chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have been feeling a little dizzy and very tired.; I have been feeling a little dizzy and very tired.; This is a spontaneous report from a contactable consumer.   A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation. Medical history included ongoing ovarian cancer. There were no concomitant medications.  "For the last two days I have been feeling a little dizzy and very tired. I am dealing with active ovarian cancer at this time and am concerned about my ability to tolerate this vaccine. I am scheduled for chemo therapy treatment a week before my second shot. I am wondering if I should get the second shot. Could the second shot be delayed for a week?" The outcome of the events was not recovered.
had 2 Crohns attacks since Feb 1 2021 and Psoriatic Arthritis has flared up extremely  in feet knees hands and hips
Information has been received from a nurse practitioner concerning a female who on 21-APR-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck). The next day, on 22-APR-2008, when the patient tried to get up she had a headache and felt dizzy. The patient lied back down and she tried to get up again she "started throwing up profusely." No medical attention was sought. On an unspecified date, the patient recovered. No product quality complaint was involved. Follow-up information has been received from a health professional, concerning a 70-year-old retired female with GERD, high cholesterol, hypertension and arthritis. On 21-Apr-2008 at 10:15 the patient was vaccinated subcutaneously with a first dose of zoster vaccine live (Oka/Merck: 659404/1826U). It was reported that at the time of vaccination the patient was recovering from a fractured rib. On 22-Apr-2008 (also reported as 22-May-2008) the patient notified the physician's office that she had nausea and vomiting which improved within 24 hours. There was no fever and no abdominal pain. There were no diagnostic or laboratory tests performed. The patient recovered from the nausea and vomiting on 23-Apr-2008. Additional information has been requested.
Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the sixth of 20 reports.  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 03Jan2021, and tested positive for the virus (COVID-19) in Jan2021.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like COVID infection date needed for a full meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
Information has been received from a registered nurse referring to an unspecified number of patients of unknown gender and age. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with doses of PNEUMOVAX23 (strength, dose, route, lot# and expiration date unknown), which were improperly stored. No adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Typical soreness in arm for 48 hrs immediately after vaccine. 7 days after vaccine, 3" red skin reaction, new soreness, swollen lymph node in armpit. Mostly gone by day 10.
pt recvd vax; mom states pt cried unconsolably for 3 hrs; entire rt thigh swollen, red & warm to touch; 1 episode of v; no fever, called MD; advised no more pertussis;
Patient reports injection was given below deltoid.  Patient reported she experienced redness, swelling, pain and warm to touch at injection.  She reported having a fever, last temperature checked was 101.  She reported that redness and swelling has increased for  the past day.  This nurse observed swelling, redness and warm to touch on her arm below the deltoid and slightly above the elbow.  Did not measure redness size but guess that it was about 3 x 5 inches in size.  Referred to MD for follow up.  She reported she did not have any reactions or side effects from her first injection of the series.  She stated that injection was given in the deltoid.
Soon after vaccination patient stated "throat feels like its closing off". Vital signs were taken and patient was assessed by medical doctor.
Begining Around 9:00 PM on Fri 1/22/2021 started having chills and probably had fever and became nauseous.  Was sick thru the night and most of day on 1/23/21.
hearing loss; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On an unknown date in 2010, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a healthcare provider at a hospital for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequently to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by an audiologist for hearing loss. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt Plaintiff had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered. The reporter considered the event of hearing loss to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of hearing loss was considered to be medically significant.
Initial report received from a health care professional on 24 September 2009. This patient is part of a cluster of 10 unidentified patients. The other nine patients experienced non-serious events and have been captured in case number 2009-04085. An unidentified patient had received an intramuscular left deltoid injection of FLUZONE SV 2009-2010, lot number U3194AA on 22 September 2009 and within 24 to 48 hours (also reported as 23 September 2009), they developed a swollen throat which required an emergency room visit. Additional symptoms may have included a scratchy throat, headache, general malaise, ear pain, GI symptoms and a red itchy injection site. According to the reporter, the patient had not recovered from the event. No additional information was provided. The reporter for this case is the same as for case 2009-04085. Documents held by sender: None.
Pt devel excessive irritability shortly p/vax; Pt began to scream & was inconsolable--persisted >3 hrs w/low-grade temp; @ MD's ofc afebrile, but excessive irritability still; admitted to hosp; resolved w/in 6 hrs p/inject;
Large, red, warm, swollen area at site, & flu vaccine (R) deltoid given ibuprofen.
PT c/o dizziness/lightheaded at 12:44 & taken to room to lie down.  Note by  MD:  Notified by Nurse  that the patient had just received COVID 19 vaccine and is feeling dizzy and not feeling well.  Patient was already brought to exam room 1 for further monitoring and assessment.  In the exam room, patient is sitting up talking to MA .   reports that patient's O2 Saturation is 98%.   While I was talking to the patient, patient states the lips and face are having symptoms of tingling and with sensation of swelling. Patient also states feeling dizzy, sleepy, nausea, and lethargic.  I asked patient to lay down on exam table instead of sitting up.  I immediately place patient's legs up with the help of patient's friend.  On exam, patient is becoming more pale. No diaphoresis. Patient has sign of becoming less arousable. Patient states vision becoming more blurred and patient was near passing out.  Due to above progressing and escalating symptoms, possible anaphylactic reaction to COVID 19 vaccine is considered. I immediately call for assistance from nursing staff to bring EpiPen.  Dr.arrived with EpiPen in the exam room.  Patient continues to have progressing symptom of difficulty with arousal in a near syncopal state.  Patient is becoming less alert.  Decision is to give EpiPen injection to reverse potential progressive and impending anaphylactic reaction with sign of progressive hypotension.  Blood pressure was not able to be taken before the EpiPen was given due to patient's rapid progressing symptoms.   EpiPen injection to right thigh done by Dr..  After the injection of EpiPen patient had nausea with dry heave.  No vomiting.   BP taken in right arm in supine position.  BP is 110/70.  Pulse Oximeter: Pulse 93.  O2 Saturation 96%.   Heart exam: RRR no murmur.  Lungs: no rales. no wheeze. breath sound equal and bilateral.   Few minutes after the injection of EpiPen, patient states is having improvement of blurred vision and blurred vision has gradually resolved.  Patient is also more arousable and alert.  Patient still has nausea.   Patient reports feeling improvement.   Paramedic arrived and evaluated the patient.  Patient transported to ER by paramedic around 1:22 pm.  At time of transport, patient is in stable condition.  Patient is awake, alert and answer all questions appropriately.   Per patient's friend, patient had symptom of tingling sensation of the lips and face and also urticaria 3 hours after receiving 1st dose of Moderna COVID 19 vaccine  which was 1 month ago.  Patient's friend learned about this 1 day after the patient had the vaccine.  Unclear if patient received any treatment for such.  Patient states never had other vaccine reaction in the past.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a six-year-old female patient for whom medication error was reported, while she received 0.5 ml of vaccine FLUZONE (0.5 ml) (batch number: UI998AE, expiration date: 30-Jun-2019, via unknown route in right deltoid) on 27-Sep-2018. On an unknown date, the patient was again vaccinated with the FLUZONE (Batch number, expiry date, dose, route and site of administration was not reported). Then the patient was given a second Flu Vaccine at school (vaccine name unknown) in the last week (on 8-Oct-2018 to 10-Oct-2018) and the child never received the Flu vaccine prior to 2018. The patient's medical history were not reported. The patient received concomitant vaccination with Hepatitis A vaccine in left arm. It was an actual medication error due to extra dose administration of vaccine. No reported reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Additional information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. The dosage regimen was updated. Narrative updated accordingly. List of documents held by sender: none.
I had dizziness difficulty breathing, headache, stuffy head. On Sunday I started vomiting, went to the emergency room, they ran blood test, CT scan, chest x-ray. All tests came back normal, they sent me home and told me to follow up with my primary care physician. I went to a balance doctor who did not find that I had an issue with my balance, he told me I did need to see my primary care. My primary care doctor's PA listened to my lungs, said it sounded like an upper respiratory infection. I was prescribed antibiotics; I have a follow up visit tomorrow to see how I am doing.
This spontaneous report was received from a healthcare worker refers to unspecified patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL (lot # J006850, exp. 31-MAR-2016). No concomitant therapy was reported. No adverse effect was reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Arm has swollen halfway through the upper arm; Upper part of arm is red; Tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Arm has swollen halfway through the upper arm), VACCINATION SITE ERYTHEMA (Upper part of arm is red) and VACCINATION SITE PAIN (Tenderness at injection site) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 002A21A and 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced VACCINATION SITE PAIN (Tenderness at injection site). On 31-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE SWELLING (Arm has swollen halfway through the upper arm) and VACCINATION SITE ERYTHEMA (Upper part of arm is red). At the time of the report, VACCINATION SITE SWELLING (Arm has swollen halfway through the upper arm), VACCINATION SITE ERYTHEMA (Upper part of arm is red) and VACCINATION SITE PAIN (Tenderness at injection site) outcome was unknown.            Relevant concomitant medication was included high blood pressure medication. Patient was advised to keep an eye out on the redness and contact HCP if it starts going down the arm. The redness has not moved towards bottom of the arm.  No medications has been taken for adverse events.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Added dosage information and new event.
Two weeks after the second vaccine shot, patient had a seizure while sleeping. It was a grand mal seizure that lasted for three minutes. Afterwards he was lethargic and does not remember the events
The next morning I woke up feeling like I was hungover and had terrible flu. I had a fever of 100.5 that rose to 100.8 later in the day. I had a terrible migraine. Took 3 Tylenol later that day and felt better by the end of the day. Ever since I got the third shot though, it caused a terrible flare up of the Hashimoto?s disease. One of the worst I?ve felt. I had to leave my job partially because of it. My symptoms in order of most bothersome are: fatigue,  headaches, light sensitivity, brain fog, swollen thyroid, very inflamed large and painful lymph nodes, trouble focusing my eyes, muscle soreness, swollen feet/legs,  swollen neck and face, slight congestion, wounds that won?t heal.
This spontaneous report was received from a pharmacist and refers to a patient of unknown demographics. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was reported. On an unknown date, the patient was vaccinated with two doses of PNEUMOVAX 23 injection, lot # N010109, expiration date 20-NOV-2018 (also reported as 20-JUN-2018) (exact dose, frequency and route of administration were not provided). No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1803USA002687.
This is a spontaneous report from a contactable physician via a sales representative. A patient of unspecified age, ethnicity and gender received TRUMENBA, via an unspecified route of administration in the arm, on an unspecified date, at single dose. Relevant medical history and concomitant medications were not reported. The patient experienced rash on the arm and burning on the site on an unspecified date. Outcome of the reported events was unknown at the time of this report. Follow-up (24JUL2015): Follow-up attempts completed. No further information expected.
Presents for worsening weakness & fever. Admit for COVID pneumonia w/hypoxia. Tx: O2, abc, vitamin C, D, zinc decadron; not a candidate for remdesivir. DC home.
pt recvd vax 1NOV93 & approx 10AM no fever reported; approx 6PM on 1NOV93 mom noted what appeared to be sz activity lasting about 30 seconds; no LOC involved but tonic clonic type acitivty described;
Immediate: intense soreness at injection site 6pm body aches 7pm chills 8pm fever 102.4F 12:30am fever broke, onset of migraine  7am nausea  Migraine & nausea intense until 6pm 3/13/21 Mild headache now
pt to ED with SOB, nasal drainage, malaise, increasing cough, some diarrhea; saw PCP via TeleHealth earlier in week and was prescribed an antibiotic and cough syrup; was instructed to go to ED, but pt refused; pt did a home COVID test and it was positive; O2 sats low; O2 supplementation; given remdesivir, baricitinib, Lovenox; has a hx of pulmonary fibrosis, chronic hypoxia requiring 5L O2 via NC prior to COVID; pt's condition worsened; DNR; transitioned to comfort care and pt passed away in the hospital
Inappropriate Reconstitution Technique/patient was administered the liquid adjuvant portion only of Shingrix; Inappropriate Reconstitution Technique/patient was administered the liquid adjuvant portion only of Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number 9AT7A, expiry date 06-AUG-2024) for prophylaxis.   On 23-JUN-2023, the patient received the 1st dose of Shingrix. On 23-JUN-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate Reconstitution Technique/patient was administered the liquid adjuvant portion only of Shingrix) and inappropriate dose of vaccine administered (Verbatim: Inappropriate Reconstitution Technique/patient was administered the liquid adjuvant portion only of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 29-Jun-2023 Department supervisor reported that the patient was administered the liquid adjuvant portion only of Shingrix and it was not reconstituted with the lyophilized component.  At the time of reporting a repeat dose has not been administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. This is 3 of 3 linked patients, reported by same reporter. The patient received only liquid adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2023090167:Same reporter US-GSK-US2023090170:Same Reporter
Patient left clinic after vaccinations and had a mild nose bleed while walking to car. Parents brought child back into clinic immediately and nosebleed had already resolved.
Itching on the bottom of the hands and feet. Itch started to spread throughout entire body. Rash appeared on arms, stomach and neck.
Strange sensation on lower right side of face near mouth. Heaviness or tight band like feeling on lower right arm and leg, same for a couple of toes on the right foot. This still continues occasionally. Next came the shock/zap like sensations all over my body. Zap here, zap there. Deep itch that scratching can't touch. Both of these have subsided but happen occasionally. Developed pins and needles, burning sensation in different areas, a lot in hands. This is everyday, some days worse than others. Occasional tinnitus in left ear. Intermittent spasm in left leg. Note, started having pain in left leg shortly after first dose in April.
Patient came in 9-30-13 and showed me her upper left arm which had a bruise about 6-8 inches long and 2-3 inches wide going down, starting a few inches from her shoulder. She said it started around 9-20-13. She had no pain, itching, or any noticeable swelling.
Patient felt pain in left thumb after injection was received in (L) arm. After evaluation by ortho - thumb xray revealed stage 3 CMC joint degeneration.
Redness and swelling at injection site. Pt advised to take BENADRYL and use HC 1% cream on rash, also, keep red area cool.
under the recommended age to receive vaccine; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under the recommended age to receive vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 19-Feb-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021 at 1:00 PM, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under the recommended age to receive vaccine). On 19-Mar-2021 at 1:00 PM, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under the recommended age to receive vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not provided. Treatment medication not provided.    This case was linked to MOD-2021-072269 (Patient Link).
99.9 degree F fever with chills for 24 hours, ibuprofen taken to lessen fever, fever subsided 24 hours after vaccine was given
Herpes zoster in a two dose varicella vaccine recipient who is immunocompromised (lupus, juvenile RA, Sjogren's Syndrome). Location of rash was on right side of face. Also developed cellulitis. Lasted <4 weeks. IV acyclovir given in hospital and continued valacyclovir at home. She reported no history of varicella disease.