a sore arm. I was up until 8:00PM and then I started gradually getting sick. Then I got a sore throat, I started coughing, I had a fever and chills, started vomiting, and then diarrhea. That lasted until about 8:00AM the next day. Then I just had a fever and the chills for two days.
2 days following vax pt exp sz like activity x 3 episodes; pt was in ICU x 3 days; hospitalized x 4 days;
FEVER UP TO 102.0 ON 5-5-07. SEVERE VOMITING AND DIARRHEA PER MOTHER AT TIME OF VISIT ON 5-7-07. PATIENT SENT TO HOSPITAL ER. SHE WAS THEN ADMITTED. 06/07/07-records received from facility for DOS 5/7/07-DC DX febrile illness. History of feverl to 102 (R) for 4 days. Increased sleep and fussiness when awake. Vomiting. Decreased oral intake.
Headache all day. Body aches all day  upset stomach  no energy. Very weak when standing up   Started 5:00 pm on 3-11-2012.   All day Friday the 12th  and  still on Saturday headache on the 13th
dizziness, nausea, vomiting, faintness, pale;epi & Solumedrol given;
Patient had a reaction to the pneumococcal vaccine prior to 9/15/08. The date of the reaction occurrence and the lot # of the pneumococcal vaccine - unknown.
Patient received DTaP, MMR, varicella on 02-24-2014. Mother states that on that on that evening and since until visit on 02-28-2014. He has had an increase in previous head-banging and rocking behavior, he is less active and less verbal and is not eating as well. No fever or other symptoms seen in office 02-28-2014 with normal exam. Has been referred for developmental evaluation.
30 minutes after shot, experienced sudden dizziness, nausea, and felt like it was hard to breathe.
Pt had the first dose of Shingrix on 2/13/20 at age 77 years and 0 days. Within one hour she was feeling painful and weak at the left arm.  This progressed over hours and days to where she had difficulty with her full strength in the arm, including but not limited to, grip.  For example, she could not lift anything as heavy as a dish.  This lasted for at least two months.  On 9/9/20, visiting with patient today and even now there are reports that she is still in some phase of recovery.  The strength is nearly back to normal.  Still cannot lay on that arm at night.
Patient experienced pain down her arm after the vaccine was administered. The pain has persisted since 9/26/14.
11 year old patient was administered DAPTACEL instead of ordered tdap vaccine with no reported adverse event; Initial information received on 28-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old male patient who was administered daptacel instead of ordered tdap vaccine with no reported adverse event, after receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.Concomitant medications included HPV VACCINE (HPV VACCINE)  and meningitis for Immunisation.  On 27-Oct-2022, the patient received a dose number 6  total dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE( lot C5883AA and expiration date: 11-May-2023) at a dose of 05ml once via intramuscular route in the left thigh for immunization.  On 27-Oct-2022 (latency: same day), the patient was administered daptacel instead of ordered tdap vaccine with no reported adverse event (wrong product administered).   Action taken:not applicable.  It was not reported if the patient received a corrective treatment for the event   Outcome: unknown     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.
A 15 month old patient who was administered 12 month vaccines (MMR/Varicella, Hepatitis A) presented an allergy with erythema of the eyelids and cheeks 60 hours after vaccine and then skin Desquamation.
I had a mammogram done on 7/14 and the image shows three lumps in my left breast and under left arm, I was called back to get a ultrasound scan which showed potential  malignancy, I had a biopsy done on 7/28 and the results confirmed existence of Diffuse Large B-Cell Lymphoma.
Hives, immediately, following influenza vaccine, resolved immediately with Benadryl PO. MR received revealing healthy infant with several food allergies and eczema, who developed hives within a few minutes of receiving Fluzone. Hives resolved quickly after PO Benadryl. F/U 1 week later with allergist who provided Epipen Jr. PRN, as well as Albuterol, and antihistamines PRN Primary DX: Influenza Vaccine  Allergy.
Two days post vax, the pt experienced a headache, nausea, no appetite, severe fatigue, temp of 100, which lasted until the following day.