chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Burning sensation, Deafness, Fear, Headache
Clinical narrative: 1 year after I had COVID I was vaccinated.  I woke the day after my vaccination at 2AM with a sense of impending doom.  I was shaking like I was cold (I had a fever >100F), but I felt like my blood was fire running through my veins.  My arm was sore, I had muscle aches, and a severe headache.  I also had terrible vertigo and lost my sense of hearing for a period of time.  My symptoms lasted 24 hours, but I thought I was dying, and am very afraid to ever be vaccinated for COVID again.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia, Sleep disorder, Tremor
Clinical narrative: 1 year after I had COVID I was vaccinated.  I woke the day after my vaccination at 2AM with a sense of impending doom.  I was shaking like I was cold (I had a fever >100F), but I felt like my blood was fire running through my veins.  My arm was sore, I had muscle aches, and a severe headache.  I also had terrible vertigo and lost my sense of hearing for a period of time.  My symptoms lasted 24 hours, but I thought I was dying, and am very afraid to ever be vaccinated for COVID again.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: 1 year after I had COVID I was vaccinated.  I woke the day after my vaccination at 2AM with a sense of impending doom.  I was shaking like I was cold (I had a fever >100F), but I felt like my blood was fire running through my veins.  My arm was sore, I had muscle aches, and a severe headache.  I also had terrible vertigo and lost my sense of hearing for a period of time.  My symptoms lasted 24 hours, but I thought I was dying, and am very afraid to ever be vaccinated for COVID again.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles lesion on right wrist 6-4-23 and Shingles lesion on right iliac crest on 6-5-23.  Patient is an M.D. and his son-n-law is also an M.D.  His son-n-law diagnosed the lesions as Shingles lesions.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Differential white blood cell count, Discomfort, Full blood count, Lymphadenopathy, Ultrasound scan
Clinical narrative: Pt describes approx 1 day after receiving Pfizer bivalent covid booster, developed enlarged lymph nodes in R axilla, imm given in R arm. Since then lymph nodes waxing/waning but haven't resolved as expected, ongoing discomfort, nodes remain enlarged on exam today largest approx 2cm x 1cm axillary.
Age: 76.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Fatigue, Nausea, Peripheral swelling, Rash
Clinical narrative: Patient reported feeling tired and nauseous as well as experiencing vomiting and chills the day of and day after vaccine.  One day later the patient developed significant itchy rash and some swelling down the arm of the injection site.  Rash localized to left arm.  Patient has had similar reactions to other vaccines this way.  Patient was instructed to report to the pharmacy and to her primary doctor any worsening of symptoms or if symptoms do not subside within a couple days.  Patient was instructed to use ibuprofen to help with swelling and steroid cream if rash continues.
Age: 76.0
Sex: F
Vaccine: PNC20
Symptoms: Rash pruritic, Vomiting
Clinical narrative: Patient reported feeling tired and nauseous as well as experiencing vomiting and chills the day of and day after vaccine.  One day later the patient developed significant itchy rash and some swelling down the arm of the injection site.  Rash localized to left arm.  Patient has had similar reactions to other vaccines this way.  Patient was instructed to report to the pharmacy and to her primary doctor any worsening of symptoms or if symptoms do not subside within a couple days.  Patient was instructed to use ibuprofen to help with swelling and steroid cream if rash continues.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Cancer surgery, Papilloma viral infection
Clinical narrative: HPV 16, Cancer Cells that had to be removed via cold knife cone  Now have HPV 16 again
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Product expiration date issue
Clinical narrative: We had wrong expiration date on box, we had expiration date of 6/7/23 when in fact the expiration date was 5/23/23, patient received out of date vaccine- did not experience any effects
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Product expiration date issue
Clinical narrative: We had wrong expiration date on box, we had expiration date of 6/7/23 when it was received, actual expiration date was 5/23/23, patient received out date vaccine
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Caught covid late May-June. It was a mild case. Was given Plaxlovid.  Chronic pain completely disappeared for 3 weeks. Came back during week 3.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, RV5
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was erroneously given Rotateq at 1 yo well visit instead of varicella.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain
Clinical narrative: PERSISTENT PAIN IN THE INJECTION SITE EVEN 6 MONTHS AFTER VACCINE WAS GIVEN
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthritis, Cardiac disorder, Myocardial infarction, Pain, Sensory loss
Clinical narrative: Progressive heart condition that has lead to me having a heart attack, spinal degeneration, loss of circulation to limbs, loss of mobility that comes and goes. Loss of spinal volumez
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Spinal vascular disorder
Clinical narrative: Progressive heart condition that has lead to me having a heart attack, spinal degeneration, loss of circulation to limbs, loss of mobility that comes and goes. Loss of spinal volumez
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthritis, Cardiac disorder, Hypertension, Intervertebral disc degeneration, Mobility decreased
Clinical narrative: Progressive heart condition that has lead to me having a heart attack, spinal degeneration, loss of circulation to limbs, loss of mobility that comes and goes. Loss of spinal volumez
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myelitis, Myocardial infarction, Nausea, Poor peripheral circulation, Vomiting
Clinical narrative: Progressive heart condition that has lead to me having a heart attack, spinal degeneration, loss of circulation to limbs, loss of mobility that comes and goes. Loss of spinal volumez
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HIBV, DTAPIPV, HIBV
Symptoms: Anger, Blood glucose normal, Blood pressure decreased, Chills, Echocardiogram normal
Clinical narrative: About 45 min post vaccines, face was flushed and complained of headache. He then started screaming that his hands itched. He angrily threw his body on the ground screaming and grabbing at his face and neck. He then seemed to ?.fall asleep?. His body was very limp but he never stopped breathing. We talked to him consistently. He would open his eyes with very slow speech responses for maybe 10 Seconds at a time and then ?sleep? again. I called 911 but they couldn?t understand me and I didn?t want to waste time. His eye got red and pupils shrunk. I put him in the water park spray and kept having him talk to me. He continually went in and out of ?sleep?. I placed him in car and kept talking to him and commanding him to drink cold sips of water. Drove 5 minutes and carried him limp in and out of ?sleep? into the clinic. He said he was hot. Then he suddenly got very cold with chills. Everyone took vitals. I asked for something to give him many times, and he deeply fell asleep starting to snore. 3 providers assessed him. 911 was called and finally About 15 min later, epinephrine was given. Immediately after the epinephrine He ?woke up? and began taking deep big breaths and came to. Over the next 10 minutes he became himself again. We were transported by ambulance to the emergency room where they did vitals and an ekg and heart ultrasound. No abnormalities noted and we were discharged. 24 hours later I have documented pictures of his left arm with a large red ring. He stated it was very ?itchy?. He has been himself since.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HIBV, DTAPIPV, HIBV
Symptoms: Electrocardiogram normal, Erythema, Feeling of body temperature change, Flushing, Headache
Clinical narrative: About 45 min post vaccines, face was flushed and complained of headache. He then started screaming that his hands itched. He angrily threw his body on the ground screaming and grabbing at his face and neck. He then seemed to ?.fall asleep?. His body was very limp but he never stopped breathing. We talked to him consistently. He would open his eyes with very slow speech responses for maybe 10 Seconds at a time and then ?sleep? again. I called 911 but they couldn?t understand me and I didn?t want to waste time. His eye got red and pupils shrunk. I put him in the water park spray and kept having him talk to me. He continually went in and out of ?sleep?. I placed him in car and kept talking to him and commanding him to drink cold sips of water. Drove 5 minutes and carried him limp in and out of ?sleep? into the clinic. He said he was hot. Then he suddenly got very cold with chills. Everyone took vitals. I asked for something to give him many times, and he deeply fell asleep starting to snore. 3 providers assessed him. 911 was called and finally About 15 min later, epinephrine was given. Immediately after the epinephrine He ?woke up? and began taking deep big breaths and came to. Over the next 10 minutes he became himself again. We were transported by ambulance to the emergency room where they did vitals and an ekg and heart ultrasound. No abnormalities noted and we were discharged. 24 hours later I have documented pictures of his left arm with a large red ring. He stated it was very ?itchy?. He has been himself since.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HIBV, DTAPIPV, HIBV
Symptoms: Hypotonia, Lip swelling, Ocular hyperaemia, Peripheral swelling, Pruritus
Clinical narrative: About 45 min post vaccines, face was flushed and complained of headache. He then started screaming that his hands itched. He angrily threw his body on the ground screaming and grabbing at his face and neck. He then seemed to ?.fall asleep?. His body was very limp but he never stopped breathing. We talked to him consistently. He would open his eyes with very slow speech responses for maybe 10 Seconds at a time and then ?sleep? again. I called 911 but they couldn?t understand me and I didn?t want to waste time. His eye got red and pupils shrunk. I put him in the water park spray and kept having him talk to me. He continually went in and out of ?sleep?. I placed him in car and kept talking to him and commanding him to drink cold sips of water. Drove 5 minutes and carried him limp in and out of ?sleep? into the clinic. He said he was hot. Then he suddenly got very cold with chills. Everyone took vitals. I asked for something to give him many times, and he deeply fell asleep starting to snore. 3 providers assessed him. 911 was called and finally About 15 min later, epinephrine was given. Immediately after the epinephrine He ?woke up? and began taking deep big breaths and came to. Over the next 10 minutes he became himself again. We were transported by ambulance to the emergency room where they did vitals and an ekg and heart ultrasound. No abnormalities noted and we were discharged. 24 hours later I have documented pictures of his left arm with a large red ring. He stated it was very ?itchy?. He has been himself since.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HIBV, DTAPIPV, HIBV
Symptoms: Pupillary disorder, Screaming, Slow speech, Sudden onset of sleep
Clinical narrative: About 45 min post vaccines, face was flushed and complained of headache. He then started screaming that his hands itched. He angrily threw his body on the ground screaming and grabbing at his face and neck. He then seemed to ?.fall asleep?. His body was very limp but he never stopped breathing. We talked to him consistently. He would open his eyes with very slow speech responses for maybe 10 Seconds at a time and then ?sleep? again. I called 911 but they couldn?t understand me and I didn?t want to waste time. His eye got red and pupils shrunk. I put him in the water park spray and kept having him talk to me. He continually went in and out of ?sleep?. I placed him in car and kept talking to him and commanding him to drink cold sips of water. Drove 5 minutes and carried him limp in and out of ?sleep? into the clinic. He said he was hot. Then he suddenly got very cold with chills. Everyone took vitals. I asked for something to give him many times, and he deeply fell asleep starting to snore. 3 providers assessed him. 911 was called and finally About 15 min later, epinephrine was given. Immediately after the epinephrine He ?woke up? and began taking deep big breaths and came to. Over the next 10 minutes he became himself again. We were transported by ambulance to the emergency room where they did vitals and an ekg and heart ultrasound. No abnormalities noted and we were discharged. 24 hours later I have documented pictures of his left arm with a large red ring. He stated it was very ?itchy?. He has been himself since.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HIBV, DTAPIPV, HIBV
Symptoms: Anger, Chills, Consciousness fluctuating, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: About 45 min post vaccines, face was flushed and complained of headache. He then started screaming that his hands itched. He angrily threw his body on the ground screaming and grabbing at his face and neck. He then seemed to ?.fall asleep?. His body was very limp but he never stopped breathing. We talked to him consistently. He would open his eyes with very slow speech responses for maybe 10 Seconds at a time and then ?sleep? again. I called 911 but they couldn?t understand me and I didn?t want to waste time. His eye got red and pupils shrunk. I put him in the water park spray and kept having him talk to me. He continually went in and out of ?sleep?. I placed him in car and kept talking to him and commanding him to drink cold sips of water. Drove 5 minutes and carried him limp in and out of ?sleep? into the clinic. He said he was hot. Then he suddenly got very cold with chills. Everyone took vitals. I asked for something to give him many times, and he deeply fell asleep starting to snore. 3 providers assessed him. 911 was called and finally About 15 min later, epinephrine was given. Immediately after the epinephrine He ?woke up? and began taking deep big breaths and came to. Over the next 10 minutes he became himself again. We were transported by ambulance to the emergency room where they did vitals and an ekg and heart ultrasound. No abnormalities noted and we were discharged. 24 hours later I have documented pictures of his left arm with a large red ring. He stated it was very ?itchy?. He has been himself since.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HIBV, DTAPIPV, HIBV
Symptoms: Feeling cold, Feeling hot, Flushing, Headache, Hyporesponsive to stimuli
Clinical narrative: About 45 min post vaccines, face was flushed and complained of headache. He then started screaming that his hands itched. He angrily threw his body on the ground screaming and grabbing at his face and neck. He then seemed to ?.fall asleep?. His body was very limp but he never stopped breathing. We talked to him consistently. He would open his eyes with very slow speech responses for maybe 10 Seconds at a time and then ?sleep? again. I called 911 but they couldn?t understand me and I didn?t want to waste time. His eye got red and pupils shrunk. I put him in the water park spray and kept having him talk to me. He continually went in and out of ?sleep?. I placed him in car and kept talking to him and commanding him to drink cold sips of water. Drove 5 minutes and carried him limp in and out of ?sleep? into the clinic. He said he was hot. Then he suddenly got very cold with chills. Everyone took vitals. I asked for something to give him many times, and he deeply fell asleep starting to snore. 3 providers assessed him. 911 was called and finally About 15 min later, epinephrine was given. Immediately after the epinephrine He ?woke up? and began taking deep big breaths and came to. Over the next 10 minutes he became himself again. We were transported by ambulance to the emergency room where they did vitals and an ekg and heart ultrasound. No abnormalities noted and we were discharged. 24 hours later I have documented pictures of his left arm with a large red ring. He stated it was very ?itchy?. He has been himself since.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HIBV, DTAPIPV, HIBV
Symptoms: Hypotonia, Injection site erythema, Injection site pruritus, Miosis, Ocular hyperaemia
Clinical narrative: About 45 min post vaccines, face was flushed and complained of headache. He then started screaming that his hands itched. He angrily threw his body on the ground screaming and grabbing at his face and neck. He then seemed to ?.fall asleep?. His body was very limp but he never stopped breathing. We talked to him consistently. He would open his eyes with very slow speech responses for maybe 10 Seconds at a time and then ?sleep? again. I called 911 but they couldn?t understand me and I didn?t want to waste time. His eye got red and pupils shrunk. I put him in the water park spray and kept having him talk to me. He continually went in and out of ?sleep?. I placed him in car and kept talking to him and commanding him to drink cold sips of water. Drove 5 minutes and carried him limp in and out of ?sleep? into the clinic. He said he was hot. Then he suddenly got very cold with chills. Everyone took vitals. I asked for something to give him many times, and he deeply fell asleep starting to snore. 3 providers assessed him. 911 was called and finally About 15 min later, epinephrine was given. Immediately after the epinephrine He ?woke up? and began taking deep big breaths and came to. Over the next 10 minutes he became himself again. We were transported by ambulance to the emergency room where they did vitals and an ekg and heart ultrasound. No abnormalities noted and we were discharged. 24 hours later I have documented pictures of his left arm with a large red ring. He stated it was very ?itchy?. He has been himself since.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HIBV, DTAPIPV, HIBV
Symptoms: Pruritus, Screaming, Slow speech, Snoring, Sudden onset of sleep
Clinical narrative: About 45 min post vaccines, face was flushed and complained of headache. He then started screaming that his hands itched. He angrily threw his body on the ground screaming and grabbing at his face and neck. He then seemed to ?.fall asleep?. His body was very limp but he never stopped breathing. We talked to him consistently. He would open his eyes with very slow speech responses for maybe 10 Seconds at a time and then ?sleep? again. I called 911 but they couldn?t understand me and I didn?t want to waste time. His eye got red and pupils shrunk. I put him in the water park spray and kept having him talk to me. He continually went in and out of ?sleep?. I placed him in car and kept talking to him and commanding him to drink cold sips of water. Drove 5 minutes and carried him limp in and out of ?sleep? into the clinic. He said he was hot. Then he suddenly got very cold with chills. Everyone took vitals. I asked for something to give him many times, and he deeply fell asleep starting to snore. 3 providers assessed him. 911 was called and finally About 15 min later, epinephrine was given. Immediately after the epinephrine He ?woke up? and began taking deep big breaths and came to. Over the next 10 minutes he became himself again. We were transported by ambulance to the emergency room where they did vitals and an ekg and heart ultrasound. No abnormalities noted and we were discharged. 24 hours later I have documented pictures of his left arm with a large red ring. He stated it was very ?itchy?. He has been himself since.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: VARIVAX was administered to patient while it had a temperature excursion; Patient is asymptomatic/No additional AE; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (lot #W031813, with an expiration date on 05-OCT-2024), administered for prophylaxis (strength, and route of administration were not provided).  Nurse reported that varicella virus vaccine live (oka/merck) (VARIVAX) was administered to the patient while it had a temperature excursion. The patient was asymptomatic and no adverse events were reported.  The dose of varicella virus vaccine live (oka/merck) (VARIVAX) was exposed to a temperature excursion of 24.4 degrees Fahrenheit (°F) during a time frame of 5 hours, 51 minutes and 0 seconds.  There was no prior temperature excursions reported.
Sex: M
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: worsening asthma symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 64-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: ASTHMA (non-serious), outcome "unknown", described as "worsening asthma symptoms".  Additional Information: It was reported that the patient mentioned that he got the booster shot in July and the reporter believes it is the monovalent booster that the patient received, but not entirely certain. The reporter wanted to know when the adult bivalent vaccine came out.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood pressure systolic, COVID-19, Computerised tomogram, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2021-BI-073949(17).  An 82-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Stroke" (unspecified if ongoing), notes: :2 TO 3 YEARS AGO. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Jan2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (12Jan2022) Increased; Blood pressure systolic: (12Jan2022) 170's; Computerised tomogram: (12Jan2022) CT SHOWED NO WORSENINGCOMPARED TO LAST YEAR; Heart rate: (12Jan2022) Increased; SARS-CoV-2 test: (12Jan2022) Positive; Spirometry: (12Jan2022) PASSED A BREATHING TEST.  Clinical Information: Patient stated she tested positive for corona virus disease (Covid) on 12Jan2022. Patient stated she had a runny nose, tired, body aches, sneezing, and sore throat. Patient stated that she had covid for about 13 days, she was not hospitalized and feels better. The reporter did not provide a causal assessment for event COVID-19, For regulatory reporting purposes, considers that there was no reasonable causal association below therapy and the events COVID-19  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, SARS-CoV-2 test, Spirometry
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2021-BI-073949(17).  An 82-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Stroke" (unspecified if ongoing), notes: :2 TO 3 YEARS AGO. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Jan2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (12Jan2022) Increased; Blood pressure systolic: (12Jan2022) 170's; Computerised tomogram: (12Jan2022) CT SHOWED NO WORSENINGCOMPARED TO LAST YEAR; Heart rate: (12Jan2022) Increased; SARS-CoV-2 test: (12Jan2022) Positive; Spirometry: (12Jan2022) PASSED A BREATHING TEST.  Clinical Information: Patient stated she tested positive for corona virus disease (Covid) on 12Jan2022. Patient stated she had a runny nose, tired, body aches, sneezing, and sore throat. Patient stated that she had covid for about 13 days, she was not hospitalized and feels better. The reporter did not provide a causal assessment for event COVID-19, For regulatory reporting purposes, considers that there was no reasonable causal association below therapy and the events COVID-19  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Sciatica
Clinical narrative: Excruciating lower back pain; My physical therapist thinks it's my sciatic nerve; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08May2023 at 15:00 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: BACK PAIN (non-serious), outcome "not recovered", described as "Excruciating lower back pain"; SCIATICA (non-serious), outcome "not recovered", described as "My physical therapist thinks it's my sciatic nerve".  Additional information: The patient was asking if there is any information on vaccine causing sciatic nerve pain.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Feb2023 at 18:00 as dose 4 (booster), single (Lot number: GJ3270) at the age of 65 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Feb2021 at 12:00 as dose 1, single (Lot number: EL9265), in right arm, on 25Feb2021 at 16:00 as dose 2, single (Lot number: EN6202), in left arm and on 11Nov2021 at 14:00 as dose 3 (booster), single (Lot number: FF883), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 25May2023 to 30May2023.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Fatigue, Pain in extremity
Clinical narrative: My arm was just a little sore; Other than a little fatigue after that for a day or so I was fine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 24Mar2021 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Other than a little fatigue after that for a day or so I was fine"; PAIN IN EXTREMITY (non-serious) with onset 24Mar2021, outcome "recovered" (Mar2021), described as "My arm was just a little sore". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Covid Vaccine side effects 1st dose 24Mar2021. Patient had the dose at 11 AM and had a stress test at 3:30 that afternoon. Her arm was just a little sore. She sat down to watch a show she recorded and had dinner about 5:30. Took a bite of a mini rice cake and the next thing she knew the phone was ringing waking me up and still had the rice cake in her mouth. Other than a little fatigue after that for a day or so she was fine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Dec2022 as dose 5 (booster), single (Lot number: GJ3275) for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Jul2022 as dose 4 (booster), single (Lot number: FM7553) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered".  Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid). No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Product contamination physical
Clinical narrative: They notice a foreign substance in that prefilled syringe and they wanted to let us know and it was not administered to any patient; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group.  The following information was reported: PRODUCT CONTAMINATION PHYSICAL (non-serious), outcome "unknown", described as "They notice a foreign substance in that prefilled syringe and they wanted to let us know and it was not administered to any patient".
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Pain assessment, SARS-CoV-2 test
Clinical narrative: Get covid symptoms 27May/ put on Paxlovid; Get covid symptoms 27May/ put on Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27May2023, outcome "unknown" and all described as "Get covid symptoms 27May/ put on Paxlovid". The patient underwent the following laboratory tests and procedures: Pain assessment: (28May2023) level 8; (29May2023) level 8; SARS-CoV-2 test: (27May2023) Negative, notes: I get covid symptoms 27May but test negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient got covid symptoms 27May but test negative. In bed all day 28May with headache and body pains at level 8. On 29May got sore throat at pain level 8. On 30May was put on Paxlovid and by afternoon sore throat and fever gone and stopped pain meds.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300209235 Same drug/events, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Computerised tomogram, Computerised tomogram heart, Pulmonary mass
Clinical narrative: my Lungs lite up like a Tree from the Contrast and showed that I had a had a population of 5mm nodules occupying my lungs bilaterally in the lower bases.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PULMONARY MASS (non-serious), outcome "not recovered", described as "my Lungs lite up like a  Tree from the Contrast and showed that I had a had a population of 5mm nodules occupying my lungs bilaterally in the lower bases.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was stated by the patient that "Right after I had my first COVID-19 Vaccination I was scheduled for a Heart Calcium Scan. I went to have the Heart Scan done and very fortunately my Score was only 22. But, my Lungs lite up like a  Tree from the Contrast and showed that I had a had a population of 5mm nodules occupying my lungs bilaterally in the lower bases. I had a bad reaction to the Pfizer COVID-19 Vaccination and Booster. My Lungs are now covered with 5mm and 6 mm nodules that no one will touch. I got C-T Scans of my Chest every 3 months for 2 years and now q 6 months."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: PNC13, UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient received pentacel and prevnar vaccines in error with no reported adverse event; Initial information received on 31-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Child of unknown gender who received PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) [PREVNAR 13] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] vaccines in error with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a Primary dose of 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (Suspension for injection) (lot: UJ799AA) via intramuscular route on left side and the patient also received an unknown dose of suspect PREVNAR 13 not produced by Sanofi Pasteur (formulation; lot number; expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization). Information regarding batch number will be requested in the case.  On an unknown date the patient received pentacel and prevnar vaccines in error with no reported adverse event (wrong product administered) (latency: same day).  It was reported, "This was a double scheduled visit with sibling, both children have same initals. Doctor requested vaccines for patient by circling vaccines on enounter (Pentacel and Prevnar-13) on both children, order was entered by nurse, Vaccines were drawn up, documented in chart prior to giving vaccines. Vaccines were given. A: After leaving exam room, I came out to nurses station and another nurse was questioning whether or not the older brother was needing these vaccines. Prompting her to look at the system, seeing that they INVALID. Dr. was notified and Manager notified: Dr. will document and contact parent. Drug rep/ manufacturer will be contacted to see if there will be any adverse effects."   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: opened IPOL was exposed to temperature of 47.7F for 47.25 mins due to the door was left open and was administered to patient with no reported adverse event; opened IPOL was exposed to temperature of 47.7F for 47.25 mins due to the door was left open and was administered to patient with no reported adverse event; Initial information received on 31-May-2023 regarding an unsolicited valid non-serious case received from nurse.  This case involves a 4 months old male patient who was administered opened IPV (VERO) [IPOL] which was exposed to temperature of 47.7F for 47.25 mins due to the door was left open with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-May-2023, the patient received a dose of 0.5 ml of suspect IPV (VERO) (Suspension for injection) (lot: V1B902M; expiry date: 02-Jun-2024; strength: standard) via intramuscular route in the right thigh for Immunization.  On 23-May-2023 the patient was administered opened IPV (VERO) [IPOL] which was exposed to temperature of 47.7F for 47.25 mins due to the door was left open with no reported adverse event (product storage error) (unknown latency) (poor quality product administered) (latency: same day).   It was reported, "A Nurse called and wants to know if their vaccines are still suitable to use after it had a temperature excursion. Caller asked also if revaccination is needed because they administered the IPOL vaccine after it had excursion."   Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Immunisation reaction, Induration, Mass, Pruritus
Clinical narrative: moderna arm. redness about 4 inches around, hard lump, itchy.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Visual impairment
Clinical narrative: Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Visual Changes/Disturbances-Medium
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Eye swelling, Injection site swelling, Mouth swelling, Swelling face, Swollen tongue
Clinical narrative: Site: Swelling at Injection Site-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Hypoxia, Symptom recurrence
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOTENSION HYPOXEMIA 5/31/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Feeling hot, Pain, Pain in extremity
Clinical narrative: After having received my second Shingrix vaccine, I had a much more severe reaction than I did to the first shot. My arm was incredibly sore the first through sixth days with swelling, itching, fever, chills, and overall body aches. Day five the swelling decreased and day six is merely red, itchy, and hot, with only moderate pain in the arm.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia, Swelling
Clinical narrative: After having received my second Shingrix vaccine, I had a much more severe reaction than I did to the first shot. My arm was incredibly sore the first through sixth days with swelling, itching, fever, chills, and overall body aches. Day five the swelling decreased and day six is merely red, itchy, and hot, with only moderate pain in the arm.
Sex: U
Vaccine: RAB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pharmacist dispensed Anti-D instead of Rabies vaccine encountering a dispensing error. The nurse received a wrong medication and without noticing, she administered it to the patient, which leaded to cause an administration error. Both the nurse and pharmacist were new staff.  reemphasis on training of new staff.   Error reached patient; no patient harm
Sex: F
Vaccine: COVID19
Symptoms: Angiogram cerebral abnormal, Cerebral venous sinus thrombosis, Computerised tomogram head abnormal, Heavy menstrual bleeding, Intensive care
Clinical narrative: Cerebral Venous Sinus Thrombosis Covid vaccine on 12/17/2020, 1/7/2021 and 11/30/2021. After first two I had worsening Menorrhagia So started loestrin in 2/2021. exactly two weeks after my Covid booster I was admitted to the Neuro ICU with the thrombus.
Sex: F
Vaccine: COVID19
Symptoms: Intracranial contrast-enhanced magnetic resonance venography, Thrombosis, Transverse sinus thrombosis
Clinical narrative: Cerebral Venous Sinus Thrombosis Covid vaccine on 12/17/2020, 1/7/2021 and 11/30/2021. After first two I had worsening Menorrhagia So started loestrin in 2/2021. exactly two weeks after my Covid booster I was admitted to the Neuro ICU with the thrombus.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Vaccine expiration date was 6/3/2023, vaccine given on 6/5/2023.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, Angiogram pulmonary abnormal, COVID-19, Chest discomfort, Dyspnoea
Clinical narrative: BREAKTHROUGH COVID: FULLY VACCINATED COVID 19 POSITIVE WITH BOOSTER. 73-year-old male presents to the ED with a 3 day history of worsening shortness of breath and requiring daytime use of oxygen.  Patient reports  family members are positive with COVID 19.  He denies any fever or chills but states that he has been coughing with a small amount of sputum production as well as some chest tightness.  He tested positive for COVID in the emergency room today was started on remdesivir and Decadron. Dx of Acute on chronic hypoxic resp failure.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Productive cough, Pulmonary mass, Respiratory failure, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: BREAKTHROUGH COVID: FULLY VACCINATED COVID 19 POSITIVE WITH BOOSTER. 73-year-old male presents to the ED with a 3 day history of worsening shortness of breath and requiring daytime use of oxygen.  Patient reports  family members are positive with COVID 19.  He denies any fever or chills but states that he has been coughing with a small amount of sputum production as well as some chest tightness.  He tested positive for COVID in the emergency room today was started on remdesivir and Decadron. Dx of Acute on chronic hypoxic resp failure.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Angiogram cerebral abnormal, Arteriogram carotid abnormal, COVID-19 pneumonia, Chronic kidney disease
Clinical narrative: BREAKTHROUGH COVID: FULLY VACCINATED COVID POSITIVE. Admitted to rule out TIA/stroke. Likely symptoms from prior stroke in setting of active infection per neurology. Patient intermittently febrile in ED. Nonproductive cough x3 days. Sore throat. Daughter was sick. Diagnosed with COVID pneumonia, remained stable on RA through entire hospitalization, acute kidney injury on CKD stage 3/4 prior to admission.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Echocardiogram, Magnetic resonance imaging head abnormal, Oropharyngeal pain, Pyrexia
Clinical narrative: BREAKTHROUGH COVID: FULLY VACCINATED COVID POSITIVE. Admitted to rule out TIA/stroke. Likely symptoms from prior stroke in setting of active infection per neurology. Patient intermittently febrile in ED. Nonproductive cough x3 days. Sore throat. Daughter was sick. Diagnosed with COVID pneumonia, remained stable on RA through entire hospitalization, acute kidney injury on CKD stage 3/4 prior to admission.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Vaccine breakthrough infection, Vertebral artery stenosis
Clinical narrative: BREAKTHROUGH COVID: FULLY VACCINATED COVID POSITIVE. Admitted to rule out TIA/stroke. Likely symptoms from prior stroke in setting of active infection per neurology. Patient intermittently febrile in ED. Nonproductive cough x3 days. Sore throat. Daughter was sick. Diagnosed with COVID pneumonia, remained stable on RA through entire hospitalization, acute kidney injury on CKD stage 3/4 prior to admission.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction
Clinical narrative: ACUTE ST ELEVATION MI, UNSPECIFIED
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Hypoxia, Pulmonary embolism, Symptom recurrence
Clinical narrative: HYPOTENSION ACUTE PULMONARY EMBOLISM HYPOXIA 12/10/2022,  12/30/2022,  1/3/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood alcohol increased, Blood potassium decreased, COVID-19, Chest X-ray normal, Chest pain
Clinical narrative: BREAKTHROUGH COVID: FULLY VACCINATED COVID POSITIVE WITH BOOSTER. COVID-19 VIRAL SYNDROME WITH PLEURITIC CHEST PAIN AND SOB. NO HYPOXIA, MONITORED CLINICALLY.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Electrocardiogram normal, Fibrin D dimer normal, Pleuritic pain, SARS-CoV-2 test positive
Clinical narrative: BREAKTHROUGH COVID: FULLY VACCINATED COVID POSITIVE WITH BOOSTER. COVID-19 VIRAL SYNDROME WITH PLEURITIC CHEST PAIN AND SOB. NO HYPOXIA, MONITORED CLINICALLY.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccine breakthrough infection, Viral infection
Clinical narrative: BREAKTHROUGH COVID: FULLY VACCINATED COVID POSITIVE WITH BOOSTER. COVID-19 VIRAL SYNDROME WITH PLEURITIC CHEST PAIN AND SOB. NO HYPOXIA, MONITORED CLINICALLY.
Age: 8.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: No adverse event
Clinical narrative: no adverse reaction
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Chronic respiratory failure, Hypoxia, Respiratory failure
Clinical narrative: ACUTE RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXIA