chrisvoncsefalvay/vaers-outcomes huggingface dataset:
temperature excursion that exceeded the stability vaccines were administered with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 4 years old male patient who was administered diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] post temperature excursion that exceeded the stability vaccines were administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received 0.5 mL dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine, suspension for injection (batch number, expiry date unknown) via intramuscular route in unknown administration site for Immunization post temperature excursion that exceeded the stability with no reported adverse event (poor quality product administered) (same day latency). Information on the batch number was requested.  It was reported that excursion occurred due to potential mechanical issue with the refrigerator; Max/Low Temperature reached: 31.5° fahrenheit for 2 hours 45 minutes (human error: no)  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event temperature excursion that exceeded the stability vaccines were administered with no reported adverse 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 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.
Patient given Tdap, MENACTRA, VARIVAX and was fine. About 10-15 minutes later TRUMENBA vaccine given when she developed sudden dizziness, dilation of pupils and near syncope. Advised to lay down. Patient sweating. Offered water and perked up some. I saw patient within 30 seconds of vaccine administration was sitting up then but reported dizziness. Back to baseline in 10 to 15 minutes.
sore arm; Back aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and BACK PAIN (Back aches) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol. Concomitant products included SIMVASTATIN for High cholesterol.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and BACK PAIN (Back aches). At the time of the report, PAIN IN EXTREMITY (sore arm) and BACK PAIN (Back aches) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-224924 (Patient Link).
3:07 pm lung sounds diminished oxygen sats 68%, oxygen applied Oxygen sats remained low for next 36 hours ( patient on Hospice care ) expired 6:22 am 1-8-21
SkinRash Narrative: He experienced a rash on his torso and arms for 24 hours. Did not seek medical attention or take medication to treat. Resolved on it's own.
Allergic reaction to flu shot.  Large hive located on bicep with pain, warmth and some itching.
Pain at Injection; Lousy/ feeling terrible; Flu-like Symptoms; Chills; Feeling tired; Hurting; not feel good/ felt like crap; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th September 2019, the patient received the 1st dose of Shingrix. On 19th September 2019, immediately after receiving Shingrix, the patient experienced injection site pain, feeling bad, influenza-like symptoms, chills, tiredness, pain and feeling unwell. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain, feeling bad, influenza-like symptoms, chills, tiredness, pain and feeling unwell were unknown.   It was unknown if the reporter considered the injection site pain, feeling bad, influenza-like symptoms, chills, tiredness, pain and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient stated that it hurt when needle was injected into her arm. The patient approximately 4 hours after vaccination felt lousy. The patent approximately 6 hours after vaccination was  in bed with flu like symptoms. The flu like symptoms described as chills, feeling tired, hurting, and not feel good. The patient took 2 extra strength Tylenol before going to bed early at 7:30 PM which helped a little. The patient took Tylenol the next morning after waking up because she felt like crap. The patient did not consent to follow up.
UTI; splitting headache; sore arm; This is a spontaneous report from a contactable consumer (patient) reported for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8732) via an unspecified route of administration, administered in arm right on 29Mar2021 (Monday) at 14:15 as dose 1, single for COVID-19 immunisation. Medical history included multiple sclerosis from 1998 to an unknown date, UTIfrom an unknown date and unknown if ongoing. Concomitant medications included ciprofloxacin (CIPRO [CIPROFLOXACIN]) taken for UTI from 26Mar2021 to an unspecified stop date; fingolimod hydrochloride (GILENYA) taken for multiple sclerosis from an unspecified start date and ongoing. The patient stated that She just wanted to talk to someone about having felt like a sore arm for two days (unspecified date in Mar2021), which she expected that from a shot in the arm and she was not concerned about that, but today (unspecified date) she woke up with a splitting headache (31Mar2021), she does not know, because she did not get sick right away, since this is the third day after the shot if she should do something about the headache or wait it out, she has multiple issues she battles anyway outside of this, she has done no treatment yet, she heard not to do anything on TV and do not take Tylenol to build up immune, but she wants to take something, which is why she guesses she called to see what she could take. The patient further stated that she started a new medication, Cipro, which was an antibiotic she was given for a UTI she got diagnosed four days ago (on an unspecified date), which she was now taking it, thought UTI started ten days ago, she did not get diagnosed until last Thursday (unspecified date) when she went to the doctor who confirmed her thoughts that she had a UTI. The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Rising fever uncontrolled with Tylenol.  Fever continued to rise until approximately 11:30 pm.  Fever reached 103 degrees even with Tylenol therapy.
After I got the shot my sinus were congested I have no taste and no smell, ears are clogged, trouble swallowing; very bad sinus headaches. Blood pressure goes high and low, get hot an cold flashes. ENT Doctor believes I am a long hauler, and I got Covid between the vaccines.
Patient experienced excessive itchiness and nausea during the 15 minute wait period & was told to wait and continued to be monitored. After 5 additional minutes patient still reported itchiness all over skin part of body (no throat itchiness)  patient was offered 25 mg of benadryl at 2:06 pm and she accepted. After 10 minutes she said it was still itchy and wasnt getting better. Was offered a 2nd 25 mg benadryl and she accepted. At 2:30 patient reported a small amount of vomiting, itching persisted but when asked about breathing she said it was not labored and was not having difficult breathing. After the vomiting occured, we determined that due to not having any breathing issues or any outward signs of distress that an epipen was not the best course of action and told patient we could contact the ambulance and have her taken to the Emergency room. Patient denied that option and refused to go. We continued to monitor at the pharmacy for an additional 30 minutes and patient reported she was getting better and wanted to go on her own. We notified her work she would be on her way and is located less than 5 minutes away. She wanted to drive and refused a driver. We told her to contact her primary care doctor before trying to receive the 2nd dose.
Kinrix was given as dose of DTaP and IPV. Kinrix is not marketed for children < age 4, and therefore its use was off-label and not recommended. Error not realized until after vaccine given.
9 days after vaccination developed injection site redness, warmth, and pain. Also with shoulder and neck stiffness and pain.
Vaccination site irritation; Arm pain; Expired vaccine used; This is a spontaneous report from a contactable pharmacist. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an intramuscular route of administration in the left arm on 13May2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration on 20Apr2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. It was unknown if patient received any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if patient had tested for COVID-19. On 13May2021, patient was administered a short expiry lot (17 days from expiration) and patient experienced vaccination site irritation and arm pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event vaccination site irritation and arm pain were resolved on an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
This was my 2nd dose of Moderna vaccine,, the first was worse, but for this 2nd does symptoms were: Soreness at injection site (for 2 days) Slight Temperature  Chills, muscle ache  All symptoms lasted less time on this 2nd shot  (I did not seek medical attention after either shot but symptoms were much more severe after first shot on 1/26/2021.
Pt broke out in hives 2 days p/immun; no tx no MD visit;
Pt recv vax on 2/15/99; in 1 hr post vax pt exp rigor & fever (102)
left anterior uveitis developed approximately 1 week after vaccination. This is the third time I have had it. (The first time was in 2019, and the second time was last year).  Currently have eye redness/ciliary flush, minimal pain/pruritis, blurred vision. Started smoldering a couple of weeks ago, became much more pronounced about 5 days ago.
A serious event of respiratory distress syndrome was reported by a Study Investigator concerning a 39-month-old male subject (Pat ID# 42455284) enrolled in a post-marketed study MI-MA 162.  Medical history included adenotonsillar hypertrophy, obstructive sleep apnea, heavy snoring since birth and worsening gasping and choking with apneic pauses.  The patient's parents both smoke.  No concomitant medications were reported.  The subject received FLUMIST on 15-Oct-2007.  The subject was scheduled for a tonsil and adenoidectomy due to known adenotonsillar hypertrophy and obstructive sleep apnea.  On 18-Oct-2007 the subject developed symptoms of respiratory distress syndrome.  On 21-Oct-2007 the subject was seen in the emergency room for respiratory difficulty after he became pale and blue.  The subject underwent a tonsillectomy and adenoidectomy, after surgery the subject was intubated and a chest x-ray on 22-Oct-2007 showed bronchial thickening, question of mild segmental area of atelectasis or infiltrate in the right base.  On 22-Oct-2007 the subject was extubated and discharged to home on 23-Oct-2007.  The subject did not receive any further doses of FLUMIST.  The Study Investigator considered the event of respiratory distress syndrome as possibly related to study drug.
Information has been received from a physician concerning a patient who was vaccinated with Rotateq PO possibly the "third dose". The physician reported that, the patient developed vomiting and diarrhea. The patient recovered from the vomiting and diarrhea on an unspecified date. The patient sought unspecified medical attention. Additional information has been requested.
hives aross arms and body within 24 hours headache fatigue chest pain rapid heart beat pain in left side of abdoamin wheezing/cough 32-48 hours after injection went to urgent care facility on the monday after reciving my shot on friday
FDA only cleared booster for this age group and CDC had not signed off on order. Provider gave vaccine under impression booster was approved.
UPON WAKING NEXT MORNING OF VACCINE, ARM NUMBNESS, EXTREME HEADACHE, OFF AND ON CHILLS, WEAKNESS, LOW GRADE FEVER. TOOK ADVIL EARLY EVENING AND NIGHTQUIL BEFORE BED. WOKE WITH MOST SYMPTOMS RESOLVED, STILL HAD SLIGHT HEADACHE AND FEELING OF LUMP UNDER ARM THAT RESOLVED BY 4TH DAY
Suspected Vaccination failure; Shingles rash; Pain; Knot at injection site; REDNESS at injection site; FEVER; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number ZP3P9, expiry date 30th April 2020) for prophylaxis.   The patient's past medical history included shingles.   On 25th December 2018, the patient received the 1st dose of Shingrix. On 25th April 2019, the patient received the 2nd dose of Shingrix .5 ml. On 26th April 2019, not applicable after receiving Shingrix and 1 days after receiving Shingrix, the patient experienced injection site nodule, injection site erythema, fever and pain. In July 2019, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was not recovered/not resolved and the outcome of the shingles and pain were unknown and the outcome of the injection site nodule, injection site erythema and fever were recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the injection site nodule, injection site erythema, fever and pain to be related to Shingrix.  Additional details were provided as follows: The patient received the 2nd dose in left arm. The day after the patient received her 2nd dose of Shingrix she experienced a large knot the size of a small basketball that was very red at the injection site. This resolved after 4 days. A fever also presented the day after the 2nd vaccination that lasted 3 days. Last week before the date of reporting a shingles rash presented on the back of her legs just below the buttocks. The patient stated that the Shingrix shots were painful. She had bad reaction from the shot. The patient wanted the money back. The patient was very dissatisfied. The reporter consented to follow up.
vaccine felt really warm going into arm; a little dizzy; Slightly nauseous; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (vaccine felt really warm going into arm), DIZZINESS (a little dizzy) and NAUSEA (Slightly nauseous) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced FEELING HOT (vaccine felt really warm going into arm), DIZZINESS (a little dizzy) and NAUSEA (Slightly nauseous). At the time of the report, FEELING HOT (vaccine felt really warm going into arm), DIZZINESS (a little dizzy) and NAUSEA (Slightly nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were provided. No treatment information was mentioned.   This case was linked to MOD-2021-270022 (Patient Link).
pt recvd vax 17OCT95 & that day devel an inj site rxn characterized by redness, warmth, swelling & hardness;the above rxn lasted for 1 day & subsided;this is one of three patients from this site who exp these sx p/flu vax
AFTER GETTING THE COVID VACCINE PATIENT EXPERIENCED SEIZURE LIKE SYMPTOMS AND AFTER THE PARAMEDIC CAME, THEY CHECKED HIS VITALS AND FOUND OUR HIS BLOOD PRESSURE AND HEART RATE WAS DOWN SO THEY BROUGHT HIM TO THE HOSPITAL
EXPIRED IPV vaccine was administered.  Additionally, the IPV was a multidose vial that had long exceeded it's shelf-life (had been open a YEAR previously)
Product storage error; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported. No adverse events reported. No temperature excursion of the product was reported. Date place in refrigerator: 22-Sep-2021.
pt resides in a local Community Living Center; pt had a positive COVID test on 8/24/22 and passed away in the facility of respiratory failure on 8/25/22
redness in area of inj w/pain in arm;pt seen in clinic for f/u lt deltoid;
In June 2021 and October 2021 Experienced reaction to  cosmetic fillers in right upper lip.  Continue to experience reoccurring reactions  in this area since Covid Vaccine.  Treated with steroids on both occasions which resolved the issue but it is still reoccuring.
11/2022 during a routine physicians visited they sent me for bloodwork and my hemoglobin's are low. I also had an episode of indigestion. I was referred to a Gastrologist 12/2022 I had an endoscopy, colonoscopy and a abdominal biopsy all were normal. 03/2023 I developed a UTI which I never had before.
Cough; Fatigue; Sore throat; Congestion; Chills; Nausea; Headache; Tiredness; Pain at vaccination site; Swelling and redness at the vaccination site; Swelling and redness at the vaccination site; This is a spontaneous report from a non-contactable consumer, the patient. A 53-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 23Sep2021 at 15:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included Diabetes, obesity, shortness of breath, dysphagia, neck, low and upper back problems. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Concomitant medications included metformin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 31Aug 2021 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. On 24Sep2021 at 00:00, the patient experienced cough, fatigue, sore throat, congestion, chills, nausea, headache, tiredness, pain, swelling and redness at the vaccination site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events cough, fatigue, sore throat, congestion, chills, nausea, headache, tiredness, pain, swelling and redness at the vaccination site was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The pertinents' medical history and concomitant therapy were not reported. On unknown date, the patients were vaccinated with doses of improperly stored VARIVAX (lot # L026406, expiration date: 15-JUL-2017) (dose and route unspecified). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
He developed fever within 24 hrs after immunization T max 102. Mother started him on Tylenol. He had an episode of shaking of his arm and eyes were rolling lasted for approx 1 minute. Loss of consciousness. He was taken to ED with Dx Febrile seizure
There is a large red spot on her arm where she received the vaccine.  Its been 2 weeks and the red spot is still on her arm.  She states that there is no pain....redness just still there.
9/10/21 PMHx of pancreatic cancer, CAD, CKD; presents w/ fever and weakness for past several days
Per mother, 10-15 minutes after receiving vaccines, on the way home with mother, sx began: (1) loss of vision, (2) heavy feeling in arms, then loss of feeling in arms and partially in legs, all over pain. Mother says went to ER right away. Per mom, loss of vision resolved 15 minutes, loss of feeling extremities resolved in 30 minutes.