chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE information provided; an unspecified number of patients were administered an improperly stored dose of VARIVAX since 2/27/2020; This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions and allergies were unknown. Concomitant therapies included sterile diluent.  Since 27-FEB-2020, the patients were vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) with lot # S010297, expiration date 03-APR-2021 (dose number, frequency, route of administration, anatomical location were not reported) for prophylaxis (product storage error).  Temperature excursion of this vaccine was minus 14 degrees Celsius to minus 10 degrees Celsius (minus 10.4 degree Celsius) for 6 hours 2 minutes. There was no previous temperature excursion. No additional adverse event was reported. Data logger was involved.  This is a non-valid case due to lack of patient identifiers and unspecified number of patients.  Follow up information has been received on 29-JUL-2020, the medical assistant was not about to talk due to office being busy. Telephone call and fax numbers were provided.  Follow-up information has been received from the medical assistant on 26-AUG-2020.  The case is valid. The identifiers of 8 patients were provided.  The patient was 5 years old. On 16-MAR-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of the eight reports from the same reporter.; Sender's Comments:  US-009507513-2008USA013489: US-009507513-2008USA013494: US-009507513-2008USA013491: US-009507513-2008USA013492: US-009507513-2008USA013493: US-009507513-2008USA013488: US-009507513-2003USA007542:
Patient presented with upper right thigh redness, swelling, hot to the touch, and covered most of the upper thigh, Started oral treatment of sulfamethoxazole-trimethoprim 200/40 mg per 5mL 17 mL twice daily X 10 days but patient also had ear infect. and patient is sched. for follow-up on 10/05/2012.
Patient states she developed left eye swelling on the morning of 03/15/21.  States she does not think its allergies since she took a claritin and it did not help her.
second dose of Shingrix a year and a half after the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2017, one and half year before receiving 2nd dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in 2019. The patient received 2nd dose of Shingrix, a year and a half after the first dose, later than the recommended schedule which led to lengthening of vaccination schedule. The reporter consented to follow up.
sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Menopausal.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore injection site arm). At the time of the report, VACCINATION SITE PAIN (sore injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication listed.  No treatment information provided. In May June, and July patient felt like she was having Menstrual symptoms.  In August Patient had a full fledged period.  Patient's Doctor performed an ultrasound a month ago and she have eggs. Her next ultrasound is scheduled for November 1, 2021.   This case was linked to MOD-2021-356223 (Patient Link).
Information has been received from a physician concerning a "child" who on an unspecified date was vaccinated with a dose of ROTATEQ (lot number not reported). On an unspecified date after the vaccination, "the entire family was infected with Rotavirus". It was unknown whether medical attention was sought. At the time of the report, the outcome of the patient was not reported. This is one of several reports from the same source. No further information is available.
1hr p/vax 1MAY96 devel swelling of tongue, lightheaded, tingling lips & extremities;IV started, epi given x 2 & DPH;BP stabilized w/in 5min to 110/70-144/80 a/discharge;
Used that punctured vial to vaccinate a male consumer; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Used that punctured vial to vaccinate a male consumer) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Used that punctured vial to vaccinate a male consumer). On 17-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Used that punctured vial to vaccinate a male consumer) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided. .
Severe aching and pulsation-like pains in left and right side lower back (kidney area); I cannot comfortably bend over (sitting or standing) for more than 30 seconds at a time, because of the pain; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8839) via an unspecified route of administration in the right arm on 05Nov2021 at 12:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were reported as not applicable. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: FF2587) via an unspecified route of administration in the right arm on 06Oct2021 at 12:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 06Nov2021 at 08:00, approximately 24 hours after receiving the second dose of the Pfizer COVID-19 vaccine, the patient experienced severe aching and pulsation-like pains in his left and right side lower back (kidney areas). He could not comfortably bend over (sitting or standing) for more than 30 seconds at a time, because of the pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe aching and pulsation-like pains in left and right side lower back (kidney area) and he could not comfortably bend over (sitting or standing) for more than 30 seconds at a time, because of the pain was not resolved at the time of report.
Pt is 12 yrs old given DTAP left arm tolerated well, then given Hepatitis A right arm tolerated fine then gave MENACTRA meningitis right arm as so as vaccine went in patient fainted. Pt recovered within second. Doctor evaluated her normal findings.
Provider spoke with parent and advised there are no adverse events, the vaccines were considered boosters and child should be well.
Pharmacist gave a flu injection to patient and noticed it was difficult to get the needle in all the way and she winced. Realizing he had hit bone he readjusted the needle then finished injection. She complained of shoulder pain to her doctor and it was determined that the immunization went into the joint. She is continuing followup with her primary care physician.
twitching muscles of arms & legs;no LOC 1wk p/vax 15APR96 -last episode 1wk ago;pt family did not bring pt to see MD;
Severe lives from neck down, swollen lips. Sx began to resolve with 1st Prednisone taper, but reappeared. Patient was then started on a second Prednisone taper.
3mins post vaccination, pt had flushing/sweating and a syncopal event there was no LOC and mom placed patient on floor face up at vax station. Vitals: 108/67, 120, 20, 100% -- > 99/57, 108 -- > (standing) 110/70 Pt stable and released from the vaccination site @13:37
I experienced all normal symptoms, chills, body aches, headache starting around 10pm the night of. Symptoms got worse throughout the night and then better during the day. They lasted throughout the day and by the next morning 10/13 I was fine. I am breastfeeding though and I did not pump and dump. My daughter is about 4.5 months old and she was very tired the morning if the 12. She was also weak. She usually stands up with holding our hands but on the morning of the 12th she would quickly collapse not being able to support her weight. I also have a baby monitor that monitors her breathing. That whole day her breathing was lower ranging from 25 to 30rpm in her sleep. She normally is stays around 29-34. She was slightly groggy in the morning hours of the 12th but still alert enough. On the 13th she seems like she is back to normal. Her breathing is back to the 29-34rpm while sleeping.
Tingling in lips immediately after vaccine that subsided. Then about two hours later I itched all over and started coughing like what happens with my typical allergic reactions. It lasted about 30 min but was fairly intense.
The shot hurt more than past flu shots.  The shoulder is still very sore at the location of the shot, as of 12/31/2013.  Certain arm movements are painful at that exact location of the shoulder.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unspecified dates, the patient may have been vaccinated with a dose of MMR II (dose, route, lot and expiration date were not provided) that was improperly stored. No adverse effect reported. Additional information has been requested.
pt recv vax 24FEB98 & devel diffuse maculopapular rash all over body;no anaphylaxis;
This spontaneous report as received from a healthcare worker refers to a 12 month old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 19-NOV-2015, the patient was vaccinated with improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017, (exact dose, route of administration and injection site were not reported). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Digital Data Logger (DDL) was used to capture the excursion. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a pharmacist via a company representative, referring to a 64 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided. Approximately on 03-MAY-2017 (reported as: " 3 to 4 weeks ago"), the patient was vaccinated with a dose of ZOSTAVAX (strength, dose number, route, anatomical location, lot# and expiration were provided) for prophylaxis, reconstituted with sterile diluent (lot# and expiration were provided). In approximately May 2017 (reported as: "On an unknown date after received ZOSTAVAX"), the patient experienced hair loss. It was unknown if the patient had received any treatment for alopecia. At the time of the report, the outcome of alopecia was unknown. The reporter did not assess the relatedness between the event and suspect therapy.
not feeling well; swollen glands on the neck which was going on and off; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well) and LYMPHADENOPATHY (swollen glands on the neck which was going on and off) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (not feeling well) and LYMPHADENOPATHY (swollen glands on the neck which was going on and off). At the time of the report, MALAISE (not feeling well) and LYMPHADENOPATHY (swollen glands on the neck which was going on and off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Rash on left and right arm along with itching and redness on both arms more than 12 cm.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included hip replacement (on 8th May 2018). Previously administered products included ZOSTAVAX (a few years ago). Concomitant products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE), cortisone (non-proprietary) (Cortisone Cream) and valaciclovir hydrochloride (Valtrex).  On 19th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, less than a month after receiving SHINGRIX, the patient experienced rash. On 19th July 2018, the patient experienced vaccine administered at inappropriate site. On 15th August 2018, the patient experienced shingles. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were reported as follows: The patient reported that she received a pneumonia vaccine a couple of weeks prior to the SHINGRIX vaccine. The patient received SHINGRIX vaccine in the afternoon on right gluteus medius. The patient received the vaccination right next to an incision she had from a hip replacement surgery in her gluteus maximus, which led to vaccine administered at inappropriate site. The patient claimed that she first got a rash early in July 2018. On 15th August 2018, 27 day after vaccination, the patient went back in the office and she was diagnosed with shingles (also it was stated that, the patient was diagnosed with shingles a few weeks later). The shingles was presenting itself on the right side of her body which was the same side that she received the vaccination on. The patient described the shingles as a mild case. The patient had an IGG and IGM test done at her dermatology office and the IGG results came back through the roof at 4000 but her IGM test came back mildly out of the normal range. The patient took Valtrex for one week and her shingles had not resolved but it helped. They gave her cortisone cream with did not work and the second week of August they gave her a higher dose of cortisone cream which also did not work.
Incredibly injected conjunctiva and high fever with chills. Headache and malaise. Onset was nearly instantaneous and began with a cough and throat swelling 2.5 hours after vaccination for influenza (IM administration).
Excessive crying, picking/swatting at arm. Family left after 15 min observation period but returned 1h. later for increased sadness, babbling/incoherent speech and picking at arm. On reassessment, VSS, A+Ox3. Crying but would laugh when asked math problems. Remainder of exam normal, neuro normal. Mom advised to monitor closely for extreme sadness, mood lability. Patient denied wanting to hurt herself. Signs of seizure activity reviewed. Plan for family to go to ED if seizure activity developed overnight. Teen slept well and mom reported no problems the next morning.
Patient was seen by her oncologist and found to have profound thrombocytopenia. Patient usually had a platelet count of 300,000-400,000, dropped to 1000 with symptomatic petechiae.  This occurred 2 weeks post flu shot with no other changes to medications. Has since returned to normal. Patient required hospitalization and received dexamethasone 40mg IV.
Father reports fever of 100-103 for 3 days fllowing immmunization. afebrile today in clinic
Chills overnight about 7 hours after injection Next day just lethargy  2 days after injection, 100% fine
FluLaval administered after temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number GF9PM, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 28-Oct-2022 Reporter's comment: A pharmacist called to ask for information about the administration of Flulaval to 7 staff members.  The Flulaval vaccines that were administered were exposed to room temperature for a few weeks.  The reporter did not provide exact data about time and temperature of the excursion, but mentioned that vaccines were out of refrigeration approximately from 15th September 2022 to 10th October 2022 and then vaccines were administered to the staff members. The reporter did not provide either the exact date of administration nor the identifiers of the 7 people that received this vaccine.  The reporter asked about the stability of Flulaval when exposed to temperatures higher than recommended and asked if the staff members had to be re-vaccinated. The reporter consented to follow-up. This case was for 1 of 7 linked patients reported by same reporter. Additional supportive information: The patient was administered Flulaval after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022156225:Same reporter US-GSK-US2022AMR157002:Same reporter US-GSK-US2022AMR157001:Same reporter US-GSK-US2022AMR157005:Same reporter US-GSK-US2022AMR157006:Same reporter US-GSK-US2022AMR157008:Same reporter
patient received a 2nd COVID vaccine and it was supposed to be moderna but the patient received Pfizer
Given on 10-10-07. S/S started 10-11-07 at 0800 S/S - welts, SOB, itching. To ER 10-14-07 RX Prednisone and Benadryl. 10-15-07 "Back to Normal"
pt stated 2 days after vaccination arm became, swollen, red and warm, pt's pcp was contacted and pt was prescribed an antibiotic and antihistamine
Persistent and severe headaches pain after vaccine - High blood pressure for example 162/102 - 151/112
My tongue began to swell around 4pm.  I took a Benadryl.  The swelling did not resume until 8pm.  I took a second Benadryl around 8:30 pm.  By 9pm the swelling began to impede my breathing.  Sought medical attention at hospital at 9:30pm where there was no ED.   A security guard called 911 and paramedics transported me to a second Hospital ED arrived approximately 10-10:15pm.  ED triage staff came to talk to me I sat upright on the gurney, vomited and my airways closed.  I managed to say "I can't breathe!" and remember nothing until 36-48 hours later during sleep/wake cycle in ICU.   I had to be intubated nasally upon admission.  **See more on Continuation page** I had to be intubated nasally upon admission.  Doctors said my airway was almost completely blocked with only a sharpie pen sized passage to insert the tube.  I am still recovering from my IUC stay.  Regaining endurance, strength, stamina as well as vocal range and strength.
24 hours after second shot fainted; This is a spontaneous report from a contactable consumer (patient). An 80-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER2613), via an unspecified route of administration, administered in left arm on 20Mar2021 12:00 at single dose for COVID-19 immunization. The patient's medical history included glaucoma, and underactive thyroid. The patient had no known allergies. The patient's concomitant medications included levothyroxine sodium (SYNTHROID), and latanoprost (XALATAN), both taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6198), in the left arm on 27Feb2021 12:00PM for COVID-19 immunization. Facility vaccine type was Physician's Office (reported as Doctor's office/urgent care). The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and was tested for COVID post vaccination. It was reported that 24 hours after second shot, the patient fainted on 21Mar2021 07:00. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent case, hospitalization. The patient was hospitalized from 21Mar2021 to an unknown date for 1 day. The patient underwent lab tests and procedures which included nasal swab: negative on 21Mar2021. Therapeutic measures were taken as a result of 24 hours after second shot fainted and included stitches on bridge of nose and lip. The outcome of the event was recovered on Mar2021.
Approximately 4 hours after receiving injection, patient reports experiencing extreme body aches and fatigue.  The following day had some neck stiffness.
Client received 1st dose of Pfizer COVID-19 vaccine. Shortly after receiving the vaccine, the client experienced chest pain. Client has history of chest pain, previous cardiac arrest, and medication non-compliance. Patient does have prescribed nitroglycerin. Client was taken to observation area. Chest pain continued, blood pressure was 194/94, pulse in low 80s, oxygen saturation 100%. Client was given 1 nitroglycerin and chest pain reduced. Follow up blood pressure 164/90 pulse 80s. 12 lead ECG was completed which showed a previously known bundle branch block that was transmitted for ED physician review. Onsite EMS recommended evaluation in the emergency department. Client was transported by EMS to ED for evaluation.