chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3rd dose 28 days after the 2nd one; A spontaneous report was received from a healthcare professional  concerning an male patient of an unknown age (approximately 60+ years old), received  third dose of Moderna's COVID-19 vaccine (mRNA-1273) vaccine by mistake (extra dose administered). (Case crosslinked to MOD21-037355, MOD21-037502, MOD21-037503, MOD21-037495). No Adverse events were reported.  The patient's medical history was not provided and concomitant medications were also not provided.  On 22 Feb 2021, the patient received their third dose of mRNA-1273 (Lot/batch: unknown) through unknown route of administration for prophylaxis of COVID-19 infection.  The third dose was given 28 days after the second one, which had also been given 28 days after the first dose (extra dose administered).  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event third dose was given 28 days after the second one was considered recovered on 22 Feb 2021.; Reporter's Comments: This report refers to a case of Extra dose administered for mRNA-1273, lot #unknown, with no associated AEs.
Case number PHEH2014US014078, is an initial spontaneous report from a health care professional received on 07 Jul 2014. This report refers to a 10-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with MENVEO (batch number: A12132) intramuscularly at a dose of 0.5 ml on 02 Jul 2014, that had a temperature excursion to 9 degrees Celsius for 1.5 hours on 01 Jul 2014. No adverse event was reported following the medication error (incorrect storage of drug).
"Arm is very bruised and sore it is getting better, but has been sore all week."
Diaphoretic History related to shots PR: 77 SPO2:96 B/P 124/82 Brought via wheelchair to med. screening room for evaluation by medic. Recorded by RN
@ approx 1145Pm started w/fever of 102-103; could not be consoled, high pitched scream; pt was fussy but much improved;
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 16-JAN-2012 at 7:30 and on 17-JAN-2012 at 7:30, ZOSTAVAX (Lot # 671141/1267AA) was exposed to -8 degrees C for an estimated total time out of range of 14 hours. On 01-MAR-2012 at 7:30, ZOSTAVAX (Lot # 671141/1267AA) was exposed to -14 degrees C for an estimated total time out of range of 10.5 hours and on 03-MAR-2012 at 11:30 it was exposed to -12 degrees C for an estimated total time out of range of 4 hours. On 05-MAR-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671141/1267AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Approx 3x4cm area of cellulitis with 2 1cm nodules on anterior and lateral left thigh x10 days.
muscle and joint pains; muscle and joint pains; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation. The following information was reported: ARTHRALGIA (non-serious), MYALGIA (non-serious), outcome "unknown" and all described as "muscle and joint pains". Therapeutic measures were taken as a result of arthralgia, myalgia.  Additional Information: She mentioned that she already received her 2nd dose of the Pfizer COVID Vaccine and had a hard time with it and had muscle and joint pains going over 2-3 weeks. She has already consulted with her HCP and has been given anti-inflammatories and muscle relaxants. She mentioned that it has been very hard and has scared her. She was asking if there have been reports of her situation and would there be a possibility for the vaccine to cause arthritis.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 1:01 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 1:25 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 77.67 for dose administered on 28-Feb-2021 and 77.75 for dose administered on 28-Mar-2021.  No concomitant medications were reported. Batch number 014M20A underwent temperature excursion on 28-Feb-2021 with temperature 27 and 26 degrees Fahrenheit at 09:00 AM and 01:00 PM respectively. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021. Batch number 019B21A underwent temperature excursion on 28-Mar-2021 with temperature 35 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
I have passed out three times.; arm pain; body aches; This is a spontaneous report from a non-contactable consumer (patient). A 21-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The facility type vaccine was school or student health clinic. There were no other vaccine in four weeks. On 09Apr2021 at 14:45, the patient have passed out three times. The patient also had arm pain and body aches on 09Apr2021 14:45. She had no fever, and she was well hydrated. She have not taken any medication at all since then. There was no treatment for the events. The patient had no COVID prior vaccination and has not been tested for COVID post vaccination. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sore; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore) and FATIGUE (Tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore) and FATIGUE (Tired). At the time of the report, PAIN IN EXTREMITY (Sore) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, SARS-CoV-2 test positive: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided. Treatment information not provided.
Pt with varicose veins received Shingrix 6/28/19. Started getting pain + firmness in varicose veins about 4-6 wks later. This progressively worsened. He got his second dose 8/29/19. The pain was getting worse so he decided to be scan. DVT was found with US and he was started on Eliquis. No other identified changes that would cause DVT.
Pt transferred from outlying critical access hospital after presenting with dyspnea. Pt has a PMH of pulmonary fibrosis and is oxygen dependent on 2L. Pt admitted with empyema on COVID-19.
Pt recvd vax 15FEB94 & was fussier than nl in evening; taken to ER w/abn ventricular thythm; died between 15FEB-PM & 16FEB-AM; h/o aortic stenosis; prev underwent ballon catherization-not completely successful;
The pt went to the ER for symptoms of light headedness, nausea, vomiting and upper body aches and on 10/13/00 states that she is still experiencing these symptoms. Went to MD and TSH was slightly low and medicine was adjusted.
pt recv vax & exp quarter size area of erythema @ inj site, generalized pruritus;advised to take atarax;
pt devel 10-12 erythematous papules on forehead & eyelid raised area in the center of the base;
Patient states got booster morning of 1/20 and starting breaking out in hives on torso and extremities by evening.  Has continued to break out in hives, but controlled by taking OTC Benedryl.   Seen at Health Services on morning of 1/24.  No other possible cause has been found.
Headache; Fever; Chills; Body aches; Swollen tongue; Low energy; Sore throat; This is a spontaneous report received from a contactable Other Health Professional. A 35-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number and expiration were not reported), via an unspecified route of administration in the left arm on 01Mar2021 at 20:00 (at the age of 35-years-old) as a single dose for COVID-19 immunization. Medical history included High blood pressure. No known allergies reported. Concomitant medications were not reported. The patient did not receive other vaccine four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced Headache, Fever, Chills, Body aches, Sore throat, Swollen tongue, and Low energy on 02Mar2021 at 20:00. No treatment medications were received for the events. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Approximately 45 minutes after receiving the Sanofi Pasture Fluzone Lot # u1839AA.  Prior to arrival back at the clinic, She felt a tightness in the chest and throat that reminded her of asthma like symptoms.  Client had a history of Asthma, and used her Inhailer (Albuterol) 2 puffs, with some relief.  Client reported the above, was seated in the clinic BP 150/80 p 100, Respirations 22 regular but slightly labored. Client was observed for 20 minutes and s/sx did not worsen she was allowed to leave with instructions to return if s/sx worsened, or to go to DR or Hospital.
felt like she was "drunk driving"; "sensitivity to sound"; prone to experiencing "neurological stuff"; headache; "had some side effects; felt like she "had a concussion"; "hard to read"; hard to "comprehend things"; "feels stupid"; "brain broken"; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT ("had some side effects), CONCUSSION (felt like she "had a concussion"), READING DISORDER ("hard to read"), ADVERSE REACTION (hard to "comprehend things") and FEELING ABNORMAL ("feels stupid") in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 09-Mar-2021, the patient experienced ADVERSE EVENT ("had some side effects), CONCUSSION (felt like she "had a concussion"), READING DISORDER ("hard to read"), ADVERSE REACTION (hard to "comprehend things"), FEELING ABNORMAL ("feels stupid"), ADVERSE REACTION ("brain broken") and HEADACHE (headache). On an unknown date, the patient experienced FEELING DRUNK (felt like she was "drunk driving"), HYPERACUSIS ("sensitivity to sound") and NEUROLOGICAL SYMPTOM (prone to experiencing "neurological stuff"). At the time of the report, ADVERSE EVENT ("had some side effects), CONCUSSION (felt like she "had a concussion"), READING DISORDER ("hard to read"), ADVERSE REACTION (hard to "comprehend things"), FEELING ABNORMAL ("feels stupid"), ADVERSE REACTION ("brain broken"), FEELING DRUNK (felt like she was "drunk driving"), HYPERACUSIS ("sensitivity to sound"), NEUROLOGICAL SYMPTOM (prone to experiencing "neurological stuff") and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant medication history included Unknown thyroid medications. Treatment information were not provided.
Redness, swelling and itching at the insertion site. Redness about 3 inches in diameter and lasted 3 days.
Twinrix: expired dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 25-SEP-2023, the patient received Twinrix. On 25-SEP-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Twinrix: expired dose administered).  The outcome of the expired vaccine used 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: 26-Sept-2023 The case was received from the health care professional. The reporter consented to follow-up. The patient received an expired dose of Twinrix, which led to expired vaccine used.
Weakness on right side of body; Extreme visual disturbances in right eye that won't go away; Nausea; Chills so bad I was hyperventilating; Chills so bad I was hyperventilating; This is a spontaneous report from a contactable consumer reporting for herself.     A 54-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 08:15 (Batch/Lot number was not reported) as single dose,   Medical history included hypertension.     The patient's concomitant medications were not reported.  The Patient received the first dose of BNT162B2 vaccine on 23Mar2021. The patient experienced weakness on right side of body  on 13Apr2021 19:00 with outcome of not recovered , extreme visual disturbances in right eye that won't go away on 13Apr2021 19:00 with outcome of not recovered , nausea  on 13Apr2021 19:00 with outcome of not recovered , chills so bad I was hyperventilating  on 13Apr2021 19:00 with outcome of not recovered. The events weakness on right side of body and  extreme visual disturbances in right eye were considered Important Medical Events.  The patient visited the ER because of the events and underwent CT scan, ultrasound, multiple medications.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I exp redness, itchiness at the injection site. On Tues spoke with school nurse at my employer she put Hydocardizone  and measured it to keep track of the sieze. As of 3/25 smaller in size and lighter in color,still exp tender now I'm applying Hydocardizone.
arm started to swell that got to about 4 inches by 4 inches; arm itched; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of   in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, AMLODIPINE and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.
Child presented on 2/2/00 with 6 x 6cm area of induration, erythema and pain. Keflex 250 mg TID given for 7 days.
A week after her first dose of the Pfizer vaccine her arm swelled at the injection site and developed a red, itchy rash.  She also had a hard knot / nodule at the site and the area was very warm to the touch.  It took about 5 days for the nodule to decrease in size.  As of July 6 she still has some redness and a rash on her arm.
Information has been received from physician concerning a patient who was vaccinated with ZOSTAVAX (Oka/Merck) on an unspecified date. Subsequently the patient experienced testing positive for Herpes Simplex Virus 2 Antibodies. At the time of this patient sought medical attention. Additional information has been requested.
Pt. states right calf swelling & pain starting 48 hrs. after administration of IPOL, IXIARO & ADACEL into right arm on 9/8/11. Pt states she was diagnosed with a muscle strain following a negative DVT work up at a local Emergency Room.
fever of 103.3, chills, nausea, shaking, headache, jaw ache, joint pain, cramping lasting 8-10 hours. took tylenol and advil
6 hours after vaccine administration, onset of shortness of breath, wheezing.  Chills, low grade fever.  No treatment required.  Symptoms resolved in eight ours.
This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients (consumer's sons). This is 2nd of 2 reports. An 18-year-old male patient started to receive the first dose of TRUMENBA, via an unspecified route of administration from an unspecified date at single dose for immunization. The patient's medical and concomitant medications were not reported. The patient experienced flu symptoms on an unspecified date. The action taken in response to the event for meningococcal group B rlp2086 was not applicable. Outcome of the event of flu symptoms was unknown. Information regarding the batch number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018311045 same reporter/different patient, same product, same event.
She developed severe right arm pain where injection was administered. Red, warm, and "streaks" going down her arm. Took NSAIDS, fine the next day. She never reacted like that to a vaccine before.
Developed achey pain in R groin that has been consistent and not yet resolved. with concern it could be the developement of a blood clot. But unknown at this time
24 hours after vaccine developed fever (101), body aches, fatigue.  10 days later still with low grade fever (100.3) and fatigue.
8/10 sudden-onset frontal sinus headache approx. 4 hours after administration of YF & flu vaccines(and immediately following 1.5 mile run).  Decreased to 4/10 after 500mg Tylenol, but headache was still present 7 hours after onset.  No hx of rxn to flu vaccines or cephalgia following physical activity.
I began to have sudden onset intense pain in left leg (from thigh to foot) originating in calf and radiated throughout (exactly 4 weeks after receiving vaccination. Then shortly after I began to have sudden swelling and redness accompanied with bruising (hematoma) starting in 1 finger then each day it occurred in different finger. It is currently happening to day of this report (12/16/2021). I have also started to experience tingling/pain (pins and needles) in left toes/foot when i flex toes that began approximately 12/10/2021. I have continued to have these adverse reactions for now 3 months since vaccination date.
Patient developed redness, tenderness and warmth to the 1/3 upper arm area. Was spreading down arm. She went to urgent care facility who diagnosed cellulitis and prescribed two antibiotics. Patient returned next day (9/28) to urgent care because redness was moving down the arm towards the hands. Patient first developed symptoms approx 24 hours after injections.
Information has been received from a medical assistant referring to three unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. From 26-APR-2016 through 03-NOV-2016, the patients received improperly stored doses of VAQTA (lot # L023936 with expiration date 15-MAR-2017; dose and route were not reported. The temperature and time frame that the vaccine was improperly stored at were reported as below: On 26-APR-2016, 34 Fahrenheit (F) for 24 hours; On 22-JUL-2016, 34 F for 16 hours 40 minutes; On 27-JUL-2016, 34 F for 16 hours 30 minutes; On 28-JUL-2016, 33 F for 15 hours 33 minutes; On 01-AUG-2016, 33 F for 64 hours 3 minutes; On 02-AUG-2016, 32 F for 14 hours 56 minutes; On 03-AUG-2016, 35 F for 16 hours 37 minutes; On 04-AUG-2016, 33 F for 16 hours 10 minutes; On 08-AUG-2016, 35 F for 62 hours 52 minutes; On 08-AUG-2016, 35 F for 62 hours 52 minutes; On 09-AUG-2016, 35 F for 16 hours 1 minute; On 15-AUG-2016, 35 F for 65 hours 30 minutes; On 08-SEP-2016, 47 F for 17 hours 18 minutes ; On 09-SEP-2016, 47 F for 15 hours 42 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. This is one of several reports received form the same reporter. Additional information has been requested.
Patient had a swollen right arm in the area of the Vaccination.  Also there was redness present in the lower forearm area.
pt recv vax 1MAY95 pt had pain @ site progressing to swelling of lymph nodes & glands under arm on lt side progressing to rt side; There is blotchiness & redness @ site of Td vax today;
No adverse effects have been reported at this time. Patient received a .2mL dose of this vaccine on 2/9/23. Per patient age range this vaccine should had been diluted before administration and it was not. No further reports have been given in regard to adverse effects for this patient at this time. Office RN made 2 attempts to contact parent via phone on 2/10/23 with no answer or return phone call. A Chart Message was sent to patient guardian explaining the situation along with a number to contact with any further questions or concerns on 2/10/23. Patient's provider, organization pharmacy, and the Health Department were all notified of this situation.