chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal tenderness, Asthenia, Asthenopia, Blood pressure increased, Blood test
Clinical narrative: After the vaccine when I was walking to my car I got an instant headache and didn't feel right.  I looked in the mirror and my face was red.  When I got home I slept for about 4 hours and when I woke I still felt horrible.  Things got worse and I continued to feel weaker, short of breathe, my head hurt, the back of my neck hurt and and by Sunday I contacted the nurse with the medical insurance I have and she suggested that I go to the ER because about 15 years earlier I was treated for guillian brea.  I went in through the ER and they did a number of test and blood work and the neurologist that was on duty had them put me in the hospital.  While I was in the hospital they did a spinal tap, all kind of blood work and nerve conduction test.  Dr. said that there was no particular test that they could do that would say yes, it was the vaccine so they were just trying to rule things out.  I left the hospital and have been under the care of my primary doctor.  Since then, my blood pressure has increased to the amount that I now am on 2 different type of blood pressure medicines.  I also have at some times severe headaches sometimes minor headaches every day.  The past 15 days I have had a constant headache.  The headaches are on the front part of my head and they are like really bad pressure headaches.  When the headaches gets really bad, the back of my neck hurts really bad.  If the headache isn't that bad, my neck doesn't seem to bother me.  I never ran a fever but my stomach was also very tender to the touch.  The tenderness comes back off and on.  I also get weakness in my legs and arms sometimes.  When the headaches are really bad, it's hard to consentrate and even hold my eyes open.  I do have an appointment with a neurologist but am not able to get in with him until the end of August.  I also have an appointment with an ears nose and throat doctor the end of July.  Before I got this vaccine, I never got headaches.  Now I pretty much have a continuous headach.
Age: 61.0
Sex: F
Vaccine: MMR
Symptoms: Disturbance in attention, Dyspnoea, Electrocardiogram, Erythema, Feeling abnormal
Clinical narrative: After the vaccine when I was walking to my car I got an instant headache and didn't feel right.  I looked in the mirror and my face was red.  When I got home I slept for about 4 hours and when I woke I still felt horrible.  Things got worse and I continued to feel weaker, short of breathe, my head hurt, the back of my neck hurt and and by Sunday I contacted the nurse with the medical insurance I have and she suggested that I go to the ER because about 15 years earlier I was treated for guillian brea.  I went in through the ER and they did a number of test and blood work and the neurologist that was on duty had them put me in the hospital.  While I was in the hospital they did a spinal tap, all kind of blood work and nerve conduction test.  Dr. said that there was no particular test that they could do that would say yes, it was the vaccine so they were just trying to rule things out.  I left the hospital and have been under the care of my primary doctor.  Since then, my blood pressure has increased to the amount that I now am on 2 different type of blood pressure medicines.  I also have at some times severe headaches sometimes minor headaches every day.  The past 15 days I have had a constant headache.  The headaches are on the front part of my head and they are like really bad pressure headaches.  When the headaches gets really bad, the back of my neck hurts really bad.  If the headache isn't that bad, my neck doesn't seem to bother me.  I never ran a fever but my stomach was also very tender to the touch.  The tenderness comes back off and on.  I also get weakness in my legs and arms sometimes.  When the headaches are really bad, it's hard to consentrate and even hold my eyes open.  I do have an appointment with a neurologist but am not able to get in with him until the end of August.  I also have an appointment with an ears nose and throat doctor the end of July.  Before I got this vaccine, I never got headaches.  Now I pretty much have a continuous headach.
Age: 61.0
Sex: F
Vaccine: MMR
Symptoms: Head discomfort, Headache, Laboratory test, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: After the vaccine when I was walking to my car I got an instant headache and didn't feel right.  I looked in the mirror and my face was red.  When I got home I slept for about 4 hours and when I woke I still felt horrible.  Things got worse and I continued to feel weaker, short of breathe, my head hurt, the back of my neck hurt and and by Sunday I contacted the nurse with the medical insurance I have and she suggested that I go to the ER because about 15 years earlier I was treated for guillian brea.  I went in through the ER and they did a number of test and blood work and the neurologist that was on duty had them put me in the hospital.  While I was in the hospital they did a spinal tap, all kind of blood work and nerve conduction test.  Dr. said that there was no particular test that they could do that would say yes, it was the vaccine so they were just trying to rule things out.  I left the hospital and have been under the care of my primary doctor.  Since then, my blood pressure has increased to the amount that I now am on 2 different type of blood pressure medicines.  I also have at some times severe headaches sometimes minor headaches every day.  The past 15 days I have had a constant headache.  The headaches are on the front part of my head and they are like really bad pressure headaches.  When the headaches gets really bad, the back of my neck hurts really bad.  If the headache isn't that bad, my neck doesn't seem to bother me.  I never ran a fever but my stomach was also very tender to the touch.  The tenderness comes back off and on.  I also get weakness in my legs and arms sometimes.  When the headaches are really bad, it's hard to consentrate and even hold my eyes open.  I do have an appointment with a neurologist but am not able to get in with him until the end of August.  I also have an appointment with an ears nose and throat doctor the end of July.  Before I got this vaccine, I never got headaches.  Now I pretty much have a continuous headach.
Age: 61.0
Sex: F
Vaccine: MMR
Symptoms: Malaise, Muscular weakness, Neck pain, Nerve conduction studies
Clinical narrative: After the vaccine when I was walking to my car I got an instant headache and didn't feel right.  I looked in the mirror and my face was red.  When I got home I slept for about 4 hours and when I woke I still felt horrible.  Things got worse and I continued to feel weaker, short of breathe, my head hurt, the back of my neck hurt and and by Sunday I contacted the nurse with the medical insurance I have and she suggested that I go to the ER because about 15 years earlier I was treated for guillian brea.  I went in through the ER and they did a number of test and blood work and the neurologist that was on duty had them put me in the hospital.  While I was in the hospital they did a spinal tap, all kind of blood work and nerve conduction test.  Dr. said that there was no particular test that they could do that would say yes, it was the vaccine so they were just trying to rule things out.  I left the hospital and have been under the care of my primary doctor.  Since then, my blood pressure has increased to the amount that I now am on 2 different type of blood pressure medicines.  I also have at some times severe headaches sometimes minor headaches every day.  The past 15 days I have had a constant headache.  The headaches are on the front part of my head and they are like really bad pressure headaches.  When the headaches gets really bad, the back of my neck hurts really bad.  If the headache isn't that bad, my neck doesn't seem to bother me.  I never ran a fever but my stomach was also very tender to the touch.  The tenderness comes back off and on.  I also get weakness in my legs and arms sometimes.  When the headaches are really bad, it's hard to consentrate and even hold my eyes open.  I do have an appointment with a neurologist but am not able to get in with him until the end of August.  I also have an appointment with an ears nose and throat doctor the end of July.  Before I got this vaccine, I never got headaches.  Now I pretty much have a continuous headach.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Arthralgia, Balance disorder, Blood test, Cytogenetic analysis
Clinical narrative: Very stiff/sore shoulder immediately following injection persisting for 3-4 weeks and onset in that same timeframe of gait irregularity and leg weakness on right side resulting in tripping, difficulty walking independently, balance issues, requiring a cane and eventually a rollator. Multiple neurologists seen with no known diagnosis or treatment plan.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electromyogram, Gait disturbance, Immediate post-injection reaction, Magnetic resonance imaging, Muscular weakness
Clinical narrative: Very stiff/sore shoulder immediately following injection persisting for 3-4 weeks and onset in that same timeframe of gait irregularity and leg weakness on right side resulting in tripping, difficulty walking independently, balance issues, requiring a cane and eventually a rollator. Multiple neurologists seen with no known diagnosis or treatment plan.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Nerve conduction studies, Scan brain, Walking aid user
Clinical narrative: Very stiff/sore shoulder immediately following injection persisting for 3-4 weeks and onset in that same timeframe of gait irregularity and leg weakness on right side resulting in tripping, difficulty walking independently, balance issues, requiring a cane and eventually a rollator. Multiple neurologists seen with no known diagnosis or treatment plan.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Balance disorder, Fall, Gait disturbance, Gait inability
Clinical narrative: Very stiff/sore shoulder immediately following injection persisting for 3-4 weeks and onset in that same timeframe of gait irregularity and leg weakness on right side resulting in tripping, difficulty walking independently, balance issues, requiring a cane and eventually a rollator. Multiple neurologists seen with no known diagnosis or treatment plan.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Musculoskeletal stiffness
Clinical narrative: Very stiff/sore shoulder immediately following injection persisting for 3-4 weeks and onset in that same timeframe of gait irregularity and leg weakness on right side resulting in tripping, difficulty walking independently, balance issues, requiring a cane and eventually a rollator. Multiple neurologists seen with no known diagnosis or treatment plan.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt was in the clinic for a PPD reading on 6/7/24. The nurse noticed that the child's left arm was red and swollen at the site of the DTap injection that was done on 6/5/24. The provider on duty was notified, and said it could be an allergic reaction to the adhesive of the band-aid, because the redness was in the shape of the adhesive parts of the band-aid. The child's parents were advised to monitor the site and come back if it worsens or new symptoms occur. The child had an acute visit on 7/3/24 and the provider noticed that there was still a bump on left arm.
Age: 2.58
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No report of adverse reaction has been stated by mother of child
Age: 37.0
Sex: U
Vaccine: CHIK, CHIK, JEV1, RAB
Symptoms: Arthralgia, C-reactive protein normal, Chest pain, Chikungunya test, Epistaxis
Clinical narrative: Fever; Rash; Muscle pain; Fatigue; Headache; Nose bleeds; Bleeding gums; Joint pain; The following information was received from a nurse on 24 June 2024.  A 37-year-old female vaccinee received one dose of IXCHIQ (prevention of disease caused by chikungunya virus (CHIKV), batch number 23J021) i.m. into her right deltoid on 14 June 2024. Co-suspect vaccines administered on the same day included booster doses of Japanese encephalitis vaccine (batch number not provided) and rabies vaccine.  On 22 June 2024, the female experienced bleeding gums, nose bleeds, headache, fatigue, joint pain and muscle pain. On 24 June 2024, she experienced rash and fever. She received Tylenol (paracetamol) as treatment drug.   At time of reporting, the reactions were still ongoing.; Sender's Comments: Company causality assessment:  IXCHIQ: Causality assessed as possibly related for IXCHIQ, for all events as time to onset is plausible (8-10 days past vaccination) and as all adverse events with exception of Bleeding gums and Nose bleeds, are well known for IXCHIQ, indicative of a systemic vaccination reaction and fulfilling in this combination the definition of Chikungunya-like adverse reactions. However, co-suspect vaccinations with Japanese encephalitis vaccine and Rabies vaccine on the same day should be taken into consideration, too.  IXIARO ('japanese encephalitis vaccine (NOS)'): Causality assessed as possibly related for IXIARO, for all events as time to onset is plausible (8-10 days past vaccination) and as all adverse events with exception of Bleeding gums and Nose bleeds, are well known for IXIARO, indicative of a systemic vaccination reaction. However, it has not yet been conclusively clarified whether the reported Japanese encephalitis vaccine is the Valneva product IXIARO, and the reported combination of events indicates more likely a chikungunya-like adverse reaction. Nevertheless, co-suspect vaccinations with IXCHIQ and Rabies vaccine on the same day should be taken into consideration, too.  A follow-up was conducted to clarify the open questions.
Age: 37.0
Sex: U
Vaccine: CHIK, CHIK, JEV1, RAB
Symptoms: Fatigue, Flank pain, Full blood count normal, Gingival bleeding, Liver function test normal
Clinical narrative: Fever; Rash; Muscle pain; Fatigue; Headache; Nose bleeds; Bleeding gums; Joint pain; The following information was received from a nurse on 24 June 2024.  A 37-year-old female vaccinee received one dose of IXCHIQ (prevention of disease caused by chikungunya virus (CHIKV), batch number 23J021) i.m. into her right deltoid on 14 June 2024. Co-suspect vaccines administered on the same day included booster doses of Japanese encephalitis vaccine (batch number not provided) and rabies vaccine.  On 22 June 2024, the female experienced bleeding gums, nose bleeds, headache, fatigue, joint pain and muscle pain. On 24 June 2024, she experienced rash and fever. She received Tylenol (paracetamol) as treatment drug.   At time of reporting, the reactions were still ongoing.; Sender's Comments: Company causality assessment:  IXCHIQ: Causality assessed as possibly related for IXCHIQ, for all events as time to onset is plausible (8-10 days past vaccination) and as all adverse events with exception of Bleeding gums and Nose bleeds, are well known for IXCHIQ, indicative of a systemic vaccination reaction and fulfilling in this combination the definition of Chikungunya-like adverse reactions. However, co-suspect vaccinations with Japanese encephalitis vaccine and Rabies vaccine on the same day should be taken into consideration, too.  IXIARO ('japanese encephalitis vaccine (NOS)'): Causality assessed as possibly related for IXIARO, for all events as time to onset is plausible (8-10 days past vaccination) and as all adverse events with exception of Bleeding gums and Nose bleeds, are well known for IXIARO, indicative of a systemic vaccination reaction. However, it has not yet been conclusively clarified whether the reported Japanese encephalitis vaccine is the Valneva product IXIARO, and the reported combination of events indicates more likely a chikungunya-like adverse reaction. Nevertheless, co-suspect vaccinations with IXCHIQ and Rabies vaccine on the same day should be taken into consideration, too.  A follow-up was conducted to clarify the open questions.
Age: 37.0
Sex: U
Vaccine: CHIK, CHIK, JEV1, RAB
Symptoms: Metabolic function test normal, Pyrexia, Rash, Red blood cell sedimentation rate normal
Clinical narrative: Fever; Rash; Muscle pain; Fatigue; Headache; Nose bleeds; Bleeding gums; Joint pain; The following information was received from a nurse on 24 June 2024.  A 37-year-old female vaccinee received one dose of IXCHIQ (prevention of disease caused by chikungunya virus (CHIKV), batch number 23J021) i.m. into her right deltoid on 14 June 2024. Co-suspect vaccines administered on the same day included booster doses of Japanese encephalitis vaccine (batch number not provided) and rabies vaccine.  On 22 June 2024, the female experienced bleeding gums, nose bleeds, headache, fatigue, joint pain and muscle pain. On 24 June 2024, she experienced rash and fever. She received Tylenol (paracetamol) as treatment drug.   At time of reporting, the reactions were still ongoing.; Sender's Comments: Company causality assessment:  IXCHIQ: Causality assessed as possibly related for IXCHIQ, for all events as time to onset is plausible (8-10 days past vaccination) and as all adverse events with exception of Bleeding gums and Nose bleeds, are well known for IXCHIQ, indicative of a systemic vaccination reaction and fulfilling in this combination the definition of Chikungunya-like adverse reactions. However, co-suspect vaccinations with Japanese encephalitis vaccine and Rabies vaccine on the same day should be taken into consideration, too.  IXIARO ('japanese encephalitis vaccine (NOS)'): Causality assessed as possibly related for IXIARO, for all events as time to onset is plausible (8-10 days past vaccination) and as all adverse events with exception of Bleeding gums and Nose bleeds, are well known for IXIARO, indicative of a systemic vaccination reaction. However, it has not yet been conclusively clarified whether the reported Japanese encephalitis vaccine is the Valneva product IXIARO, and the reported combination of events indicates more likely a chikungunya-like adverse reaction. Nevertheless, co-suspect vaccinations with IXCHIQ and Rabies vaccine on the same day should be taken into consideration, too.  A follow-up was conducted to clarify the open questions.
Age: 37.0
Sex: U
Vaccine: CHIK, CHIK, JEV1, RAB
Symptoms: Arthralgia, Epistaxis, Fatigue, Gaze palsy, Gingival bleeding
Clinical narrative: Fever; Rash; Muscle pain; Fatigue; Headache; Nose bleeds; Bleeding gums; Joint pain; The following information was received from a nurse on 24 June 2024.  A 37-year-old female vaccinee received one dose of IXCHIQ (prevention of disease caused by chikungunya virus (CHIKV), batch number 23J021) i.m. into her right deltoid on 14 June 2024. Co-suspect vaccines administered on the same day included booster doses of Japanese encephalitis vaccine (batch number not provided) and rabies vaccine.  On 22 June 2024, the female experienced bleeding gums, nose bleeds, headache, fatigue, joint pain and muscle pain. On 24 June 2024, she experienced rash and fever. She received Tylenol (paracetamol) as treatment drug.   At time of reporting, the reactions were still ongoing.; Sender's Comments: Company causality assessment:  IXCHIQ: Causality assessed as possibly related for IXCHIQ, for all events as time to onset is plausible (8-10 days past vaccination) and as all adverse events with exception of Bleeding gums and Nose bleeds, are well known for IXCHIQ, indicative of a systemic vaccination reaction and fulfilling in this combination the definition of Chikungunya-like adverse reactions. However, co-suspect vaccinations with Japanese encephalitis vaccine and Rabies vaccine on the same day should be taken into consideration, too.  IXIARO ('japanese encephalitis vaccine (NOS)'): Causality assessed as possibly related for IXIARO, for all events as time to onset is plausible (8-10 days past vaccination) and as all adverse events with exception of Bleeding gums and Nose bleeds, are well known for IXIARO, indicative of a systemic vaccination reaction. However, it has not yet been conclusively clarified whether the reported Japanese encephalitis vaccine is the Valneva product IXIARO, and the reported combination of events indicates more likely a chikungunya-like adverse reaction. Nevertheless, co-suspect vaccinations with IXCHIQ and Rabies vaccine on the same day should be taken into consideration, too.  A follow-up was conducted to clarify the open questions.
Age: 37.0
Sex: U
Vaccine: CHIK, CHIK, JEV1, RAB
Symptoms: Myalgia, Pyrexia, Rash
Clinical narrative: Fever; Rash; Muscle pain; Fatigue; Headache; Nose bleeds; Bleeding gums; Joint pain; The following information was received from a nurse on 24 June 2024.  A 37-year-old female vaccinee received one dose of IXCHIQ (prevention of disease caused by chikungunya virus (CHIKV), batch number 23J021) i.m. into her right deltoid on 14 June 2024. Co-suspect vaccines administered on the same day included booster doses of Japanese encephalitis vaccine (batch number not provided) and rabies vaccine.  On 22 June 2024, the female experienced bleeding gums, nose bleeds, headache, fatigue, joint pain and muscle pain. On 24 June 2024, she experienced rash and fever. She received Tylenol (paracetamol) as treatment drug.   At time of reporting, the reactions were still ongoing.; Sender's Comments: Company causality assessment:  IXCHIQ: Causality assessed as possibly related for IXCHIQ, for all events as time to onset is plausible (8-10 days past vaccination) and as all adverse events with exception of Bleeding gums and Nose bleeds, are well known for IXCHIQ, indicative of a systemic vaccination reaction and fulfilling in this combination the definition of Chikungunya-like adverse reactions. However, co-suspect vaccinations with Japanese encephalitis vaccine and Rabies vaccine on the same day should be taken into consideration, too.  IXIARO ('japanese encephalitis vaccine (NOS)'): Causality assessed as possibly related for IXIARO, for all events as time to onset is plausible (8-10 days past vaccination) and as all adverse events with exception of Bleeding gums and Nose bleeds, are well known for IXIARO, indicative of a systemic vaccination reaction. However, it has not yet been conclusively clarified whether the reported Japanese encephalitis vaccine is the Valneva product IXIARO, and the reported combination of events indicates more likely a chikungunya-like adverse reaction. Nevertheless, co-suspect vaccinations with IXCHIQ and Rabies vaccine on the same day should be taken into consideration, too.  A follow-up was conducted to clarify the open questions.
Age: 44.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no symptomatic adverse events; Inbound call from HCP calling to report administration of expired MMR-II to a patient.  HCP confirmed no symptomatic adverse events reported at this time.  HCP states product was administered on 14-JUN-2024 and was administered only 10 minutes prior; This spontaneous report was received from a medical assistant and refers to a 44-year-old male patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 14-JUN-2024, the patient was vaccinated with an expired dose of a Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection, 0.5 mL / once, lot number: X005836 with expiration date: 03-MAY-2024 (strength, route of administration and anatomical location were not provided) for prophylaxis. Furthermore, no symptomatic adverse events were reported at the time of vaccination and it was confirmed no temperature excursions in lifetime of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) that was administered. No additional information and no additional adverse event were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP called to report inadvertent administration of expired MMR-II to a patient. Product expired on 03JUN2024 and was administered to a patient on 12JUN2024. No additional information was known by reporter. No additional AE/PQC.; This spontaneous report was received from medical assistant and refers to a patient of unknow age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 12-JUN-20244, the patient was inadvertent vaccinated with an expiry dose of  measles, mumps, and rubella (wistar ra 27-3) (recombinant Human albumin (rHA)) virus vaccine, live (M-M-R II) subcutaneous injection, lot #X005838, expiration date reported as 03-JUN-2024 (strength, and route of administration were not provided), administered for prophylaxis. No additional adverse event was reported.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report VARIVAX was administered to a patient after experiencing a T/E.  No symptoms reported.  HCP provided consent to contact.  No additional AE/PQC reported.; This spontaneous report was received from a nurse and refers to a 15-months-old patient of unknown gender. There was no information about the patient's pertinent medical history, concomitant medications or drug reactions and allergies provided.  On 12-MAR-2024, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 0.5 mL, lot number: X021930 with expiration date: 29-AUG-2025 (strength, route of administration and anatomical location were not provided) for prophylaxis. Furthermore, it was reported that the dose administered experienced a temperature excursion (product storage error). Information regarding the temperature excursion details, time and temperature were no reported. No additional adverse event were reported (No adverse event).
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report PROQUAD was administered to a patient after experiencing a T/E.  No symptoms reported.  HCP provided consent to contact.  No additional AE/PQC reported.; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender. There was no information about the patient's pertinent medical history, concomitant medications or drug reactions and allergies provided.  On 21-MAR-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, therapy type: rHA, 0.5 mL, lot number: X022920 with expiration date: 12-MAR-2025 (strength, route of administration and anatomical location were not provided) for prophylaxis. Furthermore, it was reported that the dose administered experienced a temperature excursion (product storage error). Information regarding the temperature excursion details, time and temperature were no reported. No symptoms or additional adverse event were reported (No adverse event).
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product prescribing issue
Clinical narrative: 51 years old male patient came into the pharmacy with a prescription for GARDASIL 9 for him.; No additional AEs were reported.; This spontaneous report has been received from a pharmacy technician and refers to a 51-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On an unknown date, the patient was prescribed with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided) (product prescribing issue). On 28-JUN-2024, the patient came to the pharmacy with this prescription. The patient did not get vaccinated yet. No additional adverse event was reported (no adverse event).   Lot# is being requested and will be submitted if received.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Given Heplisav-B When 30 Weeks and 5 Days Pregnant; Initial report received on 14-Jun-2024, 19-Jun-2024.  The report was initially received from the HEPLISAV-B.  A physician reported that a 32-year-old female patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization when she was 30 weeks and 5 days pregnant.  No relevant medical history or concomitant medications were reported.  On 16-May-2024, the patient received a unspecified dose # of HEPLISAV-B (Lot #944914, expiration date 15-Sep-2026, NDC # 43528-003-05) intramuscularly in the right deltoid.  The patient was pregnant (30 weeks and 5 days).  The reporter stated that the patient had no other side effects reported.    No additional information was available.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue
Clinical narrative: Weakness; Fatigue; This non-serious case was reported by a contact via call center representative and described the occurrence of weakness in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (1st dose received on April 2023, refer linked case US2024053393).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced weakness (Verbatim: Weakness) and fatigue (Verbatim: Fatigue). Rechallenge with Shingrix was positive. The outcome of the weakness and fatigue were unknown.   It was unknown if the reporter considered the weakness and fatigue to be related to Shingrix.     It was unknown if the company considered the weakness and fatigue to be related to Shingrix.   Linked case(s) involving the same patient:  US2024053393   Additional Information: GSK Receipt Date: 25-Apr-2024 The reporter was the patient.  The patient received Shingrix vaccine and experienced fatigue and weakness. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2024053393:Same patient first dose
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Tinnitus
Clinical narrative: TINNITUS; RACING HEART LASTED ABOUT A WEEK AFTER EACH SHOT; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's past medical history included: acute covid. The patient received covid-19 vaccine ad26.cov2.s (Dose- series:1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On an unspecified date, the patient experienced tinnitus, and racing heart lasted about a week after each shot (Dose- series:1)and stated that It's very similar to what he had experienced during acute Covid, back in March of 2020. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tinnitus and racing heart lasted about a week after each shot was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Oral pain, Postural orthostatic tachycardia syndrome, Testicular pain, Tinnitus
Clinical narrative: HEART RACING POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME; PAIN IN EYES; TINNITUS; MOUTH PAIN; PAIN GENITAL; This spontaneous report received from a patient concerned a 54 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis (dose series 1). The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On an unspecified date, the patient experienced heart racing postural orthostatic tachycardia syndrome, pain in eyes, tinnitus, mouth pain, and pain genital after dose series 1. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the heart racing postural orthostatic tachycardia syndrome, pain in eyes, tinnitus, mouth pain and pain genital was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram cerebral normal, Arteriogram carotid normal, Cerebral infarction, Computerised tomogram head abnormal, Visual field defect
Clinical narrative: stroke - right posterior cerebral artery diagnosed on 1/12/21 with visual field deficit
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Red, hot, itchy patch on vaccine site. Occurred 1 day after vaccination. Tented to touch. Extremely fatigued.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Wrong product administered
Clinical narrative: Pentacel was ordered but Vaxelis was administered.  Hep B immunization also administered on 2/17/24 and 4/19/2024.
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: Hepatitis A given instead of HPV vaccine.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bronchiectasis, Chest X-ray abnormal, Condition aggravated, Haemoptysis
Clinical narrative: I had no affects after the vaccine. Two days later I had the worst bronchiectasis episode I?ve ever had of coughing up blood. I don?t know if it was a coincidence but think it?s worth reporting. I had only had two episodes of coughing up blood before - in May and August 2023 and they did not coincide with Covid shots
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Feeling abnormal, Syncope
Clinical narrative: Tdap vaccine administered in right arm, MCV4 then administered in left arm.  Patient stated "I don't feel right" and then experienced brief syncopal episode.  Patient was sitting on exam table and was laid back by nurse and mother as he fainted.  Episode was very brief and patient recovered quickly.  Patient remained in exam room until feeling better, approximately 15-20 minutes. Ate snack and water. Ambulated to personal vehicle with mother. No further distress observed.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Computerised tomogram abdomen, Computerised tomogram pelvis, Culture urine, Differential white blood cell count
Clinical narrative: Approximately 15 hours after injection fever and chills began. 4-5 hours later, uncontrollable vomiting began. Arrived at ER approximately 24 hours after injection. Was in the ER for 12 hours and received multiple doses of anti-nausea medication to stop the vomiting and a bag of fluids.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count, Influenza virus test, Lipase, Metabolic function test, Pyrexia
Clinical narrative: Approximately 15 hours after injection fever and chills began. 4-5 hours later, uncontrollable vomiting began. Arrived at ER approximately 24 hours after injection. Was in the ER for 12 hours and received multiple doses of anti-nausea medication to stop the vomiting and a bag of fluids.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Respiratory syncytial virus test, SARS-CoV-2 test, Scan with contrast, Urine analysis, Vomiting
Clinical narrative: Approximately 15 hours after injection fever and chills began. 4-5 hours later, uncontrollable vomiting began. Arrived at ER approximately 24 hours after injection. Was in the ER for 12 hours and received multiple doses of anti-nausea medication to stop the vomiting and a bag of fluids.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received second dose of Hep A before the minimum interval of 6 months.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Unknown
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received Varicella less than 28 days after receiving an MMR vaccine
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: NO ADVERSE REACTIONS! Vaccine administered past BUD.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: This is the patient's first pregnancy. The EDD is 2/2/25 based on ultrasound results from 6/26/24.   Patient arrived for appt for hepatitis B immunization on 6/27/24.  RN was unaware of pregnancy protocol for hepatitis vaccination and patient received Heplisav instead of Energix B.  Patient and provider were notified of the incident.  Patient denied any adverse symptoms related to this event and patient's next appointment is 7/25/24.  Patient will continue hepatitis immunization series per pregnancy protocol.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: NO ADVERSE REACTIONS NOTED, dose administered past BUD
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: NO ADVERSE REACTION, dose administered past BUD of 6/30/24
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site pruritus, Injection site urticaria, Pruritus, Urticaria
Clinical narrative: Scattered hives and itching began at the insertion site and spread up to the chest 10-15 minutes post injection. Provider assessed patient and child was given 5 ml of Cetirizine and a Benadryl prescription was sent to the pharmacy for the patient to take for the next few days. The patient was monitored for 30 minutes before discharge with no further complications.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine given - parent contact no post reaction reported.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine given to patient, contacted parent, patient doing well, denies any post vaccine reactions.
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site cellulitis, Injection site reaction, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: Arm developed cellulitis. Very hot to the touch red rash covering the entire upper arm. Swollen arm
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness, Musculoskeletal stiffness, Panic reaction
Clinical narrative: about 5 seconds after the patient was given the vaccine he said "I feel dizzy", his mother and I held him in a safe position and kept him from falling out of his chair while he was unconscious and stiff/shaking.  this lasted about 7 seconds and when he "woke up" he said, "what the hell just happened" and stood up in a panic.  i guided him back to his chair and once he was calm and aware i called in PA-C to check up on him. she had them wait a few more minutes before going home
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Tremor
Clinical narrative: about 5 seconds after the patient was given the vaccine he said "I feel dizzy", his mother and I held him in a safe position and kept him from falling out of his chair while he was unconscious and stiff/shaking.  this lasted about 7 seconds and when he "woke up" he said, "what the hell just happened" and stood up in a panic.  i guided him back to his chair and once he was calm and aware i called in PA-C to check up on him. she had them wait a few more minutes before going home
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Eye discharge, Influenza B virus test positive, Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: Once patient reached home he vomited his meal. Had a bath, developed a rash on face and neck causing itch. Parent administered Tylenol, rash improved slightly. Mild redness of eyes & discharge only after sleeping. On exam pt had a mild rash on volar aspect of hands & lower extremities. Left thigh with 2 cm region of mild erythema with minimal induration left thigh, nontender . No swelling or warmth. No URI symptoms.  Parent denies nausea, diarrhea, facial or lip swelling, SOB, cough, wheezing.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Ocular hyperaemia, Pruritus, Rash, Vomiting
Clinical narrative: Once patient reached home he vomited his meal. Had a bath, developed a rash on face and neck causing itch. Parent administered Tylenol, rash improved slightly. Mild redness of eyes & discharge only after sleeping. On exam pt had a mild rash on volar aspect of hands & lower extremities. Left thigh with 2 cm region of mild erythema with minimal induration left thigh, nontender . No swelling or warmth. No URI symptoms.  Parent denies nausea, diarrhea, facial or lip swelling, SOB, cough, wheezing.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC20, VARCEL
Symptoms: Breath holding, Crying, Immediate post-injection reaction, Posturing
Clinical narrative: Nurse administered 3 vaccinations. During and immediately after, child held breath. Parent picked up child trying to console.  Child continued to hold breath then began posturing in parent arms. Nurse notified MD. Shortly after pt began crying and appeared appropriate. Advised parents to stay for monitoring. Parents left against medical advice.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Chills, Fatigue, Headache, Hyperthyroidism
Clinical narrative: She developed headache, subjective fever/chills and nightsweats, and fatigue started 9/27/23.  She was diagnosed with thyrotoxicosis/painless thyroiditis based initially on labs tests from 10/20/23. Symtpoms have since resolved.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pain, Pyrexia, Red blood cell sedimentation rate increased, Thyroiditis
Clinical narrative: She developed headache, subjective fever/chills and nightsweats, and fatigue started 9/27/23.  She was diagnosed with thyrotoxicosis/painless thyroiditis based initially on labs tests from 10/20/23. Symtpoms have since resolved.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroxine free, Tri-iodothyronine free
Clinical narrative: She developed headache, subjective fever/chills and nightsweats, and fatigue started 9/27/23.  She was diagnosed with thyrotoxicosis/painless thyroiditis based initially on labs tests from 10/20/23. Symtpoms have since resolved.
Age: 0.42
Sex: F
Vaccine: COVID19, DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Forecast for vaccination given to nurse was for child's older sister. Child was due for 4 month shots. No adverse issues noted at time of administration.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed shingles following vaccine.  Patient treated with gabapentin and valtrex
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Decreased appetite, Rash, Rash morbilliform
Clinical narrative: Developed a measles-like rash on trunk, loss of appetite, no fever
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: Patient given duplicate dose less than 1 month of each medication
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: 2 weeks later, he developed plaque psoriasis
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Blood pressure increased, Chest pain, Dizziness, Electrocardiogram normal, Laboratory test normal
Clinical narrative: States pain to arm down the arm.  States light-headedness after approx 1630. States then felt chest pain. States blood pressure became elevated.  States spouse called 911 and was seen in Emergency Dept.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Pain in extremity
Clinical narrative: States pain to arm down the arm.  States light-headedness after approx 1630. States then felt chest pain. States blood pressure became elevated.  States spouse called 911 and was seen in Emergency Dept.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Bundle branch block right, Cardiac stress test normal, Dyspnoea, Echocardiogram normal, Electrocardiogram ambulatory normal
Clinical narrative: approximately 30 days after the 2nd dose the pt started having shortness of breath was evaluated in the local  ER with normal findings. within a few days this evolved into palpitations. since December 2021, the pt has been evaluated by two Cardiologist and multiple PCM encounters and ER encounters with no specific diagnosis, however, he continues to have daily palpitations that are limiting to activities of daily living .  likely Right bundle branch block.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Loss of personal independence in daily activities, Palpitations
Clinical narrative: approximately 30 days after the 2nd dose the pt started having shortness of breath was evaluated in the local  ER with normal findings. within a few days this evolved into palpitations. since December 2021, the pt has been evaluated by two Cardiologist and multiple PCM encounters and ER encounters with no specific diagnosis, however, he continues to have daily palpitations that are limiting to activities of daily living .  likely Right bundle branch block.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Inadequate aseptic technique in use of product, Injection site pain, Skin infection
Clinical narrative: Patient reports an infection in the skin from urgent care provider who referred who to her primary care physician. Bruise and redness is about 2 inches in diameter and patient reports pain at the site of injection still.  Patient also reports that the intern injected her away from where the alcohol swab was wiped on her arm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash, Swelling face
Clinical narrative: Rash and face swelling
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash
Clinical narrative: Face rash
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Patient was vaccinated with Pfizer SARS - CoV-2 vaccine on 2/23/2021, 9/27/2021, 10/10/2022, 11/6/2023.  She tested positive for Covid-19 on 6/20/24, was made comfort measures and expired on 6/26/24.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Crying, Injection site induration, Injection site swelling, Irritability, Pyrexia
Clinical narrative: RIGHT LEG AT INJECTION SITE SWOLLEN AND HARD, HIGH FEVER GREATER THAN 3 DAYS, IRRITABILITY AND CONSTANT CRYING.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Accidentally gave the Pfizer 12yr+ dose to an 11year old.  Mother was informed.  Patient was feeling fine.  No issues at time of administration or during 15 minute wait afterwards.
Age: 46.0
Sex: M
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was out of the age range of 9-45 years old. Educated patient that he was out of the age range, patient still wanted to complete the vaccine series
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events. Reporting a vaccine administration error.  A 10-year-old was administered 0.25 mL of Spikevax from a single dose vial.  This was the first dose of COVID vaccine the child has ever had.  The provider states she did not double check the color on the box or vial and assumed it was a Moderna and knew not to draw up more than 0.25 mL even if there was more liquid left in the vial.  She did not realize she had the Spikevax product.
Age: 74.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Blood glucose increased, Condition aggravated, Diabetes mellitus
Clinical narrative: She got her vaccines, and when she woke up yesterday morning it was 202, and when she went to bed it was 129, and then it went up to 300.  She took a shot and then she walked which usually brings it down but it did not help.  Today her sugar has been lower at 171, then 166.   She was not having any other symptoms other than the high blood sugar, which does not go that high.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse reaction noted.