chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 2:16 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 2:16 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced 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. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 22.95.  Concomitant products were not provided.   On 13-Feb-2021, at 09:00 A.M., the temperature recorded was 32 degree Fahrenheit and vial was initially moved to the fridge on 09-Feb-2021 and beyond use date was 10-Mar-2021. Product moved to clinic on 13-Jan-2021.  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 traceable temperature monitor at every hour. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
drops came out while giving the vaccine\more than 1 vaccine drop came out because muscle pushes vaccine out; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (drops came out while giving the vaccine\more than 1 vaccine drop came out because muscle pushes vaccine out) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Nov-2021, the patient experienced DEVICE CONNECTION ISSUE (drops came out while giving the vaccine\more than 1 vaccine drop came out because muscle pushes vaccine out). On 30-Nov-2021, DEVICE CONNECTION ISSUE (drops came out while giving the vaccine\more than 1 vaccine drop came out because muscle pushes vaccine out) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported. Treatment medications was not provided.
Left leg swollen with rash to upper left thigh. Parent took child to MD. MD give Rx for oral Pediapred. Parent states child had no fever.
FOLLOWING SECOND DOSE OF COVID-19 VACCINE PATIENT REPORTED FEELING FLUSHED AND ITCHY HANDS. PATIENT WAS TAKEN TO THE MEDICS AND GIVEN BENADRYL 25MG PO WITH WATER FROM MEDIC. PATIENT RECOVERED AND HAD NO FURTHER COMPLAINTS. PATIENT LEFT PREMISES.
Information has been received from a physician who stated that she heard about a 17 year old female who was vaccinated IM with a second 0.5 ml dose of GARDASIL.  On 11-JUN-2008 she experienced a seizure in the physician's office.  The patient sought unspecified medical attention.  On 11-JUN-2008 the patient recovered.  Upon internal review, seizure was considered to be an other important medical event.  Additional information is not expected.
Narrative:  COVID POSITIVE after completion of COVID VACCINE series 05/05 Pt seen in ED, reported bleeding from his mouth, BS less than 45 (took 12 units of insulin lispro but didn't eat) in ED, reports feeling dizzy, reports being weaker and sleepier in the past week with decreased appetite; dx'd with COVID pneumonia with hemoptysis; admitted to hospital 05/10 discharged from hospital 05/11 still c/o productive cough, body aches alleviated with apap, working from home, continued diarrhea
received an ActHIB vaccine with an expired diluent; Initial information received on 05-Apr-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to case 2019SA097023 (same reporter).  This case involves female patient of an unknown age (child) who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] with an expired diluent of 18-Feb-2019 lot number not reported via unknown route in unknown administration site.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used. The office that received an ActHIB vaccine with an expired diluent of 18Feb2019.  It was unknown if any adverse event was occurred.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
On clinic visit 11/18/03 mother reported that after receiving vaccines on 9/16/03 pt began wheezing, color became pale. Mom carried child to a clinic, was referred to ER. Dx: possible reaction to vaccines.
Local site reaction-redness, knot at injection site. 100.4f fever Muscle aches
Patient was given moderna vaccine. About 10 minutes after while she was waiting for her 15 minutes of observation to finish, she stood up and fainted. Pharmacist went over, had her lie down, and held up her legs. Patient said she felt okay but still dizzy. Emergency responders was called. Ambulance came about 10 minutes later to examine her. They took her vitals and blood sugar, found them to be within normal limits, and stated patient was okay to go home if she got a ride. She called a friend and her ride came about 30 minutes later.
This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, joint pain and swelling. On an unknown date, the outcome of the influenza-like symptoms, joint pain and swelling were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, joint pain and swelling to be related to SHINGRIX. Additional details were provided as follow: The age at vaccination was not reported. The patient experienced flu-like symptoms for 2 days and had joint soreness and swelling for 5 days post vaccination. The reporter agreed to be followed up.
Case number PHEH2015US024141, is an initial spontaneous report received from a patient who is also a nurse on 16 Nov 2015. This report refers to a 28-year-old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: 174272) intramuscularly on 11 Nov 2015. On 13 Nov 2015, the patient started to feel severe nausea, abdominal pain and diarrhea. The patient reported that, she had issues each year in getting the Flu shot. Outcome of the events was reported as condition unchanged. Events were reported as non serious and causality was not reported.
Injection site big; Injection site hot; Injection site red; Injection site sore; Injection site big; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDURATION (Injection site big), VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE ERYTHEMA (Injection site red), VACCINATION SITE PAIN (Injection site sore) and VACCINATION SITE SWELLING (Injection site big) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced INJECTION SITE INDURATION (Injection site big), VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE ERYTHEMA (Injection site red), VACCINATION SITE PAIN (Injection site sore) and VACCINATION SITE SWELLING (Injection site big). At the time of the report, INJECTION SITE INDURATION (Injection site big), VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE ERYTHEMA (Injection site red), VACCINATION SITE PAIN (Injection site sore) and VACCINATION SITE SWELLING (Injection site big) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Caller states that his nephew was taken to a local Health Department to try to get vaccine but both would not give him the vaccine. Per caller, the reason was that "it was only indicated for children under 4 and adults over 65."; This spontaneous report was received from a physical therapist referring to his 8 year-old nephew. The patient's concurrent conditions included immunodeficiency. Information about patient's concomitant medications, pertinent medical history and drug reactions/ allergies was not provided.  On an unknown date, the patient was prescribed pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, dose number, strength, route of administration, anatomical location, expiration date and lot number was not provided) for prophylaxis.   The reporter stated that, on an unknown date, the vaccine could not have been given to the patient. The reporter stated that the reason was that it was only indicated for children under 4 and adults over 65 (product dispensing issue).
Day 1- craving for food, sleepy  Day 2-3 body aches, fatigued Day 4 - now , pins and needles sensations, too fatigued to do many everyday activities, lighthearted,  Day 13-14, chest pain, shortness of breath, fainting, sent to ER twice and hospitalized
Patient came in on 10/26/2021 to received 3rd dose immunocompromised Covid Vaccine. Patient should have received Moderna 0.5mL, however received 0.25mL booster dose. Informed patient of this error upon arrival today for their "booster" dose, spoke with medical director. Medical director gave permission to give their 0.5mL dose today and report to VAERS. Patient refused to get 0.5mL as he states he is not particularly an advocate for vaccines and would prefer to just receive another half dose (0.25mL). I informed him that this is not recommended by the CDC for immunocompromised patients but he states a little bit is better than none or be given to much.
Heavy period/bleeding; ''My'' current period was 2 days late (started 2 cycles ago); This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19May2021 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included ADD (attention deficit disorder), depression and anxiety and known allergies to penicillin. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications included methylphenidate (MANUFACTURER UNKNOWN), for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 01Jun2021, the patient experienced heavy period/bleeding, her current period was 2 days late (started 2 cycles ago). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event heavy period/bleeding; her current period was 2 days late (started 2 cycles ago) was unknown at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Jun2021 (at the age of 20-years-old) as a single dose for COVID-19 immunisation.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Left arm tingling and numbness and skin mottling.  Symptoms lasted appx 5 minutes then began feeling lightheaded and dizzy with headache and mild nausea.  Patient moved to recovery area, laid down on stretcher and provided cool air and ice-pack.  Nausea improved, able to sip water, monitored for another 30 minutes and then felt normal.  Continued to monitor until 3:10 pm when left.
I had extreme shortness of breath, throat closed up, my voice was strained. I call advice nurse they directed me to go to nearest ER . They had me take my inhaler, claritin. when I got to Er they gave me they gave me a steroid and a breathing treatment. They gave me an IV, I do not remember what was in IV. I still have shortness of breath and I'm seeing a lung specialist. They have switched up my medication
Pt revaxed w/booster dose MMR 27JUL90; On 04AUG90, pt devel rt facial swelling & t102.3; 2 days later, devel bilateral facial swelling; Seen in ER tx meds; MD felt vax related; On 11AUG90 devel h/a, diarrhea, vomiting w/tenderness;
Patient reports on 5/16/11 that on day of receipt of TwinRix that 5-10 minutes after shot, she tasted metal in her mouth and throat started to close.  Called 911, then drove herself to private doctor.  She reports her face was red and throat was swollen.  Doctor gave her 3-4 pills and a steroid shot.
Pt. stated, I got dizzy and nauseous two minutes after getting vaccinated."  "I'm also afraid of needles, something happened with the first dose."  Vital signs done.  BP 110/60, HR 66, O2Sat 96%, R 18, glucose 91.  At 12:26pm pt. stated, "I feel better now."  At 12:38pm reported feeling better and wants to go home.  12:39pm patient went home with her mother.
Patient received moderna vaccine with public health department. (dose 1 1/2/21, dose 2 2/19/21). Patient came to  receive high dose flu shot. Pt was given Pfizer vaccination in error.
Oversight looking at system and gave second dose of meningococcal conjug. It should of been HPV. Caregiver informed, vaers and occurrence report completed.
12 days after getting the vaccine I started to get an extremely itchy scalp. After a couple of hours it spread to hives on my neck and chest. The next day it was all over my abdomen as well. I tried taking Benadryl, It helped. After the 3 hours the itching would come back. I continued with this for a couple days. My Dr. then prescribed Blexten which gave me such severe heart burn I did not take it again. I then started to get dermatographia. I was then prescribed Atarax. It worked a bit. But because it made me so tired I stopped after a week. It is now day 24. The hives are gone but I still have dermatographia.
Got fever; Pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 29-JUN-2023, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: Got fever) and pain (Verbatim: Pain). The outcome of the fever and pain were not reported.   It was unknown if the reporter considered the fever and pain to be related to Shingles vaccine.     It was unknown if the company considered the fever and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-JUL-2023 This case was reported by a patient via interactive digital media. The patient reported that on Thursday he/she received second vaccination dose. Patient experienced fever and was in pain but she/he already vaccinated. The follow-up could not be possible as no contact details were available.
Presented 45 min after vaccination with hives over chest and neck, and headache. Lungs clear, SAT 100% RA, HR 92, BP 154/88, RR 16. Anxious. 25mg Benadryl & 650 mg Acetaminophen given. Transported by paramedic to hospital.
Received the Moderna COVID-19 vaccine.   Ten days after vaccination constant ringing in the ears primarily on right side.   Experienced low level tinnitus in the past which was tolerable.  The ringing in the years is significant after the vaccine.  It is now at a moderate level.  Sleeping is difficult without using ambien.  The ringing is constant through the day.
Patient developed a rash, fever, and difficulty walking about 2 weeks after vaccination. Went to the ER. Per patient's wife,  labs were normal. Patient physician  believes that the patient had an allergic reaction to a component in the vaccine.
Redness/Rash/Swelling about 6 inch wide at injection site.  Flu like symptoms (jittery, headache, etc).
The injection site was swollen and sore for four days. I had a bad headache and a slight fever for four days. I had frequent headaches for a month after my second shot.
COVID-19 TEST POSITIVE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19 test positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This report was associated with product quality complaint: 90000201203.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
My hearing is distorted; I had sudden hearing loss in my right ear/repeated episodes of hearing loss; My injection site arm was hot; My injection site arm itched like crazy; my injection site arm was red; My injection site arm was swollen; I had a sore arm; This spontaneous case was reported by a physician and describes the occurrence of SUDDEN HEARING LOSS (I had sudden hearing loss in my right ear/repeated episodes of hearing loss) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (I had a sore arm). On 23-Jan-2021, the patient experienced SUDDEN HEARING LOSS (I had sudden hearing loss in my right ear/repeated episodes of hearing loss) (seriousness criterion medically significant), VACCINATION SITE WARMTH (My injection site arm was hot), VACCINATION SITE PRURITUS (My injection site arm itched like crazy), VACCINATION SITE ERYTHEMA (my injection site arm was red) and VACCINATION SITE SWELLING (My injection site arm was swollen). On 17-Aug-2021, the patient experienced HYPOACUSIS (My hearing is distorted). At the time of the report, SUDDEN HEARING LOSS (I had sudden hearing loss in my right ear/repeated episodes of hearing loss), HYPOACUSIS (My hearing is distorted), PAIN IN EXTREMITY (I had a sore arm), VACCINATION SITE WARMTH (My injection site arm was hot), VACCINATION SITE PRURITUS (My injection site arm itched like crazy), VACCINATION SITE ERYTHEMA (my injection site arm was red) and VACCINATION SITE SWELLING (My injection site arm was swollen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information was provided. Company comment: 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.   This case was linked to MOD-2021-289003 (Patient Link).; Sender'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.
Information has been received from a pharmacist referring to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored ZOSTAVAX (dose, route and lot number not provided). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
anaphylaxis; dizziness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of   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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.  Company comment: Very limited information regarding this event has been provided at this time. Basic details including the patient demographics, date of vaccine administration, event terms, and date or onset for the events are required for further assessment.   This case was linked to US-MODERNATX, INC.-MOD-2021-005623 (Linked Report).; Sender's Comments: Very limited information regarding this event has been provided at this time. Basic details including the patient demographics, date of vaccine administration, event terms, and date or onset for the events are required for further assessment. US-MODERNATX, INC.-MOD-2021-005623:
I had vaccination on 10/21/2022. On 02/17/2023 I felt terrible with fatigue headache and fever. I tested COVID-19 Positive on 02/17/2023. I was prescribed Lagevrio and felt better in 3 days.