chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Runny nose; Sneezing; Dry cough; allergy; sinus; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), SNEEZING (Sneezing), COUGH (Dry cough), HYPERSENSITIVITY (allergy) and SINUS DISORDER (sinus) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Bleeding since 12-Jan-2021. Concomitant products included DABIGATRAN ETEXILATE MESILATE (PRADAXA), HYDRALAZINE, METFORMIN and ATORVASTATIN for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced RHINORRHOEA (Runny nose), SNEEZING (Sneezing), COUGH (Dry cough), HYPERSENSITIVITY (allergy) and SINUS DISORDER (sinus). On 13-Jan-2021, RHINORRHOEA (Runny nose), SNEEZING (Sneezing) and COUGH (Dry cough) had resolved. At the time of the report, HYPERSENSITIVITY (allergy) outcome was unknown and SINUS DISORDER (sinus) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment related information has been reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2021: Event (Sinus PT) linking updated as per MR request; case inadvertently locked without making the changes.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a physician via a other health professional refers to a 18 month old male patient. There were no drug allergies, family history and prior medical history. Patient who began on PREVNAR 13 0.5 ml (milliliters) intramuscular injection on an unknown anatomical site at an unknown time on an unknown date. Vaccines given on the same day included Hib (Sanofi) vaccine and DTaP (GSK) vaccine. Vaccines taken within the last four weeks since 18-JUL-2014 were none. On 18-JUL-2014 the patient was vaccinated with PNEUMOVAX 23 lot # K004930; expiry: 16-MAR-2015, dose #: 4 (dose, route and anatomical location of the administration of the vaccine were unknown). Relevant concomitant medications were unknown. On 18-JUL-2014, it was reported that the patient received 4th dose of adult PNEUMOVAX 23 vaccine instead of PREVNAR 13. Diagnostic tests: unknown. No emergency room or doctor visit was required. No adverse event was reported. The outcome of patient received 4th dose of adult PNEUMOVAX 23 vaccine instead of PREVNAR 13 is unknown. Action taken was not applicable (also reported as dose not changed). Causality was provided as not related by the reporter. Additional information has been requested.
Moderna Lot#13L20A for #1,  Lot#014m20a for Second injection:  three days of headache, joint pain, sinus irritation, nausea, GI cramping, overall all body ache, cough
FEVER; HEADACHE; NO ENERGY; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced no energy. On 27-APR-2021, the subject experienced fever. On 27-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache and no energy was not reported. This report was non-serious.
That evening I vomited but didn't feel sick. The next am woke up with a rash that appeared to be welts on my neck, chest, and back. The welts didn't itch or hurt.  Took over the counter meds and the rash went down but then I felt like my eyes, lips and tongue were swelled. I felt sick, almost like a bad cold.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of, oral, ROTATEQ lot # K010221, K01163, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administration were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the reporting healthcare professional on 02-JUL-2015, who informed that a patient was vaccinated on 09-JUN-2015 with a dose of oral, ROTATEQ lot # K016313, expiration date not reported (administration route was not provided). According to the reporter the vaccine dose that was administered underwent a temperature excursion for 87 hours. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a female (age unknown) who in early 2007 was vaccinated with a dose of Zostavax. In 2007 the patient experienced scarring due to the injection in her arm. "A few months later", the patient got an outbreak of shingles in the arm where she was vaccinated and is still suffering post-herpetic neuralgia. About 1 week ago she came in for an outbreak of zoster on another part of her body. Additional information has been requested. 09/24/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Follow-up information was received from the physician indicating that the patient was a 77 year old female that received a subcutaneous dose of ZOSTAVAX (Oka/Merck) (lot# 654603/1405F) on 15-JAN-2007. The physician indicated that the patient had, "redness and scarring with persistent pain at the site of injection. Recurrence of HZV at a different site". The results of the questionnaire are as follows: The patient received the dose on her left side. The patient developed a rash at the site of injection approximately 3 weeks after vaccination. Pain was rated 10, on a scale of 1 to 10. The patient had a history of chicken pox. No recent exposure to chicken pox or herpes zoster. No direct fluorescent antibody was performed, no specimen for PCR was collected nor was a photo taken of the site. A biopsy was taken. No further information is expected.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 14-NOV-2012 at 22:41, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Increased congestion about 12 hours after receiving the vaccine. Congestion in back of throat and feeling like I need to clear my throat often.; When I clear my throat there is phlegm; Slight nasal congestion; Slight itching and soreness of the throat; Slight itching and soreness of the throat; coughing once through the night; pain and swelling of the injection site; pain and swelling of the injection site; fatigue; This is a spontaneous report from a contactable consumer.   A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 18-DEC-2020 09:00 AM (at the age of 36-years-old) at an unspecified dose in the left arm for COVID-19 vaccination.  Medical history was reported as "None" and the patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination.The patient was administered the vaccine in the hospital. Concomitant medication included zolpidem tartrate (AMBIEN), clonazepam (KLONOPIN) and "MVI" (not further specified). The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 18Dec2020 at 17:00, the patient experienced increased congestion "about 12 hours" after receiving the vaccine as well as congestion in back of throat which she described as  "feeling like I need to clear my throat often"  and "when I clear my throat there is phlegm." Further, on 18Dec2020 at 17:00 the patient also experienced slight nasal congestion, slight itching and soreness of the throat that lasted for about 30 minutes and she woke up coughing once through the night. Additionally, on 18Dec2020 at 17:00 the patient experienced pain and swelling of the vaccination site and fatigue. The patient did not receive any treatment for the events. The clinical outcomes of congestion in back of throat, phlegm, nasal congestion, sore throat, itchy throat, coughing, vaccination site pain, vaccination site swelling and fatigue were not recovered.  It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Patient received influenza and PNEUMOVAX 23 vaccines on 12/11/17 at 0935 in clinic (hospital-based clinic). Family notified medical team that patient developed high fevers, pain, and arm swelling on 12/12/17 at 1712. Patient was seen in ED (emergency department) for these symptoms on 12/12/17 at 2021; area of erythema on patient's arm was marked by ED staff and reaction was determined to be local and not systemic. Patient was seen again in ED on 12/14/17 at 0035 due to worsening reaction at the injection site (swelling extended past previous demarcation line). Arm swelling was concerning for cellulitis and patient was prescribed clindamycin TID x 10 days to treat cellulitis.
Approx. 3 pm patient began having itchy hands, her hands were red. The itching progressed to her arms and her back. She now had what appeared to be a rash on her back, arms. BENADRYL was given along with hydrocortisone cream at 4:30 pm. At 5:00 pm itching continued, rash now on neck. Staff was preparing to take her to the ER
High fever during the first night. Next day : pain in injected arm; fatigue/drowsiness. Duration of symptoms: 2 days.
I go shingles from the shot/Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 14-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got shingles from the shot. The reporter denied for follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Within several hours of receiving the Tdap vaccine, I had fierce pain in my right arm.  Having been advised of the potential pain, when scheduling the appointment for this vaccine, I assumed my symptoms were normal.  As a result, I did not seek medical treatment.  Over the next two days, the pain intensified to the point that I was unable to utilize my right arm.  On Tuesday, November 25, 2014, I returned to the employee health clinic.  I informed the nurse that I recently had a Tdap vaccine & asked to have my arm examined.  On a scale of one to ten, I described my pain as a ten.  The nurse did not examine my arm & informed me that "these symptoms are normal after a Tdap vaccine."  On Friday, December 12, 2014, I returned to the employee health clinic & asked to have my right arm examined.  I provided a brief history & expressed my concern about the excruciating pain & loss of functionality in my right arm.  The nurse did not examine my arm, but suggested that "you may have a blood clot under the skin."  I was instructed to take Motrin & apply a hot compress to the swollen & sore area of my right arm.  This comment just heightened my state of anxiety. Over the next seven months, I continued to suffer from excruciating pain in my right arm & shoulder.  I also lost a great deal of functionality in my right arm.  I truly can no longer perform activities of daily living.  The level of pain changes throughout the day.  If I happen to sleep on my right side, the intense pain will wake me from a deep sleep.  The pain & anxiety will last for several hours.  If I take Motrin & lay flat on my back, the pain will diminish but not disappear.  If I refrain from lifting anything with my right arm or performing activities with a repetitive motion, the pain is still chronic, but decreases to a minimal level.  On a scale of one to ten, I would describe minimal level as a three.  On most days, I take Motrin to alleviate the pain & utilize my right arm sparingly.  On Wednesday, June 24, 2015, I returned to the employee health clinic again & asked to have my arm examined.  The nurse did not examine my arm, but advised me to submit a claim with Workers Compensation.  Following the instructions provided by my employer, I scheduled a visit at Occupational Medicine.  An MRI was scheduled, but not completed.  At my next appointment, physical therapy & an orthopaedic consultation were ordered.  A few days later, I received a phone call from a claims representative at the insurance company.  The woman prefaced the conversation by saying "I am not a clinician."  She proceeded to inform me that "I have been doing this for a long time & there is no way that an injection in your arm could cause an injury to your shoulder."  She then advised me that my case was closed & any future appointments or treatments would be denied.  I canceled the physical therapy & orthopaedic consultation.  A year has passed since I received the Tdap injection.  The pain & loss of functionality in my right arm have caused a great deal of frustration & anxiety.
About 1.5-2 hours after receiving vaccine #1 patient felt light-headed.  She noticed that skin on her arms, upper chest, face and eyelids turned red.  She felt a tingling sensation over her skin as if she was going to get hives.  She took diphenhydramine 25mg and Zyretec 10mg PO and drank lots of fluids. She also had a low grade fever upto 100F for a few days after the vaccine. She did not develop any hives or itching.  The skin redness was gone the next day (3/23/21).
sore throat; within an hour (she) developed flu-like symptoms; low-grade fever; sore arm, where the shot was administered; had shortness of breath and asthmatic attack; had shortness of breath and asthmatic attack; upper respiratory infection; This spontaneous report was received from a 66 year old female patient referring to herself. The patient's concurrent condition included diabetes. The patient's drug allergy/reactions included penicillin, sulfa-drugs, iodine. The patient's concomitant medications included unspecified insulin and heart pills.  On 26-SEP-2019 the patient was vaccinated with a dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (strength, dose number, route, anatomical location, lot/batch #, expiration date were not reported) for prophylaxis. Within an hour, the patient developed flu like symptoms (influenza like illness), had a low grade fever (pyrexia), sore throat (oropharyngeal pain) and sore arm where the shot was administered (vaccination site pain). The patient had shortness of breath (dyspnoea) and asthmatic attack (asthma). On 01-SEP-2019, the patient was treated with antibiotic, steroid and breathing treatment for upper respiratory infection (upper respiratory tract infection). Thorough physical examination was done. The patient sought medical attention. No product quality complaint was involved.  The outcome of asthma, vaccination site pain, pyrexia, upper respiratory tract infection, dyspnoea, influenza like illness and oropharyngeal pain was reported as not recovered/not resolved.  The reporter's causality assessment was reported.
patient had dose 2 of the Pfizer vaccine. he had a seizure, after the seizure he immediately woke up. after 5 minutes he had a second seizure and he remained unconscious until EMS took him to the ER.
This spontaneous report as received from a medical assistant refers to a 1 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 16-JUN-2014 the patient was vaccinated with first dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J005010, expiry date: 23-OCT-2014) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA. Addtional information has been requested.
second dose after two weeks of first; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number C3455, expiry date 30th March 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 27th October 2021, the patient received the 2nd dose of Shingrix. On 27th October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The reporter stated that a patient was immunocompetent went to get the second dose of Shingrix after two week of the first dose, which led to shortening of vaccination schedule. On 20th January 2022 the patient asked for the record and then they realized the situation. The reporter wanted to know how to proceed.  The reporter consented to follow up.
09/24/2020 @5:30pm mom called reporting patient was wheezing, and retracting. Patient referred to the ED.
Information has been received from a physician assistant concerning hi daughter, a 13 year old female, who was administered her second dose of vaccination with GARDASIL vaccine (yeast) IM> Subsequently the patient experienced vision problems. The patient received a computed axial tomography (CAT) scan, and results were found to be normal. Subsequently, the patient recovered from vision problems. The physician assistant felt that vision problems are not related to therapy with GARDASIL vaccine (yeast). No further information is available.
Initial report received from a healthcare professional on 29 August 2011. This case pertains to a neonate; information for the mother is captured in case number: 2010-06766. A male neonate (aged between 20-27 weeks gestation) was exposed in utero to ADACEL (lot number C3490A) at approximately 1 week gestation. His mother was 25 years old and a smoker who was otherwise healthy; his father was 47 years old and healthy. On 01 April 2011 he experienced fetal death. No additional information was reported. Documents held by sender: None.
starting day after vaccine, swelling in one ankle. was painful to touch and made walking difficult. went away after 24-36 hours.
DIFFICULTY IN BREATHING; DULL ACHES IN LOWER BACK; This spontaneous report received from a patient concerned a 47 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included kidney stone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced dull aches in lower back. On an unspecified date, the subject experienced difficulty in breathing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dull aches in lower back, and difficulty in breathing. This report was non-serious.
arm soreness: started about 4-6 hours after injection and lasted 3 days; stabbing type stomach/intestinal pain (no nausea, vomiting or diarrhea): started the next day and lasted 3 days (completed this report 3 days after vaccine and still with GI symptoms) ; backache:  started the morning after the  injection and lasted 3 days.  Overall, similar to flu-like symptoms. No significant fever or chills.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. On 31st August 2018, the patient received the 1st dose of SHINGRIX. On 31st August 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the patient experienced fever and shivers. On 2nd September 2018, the outcome of the injection site pain was recovered/resolved. In September 2018, the outcome of the fever and shivers were recovered/resolved. It was unknown if the reporter considered the injection site pain, fever and shivers to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient had a SHINGRIX vaccination and experienced immediate pain and soreness at the injection site that lasted a couple of days along with fever and shiver symptoms. The patient had his 2nd SHINGRIX vaccination today 16th November 2018 at a pharmacy and experienced no pain or any symptoms. The patient did not feel the medicine enter to his arm which he did the first time. Also there was a loud swishing noise when the pharmacy employee injected him. The patient was asking that did this sound was normal. Was there a blood test which he could get to verify that he received the 2nd SHINGRIX vaccination. Due to the shortage of the SHINGRIX vaccination and unethical people in society. The patient concern was he got a shot of air.
fatigue on saturday and sunday,  indigestion and runny nose on sunday night, and monday morning with vomiting
Patient got the diluent only portion; Patient got the diluent only portion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Patient got the diluent only portion) and inappropriate dose of vaccine administered (Verbatim: Patient got the diluent only portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 17-APR-2023 The pharmacist did not had any patient information and did not had any information on the dosing date, lot number, expiration date. The reporter believed that the clinic might had already reported the adverse event. The reporter provided a contact email for any follow-up needed. The reporter consented to follow up. The patient was administered the diluent portion only of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.