chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a adult unk patient who received HAVRIX pediatric (batch number UNKNOWN, expiry date unknown). On an unknown date, the patient received HAVRIX pediatric 2 dosage form (s). On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving HAVRIX pediatric, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown. Additional information: Nurse reports that two doses of the pediatric HAVRIX vaccine were administered to an adult patient on the same day. She did not have any additional information about the event.
Presented with gen weakness, dyspnea; + covid  Labs: D-dimer 0.79, CRP 2.95, Ferritin 1288 CXR: RLL PNA  Tx: Decadron, singulair; Rocephin,  no remdisivir due to unknown time of symptom onset; home with O2 for ambulation
minor child has taken the Moderna vaccine; This spontaneous case was reported by an other caregiver and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (minor child has taken the Moderna vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Pre-existing disease (The mother of the patient reported that her daughter had pre-existing conditions and that's why she wanted her to have the shot).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (minor child has taken the Moderna vaccine). On 06-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (minor child has taken the Moderna vaccine) had resolved. Not Provided
Patient arrived at office for Varicella vaccine. Vaccine administered at 1:45 PM. Approximately 10 min after patient told medical staff that she was experiencing "chest tightness" and itching in her throat. Patient stated she felt like it was difficult to breath. Medical staff took vitals immediately with BP of 111/73 and Pulse 73 and alerted myself. Patient was able to speak in full sentences when talking to her. Visual inspection did not show any signs of angioedema, cyanosis, and no audible wheezing was heard. Upon physical examination there was no swelling of face, lips, or throat. Auscultation of lungs revealed bilateral wheezing. Patient stated she has allergic asthma but did not have her inhaler. Recommended to patient that I would like to give her IM Diphenhydramine 1 mL (50mg/ml) but patient initially declined and wanted to wait a few more minutes because BENADRYL makes her extremely drowsy. Waited a few minutes and reassessed BP 105/65, Pulse 73 and patient still did not feel better. Recommended Diphenhydramine again and patient agreed, but when i recommended she also go to the ER she refused. Told her we were going to call anyway. Administered Diphenhydramine IM at 245 PM. EMS called at 230 PM. A few minutes after administration patient said she felt better and the tightness in her chest was somewhat relieved. EMS evaluated patient and she declined, risks up to and including death explained to patient and she verbalized understanding. Patient remained in office for another 10-15 minutes and as time passed she felt more and more "relaxed". Patient's fiance came and picked her up. Told patient if she experiences any changes or gets worse to immediately go to the ER. Told patient she is never again to have a Varicella vaccine. Patient verbalizes understanding.
Patient presents inflammation and swelling on left arm. She describes painf and hot zone on rednes.
This spontaneous report was received from a consumer refers to a 54 year old female patient who is a ovarian cancer survivor and skin cancer survivor. No drug reactions were reported. On 09-JAN-2014, the patient was vaccinated with a dose of ZOSTAVAX. Concomitant therapies included hydrochlorothiazide, zolpidem tartrate, guanfacine hydrochloride, allopurinol, influenza virus vaccine (Manufacturer unknown) and DIAZIDE and ZOLPIDAN. On 10-JAN-2014, the patient experienced shingles. The patient stated that she experienced tingling all over her body one day after receiving the ZOSTAVAX from the physician. Two days after the vaccination, she felt as though her "blood was burning". Three day after the vaccination, she woke with a rash about the size of her open hand located just above her left hip. Four days after the vaccination, there was a second rash area about three inches away from the first one. The rash had a discharge. Consumer experienced severe leg and arm pain. Patient sought medical attention. Patient saw a physician on 13-JAN-2014 and he confirmed it was the shingles. Blood tests and other tests were performed-results not reported. Patient received oxycodone as treatment. The rash went away about a week ago but the leg and arm pain continues. The outcome of shingles was unknown. Additional information has been requested.
Vasovagal reaction, laid on floor for about 40 minutes with feet elevated.  During the 40 minutes, my blood pressure measured in the range of 112-119/69-74 and my heart rate ranged from 44 to 49 bpm.  1 hour after the start of the event, my blood pressure was 120/75 with a heart rate of 62 bpm.  3.5 hours after the start of the even my blood pressure was 109/62 and my heart rate was 63.
A non-serious spontaneous report of hand and foot disease manifested with tiny bumps, painful rash on hands, fingers and palms has been received from a physician concerning a 40-month-old female, subsequent to FLUMIST. This case will be submitted in accordance with MedImmunes FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST ON 27-Dec-2011. On approximately 10-Jan-2012, the patient experienced fine tiny bumps (1mm), painful rash on their hands, ventral side mostly fingers, but also palms, which was diagnosed as hand and foot disease. The reporter believed that the rash was probably due to a viral infection, which began with the mother and was transmitted to her sister and then her. The outcome of event was unknown. Additional information was received on 26-Apr-2012 and incorporated into the narrative: event information.
Patient stated that the right arm where the Pneumovax-23 was injected is red and hot and was diagnosed by her PCP as Cellulitis. MD prescribed antibiotics to treat it per patient.
patient reported that this injection caused significant pain and immobility of her left arm, couldn't raise arm above shoulder height for 4-5 days .
Information has been received from an investigator via agency concerning a patient who was enrolled in a study. This report was part of a post-marketing surveillance program. On an unspecified date, the patient was vaccinated a dose of PNEUMOVAX 23 (manufacturer unknown). The patient was also vaccinated with a dose of MMR II. On an unknown date (at week 16), the patient developed erythema, grade 3. The reporting investigator felt that erythema was definitely related to PNEUMOVAX 23 (manufacturer unknown) and that there was no relationship to the MMR II. Erythema, grade 3 was considered to be an other important medical event. Additional information is not expected.
Pt reports anxiety attack. bradycardia in low 50s which improved after drinking juice.
Pain in left armpit; swelling on left armpit; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8735) via an unspecified route of administration in the left arm on 01May2021 at 16:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient did not receive any medication within two weeks of vaccination. The patient not had any past medication history. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8734) via an unspecified route of administration in the left arm on 08April2021 at 15:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021 at 20:00, the patient experienced pain in left armpit and swelling in left armpit (axillary mass).  The clinical outcome of the event pain in left armpit and swelling in left armpit( axillary mass) was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Became dizzy and diaphoretic immediately after receiving Moderna vaccine. Nurse and EMS assessed pt. given cool cloth, fanned, and remained seated until feeling better. No meds given
Awoke on 2/25/21 with a severe headache.  It started in the back of my neck and  went across  my head.  It lasted for 24 hours.  Advil gave only slight relief.   Since then I have continued to have headaches.  I have had as many as 4 per week, now having one to two per week.   I saw my doctor in June and was given Flexeril,  Diclofenac , and I see a Physical Therapist.   I recently saw a Neurologist who advised it was inflammation caused by the Covid vaccine
COVID breakthrough case. I received my 2nd booster shot on 04/12/2022 and my adverse event started on 05/17/2022 evening I had little like I was getting a cold, it continued till I had a worst sore throat of my life. I felt like I wasn't able to swallow. My knee caps were hurting, I was tired but I had no fever. The worst days was Thursday afternoon, Friday, and part of Saturday. On the 05/19/2022 I tested positive for COVID. I called my doctor and she prescribed PAXLOVID 5 days. I stated taking it on Thursday night and I have 2 left. I am feeling better now.
Patient received an expired dose of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the vaccine) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the vaccine). On 14-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.
The arm administered in is red, warm and swollen. Cellulitis/MD treated with hydrocortisone and NEOSPORIN, f/u with cephalexin and prednisone.
This spontaneous report as received from a Nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with GARDASIL (dose, duration and route were not reported). The nurse reported that an unknown number of doses of GARDASIL that were stored at 32 degrees F. for 30 hours have been administered. No adverse effect report. At the time of the report action taken was not reported. This is one of the several reports from the same source. Additional information has been requested.
Pfizer vaccine was given for 2nd covid 19 vaccine dose instead of the Moderna.
Fever, non stoppable crying and moaning for few hours before falling asleep. Next morning - change of stool to mucus like, episodes of shrill crying for few following days, excessive drooling and change of "speech" from distinct throaty sounds to only bubble blowing.
vaccine may have been expired at the time of administration. patient did not experience any adverse effects from the vaccine
localized reaction, site of inj 24 hr p/vax; lo grade temp; eruption on chest & face 48 hr p/
triglycerides were a little off; This is a spontaneous report from a contactable Other healthcare professional. A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on 11Jan2021 (at the age of 64-years-old) as a single dose for covid-19 immunization and received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 2 via an unspecified route of administration on 08Feb2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported since 11Dec2020 and ongoing: noticing changes in some joints such as the top of her right pinky fingers has a new nodule and is painful, also she stated she has fluid build up behind her right knee. She also reported that due to changing weather, she has some joints that are currently a little sore. The patient did not have covid-19 and also had blood work with her cardiologist showing all positive results except triglycerides were a little off on an unspecified date. No additional information provided. Outcome of the event was unknown. Information on the Lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Patient is complaining of pain in left arm about a month after vaccine given.  She is still having pain and states she cannot move or lift her arm.  She will be having it looked at by her doctor.  She had minor muscle soreness the day after the vaccine, as she has experienced in the past.
Migraines until now 2/2/2022 sudden blurred vision Fever las 3 days 103.25 Nauseas chronical constipation  until now 2/2/2022 (laxatives are not working) Period disorder I have 2 periods on the month of January,  and since I put the first dose on Feb/12/2021 I had six month without periods. Poor circulation on y legs  Indigestion  body aches last 2 weeks
got my shot and then got the shingles/suspected vaccination failure; shingles; very painful; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported the case for herself/himself. The age at vaccination was not reported. The patient never had the shingles got his/her shingle shot and got the shingles. The patient stated that yes it was very painful. The follow up would not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
1:00 A.M.  early morning on the day after getting the shot I woke up from sleeping. I had fever, chills, rapid pulse (108 bpm normally runs 70), & chest tightness. Almost called ambulance because of the pulse and chest tightness. Within a couple hours of waking up I also began to have muscle cramps in my feet, toes, and thighs. Worse than I have ever experienced  and I have been diagnosed with PAD for over 10 years. I tried to get some sleep. I couldn't. My PCP also did not like the way my lungs sounded that morning at the Clinic. I was told after a xray that my lungs were ok. My injection site has been sore until today. It is better. I did have Covid in October 2020.
Fever; chills; sore muscles; weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Oct2021 10:00 (Lot number: FF8841) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL 3247, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM, Route of Administration: Intramuscular), administration date: 17Feb2021, when the patient was 35 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL 3247, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM, Route of Administration: Intramuscular), administration date: 27Jan2021, when the patient was 35 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 27Oct2021, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 27Oct2021, outcome "recovering", described as "chills"; MYALGIA (non-serious) with onset 27Oct2021, outcome "recovering", described as "sore muscles"; ASTHENIA (non-serious) with onset 27Oct2021, outcome "recovering", described as "weakness". Therapeutic measures were not taken as a result of pyrexia, chills, myalgia, asthenia.  Additional information: No covid prior vaccination nor covid tested post vaccination.  No known allergies.  No follow-up attempts are possible. No further information is expected.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 at 07:15 as dose 1, single (Lot number: EN6201), in right arm, on 26Feb2021 at 06:45 as dose 2, single (Lot number: EN6201), in right arm, on 27Sep2021 at 17:15 as dose 3 (booster), single (Lot number: FF8839), in right arm and on 06Apr2022 at 17:15 as dose 4 (booster), single (Lot number: FK9895) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "Known Allergies: Penicillin" (unspecified if ongoing); "Known Allergies: peanut Products" (unspecified if ongoing); "Known Allergies: Oil/Food" (unspecified if ongoing); "Known Allergies: Dust" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid Rebound; Positive, notes: Currently day 9 with with positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Addition information: Covid Rebound with heavy nasal congestion, sore throat and sneezing on day 8 after 5 day treatment with Paxlovid beginning on day 1 of symptoms/positive test; also nasty metallic taste in mouth days 1-5 while taking Paxlovid. Currently day 9 with positive test and heavy sinus/throat symptoms. Treatment start date was 29May2022. Treatment stop date was 02Jun2022.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
SWEATY; BODY ACHES; EXTREMELY THIRSTY; LEFT ARM PAIN/LEGS BURNING; LEFT ARM NUMBNESS; HEADACHE; FATIGUE; LUNG PAIN; LUNG WEIGHT/PINCH IN THE HEART/CHEST DISCOMFORT; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced lung pain. On 24-MAR-2021, the subject experienced lung weight/pinch in the heart/chest discomfort. On 24-MAR-2021, the subject experienced body aches. On 24-MAR-2021, the subject experienced extremely thirsty. On 24-MAR-2021, the subject experienced left arm pain/legs burning. On 24-MAR-2021, the subject experienced left arm numbness. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced fatigue. On 25-MAR-2021, the subject experienced sweaty. Treatment medications (dates unspecified) included: acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lung pain, lung weight/pinch in the heart/chest discomfort, headache, fatigue, sweaty, body aches, extremely thirsty, left arm pain/legs burning, and left arm numbness. This report was non-serious.
pt devel pustular dermatitis on feet; next day noted burning, pustular eruptions plantar aspect of both feet;
One week after vaccination, vaccination site started to itch a lot. Site swelled and turned red. Diameter is about 1.5 inches. Raised about 1/4 inch.
Patient received the vaccine on 12/21/2020 and shortly after began having headaches associated with decreased coordination and ataxia.  Patient had an MRI performed at another facility which showed bilateral subdural hematomas and midline shift. Patient was operated on at another facility for evacuation of subdural hematomas.  Post-op hospital course for unremarkable.  Patient underwent physical therapy and rehabilitation at Doctors Memorial and discharged on 01/25/2021.
Case number PHEH2016US033472, is an initial spontaneous report received from a pharmacist on 20 Dec 2016. This was also a quality complaint report. This report refers to 28 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1620601, expiry date: Jun 2017) on 20 Dec 2016. It was reported that on the same day the plunger on the syringe was faulty and the patient received a partial dose. No product complaint was reported for FLUVIRIN. No adverse event was reported following this administration error. The pharmacist assessed the case as non-serious.