chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Head injury, Joint dislocation, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: BRAIN BLEED; RECURRENT GUILLAIN BARRE SYNDROME; BROKEN HER FOOT; DISLOCATED HER FOOT; SMACKED HER HEAD; FALL; This spontaneous report received from a consumer concerned an 8 decade old female. The patient's weight was 191 pounds, and height was 66 inches. The patient's concurrent conditions included: penicillin allergy. The patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: 23-AUG-2021) dose was not reported, Frequency 1 total administered on 23-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  It was reported that few weeks after vaccination the patient started developing arm weakness and went to see her HCP who "misdiagnosed it as rotator cuff injury". After waiting to let that try and heal, the event progressively worsened, to the point that she could not perform her activities of daily living because of the weakness. On an unspecified date in Sep-2021, the patient became weaker, she fell at home and had broken/dislocated her foot during that fall, and smacked her head and had a brain bleed on holiday weekend. The patient was sent to the Emergency Room and subsequently hospitalized. There she was diagnosed with Guillain barre syndrome (GBS), after having an MRI (Magnetic resonance imaging), CT (Computerized tomogram) scan, and lumbar puncture was done, and the patient was started with 5-day treatment of antibodies. The patient was in hospital for about 2 weeks, and she improved greatly and was then sent for strengthening to a rehabilitation facility. At around 10 days into rehabilitation, the Guillain barre syndrome (GBS) symptoms started again. She was sent back to hospital again from the rehabilitation, and had another round of 5-day antibody treatment, was discharged back to the rehab this time with weakness still in her legs and not at 100%. The patient was in rehab at the time of reporting, and she is reporting that two days ago the same GBS symptoms started again. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from recurrent guillain barre syndrome, and the outcome of fall, broken her foot, brain bleed, smacked her head and dislocated her foot was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211058478- COVID-19 VACCINE AD26.COV2.S- Fall, broken her foot, dislocated her foot, smacked her head and brain bleed. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20211058478 -COVID-19 VACCINE AD26.COV2.S -Guillain Barre Syndrome. This event is labeled per RSI and is therefore considered potentially related.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: CHILL; FATIGUE; 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 not reported, batch number: Unk) 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 chill, fatigue, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chill and fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: SEVERE HEADACHE; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient was not pregnant at the time of reporting .The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 22-APR-2021 for prophylactic vaccination.The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 25-OCT-2021, the patient experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe headache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, UNK, COVID19, UNK
Symptoms: Psoriasis
Clinical narrative: PLAQUE PSORIASIS FLARE UP ON A SPOT ON SCALP; This spontaneous report received from a patient concerned a 64 year old male. 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, intramuscular, batch number was not reported) dose was not reported, administered on 12-AUG-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: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported.  On an unspecified date, the patient experienced plaque psoriasis flare up on a spot on scalp. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with risankizumab was not reported. The patient was recovering from plaque psoriasis flare up on a spot on scalp. This report was non-serious.
Sex: M
Vaccine: COVID19, UNK, COVID19, UNK
Symptoms: Skin disorder
Clinical narrative: PLAQUE PSORIASIS FLARE UP ON A SPOT ON SCALP; This spontaneous report received from a patient concerned a 64 year old male. 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, intramuscular, batch number was not reported) dose was not reported, administered on 12-AUG-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: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported.  On an unspecified date, the patient experienced plaque psoriasis flare up on a spot on scalp. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with risankizumab was not reported. The patient was recovering from plaque psoriasis flare up on a spot on scalp. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient via company representative was received 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: Unk) dose was not reported, administered on MAR-2021 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 MAR-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: IMMUNE SYSTEM PERMANENTLY ALTERED; This spontaneous report received from a patient 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 was not reported, administered on 20-MAY-2021 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 immune system permanently altered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of immune system permanently altered was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Influenza like illness, Off label use, Vaccination site pain
Clinical narrative: Received third dose without being immunocompromised; 0.5 ml administered as Moderna booster vaccine; Flu-like symptoms; Large tender area belowinjection site on arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), VACCINATION SITE PAIN (Large tender area belowinjection site on arm), OFF LABEL USE (Received third dose without being immunocompromised) and ACCIDENTAL OVERDOSE (0.5 ml administered as Moderna booster vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. In October 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms) and VACCINATION SITE PAIN (Large tender area belowinjection site on arm). On 17-Oct-2021, the patient experienced OFF LABEL USE (Received third dose without being immunocompromised). 17-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (0.5 ml administered as Moderna booster vaccine). On 17-Oct-2021, OFF LABEL USE (Received third dose without being immunocompromised) and ACCIDENTAL OVERDOSE (0.5 ml administered as Moderna booster vaccine) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) and VACCINATION SITE PAIN (Large tender area belowinjection site on arm) outcome was unknown.            Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-360778 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Added booster dose details. On 27-Oct-2021: Patient demographics and events were updated
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Headache, Myalgia, Pain in extremity
Clinical narrative: swelling; Stomach ache; Arm pain; Fever (101°F); headache; sore; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), ABDOMINAL PAIN UPPER (Stomach ache), PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever (101°F)) and HEADACHE (headache) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included SIMVASTATIN for Cholesterol high.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced SWELLING (swelling), ABDOMINAL PAIN UPPER (Stomach ache), PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever (101°F)), HEADACHE (headache) and MYALGIA (sore). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. At the time of the report, SWELLING (swelling), ABDOMINAL PAIN UPPER (Stomach ache), PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever (101°F)), HEADACHE (headache) and MYALGIA (sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Oct-2021, Body temperature: 101 (High) 101 Degrees F.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: swelling; Stomach ache; Arm pain; Fever (101°F); headache; sore; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), ABDOMINAL PAIN UPPER (Stomach ache), PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever (101°F)) and HEADACHE (headache) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included SIMVASTATIN for Cholesterol high.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced SWELLING (swelling), ABDOMINAL PAIN UPPER (Stomach ache), PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever (101°F)), HEADACHE (headache) and MYALGIA (sore). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. At the time of the report, SWELLING (swelling), ABDOMINAL PAIN UPPER (Stomach ache), PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever (101°F)), HEADACHE (headache) and MYALGIA (sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Oct-2021, Body temperature: 101 (High) 101 Degrees F.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever) in a female patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.8 (High) High and 101.1 (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. List of concomitant medication were not given.   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow-up contains no new information.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: accidently administered a dose from last year Fluzone quadrivalent that expired with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from Pharmacist via Medical Information  (Reference number- 00822705) and transmitted to Sanofi on 21-Oct-2021 in a specific country.  This case involves a 65-year-old male patient who was accidentally vaccinated with a 0.5 mL (once) dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] from last year (lot UJ432AA and expiry date 30-Jun-2021) via intramuscular route in the right deltoid on 21-Oct-2021 for prophylactic vaccination (expired product administered).  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  It was reported "Pharmacist wants to know is there anything she should warn the patient about side effect wise and do we have any recommendation as far as revaccination? Caller states that after a patient left she realized that and the patient is not experiencing any side effects."  At the time of report, no adverse event reported.  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 the 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.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Erythema, Joint range of motion decreased, Muscular weakness
Clinical narrative: The vaccine led to swelling and redness of the arm, a rash on the left side of the neck, arm, shoulder, and torso.  Pain on the left arm continued for months, as well as decreased range of motion, shoulder pain, and muscle weakness up to this day.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Rash, X-ray
Clinical narrative: The vaccine led to swelling and redness of the arm, a rash on the left side of the neck, arm, shoulder, and torso.  Pain on the left arm continued for months, as well as decreased range of motion, shoulder pain, and muscle weakness up to this day.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Urticaria
Clinical narrative: Patient states he had an allergic reaction, including hives and itching. Patient had to take diphenhydramine to help with the itching
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness, itchiness around injection site started 5 days after first dose of vaccine. Redness and swelling covered almost entire upper right arm.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Injection site pain
Clinical narrative: Pain at injection site, feeling of weakness, Dizziness on the 24th lasting all day. Was ok next morning.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Feeling abnormal, Injection site erythema, Injection site inflammation
Clinical narrative: Severe joint pain & body aches,  Injection site is inflamed, hot and red, approximately 3? long and 2.5 inches wide and tender when touched. Loss of appetite, foggy mind.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site warmth, Pain
Clinical narrative: Severe joint pain & body aches,  Injection site is inflamed, hot and red, approximately 3? long and 2.5 inches wide and tender when touched. Loss of appetite, foggy mind.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine
Clinical narrative: Severe migraine headaches, consistent, severe fatigue, consistent, every day since injection and still as of 10/31.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase normal, Antiphospholipid antibodies, Aspartate aminotransferase normal, Blood albumin normal, Blood bilirubin increased
Clinical narrative: recieved booster moderna on 10/22/21 with 0.25 ml.  10/30/21 had leg pain.  Dx'd with extensive DVT on 10/31/21.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood calcium normal, Blood chloride normal, Blood glucose normal, Blood osmolarity normal, Blood potassium normal
Clinical narrative: recieved booster moderna on 10/22/21 with 0.25 ml.  10/30/21 had leg pain.  Dx'd with extensive DVT on 10/31/21.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood sodium normal, Blood urea normal, Carbon dioxide normal, Deep vein thrombosis, Gene mutation identification test
Clinical narrative: recieved booster moderna on 10/22/21 with 0.25 ml.  10/30/21 had leg pain.  Dx'd with extensive DVT on 10/31/21.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Glomerular filtration rate normal, Haemoglobin normal, International normalised ratio normal, Pain, Pain in extremity
Clinical narrative: recieved booster moderna on 10/22/21 with 0.25 ml.  10/30/21 had leg pain.  Dx'd with extensive DVT on 10/31/21.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Platelet count normal, Protein total normal, Prothrombin time prolonged, Swelling, Ultrasound Doppler abnormal
Clinical narrative: recieved booster moderna on 10/22/21 with 0.25 ml.  10/30/21 had leg pain.  Dx'd with extensive DVT on 10/31/21.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: recieved booster moderna on 10/22/21 with 0.25 ml.  10/30/21 had leg pain.  Dx'd with extensive DVT on 10/31/21.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin abnormal, Pregnancy test positive, Vaginal haemorrhage
Clinical narrative: Hx miscarriage in August 2021. History of live birth September 2019. Miscarriage at 26October2921 after successful ovulation, positive pregnancy signs, positive home pregnancy test, and positive blood hcg test, then vagina bleeding and trending down hcg. I am (Privacy) so forced to get vaccine after mandate and miscarriage. I want to scream. I want someone held accountable for this killing! I want justice for my baby! I want the (Privacy) to suffer like I just did. I get no sick days or anything to grieve. I just continue to be an RN and watch others have successful pregnancies or go through miscarriages too.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Breast pain, Human chorionic gonadotropin decreased, Increased appetite, Maternal exposure during pregnancy
Clinical narrative: Hx miscarriage in August 2021. History of live birth September 2019. Miscarriage at 26October2921 after successful ovulation, positive pregnancy signs, positive home pregnancy test, and positive blood hcg test, then vagina bleeding and trending down hcg. I am (Privacy) so forced to get vaccine after mandate and miscarriage. I want to scream. I want someone held accountable for this killing! I want justice for my baby! I want the (Privacy) to suffer like I just did. I get no sick days or anything to grieve. I just continue to be an RN and watch others have successful pregnancies or go through miscarriages too.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Nausea, Pregnancy test, SARS-CoV-2 test, Vaginal discharge
Clinical narrative: Hx miscarriage in August 2021. History of live birth September 2019. Miscarriage at 26October2921 after successful ovulation, positive pregnancy signs, positive home pregnancy test, and positive blood hcg test, then vagina bleeding and trending down hcg. I am (Privacy) so forced to get vaccine after mandate and miscarriage. I want to scream. I want someone held accountable for this killing! I want justice for my baby! I want the (Privacy) to suffer like I just did. I get no sick days or anything to grieve. I just continue to be an RN and watch others have successful pregnancies or go through miscarriages too.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Hx miscarriage in August 2021. History of live birth September 2019. Miscarriage at 26October2921 after successful ovulation, positive pregnancy signs, positive home pregnancy test, and positive blood hcg test, then vagina bleeding and trending down hcg. I am (Privacy) so forced to get vaccine after mandate and miscarriage. I want to scream. I want someone held accountable for this killing! I want justice for my baby! I want the (Privacy) to suffer like I just did. I get no sick days or anything to grieve. I just continue to be an RN and watch others have successful pregnancies or go through miscarriages too.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebral haemorrhage, Computerised tomogram head abnormal, Immune thrombocytopenia, Platelet count
Clinical narrative: ITP - Immune Thrombotic Purpura leading to intercerebral hemorrhage
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: ITP - Immune Thrombotic Purpura leading to intercerebral hemorrhage
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebral haemorrhage, Computerised tomogram head abnormal, Immune thrombocytopenia, Platelet count
Clinical narrative: VAERS being submitted at the request of the family.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: VAERS being submitted at the request of the family.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Pain in extremity, Thrombosis, Vaginal haemorrhage
Clinical narrative: Started getting light spotting about 2 weeks before the time I would expect to get my period. This continued on and off, and then my actual period starting about October 25th. It is a lot heavier than usual - I soak through 3-4 extra heavy overnight pads a day, and there are many dime-to-quarter sized blood clots.   Also - I've had calf pain since the day after I got the booster and it hasn't stopped.  I did not experience any side effects after my last 2 doses of the vaccine to my knowledge.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Arthralgia, Dizziness, Fatigue, Influenza like illness
Clinical narrative: Flu like systwms 9hrs post vaccination, itching at injection site 11hrs post vaccination. Swelling, redness, itching, blister, hardness at injection site 24 hrs post vaccination, continuing to worsen still at 36hrs post vaccination. Increased pain on lymph nodes and joints, nausea, dizziness fatigue. Symptoms persist and worsen despite advil/tylenol, zyrtec/benadryl, hot cold compress. Tramadol prescribed for fibromyalgia pain has no effect on symptoms as well.  Orginal series of moderna covid injection resulted in no injection site pain, swelling, itching or hardness.  First vaccination caused mild fever. Both injections of first series caused flu like symptoms 7-10 post both injections(3/11/21 and 4/7/21).  Moderna booster 10/30/21 did not cause fever but did cause flu like symptoms as well but getting worse as opposed to better in subsequent days following vaccination.  Flu like symptoms approx 7 days post vaccination is common with any vaccination I have ever recieved.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site vesicles, Lymph node pain
Clinical narrative: Flu like systwms 9hrs post vaccination, itching at injection site 11hrs post vaccination. Swelling, redness, itching, blister, hardness at injection site 24 hrs post vaccination, continuing to worsen still at 36hrs post vaccination. Increased pain on lymph nodes and joints, nausea, dizziness fatigue. Symptoms persist and worsen despite advil/tylenol, zyrtec/benadryl, hot cold compress. Tramadol prescribed for fibromyalgia pain has no effect on symptoms as well.  Orginal series of moderna covid injection resulted in no injection site pain, swelling, itching or hardness.  First vaccination caused mild fever. Both injections of first series caused flu like symptoms 7-10 post both injections(3/11/21 and 4/7/21).  Moderna booster 10/30/21 did not cause fever but did cause flu like symptoms as well but getting worse as opposed to better in subsequent days following vaccination.  Flu like symptoms approx 7 days post vaccination is common with any vaccination I have ever recieved.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Flu like systwms 9hrs post vaccination, itching at injection site 11hrs post vaccination. Swelling, redness, itching, blister, hardness at injection site 24 hrs post vaccination, continuing to worsen still at 36hrs post vaccination. Increased pain on lymph nodes and joints, nausea, dizziness fatigue. Symptoms persist and worsen despite advil/tylenol, zyrtec/benadryl, hot cold compress. Tramadol prescribed for fibromyalgia pain has no effect on symptoms as well.  Orginal series of moderna covid injection resulted in no injection site pain, swelling, itching or hardness.  First vaccination caused mild fever. Both injections of first series caused flu like symptoms 7-10 post both injections(3/11/21 and 4/7/21).  Moderna booster 10/30/21 did not cause fever but did cause flu like symptoms as well but getting worse as opposed to better in subsequent days following vaccination.  Flu like symptoms approx 7 days post vaccination is common with any vaccination I have ever recieved.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neoplasm, X-ray
Clinical narrative: Intense pain in all joints the day after vaccine for 48 hours. Uncommon tumor development on left extremity 4 months after vaccine.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Agitation, Asthenia, Burning sensation, Diarrhoea
Clinical narrative: Itchy arm at injection time1230 10/22/21, subsided after 5 mins. Headache and eye pain 10/22/21 1400. Injection site became swollen at 1800 10/22/21. Bad headache 2100 10/22/21, fell asleep around 2200.  Woke at 0300 10/23/21 with bad stomach pain. 0400, terrible sweats, nausea, and diarrhea.  Terrible sweats and stomach pain through 0630 10/23/21.  Woke at 0900 10/23/21, with horrible headache, neck ache, swollen injection site and arm pain. Stayed in bed for the remained of 10/23/21. Tired and weak, for both days fever never broke 100 degrees. 10/24/21, still very weak, severe headache and body aches. Swelling of injection site has gone away, arm still sore.  10/25/21, still felt very weak and uneasy, severe headache, body feels like it?s on fire, but no fever and body ache. Went to ER 10/25/21 at 2100, given IV fluids and pain meds, told to rest and take it easy. 10/26/21 - 10/28/21, headache, no fever, sweats,  feel very weak. 10/29/21, a injection site, is itchy and sore. 10/30/21, injection site is very swollen and itchy headache is back, have been dizzy and faint all day. Sounds are very amplified and annoying.  10/31/21, headache, sweats are back.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye pain, Fatigue, Feeling abnormal, Headache
Clinical narrative: Itchy arm at injection time1230 10/22/21, subsided after 5 mins. Headache and eye pain 10/22/21 1400. Injection site became swollen at 1800 10/22/21. Bad headache 2100 10/22/21, fell asleep around 2200.  Woke at 0300 10/23/21 with bad stomach pain. 0400, terrible sweats, nausea, and diarrhea.  Terrible sweats and stomach pain through 0630 10/23/21.  Woke at 0900 10/23/21, with horrible headache, neck ache, swollen injection site and arm pain. Stayed in bed for the remained of 10/23/21. Tired and weak, for both days fever never broke 100 degrees. 10/24/21, still very weak, severe headache and body aches. Swelling of injection site has gone away, arm still sore.  10/25/21, still felt very weak and uneasy, severe headache, body feels like it?s on fire, but no fever and body ache. Went to ER 10/25/21 at 2100, given IV fluids and pain meds, told to rest and take it easy. 10/26/21 - 10/28/21, headache, no fever, sweats,  feel very weak. 10/29/21, a injection site, is itchy and sore. 10/30/21, injection site is very swollen and itchy headache is back, have been dizzy and faint all day. Sounds are very amplified and annoying.  10/31/21, headache, sweats are back.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperacusis, Hyperhidrosis, Injection site pruritus, Injection site swelling, Mobility decreased
Clinical narrative: Itchy arm at injection time1230 10/22/21, subsided after 5 mins. Headache and eye pain 10/22/21 1400. Injection site became swollen at 1800 10/22/21. Bad headache 2100 10/22/21, fell asleep around 2200.  Woke at 0300 10/23/21 with bad stomach pain. 0400, terrible sweats, nausea, and diarrhea.  Terrible sweats and stomach pain through 0630 10/23/21.  Woke at 0900 10/23/21, with horrible headache, neck ache, swollen injection site and arm pain. Stayed in bed for the remained of 10/23/21. Tired and weak, for both days fever never broke 100 degrees. 10/24/21, still very weak, severe headache and body aches. Swelling of injection site has gone away, arm still sore.  10/25/21, still felt very weak and uneasy, severe headache, body feels like it?s on fire, but no fever and body ache. Went to ER 10/25/21 at 2100, given IV fluids and pain meds, told to rest and take it easy. 10/26/21 - 10/28/21, headache, no fever, sweats,  feel very weak. 10/29/21, a injection site, is itchy and sore. 10/30/21, injection site is very swollen and itchy headache is back, have been dizzy and faint all day. Sounds are very amplified and annoying.  10/31/21, headache, sweats are back.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Itchy arm at injection time1230 10/22/21, subsided after 5 mins. Headache and eye pain 10/22/21 1400. Injection site became swollen at 1800 10/22/21. Bad headache 2100 10/22/21, fell asleep around 2200.  Woke at 0300 10/23/21 with bad stomach pain. 0400, terrible sweats, nausea, and diarrhea.  Terrible sweats and stomach pain through 0630 10/23/21.  Woke at 0900 10/23/21, with horrible headache, neck ache, swollen injection site and arm pain. Stayed in bed for the remained of 10/23/21. Tired and weak, for both days fever never broke 100 degrees. 10/24/21, still very weak, severe headache and body aches. Swelling of injection site has gone away, arm still sore.  10/25/21, still felt very weak and uneasy, severe headache, body feels like it?s on fire, but no fever and body ache. Went to ER 10/25/21 at 2100, given IV fluids and pain meds, told to rest and take it easy. 10/26/21 - 10/28/21, headache, no fever, sweats,  feel very weak. 10/29/21, a injection site, is itchy and sore. 10/30/21, injection site is very swollen and itchy headache is back, have been dizzy and faint all day. Sounds are very amplified and annoying.  10/31/21, headache, sweats are back.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Syncope
Clinical narrative: Itchy arm at injection time1230 10/22/21, subsided after 5 mins. Headache and eye pain 10/22/21 1400. Injection site became swollen at 1800 10/22/21. Bad headache 2100 10/22/21, fell asleep around 2200.  Woke at 0300 10/23/21 with bad stomach pain. 0400, terrible sweats, nausea, and diarrhea.  Terrible sweats and stomach pain through 0630 10/23/21.  Woke at 0900 10/23/21, with horrible headache, neck ache, swollen injection site and arm pain. Stayed in bed for the remained of 10/23/21. Tired and weak, for both days fever never broke 100 degrees. 10/24/21, still very weak, severe headache and body aches. Swelling of injection site has gone away, arm still sore.  10/25/21, still felt very weak and uneasy, severe headache, body feels like it?s on fire, but no fever and body ache. Went to ER 10/25/21 at 2100, given IV fluids and pain meds, told to rest and take it easy. 10/26/21 - 10/28/21, headache, no fever, sweats,  feel very weak. 10/29/21, a injection site, is itchy and sore. 10/30/21, injection site is very swollen and itchy headache is back, have been dizzy and faint all day. Sounds are very amplified and annoying.  10/31/21, headache, sweats are back.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Pain, Pain in extremity
Clinical narrative: Tiredness on the date of shot (March 31, 2021), then chronic throbbing pain on right side of my body from the base of the skull to the top of my right foot. On Oct. 30, 2021, I noticed a tremor on my right hand, which continued through November 1, 2021 (2 a.m.)  I am feeling this strange sensation, especially in my right index finger.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Tiredness on the date of shot (March 31, 2021), then chronic throbbing pain on right side of my body from the base of the skull to the top of my right foot. On Oct. 30, 2021, I noticed a tremor on my right hand, which continued through November 1, 2021 (2 a.m.)  I am feeling this strange sensation, especially in my right index finger.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Burning sensation, Disturbance in attention, Fatigue, Malaise
Clinical narrative: Have a rash on my collar bone up the back of my neck to the back of my head and a rash on my groin. The rash on my neck looked like red bloches had a burning feeling and itched bad and it itched worse when water hit it plus mad it feel like it was burning more. The rash on my groin has bright red blotches and bright pink blotches and itched badly and had a bad burning feeling plus it felt hot and was soar.  Went to the my doctor on October 19, 2021 and got NYSTATIN 100000UCRE PER and CLOTRIM/BETA 1-0.05%CRE GLE. I use it 2 times a day for 2 weeks then take a week off and then 2 weeks on and rhen 1 week off and then I'm to call my doctor and let him know how the rash is and how I'm feeling. I also was not feeling well on Saturday October 30, 2021. I was pale, felt weak at times, could not focus at times, very tired off and on, felt like it was in a fog, moody, and at one point my face was grey. I went to bed at 9pm that night and slept till 8am on Sunday October 31, 2021. I do feel a little better but not quite 100% yet
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mood altered, Pallor, Rash, Rash macular, Rash pruritic
Clinical narrative: Have a rash on my collar bone up the back of my neck to the back of my head and a rash on my groin. The rash on my neck looked like red bloches had a burning feeling and itched bad and it itched worse when water hit it plus mad it feel like it was burning more. The rash on my groin has bright red blotches and bright pink blotches and itched badly and had a bad burning feeling plus it felt hot and was soar.  Went to the my doctor on October 19, 2021 and got NYSTATIN 100000UCRE PER and CLOTRIM/BETA 1-0.05%CRE GLE. I use it 2 times a day for 2 weeks then take a week off and then 2 weeks on and rhen 1 week off and then I'm to call my doctor and let him know how the rash is and how I'm feeling. I also was not feeling well on Saturday October 30, 2021. I was pale, felt weak at times, could not focus at times, very tired off and on, felt like it was in a fog, moody, and at one point my face was grey. I went to bed at 9pm that night and slept till 8am on Sunday October 31, 2021. I do feel a little better but not quite 100% yet
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Myalgia, Nausea
Clinical narrative: Very rapid weight gain as evident massive edema, Extreme fatigue, nausea, imbalance muscle & joint aches, kicked in the diaphragm  feeling.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Oedema, Weight increased
Clinical narrative: Very rapid weight gain as evident massive edema, Extreme fatigue, nausea, imbalance muscle & joint aches, kicked in the diaphragm  feeling.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Chest discomfort.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cardiac stress test, Echocardiogram, Electrocardiogram, Headache
Clinical narrative: Headache, racing heart rate, high blood pressure, right side of face went completely numb, swollen.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Hypoaesthesia, Magnetic resonance imaging, Palpitations, Swelling face
Clinical narrative: Headache, racing heart rate, high blood pressure, right side of face went completely numb, swollen.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: pediatric dose instead of an adult dose; Adult use of child product; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 39-year-old female patient who received HBV (Engerix B pediatric) (batch number K329E, expiry date 24th April 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th October 2021, the patient received Engerix B pediatric .5 ml and Engerix B Pre-Filled Syringe Device. On 12th October 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that the adult patient received a pediatric dose of Engerix-b (0.5 ml) instead of an adult dose (1 ml), which led to underdose and adult use of a child product. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Weight, Weight decreased
Clinical narrative: SUSPECTED COVID 19 INFECTION; KIDNEYS SHUTTING DOWN; WEIRD FEELING AND SENSATION IN BODY / FEELING THAT LEFT ARM FALLING  OFF; CAN NOT GO BACK TO WORK; WEIGHT LOSS; GAIT/WALK OFF; This spontaneous report received from a patient (LPN) concerned a 49 year old male. The patient's height, and weight were not reported. The patient did do not have anything. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1816022 expiry: UNKNOWN) dose was not reported, 1 total, administered on 22-SEP-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 22-SEP-2021, shortly after receiving the vaccine, the patient experienced very sick, body getting weak, could not eat, lost appetite, weird feeling and sensation in body / feeling that left arm falling off, (received vaccine on right arm). Symptoms started right after obtaining the vaccine and got worse and worse. After a week, on 15-OCT-2021, patient was hospitalized for 1 day. Laboratory data included: COVID-19 virus test (NR: not provided) COVID-19 positive. The patient received one fluid. The patient was discharged on 16-OCT-2021. On same night patient went back to hospital because felt worse and was discharged on 19-OCT-2021. The patient was hospitalized for 4 days. The patient reported received tons of fluid at this location and reported kidneys were shutting down and urine was dark. The patient reported another COVID test done paid by himself on 25-OCT-2021 and got result came back on 26-OCT-2021 afternoon and tested positive for COVID-19 again. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The patient reported felt breathing stopped and gait walk was off and patient had lost weight. Laboratory data included: Lost weight (NR: not provided) lost. The patient reported still not felt well inside body. The patient was frustrated and complained that the manufacturer must be responsible when the vaccine hurts people. The patient stated can not go back to work and craving to eat but can not eat and weight loss. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from gait/walk off, can not go back to work, and the outcome of suspected covid-19 infection, weird feeling and sensation in body / feeling that left arm falling off, kidneys shutting down, and weight loss was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report was associated with product quality complaint: 90000199679 This case, from the same reporter is linked to 20211058575.; Sender's Comments: V0- 20211058708 covid-19 vaccine ad26.cov2.s- Kidney shutting down, Suspected Covid-19 infection, Weird feeling and sensation in body. 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).
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage
Clinical narrative: BLOOD DID GO ALL OVER THE ROOM; This spontaneous report received from a health care professional concerned a female 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 not reported, batch number: Unknown) dose was not reported, 1 total, administered on 14-MAY-2021 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.  It was reported that, on 14-MAY-2021, blood did go all over the room when patient got the first vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood did go all over the room was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211059801-COVID-19 VACCINE AD26.COV2.S- blood did go all over the room. 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).
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage
Clinical narrative: BLOOD DID GO ALL OVER THE ROOM; This spontaneous report received from a patient concerned a female of unspecified age, race and ethic origin. 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 was not reported, 1 total administered on 14-MAY-2021 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 blood did go all over the room. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood did go all over the room was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211060556-Covid-19 vaccine ad26.cov2.s-Blood did go all over room. 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).