chrisvoncsefalvay/vaers-outcomes huggingface dataset:
improperly stored pneumovax 23; NO SYMPTOMS; This spontaneous report was received from a medical assistant referring to 9 patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-NOV-2019, 08-NOV-2019, 06-JAN-2020, 08-JAN-2020 and 09-JAN-2020, the patients were vaccinated with one dose of improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength and anatomical location was not provided) of lot# S018405, expiry date reported as 28-MAR-2021, but upon internal validation established as 23-MAR-2021, intramuscularly for prophylaxis. On 10-JAN-2020, the patients were vaccinated with 2 doses of improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). On 28-JAN-2020 and 03-FEB-2020, the patients were vaccinated with 1 dose of improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  the patient was vaccinated with one dose each, improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) underwent a temperature excursion of 36 degree Fahrenheit to 46 degree Fahrenheit for a time frame of 2 minutes. The previous temperature excursion was reported to be below 36 degree Fahrenheit for 1 minute. The digital data logger was involved. No additional adverse effects were reported. It was reported that the medical assistant did not want to provide the patient information without the approval from her manager. No product quality complaint (PQC) was associated with this report.   This is an amended report. This case was a valid report (9 patients whose details were withheld) and should have been distributed instead of routing to non-valid workflow.
Patient was stuck twice; syringe was difficult to administer to patient; Plunger was difficult to depress, tilted from perpendicular, lot of resistance; This case was reported by a other health professional via call center representative and described the occurrence of wrong technique in device usage process in a adolescent male patient who received HBV (Engerix B pediatric) (batch number 77X47, expiry date 22nd December 2023) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced wrong technique in device usage process, syringe issue and pharmaceutical product complaint. On an unknown date, the outcome of the wrong technique in device usage process, syringe issue and pharmaceutical product complaint were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 03-Jan-2023: Reporter's Comment: HCP called to report that while an experienced nurse was administering Engerix B pediatric prefilled syringe vaccine, the plunger was difficult to depress. The needle was changed, and the plunger was able to move up and down; but, said syringe was difficult to administer to patient. The patient had to be stuck twice. (AE filed) There was also a second syringe in the same 10 count box that had a similar appearance with the plunger being tilted from perpendicular. There were also 3 other syringes remaining in the 10 count box that the HCP was not comfortable using. They were returning 4 prefilled syringes total. The one with patient involvement was discarded and can not be returned. HCP stated that they use the vaccines for children. HCP was able to pull down on the plunger but it felt askew from perpendicular. HCP could push out air, but once the needle was in the patient's arm, there was a lot of resistance with the plunger. HCP had to re-maneuver to get it to advance. There were no any blockages visible in the syringe body or barrel. There were no abnormal particles observed in the vaccine. Luer Lok needle was used. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow-up.
Patient's parent called today at 12:30pm, explaining that he had just witnessed the patient have either a fainting or seizure spell. Patient had been drinking carbonated soda, complained of chest pain, and had an episode where their eyes rolled to the back of their head and either fainted or seized. Parent is unsure. Patient is currently alert and oriented, talking, no lasting effects, no lasting verbal, sight, or motor issues. Suspected delayed syncope. Have not reported to hospital, and patient does not currently have an active primary care doctor. Expressed that if anything else happens to reach out to EMS or go to hospital for follow-up. Patient should be watched in-house for further issues if they decide to continue with second dose.
patient who received Twinrix first dose on 11/2/2022  and he has never received the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 2nd November 2022, batch number 4F3YY, expiry date 1st January 2023.).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: patient who received Twinrix first dose on 11/2/2022  and he has never received the second dose). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-MAY-2023 The reporter reported about a patient who received Twinrix first dose on and had never received the second dose.  The reporter did not consented to follow up.  Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
pt developed recurrent post herpetic neuralgia after receiving Zostravax in same area she previously had
Gave .5cc of flu vaccine left deltoid at 09:30. Asked patient to remain in medical 5-10 minutes. 09:35 Patient complained of being hot. Advised to remove outer sweater (had on turtleneck under sweater). 09:37 Color pale turned ashen, slumped in chair to right side, eyes rolled to back of head, started to seize, back ache. Jacksonian movements noted of arms and legs. Patient supported. Called across hall to maintenance. Call 911. Gently patted face calling name. Ceased breathing; Carotid pulse absent. Eased to floor. Color: deep red; in progress of starting CPR. Head back; airway patent. Patient woke up coherent. 09:55 About 3-4 minutes unresponsive. BP 124/80. A 48 reg. 911 responded and taken to hospital via ambulance.
THE PATIENT IS CALLING TELLING US THAT SHE HAD DIARREA, NAUSEA, JOINT PAIN SPECIALLY IN LEGS, FEVER AND HEAD ACHE.
10 minutes after shots given patient had dizziness, seizure, and fainting for approximately 1 minute. Patient recovered after ammonia inhalant given. No falling, no injury. Blood pressure 98/60, pulse = 58. 911 called and pt. taken to hospital.
After the first dose my periods started being VERY irregular. I stopped my regular cycle then started three days later. I had to have an ultra sound they found out that I was pregnant after the second vaccine. We discovered I had cyst that were rupturing, my pregnancy was high risk, I miscarried, my periods are still not regular.
Left arm sore at injection site for multiple days afterwards. On the second day my whole body was sore from head to toe and severe body aches. It felt like someone had best me with a baseball bat. It hurt to lie down or stand. I had a hard time standing from the pain. Mostly shoulder, lower back, lower stomach/pelvis area, left arm and hands ached. 3rd day aches were mostly gone but left arm was still tender. Today day #4 my arm still hurts.
Vaccines are kept frozen until they are ready for administration; Administered Moderna vaccines beyond the use date and/or expired.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Moderna vaccines beyond the use date and/or expired.) and PRODUCT STORAGE ERROR (Vaccines are kept frozen until they are ready for administration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Moderna vaccines beyond the use date and/or expired.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines are kept frozen until they are ready for administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered Moderna vaccines beyond the use date and/or expired.) and PRODUCT STORAGE ERROR (Vaccines are kept frozen until they are ready for administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Moderna vaccines are kept frozen until they are ready for administration which means they would have been in the fridge about 1-3 days. They tend to store 1 to 3 bottles in the fridge to thaw out and be ready for the patients when needed. No treatment medication reported.
13 year-old patient received shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 13-year-old female patient who received Herpes zoster (Shingrix) (batch number 23YG7, expiry date 12th October 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the 13 years old patient received Shingrix vaccine. The reporter did consent to follow up. Additional supportive information: The patient received Shingrix who was younger than the indicated age which led to inappropriate age at vaccine administration.
Development cellulitis (R) deltoid region < 48 hours post Tdap injection.
4-5 hour after dose - eyes swelled, urticarial rash, cough, some lip swelling, some wheezing - ER epinephrine, IV solumedrol, Benadryl - Prednisone orally, Benadryl. Some of rash looked more like erythema multiforme
PATIENT DEVELOPED RASH ON UPPER TORSO AND BACK AND UNDERNEATH ARM 2 DAYS AFTER PREVNAR AND SHINGRIX VACCINES. TOLD PATIENT TO TAKE BENADRYL AND ZANTAC/PEPCID. SHE SHOULD GO TO ER IF SWELLING IN MOUTH OR TONGUE, AND TO CALL IF IT GETS WORSE AND NOT BETTER.
Family report of fussiness for 24 hours after vaccine with low grade fever. Three days after vaccine, the family felt that baby's left foot was curved downward and stiff. Mother noticed body shaking for a few seconds.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. In 2009, the patient was vaccinated with the first dose of GARDASIL (dose, route, lot number and expiration date were not reported). On 06-MAY-2015 the patient received the second dose of GARDASIL (dose, route, lot number and expiration date were not reported). No adverse effects reported. Additional information has been requested.
Within 5 minutes of vaccination employee became flush, dizzy, diaphoretic, pale and throat felt like it was tightening. Pulse ox 98%, HR 80's, BP 116/78.   11/18/09 and 11/30/09 PCP medical records received. Service date 11/09/09 to 11/10/09. Patient feeling better at 3PM 11/09/09. No additional information abstracted.
per pt after waiting for 20 minutes at the pharmacy she went home and upon changing her clothes she notices  site of inject is swollen and had a rash  and she started to fill itchy . no difficult breathing  reported,  since 11/14 she has been expereincing headaches , body aches , itchiness along with the injection site , pt has been taking benadryl around the clock and as off 11/19 was adviced by her allergist to  go to an urgent care if symptoms persist
"pain in body" "cannot eat" "dizzy" +cough, dry "feels like I'm choking" when trying to drink water. New problem. +fatigue +chills Since December 7th. COVID diagnosed in household recently. Pt had a negative COVID test 12/13 . And is fully vaccinated.
10-15 minutes after the injection I felt my throat tightening like I was having difficulty swallowing. We got the nurse and she asked if it was severe and she was going to give me a shot but I said not at this point. I didn't want to get on the road yet just incase so she gave me a Benadryl instead and after that I felt fine. The Benadryl levitated the symptoms. I did have soreness in the injection site for about a week.
I got my covid 19 vaccine shot (Moderna) on 4/15/2021 on my left arm around 11:30AM After the vaccine I felt a discomfort, disoriented & very sleepy & tired. I slept, when I woke up that same evening I felt my neck & my arm, all my of left side really hurt, a lot of muscle aching from my neck down to my arm, also my left ear hurt too.  I couldn?t sleep for long on the night of 4/15/2021 because of the muscle discomfort. I woke up on the morning of 4/16/2021 & my arm & neck was feeling a little better. Towards the afternoon I started to feel this aching on my middle part of my neck & mid way of my back then towards the evening my left arm was way better but now the pain was on my right side of my neck & arm, almost like the pain transition over to the other side. I couldn?t sleep at all on the night of 4/16/2021 because the pain & muscle aching was now on the right side of my neck & arm.  On the morning of 4/17/2021 I am still aching a lot when moving my neck left to right & right to left and moving it in anyway it hurts a lot. My muscles on my neck & arm ache a lot. I had to take time off work due to the vaccine date and recovery 4/15 4/16.
Eztreme swelling of deltoid, hard, hot to tough. Deep pain over entire deltoid and generalized pain throughout arm, shoulder, neck, and upper back. Hives across base of deltoid, rash across chest.
Pt recv vax on 4/2/99; on 4/3/99 pt exp swollen/ painful arm, nausea, muscle fatigue, headache, neck ache
This spontaneous report as received from medical assistant regarding multiple unspecified patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored VARIVAX, lot # L030158/expiration date-11-AUG-2017 and lot no. L041205/expiration date-20-OCT-2017. No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pain). At the time of the report, PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were Reported. The patient got the 1st shot on Sunday and wants to know if can take Tylenol for pain.
Allergic dermatitis, erythematous maculopapular rash on post and trunk, extremity.
Sat down for a meeting at 1PM, injection site issues were minimal. By 3PM, site had swollen to about a 3 inch by 2 inch welt. There's heat and redness on the welt itself, as well as pain when pressed upon. Welt also itches and is a bit stiff/lumpy.
COVID 19; COVID 19; tested positive a 2nd time for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "Asscending Aorta Anyersuem" (unspecified if ongoing), notes: Asscending Aorta Anyersuem; "tumor on kidney and adrenal" (unspecified if ongoing), notes: tumor on kidney and adrenal; "mulit-polps removed Colonscopy" (unspecified if ongoing), notes: mulit-polps removed Colonscopy; "Hysterhectmy" (unspecified if ongoing); "Known allergies: some Beta Blockers" (unspecified if ongoing), notes: known allergies: some Beta Blockers; "known allergies: penicillin" (unspecified if ongoing); "tumor on kidney and adrenal" (unspecified if ongoing), notes: tumor on kidney and adrenal. There were no concomitant medications. Past drug history included: Amoxin, reaction(s): "known allergies: Amoxin"; Codene, reaction(s): "known allergies: codene". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Aug2022, outcome "unknown" and all described as "COVID 19"; DISEASE RECURRENCE (medically significant) with onset 14Aug2022, outcome "unknown", described as "tested positive a 2nd time for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (14Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Right thigh with 17 1/2cm x 18 1/2cm swelling and erythema surrounding injection site, warm and indurated.  No fluxuence noted.
The day after the vaccine, I noticed the following: (1) A blister had grown on the left side of my mouth overnight (took a picture). (2) Three red under-the-skin, semi-circle 'brusies' on my right upper arm.  The bruises were NOT raised.  I thought that I'd taken a picture of this too, but I must have deleted if for I currently cannot find a picture.  I did, however, mention these on my weekly check-in call regarding the vaccine. (3) I've had a sore throat and, periodically, a shortness of breathe since that week of the vaccine.
Narrative: 09/17/2020 COVID swab, result: not detected COVID infection following COVID vaccine series 01/13, Pfizer, dose #1 02/04, Pfizer, dose #2 08/03 pt cc: cough, chills, rhinorrhea. sore throat exposure: unknown 08/14 COVID swab, result: detected 08/14 SARS-COV-2 LINEAGE result: AY.4 08/14 SARS-COV-2 CLADE result: 21A
Got sick for 2 weeks; Initial information received on 04-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a patient f unknown demographics who got sick for 2 weeks, after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route for influenza immunization.  On an unknown date, the patient developed a non-serious got sick for 2 weeks (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Got sick for 2 weeks).  At time of reporting, the outcome was Unknown for the event got sick for 2 weeks.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown dates, an unspecified number of patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot numbers, expiration dates, doses and routes of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt exp pain @ inject site the day p/recvd flu vax; This pain continued to worsen until pt was unable to work; A bump was noted @ the inject site; MD dx tendonitis; pts MD felt area was inflamed but not infected; pt currently receiving PT;
She developed pain and tingling in her Left Arm immediately after receiving the vaccine. A few hours later she became clammy and developed a red bump on the opposite arm after vaccine. This bump was warm to touch.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 2:08 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 2:08 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 35.50.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 6-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 9-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.