chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED LESS THAN 0.5ML OF JANSSEN COVID-19 VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned an 60 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, and batch number were not reported expiry: Unknown), 1 in total, dose was not reported (dose number in series :1), for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: 11-APR-2022) dose was not reported, (dose number in series: 2), 1 total administered on 01-DEC-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the reporter mentioned that patient received less than 0.5 Milliliter (ml) of the Janssen COVID-19 vaccine as a booster dose (dose number in series 2) approximately around 0.3mL of dose (vaccine underdose which is off label use, dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml of the Janssen COVID-19 vaccine as a booster dose which is off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209551, 20211210067, 20211210058, 20211210160, 20211210588, 20211210112, 20211210824, 20211209775, 20211209874, 20211210610, 20211210409, 20211210555, 20211210733, 20211210408, 20211209880, 20211209816, 20211209782, 20211212088, 20211212082, 20211209679, 20211209740, 20211209679, 20211209706, 20211209798, 20211209843, 20211209884, 20211209912, 20211209921, 20211209976, 20211210019, 20211210106, 20211210107, 20211210112, 20211210141, 20211210143, 20211210159, 20211210165, 20211210180, 20211210334, 20211210350, 20211210385, 20211210549, 20211210585, 20211210590 and 20211210662.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED LESS THAN 0.5ML OF THE JANSSEN COVID-19 VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 60 year male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, and batch number were not reported expiry: Unknown), 1 in total, dose was not reported (dose number in series: 1), for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: 11-APR-2022) dose was not reported, (dose number in series: 2), 1 total administered on 01-DEC-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the reporter mentioned that patient received less than 0.5 Milliliter (mL) of the Janssen COVID-19 vaccine as a booster dose (captured: vaccine underdose as well as off label use) (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml of the Janssen COVID-19 vaccine as a booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209551, 20211209976, 20211210058, 20211210549, 20211210588, 20211210112, 20211210670, 20211210610, 20211210159, 20211210409, 20211210555, 20211210733, 20211210408, 20211209880, 20211209816, 20211209782, 20211212088, 20211212082, 20211209912, 20211209679, 20211209740, 20211210160, 20211209706, 20211209775, 20211209843, 20211209874, 20211209884, 20211209921, 20211209976, 20211210019, 20211210067, 20211210106, 20211210107, 20211210112, 20211210684, 20211210141, 20211210143, 20211210165, 20211210180, 20211210334, 20211210350, 20211210385, 20211210585, 20211210590, and 20211210662.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: THE INDIVIDUAL RECEIVED LESS THAN 0.5ML OF THE JANSSEN COVID-19 VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 67 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s from unspecified manufacturer (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose was not reported (dose number in series 1), 1 in total administered for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and batch number: 213D21A expiry: 11-APR-2022) dose was not reported, administered (dose number in series 2) on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-DEC-2021, the patient experienced the individual received less than 0.5ml of the janssen covid-19 vaccine as a booster dose. On 01-DEC-2021, the patient experienced off label use.(dose number in series 2)  "As per the report, the health care professional (HCP) withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5 mL but the caller mentioned that the math (she arrived at that by dividing 2.5 mL by 5 doses) did prove that they received approximately around 0.3 mL." (dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the individual received less than 0.5ml of the janssen covid-19 vaccine as a booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209551, 20211209976, 20211210549, 20211210588, 20211210112, 20211210610, 20211210733, 20211210409, 20211210555, 20211210408, 20211209880, 20211209816, 20211209782, 20211212088, 20211209775, 20211209798, 20211209874, 20211209884, 20211209679, 20211209706, 20211209740, 20211209843, 20211209912, 20211209921, 20211210019, 20211210058, 20211210067, 20211210106, 20211210107, 20211210133, 20211210141, 20211210143, 20211210159, 20211210160, 20211210165, 20211210180, 20211210334, 20211210350, 20211210385, 20211210585, 20211210590, 20211210662, 20211210670, 20211210684 and 20211210824.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: THE INDIVIDUAL RECEIVED LESS THAN  0.5ML OF THE JANSSEN COVID-19  VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 77 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s  from unspecified manufacturer (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose was not reported (dose number in series 1), 1 in total administered for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and batch number: 213D21A expiry: 11-APR-2022) dose was not reported, administered (dose number in series was 2) on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-DEC-2021, the patient experienced the individual received less than 0.5ml of the janssen covid-19 vaccine as a booster dose. On 01-DEC-2021, the patient experienced off label use. (dose number in series was 2)  ''As per the report, the HCP withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5mL but the caller mentioned that the math (she arrived at that by dividing 2.5mL by 5 doses) did prove that they received approximately around 0.3mL."(dose number in series was 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the individual received less than 0.5ml of the janssen covid-19 vaccine as a booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209551, 20211209976, 20211210549, 20211210588, 20211210112, 20211210610, 20211210733, 20211210409, 20211210555, 20211210408, 20211209880, 20211209816, 20211209782, 20211209775, 20211209798, 20211209874, 20211209884, 20211209679, 20211209706, 20211209740, 20211209843, 20211209912, 20211209921, 20211210019, 20211210058, 20211210067, 20211210106, 20211210133, 20211210141, 20211210143, 20211210159, 20211210160, 20211210165, 20211210180, 20211210334, 20211210350, 20211210385, 20211210585, 20211210588, 20211210590, 20211210662, 20211210670, 20211210684, 20211210824, 20211212082, 20211210107 and 20211213607.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SHARP SHOOTING PAIN IN LEGS AND ARMS; This spontaneous report received from a patient concerned a 72 year old female.  The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, gastrointestinal problems, hypothyroidism, anxiety, non alcohol user, non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (dose number series 1) (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported,1 total, administered on 12-MAR-2021 for prophylactic vaccination.   On 12-MAR-2021, the patient experienced tiredness (dose series 1).  On 16-MAR-2021, the patient experienced vomiting (dose series 1).   The outcome for tiredness and vomiting was reported as resolved.   The patient received covid-19 vaccine ad26.cov2.s (dose number series 2) (suspension for injection, route of admin not reported, batch number: 213A21A, and expiry: 21-DEC-2021) dose was not reported,1 total, administered on 02-DEC-2021 (also reported as 04-DEC-2021), at 11 am on left arm for prophylactic vaccination. Concomitant medications included mirtazapine for anxiety, omeprazole for gastrointestinal problems, enalapril maleate for high blood pressure, levothyroxine sodium for hypothyroidism and OTC (over the counter) multivitamin.  On 02-DEC-2021 (also reported as 04-DEC-2021), the patient experienced sharp shooting pain in legs and arms (dose number series 2). Treatment medications (dates unspecified) included: paracetamol.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  On 05-DEC-2021, the patient recovered from sharp shooting pain in legs and arms.   This report was non-serious.  This case, involving the same patient is linked to 20211212813.  This case, from the same reporter is linked to 20211212835.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: GOT COVID-19 LESS THAN WEEK AFTER THE BOOSTER; This spontaneous report received from a patient via a company representative via social media concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (suspension for injection, route of administration and batch number were not reported) dose was not reported, 1 total administered on unspecified day for prophylactic vaccination (Dose number in series 1). No adverse event reported following vaccination with covid-19 vaccine ad26.cov2.s. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number and expiration date were unknown) dose was not reported, 1 total administered on an unspecified date for prophylactic vaccination  (Dose number in series 2). The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported.  On an unspecified date the patient experienced covid-19 less than week after the booster. The patient had a mild/moderate case (dose number in series 2). The patient reported she was not qualified for monoclonal antibody treatment and wore mask whenever she left the house.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious. This case, from the same reporter is linked to 20211212699.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via media concerned a male of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 06-DEC-2021 and 08-DEC-2021. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total, for prophylactic vaccination. The dose number in series was 1. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient after vaccination, "got Covid (suspected clinical vaccination failure, and suspected covid-19 infection) and was pretty sick". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure, suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This case is a duplicate of 20211213065. This case, from the same reporter is linked to 20211212261 and 20211223580. This report was associated with a product quality complaints: 90000205503 and 90000205720 . The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0; 20211212673-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patient received expired vaccine - stored under correct refrigeration for 32 days not 31
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site pain
Clinical narrative: THE BOOSTER SEEMED TO BURN A BIT MORE THAN THE INITIAL DOSE; This spontaneous report received from a patient via a company representative concerned a 44 year old adult male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s from unspecified manufacturer (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose was not reported (dose number in series 1), 1 total administered for prophylactic vaccination. The patient experienced burns at injection site when treated with covid-19 vaccine ad26. cov2. s. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: UNKNOWN) dose was not reported (dose number in series 2), 1 total, administered on 06-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 6-DEC-2021, the patient's booster seemed to burn a bit more than the initial dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burns more at injection site on 06-DEC-2021. This report was non-serious.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patient received expired vaccine - stored under correct refrigeration for 32 days not 31
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Dizziness, Electrocardiogram, Palpitations
Clinical narrative: Heart palpitations three days after with dizziness and weakness
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patient received expired vaccine - stored under correct refrigeration for 32 days not 31
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patient received expired vaccine - stored under correct refrigeration for 32 days not 31
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Fatigue, Injection site pain
Clinical narrative: patient was given a 3 dose of vaccine.  he had tiredness and also soreness at the site of the injection
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity, Skin warm
Clinical narrative: numbness on side of arm, sharp pain on same side running down arm, sore elbow that is warm to touch. Took percocet  and aleve from previous surgery to aleviate pain
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: A  patient already received one booster dose of Moderna by another vaccinator and was waiting to receive his annual flu shot. When I called out the name on the vaccination card for a Pfizer booster, he answered it and came in for the shot. Before I injected the vaccine, I confirmed with him, "This is Pfizer, okay?" I didn't realize the mistake I made until a minute later, the patient handed back the vaccination card, claiming that's not his. That's when I learned I had given him another booster dose of Pfizer instead of his intended flu shot. We kept patient for about 30 minutes or so under observation. He showed no sign of distress or any discomfort. I explained to him what had happened and what possible side effects he might experience and how to manage if they do occur. I also got his phone number and will call him for a follow-up.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Ear pain, Muscle spasms, Tinnitus, Vertigo
Clinical narrative: Sharp pain inside my left ear follow by a continued ringing noise. It started in the morning of the third day after the vaccination and has continued since. When I woke up  I felt the sharp pain in my ear follow by strong dizziness or vertigos and the strong ringing in my head.  Following that I had muscle spasm in the upper back for a few days.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Myocarditis, Ultrasound scan
Clinical narrative: Myocarditis, chest pain, shortness of breath. Chest pain starting 15 hours after vaccination. Diagnosis 2 days later in hospital.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Myocarditis, chest pain, shortness of breath. Chest pain starting 15 hours after vaccination. Diagnosis 2 days later in hospital.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Cyst
Clinical narrative: Painful cyst in left armpit
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: WE GOT REALLY KICKED; This spontaneous report received from a patient via a company representative via social media concerned multiple patients. No past medical histories or concurrent conditions were reported. On an unspecified date, the patient previously received with covid-19 vaccine ad26.cov2.s from an unspecified manufacturer (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose was not reported (dose number in series was 1), 1 in total administered for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s. The patients received covid-19 vaccine ad26.cov2.s (dose number in series was 2) (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number were not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified dates, following vaccination with covid-19 vaccine ad26.cov2.s, multiple patient got kicked with the booster (captured as feeling abnormal). As per the reporter, "We got really kicked with the booster 2 days worth ugh". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome for the multiple patients for event got really kicked was not reported. This report was non-serious. This case, from the same reporter is linked to 20211214651.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Allergy test, Anxiety, Blood test, Cardiac monitoring
Clinical narrative: Started with Heart Palpitations. Shortness of breath. Extreme anxiety and panic attack symptoms lasting for hours and days(now months) with no prior history. Flushing (hot flash type) Tingling. Loss of appetite. Lower GI issues.  Stomach discomfort, knots, just below breast bone.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac stress test, Chest X-ray, Decreased appetite, Dyspnoea, Electrocardiogram
Clinical narrative: Started with Heart Palpitations. Shortness of breath. Extreme anxiety and panic attack symptoms lasting for hours and days(now months) with no prior history. Flushing (hot flash type) Tingling. Loss of appetite. Lower GI issues.  Stomach discomfort, knots, just below breast bone.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Gastrointestinal disorder, Hot flush, Laboratory test, Nodule
Clinical narrative: Started with Heart Palpitations. Shortness of breath. Extreme anxiety and panic attack symptoms lasting for hours and days(now months) with no prior history. Flushing (hot flash type) Tingling. Loss of appetite. Lower GI issues.  Stomach discomfort, knots, just below breast bone.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Panic attack, Paraesthesia, Physical examination, Scan
Clinical narrative: Started with Heart Palpitations. Shortness of breath. Extreme anxiety and panic attack symptoms lasting for hours and days(now months) with no prior history. Flushing (hot flash type) Tingling. Loss of appetite. Lower GI issues.  Stomach discomfort, knots, just below breast bone.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Specialist consultation
Clinical narrative: Started with Heart Palpitations. Shortness of breath. Extreme anxiety and panic attack symptoms lasting for hours and days(now months) with no prior history. Flushing (hot flash type) Tingling. Loss of appetite. Lower GI issues.  Stomach discomfort, knots, just below breast bone.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Bell?s palsy on right side of face. Started on the 5th or 6th with a numb sensation on tongue and eventually took over half of my face. Was diagnosed on the 9th.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: 16  self-registered for booster vaccination with parental consent via guardian present in the building. Pt proceeded to the vaccine station where he received a Moderna booster dose. Of note he received primary series of Pfizer vaccines with 1st dose Lot # ER 8733 on 4/7/2021 and 2nd dose Pfizer, Lot # EW0164 on 4/28/2021. Pt was notified of the inadvertently administered vaccine for his age. Present guardian was also notified of the same and his mother was notified of the event via telephone call at 1854h. Pt was observed from time of vaccination administration until 1910h. No untoward signs or symptoms were noted during the time of observation.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site inflammation, Injection site swelling, Pain in extremity
Clinical narrative: Arm was sore for four days following injection, starting in the middle of the night.  Slight bump in muscle around injection site, but not otherwise inflamed looking
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: This was a booster shot following two Pfizer vaccines in April 2021.  painful itchy red raised rash on vaccine arm below the injection site.  topical treatments, over counter pain reliever, warmth helped with pain, ice for the itching
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives non stop
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Lymphadenopathy, Pruritus
Clinical narrative: Itchy, swollen lymph nodes with back acne along the spine.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Haematuria, Lymph node pain, Protein urine, Renal failure
Clinical narrative: Armpit lymphnodes in right arm so painful they required 2 days of narcotics. Gross hematuria and protein spilled in urine (kidney failure).
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Extra dose administered, Head discomfort, Headache, Muscle tightness
Clinical narrative: Terrible headache all day, all night for 2 weeks straight.  I had it when I woke up and when I went to bed and when I woke up in the middle of the night.  No over the counter medicine could take the pain away.  It was still there in week 3 but not as debilitating.  The first few days after the booster, I was useless for work or my kids as my head hurt to move.  I was a little dizzy, nauseous and the headache wasn't like a caffeine headache, it was like pressure in my head.  My neck to the base of my skull and shoulders were tight and felt like I had whiplash.  I got massages and now 4 weeks later, that still hurts the same and the headaches come and go randomly. My vision is blurrier as well.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Sleep disorder, Vision blurred
Clinical narrative: Terrible headache all day, all night for 2 weeks straight.  I had it when I woke up and when I went to bed and when I woke up in the middle of the night.  No over the counter medicine could take the pain away.  It was still there in week 3 but not as debilitating.  The first few days after the booster, I was useless for work or my kids as my head hurt to move.  I was a little dizzy, nauseous and the headache wasn't like a caffeine headache, it was like pressure in my head.  My neck to the base of my skull and shoulders were tight and felt like I had whiplash.  I got massages and now 4 weeks later, that still hurts the same and the headaches come and go randomly. My vision is blurrier as well.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Vaccine administration error- 15 year old patient received his Pfizer booster after 6 months from his Pfizer primary series. Currently, Pfizer booster is approved only for those 16 y/o +. Patient is not immunocompromised either. Patient and parent were notified of the error and did not expressed any concerns.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood oestrogen, Inflammation, Skin burning sensation, Vibratory sense increased, X-ray
Clinical narrative: Burning throughout the body with intensity in the legs, feet, hands, forearm, face and head. Vibration in the legs and feet. Inflammation in the hands and feet, retention of liquids in the feet and hands. It is not removed with anything. They put me on Neurontin 200mg and went up to twice a day. I have no pain, my skin feels like I am burning all the time and I have inflammation.
Age: 39.0
Sex: M
Vaccine: FLUX
Symptoms: Hypersensitivity, Malaise
Clinical narrative: During previous injections and/or intranasal administrations had allergic symptoms around the area of administration and fallen ill. Overall minor effects.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient received 3 doses of pediatric (ages 5-11) Pfizer vaccine. 20 ug each, on 11/19/21, 12/10/21 and 12/13/21. The patient experience no complications at the time of this writing
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Extra dose administered, Tinnitus
Clinical narrative: Tinnitus. I first noticed Tinnitus after my first vaccine in the summer. Didn't think anything of it. Got my second dose. It got worse.  Noticed both these changes within days od vaccine. Went to an audiologist. They said some people report experiencing it after vaccine but hard to tell. I just got my booster, tinnitus is much worse. I'll never be getting a covid shot again. 3 times work 3 profound upticks the the span of a week is enough data for me. And it has never gone away after the 1st 2 shots so I'm sure this is my new normal. Thanks Pfizer since this is completely incurable.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Client received Pfizer Pediatric COVID vaccine dose.  Client should have received Pfizer Bio-NTech dose.  No adverse symptoms reported during observation period.  Client left vaccine site with father once observation complete.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: GOT REALLY KICKED WITH THE BOOSTER; This spontaneous report received from a patient via a company representative via social media 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. On an unspecified date, the patient previously received covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, and batch number were not reported), 1 in total, dose was not reported (dose number in series was 1), for prophylactic vaccination. The reporter had not reported any adverse events following vaccination. 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 (dose number in series was 2), 1 total administered for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  On an unspecified date, the patient got really kicked with the booster (captured as feeling abnormal). As per the reporter, "We got really kicked with the booster 2 days worth ugh". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got really kicked with the booster was not reported. This report was non-serious. This case, from the same reporter is linked to 20211214212.
Age: 18.0
Sex: M
Vaccine: UNK
Symptoms: Chest pain, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Myocarditis, Troponin increased
Clinical narrative: The patient presented with acute chest pain 2 days after receiving the Moderna booster vaccine (3rd shot)and was found to have a grossly abnormal EKG and severely elevated troponin level consistent with myocarditis
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient was given 4 doses of pediatric COVID Vaccine. Parents separately brought patient to both vaccine facility and clinic to recieve his doses. We believe they did not communicate with each other that they got the patient vaccinated at the other site. He has not had any complications from his vaccine at this time.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: High fever, bad chills/shakes, tired, sore muscles, headache, teeth throbbing
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Toothache
Clinical narrative: High fever, bad chills/shakes, tired, sore muscles, headache, teeth throbbing
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Bone disorder, Extra dose administered, Fatigue, Hyperhidrosis
Clinical narrative: In the late 1980s I contracted Dengue Fever in Indonesia.  Dengue symptoms returned for the first time approximately eight hours after receiving the booster shot.  For about 48 hours after the onset, it felt like someone was hammering a chisel into my thigh bones every 10 to 15 minutes, particularly my right thigh.  Heavy sweating and fatigue occurred during the same time frame.  For over two months after the shot I have had chronic fatigue.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Feeling abnormal, Pain in extremity
Clinical narrative: FEELING DEAD/ FEELING TERRIBLE; SYSTEMIC SYMPTOMS; ARM PAIN; This spontaneous report received from a patient concerned a unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient had previously received BNT 162 for prophylactic vaccination (dose number in series was1).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose not reported, 1 in total, start therapy date were not reported for prophylactic vaccination as a booster dose (dose number in series was 2). The batch number was not reported and has been requested. No concomitant medications were reported.  The patient reported feeling terrible (feeling dead) after booster vaccine. The patient stated systemic symptoms occurred for 24 hours post booster shot with arm pain more than 1 week later. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from systemic symptoms, and the outcome of arm pain and feeling dead/feeling terrible was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Dizziness
Clinical narrative: VERY DIZZY; BAD REACTION; This spontaneous report received from a patient via a company representative concerned a 69 year old male.  The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, first dose administered on 01-APR-2021 and second dose on an unspecified date in 2021 for prophylactic vaccination (dose number in series 1).  On an unspecified date, the patient experienced foggy eyed in the left eye/was seeing double some days, when used hands a lot of pain and when used wrists a lot of pain (dose series 1). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The outcome for foggy eyed in the left eye/was seeing double some days, when used hands a lot of pain and when used wrists a lot of pain was unknown.   The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in  series 2) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total, administered on an unspecified date in 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported.   On an unspecified date in 2021, after getting the booster shot, the patient was very dizzy and was having bad reaction (dose series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported.  The outcome of the very dizzy and bad reaction was not reported.  This report was non-serious.  This case, involving the same patient is linked to 20211050535.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: ITCHING ON STOMACH, BACK AND BACK OF THE NECK; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient had previously received covid-19 vaccine ad26.cov2.s from unspecified manufacturer (suspension for injection, route of admin, batch number, and expiry not reported) dose was not reported (dose number in series was 1), 1 total, administered for prophylactic vaccination.  It was unknown whether patient had any adverse events (dose series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 182281 expiry: UNKNOWN) dose was not reported (dose number in series was 2),1 total, administered on 22-NOV-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 24-NOV-2021, two days after booster shot, the patient experienced itching on stomach, back and back of the neck. It started at the same time in the all of the above mentioned areas (dose series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching on stomach, back and back of the neck. This report was non-serious. This case, involving the same patient is linked to 20050503613.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM SORE AND HURTING; This spontaneous report received from a patient concerned a 41-year-old female patient of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: blood clotting disorder (Factor 5 leiden). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration was not reported, and batch number: 043A21A, expiry: unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, (dose number in series 1), the patient experienced sore arm, nausea and fatigue.  The patient recovered from sore arm. The outcome for nausea and fatigue was not reported.  The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of administration was not reported, batch number: unknown, expiry: unknown) dose was not reported, 01 total, administered on 14-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, after vaccination with booster dose of covid-19 vaccine ad26.cov2.s, the patient had sore vaccinated arm which was hurting (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm sore and hurting. This report was non-serious. This case, involving the same patient is linked to 20211212291.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use
Clinical narrative: RECEIVED TWO DOSES DUE TO BEING IMMUNOCOMPROMISED; OFF LABEL USE; This spontaneous report received from a patient concerned a female patient of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: kidney transplant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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 received two doses due to being immunocompromised, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received two doses due to being immunocompromised and off label use was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer via  media via company representative concerned a female of unspecified age and race. 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 (Janssen series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots. The reporter stated that "Neighbors he had stroke and she had blood clots". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter was linked to 20211223284.; Sender's Comments: V0: 20211222253 -COVID-19 VACCINE AD26.COV2.S- Blood clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s)
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Feeling abnormal, Headache, Ophthalmological examination, Vision blurred
Clinical narrative: UNBALANCED FEELING; BLURRY VISION; MORE INTENSE AND MORE FREQUENT HEADACHES; UNSTEADY FEELING / DISEQUILIBRIUM; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: dander allergy, and developed shrimp allergy a couple of years ago, and other pre-existing medical conditions included: Patient did not had acute symptoms after vaccination for few months. He was active and in good physical shape. Patient wears contact lens. The patient experienced drug allergy when treated with ciprofloxacin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On SEP-2021, the patient experienced unsteady feeling / disequilibrium. On an unspecified date, the patient experienced unbalanced feeling, more intense and more frequent headaches, and blurry vision. Laboratory data (dates unspecified) included: Eye exam (NR: not provided) 20/20. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unbalanced feeling, more intense and more frequent headaches, unsteady feeling / disequilibrium and blurry vision was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: POOR QUALITY PRODUCT ADMINISTERED; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned an adult female. 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: 211D21A expiry: 11-APR-2022) dose was not reported, administered on 10-DEC-2021 13:25 for prophylactic vaccination. No concomitant medications were reported. On 10-DEC-2021, the patient experienced poor quality product administered. On 10-DEC-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the poor quality product administered and incorrect product storage was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction, Illness
Clinical narrative: SICK; HAD AWFUL SIDE EFFECTS; This spontaneous report received from a consumer concerned a male of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced sick, and had awful side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick and had awful side effects was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: PAIN HURTED; HUGE FEVER; This spontaneous report received from a patient via a company representative 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, and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced pain hurted, and huge fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain hurted, and huge fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SEVERE REACTION; This spontaneous report received from a consumer via a company representative 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination (series 1). The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced severe reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe reaction was not reported. This report was non-serious. This case, from the same reporter is linked to 20211225526.