chrisvoncsefalvay/vaers-outcomes huggingface dataset:
early DEC pt devel sx later dx as diabetes type 1;since diabetes can occur in people who are predisposed, prior to this concern arouse that because varivax is a live virus could be relationship between varivax & onset of diabetes mellitus
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number, dosage and route of administration was unknown) as recommended for the prevention of shingles. Within six months of receiving ZOSTAVAX, the patient developed a rash and pain and was subsequently diagnosed with shingles (date not reported). The patient's conditioned subsequently developed into Bell's palsy on her right side and then her left side. As a direct and proximate result of the defective ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX product. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further as a result, the patient has suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of the use of ZOSTAVAX. The outcome of the events was not recovered. Upon internal review, Bell's palsy was determined to be medically significant. Additional information has been requested.
shingles; Information has been received from a lawyer regarding a case in litigation. This case is regarding a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unspecified date in 2017, the patient received a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage, route, lot # and expiration date were not provided) administered by her physician for long-term shingles and/or zoster-related conditions (prophylaxis). Subsequently, on unspecified date, the patient was treated by a healthcare provider at urgent care center for shingles. As a direct and proximate result of patient's use of Zoster Vaccine Live (ZOSTAVAX), the patient had and would continue to suffer ongoing injuries, included but not limited to medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries; included but not limited to medical losses and costs included care for hospitalization, physical care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life and diminished quality of life. At the time of the report, the patient's outcome was not recovered, and the reporter considered the event of shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Presented w/ sepsis/pneumonia, SOB, sore throat, cough, chest congestion, wheezing. Covid + pneumonia. Tx w/ Remdesivir, Dexamethasone
This spontaneous report was received from a physician and refers to a female patient of unknown age. The patient's concurrent condition included hypothyroidism since an unknown date. No information regarding the patient's concomitant medications was provided. On an unspecified date in May 2017, the patient was vaccinated with the first dose of VARIVAX injection, lot # M035688 with expiration date on 18-AUG-2018 (dose and route of administration was not reported) for prophylaxis and the second dose of the vaccine on an unknown date in June 2017. Within three days after the first dose, the patient experienced ulcers in the mouth, cheeks and palate. The patient sought for medical attention at the ear, nose and throat (ENT) specialist, dentist and oral surgeon. Two biopsies have been sampled on unknown dates, one of which showed inflammation and the other one's results were pending at the time of the report. The reporter also stated that the patient had difficulties swallowing even her own saliva so methylprednisolone (MEDROL DOSEPAK) was prescribed as a treatment which has helped for this event, however it was not specified if the patient fully recovered. The reporter mentioned that the patient was not able to work, but did not disclose the timeframe. The patient did not recover from the ulcers in mouth, cheeks and palate at the time of the report. The outcome of the inflammation and problems swallowing was unknown. The relatedness between the event and VARIVAX was not reported.
My first event was shortness of breath and difficulty exerting myself. Feeling winded generally throughout the day even when mildly active. I felt nauseous throughout the day and needed to sleep more. I had a lack of appetite and a feeling of overall fatigue coupled with achiness in my joints, especially my hand. I had extremely swollen lymph nodes under my armpits that looked like a water balloon. It was red swollen and hot to the touch. I experienced tenderness in the bottom with periods of being flushed and sweaty. I had a telehealth appointment about 2 weeks after having my vaccination. They wanted to prescribe narcotics but I denied them as I am in recovery. They told me to take the ibuprofen and Tylenol which I did about 2 weeks and then began to wing myself off. It took a long time for the lymph node and feeling of fatigue. These things caused me not to be able to do my normal daily activities like working. It took about 12 weeks for it all to go away. I still have waves of weirdness since having the vaccine that feel like I am uncomfortable in my body.
This spontaneous report was received from a Registered Nurse concerning an unknown number of patients of unknown age and gender. On unknown dates incorrectly stored doses of inactivated PNEUMOVAX 23 ( lot # M006139; exp date: 13-MAY-2017) could have been administered. It was reported that, on an unknown date, the refrigerator was out of range for 22 hours, with a highest temperature of 48.6 degree F. Temperature was back in range at the time of call. The Registered Nurse reported that vaccines could have been administered before the excursion was identified. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Headache, fever, body aches, chills, nausea, loss of appetite, fast heart rate, 91-94 Blood oxygen, fatigue, shortness of breath
Patient received COVID19 vaccine on 03/16/2021; no booster doses given. Patient tested positive for covid19 on  07/07/2022, admitted to the hospital on 07/07/2022, died on 07/14/2022
I started to feel unwell on 12/14/2022. On 12/15/2022, I started to have a fever and I was experiencing chest heaviness as well. I sent a note to my doctor's office that I tested positive for COVID-19. I went to the pharmacy to pick up a prescription for Paxlovid. I spoke with the Hospital Covid Nurse and she said that she would send the information to my GP. The Paxlovid helped me tremendously. I have not had a fever since 12/17/2022, but I still have a cough every now and then. I am still testing positive.
On September 27, 2013 I had my annual physician visit to refill my prescriptions. During the course of this visit I received 2 shots. One was a flu vaccine. The other was the shingles vaccine (ZOSTAVAX). Within 12 hours I was taken to the medical center emergency room. I had the following symptoms: I was very dizzy and I was unable to walk or stand, extreme nausea, extreme diarrhea, extreme body and joint aches and pains to the point where I was just writhing in misery I was able to call a friend for help who took me to the emergency room. After treating me, the physicians told me I had a severe reaction to the shingles vaccine I received by my medical provider about 12 hours earlier. I was very ill and thought I may die. I believe I have died had I not gone to the emergency room. In addition, I think the shot adversely affected my immune system. I haven't gone to see a doctor for an illness in years. Since the adverse reaction to the shot, I've had some ongoing health issues. I'm very disappointed in what happened to me. I had to pay $389 for my share of the emergency room visit. I will no longer have any sort of preventative vaccine again except a flu vaccine.
I got the shot on a Tuesday , woke in the middle of the night at 3 am with a fever of 101,  body aches, and swollen lymph nodes on the sidt that I get the shot. Took tylenol and still had body aches until 3PM.  My skin was sore afterwards.
After 2nd dose of vaccine, had coughing and cold for 2 days and cleared up.  Then after 4 days of vaccine, started with joint pain and inflammation.  All major joints experiencing severe pain periodically.  Also will experience chills.  Pain is severe, that is not experienced before vaccine.  Also, feeling short of breath.
The second day of the vaccine the right side of my face swelled up. I had body aches and a fever for two days. 3 weeks later and every day I have extreme dizzy spells where I get extremely weak and can't hold anything of significant weight. I almost pass out, I feel disoriented, weak, tingling in joints, nausea and a headache.
W/I 15 min after flu shot, pt developed 4+ nasal congestion. RTC: Very congested, body was flushed and he c/o being itchy. MOC states that pt was covered with hives. BP = 104/80 P = 110 R = 20 T = 98.1. He was treated with Epi 0.30 mg IM at 11:10. ZANTAC 75 mg po at 11:10 ZYRTEC 10 mg po H am PFT was normal.
Parent reported patients date of birth at time of vaccine check in, confirmed date of birth at vaccination table with vaccinator. Child was vaccinated. Vaccine well tolerated. At check out to enter vaccine information, patient could not be found in system. Patients parents disclosed the patients actual date of birth. Patient and parent given education regarding expected side effects.
Within 24hrs after receiving injection site was red, edematous, warm. Pt c/o dizziness within 60 degrees Pt again came to see HD. This time more fluid built up in right deltoid and down below elbow. Needed Veflex for cellulitus.
felt like she was going to faint; Taste in the back of throat; eyes were so red; A spontaneous report was received from 69-year-old female patient who experienced events such as felt like she was going to faint'/ near syncope, taste in the back of throat/taste abnormality and eyes were so red/ ocular hyperaemia after receiving Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No concomitant product use was reported.  On 02 Feb 2021, the patient received first of the two planned dose of m-RNA-1273 (lot number: unknown) intramuscularly on an unknown arm for prophylaxis of COVID-19 infection.  Five minutes following vaccination, she experienced a taste in the back of her throat, her eyes were so red, She also felt like she was going to faint. She felt like her throat was sticking to itself. She did not receive any treatment for the same.  Action taken with mRNA-1273 in the response to the events felt like she was going to faint', taste in the back of throat and eyes were so red was not known.  The outcome of the events felt like she was going to faint', taste in the back of throat and eyes were so red were considered as resolved in about 2 hours from the time it started.; Reporter'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 pharmacist refers to a female patient of unknown age. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date in 2015 (also reported as a year ago) the patient was vaccinated with first dose of PNEUMOVAX 23. On an unknown date 2015 the patient experienced injection site reaction. On an unknown date (also reported as a few days ago) the patient was vaccinated with another dose of PNEUMOVAX 23. The outcome of the event injection site reaction is unknown. The reporter did not provide the causality assessment between the event and the suspect therapy. Additional information has been requested.
Sore throat; Runny nose; Coughing; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose) and COUGH (Coughing) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose) and COUGH (Coughing). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) for Adverse event, at a dose of 1 dosage form and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Adverse event, at a dose of 1 dosage form. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose) and COUGH (Coughing) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.
Parent noted redness, heat, and a hard swollen area aprx. 2x2 inch the day after vaccines. Area noted on Right thigh. Area seen by public health nurse on 3-17-11. Parent denied any hives or respiratory sx. at any time after vaccines. Child complains area itches.
Potential progression of condition after taking her original shot; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team.  A 46-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Xeljanz. The following information was reported: DISEASE PROGRESSION (non-serious), described as "Potential progression of condition after taking her original shot".   Additional information: The patient wanted to take the booster shot and wanted to know if she should stop taking Xeljanz. The patient is planning to get her (Pfizer COVID19) bivalent booster next week. The patient mentioned getting an original shot when she was not on Xeljanz. Potential progression of condition after taking her original shot (could not confirm which shot the patient was referring to).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
High blood pressure Arrythmia for two weeks after first dose Came back less strongly after second dose. Vertigo three days after second shot. Ended up at ER.
2 patients received first dose of the Covid-19 Vaccine and then contracted Covid-19.; 2 patients received first dose of the Covid-19 Vaccine and then contracted Covid-19.; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. This consumer reported similar events for two patients. This is 2nd of two reports. A patient of unspecified age and gender received the first dose of Covid-19 Vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration from an unspecified date to an unspecified date at single dose for covid-19 immunization. The patient medical history includes patients were exposed to the virus. The patient's concomitant medications were not reported. The patient received first dose of the covid-19 vaccine and then contracted covid-19. Caller stated it is not an AE since her patients were exposed to the virus. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021085846 Same reporter/ drug/ event, different patient
appetite loss; fatigue; headache; joint pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (appetite loss), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain) and CHILLS (chills) in a 77-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 202F23A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 20-Sep-2023, the patient experienced FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain) and CHILLS (chills). On 25-Sep-2023, the patient experienced DECREASED APPETITE (appetite loss). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (appetite loss), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain) and CHILLS (chills) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. On 21Sep2023, patient reported that her joints were painful in the morning. Patient took 2 Tylenol went back to bed for an hour and a half and felt fine the rest of the day.   This case was linked to US-MODERNATX, INC.-MOD-2023-742800, US-MODERNATX, INC.-MOD-2023-742929 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742800:Same patient, monovalent moderna vaccine US-MODERNATX, INC.-MOD-2023-742929:Husband's case
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unspecified date, the GARDASIL 9 vaccine had a temperature excursion of 24 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". On 24-JUN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 "0.5mL-10 Pk SD PFS-Luer-Lok" which had a lot number of M003659 and expiration date on 20-SEP-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning an 8 year old Hispanic male with asthma who on 05-FEB-2007 at 17:00 was vaccinated SC in the left arm with a second dose of varicella virus vaccine live (Oka/Merck) (lot # 654753/1250F). Concomitant vaccination at the same time included a first dose of hepatitis A virus vaccine inactivated (MSD) (lot # 656497/1213F) given IM in the right arm. On 28-MAR-2007 the patient presented to the office with an itchy, painful rash on his face which started on 27-MAR-2007. The patient had no fever. The patient was diagnosed with chickenpox. The patient was treated with mupirocin ointment. At the time of the report the patient's recovery status was unknown. Additional information received from the registered nurse indicated that this was a case of vaccine failure. On an unspecified date the patient recovered. It was noted that there were no complications. Additional information was not expected.
Case number PHEH2014US003841 is an initial spontaneous report received from a nurse on 21 FEB 2014. This report refers to a 17-year-old patient of unknown gender who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) on an undetermined date. The vaccination was reported to be from the 2013/2014 season. No adverse event was reported following this administration error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
This is a spontaneous report from a contactable consumer reporting for a patient received from a Pfizer sponsored program COVAX US support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. Medical history included covid-19 on an unknown date. The patient's concomitant medications were not reported. The reporter stated that someone in her family who had COVID after doing what she was told to do go the second dose of the vaccine and she was sick as a dog on an unspecified date. The outcome of event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient states that she experienced pain immediately upon administration and has had a throbbing/shooting pain ever since that radiates down her left arm and up to her shoulder. Patient was referred to her MD for diagnosis.
Limited range of motion and dull, throbbing pain in right arm at and around site of injection. Pain is worsened with physical exertion and exercise. At times, slight loss of sensation in entirety of right arm.