chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nerve conduction studies abnormal
Clinical narrative: GUILLAIN BARRE SYNDROME; UNABLE TO SLEEP; BELL'S PALSY; ALTERED TASTE; ALTERED SMELL; This spontaneous report was received from a patient and concerned a 59 year old male. The patient's weight was 152 pounds, and height was 76 inches. The patient's concurrent conditions included high blood pressure controlled with unspecified medication, smoker 6-8 cigarettes per day, and no known allergies. 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 23-MAY-2021 to his left arm for prophylactic vaccination. Batch number was not reported. Company will perform follow up to obtain batch number. Concomitant medications included unspecified medication for blood pressure.  On 30-MAY-2021, the patient experienced Guillain Barre syndrome requiring hospitalization. He also experienced altered taste and altered smell. His symptoms started off as minor leg pain as cramps, then spread to abdomen, lower back, upper back, chest, arms and feet. He also had tingling in fingers and toes and numbness in hands and feet. The patient was seen by a doctor 2 weeks after receiving vaccine because was was experiencing  Bell's Palsy. The doctor prescribed ibuprofen to help alleviate the pain, but it did not help much. The doctor continued to give him pain killers. He was unable to sleep and went days without sleep. He recently was prescribed Percocet which also did not help much either. The patient was hospitalized on an unspecified date in JUN-2021 and discharged on an unspecified date in JUL-2021.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the Guillain Barre syndrome, altered taste, altered smell, unable to sleep and Bell's Palsy was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:  This spontaneous report received from a consumer concerns a 59-year-old white male patient who was hospitalized with Guillain Barre syndrome (GBS) 7 days after receiving the Janssen Covid-19 vaccine.  The patient have concurrent high blood pressure and is a smoker (6-8 sticks/day).  Symptoms reported were altered taste and smell, leg pain and cramps that spreads to abdomen/lower back/upper back/chest/arms/feet, tingling in fingers and toes, and numbness in hands and feet.  No treatment was reported.  Approximately 2 weeks after vaccination, the patient was found to have Bell's palsy, and was prescribed with ibuprofen and Percocet.  The outcome of the events was not reported.  No other pertinent details reported.  The information available precludes a complete and meaningful assessment.  Based on the information available, the occurrence of the events could represent background incidence of such events in the general population. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy, Guillain-Barre syndrome, Insomnia, Parosmia, Taste disorder
Clinical narrative: GUILLAIN BARRE SYNDROME; UNABLE TO SLEEP; BELL'S PALSY; ALTERED TASTE; ALTERED SMELL; This spontaneous report was received from a patient and concerned a 59 year old male. The patient's weight was 152 pounds, and height was 76 inches. The patient's concurrent conditions included high blood pressure controlled with unspecified medication, smoker 6-8 cigarettes per day, and no known allergies. 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 23-MAY-2021 to his left arm for prophylactic vaccination. Batch number was not reported. Company will perform follow up to obtain batch number. Concomitant medications included unspecified medication for blood pressure.  On 30-MAY-2021, the patient experienced Guillain Barre syndrome requiring hospitalization. He also experienced altered taste and altered smell. His symptoms started off as minor leg pain as cramps, then spread to abdomen, lower back, upper back, chest, arms and feet. He also had tingling in fingers and toes and numbness in hands and feet. The patient was seen by a doctor 2 weeks after receiving vaccine because was was experiencing  Bell's Palsy. The doctor prescribed ibuprofen to help alleviate the pain, but it did not help much. The doctor continued to give him pain killers. He was unable to sleep and went days without sleep. He recently was prescribed Percocet which also did not help much either. The patient was hospitalized on an unspecified date in JUN-2021 and discharged on an unspecified date in JUL-2021.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the Guillain Barre syndrome, altered taste, altered smell, unable to sleep and Bell's Palsy was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:  This spontaneous report received from a consumer concerns a 59-year-old white male patient who was hospitalized with Guillain Barre syndrome (GBS) 7 days after receiving the Janssen Covid-19 vaccine.  The patient have concurrent high blood pressure and is a smoker (6-8 sticks/day).  Symptoms reported were altered taste and smell, leg pain and cramps that spreads to abdomen/lower back/upper back/chest/arms/feet, tingling in fingers and toes, and numbness in hands and feet.  No treatment was reported.  Approximately 2 weeks after vaccination, the patient was found to have Bell's palsy, and was prescribed with ibuprofen and Percocet.  The outcome of the events was not reported.  No other pertinent details reported.  The information available precludes a complete and meaningful assessment.  Based on the information available, the occurrence of the events could represent background incidence of such events in the general population. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: RECEIVED DOSE OF JANSSEN COVID 19 VACCINE INADVERTENTLY; VACCINE UNDERDOSE; This spontaneous report received from a pharmacist concerned a 63 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, route of admin not reported, batch number: 1821281 expiry: 06-SEP-2021) dose was not reported, administered on 19-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-JUL-2021, the subject experienced received dose of janssen covid 19 vaccine inadvertently. On 19-JUL-2021, the subject experienced vaccine underdose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received dose of janssen covid 19 vaccine inadvertently and vaccine underdose was not reported. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administration error, Underdose
Clinical narrative: RECEIVED DOSE OF JANSSEN COVID 19 VACCINE INADVERTENTLY; VACCINE UNDERDOSE; This spontaneous report received from a pharmacist concerned a 63 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, route of admin not reported, batch number: 1821281 expiry: 06-SEP-2021) dose was not reported, administered on 19-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-JUL-2021, the subject experienced received dose of janssen covid 19 vaccine inadvertently. On 19-JUL-2021, the subject experienced vaccine underdose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received dose of janssen covid 19 vaccine inadvertently and vaccine underdose was not reported. This report was non-serious.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Pt received vaccine that was stored improperly. Vaccine was moved from ultra-cold freezer to freezer on 6/17/21. According to Pfizer, vaccine stored in the freezer after day 17 is considered improperly stored, and the pt will need to be re-vaccinated.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Expired product administered, Incomplete course of vaccination
Clinical narrative: Pt received vaccine that was stored improperly. Vaccine was moved from ultra-cold freezer to freezer on 6/17/21. According to Pfizer, vaccine stored in the freezer after day 17 is considered improperly stored, and the pt will need to be re-vaccinated.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Pt received vaccine that was stored improperly. Vaccine was moved from ultra-cold freezer to freezer on 6/17/21. According to Pfizer, vaccine stored in the freezer after day 17 is considered improperly stored, and the pt will need to be re-vaccinated.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Pt received vaccine that was stored improperly. Vaccine was moved from ultra-cold freezer to freezer on 6/17/21. According to Pfizer, vaccine stored in the freezer after day 17 is considered improperly stored, and the pt will need to be re-vaccinated.?
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Pt received vaccine that was stored improperly. Vaccine was moved from ultra-cold freezer to freezer on 6/17/21. According to Pfizer, vaccine stored in the freezer after day 17 is considered improperly stored, and the pt will need to be re-vaccinated.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ?Pt received vaccine that was stored improperly. Vaccine was moved from ultra-cold freezer to freezer on 6/17/21. According to Pfizer, vaccine stored in the freezer after day 17 is considered improperly stored, and the pt will need to be re-vaccinated.?
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: ?Pt received vaccine that was stored improperly. Vaccine was moved from ultra-cold freezer to freezer on 6/17/21. According to Pfizer, vaccine stored in the freezer after day 17 is considered improperly stored, and the pt will need to be re-vaccinated.?
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ?Pt received vaccine that was stored improperly. Vaccine was moved from ultra-cold freezer to freezer on 6/17/21. According to Pfizer, vaccine stored in the freezer after day 17 is considered improperly stored, and the pt will need to be re-vaccinated.?
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: ?Pt received vaccine that was stored improperly. Vaccine was moved from ultra-cold freezer to freezer on 6/17/21. According to Pfizer, vaccine stored in the freezer after day 17 is considered improperly stored, and the pt will need to be re-vaccinated.?
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ?Pt received vaccine that was stored improperly. Vaccine was moved from ultra-cold freezer to freezer on 6/17/21. According to Pfizer, vaccine stored in the freezer after day 17 is considered improperly stored, and the pt will need to be re-vaccinated.?
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: ?Pt received vaccine that was stored improperly. Vaccine was moved from ultra-cold freezer to freezer on 6/17/21. According to Pfizer, vaccine stored in the freezer after day 17 is considered improperly stored, and the pt will need to be re-vaccinated.?
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Axillary pain, Lymphadenopathy, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: 1 week and 1 day after second Pfizer COVID19 vaccineat CVS Pharmacy 5254, 7/4/21, noticed pain to entire Rt shoulder and upper arm which waxes and wanes, unable to describe pain, sometimes only occurs on outer right upper arm and other times radiates to shoulder or upper arm, present for 2 weeks and 3 days now, noticed pain and swelling also to Rt axilla on 7/6/21, present for 2 weeks and 1 day now;
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Axillary pain, Injection site pain, Lymphadenopathy, Oedema peripheral
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: 1 week and 1 day after second Pfizer COVID19 vaccineat CVS Pharmacy 5254, 7/4/21, noticed pain to entire Rt shoulder and upper arm which waxes and wanes, unable to describe pain, sometimes only occurs on outer right upper arm and other times radiates to shoulder or upper arm, present for 2 weeks and 3 days now, noticed pain and swelling also to Rt axilla on 7/6/21, present for 2 weeks and 1 day now;
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cold sweat, Heart rate increased, Loss of consciousness, Seizure
Clinical narrative: Vaccine administered ~7:30pm on 7/21. Patient sat down in observation area to begin medical monitoring. Within 2 minutes patient described feeling sweaty and looked pale. As the nurse began to check on the patient's status, he began having a seizure for about 10-15 seconds. 911 was called. Patient came to and was somewhat disoriented but responsive and still pale. Police/EMS came and recommended he go to the hospital for evaluation. He refused and did not go in the ambulance. Patient indicated no history of seizures. Nurse followed up with patient 7/22 - he is feeling well and did go to the ED. Treating physician advised that it was a "psychological reaction" and "not life threatening." Patient reported feeling well otherwise and has a follow up appointment with his primary care provider.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Disorientation, Hyperhidrosis, Pallor, Seizure
Clinical narrative: Vaccine administered ~7:30pm on 7/21. Patient sat down in observation area to begin medical monitoring. Within 2 minutes patient described feeling sweaty and looked pale. As the nurse began to check on the patient's status, he began having a seizure for about 10-15 seconds. 911 was called. Patient came to and was somewhat disoriented but responsive and still pale. Police/EMS came and recommended he go to the hospital for evaluation. He refused and did not go in the ambulance. Patient indicated no history of seizures. Nurse followed up with patient 7/22 - he is feeling well and did go to the ED. Treating physician advised that it was a "psychological reaction" and "not life threatening." Patient reported feeling well otherwise and has a follow up appointment with his primary care provider.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Headache, Hypoaesthesia, Swelling face
Clinical narrative: 7 DAYS POST-ADMINISTRATION, HALF OF PT'S FACE WAS SWOLLEN WITH NO SENSATION. EXPERIENCED SUDDEN SHARP HEADACHES, CHEST PAIN
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Chills, fever of 102, lethargy, headache, body pain, subsequent ?COVID arm? at injection site 1-3 days later with itching, soreness, swelling, heat.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Lethargy, Pain, Pyrexia
Clinical narrative: Chills, fever of 102, lethargy, headache, body pain, subsequent ?COVID arm? at injection site 1-3 days later with itching, soreness, swelling, heat.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: Chills, fever of 102, lethargy, headache, body pain, subsequent ?COVID arm? at injection site 1-3 days later with itching, soreness, swelling, heat.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Chest X-ray, Chest pain, Dyspnoea, Headache
Clinical narrative: Day 2 after getting the vaccine I went to the hospital over headache, tinnitus, chest pain and breathing problems. The pain never went away but it slowly got worse over time. 5-6 weeks and I am severely suffering from chest pain and shortness of breath. Airways feels very tight. Went to the doctors and got perscribed prednisone and an inhaler. I've never needed or used an inhaler before. I've never had breathing problems other than nasal congestion during flu season. Neither the prednisone or the inhaler help at all. The prednisone and inhaler do not help the breathing even a tiny bit and this is after using them for all 5 days that they were perscribed. Breathing never feels satisfying. I am constantly breathing deep breaths through the mouth for air but it never feels like I'm getting enough air.  Whether it be stress, allergic reactions, or exercise, I have never had breathing problems like this before and I have not done anything else that could have brought these problems on.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Tinnitus
Clinical narrative: Day 2 after getting the vaccine I went to the hospital over headache, tinnitus, chest pain and breathing problems. The pain never went away but it slowly got worse over time. 5-6 weeks and I am severely suffering from chest pain and shortness of breath. Airways feels very tight. Went to the doctors and got perscribed prednisone and an inhaler. I've never needed or used an inhaler before. I've never had breathing problems other than nasal congestion during flu season. Neither the prednisone or the inhaler help at all. The prednisone and inhaler do not help the breathing even a tiny bit and this is after using them for all 5 days that they were perscribed. Breathing never feels satisfying. I am constantly breathing deep breaths through the mouth for air but it never feels like I'm getting enough air.  Whether it be stress, allergic reactions, or exercise, I have never had breathing problems like this before and I have not done anything else that could have brought these problems on.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Anxiety, Aphasia, Arthralgia, Chest X-ray normal
Clinical narrative: Since February- dizziness, lightheadedness, brain fog, migraines, depression, anxiety, memory loss, difficulty finding words, elevated HR,  palpitations, shortness of breath, incontinence, nausea, vomiting, diarrhea, continuous tremors, muscle spasms, neuropathy, joint pain, swollen lymph nodes
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Colonoscopy abnormal, Computerised tomogram head normal, Depression, Diarrhoea, Dizziness
Clinical narrative: Since February- dizziness, lightheadedness, brain fog, migraines, depression, anxiety, memory loss, difficulty finding words, elevated HR,  palpitations, shortness of breath, incontinence, nausea, vomiting, diarrhea, continuous tremors, muscle spasms, neuropathy, joint pain, swollen lymph nodes
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Heart rate increased, Incontinence, Irritable bowel syndrome
Clinical narrative: Since February- dizziness, lightheadedness, brain fog, migraines, depression, anxiety, memory loss, difficulty finding words, elevated HR,  palpitations, shortness of breath, incontinence, nausea, vomiting, diarrhea, continuous tremors, muscle spasms, neuropathy, joint pain, swollen lymph nodes
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Magnetic resonance imaging normal, Migraine, Muscle spasms, Nausea
Clinical narrative: Since February- dizziness, lightheadedness, brain fog, migraines, depression, anxiety, memory loss, difficulty finding words, elevated HR,  palpitations, shortness of breath, incontinence, nausea, vomiting, diarrhea, continuous tremors, muscle spasms, neuropathy, joint pain, swollen lymph nodes
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Oesophagogastroduodenoscopy abnormal, Palpitations, Tremor, Ultrasound abdomen normal
Clinical narrative: Since February- dizziness, lightheadedness, brain fog, migraines, depression, anxiety, memory loss, difficulty finding words, elevated HR,  palpitations, shortness of breath, incontinence, nausea, vomiting, diarrhea, continuous tremors, muscle spasms, neuropathy, joint pain, swollen lymph nodes
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Since February- dizziness, lightheadedness, brain fog, migraines, depression, anxiety, memory loss, difficulty finding words, elevated HR,  palpitations, shortness of breath, incontinence, nausea, vomiting, diarrhea, continuous tremors, muscle spasms, neuropathy, joint pain, swollen lymph nodes
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Biopsy skin abnormal, Lichenoid keratosis, Metabolic function test
Clinical narrative: Developed rash on 06/30 that started on her abdomen, then spread to behind the knees, up her legs, with a mild amount a rash on her back and her forearms, left greater than right.  Rash is not itchy, peaked around 7/9 and is slowly improving.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urine analysis
Clinical narrative: Developed rash on 06/30 that started on her abdomen, then spread to behind the knees, up her legs, with a mild amount a rash on her back and her forearms, left greater than right.  Rash is not itchy, peaked around 7/9 and is slowly improving.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Disturbance in attention, Dysphemia, Feeling hot, Hypoaesthesia
Clinical narrative: Started feeling hot about 19 hours later 07/15/21 around 2:30pm, then both forearms and hands felt tingly/numb sensation on and off for about 7 hours. Started feeling confusion in the brain with stuttering lightly, trouble concentrating, inside brain kept feeling not as aware around 4:30PM for 2 hours,  then started feeling like throwing up lightly around 6:30PM on and off for 3 hours, body ached all over starting at 8:30PM for about 4 hours towards end of night. I took 2 aspirin and 4 Tylenol around 10:00PM, then felt better at 3:30am.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Paraesthesia
Clinical narrative: Started feeling hot about 19 hours later 07/15/21 around 2:30pm, then both forearms and hands felt tingly/numb sensation on and off for about 7 hours. Started feeling confusion in the brain with stuttering lightly, trouble concentrating, inside brain kept feeling not as aware around 4:30PM for 2 hours,  then started feeling like throwing up lightly around 6:30PM on and off for 3 hours, body ached all over starting at 8:30PM for about 4 hours towards end of night. I took 2 aspirin and 4 Tylenol around 10:00PM, then felt better at 3:30am.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Dyspnoea, Heart rate increased
Clinical narrative: Increased heartbeat, flutter, difficulty breathing
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Breast feeding, Exposure during pregnancy, Pregnancy, Pregnancy test urine positive
Clinical narrative: missed period 2/17/2021 with NEG urine preg test. was breastfeeding 11 month old baby.  received 2nd Pfz vacc 2/18/2021; Pos urine preg 2/22/2021. Confirmed PREG at OBGYN exam with usg and heart beat in March 2021.  No heart beat at routine exam 4/15/2021; D&C 4/16/2021. gestation 11 weeks; baby measured 9 weeks gestation. pregnancy #6. 4 healthy children. 1 previous miscarriage in 2015 after Tamiflu in the periconception time.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Uterine dilation and curettage
Clinical narrative: missed period 2/17/2021 with NEG urine preg test. was breastfeeding 11 month old baby.  received 2nd Pfz vacc 2/18/2021; Pos urine preg 2/22/2021. Confirmed PREG at OBGYN exam with usg and heart beat in March 2021.  No heart beat at routine exam 4/15/2021; D&C 4/16/2021. gestation 11 weeks; baby measured 9 weeks gestation. pregnancy #6. 4 healthy children. 1 previous miscarriage in 2015 after Tamiflu in the periconception time.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein increased, Chest X-ray, Differential white blood cell count, Electrocardiogram, Full blood count
Clinical narrative: severe headache, 104.1 fever, high heart rate (160)  treatment: IV, ketorolac discharged from ER after 4 hours
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Metabolic function test abnormal, Procalcitonin increased, Pyrexia
Clinical narrative: severe headache, 104.1 fever, high heart rate (160)  treatment: IV, ketorolac discharged from ER after 4 hours
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory viral panel, SARS-CoV-2 test negative
Clinical narrative: severe headache, 104.1 fever, high heart rate (160)  treatment: IV, ketorolac discharged from ER after 4 hours
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Full blood count normal, Platelet count normal
Clinical narrative: I was lying on my bed reading and suddenly I felt my nose bleeding.  I don't get nosebleeds so it was unusual.  I was able to stop it fairly quickly, but it was a very unusual event for me.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Tendon rupture
Clinical narrative: A week after I received the vaccine i tore my bicep in the same arm helping someone change a tire. All I did was pick up a tire with both hands with a proper base and lifting motion, then i turned the tire about 2 inches to line line up with the lug nuts and I heard a loud velcro tearing noise. It really wasnt alot of weight so Im still confused as to how it happened.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Balance test, Electroencephalogram, Feeling abnormal, Gait disturbance
Clinical narrative: March 31st I began feeling like everything was moving quickly and off balance.  Within a few hours, everything appeared to be spinning and I was nauseous.  Could not balance, walk unassisted, or tolerate light.  I was given a prescription for Meclazine to take as needed - I have recovered about 80%, I am still unable to drive or track fast moving objects
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired driving ability, Magnetic resonance imaging, Nausea, Photophobia, Ultrasound Doppler
Clinical narrative: March 31st I began feeling like everything was moving quickly and off balance.  Within a few hours, everything appeared to be spinning and I was nauseous.  Could not balance, walk unassisted, or tolerate light.  I was given a prescription for Meclazine to take as needed - I have recovered about 80%, I am still unable to drive or track fast moving objects
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: March 31st I began feeling like everything was moving quickly and off balance.  Within a few hours, everything appeared to be spinning and I was nauseous.  Could not balance, walk unassisted, or tolerate light.  I was given a prescription for Meclazine to take as needed - I have recovered about 80%, I am still unable to drive or track fast moving objects
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Breast feeding, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: After I received the vaccine, I began to experience pain and tenderness at the injection site almost immediately. Later that night I began to feel extremely tired so I went to sleep but woke up with chills a few hours later. A short time later I noticed that my neck was stiff and my tonsils began to swell a little. I also developed a slight fever of 100.6 and had headaches throughout the day. I called my doctor and asked if I could come in and if it is okay for me to continue breastfeeding my 5 month old. I was told that if my symptoms persisted or got worse, then I should come in but that I should take Tylenol, drink plenty of fluids and get as much rest as I can and that it was perfectly fine for me to continue to breastfeed my son. The effects lasted about 2 days the worst of it being within the 24 hours of receiving the vaccine.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pyrexia, Sleep disorder, Tonsillar hypertrophy
Clinical narrative: After I received the vaccine, I began to experience pain and tenderness at the injection site almost immediately. Later that night I began to feel extremely tired so I went to sleep but woke up with chills a few hours later. A short time later I noticed that my neck was stiff and my tonsils began to swell a little. I also developed a slight fever of 100.6 and had headaches throughout the day. I called my doctor and asked if I could come in and if it is okay for me to continue breastfeeding my 5 month old. I was told that if my symptoms persisted or got worse, then I should come in but that I should take Tylenol, drink plenty of fluids and get as much rest as I can and that it was perfectly fine for me to continue to breastfeed my son. The effects lasted about 2 days the worst of it being within the 24 hours of receiving the vaccine.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Decreased appetite, Dyspnoea, Headache
Clinical narrative: At first, waking up with  difficulty breathing (around 4:30 AM), pain when breathing (throat), Chest pain. Headache.  Very fast heartbeat.   Took a lot of effort to walk, especially down stairs.  Took Tylenol (around 5:00 AM) , went back to bed.  After  7 hours of sleep, had no appetite. Headache.   Symptoms faded after a couple more hours.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Oropharyngeal pain
Clinical narrative: At first, waking up with  difficulty breathing (around 4:30 AM), pain when breathing (throat), Chest pain. Headache.  Very fast heartbeat.   Took a lot of effort to walk, especially down stairs.  Took Tylenol (around 5:00 AM) , went back to bed.  After  7 hours of sleep, had no appetite. Headache.   Symptoms faded after a couple more hours.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, General physical condition abnormal, Pain
Clinical narrative: I had the expected body aches , pains , fatigue and chills approximately 24 hours after the shot. I controlled them with Tylenol and they were gone in 24 hours but? I have had at least one to 2 times per week since the shot the same symptoms of body aches, pain , fatigue and chills come on and affect me for approximately 24 hours each time. This has gone on for the past 4 weeks. They feel exactly like the very first set of body aches, fatigue  and chills I had 24 hours after the shot.  They just keep hitting me out of the blue . I will be feeling good and I suddenly start feeling sick again. I have not been able to find anything that says that continuing to have these side effects for 4 weeks coming and going is an expected side effect and I am starting g to get very concerned and scared to take the 2nd shot.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Rash, Rash erythematous
Clinical narrative: Red sore arm approximately 3 inches below injection site.  Red rash like area on left inside area of lower leg. Pictures available.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Abdominal pain, Constipation
Clinical narrative: Abdominal pain, distended abdomen, constipation starting in April 2021. Had an appointment with PCP in June 2021 due to recurring pain and an increase in symptom severity. PCP recommended the FODMAP diet for IBS (didn't get an IBS diagnosis) and to get another appointment if symptoms didn't improve within 2 months.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Food allergy, Lacrimation increased, Menstrual disorder, Pruritus
Clinical narrative: All periods (starting 24 May) have been predominantly blood clots; atypical to see any.  Sudden onset of banana allergy. Itchy ENT, swollen/watering eyes, full-body itch.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram ambulatory abnormal, Myocarditis, Tachycardia
Clinical narrative: Suspected myocarditis and diagnosed tachycardia when seen by physician days later.  Tachycardia lasted for period of 3 weeks.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Faeces discoloured
Clinical narrative: Diarrhea.    black stools for 7 days after vaccine... still black today...
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: No additional AE; A patient was given VARlVAX intramuscularly; This spontaneous report was received from a physician (conflicting information also reported as pharmacist) referring to a patient of unknown age and gender. The patient concurrent conditions, pertinent medical history, concomitant therapies and drug reactions or allergies were not reported.  On 28-MAY-2021, the patient was vaccinated with a dosage of varicella virus vaccine live (oka/merck) (VARIVAX) dose 1, intramuscular (IM), (lot # T010298), (expiration date 24-MAR-2022) (strength, and dose were not reported) for prophylaxis; and on the same date, the vaccine was recontinued with sterile diluent/ vaccine lot # T005074, (expiration date 09-SEP-2022) (strength, dosage, route of administration were not reported) for prophylaxis (incorrect route of product administration). The patient did not experience any adverse event.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE reported.; Medical Assistant called and reported that a dose of MMR-II was administered on 7/2/2021 and expired on 6/30/2021./ lnadvertently administered post expiry; This spontaneous information has been received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 02-JUL-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 mL, as prophylaxis, lot number reported as 020161 with expiration date reported as 30-JUN-2021 (strength, frequency, route of administration, and anatomical location were not reported) (expired vaccine used).  No additional adverse events reported.
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Adverse event reported ? Yes; This spontaneous report was received from a female consumer of unknown age reporting on herself.     Information regarding the patient's concurrent conditions, medical history, and concomitant medications was not provided.  On an unknown date, the patient was vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route, frequency, lot # and the expiration date were not reported) for prophylaxis.         On an unknown date, the patient experienced a potential adverse event. Consumer did not confirm weather or not she had any side effects from the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine.   Consumer stated that she was concerned about safety and efficacy of the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine that covered types 6, 11, 18,and 16. Consumer then stated that she had been harassed from outside person that was making outside comments about being fully vaccinated and she wanted to talk to safety division and legal division. Consumer stated "he did not know what he was doing." Consumer refused to elaborate or answer any further questions.   At the time of reporting the outcome of adverse event was unknown.  The relatedness between the adverse event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Myelitis transverse
Clinical narrative: Myelitis transverse; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   In or around 06-JUN-2012, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not reported) for routine health maintenance and for it's intended purpose: the prevention of shingles (herpes zoster).  Shortly, after receiving Defendants' zoster vaccine live (ZOSTAVAX)vaccine, Plaintiff suffered transverse myelitis.   As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX)vaccine, Plaintiff's symptoms have resulted in physical limitations not present prior to using the product. Plaintiffs also experience mental and emotional distress due to resulting physical limitations and seriousness of Plaintiffs' condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), Plaintiffs sustained severe and permanent personal injuries. Further, as a tragic consequence of the wrongful conduct, Plaintiffs suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Defendants' conduct, Plaintiffs have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, transverse myelitis was determined to be a medically significant event.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: hearing loss; other zoster-related conditions; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown gender  whose age at vaccination was 65 years old. No information was provided regarding the pt's medical history, allergies, drug reactions, concurrent conditions or concomitant medications. On 16-JAN-2014, the pt was administered zoster vaccine live (ZOSTAVAX) by the pharmacist at a pharmacy (dose, route of administration, anatomical location, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the pt was treated by a physician for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: hearing loss and other zoster-related conditions. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of hearing loss was determined to be medically significant.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: No other AE. No PQC.; The second dose of PEDVAX HIB that was administered was expired; This spontaneous report has been received from a medical assistant referring to a 4-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported. On an unspecified date in 2021, the patient received the first dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) at the age of 2 months.   On 14-JUL-2021, the patient was vaccinated with the second dose, which was expired, of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (dose, route of administration, anatomical site of vaccination were not provided; lot number r027320 has been verified to be a valid lot number, expiration date 08-JUL-2021) (expired product administered). The reporter stated that the vaccine did not experience a temperature excursion prior to administration. No additional adverse events (AEs) reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: The patient did not report any additional adverse experiences; expired dose of PNEUMOV AX 23 was administered to an adult patient; This spontaneous report was received from a pharmacist via company representative and refers to an adult patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 15-JUL-2021, the patient was vaccinated with single expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, exact dose, route of administration, anatomical location and lot number were not reported)for prophylaxis (expired product administered). Vaccine expired on 12-JUN-2021.  The patient did not report any additional adverse experiences.
Sex: F
Vaccine: HPV9
Symptoms: Anal incontinence, Dysstasia, Feeling of despair, Gait inability, Hypotonia
Clinical narrative: patient was staring in to space and very despondent; patient was staring in to space and very despondent; lost control of her bowels; lack of muscle tone; could not get up and walk; This spontaneous report was received from a licensed practical nurse via company representative and refers to a 13-year-old female patient. Her concurrent conditions included autism. The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with a second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, administered intramuscularly (anatomical location, lot # and expiration date were not reported) as human papillomavirus prevention. On an unknown date (reported as "within a couple hours of receiving the vaccine"), the patient was staring into the space and was very despondent. She also lost control of her bowels, had lack of muscle tone and count not get up and walk. Due to above event, the patient was hospitalized on an unknown date. The reporter stated that HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was the only vaccine that the patient received on that day. It was reported that the patient received treatment for the events and sought medical attention. The outcome of the events was reported as recovered.  Causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the events was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Staring
Clinical narrative: patient was staring in to space and very despondent; patient was staring in to space and very despondent; lost control of her bowels; lack of muscle tone; could not get up and walk; This spontaneous report was received from a licensed practical nurse via company representative and refers to a 13-year-old female patient. Her concurrent conditions included autism. The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with a second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, administered intramuscularly (anatomical location, lot # and expiration date were not reported) as human papillomavirus prevention. On an unknown date (reported as "within a couple hours of receiving the vaccine"), the patient was staring into the space and was very despondent. She also lost control of her bowels, had lack of muscle tone and count not get up and walk. Due to above event, the patient was hospitalized on an unknown date. The reporter stated that HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was the only vaccine that the patient received on that day. It was reported that the patient received treatment for the events and sought medical attention. The outcome of the events was reported as recovered.  Causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the events was not provided.
Age: 28.0
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Heplisav-B Dose Administered; Initial Report Received on 11-Jun-2021  A pharmacist reported that a 28 year-old male (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   No relevant medical history was reported.  No relevant concomitant medications were reported.  On 11-Jun-2021, the patient received a dose of HEPLISAV-B (Lot # 933841, expiration date 06-Jun-2021, NDC # unknown, serial number 699727536567) in the left deltoid from a nurse. At the time of reporting, no site reactions or other adverse symptoms were reported.   No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: SMALL
Symptoms: Myocarditis
Clinical narrative: Myocarditis; Information was received on 09JUL2021 in review of scientific literature.    This case describes an additional single patient identified during review of the entire registry who experienced myocarditis (PT: Myocarditis) after receiving a smallpox vaccine (date unknown).  This study was conducted to review a prospective outcomes registry of COVID-19 vaccinated patients who developed myocarditis for the 3-month period between 01FEB2017 to 30APR2017 and though 2021 and to also identify all patients with possible vaccine-associated myocarditis during the past 20 years.  One of the patients (age, 23-36 years), a member who developed myocarditis after COVID-19 vaccination also had history of documented (as per author) myocarditis approximately 4 years earlier after administration of smallpox vaccine.    Medical history and concomitant medications specific to this patient was not reported.   No additional information is available at the time of report.  Company Comment:  Myocarditis is a known complication that has been reported after ACAM2000 vaccination. However, due to the lack of information the causality cannot be properly assessed; therefore it is considered as "Not assessable". If the occurrence of myocarditis has been documented, it is possible that this case is duplicated. More information will be sought. Although there is no information, the case Is considered serious.; Sender's Comments: Myocarditis is a known complication that has been reported after ACAM2000 vaccination. However, due to the lack of information the causality cannot be properly assessed; therefore it is considered as "Not assessable". If the occurrence of myocarditis has been documented, it is possible that this case is duplicated. More information will be sought. Although there is no information, the case Is considered serious.