chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt unwell; she has not had any energy; all she wants to do is sleep/she was drowsy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18May2021 12:00 (Lot number: EN6205) at the age of 79 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "cataracts" (unspecified if ongoing); "macular degeneration" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN B12 [VITAMIN B12 NOS] taken for bone deformity, start date: Mar2021; VITAMIN D NOS, start date: Mar2021; ZINC taken for cataract. Vaccination history included: Bnt162b2 (DOSE 1, Lot number : EN6205, Time at vaccination : 11:00, Anatomical Location: Upper left arm), administration date: 26Apr2021, when the patient was 79 years old, for COVID-19 Immunization, reaction(s): "dizzy", "dizzy like all the energy went out of her foot"; Penicillin vaccine (she came home and she got hives on her chest and neck and up on her face), for allergic to Penicillin. The following information was reported: MALAISE (non-serious) with onset 18May2021, outcome "not recovered", described as "felt unwell"; ASTHENIA (non-serious) with onset 18May2021, outcome "not recovered", described as "she has not had any energy"; SOMNOLENCE (non-serious) with onset 18May2021, outcome "not recovered", described as "all she wants to do is sleep/she was drowsy". The patient underwent the following laboratory tests and procedures: bone scan: it showed her bones were deteriorating, notes: from get older. Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient got the second dose from a hospital. No family medical history relevant to AE. She was taking Vitamin B12 that way before the shot, had a bone scan and it showed her bones were deteriorating from get older so that was why she started taking it. Vitamin D (the bottle says 125 mg [5000 mcg]) started when she had her wellness check. she had enough trouble with her eyes (cataracts and macular degeneration). So, she takes it for her eyes. She confirmed she had those prior to using the Zine. She was going to have cataract surgery on 04Aug2021. No further information provided. Patient confirmed that both doses were given in her upper left arm. She got the second dose on 18May2021 and she began feeling unwell the same day, in the late afternoon, early night. It was like she just duh, like drugged out and did not have any energy. She said that was ongoing, all she wanted to do was sleep. She said she began feeling like all she wanted to do was sleep the same day as well, about late afternoon, she was drowsy and went to bed. The events did not result in emergency room or physician office visit. Patient did not undergo any investigation assessment.  Follow-up attempts are completed. No further information is expected.
School nurse called office today. She described a swollen, red and hot knot at injection site measuring 3" x 4". Will mark redness, apply ice and bring in center tomorrow if no better.
fever; chills; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills) and MYALGIA (muscle aches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills) and MYALGIA (muscle aches). At the time of the report, PYREXIA (fever), CHILLS (chills) and MYALGIA (muscle aches) outcome was unknown.            No treatment was reported. No concomitant medication was reported.
Head itching - 2 hours after received MMR and PPD. Before 12 PM TST site (forearm) itching. Later afternoon new itching and localized skin rash. Denied trouble breathing but feeling of heaviness at times. Seen in E.R. Medication given - Epinephrine, Solumedrol, Pepcid, ZOFRAN and BENADRYL. Treated in E.R. by P.A.
5 hrs of nonstop crying from approx 330PM to 10PM on 16AUG93 per mom; pt screaming occas consolable, but would immed begin crying again; t100.1 R;
This is a spontaneous report from a contactable pharmacist. This report was received via a Pfizer sales representative. A patient of unspecified age, ethnicity and gender, received PREVNAR 13, via an unspecified route of administration in the arm on an unspecified date at a single dose for routine vaccination and influenza vaccine, via an unspecified route of administration in the arm on an unspecified date at an unspecified dose for immunization. The patient's medical history and concomitant medications were not reported. For the first 4 patients during the flu season, the pharmacist coadministered the flu vaccine with pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) in the same arm with an inch apart. The patient called back and stated that it hurt. The patient couldn't move the arm, it was red and swollen and got a lump. The pharmacist thought that the events happened between Sep2017 and Nov2017 and she believed that the patient had recovered completely on an unspecified date in 2017. The pharmacist stated he changed his vaccinating procedures to one vaccine in each arm and hasn't had any problems since. The information on the batch number and expiration date has been requested.
Blood pressure up to 236/119,  Heart rate 131, O2 dropped to 79, blood sugar dropped to 36, temp 101.7, SEVERE CHEST, RIB & Upper back pain
Localized swelling and redness 3 cm on 5/5/10, baseball sized area by afternoon of 5/6/10.  No fever, pain or other sx.
Patient called us to report severe pain (12 out of 10) in left arm where he received two immunizations the day before.  He received the vaccines around 10AM on 10/26/19 and didn't have any concerns before going to bed that night. He woke up at 3AM on 10/27/19 with severe pain and reports very little mobility without shooting pain from front of shoulder to back of shoulder where vaccines were given. He was applying ice and using ibuprofen to help relieve the pain.  He was instructed to contact his doctor if the pain did not improve over the next 24 - 36 hours.
Within 1 1/2 hours following vax, the pt developed a rash, wheezing, irritability. Was treated with Benadryl. The rash resolved within 1-2 days.
The pt woke up at 1:00 am with a fever of 101, vomiting, shaking and very irritable. Vomiting was constant and would not stop. Taken to the ER and given an unknown medication for vomiting and an antihistamine. Advised liquids for 24 hours.
Heart fluttering; Severe headache neck pain shoulder pain jaw pain; Severe headache neck pain shoulder pain jaw pain; Severe headache neck pain shoulder pain jaw pain/Joint pain; Severe headache neck pain shoulder pain jaw pain; Teeth pain tingling in left fingers; Teeth pain tingling in left fingers; Fatigue; lot of pain; Nausea; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number unknown), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. No concomitant medications were reported. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization and experienced no events. On an unspecified date after second COVID vaccine, the patient experienced heart fluttering, severe headache, neck pain, shoulder pain, jaw pain, teeth pain, tingling in left fingers, joint pain, fatigue and nausea. Patient reported that it was the first day and patient felt well enough to do anything after receiving the vaccination. Patient had a lot of pain with the vaccine. Events took place after use of product. The clinical outcome of the events was reported as unknown.   Information on the Batch/lot number has been requested.
This is a spontaneous report from a contactable pharmacist based on the information received by Pfizer from Merk & Co., Inc. (manufacturer control number: 00449354). A patient received PREVNAR 13 on 30Nov2016 at single dose for immunization. It was reported that patient had a "cardiac condition". The reporter disconnected prior to the event questions were asked. It could not be ruled out that the patient had the "cardiac condition" before pneumococcal 13-val conj vaccine. No follow up attempts are possible. No further information is expected.
administered only the adjuvant component in the syringe to the patient; administered only the adjuvant component in the syringe to the patient; 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 LG374, expiry date 28-MAY-2024) for prophylaxis.   On 02-JUN-2023, the patient received the 2nd dose of Shingrix. On 02-JUN-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: administered only the adjuvant component in the syringe to the patient) and inappropriate dose of vaccine administered (Verbatim: administered only the adjuvant component in the syringe to the patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 6-Jun-2023 A medical assistant calling from a physician's office to report that a physician's assistant (PA) in the office administered the 2nd dose of Shingrix to a patient in the office. The adjuvant component had been drawn into a syringe, but had not been added to the antigen component and the physician's assistant did not realized and administered only the adjuvant component in the syringe to the patient. The reporter had no further information about this event. The reporter consent to follow up with health care professional. The patient received a dose of Shingrix without reconstituting the vaccine, which led inappropriate preparation of medication and inappropriate dose of vaccine administered.
Redness, swelling, tenderness, warmth 6x6 in area of erythema post (L) upper arm above elbow.
Comvax given @ 2 pm 4-1-02. 1:30 am on 4-3-02 fever 104 degrees F. Resolved with Tylenol. 4-3-02 injection site red, war, indurated 72 in diameter. 4-8-02 injection site indurated, slight discolored 1" diameter induration.
I?m going to start discussing with MD concerns. Past 3 years my vision went from 20/50 at a steady rate to now one month ago being 20/70. I did forget to place Axenfiield Reiger Syndrome as a condition but again. Although normally not perfect my numbers stayed consistent and changed very little until after the Covid vaccine. I have also started getting migraines more frequently with nausea and vomiting. For the past two years I?ve also continued to have low grade fevers that come and go. Daily , sometimes a whole month etc. I?ve had issues with inflammation before but it seems to be getting worse. I?m starting to journal to keep track but I am concerned.
Patient presents to the emergency department due to reported fatigue and weakness. On day of adverse event, house resident paged to bedside to evaluate for nasal congestion, rhinorrhea and dry cough.
inadvertently administered an expired dose of ACT-HIB, no AE; formatting of the expiration date was confusing; Initial information regarding an unsolicited valid non-serious case was received from the other healthcare professional via Agency (reference number- 00553490 and 00552458) and transmitted to Sanofi on 07-Apr-2021.  This case involves a HIB (PRP/T) VACCINE [ACT-HIB] (lot number and expiry date not reported) whose diluent was expired on 22-Mar-2021, and a 0.5ml dose was inadvertently administered to a five month old female patient via unknown route in unknown administration site for prophylactic vaccination on 07-Apr-2021 (expired product administered) and the formatting of the expiration date was confusing (Product label confusion).  Medical history, medical treatment(s), past vaccination(s), and family history were not provided.  Concomitant vaccines included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX), ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) for prophylactic vaccination.   It was a case of an actual medication error due to expired vaccine used and Expiration date format confusion (latency same day).  The reporter stated that the patient was inadvertently administered an expired dose of ACT-HIB. Further, the reporter explained that the diluent of vaccine had expired on 22-Mar-2021. The contributing factor to the error was the format of the expiration date on the box which was "22 Mar 21." The healthcare professional (HCP) at the clinic interpreted this as "21-Mar-2022" rather that the correct expiration date was 22-Mar-2021. Also, it was reported that there was no actual damage or defect for the ACT-HIB, just the formatting of the expiration date was confusing.  At the time of this report no adverse event was reported.  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.  There will be no information available on batch number for this case.
I've been experiencing a sharp, dull, and hot pain in my appendix area that lasts for several hours. The pain has been becoming more and more severe. I haven't been taking any treatment for it and my doctor has not prescribed anything yet.
Fever chills Narrative: x1 d after #1dose fever and chills  Other Relevant History:
This spontaneous report was received from a physician concerning a 69 year old female patient with sulfa allergy. On 05-DEC-2012, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number: H010916, expiry date: 15-FEB-2014) (dose, route unspecified). Concomitant medications included lisinopril, simvastatin (manufacturer unknown) and omeprazole. On 05-DEC-2012, after the administration of PNEUMOVAX23, the patient experienced localized erythema, swelling, not too much heat that spanned around the circumference of the unspecified arm of the patient. The patient visited the office and she was prescribed with prednisone (formulation, dose, frequency unspecified). It was unspecified if the laboratory diagnostic studies were performed. The outcome of localized erythema, swelling and not too much heat that spanned around the circumference of the arm of the patient was reported as not resolved. Additional information has been requested.
Swelling of injection site with numbness in fingers of right hand. (Right arm injection) Duration of 3 days until medical help was asked for. LR-6 from literature
Nose bleed; Joint pain; Headache; Tired; This is a spontaneous report from a contactable Other HCP. A 49-year-old female (non-pregnancy) female patient receive second dose of bnt162b2 (BNT162B2, Solution for injection), via unknown route of administration on Left arm on unknown date at single dose for covid-19 immunisation. The patient's medical history includes Asthmatic, and known allergies includes shellfish, and Penicillin, and Historical Vaccine includes first dose of BNT162B2 (Lot number: El1283) on 05Feb2021 08.00 AM on left arm. Concomitant medications were not reported. It was reported that patient experienced Nosebleed, headache, tired, joint pain on 13Feb2021 04.00 AM and did not received any treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The outcome of events was "Recovering".
Bell's palsy. I feel pain and numbness on left side of my face and eye. my left eye feels irritated and bulgy. I can not make facial expressions, such as smiling or frowning on my left side of the brain.
Patient got SOB and passed out following vaccine administration. Patient had severe headache and dizziness in ER.
This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients "over 14 years of age" received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this patient (gender not specified) were reported to be 1) 22-JUL-2013 and 2) 28-JUL-2014. No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
From patient interview: The patient stated feeling dizzy with lightheadedness and seeing spots. She felt like she was going to pass out. She was transported to our emergency department for examination. When I spoke with her she was resting and felt she had returned to baseline.  From medical record:Patient Stated Complaint SYNCOPE, Narrative of Presenting Problem Patient is a 35-year-old female with history of vasovagal episodes during her prior pregnancy was in the hospital getting a Covid vaccination and became weak dizzy and sweaty and had a syncopal episode while in a chair. Patient did not hit her head. Upon evaluation patient is awake alert lying supine with no complaints. Patient states she has been suffering with Covid related anxiety and depression.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 07-JUN-2016, the patient was vaccinated with improperly stored ROTATEQ lot # L027076 with expiry date: 25-MAY-2017, Lot# L033545 expiry date: 30-MAY-2017 (lot not specified for each patient) (dosing details and route of administration were not reported). No adverse effect was reported. It was reported that the vaccines were exposed to the temperature 55F for 30 minutes. The previous temperature excursion was 32.9F for 17 hours. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Moderna Vaccine expired on 9/4/2021 and was administered to individual on 9/7/2021. During fifteen therapeutic  observation patient did not report any adverse signs and/or symptoms after administration of vaccine.
Hears voices in her stomach and head; Feels like her body has been taken over/Feels like things are running through her body; Feels like her skin is tingling; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN), via an unspecified route of administration on an unspecified date 2 months ago (May2021) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient mentioned she went to the ER and the doctor. She received the vaccine two months ago. She felt like her body had been taken over. She hears voices in her stomach and head. It is just not like sounds, but actual people voices. She feels like her skin is tingling. She feels like things are running through her body. The ER gave her a mental assessment and could not find anything wrong with her. The patient mentioned she had issues in the past and the doctor gave her a pill with a camera in it. She was informed the pill would leave her body after 24 hours. She believed this was in the past and not related ot the COVID-19 vaccine. The outcome of hears voices in her stomach and head, feels like her body has been taken over/feels like things are running through her body and feels like her skin is tingling was unknown.
Left side of my face started numbing, felt like if a nerve popped while eating a sub, next day in the morning lost control on my left side lip, started dripping saliva while sleeping and water while brushing my teeth., couldn?t drink water, couldn?t blink my eye. Im still the same until now.
High fever for multiple days 7/7/05 - 7/10/05 of 101.5F. Motrin helped control. On 7/10, baby developed rash/bumps all over stomach, back/face.
After injection, left side finger tips and face tingled. Finger tips resolved, face felt numb afterwards including head and neck.  Feels  like patient had dental work and the numbing is wearing off.; After  face felt numb afterwards including head and neck.  Feels like patient had dental work and the numbing is wearing off.; This is a spontaneous report from a contactable consumer reporting for himself. A 47-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number EL3249, via an unspecified route of administration on 22Jan2021 10:00 (at the age of 47-years-old) as a single dose in the left arm for COVID-19 vaccination.   Medical history included acromegaly (surgery done to remove tumor) from an unknown date and unknown. The patient's concomitant medications were not reported.  The patient previously took doxycycline and experienced drug allergy.  The facility where the most recent COVID-19 vaccine was administered was at a hospital.On 22Jan2021 10:00AM, the patient experienced after injection, left side finger tips and face tingled. Finger tips re-solved, face felt numb afterwards including head and neck. Feels like patient had dental work and the numbing is wearing off. The events after injection, left side finger tips and face tingled. Finger tips re-solved, face felt numb afterwards including head and neck. Feels like patient had dental work and the numbing is wearing off were reported as non-serious and did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events. The clinical outcomes of the "after injection, left side finger tips and face tingled. Finger tips resolved, face felt numb afterwards including head and neck.  Feels like patient had dental work and the numbing is wearing off" was not recovered. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.