chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered liquid portion only / not reconstituted with lyophilized portion.; administered liquid portion only / not reconstituted with lyophilized portion.; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA438A, expiry date 31st October 2021) for prophylaxis.   On 30th June 2021, the patient received Menveo. On 30th June 2021, unknown after receiving Menveo, 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 details were provided as follows: The nurse reported that, the patient was administered liquid portion only of Menveo, the vaccine was not reconstituted with lyophilized portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with case US2021160399, reported by same reporter for diferent patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021160397:FU1 DELETED US-GLAXOSMITHKLINE-US2021160399:Same reporter US-GLAXOSMITHKLINE-US2021160399:Same reporter
Beginning 12 hours after vaccination: Fever of 101-102 degrees F lasting 36 hours with body aches, chills, shivering, and repeated vomiting over approximately 8 hours. Those severe symptoms resolved by 48 hours post-vaccine, but fatigue and severe headache continued another 3 days.
I felt heaviness on my chest; I felt numbness in my leg; I felt numbness in my leg and arm small bumps; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Aug2021 (Lot number: Ew0191) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Kidney reflux" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing); "Known allergies: mosquitoes (skeeter syndrome)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHEST DISCOMFORT (non-serious) with onset 11Aug2021, outcome "recovered", described as "I felt heaviness on my chest"; HYPOAESTHESIA (non-serious) with onset 11Aug2021, outcome "recovered", described as "I felt numbness in my leg"; LIMB MASS (non-serious) with onset 11Aug2021, outcome "recovered", described as "I felt numbness in my leg and arm small bumps". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient didn't received any other vaccine in four weeks, She delivered a baby the day before. No vaccination received prior covid vaccination. The patient went for covid test post vaccination. They let me leave right away. Within 40 min she felt heaviness on her chest. For the next week or more she felt numbness in her leg and arm small bumps.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown demographics. The patients' concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (dose and route of administration were not reported; lot # M027344, expiry date 01-JUN-2018, lot # M033906, expiry date 20-JUL-2018 and lot # M028553 with expiry date 07-JUN-2018). No adverse effect was reported. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA009287.
FEVER; BODY ACHES; This spontaneous report received from a consumer concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included latex allergy. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808609,expiry: UNKNOWN) dose was not reported, administered to left deltoid on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAR-2021, the subject experienced body aches.  On 29-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine was not applicable. The patient recovered from fever on 29-MAR-2021, and had not recovered from body aches. This report was non-serious.
the vial was initially stored in the refrigerator 20-MAR-2023, administration of vaccine 21-APR-2023; No adverse event; Vaccine expired on 19-APR-2023 and was used for vaccinations on 21-APR-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 19-APR-2023 and was used for vaccinations on 21-APR-2023), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 20-MAR-2023, administration of vaccine 21-APR-2023) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 19-APR-2023 and was used for vaccinations on 21-APR-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 20-MAR-2023, administration of vaccine 21-APR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 19-APR-2023 and was used for vaccinations on 21-APR-2023), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 20-MAR-2023, administration of vaccine 21-APR-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medication were reported. Vaccine expired on 19-APR-2023. Individual vials with vial size of 2.5 ml. The vial was initially stored in the refrigerator 20-MAR-2023. The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721047 (E2B Linked Report). Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721047:2nd patient case.
Gave the vaccine on 10/23/23 around 1130am. Patient denied prior reactions to any vaccine. Approximately 2.5 hours later patient complained of rashes developing on both arms, on the back of the neck and on their back. Airway was not compromised, but there was a sensation of the tongue possibly swelling. Gave patient 12.5mg of diphenhydramine chewable. Patient went home form work an hour or two later. Returned to work on 10/24/23.
I had the swollen lymph nodes and feeling unwell; I had the swollen lymph nodes and feeling unwell; Nauseated; Chills; Dizziness; Weakness; I was very confused; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), MALAISE (non-serious), outcome "unknown" and all described as "I had the swollen lymph nodes and feeling unwell"; NAUSEA (non-serious), outcome "unknown", described as "Nauseated"; CHILLS (non-serious), outcome "unknown", described as "Chills"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; ASTHENIA (non-serious), outcome "unknown", described as "Weakness"; CONFUSIONAL STATE (non-serious), outcome "unknown", described as "I was very confused".  Additional information: Batch/lot number, Dates for Covid-19 Vaccine, Expiry Date of Covid-19 Vaccine, Covid-19 Vaccine manufacturer, NDC number of Covid-19 Vaccine, UPC number of Covid-19 Vaccine, Reason for no lot number: of Covid-19 Vaccine: Unknown. Covid-19 Vaccine was a Pfizer product. The patient had a shot (Covid-19 Vaccine by Pfizer) last Monday and had a reaction, the regular stuff with the fluid. The patient went to the hospital but they really didn't do much because the patient didn't have any rash and swelling or anything like that and didn't know if the patient should have the second shot or not, had a doctor's appointment Friday.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Developed numbness and tingling and loss of sensation in soles of feet and progressed up bilateral legs to hips.
Left arm pain continuing 5 days later. Having hard time lifting arm up high.  Causing neck and shoulder pain . Hard time sleeping due to the pain in arm and shoulder.  Dry mouth
This spontaneous report was received from a physician and refers to a 21-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 14-SEP-2018, the patient was vaccinated with GARDASIL 9 lot # R000303 with expiration date on 29-AUG-2020 (reported as 29-SEP-2020), intramuscularly in the left arm for prophylaxis (dose and frequency were not reported). On 03-SEP-2018, the patient woke up with a raised, hard knot, 3 centimeters in diameter, at the site of the injection, and it was difficult for the patient to lift her left arm. The patient sought medical attention and received treatment (unspecified). The outcome of the events was reported as recovering. The relatedness between the events and GARDASIL 9 was not reported.
On Friday January 8th (1 week following the vaccine injection), my left arm at the injection site became very hot, red, painful, and swollen.  There was also tenderness and pain in my left axillary lymph nodes. The swelling and redness continued until 1/13/21 until it started to dissipate. On 1/15/20 I woke up with a sore throat on my left side.
I contracted covid anyway in Jan; I contracted covid anyway in Jan; Covid attacked my brain and joints.; Covid attacked my brain and joints.; cognitive issues; joint pain; fatigue; I have great trouble with daily activities; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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 "I contracted covid anyway in Jan"; BRAIN INJURY (medically significant), JOINT INJURY (non-serious), outcome "unknown" and all described as "Covid attacked my brain and joints."; COGNITIVE DISORDER (non-serious), outcome "unknown", described as "cognitive issues"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; FATIGUE (non-serious), outcome "unknown"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "I have great trouble with daily activities". Clinical course: I was fully vaccinated for covid with your vaccine. I contracted covid anyway in Jan. Covid attacked my brain and joints. 8 months later and I am still suffering with debilitating cognitive issues, joint pain and fatigue. I can't work, I have great trouble with daily activities. I felt that I was safe using your vaccine, now I wonder if the vaccine is why I have these issues. I feel I was lied to.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt vaccinated with DTP several hrs after found shaking, not responsive 15mins, mottled & bluish, limp; Taken directly to ER then to office.
Moderna COVID-19 Vaccine EUA The day following the vaccination I experienced very slight flu-like symptoms: headache, muscle aches, low fever (99°). The symptoms improved in the next days.
Administered vaccine after 12 hrs of 1st puncture of vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-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. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was provided. No treatment drug details was included.
Patient began c/o pain in her genitals on 12/4/21 and says it began the night before. Pain worsened over the weekend and she allowed me to look at the area on 12/05/21.  Her labia appeared to have 3 ulcers/lesions which were white/yellow, and the entire surrounding area was red  and ?angry? looking.  The lesions almost appeared to be ?rotting?.  There was discharge present (she has not yet begun menstruating nor is she sexually active), but no odor noted. My kiddo was miserable and I was horrified by what I saw because I now understood how much she was suffering.  We attempted to contact her pediatrician to no avail so went to a local medical facility Monday morning 12/06/21.
11:54 AM Mom called. Patient complaiNed of having chills & headache to back of head. No difficulty Breathing. Advised ibuprofen & rest per MD. 2:58 PM Follow up Phone call. Hives to face later. No rash elsewhere. No Breathing difficulty. Benadryl 25 g was given Spoke with MD Labeled Trumenba allergy in chart. Advised ClaritiN or Zyrtec 10 mg daily x 5 - 7 days. Spoke with Mom 5/18/20 AM - Pt symptoms resolved the evening of 5/15/20. Hives have Not returned.
Pt. complained of pain at injection site several days of the injection. Talked to manager after this.
Information has been received from a pharmacist concerning a 67 year old female patient with no allergies and no medical history who on 14-DEC-2010 was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) (Lot# 664636/0874Y), SQ. The patient also received on the same date a dose of PNEUMOVAX 23. Concomitant therapy included thyroid and FORTICAL. Pharmacist stated that on 16-DEC-2010 the patient developed "chicken pox like rash". There were no laboratories performed. BENADRYL and hydrocortisone was given, both topically as the treatment. At the time of the report the patient was recovering. The patient sought medical unspecified medical attention. Additional information has been requested.
firm to touch 4 in by 3 in lump at the injection site; redness at injection site; pain and soreness at injection site; A spontaneous report was received from a consumer concerning a 53 -years -old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain and soreness at injection site/ injection site pain ,firm to touch 4 in by 3 in lump at injection site/ vaccination site mass, redness at injection site/injection site erythema.  The patient's medical history as reported by the reporter as she had history of anaphylaxis with NSAIDs. Concomitant medication included diltiazem.  On 26 DEC 2020, prior to the onset of the events, patient received their first two doses of mRNA-1273 (Lot number: unknown) through intramuscular route at unspecified site  for prophylaxis of COVID-19 infection.  On 26 Dec 2020, the first day she felt pain, soreness at injection site which went away on its own. On 04 Jan 2021,10 days later she noticed a 4 in by 3 in lump at the injection site along with redness. The lump was firm to touch.  Treatment activities for event was reported as none.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, pain and soreness at injection site was recovered/resolved on an unknown date, a 4 in by 3 in lump at the injection site along with redness, lump was firm to touch was 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 events, a causal relationship cannot be excluded.
Right thalamic stroke; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Feb2021 (Lot number: EL3247) at the age of 57 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart murmur" (unspecified if ongoing); "Environmental allergies" (unspecified if ongoing); "Allergic to Penicillin" (unspecified if ongoing); "dyslipidemia" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "Bronchial asthma" (unspecified if ongoing); "COVID 19" (unspecified if ongoing), notes: recently recovered. There were no concomitant medications. Vaccination history included: Bnt162b2 (Vaccine Name: First dose, Lot Number / Expiry Date: EL0140/ Unknown , ), administration date: 13Jan2021, when the patient was 57 years old, for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization) with onset 11Feb2021, outcome "unknown", described as "Right thalamic stroke". The patient was hospitalized for cerebrovascular accident (start date: 11Feb2021, discharge date: 15Feb2021, hospitalization duration: 5 days). The event "right thalamic stroke" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: (11Feb2021) unknown result; echocardiogram: (11Feb2021) unknown result; (11Feb2021) unknown result; investigation: (11Feb2021) unknown results; magnetic resonance imaging head: (11Feb2021) unknown result. Therapeutic measures were taken as a result of cerebrovascular accident.  The caller found the note the Cardiologist had written and it said "female with a past medical history of dyslipidemia and hypertension presented with a right thalamic stroke with symptoms of gait instability and slurred speech thought to be related to small vessel disease.  Follow up information has been requested.
A report has been received from a physician concerning a 4 year old female child. No concomitant medication or medical history was reported. On 05-Dec-2012, the patient received vaccination with Nasal FLUENZ. Four days later, on 09-Dec-2012, the patient developed fever, rhinitis and headache. On 10-Dec-2012 a smear has been taken in order to distinguish an adverse event from influenza. The test was H1N1 positive. The child received symptomatic treatment. At the time of reporting the event of fever, rhinitis, and headache were ongoing. The reporting physician considered th events of fever, rhinitis and headache possibly related to FLUENZ. The events of fever, rhinitis and headache were considered to be non-serious by the reporter. Summary of follow-up information received on 20-Dec-2012: patient demography, event onset date, outcome of events were updated. Vaccine start date updated. Physician's assessment of casualty added. Diagnostic test result added. Narrative updated.
after 4 days had headaches, nausea, vertigo, tennitus, heart pounding, numbness and tingling in lower extremities and lips.  all adverse symptoms resolved themselves after two weeks except the numbness and tingling which is still present.
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Moderna product on 01/21/2021 and 02/18/2021. They presented to emergency department on 11/04/2021 with a primary complaint of diminished responsiveness. They were admitted to hospital same-day and tested positive for COVID-19 upon admission. They were found to be experiencing complications of apnea, ventricular tachycardia (pacemaker in place), pleural effusion, bilateral interstitial edema, and general poor health. They were in process of transferring to a hospice home facility but the individual died before this transfer could happen. Date of death is 11/16/2021.
temp and upper arm soreness; temp and upper arm soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6200) at the age of 71 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), PYREXIA (non-serious), outcome "unknown" and all described as "temp and upper arm soreness".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300101946 same patient, different vaccine dose/event;
Patient received 2nd shingrix shot on 12-14-19 and went to Doctor's office and they reported it seems to be shingles that she broke out on the left side of her body. Patient describes it as upper left torso, 10-11 blisters, occuring 1 week after she shot. Stated she first had internal pain then 4 days later blisters appeared.
HPV was given at 3:45 PM & at 4:05 PM he complained of dizziness. he was placed in partial Trendelenburg for 5 mins & this relieved his dizziness. At 4:12 PM he was not dizzy, got up, walked well.
Had the booster on Sat. morn. at 3am next morning went to bathroom and it hit me like ton of bricks and could hardly make it back to bed.  I was shaking and fast heartbeat and very weak.  Next morning was very weak an shaky, had to just rest all day, no appetite.  Very bad headache.  Next day somewhat better, but almost passed out at one point.  Still weak and shaky on the 3rd day of the shot.  The first two shots that I had last Jan. and Feb.  there were no reactions at all.  Why would this booster be so different.  I thought it was supposed to be a weaker dose.
Patient fainted immediately following administration of 3 immunizations (Tdap, pediatric Hepatitis B, and Varicella).  When patient fainted, she fell from a seated position to the floor, hitting her head.  She initially complained of dizziness and pain at the site of injury; VS WNL.  Within 1 hour, pt complained of frontal headache and nausea; referred to local emergency room for evaluation.
Fatigue for two days after the vaccination. One week after that, swelling, itching, pain, and burning at the inoculation site started. One week after that, I started to feel numbness. But it doesn't interfere with my daily life, so I'm keeping an eye on it.