chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of rash in a 73-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included asthma and eczema. On 17th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a day after receiving SHINGRIX, the patient experienced rash, pain and watering eyes. On 17th August 2018, the patient experienced pain in arm. On 21st August 2018, the patient experienced pustular rash and itchy rash. The patient was treated with boric acid. On an unknown date, the outcome of the rash, pustular rash, pain and itchy rash were recovering/resolving and the outcome of the pain in arm was recovered/resolved and the outcome of the watering eyes was not recovered/not resolved. It was unknown if the reporter considered the rash, pustular rash, pain in arm, pain, itchy rash and watering eyes to be related to SHINGRIX. Additional information was received as follows: The patient stated that she did not have any other immunizations 4 weeks prior to or on the day of her SHINGRIX administration. At 10:26 AM, the patient received SHINGRIX on the left arm at a local pharmacy. The patient stated that it was uncertain of whom actually administered the injection and it was the most painful shot she ever received. The patient experienced the rash on face along with the bumps underneath the skin. On Saturday, 18th August 2018, within 12 to 20 hours after receiving the vaccine, her left arm had a 4 inch rash patch and was also very sore, to where she could not sleep on that side. On Tuesday, 4 days after receiving the SHINGRIX vaccine, the patient noticed a pustular, itchy rash on her left cheek. On Wednesday, 22nd August 2018, she then had a rash develop on her right cheek. The patient stated she self treated at the time of reporting as she had a history of eczema and the rashes were recovering. The patient stated that the rash was clearing up. She had been treating it with prescription eczema cream. On 22nd August 2018, the rash on her arm was resolved. However, the rash on her face was still recovering. On the left side of her face where the rash was the worst, her eye had been watering constantly. She had been flushing her eye with over the counter Boric acid solution, but it kept tearing and weeping. She had an appointment to see her eye physician next week of reporting date for a follow up from a laser surgery to treat cataracts, so she would have him look at her eye. The patient was unable to provide lot number or expiry date. The patient was concerned to get the 2nd dose of SHINGRIX. The patient initially called the Regulatory Authority during after-hours. The patient later stated that, she called and reported this information to the Vaccine Service Center but was not asked as many questions for reporting the adverse event. The patient gave the information of vaccination location and the physician who prescribed the SHINGRIX. No further information was provided.
This spontaneous report as received from a pharmacist refers to a 11-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date in March 2017, the patient was vaccinated with the first dose of GARDASIL and on an unknown date in May 2017, the second dose of GARDASIL (both doses, routes of administration, lot # and expiration dates were not reported). The pharmacist reported that the patient would receive the third dose of GARDASIL 9 on an unknown date in November 2017 (dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported. No causality assessment was provided by the reporter.
1 of 8 pts (4-6 yr old range) seen /win the past wk /w severe local rxns. Pt has 2 X 3 inch area of redness, tenderness, warmth & low fever
At the injection site, shortly after vaccination, the site became swollen and red with bumps. Day 2 symptoms of diarrhea, racing heart, high blood pressure (resting 121-130), loss of appetite, nausea and vomiting. Morning of day 3 she woke up with a swollen tongue, face, and throat, loss of sleep due to being scared and worried. Day 4 swelling was still prevalent. On Sep 1st, when the reaction was noticed, the patient called her family care doctor. They said that it was normal and it's nothing to worry about. Eating solid food was attempted but only apple sauce could make it past the tongue. This went on for about 5 days, the doctor's office gave an appointment via telemedicine with the assistant. No advice was given during the consultation. A follow up was done on 15 Sep with the attending doctor. This is when they explained that the pharmacy where the shot was administered would need to be told about the reactions. The Pharmacy said the patient would have to fill out the form on the website. The patient is now doing fine but during the reaction no one was trying to get her in touch with VAERS. This caused a delay in reporting and added more confusion to the situation.
This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, patients were administrated improperly stored doses of GARDASIL 9 (lot # and expiration date were not reported). It was reported that the vaccine was exposed for 270 hours at 9 C degrees. No adverse effects were reported. It was reported that all the vaccines were back in range. The data logger was reported as yes. This is one of the several reports received from the same reporter. Additional information has been requested.
delayed shipment vaccine of Fluzone Quadrivalent received by a patient/no AE; delayed shipment vaccine of Fluzone Quadrivalent received by a patient/no AE; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a non-health professional.  This case is linked to cases 2019SA311015, 2019SA311021, 2019SA311020, 2019SA311022, 2019SA311024 and 2019SA311025 (same reporter)  This case involves a 41 years old male patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Prefilled Syringe Lot UT6713KA, Exp. Date: 30-Jun-2020, Box: Lot UT6713KA, Exp. Date: 30-Jun-2020) on 05-Nov-2019 after product received late due to delayed shipment.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to Incorrect product storage and Product shipment delay.  It was not confirmed whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
Day after second Pfizer vaccine in the am woke to bad hip pain and stiffness in the right arm from top of arm at shoulder to hands felt stiff  feels inflamed though not visible and muscle pains .This  arm stiffness and feeling is still l on going and it seems worse when I wake up in the am though I sleep on my back . The lower back muscle pain come sand goes but the pain in my hips around my back is on and off not sure if this is related to vaccine but the day after the vaccine it was so bad hard to walk then it seem to ease by nine pm that day . My arm stiffness is on going. I had swollen lymph nodes under my right arm that started the 16th April two days after the second vaccine lasted about  a week or a few days past the week . Day after second vaccine I had very bad muscle pains an stiffness in my back hips especially and arm and even had slight jaw pain the right side .I felt cold starting around two pm that day on and off then around five pm to eight pm or nine pm had chills come and go those went by  around nine pm that all stopped .
First vaccine 12/30/2020 LOT EH9899 - I had the malaise, fever, HA, Sore arm, Diarrhea within 12 hours of injection and lasted about 24 hours. Then just sore arm Second vaccine 01/18/2021 LOT EL3246 -  I had the malaise, fever, HA, body aches, sore arm, within 12 hours of injection and lasted about 24 hours. Then sore and swollen arm that was itchy for about 3-4 days until resolved Third vaccine - I had malaise, fever, HA, chills, body aches within 12 hours if injection and lasted 36 hours. Then had itchy /red ears bilateral with small rash behind ears. Started hydrocortisone cream on Monday 12/13/2021 and used the cream for 3 days. Today 12/16 I forgot to use cream in AM and by 12:00 developed hives on neck and face along with ears still itchy and red and warm to touch.
The day after the vaccine I started to itch, and the next day my entire torso was red and covered in rash, I went to urgent care and they diagnosed me with rash and hives and prescribed prednisone and I had to go back after three days and was given a steroid shot and I am still dealing with this after almost three weeks.
LEFT ARM NUMBNESS AND TINGLING THROAT FELT THICK  BENADRYL 50MG IM GIVEN
Shortness of breath extreme started next am. Chest pain started next am, Headache started four hour after. Cough started 15 days after, and very achy.
fever 103, gasping for air, cried x 3hrs;high pitched;went to ER 23APR96; f/u 24APR96 no treatment;
Information has been received from a pharmacist via field employee referring to a patient of unknown age and gender. Information about concurrent condition, medical history and concomitant therapy were not provided. On approximately 19-OCT-2016 (reported as 3 weeks ago as of 19-NOV-2016), the patient was vaccinated with a dose of ZOSTAVAX subcutaneous injection (19400 plaque forming unit, lot # and expiration date were unknown) intramuscularly which was outside of the prescribing information recommendation. On an unknown date in 2016, the patient had redness and swelling at the injection site that "looks like a bee sting". The events had lasted for "a couple of weeks". The outcome of redness and swelling at the injection site was reported as not recovered. The reporter did not provide the relatedness between ZOSTAVAX and redness and swelling at the injection site. The patient has spoken to the pharmacist and it was unknown if the patient has sought further medical attention. Additional information has been requested.
Redness, soreness, swelling, mild lump, warmth around the site of injection down to her elbow. Left shoulder and neck has a tingly feeling.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Injection site had redness, swelling, and blisters filled with fluid and patient complained of pain
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.  The vaccine was stored in freezer and taken out one or two vials and placed in fridge each day as needed.
Moderna boost doses were given today on refrigerator day 31; does Moderna have stability data to support the efficacy of these doses on day 31, or should they be repeated?; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna boost doses were given today on refrigerator day 31; does Moderna have stability data to support the efficacy of these doses on day 31, or should they be repeated?) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna boost doses were given today on refrigerator day 31; does Moderna have stability data to support the efficacy of these doses on day 31, or should they be repeated?). On 20-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Moderna boost doses were given today on refrigerator day 31; does Moderna have stability data to support the efficacy of these doses on day 31, or should they be repeated?) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   Reporter did not allow further contact
No adverse effects reported; An unknown number of unspecified patients may have been administered vaccines improperly stored; This spontaneous report was received from a nurse and an office manager and refers to an unknown number of patients of unknown age and gender. There was no information provided about the patients' concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or medical history.  On multiple unspecified dates, the patients were vaccinated with improperly stored doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# R025725, expiration date 25-MAY-2021) (exact dose, frequency, route and site of administration were not reported); with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (lot# R000550, expiration date 08-JAN-2020) (exact dose, frequency, route and site of administration were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate (LIQUID PEDVAXHIB) (lot# R000877, expiration date 24-SEP-2020) (exact dose, frequency, route and site of administration were not reported) all administered for prophylaxis. The administered doses were exposed to a temperature below 36 Fahrenheit degrees (F): 31.6 F for 2 hours and 13 minutes and 25.7 F for 1 hour and 35 minutes, and temperature above 47 F: 50.5 F for 18 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.  Follow-up information was received from a physician's receptionist on 01-AUG-2019. The patient was a 16-year-old female. On 11-JUL-2019, she was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# R025725, expiration date 25-MAY-2021) 0.5 mg in left deltoid (frequency and route of administration were not reported). It was clarified that no patient received measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) and haemophilus b conjugate vaccine (meningococcal protein conjugate (LIQUID PEDVAXHIB). The reported temperature excursion occurred from 30-MAY-2019 to 22-JUL-2019. The reporter stated that the temperature probe was misplaced, which resulted in an incorrect reading. No adverse effects were reported.  This is one of 3 reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA003824: US-009507513-1908USA003825:
pt recv vax 28MAR96 & on 19APR96 pt exp GBS;pt hosp & exp was considered life threatening;
Information has been received from a registered nurse concerning a patient who at 2 months of age received the first dose of ROTATEQ.  The patient on 11-APR-2008 had returned to the office (12 weeks from the first dose) to receive the second dose of ROTATEQ.  The patient had not experienced any difficulties.  The patient sought medical attention in the physician's office.  There was no product quality complaint.  Additional information has been requested.
bilateral sensorineural hearing loss; tinnitus; chronic itching and multiple outbreaks of a zoster-like rash on patient's left thigh; chronic itching and multiple outbreaks of a zoster-like rash on patient's left thigh; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 69-year-old male patient (pt). No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 25-JUL-2017, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, and route of administration were not specified), as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On unknown dates, pt suffered the following injuries and was diagnosed on the following dates as a result of the zoster vaccine live (ZOSTAVAX) vaccine: chronic itching and multiple outbreaks of a zoster-like rash on pt's left thigh. Pt also suffered moderate to severe bilateral sensorineural hearing loss and tinnitus in which he required a hearing aid at the time of the report. The outcome of the events was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of bilateral sensorineural hearing loss was considered to be medically significant.
Resting Heart Rate is 125; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Resting Heart Rate is 125) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced HEART RATE INCREASED (Resting Heart Rate is 125). At the time of the report, HEART RATE INCREASED (Resting Heart Rate is 125) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Heart rate: 125 (High) Unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported Treatment information was not provided
Aggravation of neurological issues; Aggravation of neurological issues; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NERVOUS SYSTEM DISORDER (Aggravation of neurological issues) and CONDITION AGGRAVATED (Aggravation of neurological issues) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Neurological symptom.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced NERVOUS SYSTEM DISORDER (Aggravation of neurological issues) and CONDITION AGGRAVATED (Aggravation of neurological issues). At the time of the report, NERVOUS SYSTEM DISORDER (Aggravation of neurological issues) and CONDITION AGGRAVATED (Aggravation of neurological issues) outcome was unknown. Not Provided          Concomitant product use was not provided.   The patient was advised by the physician to wait until 2 weeks in order to start the medication post second dose.  Treatment information included anti-epilepsy medication and carbamazepine.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Very limited information regarding this event has  been provided at this time.  Further information has been requested; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Very limited information regarding this event has  been provided at this time.  Further information has been requested
Two weeks after second vaccine, I developed a blood clot in my right eye which caused   a Central Retinal Occlusion. I temporarily lost sight in my eye and went to a Eye Surgeon. I was referred to Retina specialist and started getting Eylia injections in my eye which I am still getting today. My sight has improved. I also developed Polymyalgia Rheumatica and started on 60 mgs of Prednisone daily. I am still taking 15 mgs of Prednisone one year later. As a result of the Prednisone my blood sugar and A1C went from 5.8 to 7.2 and I have to take Farxiga daily. My Blood Pressure has spiked, and I now have to take three Lisinopril tablets a day instead of one.
Itchiness, chest pain, cough, chills, sneezing, body aches, headaches, shortness of breath, fatigue and spitting up flem.
This spontaneous report was received from a registered nurse referring to an unspecified number of elderly patients (65 years old or older). No information was provided regarding the patients' historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications. The nurse stated that on unknown dates, "possibly back to 1998", the patients inadvertently received a second dose of PNEUMOVAX 23 for prophylaxis (dose, route of administration, lot number and expiration date were not reported) based on "oversights in self reporting". It was reported that most of this information was related to historical vaccination records possibly dating back to 1998. The nurse did not have any specific patients information or reactions that may have occurred.
pt recv vax & devel a local rxn & swelling @ the inj site;pt was treated w/DPh & was recovered as of the date of this report;this is one of three pt from this site;
Patient noted to have fever, nausea, vomiting and left arm and left leg stiffness.