chrisvoncsefalvay/vaers-outcomes huggingface dataset:
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from  other health professional.  This case is linked to cases 2023SA057733 and 2023SA057309.  This case involves Adult patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It was unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (latency: unknown)  (poor quality product administered) (latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   It was unknown if the patient experienced any additional symptoms/events   It was unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported 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 guidelines. 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 situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
mild whizzing; nose running; sneezing; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (mild whizzing), RHINORRHOEA (nose running) and SNEEZING (sneezing) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021 at 5:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced RHINORRHOEA (nose running) and SNEEZING (sneezing). On 09-Feb-2021, the patient experienced WHEEZING (mild whizzing). The patient was treated with FEXOFENADINE HYDROCHLORIDE at a dose of 180 mg. At the time of the report, WHEEZING (mild whizzing), RHINORRHOEA (nose running) and SNEEZING (sneezing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
Moderna COVID?19 Vaccine EUA On Jan 19, 2021 I received my first dose of the Moderna vaccine. I had minor pain at the injection site for 3 days. On Jan 28, 2021 I noticed stiffness and pain in both of my knees. My Right knee was replaced in 2015 and my Left knee was replaced Oct 5, 2020.  I thought it was strange to have pain in the Right knee. The stiffness has increased in both knees since Jan 28. I otherwise feel fine but am having difficulty bending both knees and I have pain when I am weight bearing. I am wondering if the vaccine is attracted to artificial joints? I am scheduled to get my second dose on Feb 17.  Please advise if this is a common reaction.
About 1 1/2 weeks after shot, daughter developed hair loss. Was diagnosed as having alopecia areata.
Immediate swelling, heat and pain at injection sight. Hours later arm swelled to twice its normal size. A softball-sized red welt formed at injection sight. Then my face became red and swollen, which I fought by taking several kinds of antihistamines throughout the day. I had headaches and stomach issues for two weeks after the injection. Lastly, I have a very sore muscle in my right side back that is still a problem.
Large red lesion at the injection site with extreme itching and rash that showed up on day 7 Pain upon injection for 24 hours after injection Fever/Chills for 24 hours after injection
12 days after receiving MMR vaccine pt developed a red raised blotching diffuse rash on trunk, extremities face. Initial was separate spots but they condensed as the rash faded. He was also put on Amox and Tobrex eye drops.
Booster dose was given 7 days early. Pt did not report any side effects.
On July 6,2021 I was admitted into the hospital with Multiple blood clots in both lungs.  Doctors can't figure out why this happened to me.  All blood work shows It was not genetic, I didn't have any surgeries, did not travel at all, and I am very active and not over weight.
Patient received dose of COVID 1 day past BUD on bag from pharmacy. Contacted manufacturer who states that stability has been established for 10 weeks + 2 Days out, but since it was beyond the 10 week date, it was considered an off label use.
wild swelling of tongue and throat.  given  benadryl, symptoms subsided.  Cleared by telehealth to go home.
Received 1st Moderna COVID-19 vaccine dose on 1/12/21 and second dose on 2/9/21 without noted adverse events. Individual was exposed to two COVID-19 positive individuals on 3/12/21 and evaluated in the clinic on 3/18/21. She was experiencing fatigue and sore throat for one day. BinaxNOW COVID-19 antigen test was negative on 3/18/21. She was seen in clinic again on 3/24/21 with additional symptoms of body aches, fatigue, headache, congestion and low grade fever. BinaxNOW COVID-19 antigen test was repeated on 3/24/21 and was positive. She was called back to clinic on 3/25/21 for a confirmatory SARSCOV2 Cepheid PCR which returned positive. This sample was frozen and will be sent to the Department of Public Health for further analysis.
Had Pfizer shot #1 at 4:50 PM on 5/13. Arm soreness at the injection site began later that evening around 11:00 PM.   I am still having soreness today. 5/14 began feeling tired around 4:30 PM. Took a nap from 5:30 - 7:30 PM. Went to bed 10:30 PM. Woke up Sat...felt tired throughout the day.  Ran a couple errands in the am. Came home and took a nap form 12:00 PM - 2:00 PM. My face also felt a little warm Saturday but I did not take my temp. Saturday morning I also noticed that my left armpit was sore and still is this morning. It is now 9:45 AM , Monday, 5/17.  I have been taking advil and motrin on and off since Thursday.
Woke up on Saturday 12/12/09 - I had red blotches the size of a silver dollar on my left side of face with occasional itching. On 12/13/09 the blotches showed up on my right side of my face. On 12/14/2009 The blotches appeared on my forehead with occasional itching. It is not raised, and I plan on seeing my Medical Doctor. This vaccine H1N1 is the only thing different. Patient denies any shortness of breath, pain, or fever at this time.
Patients mother gave the wrong DOB at time of initial vaccine. Patients mother was present and stated the patients birthday was 2008, but in actuality, the patients birthday is 2009. This was discovered on 06/02/2021 when the patient was due back for second immunization. The patients mother stated today that the child was 12 and was born in 2009. Upon more questioning, we discovered the patient is not 12 and was not born in 2008 and that the patient is currently 11 years old. Staff instructed patients mother to not return for second dose until patient was 12.
PATIENT IS ONLY 17 YEARS AND 3 MONTHS OLD AND RECEIEVED MODERNA BOOSTER. SHE COMPLETED HER PFIZER PRIMARY SERIES ON 5/4/21. CURRENTLY MODERNA IS ONLY APPROVED FOR 18+ FOR BOOSTERS
This spontaneous report as received from a pharmacist refers to a 69 year old male patient. The patient had none pertinent medical history and none drug reactions or allergies. On 20-OCT-2014, the patient was vaccinated with PNEUMOVAX 23 lot # K004281, expiration date: 22-MAR-2015 in the arm (dose, route of administration were not reported). The patient did not take any concomitant medications. On an unspecified date in October 2014 (reported as last night), the patient began to experience discomfort at the injection site. The pharmacist reported that the discomfort changed to pain and itching overnight and then in the morning, on 21-OCT-2014, the patient began to experience redness at the injection site and swelling in the injection arm's biceps area, along with pain and itching. The pharmacist also reported that, on 21-OCT-2014 (reported as "now") the swelling has spread down to the patient's elbow. The patient applied a cool compress to his arm this afternoon to treat the symptoms. There was none lab diagnostics studies performed. The patient sought medical attention by coming back to pharmacy. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and the vaccination with PNEUMOVAX 23 was unknown. Additional information has been requested.
sore arm, prevent a good night sleep.  Took Tylenol the next day of shot chill knee caps (both) pain run down
experienced another case of shingles/Suspected Vaccination Failure; experienced another case of shingles; pharmacy administered a first shot dose; Tiredness; Muscle pain; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 75-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On 19-JUN-2023, more than 2 years after receiving Shingles vaccine and Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced tiredness (Verbatim: Tiredness) and muscle pain (Verbatim: Muscle pain). On an unknown date, the patient experienced vaccination failure (Verbatim: experienced another case of shingles/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: experienced another case of shingles) and extra dose administered (Verbatim: pharmacy administered a first shot dose). The outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles was not reported and the outcome of the tiredness and muscle pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, tiredness and muscle pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, tiredness and muscle pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 19-JUN-2023 The patient self-reported this case. The patient had the 2 Shingles shots in 2018. In 2022, he experienced another case of shingles. The patient asked if he could get another round of vaccines at that time, but he was told by my pharmacy and by you that a second round had not been authorized. One day before reporting, pharmacy told me him was now eligible for another round of vaccines. Pharmacy administered a first shot dose. The reporter asked was pharmacy correct ? The symptoms were not treated. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The reporter did not consent to follow up. The patient received 3rd dose of Shingles vaccine (first shot from second round), which led to extra dose administered.
Patient 14 yo, male, in excellent health.  PFizer EWO178 vaccine dates (pharmacy near  grandma's house ) were 6/4/21 & 6/25/21.  He was hurting all week and on 7/7/21, he had an emergency appendectomy at hospital
On 08MAY2023 I had chills and  a minor cough. My temperatre was one hundres point four.  The next morning 09MAY2023 I tested positive for the COVID-19 virus.
bags under eyes; flu like symptoms; swelling of the lymph nodes in the neck; feeling achy; This spontaneous case was reported by a consumer and describes the occurrence of PERIORBITAL SWELLING (bags under eyes), INFLUENZA LIKE ILLNESS (flu like symptoms), LYMPHADENOPATHY (swelling of the lymph nodes in the neck) and MYALGIA (feeling achy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PERIORBITAL SWELLING (bags under eyes), INFLUENZA LIKE ILLNESS (flu like symptoms), LYMPHADENOPATHY (swelling of the lymph nodes in the neck) and MYALGIA (feeling achy). At the time of the report, PERIORBITAL SWELLING (bags under eyes), INFLUENZA LIKE ILLNESS (flu like symptoms), LYMPHADENOPATHY (swelling of the lymph nodes in the neck) and MYALGIA (feeling achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported. Treatment medications were not provided by the reporter.
8.19.21  diaphoretic, nausea, sharp shooting, zapping pain in neck, bilateral wrists, fingers, knees and both ankles. Chills with no fever. Took Motrin at home with no relief. Resolved the following day, 8.20.21.  8.20.21 noticed numbness, tingling in right hand and lack of movement in right pointer finger. The numbness and tingling progressed to lack of movement and pain in the middle, ring and pinky finger of my right hand in the following 3 days.   9.1.21 noticed numbness and tingling in my left hand. Constant, but not painful.  9.3.21 woke up at 9am with intractable headache, pain, numbness, tingling in both hands and still lack of movement in my right fingers from pointer, index, ring and pinky. 9.3.21 went to ER
I am experiencing jaw joint tightness along with a headache.  NP at pharmacy said I should report it since she has never heard of jaw pain with the Tdap shot.
Pain and stiffness in shoulder where injected. Unable to move arm. Dr sent patient to physical therapy.
Patient was seen today on 09/13/18. Rash to stomach and back area. Was diagnosed as Urticaria. Treatment was diphenhydramine 12.5mg, 5ml every 6 hr PRN x12 days.
Fever; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease. Concomitant products included USTEKINUMAB (STELARA) for Crohn's disease.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 99 (High) 99 F. On 13-Mar-2021, Body temperature: 99 (High) 99 F.     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.
After administration of Pneumovax in Right Deltoid and Flu Vacc in Left Deltoid, both areas bruised, but the right arm later that day began swelling and hurting.  Today, pt states arm has gotten better, but still has swelling ,tenderness and redness with central bruising.No shortness of breath or chest pain.
Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a patient of an unknown age and gender 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 VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.
Soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness of arm). At the time of the report, PAIN IN EXTREMITY (Soreness of arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Received 1st shot in series Sunday evening, Monday morning a rash on the back of left leg was about the size of a silver dollar.  Tuesday morning went to Urgent Care where they incorrectly diagnosed it as a yeast infection and gave me an anti-fungal prescription.  Weds morning rash had 2x3? across, and by mid-day, it had nearly doubled in size and started to turn dark red / purple.  Went to the emergency room where they identified it as cellulitis and sent me home with antibiotics. Thursday it continued to slowly get worse, and Friday morning I went back to the Emergency room and the same ER doctor saw me and assessed it wasn?t improving and admitted me to the ER.  By Sunday there wasn't resolution, but I was stable and was discharged for treatment with my regular doctor.  He switched me to a different antibiotic and referred me to a dermatologist.  I was put on prednisone and over the next month the rash continued to resolve.
Fever 103 to 100.8 with Ibuprofen. Swelling thigh right. Erythematous macular rash at injection site (8cm).
Informtion has been received from a concerning a 16 year old female who on 24-AUG-2007 was vaccinated with a first dose of GARDASIL (lot # 657737/0522U). Concomitant therapy on the same day included VARIVAX in the left arm and there was no adverse event involved with that arm. On 28-AUG-2007 the patient developed erythema, pain and minimal swelling at the injection site. The patient stated that the pain hurt from elbow all the way to the back of her neck. the physician recommended a warm compress and "benderly". On 29-Aug-2007 the patient called back and reported she  had a fever of 100.1. The physician stated that "it was due to perception of swelling to the wrist" and recommended ALVEVE. Medical attention was sought. At the time of reporting it was unknown of the patient had recovered.
Complete exhaustion/Tired; Headache; Nauseated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 93 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Complete exhaustion/Tired"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; NAUSEA (non-serious), outcome "unknown", described as "Nauseated". Therapeutic measures were taken as a result of headache.  Additional information: After her 2nd shot, the patient felt absolutely nothing. But on the 4th day after the 2nd shot, she had complete exhaustion for 15 mins. On the 6th day after the 2nd shot, the patient woke up with headache and was nauseated. She took medicine for headache and she woke up slightly tired. She just hopes that the vaccine worked, and she asked if she should get an antibody test.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
03/17/2021 Evening- soreness, warmth, redness, and swollen all localized to the injection site Pt was advised to seek medical care to examine the arm.  was consulted and Dr.was notified.
This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Tiredness) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 043B21A) for COVID-19 vaccination.No Medical History information was reported. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Tiredness). On 26-Apr-2021, PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Tiredness) had resolved. No relevant concomitant medications were reported. No treatment details were reported. This case was linked to MOD-2021-064397 (Patient Link).
pt states she had the chills, she was very cold, and had a temp of 101.  The fever broke after taking Tylenol.   the next day she is still achy and her arm is still sore but says she is feeling better.
headache, fatigue, body aches, chills on and off on 1/21/21 starting around 2:30pm.  Headache, fatigue, body aches, chills consistently on 1/22/21 starting at 3:00am-current.  Did not seek treatment or take medications.
The patient is a 12 year old female that received two Pediatric doses of Hepatitis B vaccination instead of one dose. The patient did not exhibit any reaction or adverse event at the clinic and no adverse events have been reported to date.
about 4min p/vax pt almost fainted;BP was down to 90/60 from 120/75;recv adrenalin w/recovery;
Diarrhea; Cough; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), COUGH (Cough) and VOMITING (Vomiting) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B211A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), COUGH (Cough) and VOMITING (Vomiting). At the time of the report, DIARRHOEA (Diarrhea), COUGH (Cough) and VOMITING (Vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
He started with some nasal congestion and sinus pressure about 3 days ago. He felt a bit feverish a couple of days ago, but his temp was not elevated. He feels like he perhaps had a mild head cold. starting 10/5/21