chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Polymyalgia rheumatica; Giant Cell Arteritis; chronic pain; Osteopenia; This serious case was reported by a consumer via call center representative and described the occurrence of polymyalgia rheumatica in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included prednisone for product used for unknown indication.   Concurrent medical conditions included hashimoto's disease.   On 13-MAR-2023, the patient received the 1st dose of Shingrix. On an unknown date, the patient started prednisone. On an unknown date, an unknown time after receiving Shingrix, the patient experienced polymyalgia rheumatica (Verbatim: Polymyalgia rheumatica) (serious criteria GSK medically significant), giant cell arteritis (Verbatim: Giant Cell Arteritis), chronic pain (Verbatim: chronic pain) and osteopenia (Verbatim: Osteopenia). The action taken with prednisone was unknown. The outcome of the polymyalgia rheumatica, giant cell arteritis, chronic pain and osteopenia were unknown.   It was unknown if the reporter considered the polymyalgia rheumatica, giant cell arteritis, chronic pain and osteopenia to be related to Shingrix.     It was unknown if the company considered the polymyalgia rheumatica, giant cell arteritis, chronic pain and osteopenia to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-NOV-2023 The patient stated that she had been diagnosed with two serious autoimmune diseases after vaccination with one dose of Shingrix.  The patient reported that she was diagnosed with Polymyalgia Rheumatica and Giant Cell Arteritis.  She had chronic pain.   The patient also reported that as a consequence of Prednisone usage she had developed osteopenia.   The patient reported that she had lost her job due to her diagnosis and she used to be a daily runner, and now she could not run anymore.   The patient stated that she was seeing a therapist for grief therapy for all that she had endured.   The patient stated that she was very angry that doctors were pushing patients to have the Shingrix vaccine.   The patient stated that due to her diagnosis of Hashimoto's disease she was not a good candidate to have the vaccine administered but that information was not given to her by her doctor. The patient was requesting a call back from the safety department at the phone number provided in account. It was unknown if the reporter considered the polymyalgia rheumatica, giant cell arteritis, chronic pain and osteopenia to be related to Prednisone.  The reporter did not consent to follow-up.
03/01/22 presents to ED for "Chest pressure". PMHx of "HTN, HLD, CKD stage 4, polycystic liver and kidney disease, atypical brain meningioma s/p resection/radiation and seizure disorder"
Patient called morning of 10-17-11. She spoke with my overnight pharmacist. She said she has had swelling down to her elbow & redness on the arm she received her vaccine. Swelling was noticed Sunday morning. As of Monday afternoon swelling and redness have decreased but are still present. Told patient to keep eye on arm. Advised her to use ice and Ibuprofen.
Patient said that one day after she got two vaccines she noticed rash on injection site, then it spreads all over the body. It is not painful but itchy.
Several hours post vax, the pt spiked a fever and became very irritable, screaming and crying. He lost his appetite and stopped eating. Symptoms lasted 3 days. Maximum temp was 102.9. Symptoms then resolved spontaneously. The pt was treated only with Tylenol and Motrin.
Hot Flashes, Dizziness and Nausea, Tremor and Headache.
Information has been received from a physician concerning a female patient who had an outbreak of shingles in July 2008 and in December 2008 was vaccinated with a dose of ZOSTAVAX (lot # provided). At the time of the vaccination the patient did not have any symptoms of shingles. On approximately 15-JAN-2009, "in mid-January 2009", the patient experienced a recurrence of shingles. Patient sought unspecified medical attention. No further information is available.
This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter.  Sender's Comments: US-009507513-1804USA005153.
Patient presented for her COVID vaccine. She completed paperwork for vaccine and it was determined that she was eligible to receive the COVID vaccine. She received her Pfizer vaccine at 8:28 am. About 3 minutes after receiving the vaccine, the nurses noticed that she was looking pale. The patient told them that she was not feeling well. She became diaphoretic and this NP was alerted. At 8:35 the patient lost all color, diaphoresis increased and she had a syncopal episode. We removed her from the chair and lowered her cautiously to the floor. This NP was able to arose by sternal rub. Wheezes were noted upon auscultation on right side. At 8:38 am Epi 0.3 mg was administered to left thigh - injector held to leg for 10 second count. 8:45 am 20 G place into right hand by nurse.  8:46 am EMS on scene
Pfizer, Date: 14Oct2022; J&J, Date: Unknown; COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 2 (booster), single (Batch/Lot number: unknown) and on 14Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "not recovered" and all described as "COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Pfizer, Date: 14Oct2022; J&J, Date: Unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Positive. The patient was treated with Paxlovid from 16Feb2023 to 22Feb2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a Medical Assistant refers to 6 months old infant, gender not reported. On 05-DEC-2014, the patient was vaccinated with ROTATEQ, Lot # K010642, orally. It is was reported that the administered vaccine was subjected to temperature excursion during storage. No adverse event reported. This is one of the several reports from the same reporter. Additional information has been requested.
devel dime sized wheal & erythematous flare @ MMR inject site w/in 20 mins; 40 mins later size had dec; no other S/s; resolved w/in 2 1/2 hrs of vax;
My arm hurt for 2 days and then starting in the morning of 12/25/2020 a spot under my left arm  and my left breast  hurt for 5 days.  My left breast tissue felt like it was on fire, burning and swollen.  I  applied ice on the 5th day and it stopped burning and the swelling went down. It still hurts in the nipple area.
Pt was given his 4 year old immunization on Feb 25, 2009. MMR was given on his right leg and mom stated pt developed rash around the site few hours after. That night, per mom, rash grew bigger, warm to touch and painful. Pt was given Ibuprofen and sx subsided. Pt's mom was intructed to keep an eye on the affected area and will come back if sx gets worse
Flu vaccine Health Department 9/29/17. The following day, 9/30/17, I removed the bandage from the injection site of my right arm and felt a jolt as if the dosage from the shot was being dispelled into my system up my neck to the base of my scull. For the next three weeks, I experienced nearly continual pain at the injection site and base of skull rating from a 3-7 pain wise. I was on vacation so coped with over the counter pain meds, massages and acupuncture. The pain was beginning to recede by the end of the vacation. I went to the chiropractor/massage therapist on 10/20/17 and I was relieved of the pain. A similar event happened in October 2014 when I got a flu vaccine at the Health Fair soon after having a chair massage on my neck. I believe at that time I experienced a pinched nerve from that massage. I had the same reaction as the one above with pain radiating from the injection site (right arm) to the base of my scull. This pain lasted over several months and my doctor ended up sending me for physical therapy in May 2015 until the pain ended. I have had flu shots every year in between without adverse side effects so I'm wondering if I should stop getting the shots, get them only in my left arm, or if I'm affected by something that was the same in both the shots from 2014 and 2017?
Severe leg on the right side; Maimed for life; Severe hip pain on the right side; Diagnosed with essential tremors; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe leg on the right side), ESSENTIAL TREMOR (Diagnosed with essential tremors), FEELINGS OF WORTHLESSNESS (Maimed for life) and ARTHRALGIA (Severe hip pain on the right side) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced ESSENTIAL TREMOR (Diagnosed with essential tremors). On an unknown date, the patient experienced PAIN IN EXTREMITY (Severe leg on the right side), FEELINGS OF WORTHLESSNESS (Maimed for life) and ARTHRALGIA (Severe hip pain on the right side). The patient was treated with PROPRANOLOL for Essential tremor, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Severe leg on the right side), ESSENTIAL TREMOR (Diagnosed with essential tremors), FEELINGS OF WORTHLESSNESS (Maimed for life) and ARTHRALGIA (Severe hip pain on the right side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Name of concomitant medications for seizure were denied by the patient.     This case was linked to MOD-2021-215104 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up information received on 09-JUL-2021 contains no new information.
Blood pressure went up/high blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure went up/high blood pressure) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2022, the patient experienced HYPERTENSION (Blood pressure went up/high blood pressure). At the time of the report, HYPERTENSION (Blood pressure went up/high blood pressure) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2022, Blood pressure measurement: high (High) Result Patient reported high blood pressure.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information provided. patient was antivaxxer
MODERNA COVID-19 Vaccine: Left arm below shot large red area  appeared with tender spot in cneter or shot area.  It is hot,  raised with size has growing  since Monday  to size of hand over biceps area. I have applied cortozone -10 , and anti ich topical to area with out results. I took benadryl on  1..6.20.  Honestly looks like a infected bug bite or skin infection.  Intially had a solid fluid hard area.. no w area just tender.
flu like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-015841 (Moderna).  A female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster, single) (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METFORMIN; LYRICA; FARXIGA; LIPITOR; METOPROLOL; FENOFIBRATE; DICYCLOMINE; ZETIA; AMLODIPINE; SYNTHROID; CIMETIDINE; EDARBI; CORLANOR; REGLAN [METOCLOPRAMIDE]; PROTONIX [OMEPRAZOLE]. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms". Therapeutic measures were taken as a result of influenza like illness.  Additional information: The patient was treated with Benadryl.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
missed 2nd dose,its almost 9 weeks and 2 days passed after the 1st dose; Received Moderna vaccine at 16 years of age; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received Moderna vaccine at 16 years of age) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed 2nd dose,its almost 9 weeks and 2 days passed after the 1st dose) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received Moderna vaccine at 16 years of age). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed 2nd dose,its almost 9 weeks and 2 days passed after the 1st dose). On 22-Jan-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received Moderna vaccine at 16 years of age) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed 2nd dose,its almost 9 weeks and 2 days passed after the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details was provided.  No treatment drug was provided.   This case was linked to MOD-2021-065366, MOD-2021-210740, MOD-2021-210713 (Patient Link).; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old) and Inappropriate schedule of vaccine administration for second dose for mRNA-1273 (lot number unknown) with no associated AEs.
After flu shot within few minutes pt notified staff of redness around injection site - a few minutes later she had a syncopal episode and was lowered to floor by staff. BP 170/102, P72. Awoke in few minutes but drowsy & weak. Sent to ER & had (?) seizure-like activity en route in EMS unit. In hospital alert & oriented by diffuse but inconsistent weakness of arms & legs. All tests by neurology negative and had gradual recovery of all movement over several weeks.
Systemic: Headache-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient had visual disturbances within 1 hour of vaccination and lasted for an hour. then a migraine proceeded after the visual disturbances. the migraine last 3 hours, that is the first migraine he has ever had in his life. he managed the migraine with tylenol and ibuprofen. after 3 hours the migraine turned into a headache and last until late in the evening
Pt received vaccines at approximately 4:15 - 4:30. At 6:15 mom noted left eye was swollen shut. The right eye was swollen and lips were swollen. Hives were all over the body. The child was taken to the ER and given Benadryl and Prednisone and released home with Benadryl and Prednisone to be taken the following day.
Initial overdose report received from a healthcare professional on 12 August 2013. It was reported, that a patient (No information was provided regarding the patient) received two doses of MENACTRA on the same day. No adverse event was reported. List of documents held by sender: none.
About 10 min after receiving vaccine in her left arm she began complaining about severe pain in her entire right arm and began holding her right arm out rigidly. She got sleepier as the evaulation continued. Elevated bp 170s/100s, O2 sats 96-97%
Information has been received from a RN pharmacist concerning a 53 yr old female with a sulfa allergy who on 04Oct05 was vaccinated IM in the deltoid with her second 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 650649/0790P, also reported as lot 650648/0967P). It was reported in follow up information that the pt developed soreness, redness and tenderness at the injection site and into her chest area on 04Oct05 at 8PM. She required medical intervention and was diagnosed with cellulitis and was hospitalized for treatment. Wound cultures were taken on 06Oct05 and were reported on 08Oct05 as no growth. At the time of this report the pt was recovered. No product quality complaint was involved. The pharmacist considered the pt's adverse experience to be an other important medical event (OMIC). Additional information is not expected.
A few hours after receiving the Tdap booster I started to have negative health side effects starting with nausea, upset stomach, aches, diarrhea, and chills. These effects continued for approximately 36 hours, and starting around 18 hours also included elevated temperature (no fever, highest recorded 99.5F), and elevated heart rate (100-110bpm). The vaccine was administered during pregnancy as recommended by my OBGYN for immunity for the baby. I had recently had the Tdap booster in 2015, and had no reaction that I can recall. All symptoms appear to have substantially decreased.
patient started to sweat and feel light headed... she thought she was going to pass out and felt like she couldn't breath. we went and got her water and she then started vomiting and coughing.
This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: FISH OIL; WARFARIN. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "I had my lawyer, had two, uh, Pfizer, two, uh, boosters. She's in the hospital now". The patient underwent the following laboratory tests and procedures: International normalized ratio: 1.8; 5. Reporter stated his lawyer experienced COVID vaccine inefficacy; Pt (patient) reports INR spike while taking Lipitor. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported events.
Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 30-OCT-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, Lot # L024997, expiration date: 06-OCT-2016), which was improperly stored for 46 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Got the second dose vaccine around 1:45 and was feeling completely fine. I was about to leave at 2:00pm when my heart rate started to increase. I took some deep breathes and started to feel better. Then as I walked out to my car and on my drive home, my whole face felt like some type of electricity was racing through it. I would touch my face and wherever I touched, the skin would feel tight and tingling. This lasted for 30-40 minutes and never came back.
No additional AE/PQC reported; ROTATEQ administered after temperature excursion; Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not provided.      On 12-JUL-2021, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1741377, expiration date 07-MAR-2022) underwent a temperature excursion prior to being administered. On the same day, the patient was administered with the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (oral, 2ml) for prophylaxis (product storage error).   The storage temperature of the vaccine was 9.6 degree Celsius for a time frame of 11 minutes. There was no previous temperature excursion. The call was because of a data logger. No additional adverse events or product quality complaint was reported.
Redness and hot below site of injection and swelling, sore throat, runny nose.
Noticed redness starting on the 9th of January 2021. Increasing redness, warm to touch. 1-15-21 measures 5 inches by 5 1/2 inches and is slightly raised. Patient complains of area feeling hot and itching. Has been using cold compresses on area.
Patient stated that her arm was sore for over two weeks and that she could not reach her arm behind her back because it was too sore.
Patient started acting very lathargic on Monday, April 8th 6 days after the vaccine.  He had a fever and was throwing up.  The morning of Wednesday, April 10th 8 days after the vaccine patient woke up covered in red spots.  I called the office and was told it was a reaction to the Varicella vaccine and all I could do was treat the symptoms.  I was not offered an appointment for him to be seen.
Adverse event(s)-enjoyed normal activities including golfing, bowling, mowing, household repairs including climbing and lifting.  Over night became unable to do any of these things due to pain, numbness, and tingling affecting back, spine, and legs.  Walking gait became severely distorted.  Started using cane, gait still distorted.  Started using walker which helped mobility.  Still distorted walking gait if walker not used.  These abnormalities began within two weeks of second Covid-19 shot which was administered March 2, 2021.  Medical expertise commenced March 29, 2021 which has continued as of this report dated October 7, 2021.  This has included trips to primary care physician, physical therapists, neurosurge
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 on 12/08/2022 and I had a fluctuating fever. I contacted my doctor and got a prescription for Paxlovid, an antibiotic and a steroid. I had not complications taking the medication. As of today, I am feeling better.