chrisvoncsefalvay/vaers-outcomes huggingface dataset:
powder vials unmatched adjuvant diluents; Adjuvant only administered; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-Jun-2022 Reporter's Comments: The pharmacist reported that they found in their stock three Shingrix powder vials unmatched with adjuvant diluents. The patient might had received the diluent only. The reporter gave consent to follow up. Additional supportive Information: The patient might had received the diluent only which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This is one of 3 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022099168:Same reporter. Patient 1 US-GLAXOSMITHKLINE-US2022AMR099689:Same reporter. Patient 3
Patient presented to the ED on 4/6/21, 4/11/21. Patient presented to the ED on 4/22/21 and was subsequently hospitalized within 6 weeks of receiving COVID-19 vaccination.
This spontaneous report as received from a physician refers to a 59 year old female patient. Pertinent medical history was reported as none. On 31-JAN-2013 the patient was vaccinated with ZOSTAVAX lot # H020683 (route and indication not specified). Concomitant therapies included ibuprofen. On 21-FEB-2013, 22 days a blood test was positive for hepatitis B surface antigen, negative for hepatitis B virus nucleic acid and negative for hepatitis B core antibody. On 28-MAR-2013 the above 3 blood tests were all negative. The physician requested a lot check. No further information was available. Additional information has been requested.
Systemic: Allergic: Difficulty Breathing-Moderate, Systemic: tighness in arms and hands--clenching hands-Moderate
Patient returned 1hour after vaccine was given claiming that her tongue was tingly and that she felt like she had a hard time speaking because her tongue was "not working correctly". Patient denied any trouble breathing and was speaking clearly to me in the observation room. I recommended that she go to an Emergency Room as a precaution. Patient felt okay to travel to emergency room on her own. She had a plan to go .  and was told to self report these symptoms as well. Patient denied any allergies and any previous vaccine reactions.
chills; sore arm; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (sore arm), PYREXIA (fever) and HEADACHE (headache) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), MYALGIA (sore arm), PYREXIA (fever) and HEADACHE (headache). At the time of the report, CHILLS (chills), MYALGIA (sore arm), PYREXIA (fever) and HEADACHE (headache) outcome was unknown. Not Provided          No concomitant and treatment medication information was reported.
a feeling of breathlessness and a pounding or fluttering heartbeat with some chest pain that comes and goes
He kept falling over, slipping and very emotional for 24 hours after HPV #1.
DURING VACCINATION, THE SYRINGE/NEEDLE CAME OUT OF THE DELTOID, HAD TO READMINISTER
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe
server muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (server muscle pain) 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 MYALGIA (server muscle pain). At the time of the report, MYALGIA (server muscle pain) outcome was unknown.            no treatment information was reported no concomitant medication were reported
I developed flu like symptoms after 3rd dose of Lymerix and then developed severe joint and muscle pain and neck stiffness, blurry vision, light headedness, difficulty thinking and concentrating, mood swings, sleep problems, photophobia, rashes, sensitivity to sand, stomach problems, diarrhea from 06/10/2000 to present. Unable to work for six months Per 1 year follow up: pt has not recovered. I still continue to have fatigue, muscle and joint pain, severe neck pain and stiffness, memory loss, mood swings, headaches, diarrhea and constipation, numbeness to face and extremities, lightheadedness, facial rashes, swollen lyph nodes, teeth pain, decreased sense of taste, intermittent heart palpitations.
Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX (lot# and route not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2013, a pharmacist administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Felt incredibly weak, tired, ached all over body, trouble sleeping and anxiety (worsened). Patient spilled hot coffee on her arm due weakness, which resulted in blistering and scarring. Symptoms lasted about 3 months before starting to get better, but have not completely resolved. The doctor said patient has systemic inflammation.
Patient here for her 2nd Pfizer vaccine.   Immediately after she got it, she began to have moderate/severe nausea.   She is also having light headedness.   Her vitals are 136/90, P-98, O2- 98 @ 1447.  She denies history of vaccine allergic reactions.   Her only reaction from 1st injection was a sore arm.    Her baseline vitals are 121/?, P-60-70.   @1452 vitals are 134/88, P-122, o2-99.   No meds have been given.   Patient given ice pack for neck and reclined in reclining chair.  Dr. consulted.  Vitals @ 1510 130/70, P-106, 24 resp.  Dr. advised further monitoring for the mean time.  TC to patient's manager, that patient is having reaction to vaccine and is being monitored and will be delayed in returning to dept.  Manager verbalized understanding and appreciation. (Created on 2/04/2021 and 3:42pm)  Vitals @ 1553 147/80, P-98.  Patient reported that nausea is still the same but that her throat started feeling funny.  50mg Benadryl IM given in Right Deltoid by RN @1600.  Dr.  informed.  Director and AD also informed of situation.  Patient's manager called by RN to give update on patient and to request that someone in dept bring patient's handbag. (Created on 2/04/2021 and 4:21pm) Vitals @ 1620 139/86, P-86, O2-97, Resp- 28.  Patient reports that strange feeling in throat is improving. Nausea & light headedness is the same.  She said that she had been feeling hot earlier but not anymore.  Updated Dr.  on patient's status.  Asked Dr.  if she may be released to go home with her aunt who is picking her up at 5pm if patient is stable and her vitals are stable.  Dr. stated that patient may be released with a Benadryl tablet to go. (Created on 2/04/2021 and 4:43pm)  Vitals @ 1720 163/96, P-114, O2-100  Called IMT to PFW 4.  Patient initially refused to be taken to ER.  Noticed that patient was having labored breathing.  Vitals @ 1739 162/91, P-124.  After IMT team spoke with patient about vitals, patient decided to go to  ER.  Patient was taken in wheelchair by IMT team@ 1745.
Heart palpitations; This is a spontaneous report received from a contactable consumer, the patient. A 37 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247) first dose via an unknown route in left arm on 08Mar2021 at 08:30 AM as a single dose (at the age of 37 years) for COVID-19 vaccination. The patient was not allergic to the medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no COVID prior immunisation. Medical history reported as none. Concomitant medication includes ibuprofen (ADVIL) and congestion medicine occasionally. On 12Mar2021, the patient experienced heart palpitations. No therapeutic measures were taken as a result of these events. The clinical outcome of palpitation's was reported as not resolved. No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: reporter/patient details updated, patient's age added, medical history details updated, lab data corrected("COVID-19 virus test" deleted), stop date of vaccine added, concomitant drugs details updated, vaccine facility information added and treatment information added(no).
It was warm; Dizziness; Red hardness area ( it was warm) 6 inches down at from the injection site; Red hardness area ( it was warm) 6 inches down at from the injection site; A spontaneous report was received from a Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizziness, Red hardness area (it was warm) 6 inches down at from the injection site (vaccination site induration and vaccination site erythema) and (Feeling hot).  The patient's medical history included Lyme disease.. Relevant concomitant medications were reported as mental illness medicines.  On 13 Feb 2021, prior to the onset of the event, the patient received their first dose of two planned doses of mRNA-1273 (lot/batch: 031M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   After vaccination the patient experienced dizziness and spoke with a doctor because her pass of Lyme disease (on the 90).  On 16 Feb 2021, the patient experienced red hardness area (it was warm) 6 inches down at from the injection site (Erythema induratum) and (Feeling hot).   Laboratory details were not provided. Treatment information included Loratadine and Benadryl.  Action taken with mRNA-1273 in response to the events was unknown.  At the of this report, the outcome of the events were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event (vaccination site erythema, vaccination site induration, feeling hot, and dizziness), a causal relationship cannot be excluded. Further information has been requested.
Employee reported feeling lightheaded and fainted approximately 5 minutes after vaccination. Loss of consciousness approximately 5 seconds. When employee woke up, he reported feeling nauseous and warm. Employee recovered quickly (5 minutes).
Information has been received from a registered nurse and physicians concerning an 8 year old female with allergies to penicillin, amoxicillin (causes rash) and questionable allergy to azithromycin (Zithromax) (may have caused rash) with a history of being born at 36 weeks gestation, being on oxygen briefly immediately after birth, hospitalization 8 days after birth for jaundice, multiple ear infections during her first year of life and a geographic tongue noted on physical exam. The patient also developed croup, very high fever, Evan's syndrome, autoimmune neutropena, severe stomach virus, reticulocytosis, warts on knees, tetanus antibody level not in protective range, rubella antibody not in protective range, lower extremity pruritic rash and autoimmune hives following vaccinations with MMR live (second generation) on 15-Dec-1995 (WAES#0304USA02183). Due to the rubella antibody not being in the protective range the patient was vaccinated subcutaneously in the right arm on 01-Aug-2002 with a first dose of MMR live (lot #635740/1876K). Laboratory evaluation in December 2002 revealed that the patient still did not have a documentable measles antibody. The patient was seen by a physician who noted that the plan was to vaccinate the patient with a "third measles vaccine" and then recheck titers. At the time of this report it is unknown if the patient has received the 'third measles vaccine." Additional information has been requested.
Vaccine 4/5/21.  Fever and fatigue 4/6/21.  Better 2 days later.  Started feeling ill Wednesday 4/14/21.  Went to the Doctors 4/16.  They treated as sinus infection.  Sunday 4/18 started rash - Clinic gave shingles medication.  Went to Optomologist and Medical MD on Monday 4/19/21.  Shingles on face left side, eye, eyelid, head, swelling.  Cornea 3 lesions.  Scrip for eye medication also.  First shot on 3/13 no reaction, only a little tired the next day, fully functional.
Numbness in both legs and feet,,pins & needle feeling in both legs & feet ,,muscle weakness in both legs
Pt received Pfizer COVID 19 vax #3 during a vaccine blitz on 10/07/21 on the parking lot. She parked her car for monitoring after the vaccine. She c/o nausea to the staff who then called provider. Pt is alert, oriented x 3. Drinking water. Denies chest pain, shortness of breath, aches, vision changes, headche. BP was wnl 100/80. Pt said she usually runs low BP. HR and O2 saturation were wnl. She left the parking lot after about 30 minutes. Instructed to report to the ER if her symptoms worsen.
Fatigue, fever, dizziness, nausea,  head age, body ache,
pt recvd vax & devel hives; rash began 2 days after vax; headache; n on 30sep94;
About 4 hours after second shot, headache, chills and body aches for 36 hours.  Then felt fine for 12 hours, and then the next 12 hours body sweats all night and some diarrhea the next morning and a feeling of just not being right.  I attribute this to flu like symptoms that everyone says is associated with Moderna shot 2.
Patient was given the moderna vaccine and waited in clinic the requested 15minutes.  Patient was fine when she left the office.  She advised when she got home about 5 or so minutes later, she started to feel like her throat was swelling.  Denied any trouble breathing, she kept drinking water to make sure her throat was still open.  She took 2 large teaspoons of liquid benadryl.  She never went to ER or called the office until 5/24/2021.  After the benadryl started working she felt better and did not have any further symptoms.
and her whole body broke out and she experienced itching which is still persistin; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (COMIRNATY), on 10Jun2021 as dose 2, single (Lot number: EW0180), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Covid-19 first vaccine Manufacture: Pfizer BioNTech: Unknown Lot: EW0183 Expiration: Unknown, Dose given: Unknown;  , Time given: After 3:30 pm , Anatomical location: Right upper arm , Date given: 20May2021), administration date: 20May2021, for COVID-19 immunization, reaction(s): "first shot caused her face to break out.". The following information was reported: PRURITUS (non-serious) with onset Jun2021, outcome "not recovered", described as "and her whole body broke out and she experienced itching which is still persistin".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200760970 similar report from same reporter
I administered a pre-drawn up 0.3 mL dose of Pfizer bivalent booster in patient's R deltoid. There was a little bleeding, but I did not detect/experience anything out of the ordinary while giving the vaccine. Once done with the injection, I initially noticed a small lump forming. I went back to check in 1-2 min later, and it was much larger (flesh colored/a little black/blue).  Immediately got an MD to evaluate. Upon evaluation, she felt it was unusual but might be a combination of inflammation/bleeding (hematoma). Applied ice pack and observed patient in clinic for ~30 min. He denied feeling unwell or any arm pain. He was moving his arm normally. Pt discharged with instructions to apply ice off/on for a few more hours today and seek medical attention if it worsened, redness spread down arm, etc.
Phone call from mom on 4/27/01. She described 2" X 1 1/2" slightly raised and red area on left arm. Warm to touch but not painful. She will continue to observe reactions and call if not improving. According to mom, the reaction was in area where the MMR vaccine would have been given.
Syncopal episode, fell face first from exam table. Loc 2 1 min with mild seizure actually prior to coming to vs stable -BP 106/68, pale. Hr WNL Perla hematoma on forehead, bit upper lip and tongue c/o neck pain. Observed x 1 hr 10 min A&O x 3 vs stable
pt recv vax & devel a 5cm area of redness, swelling & tenderness @ the inj site;MD dx cellulitis & prescribed an ATB;pt recovered;
fever of 104; pain is okay when not moving arm and when moving pain 6-7 on pain scale; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via medical information (reference number- 00432183) and transmitted to Sanofi on 15-Jan-2021.  This case involves a 69 year old female patient who experienced pain in deltoid region which was okay when not moving arm and when moving pain 6-7 on pain scale (pain) and fever of 104 (pyrexia), after she received TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI].  Medical history, medical treatment, vaccination, family history and concomitant medication were not reported.  At the time of the event, the patient had ongoing breast cancer.  On 12-Jan-2021, the patient received a dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE [lot 9LU44A, expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On 12-Jan-2021, the patient developed a non-serious pain in deltoid region which was okay when not moving arm and when moving pain 6-7 on pain scale (pain) and fever of 104 (pyrexia), on the same day following the administration of TYPHOID VI POLYSACCHARIDE VACCINE.  Relevant laboratory test results included: Body temperature - On 12-Jan-2021: 104 Pain assessment - On 12-Jan-2021: pain of 6-7 (in a scale of 10 being the worst)  It was not reported if the patient received any corrective treatment.  At the time of reporting, it was reported that fever was resolved but the arm pain remains the same when the patient was checked on 15-Jan-2021.
Pt was admitted 01/20/2022 with chief complaint of dizziness. Tested + for COVID.
Rash started on Day 12 post vaccines on stomach and back.  On day 13, chicken pox like rash has spread all over except for on the legs. No fever, only a little itchy on belly and in diaper area. Monitoring. Hydrocortisone cream as needed.
Injection site pain; Headache.; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration on 03Mar2021 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Mar2021, the patient experienced injection site pain and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site pain and headache were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.