chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine given to a 14 year old male; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine given to a 14 year old male) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine given to a 14 year old male). On 14-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine given to a 14 year old male) had resolved. Not Provided      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.   This case was linked to MODERNATX, INC.-MOD-2021-132265 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-132265:
Itchy, trouble staying asleep, headache. I am also breastfeeding my 10mth old son and he struggled to fall asleep and stay asleep for 48 hours following my vaccine.
Patient received Comirnaty 12+ 23-24 PFS for the first time, previous doses of Covid 19 vaccine were Moderna. Patient remained seated in waiting area and after about 10 minutes her husband reported she was not doing well. I immediately went over and observed her skin felt cold and sweaty and when I felt for her radial pulse I could not feel it. As I was evaluating her a technician called emergency services. Patient verbally reported feeling dizzy before fainting, she remained unconcious for approximately one minute and continued breathing throughout. She arose and began to take deep breaths and reported verbally that she still felt lightheaded and her fingers were tingling. She also reported nausea. EMS arrived and she was hypotensive and began to vomit. She was transported to hospital via ambulance for further evaluation.
weakness; Chilling; felt bad like the flu; anxiety; felt like skin was crawling; felt miserable; This spontaneous case was reported by a nurse and describes the occurrence of ASTHENIA (weakness), FEELING COLD (Chilling), INFLUENZA LIKE ILLNESS (felt bad like the flu), ANXIETY (anxiety) and FORMICATION (felt like skin was crawling) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 007M20A and 039K20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient had never COVID-19 test or diagnosis.  The patient never had reaction to taking the Flu shot.  The patient's past medical history included Breast cancer and Mastectomy (breast cancer removal and repair in 2013) in 2013. Concurrent medical conditions included Penicillin allergy, Drug allergy (Keflex), Stevens-Johnson syndrome and Irritable bowel syndrome. Concomitant products included VITAMINS NOS, FISH OIL, POLYCARBOPHIL CALCIUM (FIBER), CALCIUM, DOCUSATE SODIUM (STOOL SOFTENER) and PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHENIA (weakness). On an unknown date, the patient experienced FEELING COLD (Chilling), INFLUENZA LIKE ILLNESS (felt bad like the flu), ANXIETY (anxiety), FORMICATION (felt like skin was crawling) and FEELING ABNORMAL (felt miserable). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at a dose of Benadryl at night. At the time of the report, ASTHENIA (weakness) was resolving and FEELING COLD (Chilling), INFLUENZA LIKE ILLNESS (felt bad like the flu), ANXIETY (anxiety), FORMICATION (felt like skin was crawling) and FEELING ABNORMAL (felt miserable) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2022-588873, MOD-2022-589031, MOD-2022-589045, MOD-2022-589106 (Patient Link).
feeling very tired; she is feeling cold all day too; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 23Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "feeling very tired"; FEELING COLD (non-serious) with onset 2021, outcome "unknown", described as "she is feeling cold all day too".  Additional information: Clinical course reported as patient took the first Pfizer Covid 19 shot on 23Sep2021 and has been feeling very tired since. Recently she is feeling cold all day too.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm  was a little sore) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     The patient's past medical history included Accident (car accident). Concurrent medical conditions included ADHD and Allergy to vaccine (reactions to the flu shot).    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm  was a little sore). On 05-Apr-2021, PAIN IN EXTREMITY (arm  was a little sore) 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 medications were reported. No treatment information was not given.   This case was linked to MOD-2021-255614 (Patient Link).
L shoulder red/tender X 1 day. Had 5cm light red macula on L shoulder/upper arm. Pt given Benadryl 12.5/5 to 8cc po q6h. No response to phone calls.
On 06/13/2022 just 48 hours after I received dose 4, I experienced shingles that began with nerve pain in my back right below scapula on the left side of my spine. While I was traveling to my daughter's the pain really began to set in, and I began to feel a burning sensation. The pain and burning intensified to the point that I could not sleep due to being so uncomfortable. It developed a classic shingles rash in 3 spots about a quarter size each. I was prescribed valacyclovir, and I was also given gabapentin and NEURONTIN for the nerve pain. I am still experiencing the burning and pain sensation intermittently as of 07/05/2022.
Patient felt dizzy about 10 minutes after administration. BP was 118/70 and patient had normal color to her face. Monitored patient for 30 minutes. Pt left at 436PM feeling fine. Mom comfortable to leave as well with patient
Vomiting and fatigue/drowsiness on 01/10/2021, fatigue continued through present (1/12/21)
Severe flu symptoms; Initial information was received on 16-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case is linked to cases 2020SA342078 and 2020SA342079 (same reporter).  This case involves a male patient age not reported who experienced severe flu symptoms (influenza), while he received INFLUENZA VACCINE.  Medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (Produced by unknown manufacturer, batch number and expiration date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious severe flu symptoms (influenza), unknown latency following the administration of INFLUENZA VACCINE.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown at the time of reporting.  There will be no information on the batch number for this case.
the patient received an adult dose of the Pfizer COVID-19 vaccine.  no reported symptoms.
Body soreness and a low grade fever began the day after the vaccine. Two days after the vaccine, the fever had gone up and I was experiencing throat pain and fatigue. This lasted a couple of days until I got to a doctor and began taking an antibiotic. I ceased taking the antibiotic four days in and the fever resurfaced within 24 hours. Went back on the antibiotic.
The patient was given influenza and PCV 23 vaccines at his PCP's office on 10/2/2014 around 1100. That evening he began to have R arm pain, which progressed on 10/3/14 to include redness at the site and severe pain. It progressed to severely limiting range of motion of the R arm, and by the time of evaluation on 10/4/14 he had an erythematous, 10x5cm well demarcated inflammatory response with extreme tenderness and severely limited range of motion. He had systemic symptoms including fever, vomiting, and HA. He was covered with IV clindamycin for possibility of bacterial source. The inflammation progressed beyond original borders to include the lateral aspect of the majority of the right upper arm, with more diffuse borders; very warm to touch. Most likely arthus reaction vs possibly cellulitis or erysipelas, and most likely due to PCV 23 vaccine.
Started immediately light headed, muscle and joint aches, fever, chills, nausea, headache
On March 15 2021,in the ten o'clock hour my Mother experienced aphasia which progressed to muteness. In the ambulance she is reported to have had two gran mal seizures(no hx of such). She was intubated and, after a negative head ct, given tpa.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 67-year-old female patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, (SINGLE), she has taken three Pfizer Covid 19 Vaccines), for COVID-19 immunization; Bnt162b2 (DOSE 2, (SINGLE), she has taken three Pfizer Covid 19 Vaccines), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Caller voiced she had five days of fever. She didn't believe the fog was real that everyone talks about but, it is"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "fog". Relevant laboratory tests and procedures are available in the appropriate section. Additional information included that the patient took three of the Pfizer shots and there has been a gap in the shots for a while. Now she has tested positive for covid. Caller voiced "She had no immunity from the shots didn't work or now it's been to long spaced out. Was what she was thinking. Does that sound like what's happened or could had just got one that the shots don't work? Caller voiced that she had taken three Pfizer Covid 19 Vaccines since covid started. Per caller she thinks the last one was probably the very end of Oct. Caller asking now that she has covid and has taken the three Pfizer Covid Vaccines and will possibly take the Paxlovid once consulting with HCP will she have enough immunity to put off the second Pfizer Covid 19 booster until later? Caller voiced she had five days of fever. She didn't believe the fog was real that everyone talks about but, it is. It"seems like everything she was reading it's talking about people clotting that had covid. They found clots in people after they died when doing autopsy's and stuff." The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient is a 25 year-old Male with past medical history of nothing. Patient presented to the Center vaccination site for their first Pfizer vaccination.  Patient received vaccination at 11:02. Approximately 10 minutes after receiving vaccination patient began experiencing Dizziness.  Patient did not lose consciousness. Patient did not fall, hit their head or sustain any injuries. On exam patient  GENERAL: Does not appear to be in distress, is alert and fully oriented, following commands.  RESP: Speaking in full sentences, no cough, no signs of respiratory distress, no audible wheezing  SKIN: No visible rash or lesion.   SKIN: Positive for: moist. Patient had no urticaria, angioedema, or other signs of severe allergic reaction/anaphylaxis.  Patient was brought to vaccination observation area and vitals were as follows     Blood pressure 95/.59 initial and now 102/64 Heart rate 69 bpm now 80 O2 saturation 100 % on room air Respiratory Rate 12     Patient was placed in supine position and legs were elevated.  Patient showed rapid improvement towards complete resolution of symptoms.  Patient was able to tolerate p.o.  Patient was observed for at least 15 minutes after onset of symptoms.  Patient reported significant improvement and was able to ambulate with steady gait. Patient requesting to return home. Patient is well appearing and repeat vital signs at time of discharge were stable.
Patient states rash began at her right wrist the  morning after her injection, slowly progressed up her arm past her elbow  8 days later she stopped in (today) to show me and it is hive-like and broke thru the skin above her elbow on the inside of her arm
I got the vaccine on May 2, 2021. On May 29, 2021, notified the baby was no longer viable and I had to go to the hospital had D & C procedure. I have 2 healthy children and no history of miscarriages. My estimated date of delivery was February 2022.
>10 cm area of redness on L thigh ice packs and Benadryl.
Sweating; nausea; chills; fever of 100 F starting about 10 hours after dose was received. Continued until 48 hours after dose was received; This is a spontaneous report from a contactable consumer (patient). A 24-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL0142), via an unspecified route of administration in left arm on 22Jan2021 14:45 at second single dose for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took BNT162B2 (Lot number=EL8982) in left arm on 04Jan2021 07:15 PM at first single dose for Covid-19 immunization. The patient experienced sweating, nausea, chills, fever of 100 F starting about 10 hours after dose was received. Continued until 48 hours after dose was received. Event start date: 23Jan2021 12:00 AM. Events were considered as non-serious. No treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered in Jan2021.
PATIENT RECEIVED FIRST DOSE OF FIZER VACCINE.  PATIENT FELT HIS PALM SWEAT AFTER 30 SECONDS. HE CAME IN TO THE WAITING ROOM. THE PATIENT'S WIFE NOTICED THAT HE BECAME YELLOW, AND HIS HEAD WENT TO THE SIDE. HE STARTED TO SHAKE HIS HEADS FOR 10 SECONDS, AND THEN STOPPED SHAKING. PATIENT ALERTED THE PHARMACY TEAM. PHARMACY TEAM GAVE PATIENT SOME WATER AND GATORADE AS WIFE TOLD US THAT PATIENT HAS LOW BLOOD SUGAR. I CALLED 911 IN CASE IT BECAME WORSE. THE PATIENT THEN WENT INTO THE RESTROOM. PARAMEDIC ARRIVED AND MONITORED PATIENT BLOOD PRESSURE AND HEART RATE. HE WAS FINE, BUT PARAMEDICS RECOMMENDED HE GO IN THE AMBULANCE RIDE. THE PARAMEDICS SAID IT COULD JUST BE A SYNCOPE EPISODE AS PATIENT IS AFRAID OF NEEDLES. HOWEVER, THE PATIENT DECLINED THE RIDE. WIFE TOLD US SHE MIGHT TAKE HIM TO ER.
Patient rec'd 6 immunizations here in clinic. After standing waiting about 4 min. she felt dizzy, sat down, rested, wet paper towels on face and neck. Recovered well. She was dressed very warmly with scarfs on head. Foreign language, used language with her father.
This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 55-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3247), on 18Feb2021 as dose 2, single (Lot number: EL3247) and on 07Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 02Jan2023, outcome "recovering", COVID-19 (medically significant) with onset 02Jan2023, outcome "recovering" and all described as "positive home Ag". The event "positive home ag" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jan2023) Positive, notes: positive home Ag 02Jan2023; (03Jan2023) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events vaccination failure, covid-19 and suspect drug BNT162B2 cannot be excluded.
while vaccine was being administer by RN into deltoid muscle(left arm), the vanish point syringe leaked out from the top where the needle comes out. Head clinician and  other facility made aware. Hot line was notified of the incident. It was determine that the patient received less than half a dose  of the Pfizer vaccine. As per CDC protocol, the repeated dose was administered on the opposite arm.
pt recvd vax  & in later Pm c/o rt side pain & sweating & warm of rt arm;
I began to bleed and pass blood clots from my vagina; I began to bleed and pass blood clots from my vagina; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 11Mar2021 01:15 (at the age of 32 years) (Batch/Lot Number: EN6208) as a single dose for COVID-19 immunisation. Medical history included birth control. Concomitant medications were not reported. The patient is not pregnant. On 13Mar2021 04:00, the patient began to bleed and pass blood clots from her vagina. The event blood clots was assessed as serious (medically significant). The patient visited the doctor for the events and the events were given treatment. The outcome of the events was not recovered.
Pt recv vax on 10/14/97; on 10/16/97 pt exp erythema/ red/ sore vax site
This spontaneous report as received from a nurse refers to a 1 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 31-AUG-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N008823, expiry date: 26-MAY-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
Patient received vaccine after 10 minutes in observation patient had a syncope  amonia capsule use patient recover well and was send home with no further incident
Pt. had redness and swelling at PNEUMOVAX immunization site. Family Dr. said he suspected her hospitalization was tied to her N & V, chills, and dehydration. Questioned if it was the PNEUMOVAX.
her body felt uncomfortable; had pain at injection site for a little bit; muscle soreness/muscle soreness in left arm at injection area after receiving the second dose; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse (patient) reported that a 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302, expiration date: May2021), intramuscular on 12Jan2021 09:00 at 0.3 mL, single on left arm for COVID-19 immunization. The patient medical history was not reported.  There were no concomitant medications. The patient received her first dose of BNT162B2 on 22Dec2020 around 08:15am to 08:30 am, intramuscular injection in left arm. The dose she received was 0.1ml (lot number: EH9899). The patient received flu shot on Nov (no year reported). The patient experienced headache on 12Jan2021 and muscle soreness on 13Jan2021 in left arm at injection area after receiving the second dose. Her headache was not very strong. It was mild headache since she took Tylenol. She clarified it recovered completely as of yesterday (14Jan2021). When querying seriousness, she states it was a normal side effect so she did not think it is serious. She reported her body felt uncomfortable, and she cannot explain what it was happening, she did not have shortness of breath or diarrhea or anything. States it was like she got flu vaccine and had pain at injection site for a little bit. She received the flu vaccine in Nov (no year reported) and she does not know the name of the flu vaccine. The patient recovered from headache and muscle soreness/muscle soreness in left arm at injection area after receiving the second dose on 14Jan2021. Outcome of the rest of the events was unknown.
1st dose on 07Jan2020, 2nd on 17Nov2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 81-year-old male patient who received Herpes zoster (Shingrix) (batch number 9254S, expiry date 18th September 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 7th January 2020).   On 17th November 2022, the patient received the 2nd dose of Shingrix. On 17th November 2022, 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 Information: GSK Receipt Date: 17 NOV 2022 Reporter's comment: The patient did not receive the second dose until 17th November 2022. The first dose was given at a different location and the reporter did not have the lot number/expiration date information.  Additional supportive information: The patient received the second dose later than the recommended schedule, which led to lengthening of vaccination interval. The reporter consented to follow up.
I developed a rash on the back of both hands and my body is very itchy. I also have body aches in my left arm with sharp needle like pain going down my left side and a headache.