chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 06-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a six months old female patient who was vaccinated with PENTACEL, which was reconstituted with sterile diluent instead of ACT-HIB, on 05-Dec-2018. Batch number: (Box: NDC 49281-510-05, Lot C5507AA, expiry date 05 Sep 2019 Liquid: (Not administered) NDC 49281-560-05, Lot C5324AC, expiry date 05 Sep 2019 Lyphoized Powder: Lot NDC 49281-510-05, Lot C5507AA, expiry date 05 Sep 2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTARIX and PREVNAR for Immunisation. It was an actual medication error wrong solution used in vaccine reconstitution and Wrong technique in product usage process as 1/2 of the PENTACEL componenent given with sterile diuent for routine vaccination in the Left thigh. 1/2 component of PENTACEL given with improper diluent  The patient had no adverse event. 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. List of documents held by sender: none.
Day after vaccines were administered experienced numbness/weakness in left leg. On follow up visit on 6/25/2019 expressed concern to doctor. Symptoms continued to get worse and by 6 weeks I lost most sensation and feeling to leg and it was starting to impact ability to walk normally and I was developing an antalgic gait favoring right side because I couldn't feel the other one which was causing me to not be able to walk normally at work so on 8/9/2019 went back to doctor. On 8/27/2019 I got an electromyography (EMG)/nerve conduction study (NCS) test done which showed that I had Myelin Nerve damage and a nerve blockage in left leg. That doctor ruled out it being from back/spine due to nerve effected and location and also stated that it could be an autoimmune reaction to the vaccine itself- Guillain-Barré syndrome (GBS).
Pt. is a 21 year old female complained of dizziness, lightheadedness.  Encouraged patient remain calm, relax.  Fire Rescue arrived on scene for further evaluation.  Vital signs rendered.  Pt. denies any pain, discomfort.  Pt. recovered from adverse event at 9:00am and left via personal vehicle.
Breakthrough COVID infection in fully vaccinated patient. Positive date 08/19/2021.
several pt recv vax & devel an inj site rxn;the indication for administering a 2nd dose of vax was not provided;the reporter stated that this event was not due to the vax itself;declined to provide addtl info;
4-6 weeks after receiving Gardasil, patient developed severe pedal edema and abdominal swelling. She went to the E.R. She was found to be hypertensive with proteinuria. She was diagnosed with SLE by Nephrologist. Currently on Prednisone, Plaquenil, Lisinopril, Procardia, Celicept and Boniva.  01/03/2008 MR received for multiple OVs.  AE onset date received as early January 2007.  Updated in database OV 12/06/06 requesting Gardasil. OV 2/8/07 in F/U to ER visit for pedal edema, abd swelling, (+) proteinuria, and increased BP.  DX: SLE. Per 60 day follow up: The patient is still being treated for SLE with several medications including CELLCEPT, prednisone, PLAQUENIL, lisinopril and PROCARDIA. She is under the care of a nephrologist. 1/15/2010 She is still undergoing treatmen for S.L.E. Her current medications include Prednisone, Plaquenil, Cellcept, Lisinopril, Procardia and Boniva.
Headaches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) 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 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 HEADACHE (Headaches). At the time of the report, HEADACHE (Headaches) had not resolved.            No concomitant medications was reported. No treatment drug details was reported.
No additional AE reported; Caller is a nurse calling to report a medication error for PEDVAXHIB. Caller reports that the patient was inadvertently administered a dose of PEDVAXHIB. Caller reports that the patient was scheduled to receive a dose of VARIVAX, M-M-R II, and HAVRIX; This spontaneous report was received from a nurse and refers to a 12-month-old patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On unknown dates in 2021, at the age of 2 and 4 months, the patient received the first and the second doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On 04-MAY-2022, at the age of 12 months, the patient was inadvertently vaccinated only with the third dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 ml, lot #U014992, expiration date: 29-OCT-2023, (strength, anatomical location, and route of administration were not provided) administered for prophylaxis instead of scheduled doses of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, (strength, dose description, lot #, expiry date, anatomical location, and route of administration were not provided), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, (strength, dose description, lot #, expiry date, anatomical location, and route of administration were not provided), and hepatitis A vaccine inact (HAVRIX) (strength, dose description, lot #, expiry date, anatomical location, and route of administration were not provided) (wrong product administered). No additional adverse events (AE) was reported (No adverse event).
HIBRIX vaccine was given to 2 month old baby in error as is indicated for children within 15mos. No adverse events observed.
pt recvd vax & 3 wks p/vax exp knee pain & diffuse joint pain;
Had the shot but I still get it/Suspected vaccination failure; Still get it; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the shot but I still get it/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Still get it). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2023 This case was reported by the patient via interactive digital media. The patient received the Shingles shot but still got it there but not as bad.  Follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Pt is having arm pain, can't raise arm fully - still having problem on 11/23/16 per husband.
This spontaneous report was received from a medical assistant, referring to an unspecified number of patients, of unknown ages and genders. No medical history or concurrent conditions were reported. Since 02-NOV-2015, an unspecified number of improperly stored doses of PROQUAD (Merck) (Lot # L016395 expiry date on 08-NOV-2016; lot numbers reported as L011082 expiry date on 01-APR-2017, K020758 expiry date on 03-JUL-2016, L011082 expiry date on 01-APR-2017, K020758 expiry date on 30-OCT-201) were inadvertently administered to an unspecified number of patients. No adverse events were reported. This is one of 4 reports received from the same source. Additional information has been requested.
Fever, extreme body soreness, sore throat, muscle weakness & fatigue, dizziness, abdominal pain, severe mood swings.
Patient presented with large area of redness approximately six inches that wrapped around upper part of left arm. Area was also hot to touch and patient complained of itching. Patient noticed redness between 11am - 1pm 10/29/2019. Patient's mom returned to pharmacy at approximately 5pm 10/29/2019.  Patient was advised to take benadryl and ibuprofen to help with symptoms.   Symptoms improved after first dose of benadryl.
Severe muscle spasms from muscle scarring from an accident 20 years ago.  See earlier accident history for more details.
a red vertical line, like about 3 inches, in her vision; This is a spontaneous report received from a contactable consumer (patient). This consumer reported for herself that a female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 09Jun2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient historically received first single dose of BNT162B2 for COVID-19 immunization and had no reaction on previous exposure to drug. The patient reported that received her second dose yesterday morning on 09Jun2021, and at 20:30 (8:30 pm) in the evening, while she was watching television, all the sudden she experienced a red vertical line, like about 3 inches, in her vision for 30 seconds. She said that when she looked away from the television the red line was still with her. She was asking if this was related with the vaccine. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Numbness in hands and feet, seen in hospital 1/29/10. Returned home and seen 2/3/10 at clinic-sent to Med for eval by neurology. 2/8 again seen at clinic-Lyme titers pending, MRI/CT neg. 2/12/10 again consulted neuro at Med, has appt 2/16/10. 2/16/10 admitted with non-typical Guillain-Barre Syndrome.
Patient receive FLUZONE HD and said her arm was extra sore. She said that it's been going on from 11/1/16 through today,  11/19/16. She spoke to her doctor and he wasn't sure what was causing it. I asked patient if she would like us to contact doctor and she said no.
This spontaneous case was reported by a physician and describes the occurrence of CONTRAST MEDIA ALLERGY (Contrast media allergy), DIARRHEA (Diarrhea), DERMATITIS ALLERGIC (Allergic rash all over her body) and PERIPHERAL SWELLING (Arm swelling) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphocytic leukemia and Malignant neoplasm of central portion of female breast. Concurrent medical conditions included Chronic lymphocytic leukemia (Symptomatic chronic lymphocytic leukemia of B-cells reported.), Allergy to antibiotic (Allergy to sulfa-antibiotics reported.), Iodine allergy, Malignant neoplasm of central portion of female breast and Estrogen receptor positive breast cancer. Concomitant products included ANASTROZOLE (ARIMIDEX), VITAMIN D3, CYANOCOBALAMIN, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), PROBIOTICS NOS and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication. On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and IBRUTINIB (IMBRUVICA) (Oral) 420 milligram. On an unknown date, the patient experienced CONTRAST MEDIA ALLERGY (Contrast media allergy), DIARRHOEA (Diarrhea), DERMATITIS ALLERGIC (Allergic rash all over her body) and PERIPHERAL SWELLING (Arm swelling). At the time of the report, CONTRAST MEDIA ALLERGY (Contrast media allergy) and DIARRHOEA (Diarrhea) outcome was unknown and DERMATITIS ALLERGIC (Allergic rash all over her body) and PERIPHERAL SWELLING (Arm swelling) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Scan: n/a No results reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medications were provided by the reporter. This case was linked to MOD-2021-086818, MOD-2021-086711, MOD-2021-086996, MOD-2021-087217, MOD-2021-087097 (E2B Linked Report).; Sender's Comments:  MOD-2021-086818:Case received in same source doc email; MOD-2021-086711:Case received in same source doc email MOD-2021-086996:Case received in same source doc email; MOD-2021-087217:Case received in same source doc email; MOD-2021-087097:Case received in same source doc email.
I received the vaccine on 1/8/21, I was tired, dizzy, and had diarrhea, I went snowshoeing on 1/10/21 and was tired and had diarrhea, I went snowshoeing on 1/11/21 and almost turned around (which I never do) as I was super tired, had diarrhea, and dizzy, I slept half the day 1/13/21 and was tired and congested in my nose and lungs (I thought it was bronchitis which I usually get this time of year), I missed work 1/16/21 being super tired and congested in my nose and lungs, I went for a Covid test 1/21/21, I was diagnosed with Covid 1/23/21.  I went snowshoeing 3/1/21 and landed in the ED for 2 days with post-Covid breathing trouble.  I still have a productive cough and will go to healthcare facility 5/24/21
2 hours after my first vaccination my face went numb for about 30 minutes. Then six days later (on 6/1/21) my left leg went numb for about 12 hours.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Visual Changes/Disturbances-Medium
"No PMH, Allergies, or medications on file. Pt vaccinated in the AM 8/9.  That evening, pt reports feeling host and SOB during the night.  ~24hrs post vaccination, pt developed Rash (generalized morbiliform rash).  Pt started taking benadryl w/ out improvement.  Pt went to the ED/UC on 8/11 and was given methylprednisolone 40mg x1 in the UC, Prednisone 20mg PO Daily x3 days and Cetirizine 10mg PO Daily x1wk."
Atypical Smallpox vaccine reaction with vesicle and cellulitis. Initial onset occurred (dime size), 10 days after vaccination with redness 3" in diameter.
Reported rash on face and on groin. Also on arms, "lump" on back/side of neck.
Pt is 70 years old. She received an influenza vaccine and pneumococcal vaccine on 10/11/2003 at drug store. Flu vac in right arm; pneumovac left arm. Within 6-8 hours pt developed fever to 100 degrees. swelling of right upper extrem extending to right neck and right anterior chest wall. She was seen in ER 10/12/03 and treated with Dicloxacillin for "cellulitis". The timing does not fit occurrence of cellulitis. ?Significant "local reaction" to flu vac.
body aches, extreme soreness at injection site, chills....lasted for approx 12 hrs
08/03/2016 Moderate rash < 14 days. Cellulitis to injection site.
Patient Received 1 Dose of Heplisav-B, Then Given 1 Dose of Engerix; Initial Report Received on 18-Aug-2022 and 22-Aug-2022  A representative at a health department reported to a sales representative that a 40-year-old male patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then one dose of Engerix Hepatitis B vaccine.  Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  In 2005, the patient received one dose of Engerix Hepatitis B vaccine (no details provided).  On 19-Jul-2022, the patient received one dose of HEPLISAV-B (Lot # 937233; expiration date 11-Mar-2023, NDC # 43528-003-05) intramuscularly in the deltoid (left or right side not specified).  On 16-Aug -2022, 29 days after having been vaccinated with HEPLISAV-B, the patient received one dose of Engerix Hepatitis B vaccine (details not provided).  No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Case number PHEH2011US011883 is an initial spontaneous report received from a consumer on 13 Dec 2011: This report refers to a 79-year-old female patient. She was vaccinated with FLUVIRIN (batch number: unknown) into the left arm on an undetermined date. On 16 Sep 2011 she developed loss of some arm movement, aching arm and two numb fingers. She underwent an electromyogram (EMG) test on 28 Nov 2011 due to left arm pain and weakness. The study of the left upper extremity revealed mild insertional abnormalities in the pronator teres muscle suggestive of median nerve versus C6 denervation. The final outcome of the events was reported as ongoing.
Breakthrough case admission after 2 vaccines Pfizer 3/27/21 Lot# EP7534;  Pfizer 4/16/21 Lot# ER8734
Vaccinator inadvertently administered the incorrect vaccine to the patient. Patient was clearly marked with a separating wrist band for Booster of Pfizer. Patient presented a CDC card with 1st dose Pfizer on it. Patient had no English proficiency and somewhere in translation patient gave verbal consent for Janssen instead of Second Dose of Pfizer.
left arm swollen, pain down arm, not relieved by anti-inflamatory, some nausea....limited range of motion
Cough; Fever; Muscle pain all over thebody; Headache; Fatigue; Muscle pain at the injection site; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6951), via an unspecified route of administration in the left arm on 22Mar2021 at 16:15 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient did not have any allergies to food, medications, or other products. 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 was receiving unspecified concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22Mar2021 at 18:00 (reported as first day), the patient experienced muscle pain at the injection site. On 23Mar2021 (reported as second day), the patient experienced fatigue and muscle pain at the injection site. On 24Mar2021 (reported as third day), the patient experienced fever, muscle pain at the injection site, muscle pain all over the body, headache, cough and fatigue. The adverse events resulted in a visit to the doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the events muscle pain at the injection site, fever, muscle pain all over the body, headache, cough and fatigue. The clinical outcomes of the events muscle pain at the injection site, fever, muscle pain all over the body, headache, cough and fatigue were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Dose 1:  -Minor headache and fatigue for 3-4 days Dose 2:  -Day 0 (date of vaccine) = Pain in plantar of left foot (cramp within 30 minutes of vaccine) -Day 1 Post Vaccine = Fatigue, Muscle aches all over body, pain in left foot continued same duration/pain level as arm where vaccine was administered, sever flu-like symptoms -Day 2 Post Vaccine = Felt fine mostly, slight fatigue -Day 3 Post Vaccine = Severe Migraine with light/sound/smell sensitivity, fatigue, nausea, vomiting -Day 4 Post Vaccine (reporting date) = Minor headache
This spontaneous report was received from a registered nurse, via Pfizer (manufacturer control number 2016496059), reporting on herself an approximately 74 year old white female patient. Medical history, concurrent conditions and concomitant therapies were not reported. In approximately 2011, reported as "about 5 years ago", the patient was vaccinated with a dose of ZOSTAVAX, strength, frequency, dose, route, lot/batch number and expiration date were not reported. The reporter referred that she had received the ZOSTAVAX, and it caused, on an unknown date, her arm to get red, swollen and hot at the injection site for about 7 to 10 days. She also reported that the vaccine did not work for her because she had shingles on her scalp and the back of the neck on approximately 2014, reported as "about 2 years ago". The outcome of the vaccine did not work for her was unknown, for the events shingles, her arm to get red, swollen and hot at the injection site and herpes zoster was reported as resolved. The reporter considered her arm to get red, swollen and hot at the injection site to be related to ZOSTAVAX. The relationship of herpes zoster and the vaccine did not work for her to ZOSTAVAX was not provided. Additional information has been requested.
COVID vaccine breakthrough case. Moderna 1/23/21 012L20A, 2/20/21 004M20A and bossted on 1/24/22 066H21A.
anaphylactic reaction; Swollen throat; This case was reported by a nurse via sales rep and described the occurrence of anaphylactic reaction in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced anaphylactic reaction (serious criteria GSK medically significant) and throat swelling. The patient was treated with Benadryl (nos) (Benadryl). On an unknown date, the outcome of the anaphylactic reaction and throat swelling were unknown.   It was unknown if the reporter considered the anaphylactic reaction and throat swelling to be related to Shingrix.  Additional details were provided as follows: The age of the patient and age at vaccination was not reported. The batch number or expiry date were not provided. The patient experienced swollen throat, possibly an anaphylactic reaction, after receiving Shingrix. The reporter consented to follow up. The patient went to the emergency department and was given Benadryl and later discharged home.
Patient experienced a painful bruise approx 3 x 3 inches. Noticed 48 -72 hours post immunization. She has treated w/ice.
Symptoms happened individually in following sequence, each lasting about 30-60 minutes, exception was rapid heart beat - about 10 min. significant muscle pain, slight chills, fever, rapid heart beat, intense jaw pain, headache, dizziness, fatique. Total time of side effects was about 12 hours.  Debated taking NSIADS, but didn't. worst symptoms were rapid heart beat and intense jaw pain.