chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: BODY ACHES; CRAMPING IN LEGS; FEEL HOT; FACIAL FLUSHING; STUFFY NOSE; BAD CHILLS (DREAMING THAT WAS STUCK IN SNOW) / FREEZING AND SHAKING BAD AND UNCONTROLLABLY (FELT LIKE A TRUCK RAN OVER); HEADACHE; POTENTIAL MEDICATION ERROR (ADMINISTRATION OF FIRST DOSE OF MODERNA VACCINE BEFORE JANSSEN VACCINE); This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. The patient's past medical history included: Clostridioides difficile, muscle eating infection in right arm, left wrist surgery, dialysis, coma, hit by a car, head injury, and shattered knee, and concurrent conditions included: shingles, kidney failure, non alcohol user, smoker, and Charlie horses, and other pre-existing medical conditions included: The patient had history of drug abuse or illicit drug usage (had a substance abuse problem and has been clean for several years). The patient experienced drug allergy when treated with haloperidol for drug used for unknown indication. 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 13-OCT-2021 18:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included miRNA 1273 for prophylactic vaccination. On 13-OCT-2021, the patient experienced potential medication error (administration of first dose of Moderna vaccine before Janssen vaccine). On 14-OCT-2021, the patient experienced body aches. On 14-OCT-2021, the patient experienced cramping in legs. On 14-OCT-2021, the patient experienced feel hot. On 14-OCT-2021, the patient experienced facial flushing. On 14-OCT-2021, the patient experienced stuffy nose. On 14-OCT-2021, the patient experienced bad chills (dreaming that was stuck in snow) / freezing and shaking bad and uncontrollably (felt like a truck ran over). On 14-OCT-2021, the patient experienced headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) One degree above normal. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bad chills (dreaming that was stuck in snow) / freezing and shaking bad and uncontrollably (felt like a truck ran over), and cramping in legs, had not recovered from body aches, headache, feel hot, facial flushing, and stuffy nose, and the outcome of potential medication error (administration of first dose of moderna vaccine before janssen vaccine) was not reported. This report was non-serious.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Feeling hot, Flushing, Headache
Clinical narrative: BODY ACHES; CRAMPING IN LEGS; FEEL HOT; FACIAL FLUSHING; STUFFY NOSE; BAD CHILLS (DREAMING THAT WAS STUCK IN SNOW) / FREEZING AND SHAKING BAD AND UNCONTROLLABLY (FELT LIKE A TRUCK RAN OVER); HEADACHE; POTENTIAL MEDICATION ERROR (ADMINISTRATION OF FIRST DOSE OF MODERNA VACCINE BEFORE JANSSEN VACCINE); This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. The patient's past medical history included: Clostridioides difficile, muscle eating infection in right arm, left wrist surgery, dialysis, coma, hit by a car, head injury, and shattered knee, and concurrent conditions included: shingles, kidney failure, non alcohol user, smoker, and Charlie horses, and other pre-existing medical conditions included: The patient had history of drug abuse or illicit drug usage (had a substance abuse problem and has been clean for several years). The patient experienced drug allergy when treated with haloperidol for drug used for unknown indication. 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 13-OCT-2021 18:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included miRNA 1273 for prophylactic vaccination. On 13-OCT-2021, the patient experienced potential medication error (administration of first dose of Moderna vaccine before Janssen vaccine). On 14-OCT-2021, the patient experienced body aches. On 14-OCT-2021, the patient experienced cramping in legs. On 14-OCT-2021, the patient experienced feel hot. On 14-OCT-2021, the patient experienced facial flushing. On 14-OCT-2021, the patient experienced stuffy nose. On 14-OCT-2021, the patient experienced bad chills (dreaming that was stuck in snow) / freezing and shaking bad and uncontrollably (felt like a truck ran over). On 14-OCT-2021, the patient experienced headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) One degree above normal. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bad chills (dreaming that was stuck in snow) / freezing and shaking bad and uncontrollably (felt like a truck ran over), and cramping in legs, had not recovered from body aches, headache, feel hot, facial flushing, and stuffy nose, and the outcome of potential medication error (administration of first dose of moderna vaccine before janssen vaccine) was not reported. This report was non-serious.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Medication error, Muscle spasms, Nasal congestion, Pain
Clinical narrative: BODY ACHES; CRAMPING IN LEGS; FEEL HOT; FACIAL FLUSHING; STUFFY NOSE; BAD CHILLS (DREAMING THAT WAS STUCK IN SNOW) / FREEZING AND SHAKING BAD AND UNCONTROLLABLY (FELT LIKE A TRUCK RAN OVER); HEADACHE; POTENTIAL MEDICATION ERROR (ADMINISTRATION OF FIRST DOSE OF MODERNA VACCINE BEFORE JANSSEN VACCINE); This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. The patient's past medical history included: Clostridioides difficile, muscle eating infection in right arm, left wrist surgery, dialysis, coma, hit by a car, head injury, and shattered knee, and concurrent conditions included: shingles, kidney failure, non alcohol user, smoker, and Charlie horses, and other pre-existing medical conditions included: The patient had history of drug abuse or illicit drug usage (had a substance abuse problem and has been clean for several years). The patient experienced drug allergy when treated with haloperidol for drug used for unknown indication. 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 13-OCT-2021 18:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included miRNA 1273 for prophylactic vaccination. On 13-OCT-2021, the patient experienced potential medication error (administration of first dose of Moderna vaccine before Janssen vaccine). On 14-OCT-2021, the patient experienced body aches. On 14-OCT-2021, the patient experienced cramping in legs. On 14-OCT-2021, the patient experienced feel hot. On 14-OCT-2021, the patient experienced facial flushing. On 14-OCT-2021, the patient experienced stuffy nose. On 14-OCT-2021, the patient experienced bad chills (dreaming that was stuck in snow) / freezing and shaking bad and uncontrollably (felt like a truck ran over). On 14-OCT-2021, the patient experienced headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) One degree above normal. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bad chills (dreaming that was stuck in snow) / freezing and shaking bad and uncontrollably (felt like a truck ran over), and cramping in legs, had not recovered from body aches, headache, feel hot, facial flushing, and stuffy nose, and the outcome of potential medication error (administration of first dose of moderna vaccine before janssen vaccine) was not reported. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Myalgia, Pyrexia, Tachycardia
Clinical narrative: I had a spike in temperature 100.4. I went to ER , They gave me ibuprofen . it was about 3 am when my temp went down.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Body temperature increased
Clinical narrative: I had a spike in temperature 100.4. I went to ER , They gave me ibuprofen . it was about 3 am when my temp went down.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: STORAGE OF VACCINE OUTSIDE OF THE RECOMMENDED STORAGE CONDITIONS; ADMINISTRATION OF VACCINE STORED OUTSIDE OF THE RECOMMENDED STORAGE; This spontaneous report received from a health care professional concerned a 23 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry: 14-DEC-2021) dose was not reported, administered on 13-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-OCT-2021, the patient experienced administration of vaccine stored outside of the recommended storage. On an unspecified date, the patient experienced storage of vaccine outside of the recommended storage conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine stored outside of the recommended storage and storage of vaccine outside of the recommended storage conditions was not reported. This report was non-serious.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: STORAGE OF VACCINE OUTSIDE OF THE RECOMMENDED STORAGE CONDITIONS; ADMINISTRATION OF VACCINE STORED OUTSIDE OF THE RECOMMENDED STORAGE; This spontaneous report received from a health care professional concerned a 23 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry: 14-DEC-2021) dose was not reported, administered on 13-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-OCT-2021, the patient experienced administration of vaccine stored outside of the recommended storage. On an unspecified date, the patient experienced storage of vaccine outside of the recommended storage conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine stored outside of the recommended storage and storage of vaccine outside of the recommended storage conditions was not reported. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Chills, Headache, Injection site swelling
Clinical narrative: CHEST PAINS, CHEST PRESSURE, HEADACHE, FEVER, CHILLS, SWEATING
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: CHEST PAINS, CHEST PRESSURE, HEADACHE, FEVER, CHILLS, SWEATING
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Chills, Headache, Hyperhidrosis
Clinical narrative: CHEST PAINS, CHEST PRESSURE, HEADACHE, FEVER, CHILLS, SWEATING
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Pt  presented to the vaccination site on 10/15/21. The client notified RN  that she received a single dose of the  COVID vaccine on 7/10/21. RN  submitted a medical consult via text message to Vaccine Operations Leads, requesting to proceed with the COVID vaccine Pfizer. Per CDC guidance, approval to proceed with COVID vaccine Pfizer first dose with 30 minute observation was obtained from medical consult team, Vaccine Operations Lead via text message. Client received COVID vaccine Pfizer Lot# 30145BA on 10/15/2021. The client did not report any symptoms during the observation period. The client left the vaccination site at 1047.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Pt  presented to the vaccination site on 10/15/21. The client notified RN  that she received a single dose of the  COVID vaccine on 7/10/21. RN  submitted a medical consult via text message to Vaccine Operations Leads, requesting to proceed with the COVID vaccine Pfizer. Per CDC guidance, approval to proceed with COVID vaccine Pfizer first dose with 30 minute observation was obtained from medical consult team, Vaccine Operations Lead via text message. Client received COVID vaccine Pfizer Lot# 30145BA on 10/15/2021. The client did not report any symptoms during the observation period. The client left the vaccination site at 1047.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aspiration pleural cavity, Biopsy, Dyspnoea exertional, Fatigue, Haemodialysis
Clinical narrative: Received vaccination April 7th with developed of generalized rash. Biopsy showed psoriatiform eczema. Had multiple hospitalizations for SOB/DOE/fatigue between May and Sept 2021, found to have recurrent pericardial effusions requiring pericardiocentesis with negative cardiologic/rheumatologic workup.  Subsequently hospitalized September 2021 for persistent pericardial effusion requiring pericardiocentesis. Found to have worsening AKI with renal biopsy showing evidence of thrombotic microangiopathy requiring initiation of dialysis for uremic encephalopathy and anuria. Rheumatologic workup negative again. Pan CT showed pancreatic mass but unable to pass scope for biopsy. Developed RLE DVT with acute hypoxic respiratory failure with improvement after initiation of PLEX with negative HIT workup. Subsequently developed esophageal dysmotility with grade B erosive esophagitis and class III ulcers at duodenal bulb requiring initiation of tube feeds. Pending transition of care.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test normal, Normocytic anaemia, Orthopnoea, Pericarditis, Pleural effusion
Clinical narrative: Received vaccination April 7th with developed of generalized rash. Biopsy showed psoriatiform eczema. Had multiple hospitalizations for SOB/DOE/fatigue between May and Sept 2021, found to have recurrent pericardial effusions requiring pericardiocentesis with negative cardiologic/rheumatologic workup.  Subsequently hospitalized September 2021 for persistent pericardial effusion requiring pericardiocentesis. Found to have worsening AKI with renal biopsy showing evidence of thrombotic microangiopathy requiring initiation of dialysis for uremic encephalopathy and anuria. Rheumatologic workup negative again. Pan CT showed pancreatic mass but unable to pass scope for biopsy. Developed RLE DVT with acute hypoxic respiratory failure with improvement after initiation of PLEX with negative HIT workup. Subsequently developed esophageal dysmotility with grade B erosive esophagitis and class III ulcers at duodenal bulb requiring initiation of tube feeds. Pending transition of care.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Renal failure, Renal-limited thrombotic microangiopathy, Skin hyperpigmentation, Thrombocytopenia
Clinical narrative: Received vaccination April 7th with developed of generalized rash. Biopsy showed psoriatiform eczema. Had multiple hospitalizations for SOB/DOE/fatigue between May and Sept 2021, found to have recurrent pericardial effusions requiring pericardiocentesis with negative cardiologic/rheumatologic workup.  Subsequently hospitalized September 2021 for persistent pericardial effusion requiring pericardiocentesis. Found to have worsening AKI with renal biopsy showing evidence of thrombotic microangiopathy requiring initiation of dialysis for uremic encephalopathy and anuria. Rheumatologic workup negative again. Pan CT showed pancreatic mass but unable to pass scope for biopsy. Developed RLE DVT with acute hypoxic respiratory failure with improvement after initiation of PLEX with negative HIT workup. Subsequently developed esophageal dysmotility with grade B erosive esophagitis and class III ulcers at duodenal bulb requiring initiation of tube feeds. Pending transition of care.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, Anuria, Biopsy kidney abnormal, Biopsy skin abnormal
Clinical narrative: Received vaccination April 7th with developed of generalized rash. Biopsy showed psoriatiform eczema. Had multiple hospitalizations for SOB/DOE/fatigue between May and Sept 2021, found to have recurrent pericardial effusions requiring pericardiocentesis with negative cardiologic/rheumatologic workup.  Subsequently hospitalized September 2021 for persistent pericardial effusion requiring pericardiocentesis. Found to have worsening AKI with renal biopsy showing evidence of thrombotic microangiopathy requiring initiation of dialysis for uremic encephalopathy and anuria. Rheumatologic workup negative again. Pan CT showed pancreatic mass but unable to pass scope for biopsy. Developed RLE DVT with acute hypoxic respiratory failure with improvement after initiation of PLEX with negative HIT workup. Subsequently developed esophageal dysmotility with grade B erosive esophagitis and class III ulcers at duodenal bulb requiring initiation of tube feeds. Pending transition of care.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiovascular evaluation, Computerised tomogram pancreas abnormal, Deep vein thrombosis, Dermatitis psoriasiform, Dialysis
Clinical narrative: Received vaccination April 7th with developed of generalized rash. Biopsy showed psoriatiform eczema. Had multiple hospitalizations for SOB/DOE/fatigue between May and Sept 2021, found to have recurrent pericardial effusions requiring pericardiocentesis with negative cardiologic/rheumatologic workup.  Subsequently hospitalized September 2021 for persistent pericardial effusion requiring pericardiocentesis. Found to have worsening AKI with renal biopsy showing evidence of thrombotic microangiopathy requiring initiation of dialysis for uremic encephalopathy and anuria. Rheumatologic workup negative again. Pan CT showed pancreatic mass but unable to pass scope for biopsy. Developed RLE DVT with acute hypoxic respiratory failure with improvement after initiation of PLEX with negative HIT workup. Subsequently developed esophageal dysmotility with grade B erosive esophagitis and class III ulcers at duodenal bulb requiring initiation of tube feeds. Pending transition of care.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Duodenal ulcer, Dyspnoea, Dyspnoea exertional, Eczema, Erosive oesophagitis
Clinical narrative: Received vaccination April 7th with developed of generalized rash. Biopsy showed psoriatiform eczema. Had multiple hospitalizations for SOB/DOE/fatigue between May and Sept 2021, found to have recurrent pericardial effusions requiring pericardiocentesis with negative cardiologic/rheumatologic workup.  Subsequently hospitalized September 2021 for persistent pericardial effusion requiring pericardiocentesis. Found to have worsening AKI with renal biopsy showing evidence of thrombotic microangiopathy requiring initiation of dialysis for uremic encephalopathy and anuria. Rheumatologic workup negative again. Pan CT showed pancreatic mass but unable to pass scope for biopsy. Developed RLE DVT with acute hypoxic respiratory failure with improvement after initiation of PLEX with negative HIT workup. Subsequently developed esophageal dysmotility with grade B erosive esophagitis and class III ulcers at duodenal bulb requiring initiation of tube feeds. Pending transition of care.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeding tube user, Heparin-induced thrombocytopenia test, Laboratory test normal, Oesophageal motility disorder
Clinical narrative: Received vaccination April 7th with developed of generalized rash. Biopsy showed psoriatiform eczema. Had multiple hospitalizations for SOB/DOE/fatigue between May and Sept 2021, found to have recurrent pericardial effusions requiring pericardiocentesis with negative cardiologic/rheumatologic workup.  Subsequently hospitalized September 2021 for persistent pericardial effusion requiring pericardiocentesis. Found to have worsening AKI with renal biopsy showing evidence of thrombotic microangiopathy requiring initiation of dialysis for uremic encephalopathy and anuria. Rheumatologic workup negative again. Pan CT showed pancreatic mass but unable to pass scope for biopsy. Developed RLE DVT with acute hypoxic respiratory failure with improvement after initiation of PLEX with negative HIT workup. Subsequently developed esophageal dysmotility with grade B erosive esophagitis and class III ulcers at duodenal bulb requiring initiation of tube feeds. Pending transition of care.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pancreatic mass, Pericardial drainage, Pericardial effusion, Plasmapheresis, Rash
Clinical narrative: Received vaccination April 7th with developed of generalized rash. Biopsy showed psoriatiform eczema. Had multiple hospitalizations for SOB/DOE/fatigue between May and Sept 2021, found to have recurrent pericardial effusions requiring pericardiocentesis with negative cardiologic/rheumatologic workup.  Subsequently hospitalized September 2021 for persistent pericardial effusion requiring pericardiocentesis. Found to have worsening AKI with renal biopsy showing evidence of thrombotic microangiopathy requiring initiation of dialysis for uremic encephalopathy and anuria. Rheumatologic workup negative again. Pan CT showed pancreatic mass but unable to pass scope for biopsy. Developed RLE DVT with acute hypoxic respiratory failure with improvement after initiation of PLEX with negative HIT workup. Subsequently developed esophageal dysmotility with grade B erosive esophagitis and class III ulcers at duodenal bulb requiring initiation of tube feeds. Pending transition of care.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombotic microangiopathy, Uraemic encephalopathy
Clinical narrative: Received vaccination April 7th with developed of generalized rash. Biopsy showed psoriatiform eczema. Had multiple hospitalizations for SOB/DOE/fatigue between May and Sept 2021, found to have recurrent pericardial effusions requiring pericardiocentesis with negative cardiologic/rheumatologic workup.  Subsequently hospitalized September 2021 for persistent pericardial effusion requiring pericardiocentesis. Found to have worsening AKI with renal biopsy showing evidence of thrombotic microangiopathy requiring initiation of dialysis for uremic encephalopathy and anuria. Rheumatologic workup negative again. Pan CT showed pancreatic mass but unable to pass scope for biopsy. Developed RLE DVT with acute hypoxic respiratory failure with improvement after initiation of PLEX with negative HIT workup. Subsequently developed esophageal dysmotility with grade B erosive esophagitis and class III ulcers at duodenal bulb requiring initiation of tube feeds. Pending transition of care.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Chest pain, Dyspnoea
Clinical narrative: Anaphylaxis shortness of breath chest pain can't breath out of one nostril
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: administering vaccines nurse gave 1 cc of undiluted pfizer vaccine i/m
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: administering vaccines nurse gave 1 cc of undiluted pfizer vaccine i/m
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: administering vaccines nurse gave 1 cc of undiluted pfizer vaccine i/m
Age: 36.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Atrial fibrillation, Palpitations
Clinical narrative: Palpitations and heart is in afib. Admitted today and staying overnight
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure decreased, Dysstasia, Electrocardiogram normal, Loss of consciousness
Clinical narrative: Mom?s blood pressure dropped and she passed out while in the shower, she was revived by care helper and passed out a second time.  Home nurse and EMT noted a pulse of 30.  She was stabilized,  taken to ER where her vitals returned to normal.  However she was admitted and kept for two nights in order to perform tests because she was so weak she could not stand on her own.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging normal, X-ray normal
Clinical narrative: Mom?s blood pressure dropped and she passed out while in the shower, she was revived by care helper and passed out a second time.  Home nurse and EMT noted a pulse of 30.  She was stabilized,  taken to ER where her vitals returned to normal.  However she was admitted and kept for two nights in order to perform tests because she was so weak she could not stand on her own.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Culture urine negative, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever of 101, extreme fatigue, chills, muscle aches. Unexplained vaginal bleeding (just ended period 4 days prior). Have been experiencing vaginal bleeding for 2 weeks after receiving vaccine. Bleeding is brown in color. Foul odor in urine.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Urine odour abnormal, Vaginal haemorrhage
Clinical narrative: Fever of 101, extreme fatigue, chills, muscle aches. Unexplained vaginal bleeding (just ended period 4 days prior). Have been experiencing vaginal bleeding for 2 weeks after receiving vaccine. Bleeding is brown in color. Foul odor in urine.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Urticaria
Clinical narrative: Hives on B LE occurred on 10/01/2021; L sides Bell?s Palsy developed on 10/14/2021.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Inflammation, Musculoskeletal stiffness, Neck pain
Clinical narrative: The effects lasted 48 hrs. Sore arm, tiredness, stiffness. But about a month later both shoulders became inflamed and I started experiencing shooting pains particularly in the left arm, but also in the left hip, left knee, both sides of the neck, and right arm. The pains in the left arm are at times consistent with brakes that can last 30 seconds to a few minutes.  More pains on the left side of the body than the right.  The tendons in both shoulders are tight due to inflammation. More so on the left shoulder. The effect is Shoulder impingement syndrome.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Rotator cuff syndrome, Tendon disorder
Clinical narrative: The effects lasted 48 hrs. Sore arm, tiredness, stiffness. But about a month later both shoulders became inflamed and I started experiencing shooting pains particularly in the left arm, but also in the left hip, left knee, both sides of the neck, and right arm. The pains in the left arm are at times consistent with brakes that can last 30 seconds to a few minutes.  More pains on the left side of the body than the right.  The tendons in both shoulders are tight due to inflammation. More so on the left shoulder. The effect is Shoulder impingement syndrome.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Gingival pain, Gingival swelling, Mouth swelling, Oral pain
Clinical narrative: Swelling in mouth and gums. Very painful
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Atrial fibrillation, Cardioversion, Electrocardiogram, Ultrasound scan
Clinical narrative: Atrial fibrillation  Heart rate 120-140
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Feeling cold, Myalgia, Pain
Clinical narrative: Body Aches - random spots on the body starts hurt, mostly joint areas AND MUSCLES Chills - my sense of heat was mostly gone. I felt cold under heavy blanket. I took a hot shower, but the highest setting (111*F) felt lukewarm.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Ventricular extrasystoles
Clinical narrative: No issues
Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Big Hard red lump
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Maternal exposure during pregnancy
Clinical narrative: PATIENT WAS ADMINISTERD PFIZER VACCINE WHEN SHE SHOULD HAVE RECEIVE MODERNA VACCINE. PT IS 15 WEEKS PREGNANT.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Ear swelling, Gait disturbance, Headache, Injection site pain
Clinical narrative: -High fever (102F+) for 2 days after injection -Dizziness impacting ability to walk for 2 days after injection -Significant facial swelling, left and right side near ears, starting 2 days after injection lasting 1 day -Body aches, lethargy, headaches for 2 days after injection -Significant pain at injection site, and radiating inwards to underarm for 3 days after injection
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lethargy, Pain, Pyrexia, Swelling face
Clinical narrative: -High fever (102F+) for 2 days after injection -Dizziness impacting ability to walk for 2 days after injection -Significant facial swelling, left and right side near ears, starting 2 days after injection lasting 1 day -Body aches, lethargy, headaches for 2 days after injection -Significant pain at injection site, and radiating inwards to underarm for 3 days after injection
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Dizziness, Headache, Lethargy, Pain
Clinical narrative: -High fever (102F+) for 2 days after injection -Dizziness impacting ability to walk for 2 days after injection -Significant facial swelling, left and right side near ears, starting 2 days after injection lasting 1 day -Body aches, lethargy, headaches for 2 days after injection -Significant pain at injection site, and radiating inwards to underarm for 3 days after injection
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Swelling face, Vaccination site pain
Clinical narrative: -High fever (102F+) for 2 days after injection -Dizziness impacting ability to walk for 2 days after injection -Significant facial swelling, left and right side near ears, starting 2 days after injection lasting 1 day -Body aches, lethargy, headaches for 2 days after injection -Significant pain at injection site, and radiating inwards to underarm for 3 days after injection
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: Pt received first dose Moderna (Lot 038C21A) on 01 SEP 2021 (Left Arm via IM). Pt returned and accidentally given Pfizer as a second shot, instead of Moderna, on 19 OCT 2021. Pt was observed for 30 minutes after the second injection, at which time he did not develop any adverse reactions.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Musculoskeletal pain, Pain in extremity, Palpitations
Clinical narrative: Pt states he started having heart palpitations, leg px and musculoskeletal px. Pt states malaise as well and went to Emergency Room.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Paraesthesia, Pruritus, Vaccination site pruritus
Clinical narrative: I have felt an itch mainly in the arm where I was injected; As the times passes I feel it in various parts of the body.; Tingling in the legs; Joint pain; Headache; This is a spontaneous report from a contactable consumer (patient herself). A 22-years-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: EW0179, Expiry date: Unknown), via an unspecified route of administration in Arm Left on 04May2021 13:15 as dose 2, single (at the age of 22-years-old) for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. The most recent COVID-19 vaccine was administered in Hospital. The patient's medical history included thyroid disorder and seafood allergy from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID 75 and SYNTHROID 88) taken for an unspecified indication, start and stop date were not reported. The patient previously received past drug BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: EW0161, Expiry date: Unknown), via an unspecified route of administration in Arm Left on 13Apr2021 10:15 as dose 1, single for COVID-19 immunisation. On 04May2021 14:00, after a couple of hours, the patient experienced that she had felt an itch mainly in the arm where she was injected, as the times passed, she felt it in various parts of the body, tingling in the legs, joint pain and headache. Therapeutic measures were not taken as a result of adverse events. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's/PQC's reported; products experienced an excursion; This spontaneous report has been received from a medical assistant referring to a 4 year old patient with unknown gender. The patient's medical history, concurrent condition and concomitant medication were not reported.   On 07-SEP-2021 during transport varicella virus vaccine live (oka/merck) (VARIVAX) experienced temperature excursion of -10 Degrees Celsius to 8 Degrees Celsius (4C) for 20 minutes and on 09-SEP-2021 -10 Degrees Celsius to 8 Degrees Celsius (4C) for 20 minutes. Previous temperature excursion included -10 Degrees Celsius to 8 Degrees Celsius (4C) for 7 hours and 30 minutes.  On 09-SEP-2021 the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (1 dosage form; lot # U002394, expiration date 22-JAN-2023; route and strength were unknown) for prophylaxis (Product storage error).  No additional adverse event was reported (No adverse event).      This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA005628: US-009507513-2109USA005648: US-009507513-2109USA005662: US-009507513-2109USA005618: US-009507513-2109USA005639: US-009507513-2109USA005632: US-009507513-2109USA005910: US-009507513-2109USA005742: US-009507513-2109USA005891: US-009507513-2109USA005964: US-009507513-2109USA005651: US-009507513-2109USA005918: US-009507513-2109USA005758: US-009507513-2109USA005760: US-009507513-2109USA005705: US-009507513-2109USA005776: US-009507513-2109USA005901: US-009507513-2109USA005752: US-009507513-2109USA005641: US-009507513-2109USA005945: US-009507513-2109USA005881: US-009507513-2109USA005902: US-009507513-2109USA005701: US-009507513-2109USA005795: US-009507513-2109USA005730: US-009507513-2109USA006765:
Age: 0.08
Sex: U
Vaccine: VARCEL
Symptoms: Product administered to patient of inappropriate age, Product storage error
Clinical narrative: No additional AE's; a temperature excursion for VARlVAX; the patients dob: 23-JUL-2021; This spontaneous report has been received from a registered nurse (also reported as medical assistant), referring to a 7 weeks old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  The reporter to report a temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX). Per the reporter, varicella virus vaccine live (oka/merck)(VARIVAX) experienced an excursion of (4 degree Celsius (C)) for 20 minutes on 07-SEP-2021 during transport and (4C) for 20 minutes on 09-SEP-2021 during transport. On 13-SEP-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot#U002394 with expiration date: 22-JAN-2023; dose: 1 (units not provided), strength and route were unknown) for prophylaxis (product storage error and product administered to patient of inappropriate age). No additional AE reported.  Administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) experienced the temperature excursion under 10C below zero to 8C (4C) for 20 minutes and 10C  below zero to 8C (4C) for 20 minutes. There previous temperature excursion was under 10C below zero to 8C (4C) for 7 hours and 30 minutes.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA005628: US-009507513-2109USA005632: US-009507513-2109USA005639: US-009507513-2109USA005641: US-009507513-2109USA005648: US-009507513-2109USA005651: US-009507513-2109USA005701: US-009507513-2109USA005705: US-009507513-2109USA005730: US-009507513-2109USA005742: US-009507513-2109USA005744: US-009507513-2109USA005752: US-009507513-2109USA005758: US-009507513-2109USA005760: US-009507513-2109USA005881: US-009507513-2109USA005891: US-009507513-2109USA005901: US-009507513-2109USA005902: US-009507513-2109USA005910: US-009507513-2109USA005918: US-009507513-2109USA005945: US-009507513-2109USA005964: US-009507513-2109USA006765: US-009507513-2109USA005776: US-009507513-2109USA005618: US-009507513-2109USA005662:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: First case of shingles after ZOSTAVAX; the second case after SHINGRIX; This spontaneous report has been received from a female patient of unknown age via Glaxosmithkline, referring to herself. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was unknown.  In 2017 (reported as about 4 years ago), the patient had varicella zoster vaccine rge (cho) (SHINGRIX) vaccine (and completed the series) (indication unknow). On unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis. The dose, strength, route, lot number and expiration date were unknown.  Then, on unknown date, she had a mild case of shingles. The patient had cases of shingles twice. First case of shingles after zoster vaccine live (ZOSTAVAX) and the second case after varicella zoster vaccine rge (cho) (SHINGRIX). The outcome of the events was unknown. The causality assessment between the events and suspect vaccines was not reported.  This is one of two reports from the same reporter. ; Sender's Comments:  US-009507513-2109USA005810:
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product preparation issue
Clinical narrative: No adverse side effects; accidently reconstituted MMR-11 with preservative free saline instead of Merck sterile diluent; This spontaneous report was received from a pharmacist and refers to a 21-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 18-SEP-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 1 dose, 0.5mL subcutaneously (lot # S031483, expiration date: 07-OCT-2021) for prophylaxis, which was accidently reconstituted by a nurse, with a preservative free saline instead of Merck sterile diluent. No adverse event was reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: ?? additional ?? reported; PROQUAD was concomitantly administered with VARIVAX; This spontaneous report was received from a nurse practitioner and refers to a patient of unspecified age and gender. The patient's pertinent medical history, concomitant medications, past drug reactions or allergies were not reported.  On 06-OCT-2021, the patient was vaccinated  with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live rHA (recombinant Human albumin) (PROQUAD) 0.5 milliliter (ml) (lot number T034827 that was verified to be a valid lot number with an expiration date reported and established as 11-APR-2022) and was concomitantly administered with varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter (ml) (lot number U010395 that was verified to be a valid lot number with an expiration date reported and established as 01-APR-2023) for prophylaxis (dose numbers, vaccination scheme frequencies, routes and anatomical sites of administration were not reported) (inappropriate schedule of product administration).  No additional adverse event (no adverse event) was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; She reported that on 21SEP2021, VARlVAX that expired on 16SEP2021 was administered to a patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, and drug reactions/allergies were not reported.  On 21-SEP-2021, the patient was vaccinated with an expired varicella virus vaccine live (Oka/Merck) (VARIVAX) (0.5 mL, lot # S028926 has been verified to be a valid lot number, expiration date was 16-SEP-2021; strength, route of administration, and anatomical location were not reported) for prophylaxis (expired product administered). It was reconstituted with not expired sterile diluent (manufacturer unknown) (0.5 mL, lot number T011343 has been verified to be a valid lot number, expiration date was 06-NOV-2022; strength and route of administration were not reported). It was reported that varicella virus vaccine live (Oka/Merck) (VARIVAX) had not experienced a temperature excursion. The reporter was provided with the expired supported disclaimer. No other adverse events were reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; following a temperature excursion; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 11-OCT-2021, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T022294 was confirmed to be valid, with expiration date 26-MAR-2022 (dose, route of administration, vaccination site were not specified) for prophylaxis. The temperature excursion was 52 degrees Fahrenheit (F) for 62 hours. There were no previous excursions reported. No adverse effects were reported.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Scar, Urticaria, Wrist fracture
Clinical narrative: rash, got worse after the second shot, on his upper torso, chest, arms, and back, on his lats; it started out as "hives" but it is now"blown out."; has left scarring from where he had itched (scratched); rash got worse and it is that red!; rash got worse and It feels like "a poison ivy and mosquito bite itching; This case was reported by a consumer via call center representative and described the occurrence of rash aggravated in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of rash (1st dose received on 20th June 2021 refer case US2021210530).   On 27th August 2021, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced rash aggravated, hives, scar, rash erythematous aggravated and itchy rash. On an unknown date, the outcome of the rash aggravated, hives, scar, rash erythematous aggravated and itchy rash were not recovered/not resolved.   The reporter considered the rash aggravated, hives, scar, rash erythematous aggravated and itchy rash to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient himself. The patient received a dose of Shingrix in left arm and experienced a terrible rash that he has had for 3 months and it progressively got worse after the second shot. he thought that it may be related to Shingrix. The patient stated that the best way to describe the rash is that his arms and chest look like he felt slept on the beach with no sunscreen. it was that red as it felt like a combination of poison ivy and mosquito bite itching along with the worst sunburn it ever had. The patient had seen a general practitioner and an allergist and was wondering if he should see an infectious disease specialist. he indicated that in the beginning it started out as hives but was now blown out. he said that initially it was on his legs then it dissipated from his legs and has left scarring from where he had itched (scratched). at the time of reporting, the rash was more concentrated on his upper torso, chest, arms, and on his back were his lats are. rash was not resolved. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021210530:same reporter and patient
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   In March 2021, the patient received the 2nd dose of Shingles vaccine. In February 2021, the patient received the 1st dose of Shingles vaccine. In October 2021, between 6 and 8 months after receiving Shingles vaccine and between 7 and 9 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. For the last week before the date of reporting, the patient had been suffering with the shingles and the patient had very painful shingle for the last 5 days. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation of shingles was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.