chrisvoncsefalvay/vaers-outcomes huggingface dataset:
So cold; Feel overly warm; Severe chills, not every night /both times were very severe; Flu-like symptoms; A buzz that goes in and out of my head, like a tiny vibration.; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (A buzz that goes in and out of my head, like a tiny vibration.), INFLUENZA LIKE ILLNESS (Flu-like symptoms), FEELING COLD (So cold), FEELING HOT (Feel overly warm) and CHILLS (Severe chills, not every night /both times were very severe) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052C21A and 017C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (A buzz that goes in and out of my head, like a tiny vibration.). On 01-Jul-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). On an unknown date, the patient experienced FEELING COLD (So cold), FEELING HOT (Feel overly warm) and CHILLS (Severe chills, not every night /both times were very severe). At the time of the report, TINNITUS (A buzz that goes in and out of my head, like a tiny vibration.), INFLUENZA LIKE ILLNESS (Flu-like symptoms), FEELING COLD (So cold), FEELING HOT (Feel overly warm) and CHILLS (Severe chills, not every night /both times were very severe) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported.  It was reported that patient patient's doctor ran some tests and the results were negative. Further stated that chills were minor sometimes and very very severe other times, started getting these after she got her shots. Patent had very severe chills on 11-Oct-2021 and 23-Oct-2021.
1 week after getting the vaccine I woke up with a painful lump and rash at the site of the injection. The lump and rash got larger over that day and the next 2/1-2/2).  By 2/3, the lump started to soften and the rash started to fade by 2/5 the rash and lump were gone.
Noted with prolonged menstruation of over 10 days. Menstruation started on 11/7/21 and continued with moderate to heavy flow until provider visit on 11/18/21. Menstruation is usually regular (approximately 4-5 days total), occurs around the same time of the month (between 6th-8th of month). This is first time patient?s menstruation was longer than 5 days.
Day of immunization: fever, chills, ache, nausea night of immunization: fever, chills, diarrhea day 2-6 diarrhea, nausea.
My peripheral neuropathy has been under good control for over a year, with Gabapentin. The day after the vaccine was given, I had a very painful, severe almost 24 hour period of pain in both feet exactly like my neuropathy was over a year ago. Gabapentin and Tylenol provided no relief. There was burning and stinging in both feet, worse in the hallux.  This went away in less than 24 hours, but was severe for over 12 hours.  I have not had this severity of pain (8/10) in over a year.  I did have 103 fever, body aches and headache the day after the vaccine all of which subsided within 24 hours.
evening post vax pt exp itchiness-morning post vax pt devel rash on trunk, arms, face & legs consistent w/hives;rx atarax;
Strong headache since Tuesday October 15th and today is the 17-Oct the pain continues.
No additional adverse effect were reported; patient received an expired dose of VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided.  On 23-JUL-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 50/1 U/ml (lot # S007265, expiration date 07-JUL-2020), 1 milliliter once for prophylaxis (route and anatomical site of administration were not provided). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S007265; expirationdate: 07-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
A 39 year old female pt reported that she received a dose of Flumist on 12/8/03. The pt's concurrent illness includes hypersensitivity (allergic to Sudafed). The pt previously experienced heart rate increased, influenza like illness and headache while taking Sudafed. On 12/8/03, a 39 year old female pt reported that she experienced heart racing, flu-like symptoms and headache within minutes of receiving a dose of Flumist. The reporter stated that she experienced a similar reaction after receiving a dose of Sudafed in the past. The adverse events have not resolved. No additional info was available at the time of this report. Follow-up information was received on 09-Jan-2004 from the reported which provided additional adverse event information. A 39-year old female patient reported that she recieved a dose of Flumist (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) on 08-Dec-2003 and experienced flu-like symtpoms, heart palpitations, headache, sweating, shortness of breath, and shaking. According to the reporter, the adverse events resolved withing twenty minutes after the receipt of Flumist. She stated that she experienced a similar reaction after receiving Sudafed. The patient reported that on two previous occassions, after the adminstration of Sudafed, she was seen in an emergency room for her allergy. She reported that she did not seek treatment for the adverse events related to the administration FluMist.
throat pain; increase body temperature; feels has something in throat; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 28Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. After getting the vaccine on 28Dec2020, the patient asked if it is okay to get tested for Covid or if it might result in false positive. The patient reported that she has throat pain, increase body temperature and feels has something in her throat and keeps swallowing to clear it. She felt it yesterday (29Dec2020) and now is okay, only her throat was hurting. The outcome of event throat pain was not recovered, while the outcome of other events was recovered on an unspecified date.  Information on the batch/lot number has been requested.
Diarrhea started around 1 PM the day after the vaccine.  Currently still occuring at almost 2 PM.     Not sure if this should be reported or not.  Someone told me we had to report instances.  Injection site is still sore.
Vaccines are kept frozen until they were ready for administration, in fridge about 1-3 days.; The patient received Moderna vaccine beyond the use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received Moderna vaccine beyond the use date) and PRODUCT STORAGE ERROR (Vaccines are kept frozen until they were ready for administration, in fridge about 1-3 days.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received Moderna vaccine beyond the use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines are kept frozen until they were ready for administration, in fridge about 1-3 days.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received Moderna vaccine beyond the use date) and PRODUCT STORAGE ERROR (Vaccines are kept frozen until they were ready for administration, in fridge about 1-3 days.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter had stated that tended to store 1 to 3 bottles in the fridge to thawout and ready for the patients when needed. At worst scenarios, the vials would have been in fridge for about week if no once came in to be vaccinated. No treatment medications were reported.
Diarrhea every time I eat anything; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea every time I eat anything) 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 DIARRHOEA (Diarrhea every time I eat anything). At the time of the report, DIARRHOEA (Diarrhea every time I eat anything) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided by reporter.   This case was linked to MOD-2021-223096 (Parent-Child Link).   See case MOD-2021-223096 for details regarding the child case.  Reporter did not allow further contact
3 days after vaccine pt was working as a social worker telehealth and developed sudden loss of speech and understanding of what she was writing.  lasted about 15 minutes. but also had trouble using her cell phone to get help, eventually called her cousin who came over and walked her to ER. pt was admitted overnight, had CT and MRI both normal and saw neurologist and diagnosed with aphasia and TIA.  was given baby aspirin, eloquis and atorvastatin to go home. has follow up scheduled for EEG and neurology and echo and heart monitor.
Patient was given Moderna bivalent vaccine 24 hours after the use by expiration date. Patient without symptoms. MD was notified. Manufacturer was notified to determine stability of vaccine and adequacy of coverage against COVID.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site wheal in a 51-year-old female patient who received SHINGRIX (batch number 79N59, expiry date January 2019). On 27th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On 27th April 2018, the patient experienced injection site wheal. The patient was treated with medication unknown, medication unknown (Ice Pack (Nos)). On an unknown date, the outcome of the injection site wheal and injection site pain were not recovered/not resolved. The reporter considered the injection site wheal and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient had a lot of concurrent medications (not specified). At 16:30 hours, the patient received SHINGRIX in the left deltoid. The patient had a big red welt at the injection site. The injection site was treated with ice right away. Less than a week after receiving SHINGRIX, the welt at the injection site was painful. At the time of the report, the patient still had the welt.
Pt felt shortness of breath. Chest pain. Condition resolved after approximately 10-15 min. Cleared by EMT.
20 hours after the first dose of the Pfizer vaccine I developed right flank pain that felt like a kidney stone. The pain was mild at first but got quite severe within an hour to the point where I was on the floor crying. My boyfriend talked me into going to the ER, and I felt very nauseated in the elevator and the car. At the Hospital?s ER I received pain medication (Toradol and an opiod I can?t remember the name of), and a CT scan to determine if I had a kidney stone. No stone was seen on CT. After discussing the events with Dr., we determined that the Pfizer vaccine was the most likely, yet still quite unlikely, cause of my symptoms. I was sent home with some pain (Norco) and nausea (Zofran) medications and was told to follow up if the lain didn?t resolve over the next few days. My pain slowly faded and was gone by the next morning. Later that day (Jan. 16, 2021) I noticed I felt like I had a sunburn starting just superior to my right iliac crest and descending anteriorly about 20 cm, but my skin had no visible abnormalities. A few days later on Jan. 21 I noticed the area was slightly red. I took a photo and sent it to my mother, who is a PCP, asking what I should do and she instructed me to try applying topical Hydrocortisone. I did so 2-3 times per day as needed and the redness resolved within a few days. The sunburn sensation faded slowly but lasted until about a week ago (Feb. 12). Yesterday (Feb. 17) I noticed that my skin in that area is slightly numb. I can feel pressure and temperature, but I am unable to tell the difference between a touch and a light scratch. Sensation outside the affected area is normal.
Narrative:  Patient received a COVID-19 vaccine and <10 minutes after receiving the injection, patient complained of feeling like he is going to pass out and needed to lay down, feeling flush, mildly diaphoretic, weak, with sweaty hands. Wheelchair obtained and patient taken from exam room to lay down. Water given to patient and vitals obtained (see below vitals & time). Patient stated that he was at an ENT appointment earlier and his blood pressure was 150s/110s at the time of his appointment. 1550 BP 184/134, HR 126, O2 sat 98% 1605 BP 167/129, HR 109, O2 sat 100% 1620 BP 167/117, HR 88, O2 sat 100% 1640 BP 166/125, HR 87, O2 sat 100%
Pt is a 20 year old. He states that he was in good health until receiving his 2nd anthrax injection on 3/4/03. Since then he as been troubled with multiple complaints to include headache, nausea and vomiting, abdominal pain, paresthesia of his lower extremities and testicular pain. A description of these symptoms is as follows: left arm-erythema and swelling with "quarter-size nodule" again lasted 2-3 days. Reported "cold symptoms" dry cough and chest congestion 4 days after injection. Seen and Rx with zithromax and cough syrup. On 3/12 he developed a red, itchy rash across his chest that spread to include his upper body after showering. He was seen at the clinic Dx as atopic dermatitis, and given Benadryl that afforded little relief. he was seen in he ER later that evening, given a steroid shot and a Medrol dose-pak. On 3/14 he had "sharp shooting chest pains," SOB, elevated BP, abdominal pains, nausea, vomiting, constipation and myalgias. His EKG, X-ray ahd labs were essentially normal. He was diagnosed with viral gastritis, RX with IV fluids, phenergan, Lortab and Aciphex. He continued to vomit and was seen again in the ER March 15 where he was Dx with dehydration, again given phenergan, IV fluids and colase. On March 17 he began having bilateral leg pains (described as 10 on the pain scale) with "tingling" from thighs down to his feet "my toes turned purple." He was seen in ER where Doppler studies were negative, given pain meds, and ZoFram for nausea (the abdominal and leg pains remained at 8). On March 23rd he experienced excruciating abdominal pains radiating down into his testicles that necessitated in ambulance trip to the ER. There testicular US, labs, U/A and physical exam were essentially WNL. He was given MS injection and sent home with Darvocet. His abdominal, testicular and myalgias persist at an 8 on the pain scale.
Information has been received from a RN concerning a first grade male pt who on 11/17/98 was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt developed chickenpox. Unspecified medical attention was sought.  There was no product quality complaint involved. Additional information has been requested. It was noted that pt's from the same source had similar experience. (WAES # 0403USA02088, 0403USA02110, 0403USA02111, 0403USA02112, 0403USA02113, 0403USA02114, 0403USA02115). **Follow up information was received from the registered nurse who indicated that the patient was vaccinated at another facility. Chickenpox was diagnosed on or about 01/17/2004. No further information is expected.
70 year old male received two doses of the Fluzone Quadrivalent High Dose in the same flu season with no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Information (Reference number- 00324036) and transmitted to Sanofi on 20-Oct-2020.  This case involves a 70 years old male patient who received two doses of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] in the same flu season on 13-Oct-2020 [batch number, expiration date not reported] via an unknown route and site and on 20-Oct-2020 [batch number-UJ510AA and expiration date 30-Jun-2021, 0.7 ml, frequency- twice] via an intramuscular route at left deltoid for prophylactic vaccination(extra dose administered).  The patient's medical history, past medical treatment(s), vaccination(s), family history were not provided.  Concomitant medication includes Shingles vaccine (VARICELLA ZOSTER VACCINE).  It was a case of an actual medication error due to extra dose administered (latency 7 days from 1st dose and on same day of 2nd dose).  At the time of report, no adverse event was reported.  The nurse reported that their clinic has a database that was checked to see if a flu vaccine had been given and the database showed no flu vaccine given this season, however the patient  realized he got another flu vaccine when he was reviewing his paper work. The original injection on 13-Oct-2020 took place at a local pharmacy. Nurse wanted information on any reactions regarding this occurrence which could be conveyed to patient.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.  There will be no information available on the batch number for this case for first dose.
Pt had pain right after getting the shot that was radiating to her shoulder, arm, and neck.  On 3/16/23  she had a rush and went to doctor's office and was diagnosed with shingles.  Pt thinks she got shingles because she had the shot. Pt had huge blisters in her mouth the following day.
Reported waves of dizziness after vaccine. GIven water, legs elevated, rested. BP 122-130/62-80
Hot to touch on the injection site; Itching on the injection site; Swelling on the injection site; Pain on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch on the injection site), VACCINATION SITE PRURITUS (Itching on the injection site), VACCINATION SITE SWELLING (Swelling on the injection site) and VACCINATION SITE PAIN (Pain on the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS), METOPROLOL and ATORVASTATIN for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot to touch on the injection site), VACCINATION SITE PRURITUS (Itching on the injection site), VACCINATION SITE SWELLING (Swelling on the injection site) and VACCINATION SITE PAIN (Pain on the injection site). At the time of the report, VACCINATION SITE WARMTH (Hot to touch on the injection site), VACCINATION SITE PRURITUS (Itching on the injection site), VACCINATION SITE SWELLING (Swelling on the injection site) and VACCINATION SITE PAIN (Pain on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Medications were not provided by the reporter.
Fever 105.0 & lower several hrs p/vax; high-pitched abnormal cry x 8 hrs off & on; resting 10-15min betwen 20min crying spells; Pt to ER advised to dec temp by sponge bath; returned to ER a total of 3x, last time ER staff sponged bathed pt;
Saturday 1/9/21 I felt fine all day, until approximately 6:15 pm when I suddenly felt light-headed, dizzy, increased heart rate, palpitations, feeling of tight throat, disconnect between what I was saying and how I was hearing my own voice, difficulty expressing my thoughts, headache, shortness of breath. The following day I continued having some dizziness, headache, nausea, shortness of breath. Mon. 1/11-Thurs. 1/14 I had splitting headaches and nausea. I developed a rash on my arm at the site of the injection at some point, unsure when. The rash wasn't noticed until Sunday 1/17 and still remains today, 1/18.
Severe Vertigo lasting 12 hours requiring confinement to bed.  Called ambulance and taken to Emergency Room.   Treated with fluids and meclazine.  Vertigo  attributed to Vestibular Neuritis/labyrinthitis.  This condition is often caused by a virus, however patient did not have any known virus prior to onset of symptoms.
This spontaneous report as received from a consumer regarding himself refers to a male patient of unknown age. The pertinent medical history of the patient included allergic rhinitis and GERD. Approximately on an unknown date in 2013 the patient was vaccinated with ZOSTAVAX (routed as about 1 year ago) (dose, route not reported) to prevent shingles. Other suspect therapies included BEXTRA and LAMISIL reported as BEXTRA and LAMISIL. Concomitant therapies included PROTONIX and SINGULAIR. The reporter stated that approximately on an unknown date in March 2014 (reported as 2 months ago) the patient experienced itchy rash from the back of the hip to the medial lower leg on just on of his leg and there are no open lesions or pustules and the patient went to the physician who gave him ECONAZOLE. It was also reported that the physician believed that the patient has a fungal infection and this treatment had no effect. The physician performed a biopsy of the rash (unknown date) which showed spongiform inflammation and the patient was then given clobetasol and Cutemol (manufacturers unspecified). The patient also stated that he had erythema minor on an unspecified date after BEXTRA and LAMISIL (manufacturers unspecified) use. The outcome of fungal infection and itchy rash was reported as not recovered/not resolved. The outcome of erythema minor was reported as recovered/resolved on an unknown date. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Rash, lesions 2-5 mm, scattered over upper extremities and neck; bruise like. Rash occurred 4/24 with viral syndrome. Vaccines given 4/19/10.
Pt had vaccine 9/11/2020. 9/23/2020 mom noticed red papular rash all over body. Mom sent picture to Doctor.