chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First Shingrix vaccine about 2 years ago and has not yet received his second Shingrix vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received by intramuscularly at unknown arm about 2 years ago prior to the reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: First Shingrix vaccine about 2 years ago and has not yet received his second Shingrix vaccine).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 23-AUG-2023. The case was reported by patient's wife. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. No other information was known. The reporter did not consent to follow-up. The caller did not give permission to contact HCP. This case had been linked with case US2023114894, as reported by the same reporter.; Sender's Comments:  US-GSK-US2023114894:Same reporter
Administration error. Varicella expired on 4/23/2020 and given on 4/27/2020. Patient had no adverse reaction.
A report has been received from a Pharmacist concerning a patient, Female subject, who had been received FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 10-Sep-1995. The patient experienced accidentally gave expired FLUMIST. The outcome of the event of accidentally gave expired FLUMIST is unknown. The report was considered to be non-serious.
Myalgia soreness at injection site, fatigue Narrative:  Per nursing report: "/o took 2nd dose of Moderna vaccine on Friday February 5th,2021. C/o left arm soreness, body aches and fatigue all weekend [2/6, 2/7] and today [2/8]."  Other Relevant History:
5/5/21 - Red and swolen around injjection left upper arm approx 5 inches, slight itch duration 1 week - took benedryl 7/19/21 - 3 bumps like bug bites above elbow left arm, red and swolen oosing from bumps approx 5 inches out from bites, itches, duration 1 week, took benedryl 8/20/21 - 5 or 6 bumps like bug bites above elbow left arm, red and swolen oosing from bumps approx 8 inches around, itchy, duration 2 weeks, ER visit 3rd day after, diagnosed as cellulitis given IV vancomycin, azithromycin5 day 250 mg and doxycycline 100mg, duration 1.5 weeks 10/29 bump on left thumb, red and swolen oozing from bump, pharmacy clinic, doxycycline 100 mg, duration 4 days - benydryl   11/25 bump like bite on left wrist oozing swelling out 5 inches from bump itch, taking ben;ydrl.  Active  Bites on right side of body go away in a day with no swelling or redness.
Afib episodes increased to daily, lasting longer and more severe for 3 weeks and now random heart palpitations. 2 weeks after second dose-Hives appeared and disappeared for 2 days.
2nd Moderna vaccination on a Tues. Development of severe posterior thoracic muscle spasms 40-48 hrs later. No known comorbidities. No injury/trauma, exercise or other physical activity to cause injury. Spasms required local heat, NSAIDs, muscle relaxants, rest. Started resolving about 7 days later.
Pt received Moderna Bivalent instead of requested Pfizer Bivalent.  Pt notified.  No adverse event noted
Administered expired vaccine to the patient, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration.) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. Vaccine manufacture date of expiry reported was 09-Nov-2021.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains Non-significant information.
The patient fainted after being administered the vaccine. Patient reported history of fainting at sight of needles. Patient refused EMS and felt fine to leave on her own after resting for 15 minutes.
Initial symptons began Sunday(4/01). They were fatigue, lightheadedness,brain "fog",peripheral weakness,numbness across bridge of nose, walking gait disruption and loss of balance.Essetially all of these symptoms have persisted with varying degrees. No treatment was rendered.
patient has been experiencing significant pain in arm since administration. it is worth noting that this was not done in our office and the urgent care report does not state which type of TDaP injection was given (adacel, boostrix, etc.)
A physician reported the occurrence of shaking of both hands in an 18-year-old male who was vaccinated with hepatitis B vaccine recombinant (Engerix-B for prophylaxis. The pt's relevant medical history, concurrent conditions and concurrent medications were unknown. On 12/16/2002, the pt received his 1st injection of Engerix-B. "Immediately" afterward, the pt experienced shaking in both hands. He was seen in the physician's office and was then referred to a neurologist. The reporting physician stated that the event was unrelated to Engerix-B administration. As of 12/17/2002, the event persisted. As of 02/03/2003, the outcome of the event was unknown.
Inj site rxn: red, itchy, grew to size of hand. Pain in upper back & neck (ok of previous shingles infxn in late 30's). Developed headache. Rec'd to use ice on inj & APAP for HA. BENADRYL rec'd but pt didn't want to use b/c drowsy feeling assoc'd with & seen by PCP on 2-6-12. No tx prescribed - just set APAP.
pt recvd vax & called next  day stated arm became painful 1 hr p/inject & progressed thru day & into nite;
Ringing in ears; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received first and second dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced ringing in ears on an unspecified date. States that 2 other friends have gotten ringing in the ears as well after the vaccine and she is not sure if Pfizer has had reports of that. States that she wanted to report this. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Now there was pressure in "my" chest; Hard to breathe; "I" had slight muscle pain in "my" right arm.; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 30Apr2021 at 10:45 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included pneumonia which the patient had when he was around six years old. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 04Apr2021 at 10:45 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. On 02May2021 at 23:00, the patient reported that after he finished cutting the grass and coming inside to have noodles for dinner, he experienced slight muscle pain in his right arm, went to bed for the night.  After waking up today (as reported), there was still a slight muscle pain in his right arm. As the morning passed, the muscle pain in his right arm went away.  However, on 03May2021, there was pressure in his chest and he found it hard to breathe. 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 event muscle pain was recovered on 03May2021; while the outcome of the events pressure in my chest and find it hard to breathe were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt recvd vax & immed upon 3rd inj. exp bad burning sensation @ inj. site;the next day upon awakening the inj. site had swollen 2 in. in diameter & was red,hot,itchy & raised;48 hrs p/3rd inj. pt also had an itchy rash;stiff neck;lips numb;
Right deltoid: red, tender to touch, unable to lift arm up. No wheezing or SOB, hives or dizziness.
Severe vasovagal response ~9 hours after injection. Got chills, 15 minutes later got up to get water. Made it about ~20 feet before getting severely lightheaded where I had to sit on the floor for 15+minutes. My roommate reported I was white as a ghost. I was on the cusp of fainting for roughly 15minutes.
4/1-Hive like marks on arm chest face, went away after taking Zyrtec also felt fatigue(lasted two days), now it is a hard lump, hard to touch, red circle around injection site.  Red raised all different shapes Took Zyrtec
Client verbalized feeling dizzy after receiving the vaccine.  Client was then evaluated by Fire Rescue and cleared to go home at 8:57 am after symptoms resolved.
Approx. 3 inch area of redness and induration, discomfort of the left deltoid, no other hives/rash.
the child was only supposed to receive 4 doses of Pentacel but the MA read the order wrong and misunderstood it; Initial information received on 29-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17 months old patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that the child was only supposed to receive 4 doses of Pentacel but the MA read the order wrong and misunderstood it.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  On an unknown date, the patient received 5th dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to extra dose administered.  It was not reported if any adverse event occurred or not.  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.  Information on the batch number was requested  List of documents held by sender: none.
Approximately 72 hours after second shot, I discovered a lump on my left arm about two inches below the injection site. It's been five months since second dose, and I still have the lump. It can be as small as a marble or as large as a gumball depending on the day. It isn't painful but very noticeable.
One week to the day of the second injection, Pt collapsed and had a seizure while on a scout trip. Was feeling fine one minute and then out the next. Taken to ER.  EKG, Chest X-Rat and CT all came back fine. Was referred back to his doctor.
Neck seizes up - mostly on left side. Really painful Dupuytren's  in left hand. One week later, still has lingering side effects. 3 days of acute pain.
Narrative: Pt states that he received his 2nd Covid injection from the VA yesterday. Today he is experiencing extreme fatigue, dizziness, & an unusual hot feeling from his skin at the injection site.
Moderna COVID-19 vaccine raises blood sugar; This spontaneous case was reported by a pharmacist and describes the occurrence of BLOOD GLUCOSE INCREASED (Moderna COVID-19 vaccine raises blood sugar) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (Moderna COVID-19 vaccine raises blood sugar). At the time of the report, BLOOD GLUCOSE INCREASED (Moderna COVID-19 vaccine raises blood sugar) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: high (High) raised blood sugar.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported.
Five hours after vaccination, I began to have trouble breathing.  My voice got really horse and I felt that I was only able to take in about 60-70% of my normal air.  Then, I got extremely cold and couldn't get warm.  I got under covers and began shaking fiercly.  This went on for several hours and finally stopped after several sweats.
Pt recv vax on 1/25/99; on 1/27/99 pt exp fine red rash at vax site w/ itching
Significant fatigue; This is a spontaneous report from a contactable consumer (patient), and another contactable consumer. A 65-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was EP6955) in Left Arm on 07Apr2021 at 11:45 (at the age of 65-years-old) via an unspecified route of administration, at single dose for COVID-19 immunization. Medical history included diabetes type 2. Concomitant medication included metformin and daily insulin received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, it was not known if patient has been tested for COVID-19. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number was EP6955) in left arm on 17MAR2021 at 11:30 (at the age of 65-years-old) at single dose for COVID-19 immunization. The patient had most recent COVID-19 vaccine at Workplace clinic. The patient experienced significant fatigue on 08Apr2021 at 06:00 after the second dose. No treatment was received for the event. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
she felt miserable; achy all over her body; Patient received  second bivalent Moderna on 26-Apr-2023; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (she felt miserable), PAIN (achy all over her body) and EXTRA DOSE ADMINISTERED (Patient received  second bivalent Moderna on 26-Apr-2023) in an 84-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 045H22A and 041H22A) for COVID-19 prophylaxis.     The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (1st dose , EK9231) on 31-Jan-2021, PFIZER BIONTECH COVID-19 VACCINE (2nd dose ,EL3302) on 17-Feb-2021, PFIZER BIONTECH COVID-19 VACCINE (3rd dose ,303388A) on 29-Aug-2021, PFIZER BIONTECH COVID-19 VACCINE (4th dose andFP4554) on 30-Mar-2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Blood pressure high (taking meds for high blood pressure).   On 07-Dec-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Apr-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (Patient received  second bivalent Moderna on 26-Apr-2023). On 27-Apr-2023, the patient experienced FEELING ABNORMAL (she felt miserable) and PAIN (achy all over her body). The patient was treated with PARACETAMOL (TYLENOL) for Feeling miserable and General body pain, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (she felt miserable), PAIN (achy all over her body) and EXTRA DOSE ADMINISTERED (Patient received  second bivalent Moderna on 26-Apr-2023) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. It was reported that patient did not get sick after getting the all of the vaccines except for the last bivalent Moderna dose.
couldn't breathe; This is an initial spontaneous report from a contactable consumer (patient, self-reported). A 49-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration dates were not reported), via unspecified route of administration on 21Feb2021, as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that, the severe allergic reaction was she could not breathe. Within 30 minutes of the first dose patient started having breathing problems. Still patient was not feeling like she is breathing properly. The outcome of the patient's event was unknown.  Information about lot/Batch number has been requested.
caught COVID; caught COVID; His main COVID symptoms were stiff neck and chills; His main COVID symptoms were stiff neck and chills; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 77-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "caught COVID"; MUSCULOSKELETAL STIFFNESS (non-serious), CHILLS (non-serious), outcome "recovered" and all described as "His main COVID symptoms were stiff neck and chills". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Approximately 3 weeks after receiving his 2nd COVID booster shot, this man went on a cruise and caught COVID despite wearing a mask.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
she "was terrified and passed out."; she "was terrified and passed out."; blood pressure was low; she was shaking; This is a spontaneous report from a contactable pharmacist. A 21-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown, Expiry date: Unknown), via an unspecified route of administration on 14Sep2021 (at age of 21-year-old), as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included flu vaccine on an unspecified date and never had a reaction. On 14Sep2021, after first dose of vaccine, the patient "was terrified and passed out" and fell and was taken to the ER due to the fall. Patient was flat on the floor and opened her eyes, no lip swelling and was breathing. Patient was not given epi pen. The patient was shaking and blood pressure was low. Reporter made her lay flat on her back in case she needed to do CPR. Reporter was hesitant to give the epi pen so did not. The clinical outcome of all the events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Pregnant at 17 weeks gestation.  No adverse reaction noted.  Medication Beyond Use Date 10/30/2021, Medication Expire Date 12/21, Medication administered on 11/1/21
This case was reported by a consumer via call center representative and described the occurrence of mitral valve prolapse in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 21st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 12th September 2018, less than a year after receiving SHINGRIX, the patient experienced mitral valve prolapse (serious criteria hospitalization). The patient was treated with blood transfusion, auxiliary products (Blood Transfusion) and non-drug therapy (Surgery). On an unknown date, the outcome of the mitral valve prolapse was recovering/resolving. It was unknown if the reporter considered the mitral valve prolapse to be related to SHINGRIX. Additional information was reported as follows: After vaccination with the first dose of SHINGRIX on right arm, the patient underwent a open heart surgery to fix mitral valve prolapse and carried out two bypass surgeries. The patient received blood transfusions during and after the surgery. The patient was hospitalised for a total period of 7 days. At the time of reporting, the patient was recovering. The patient enquired if he should receive the SHINGRIX vaccine considering that he had received a blood transfusion. The patient was referred to his health care provider. The reporter provided information as per content. The reporter gave consent to follow up.