chrisvoncsefalvay/vaers-outcomes huggingface dataset:
other zoster related injuries; postherpetic neuralgia; shingles; Information was received from a lawyer regarding a case in litigation concerning an elderly patient of unspecified age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. On or about 25-OCT-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX), administered by a healthcare provider at a pharmacy, for the long-term prevention of shingles and zoster-related conditions (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unknown date (Reported as "subsequently"), the patient was treated, by a nurse practitioner (NP) and a physician, for shingles, postherpetic neuralgia, and other zoster related injuries (Ill-defined disorder). Loss of consortium was also alleged. The outcome of the events was not provided. Causality was related.
Got shingles within 4 days of taking vaccine shot; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 14Apr2021 at 14:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, within 4 days of taking vaccine shot, the patient experienced shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt became diaphoretic, hypotensive (sbp<70), dizziness.  Benadryl po administered.  BP return to normal after 10 min.  Monitored for additional 30 min.  Full return to prevaccination s/sx.
pain under right arm pit; very stiff neck; pain radiating into ear; pains radiating down right arm, chest and back; pains radiating down right arm, chest and back; nausea; Vomiting; severe chest and back pains on right; severe chest and back pains on right; This is a spontaneous report from a contactable Other Health Professional (patient). A 79-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in right arm on 18Dec2020 08:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient medical history was not reported. Concomitant medication in two weeks included citalopram, levothyroxine, atorvastatin, anastrozol.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 3rd day (21Dec2020), the patient experienced severe chest and back pains on right at time of 12:30 AM. On 4th day (22Dec2020) pains radiating down right arm, chest and back, nausea and vomiting. On 5th day (23Dec2020) pain under right arm pit, very stiff neck, pain radiating into ear. Temperature was normal. On 6th day (24Dec2020) most symptoms dissipated. On 7th day (25Dec2020) almost back to normal. No treatment received for the events. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was recovered in Dec2020.
This case was reported by a other health professional via call center representative and described the occurrence of pain in a 16-year-old female patient who received BEXSERO (batch number 151303D, expiry date 1st December 2016). On 9th March 2016, the patient received the 1st dose of BEXSERO .5 ml. On an unknown date, less than a year after receiving BEXSERO, the patient experienced pain, redness and swelling. On an unknown date, the outcome of the pain, redness and swelling were recovered/resolved. It was unknown if the reporter considered the pain, redness and swelling to be related to BEXSERO. Additional details were provided as follows: The BEXSERO was administered in right arm. No further information was provided by the healthcare professional.
could hardly stand up; was extremely tired; bad headache; body aches; joint aches; Nausea; Vomiting, Threw up 3 times; light headed; very sleepy; freezing cold, chills; freezing cold, chills; hips hurt; very disoriented; This is a spontaneous report from a contactable consumer (patient's parent) reported for a patient. This is report 2 of 3. A 19-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0177, Expiration date: unknown) intramuscular, administered in upper right arm on 24May2021 at 10:30 am (age at vaccination was 19 years) as dose 2, single for COVID-19 immunization. The patient did not have any medical history. The patient's concomitant medications were not reported. The patient's family medical history relevant to adverse events was unknown. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0170, Expiration date: unknown) intramuscular, administered in upper left arm on 03May2021 at 10:30 am (age at vaccination was 18 years) as dose 1, single for COVID-19 immunization. The patient was a healthy kid. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24May2021 at 22:00 pm, the patient had the worst reaction of a bad headache, body aches, joint aches, nausea, vomiting, threw up 3 times, hips hurt, very disoriented, freezing cold, chills and was light headed for 24 hours, she was just a mess for 24 hours. She was very sleepy. This was after the 2nd dose of the COVID 19 Vaccine. The patient received vaccine at 10:30 am on Monday and was at work by 11:30 am. She came around 19:00 pm on 24May2021 that evening and was freezing cold, also had chills and was tired. Within 4-5 hours she started feeling something. The reporter didn't think that the patient had nausea straight away but all happened on 24May2021 and by 22:00 pm had all symptoms. After going to bed, patient talked about throwing up and was very disoriented and thought she had to go to work. She got up the next morning, went to work, and was home within 30 minutes, she could hardly stand up at work on 25May2021 at 07:30 am. She came home around 07:30 am with body aches, joint aches, her hips hurt, a bad headache, was extremely tired, nauseas, and had chills. She never ran a temp though. The patient had Tylenol about every 6 hours during that time. Started off with 1 since she was so small but the reporter thought it was bad she was giving patient two and was probably giving her the extra strength so her guess was 500mg. The patient woke up on Wednesday 26May2021 and felt perfectly fine. So, 48 hours from vaccination time she felt fine. She stopped experiencing all symptoms and felt perfectly fine by 26May2021 at 08:00 am and recovered completely. The adverse events did not require a visit to Emergency Room or Physician Office. No relevant tests were done. The outcome of the events was resolved on 26May2021 at 8:00 am.  Follow-up attempts are completed. No further information is expected.
Local skin reaction at injection site, which began about one week after vaccination, and persists 6 weeks later, with erythematous rounded rash, raised edges, hyperpigmented center. Skin rash is itchy.
none. Expired vaccine 10/25/2022. Given on 01/13/2023
30 minutes after flu vaccine, patient experienced migraine type headache with flashing lights, vision in periphery going in and out, flushing, nausea, dizziness, tachycardia.
Patient developing fever, weakness and AMS after receiving the vaccine requiring admission to the hospital for AMS which resolved shortly after admission
High Fever 102.5 Severe Abdominal Pain Severe Lower Back Pain Body Aches
Immunization at around 10.30AM. 4yo hiiponic female with presents within 40-50 minutes symptoms of itching and mom noted rash. Noted with erythematous macular. No difficulty of breathing, No edema noted. of review. N1 exam otherwise. Diagnosed urticaria.
29JUL94 pt had elevation in temp between 98-102 & fussy;
5 cm x 4 cm with erythema and warmth, no drainage.  Treated with Prednisolone once at home.  Prescribed Qrapred.
Patient moved from vaccine area to observation in pharmacy lobby, told his dad he didn't feel good and passed out before dad could get him to sit down. Patient came to immediately, asked for a sip of water. Checked pulse and monitored patient for worsening symptoms. questioned patient on meals, activity before vaccine=he had not eaten since dinner night before. Patient moved to chair, where he and his dad waited for 30 mins. Symptoms improved after water and a couple pieces of candy. Color and pulse were normal when patient left lobby
This case was reported by a physician via sales rep and described the occurrence of lymphoma in a male patient who received FLULAVAL Quadrivalent (batch number K5T45, expiry date 31st May 2018). On 19th September 2017, the patient received FLULAVAL Quadrivalent. On an unknown date, less than a year after receiving FLULAVAL Quadrivalent, the patient experienced lymphoma (serious criteria GSK medically significant) and lymphadenopathy. On an unknown date, the outcome of the lymphoma and lymphadenopathy were unknown. The reporter considered the lymphoma and lymphadenopathy to be almost certainly related to FLULAVAL Quadrivalent. Additional details were reported as follows: The age at vaccination was not reported. The diagnosis date was not known.
Pt complained of dizziness soon after receiving vaccine.  Vitals were taken BP 140/84,O2 99% .  Pt advised to go to ER, pt denied advice stated she got same reaction with 2 previous vaccines and was fine.  Pt signed refusal to transport form, relative driving her home.  Again pt advised to go to ER if symptoms persist.
Red, burning, itching of upper arm, spreading and continuing at present time 6:45 AM, 11/26/2015.
Itching on the back of her neck and around the sides of her neck; Fever; Chills; Tiredness; Nausea / it came back about 10 days ago / nauseated morning and night; This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure high and diabetes. Concomitant products included atorvastatin calcium (Lipitor).   On 24th April 2021, the patient received the 1st dose of Shingrix (intramuscular). On 24th April 2021, 2 hrs after receiving Shingrix, the patient experienced fever, chills, tiredness and nausea. On 14th May 2021, the patient experienced pruritus. On 27th April 2021, the outcome of the fever and chills were recovered/resolved and the outcome of the tiredness was not recovered/not resolved. On an unknown date, the outcome of the nausea and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, tiredness, nausea and pruritus to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient herself. About 2 hours after receiving the Shingrix vaccine, the patient began to get fever, chills, tiredness and nausea. The fever, chills and tiredness all resolved in the few days. The nausea resolved after 3 days initially, then it came back about 10 days prior to the reporting. Since the nausea came back 10 days ago, the patient was nauseated morning and night. The patient reported that about 1 week prior to the reporting, she began itching on the back of her neck and around the sides of her neck. The patient was going to contact her health care professional on the nausea and itching on her neck since they had not resolved till the time of reporting. The reporter did not consent to follow up. The case has been liked with case US2021109086, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021109086:Same reporter. Husband's case.
PATIENT HAS UNUSUAL MUSCLE SORENESS AND A REDDENDED, WARM PATCH OF SKIN NEAR THE INJECTION SITE.
I have lost vision. Have numbness in my legs and arms. Weakness in arms and legs. Extremely stiff neck. Pressure in my face especially the bridge of my nose. 4 trips to the ER. 1 hospital stay. Treatment with steroids. Problems continue
fever and headache since second pfizer COVID vaccine that was given on 5/1/2021, noted at urgent care appt on 5/10/2021
possible inflammatory vs allergic reaction. suspect more 2/2 hematoma and resultant pressure on nerves
nausea; fatigue; muscle pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), FATIGUE (fatigue), MYALGIA (muscle pain) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A. and 020B21A) for COVID-19 vaccination.     Concomitant products included CITALOPRAM for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NAUSEA (nausea), FATIGUE (fatigue), MYALGIA (muscle pain) and HEADACHE (headache). The patient was treated with IBUPROFEN for Headache and Myalgia, at a dose of 1 dosage form. At the time of the report, NAUSEA (nausea), FATIGUE (fatigue), MYALGIA (muscle pain) and HEADACHE (headache) outcome was unknown.
Had flu shot 5:50 on 10-18-17. After injection site began to itch and then proceeded to get swollen then red and warm. Pt states had had the flu shot in past without any reaction. Mild reaction and runny nose.l
CLIENT CALLED. C/O (L) ARM & SHOULDER PAIN THAT BEGAN IN MARCH 2008 AFTER RECEIVING VACCINATIONS. CLIENT CONTINUES TO EXPERIENCE PAIN IN (L) ARM. REFERRED TO PHYSICIAN FOR MEDICAL EVALUATION. RECOMMENDED ADVIL OR MOTRIN FOR PAIN/INFLAMMATION. ATTEMPTED TELEPHONE FOLLOW-UP WITH CLIENT ON 6/3/08. NO CONTACT MADE - LEFT MESSAGE.
Inconsolable crying for several hours. Induration and warmth of leg of injection site clearly around HIB injection site.
left shoulder joint pain; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 20Feb2021 at 11:45 as a single dose for COVID-19 immunisation. Medical history included stage 1 hypertension and ankle pain from injury. Concomitant medications included telmisartan (MANUFACTURER UNKNOWN) 20 mg, started on an unknown date for unspecified indication and was taking once per day and isradipine (MANUFACTURER UNKNOWN) 2.5 mg, started on an unknown date for unspecified indication and was taking twice per day. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration on 30Jan2021 at 12:15 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Feb2021, the patient experienced right hip and left shoulder joint pain, mild to severe in hip, mild in shoulder and prior ankle pain from long ago injury was now noticeably worse. Therapeutic measures were taken as a result of right hip and left shoulder joint pain, mild to severe in hip, mild in shoulder and ankle pain which included treatment with meloxicam once per day for 14 days. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events right hip and left shoulder joint pain, mild to severe in hip, mild in shoulder and ankle pain was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a pharmacist refers to a 60 years old female patient. The patient's concurrent conditions included breast cancer, depression, blood pressure abnormal and cholesterol abnormal. Concomitant therapies included letrozole (reported also as suspect therapy), losartan potassium (+) hydrochlorothiazide (manufacturer unknown) (reported also as suspect therapy), simvastatin (manufacturer unknown) and VENLAFAXINE ER. The patient did not have any preexisting physician-diagnosed allergies, birth defects or other medical conditions. On 07-SEP-2017, the patient was administered 1 dose of expired ZOSTAVAX, 19400 plaque-forming units (PFU) vial, lot # M042503 with expiration date on 17-AUG-2017, first dose, subcutaneously (exact dose and anatomical location were not reported). The expiration date was not checked by the pharmacist before administration of ZOSTAVAX and the expiration date in a computer was not updated (was wrong). It was reported that the medication error occurred also at the point of administration and preparation for administration. The lot number of the sterile diluent (manufacturer unknown) used for reconstitution was M024765 with expiration date on 20-FEB-2019. No adverse effects occurred, the patient had no bad experience. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1711USA002266.
This spontaneous report as received from a registered nurse refers to a 74 year old female patient. Pertinent medical history and drug reactions/allergies were not reported. On 11-JUN-2013, the patient was vaccinated with PNEUMOVAX23 (lot # H015780, expiration date  11-JUN-2014) 0.5 ml, intramuscular. Concomitant therapy was not reported. On 12-JUN-2013, the patient experienced injection site reactions after receiving PNEUMOVAX23, redness and swelling at the injection site. The patient did not receive treatment. The patient called the office and the office informed to monitor the injection site and to call back in 24 hours to follow up with the condition of her arm. It was reported that therapy with PNEUMOVAX23 was continued. At the time of the report the patient was recovering. This is one of two reports from the same source. Additional information has been requested.
Vaccine taken on 1/20.  1/24 began symptoms of exhaustion, fatigue, headache and brain fog.  1/24 began additional symptoms of decrease /altered taste in mouth.  symptoms last 3-4 days.
This spontaneous report as received from a pharmacist refers to a female patient who is currently 55 years old. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date in 1970's the patient was vaccinated with M-M-R II (dosing details were not reported) for prophylaxis. On an unknown date in 1970's the patient experienced arthralgia and rubella. The outcome of the events was unknown. The reporter did not provide the causality assessment between the events and the suspect therapy. There was no product quality complaint involved. Additional information is not expected as the reporter did not wish further contact.
Received an expired dose; This case was reported by a consumer via call center representative and described the occurrence of expired vaccine used in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2022, the patient received the 1st dose of Shingrix. On 24th January 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient self-reported this case. The patient received the Shingrix which was already expired, which led to expired vaccine used. The agent could not get additional information to file adverse event as the caller was not responding. The agent could not ask for the consent to follow-up with health care professional. .
I awoke in the middle of the night convulsing from chills and a fever, I remained awake throughout the night experiencing extreme cold, body pain, and headache, which transitioned to extreme heat and sweating. In the morning I had a migraine and felt nauseous with significant body pain.
involuntary tremors of upper and lower extremities post his 2nd dose of Moderna Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (involuntary tremors of upper and lower extremities post his 2nd dose of Moderna Vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TREMOR (involuntary tremors of upper and lower extremities post his 2nd dose of Moderna Vaccine). At the time of the report, TREMOR (involuntary tremors of upper and lower extremities post his 2nd dose of Moderna Vaccine) outcome was unknown.            No concomitant medication were provided No treatment medication were provided
Swelling  1:30 on 1/27/2021 Bruised at site on 1/27/2021 Joint pain everywhere 1/28/2021 Fingertips numbness 4:30 pm.  1/28/2021 Nausea 1:30 pm 1/28/2021
My third vaccination was administered on October 8, 2021.  On October 9th I experienced heart palpitations in the evening.  I continued to have them about every day (sometimes several times a day at varying times and durations) for approximately two months.  In December they began to subside and and at this time I no longer have them.
I had a fever, cough, exhaustion, and a headache. I was sneezing and very stuffy in the head endlessly. I went to an urgent care  on Friday 9/24/2021. I was prescribed methylprednisolone for 6 days, Tylenol 325mg for fever and pain, a low dose 81mg aspirin, a nasal decongestion called Wal-Phed D  600mg 2xday, Vitamin C 1000mg 1xday, and Zinc 50mg 1xday. My cough was so bad to the point that I felt like I was going to throw up so I called my doctor. On Monday she prescribed me with benzonatate 100mg 1 to 2 capsules 3xday for 1 week. I have been still dealing with sinus stuffiness up until a week ago. My ears had been stopped up and if I try to blow my nose that wouldn't help anything. My nose was also runny. When I went to a follow up appointment with my doctor she had me start taking Mucinex 2xday, and since then it has helped with the stuffiness. Ever since I caught covid I have been having issues with occasionally losing my breath, and I am using my inhaler more often. I am a former smoker and the last time I smoked was back in 2009 when I had an aneurysm.
DIZZY, LIKE MOTION SICKNESS DIZZINESS,I feel like I have motion sickness, but not all the time...it comes and goes.I work nites..had a hard time Monday night...Tuesday a little better.
pt w/h/o crying & irritability x several hrs p/receiving vax; lt thigh became red & swollen; very tender to touch; sx resolved spontaneously;
Break out over entire body 11 days after MMR given.  Antihistamine for itchiness, and OTC calamine lotion.
It was reported that a pt (1 of 4) complained of redness and rash 3-4 inches in diameter after receiving the 98-99 Fluzone.
Face swelling within an hour of vaccination. Following day: itching, rash and sore throat (described as raw), cough Pt self-treated with diphenhydramine