chrisvoncsefalvay/vaers-outcomes huggingface dataset:
maldaministration, one week after expiry date; This case was reported by a nurse via sales rep and described the occurrence of expired vaccine used in a infant female patient who received Rota (Rotarix lyophilized formulation) (batch number AB445, expiry date unknown) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received the 1st dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 26-JUL-2022 Reporter's comment: The patient's age was reported as 4 month 1 day old at the time of the event. The date was not provided but maldaministration occured one week after expiry date. The one week after product expiry date, no adverse events had been reported to the clinic. The reporter thinks it was a mistake by the vaccine clinic personel. The reporter did not consent to follow up. Additional Supportive Information: The patient received an expired dose of Rotarix, which led to expired vaccine used. There was discrepancy in reported patient's age as partial and its age was lesser than 4 months hence not captured in patient tab.
Days after shot started to develop itching. Redness at injection site, then started to get rashes on chest area, severe itching all over for 6 days. Itching continues 11 days after injection. Itching in ear and fingertips.
Soreness at site of injection, sore arm for 3 days.  Brief slight sharp pain above lip and below left nostril (likely near lymph node) on same day of vaccination. Diarrhea (may or may not be related) a few hours after vaccine. No other symptoms.
February 7, 2021 to March 20, 2021: Same evening burning sensation in forehead, muscle aches in legs.  Following three weeks: sore throat, 3 weeks laryngitis, shortness of breath, chest and upper respiratory pain, overall lethargy,  late February and March: 3 weeks abdominal pains and continuous diarrhea .
right foot has been hot since I got my vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (right foot has been hot since I got my vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (right foot has been hot since I got my vaccine). At the time of the report, FEELING HOT (right foot has been hot since I got my vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was unknown by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: NNI
Patient complains of nausea, lightheaded, and not feeling well.  Patient looks weak, clammy, and lethargic.  Pt at this time is unresponsive to verbal. She is laid down on supine position. Pulse is present and strong per carotid artery. Epi is given per IM (epi pen) at 10:46am and help is called. The facility code team report to the scene and patient is assessed by the MD. Pt is at this time approx. 10:48am is alert and oriented x3. Vitals BP: HR:98 RR: 22 Biox: n/a. Pt report feeling weak but ok. She states before the start of the event; she had tingling in her arm. Pt post event vitals are taken and within normal. Patient is assessed by the physician and recommend to be observed at the site for extra 30minutes and discharged to home.
Mild heart palpitations.... maybe for 10 or 15 minutes, a few times a day.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 74-year-old, elderly patient of unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 17-Oct-2018, the patient was administered FLUAD (TIV), [route of administration: intramuscular, anatomical location: right deltoid, batch number: 250802, expiry date: 30-Jun-2019 and dose: not reported] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805454 was crossed linked to original case 201804863 due to same reporter.
One month after receiving the booster vaccine of Moderna, I tested positive for COVID-19. In the beginning of February 2022, I started to notice a change in my menstrual cycle. I have always had normal cycles, but I noticed that my cycle was fierce. I had terrible cramping and heavy bleeding. I feel like things were just thrown off. March 2022 was fine, but then April 2022 I experienced a very long cycle. I went to the Gynecologist to find out what was wrong. I had an ultrasound performed and a hysteroscopy. Those results were normal. I did have a polyp and they did remove it. I do not have any previous history of polyps. After that, my cycle has not returned. The gynecologist believes that this is because of my age, but I'm not experiencing any other symptoms to menopause.
Narrative:  Pt states he received 2 vaccines on 4/19, PPV23 on right arm and  Herpes Zoster on the left here at the facility (documented). Pt states he woke up this morning and his right arm was red and painful. Pt states he has not taken anything for it or tried to treat the area with anything. Right arm- Redness and swelling noted from upper arm/shoulder to elbow. No heat, drainage, streaking, hives, open  areas of skin noted. New script for Benadryl given for fill at pharmacy.
finger started swelling; Potential Small Finger Vasculitis; Intense Finger Pain; Bruising on the Finger; wrist on that same hand started hurting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Intense Finger Pain), CONTUSION (Bruising on the Finger), ARTHRALGIA (wrist on that same hand started hurting), PERIPHERAL SWELLING (finger started swelling) and VASCULITIS (Potential Small Finger Vasculitis) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (Intense Finger Pain), CONTUSION (Bruising on the Finger) and ARTHRALGIA (wrist on that same hand started hurting). On 20-Jan-2021, the patient experienced PERIPHERAL SWELLING (finger started swelling) and VASCULITIS (Potential Small Finger Vasculitis). At the time of the report, PAIN IN EXTREMITY (Intense Finger Pain), CONTUSION (Bruising on the Finger), ARTHRALGIA (wrist on that same hand started hurting), PERIPHERAL SWELLING (finger started swelling) and VASCULITIS (Potential Small Finger Vasculitis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Magnetic resonance imaging: potential small vasculitis (abnormal) Potential small vasculitis..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported.
Blotchy Rash covering the upper arm about 6 inches in length and about 5 inches wide.  It is a little bit warm to  the touch.  very mild itching from time to time.  It may have appeared before this report but I was wearing long sleeves until the weather got warmer yesterday so never notices it.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after the 30 day BUD) 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. AS7171B) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 04-Feb-2023, 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 04-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered after the 30 day BUD) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (dose administered after the 30 day BUD).
I went to my grandson's football game over the weekend. I started feeling like I was getting a cold on Tuesday, my daughter told me to test myself. I used a home COVID-19 test. It came back negative, I still felt bad on Wednesday, so I retested this time it came back positive. I did not want to believe it came back positive, so I retested on Thursday. This time I called my doctor and told her I had cold like symptoms, tested and it came back positive for COVID-19. She called me in prescription for PAXLOVID that I started taking that night. I had hot and cold sweats, stuffy nose, it felt like a head cold to me. By Sunday I was feeling better and testing negative for COVID-19. I thank God for PAXLOVID.
A few hours after receiving my first dose of the vaccine, as I was going to sleep, my heart started beating very fast. It was hard getting to sleep as I could not seem to slow it down with breathing. As of this morning at 6:41am, it still feel as though it is beating abnormally fast.
At 48 hours I developed a rash and itching from head to toe.  Mild.  Benedryl helped.  Then at 72 hrs, I developed chronic sneezing. All reactions have resolved as of today, 1/15/21.
Pt presented to the office with non pruritic rash which initiated 1-2 days prior to OV on 5/6/2013. Developed fever to 102F two days after visit with painful lesions following.
dizziness; nausea; headache; soreness; This is a spontaneous report from a contactable consumer. A 30-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Apr2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as unknown. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19 and also unknown if the patient was pregnant at the time of vaccination. It was unknown if the patient had any allergies to medications, food, or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 21:00, the patient experienced dizziness, nausea, headache, and soreness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness, nausea, headache, and soreness was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
No adverse event; 14 year old received bivalent booster; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old received bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 14-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Oct-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 05-Oct-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old received bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old received bivalent booster) 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 assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old received bivalent booster).    No concomitant medication were reported. The nurse stated that one of the employees gave a bivalent booster shot to a 14 year old.    No treatment medication was provided.
Information has been received from a licensed visiting nurse concerning 10 adult patients who have been vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). It was reported that in the last 1 month the 10 patients have complained of injection site redness, soreness and warm to touch. It was also reported that the lot number used for all patients was not the same. The patients sought unspecified medical attention. The patient's outcome was reported as "improved 48 hours after injection." There was no product quality complaint involved. Additional information has been requested.
I received the vaccination on 2/10/21. I had the normal symptom I was warned about. Those symptoms were gone in two days. Everything was normal until 2/17/2021. I felt a knot on my arm where I received the vaccination. The next morning/through the night         (2/18/2021)  I felt pain in my arm and experienced swelling, redness and it is warm to  touch.  I am still feeling this at this time..  My concern is, I am having these symptoms a week after I had the first dose of the vaccine. Is this a normal reaction? Should I seek medical attention?
This case was reported by a physician via call center representative and described the occurrence of nausea in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced nausea and vomiting. On an unknown date, the outcome of the nausea and vomiting were recovered/resolved. The reporter considered the nausea and vomiting to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional stated that this incident occurred a month before the date of reporting and he had forgotten the details at the time of reporting. The reporter did not report to GlaxoSmithKline initially, as he read in the product information (PI) that this was a known adverse event following SHINGRIX administration. No additional information provided.
Four months later, I have been traveling, I went to a major airport, on the plane. I had fever, coughing, I went to see the provider, he listened to my lung and was diagnosed with Pneumonia. I have a COVID-19 test and it was negative. I also had the Flu test and it was negative. They gave antibiotics.
sore under my left arm (armpit area) - presumably the lymph node - started approx. 48 hours after receiving the second dose; sore under my left arm (armpit area) - presumably the lymph node - started approx. 48 hours after receiving the second dose; soreness seems to radiated onto my upper pectoral area on my chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Aug2021 (Lot number: EW0171) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: D3; GINKGO BILOBA; OSTEO BI-FLEX EASE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/lot number: EW0169 , Anatomical Location: Arm Left), administration date: 31Jul2021, for COVID-19 immunization.  The following information was reported: AXILLARY PAIN (non-serious), LYMPH NODE PAIN (non-serious) all with onset 23Aug2021 07:45, outcome "not recovered" and all described as "sore under my left arm (armpit area) - presumably the lymph node - started approx. 48 hours after receiving the second dose"; NON-CARDIAC CHEST PAIN (non-serious) with onset 23Aug2021 07:45, outcome "not recovered", described as "soreness seems to radiated onto my upper pectoral area on my chest". The events "sore under my left arm (armpit area) - presumably the lymph node - started approx. 48 hours after receiving the second dose", "sore under my left arm (armpit area) - presumably the lymph node - started approx. 48 hours after receiving the second dose" and "soreness seems to radiated onto my upper pectoral area on my chest" were evaluated at the physician office visit and emergency room visit. It was unknown if therapeutic measures were taken as a result of axillary pain, lymph node pain, non-cardiac chest pain.  Additional information: The patient had no relevant past drug history and concurrent conditions. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included fertility drug. Patient had sore under his left arm (armpit area) - presumably the lymph node -started approx. 48 hours after receiving the second dose. That soreness seems to radiated onto his upper pectoral area on his chest - making him think he had lung or heart related issues associated with the vaccine. Patient wanted to know if it was something to get tested. He scheduled a doctor appointment; however, did not require immediate attention.   Follow-up attempts are completed. No further information is expected.
lower back was completely frozen solid and has been very uncomfortable/ hard to straighten up/ tightens up when moving; lower back was completely frozen solid and has been very uncomfortable/ hard to straighten up/ tightens up when moving; back pain on the area where the patient had back surgery 47 years ago; a little flu like; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 11Mar2021 (Lot number: EN6206) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Back surgery", start date: 1974, stop date: 1974, notes: 47 years ago; "could not straighten up the back (only for a single time)" (not ongoing). The patient took concomitant medications. Vaccination history included: BNT162B2 (DOSE 1, SINGLE (Lot No: EN6201)), administration date: 10Feb2021, when the patient was 74 years old, for COVID-19 immunization, reaction(s): "arm was sore". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 12Mar2021, outcome "unknown", described as "a little flu like"; MUSCULOSKELETAL STIFFNESS (non-serious), MUSCULOSKELETAL DISCOMFORT (non-serious) all with onset 13Mar2021, outcome "recovering" and all described as "lower back was completely frozen solid and has been very uncomfortable/ hard to straighten up/ tightens up when moving"; PROCEDURAL PAIN (non-serious) with onset 13Mar2021, outcome "recovering", described as "back pain on the area where the patient had back surgery 47 years ago". Therapeutic measures were taken as a result of influenza like illness, musculoskeletal stiffness, musculoskeletal discomfort, procedural pain. Additional information: Treatment included paracetamol (TYLENOL) 500 mg cut in half (250 mg) along with a half of methocarbamol (muscle relaxant) which seemed to help. The patient was also concomitantly taking unspecified "heart drugs" for an unspecified indications.  No follow-up attempts are possible. No further information is expected.
lt arm immed stared swelling p/vax;cold compress applied;APAP given q 4-6hr;called PMD same evening;advised to cont APAP & cold compresses;swelling worsened during noc;fingers swollen & neck swollen & reddened;blisters @ bandaid site;
Information has been received from a physician concerning a female patient who on 22 Nov 2006 was vaccinated with a 0.5 ml dose of Gardasil. On approximately 22 Nov 2006, the physician reported that the patient experienced reaction a "tendonitiis like" pain near the injection site. It was noted that there were no signs of cellulitis and the pain has not been responsive to OTC non-steroidal medication. At the time of this report, the patient had not recovered. Additional information has been requested.
Tinnitus and ringing in ears, comes and goes but more frequent at night, wakes me up out of sleep, has been happening more consistently over last week and a half
Autoimmune Disorder; Postural orthostatic tachycardia syndrome (POTS); Dizziness; Headache; Orthostatic Intolerence; Autonomic Dysfunction; Palpitations; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 26-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported). On an unspecified date in 2013, the pt experienced following vaccination autoimmune disorder, postural orthostatic tachycardia syndrome (POTS), orthostatic intolerance, dizziness, headache, palpitations, and autonomic dysfunction. The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.   Upon internal review, the autoimmune disorder was considered as a medically significant event.; Sender's Comments:  US-009507513-2301USA007498: US-009507513-2301USA007522: US-009507513-2301USA007524: US-009507513-2301USA007521:
numbness, hard to get breath, hiccups, Can't tell difference to hot and cold with are and hand, hand and arm ice cold inside. Sensitivity to touch.
H1N1 LAIV on 10/28. Fever and cough and clear rhinorrhea 10/29.
Area 5 in. in size, red and warm on right deltoid area x 36 hrs.  Taking Tylenol and using cool compresses.  Wife sts. "better today"