chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; Shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient cousin had a shingles).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by the cousin of the patient. The age at vaccination was not reported. The patient developed shingles after receiving Shingles vaccination. The reporter stated that, the patient had them just as bad as reporter did. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation test were unknown at the time of reporting.
headache; feels sleepy after taking it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 07May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 07May2021, outcome "unknown", described as "headache"; SOMNOLENCE (non-serious) with onset 07May2021, outcome "unknown", described as "feels sleepy after taking it".  Additional information: The patient got the 1st shot of the Pfizer Covid19 Vaccine today, but started having  headache and feels sleepy after taking it. She enquired if that's normal in taking the vaccine. Prior to vaccination, the patient  was not diagnosed with COVID-19 nor Since the vaccination, has the patient been tested for COVID-19   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
20May2021 A customer received the 1st dose of the Moderna Covid-19 vaccine. They're wanting to get the 2nd dose today.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (20May2021 A customer received the 1st dose of the Moderna Covid-19 vaccine. They're wanting to get the 2nd dose today.) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (20May2021 A customer received the 1st dose of the Moderna Covid-19 vaccine. They're wanting to get the 2nd dose today.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (20May2021 A customer received the 1st dose of the Moderna Covid-19 vaccine. They're wanting to get the 2nd dose today.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants medication were provided. No treatment medication were provided.    Reporter did not allow further contact
expired dose/The pharmacist confirmed that she had Moderna COVID19 Vaccine that was expired on 09Oct2021, but it was administered to 6 different patients on 12Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose/The pharmacist confirmed that she had Moderna COVID19 Vaccine that was expired on 09Oct2021, but it was administered to 6 different patients on 12Oct2021) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A, 044A21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose/The pharmacist confirmed that she had Moderna COVID19 Vaccine that was expired on 09Oct2021, but it was administered to 6 different patients on 12Oct2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose/The pharmacist confirmed that she had Moderna COVID19 Vaccine that was expired on 09Oct2021, but it was administered to 6 different patients on 12Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reportedly, The pharmacist updated the details to previous case, and had confirmed that she had Moderna COVID19 Vaccine that was expired on 09Oct2021, but it was administered to 6 different patients on 12Oct2021. Pharmacist was willing to know whether the patients had to be revaccinated and also whether the patients were going to be fine. She had confirmed that the patients had received all their doses from her facility. Consent given for safety to contact the pharmacist. The pharmacist confirmed that the patient was immunocompromised.  Concomitant product use was not provided.  Treatment product information was not provided.   This case was linked to MOD-2021-350559 (Patient Link).
A 17 year old patient came in to the HU on 10/3/23 for flu vaccination. Flu vaccine was pulled from Accutemp cooler and given to 17-year-old female in left deltoid per request. When documenting vaccine information on consent form after vaccine was administered, RN realized the vaccine was the Fluzone 65+ influenza vaccine. The RN called CDNS immediately after realization. Employee reported to PCM and Immunization Program Nurse. Dr was notified by IP Nurse and no orders/recommendations were received. The parent was notified of increased risk of side effects due to higher dose of vaccine administered. VAERs completed. RN
Info has been received from a physician concerning an 18 month old male with no known medical history or allergies who on 11/5/05 was vaccinated with, SC, 0.5 ml dose of varicella virus vaccine live (lot 651178/0427R). Concomitant vaccinations the same day included a dose of MMRII. On 11/20/05, the pt experienced a rash. He was seen in the office on 11/23/05 with 6 lesions. No treatment was required. At the time of the report, the pt had not recovered. There was no product quality complaint involved. Additional info has been requested.
My arm near the vaccine area got sore. Next morning I could not lift my arm higher than my shoulder. Put an ice pack on it an there was a lot of pain enough to keep me from sleeping for 4 days at night and I'm still having problems.
Immediately after vaccination I started to get a sore arm.  It wasn?t like a sore arm with other vaccinations, it was like a golf ball was in my arm, and the site ached slightly.  A few hours later, the aching feeling spread throughout my body and I felt like I was in the first stage of that ?flu? like feeling along with exhaustion.  The strangest thing to me is that my uterus began to cramp somewhat, almost like the start of a period.  I finally gave in and took ibuprofen, and drank tons of water.  Felt somewhat better, slept through the night and all side effects slowly went away as the next day went on.
Information was received on 26-MAY-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with ZOSTAVAX (dose, site, lot and expiration not reported) on or about 25-FEB-2008, at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 23-APR-2014, the patient was treated by a physician at a physician office for a vesicular outbreak that was diagnosed as severe shingles. On or about 01-DEC-2014, the patient was treated again for ongoing and worsening symptoms by a physician who affirmed the diagnosis of shingles.  The patient was prescribed valacyclovir (VALTREX) for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
CONCERNS WITH IMMUNIZATION REACTION FROM FLU SHOT, RECEIVED ON WEDNESDAY   an hour later ARM RED, SWOLLEN, BRUISED AND WARM TO THE TOUCH    HURTS WHEN SHE MOVES OR TOUCHES IT    no fevers, no other sick symptoms  Denies any trouble breathing   cool compress to area  no concerns for cellulitis at this time, if redness continues to spread would consider antibiotic
On 01/20/17, 4 yo F was brought to clinic for well child check. During this visit, pt was ordered to receive DTaP IPV combined vaccine IM vaccine (KINRIX) (Order #299585402). At 1345, pt received 0.5 mL injection in right quadriceps (NDC #58160-812-43, Mfg: GlaxoSmithKline; Lot:  JD797, Exp: 11/13/2017). On 01/22, pt developed erythema, warmth and tenderness over her right anteromedial thigh surrounding the site of the injection. Pt was taken to Urgent Care clinic where MD  notified mother that the symptoms were suggestive of an inflammatory response to the recent inoculation. Based on the size of the involved area and concern for cellulitis, MD prescribed sulfamethoxazole-trimethoprim (SEPTRA) suspension with instructions to take 13.6 mLs (108.8 mg of trimethoprim total) by mouth 2 (two) times daily for 10 days. On 01/25, mother notified the primary care clinic of the reaction. By that time, pt's symptoms had improved with only some residual discomfort at the site. No report of adverse sequela.
Upper left arm was red & swollen & had a lot of pain & discomfort. Difficult to sleep. Felt very weak & tired from 9/2/11 thru present. Rec'd antibiotic treatment at ER on 9/4/2011. Discharged same evening with prescription for BACTRIM DS 800mg & KEFLEX 500mg for 10 days.  Follow up with Dr. on 9/15/2011. Hospital diagnosis: cellulitis.
This is a spontaneous report from a contactable female consumer reporting for herself. A female patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration at 0.5ml single on an unspecified date at the end of May for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced eczema in different part of her body, she got some of the benign growth called seborrheic keratosis on her back and different places. Consumer commented to have eczema and doctors have not been able to determine the cause of it, she received a shot of Prevnar 13 recently and that is why she suspects the eczema could be a systemic reaction to the vaccine. This eczema is like a rash and it was on different parts of the body and not limited to the administration site. The outcome of the events was unknown. She had bug bites (she believed that were bug bites) but she did not know if bug bites were due to Prevnar 13 shot. She had one of the spot biopsied, it came back that it said to contact dermatitis or drug reaction. She had a bunch of inflammatory skin conditions. Consumer mentioned that she was not sure if side effects she had were due to Prevnar 13 shot or not.
Body aches, joint pain, (started about 10 hours after vaccine administration), fever (100.5 - 101.5), chills, (started about 12 hours after vaccine administration), headache (following day, about 24 hours after vaccine administration). Took Tylenol 12 hours after vaccine administration for fever, which quickly helped to ease the symptoms. Took Tylenol again about 5 hours later when symptoms started again. Fever was higher and Tylenol took longer to ease symptoms. Took Tylenol again 24 hours after vaccine administration for fever (100.5), headache and body discomfort, which was less severe than before.
Felt very tired and had joint aches for 2 days after vaccine. Did not note a fever. No reaction with first dose of Hep B,.
SHINGRIX given SQ instead of IM, led to pronounced adverse affects namely pain at injection site, erythema, heat, and swelling.
Case number PHEH2012US023201 is an initial spontaneous report received from a medical assistant on 21 Nov 2012 with the follow-up received on 21 Nov 2012: This case refers to an 11-years-old female patient. She was received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: A11051 and expiry date: 01 Apr 2014), intramuscularly without being reconstituted with Men A component on 19 Nov 2012. No adverse reaction reported following this administration error. Follow-up received on 21 Nov 2012; Updated vaccine expiry date (01 Apr 2014).
Approximately 5 hours after shot, right leg began to hurt - like running into a piece of furniture.  For two days patient was completely debilitated like having a severe case of arthritis in right hip and leg.
Tiredness; This is a spontaneous report from a contactable consumer (Patient). A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 04May2021 as 1st dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient received his both doses of the Pfizer covid vaccine and experienced only tiredness with first dose in May 2021. He got the second vaccine on Tuesday, 25May2021, he felt sleepy and tired that evening. He received the vaccine at lunch time. The next day after the vaccine he had a sore throat and a hot flash in his head that night. He had pizza and 2 beers and 2 beer have not effective him this way before but he experienced heavy heart, pain in the chest, fast heartbeat, he does not feel good. He will be traveling and wanted to know about side effects. He felt that his chest was heavy and it's a little bit uncomfortable. After second dose, not sure if his blood pressure is high or low. He was feeling all this pain after the Covid 19 vaccine. He was asking what kind of medicine he can take or what can he do. He provided an email as his phone is not reliable. He did not provide an address as he is getting ready to move. Patient stated that Yesterday, 27May2021, he was feeling good but today in the morning he had a high rate of his heart beat. A couple beers never affected him in this way. He did check his heart beat with his hand and it felt much higher than normal. He also had a headache. He cannot relate how he was feeling to drinking 2 beers. He was asking if these are side effects of the Covid 19 vaccine. He had read online that these can be side effects. He called Pfizer for support this is to complicated, maybe he can buy some pills or medicine. He also would like to measure his blood pressure because he had a headache. He will go to Urgent Care for a check up, the Urgent Care is across the street. While transferring the call patient stated he was at the urgent care and did not wishes to speak at this time. he stated he was ok. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Left shoulder tendinitis of infraspinatus, biceps long-head, triceps ipsilateral to both shots
Wednesday evening 7/14/10 6pm - c/o hurting, burning and itching. Today large area red warm, burning. Ice applied to area (L) thigh 8 x 10 cm red, raised.
Pt complained of tingling of face, feeling flush and swelling of bottom lip after the first 5 minutes after shots pt states continued to get worse. Pt given 25 mg of BENADRYL IM, vitals were stable. Pt left clinic without any assistance. Felt fine after BENADRYL was given.
Pt vaccinated w/DTP became pale & limp w/several sec. of apnea. Color was cyanotic while apnic. Began to slowly respond but remained sluggish 10-15min.
employee reported fever and chills beginning 3:30am. He treated w/ Tylenol, no effect and then later took Ibuprofen. At 11:50 am on 1/7 his temp was down to 99.7.
pt recvd vax & the next day had an episode of extreme agitation & eyes had a glassy appearance; On the 29th sores started in mouth; returned to MD & medication given for sores in mouth;
Normal labor and delivery on 11/17/2021. Hospital admission within 6 weeks of receiving the COVID vaccine.
This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. On 23-NOV-2016, 20-JAN-2017, 06-MAR-2017 and on 10-MAR-2017, the patients were vaccinated with improperly stored doses of VAQTA (lot # L048456, expiration date: 25-MAY-2017) (dosage and route of administration were not reported) for prophylaxis. From 06-APR-2016 to 08-MAR-2017, the doses were stored outside of recommended temperature (from 36 to 46 degrees of Fahrenheit). The lowest temperature was 33 degrees of Fahrenheit and the highest temperature was 73 degrees of Fahrenheit. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA008959:
itchiness all over her body; soreness on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness all over her body) and PAIN IN EXTREMITY (soreness on her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PRURITUS (itchiness all over her body) and PAIN IN EXTREMITY (soreness on her arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at a dose of UNK dosage form. At the time of the report, PRURITUS (itchiness all over her body) and PAIN IN EXTREMITY (soreness on her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took bipolar, depression and a lot of other medication as concomitant medication.
Red inflamed itchy skin with burning sensation under skin. Injection site feels hot and painful. Light headed and dizzy the first five days. Three weeks later my skin is still burning and itching.
Severe joint pain leading to joint damage to the shoulder in the arm the vaccine was given.   Chills, sweating, racing heart rate.
the next morning while making breakfast I began to feel dizzy and nauseous and light headed. It was frightening and I was unsure if I would even make it to the couch. I was eventually able to make it to my bedroom. I stayed in bed and rested until mid day. I got up but took it easy for the rest of the day. About a week later, I was able to see my doctor. He confirmed that I was not having a heart attack or stroke and that others had reported to him having a similar reaction after the booster and that I shouldn't concern myself too much with it. He did state that it was possible for it to happen again if I receive another vaccine.
Patient had a ST elevation myocardial infarction but presented late to the hospital on 3/9/21 (he thought his symptoms were secondary to vaccine side effects). He underwent a percutaneous intervention to his left anterior coronary artery and had significant left ventricular systolic dysfunction (EF 20-25%) with cardiogenic shock requiring inotropes. He was evaluated by palliative care and transferred to our inpatient hospice unit.
Information has been received from a certificated medical assistant (also reported as registered nurse) referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, drug reactions/allergies and medical history was unknown. Concomitant therapies included sterile diluent. On an unknown date, the patients each was vaccinated with PROQUAD (dose and route unknown, lot # N013865 with expiry date 31-OCT-2018 and lot # N002325 with expiry date 19-JUL-2018) for prophylaxis. No adverse effect was reported. The vaccines were under the temperature of -11.8 degree Celsius (-14 degree Celsius to -10 degree Celsius) for 3 hours and 35 mins. There was no previous excursion. A data logger was used. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA004611: US-009507513-1708USA013799.
Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 16 years old female patient. The patient's history of previous pregnancies and live births is not known. The patient was vaccinated with the first and second dose of 0.5 ml GARDASIL (lot # 70049/1261AA, 672232/1495AA) intramuscularly on 14-MAR-2012 and 14-AUG-2012, respectively. No other co-suspects were reported. No concomitant medications were reported. The patient became pregnant with an LMP of 24-JUL-2012 and an EDD of 30-APR-2013. Initial exposure to GARDASIL was at 0 weeks. The patient was exposed to GARDASIL during trimester 1. The pregnancy was discovered within in the past week, in approximately August 2012, on an unspecified date. There were no adverse experiences. The patient had not seen a physician at the time of the report. Additional information has been requested.
Fever over 103, scratchy throat, headache Taking some kind of fever reducer Will not see doctor