chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: M
Vaccine: COVID19-2, FLU4, COVID19-2, FLU4, VARZOS
Symptoms: Agitation, Arthralgia, Back pain, COVID-19, COVID-19 pneumonia
Clinical narrative: Discharge Provider: MD Primary Care Physician at Discharge: DO  Admission Date: 1/13/2023   PRESENTING PROBLEM: Compression fracture of L5 lumbar vertebra, closed, initial encounter [S32.050A] Compression fracture of L5 vertebra, initial encounter [S32.050A] Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1]   HOSPITAL COURSE: Patient was a 88-year-old man who presents to the hospital with COVID-19 infection causing pneumonia.  He started having frequent falls.  He then developed severe back pain and presented to the emergency department on 01/13.  He was found to have L5 superior endplate compression fracture.  He was started on Lyrica, Flexeril and oxycodone.  He was awaiting rehab placement since he was in quarantine for COVID-19.  On the morning of 1/18 he was found on the floor.  CT head was negative.  X-ray of right shoulder done secondary to pain was negative.  On that day he seems slightly confused.  Oxycodone was discontinued and changed to Norco.  He started to require Zyprexa for confusion and agitation.  Norco and Lyrica were then discontinued.  The patient had another fall on 01/19.  CT head was repeated and negative.  CT lumbar spine repeated show worsening of the previous L5 compression fracture.  He started to develop delirium.  He then started to have decreased oral intake.  He started complaining of throat pain and was unable to swallow.  Strep swab was collected and negative.  Due to continued severe pain and inability to swallow, CT neck with contrast was performed which revealed epiglottitis.  I spoke with family about his poor oral intake, very low body mass index and concern for failure to thrive.  Patient decided to convert to comfort care measures only.  He was placed on sublingual morphine and passed away peacefully with his family at bedside.   Time of death 4:09 p.m. on 01/25/2023
Age: 88.0
Sex: M
Vaccine: COVID19-2, FLU4, COVID19-2, FLU4, VARZOS
Symptoms: Computerised tomogram head normal, Computerised tomogram neck, Computerised tomogram spine, Confusional state, Death
Clinical narrative: Discharge Provider: MD Primary Care Physician at Discharge: DO  Admission Date: 1/13/2023   PRESENTING PROBLEM: Compression fracture of L5 lumbar vertebra, closed, initial encounter [S32.050A] Compression fracture of L5 vertebra, initial encounter [S32.050A] Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1]   HOSPITAL COURSE: Patient was a 88-year-old man who presents to the hospital with COVID-19 infection causing pneumonia.  He started having frequent falls.  He then developed severe back pain and presented to the emergency department on 01/13.  He was found to have L5 superior endplate compression fracture.  He was started on Lyrica, Flexeril and oxycodone.  He was awaiting rehab placement since he was in quarantine for COVID-19.  On the morning of 1/18 he was found on the floor.  CT head was negative.  X-ray of right shoulder done secondary to pain was negative.  On that day he seems slightly confused.  Oxycodone was discontinued and changed to Norco.  He started to require Zyprexa for confusion and agitation.  Norco and Lyrica were then discontinued.  The patient had another fall on 01/19.  CT head was repeated and negative.  CT lumbar spine repeated show worsening of the previous L5 compression fracture.  He started to develop delirium.  He then started to have decreased oral intake.  He started complaining of throat pain and was unable to swallow.  Strep swab was collected and negative.  Due to continued severe pain and inability to swallow, CT neck with contrast was performed which revealed epiglottitis.  I spoke with family about his poor oral intake, very low body mass index and concern for failure to thrive.  Patient decided to convert to comfort care measures only.  He was placed on sublingual morphine and passed away peacefully with his family at bedside.   Time of death 4:09 p.m. on 01/25/2023
Age: 88.0
Sex: M
Vaccine: COVID19-2, FLU4, COVID19-2, FLU4, VARZOS
Symptoms: Delirium, Dysphagia, Epiglottitis, Fall, Fracture
Clinical narrative: Discharge Provider: MD Primary Care Physician at Discharge: DO  Admission Date: 1/13/2023   PRESENTING PROBLEM: Compression fracture of L5 lumbar vertebra, closed, initial encounter [S32.050A] Compression fracture of L5 vertebra, initial encounter [S32.050A] Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1]   HOSPITAL COURSE: Patient was a 88-year-old man who presents to the hospital with COVID-19 infection causing pneumonia.  He started having frequent falls.  He then developed severe back pain and presented to the emergency department on 01/13.  He was found to have L5 superior endplate compression fracture.  He was started on Lyrica, Flexeril and oxycodone.  He was awaiting rehab placement since he was in quarantine for COVID-19.  On the morning of 1/18 he was found on the floor.  CT head was negative.  X-ray of right shoulder done secondary to pain was negative.  On that day he seems slightly confused.  Oxycodone was discontinued and changed to Norco.  He started to require Zyprexa for confusion and agitation.  Norco and Lyrica were then discontinued.  The patient had another fall on 01/19.  CT head was repeated and negative.  CT lumbar spine repeated show worsening of the previous L5 compression fracture.  He started to develop delirium.  He then started to have decreased oral intake.  He started complaining of throat pain and was unable to swallow.  Strep swab was collected and negative.  Due to continued severe pain and inability to swallow, CT neck with contrast was performed which revealed epiglottitis.  I spoke with family about his poor oral intake, very low body mass index and concern for failure to thrive.  Patient decided to convert to comfort care measures only.  He was placed on sublingual morphine and passed away peacefully with his family at bedside.   Time of death 4:09 p.m. on 01/25/2023
Age: 88.0
Sex: M
Vaccine: COVID19-2, FLU4, COVID19-2, FLU4, VARZOS
Symptoms: Hypophagia, Lumbar vertebral fracture, Oropharyngeal pain, Scan with contrast abnormal, Spinal compression fracture
Clinical narrative: Discharge Provider: MD Primary Care Physician at Discharge: DO  Admission Date: 1/13/2023   PRESENTING PROBLEM: Compression fracture of L5 lumbar vertebra, closed, initial encounter [S32.050A] Compression fracture of L5 vertebra, initial encounter [S32.050A] Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1]   HOSPITAL COURSE: Patient was a 88-year-old man who presents to the hospital with COVID-19 infection causing pneumonia.  He started having frequent falls.  He then developed severe back pain and presented to the emergency department on 01/13.  He was found to have L5 superior endplate compression fracture.  He was started on Lyrica, Flexeril and oxycodone.  He was awaiting rehab placement since he was in quarantine for COVID-19.  On the morning of 1/18 he was found on the floor.  CT head was negative.  X-ray of right shoulder done secondary to pain was negative.  On that day he seems slightly confused.  Oxycodone was discontinued and changed to Norco.  He started to require Zyprexa for confusion and agitation.  Norco and Lyrica were then discontinued.  The patient had another fall on 01/19.  CT head was repeated and negative.  CT lumbar spine repeated show worsening of the previous L5 compression fracture.  He started to develop delirium.  He then started to have decreased oral intake.  He started complaining of throat pain and was unable to swallow.  Strep swab was collected and negative.  Due to continued severe pain and inability to swallow, CT neck with contrast was performed which revealed epiglottitis.  I spoke with family about his poor oral intake, very low body mass index and concern for failure to thrive.  Patient decided to convert to comfort care measures only.  He was placed on sublingual morphine and passed away peacefully with his family at bedside.   Time of death 4:09 p.m. on 01/25/2023
Age: 88.0
Sex: M
Vaccine: COVID19-2, FLU4, COVID19-2, FLU4, VARZOS
Symptoms: Streptococcus test negative, X-ray limb normal
Clinical narrative: Discharge Provider: MD Primary Care Physician at Discharge: DO  Admission Date: 1/13/2023   PRESENTING PROBLEM: Compression fracture of L5 lumbar vertebra, closed, initial encounter [S32.050A] Compression fracture of L5 vertebra, initial encounter [S32.050A] Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1]   HOSPITAL COURSE: Patient was a 88-year-old man who presents to the hospital with COVID-19 infection causing pneumonia.  He started having frequent falls.  He then developed severe back pain and presented to the emergency department on 01/13.  He was found to have L5 superior endplate compression fracture.  He was started on Lyrica, Flexeril and oxycodone.  He was awaiting rehab placement since he was in quarantine for COVID-19.  On the morning of 1/18 he was found on the floor.  CT head was negative.  X-ray of right shoulder done secondary to pain was negative.  On that day he seems slightly confused.  Oxycodone was discontinued and changed to Norco.  He started to require Zyprexa for confusion and agitation.  Norco and Lyrica were then discontinued.  The patient had another fall on 01/19.  CT head was repeated and negative.  CT lumbar spine repeated show worsening of the previous L5 compression fracture.  He started to develop delirium.  He then started to have decreased oral intake.  He started complaining of throat pain and was unable to swallow.  Strep swab was collected and negative.  Due to continued severe pain and inability to swallow, CT neck with contrast was performed which revealed epiglottitis.  I spoke with family about his poor oral intake, very low body mass index and concern for failure to thrive.  Patient decided to convert to comfort care measures only.  He was placed on sublingual morphine and passed away peacefully with his family at bedside.   Time of death 4:09 p.m. on 01/25/2023
Age: 60.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Blood test, Chronic inflammatory demyelinating polyradiculoneuropathy, Computerised tomogram, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Guillen Barre Syndrome; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Dec2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing). Concomitant medication(s) included: ALPHAGAN; AZOPT [BRINZOLAMIDE]; JANUMET; NEXIUM [ESOMEPRAZOLE SODIUM]. Vaccination history included: Covid-19 vaccine (DOSE: 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE: 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE: 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization. No known allergies, no covid prior vaccination, no covid tested post vaccination. Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks. The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization, medically significant) with onset 19Dec2022 at 09:00, outcome "recovering", described as "Guillen Barre Syndrome. The patient was hospitalized for guillain-barre syndrome (hospitalization duration: 19 day(s)). The event "guillen barre syndrome,  required physician office visit and emergency room visit. Therapeutic measures were taken as a result of guillain-barre syndrome. Treatment included Plasma Pharisees, Steroids, Various IV's. Insulin.  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: 60.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Lumbar puncture, Magnetic resonance imaging, Plasmapheresis, X-ray
Clinical narrative: Guillen Barre Syndrome; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Dec2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing). Concomitant medication(s) included: ALPHAGAN; AZOPT [BRINZOLAMIDE]; JANUMET; NEXIUM [ESOMEPRAZOLE SODIUM]. Vaccination history included: Covid-19 vaccine (DOSE: 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE: 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE: 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization. No known allergies, no covid prior vaccination, no covid tested post vaccination. Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks. The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization, medically significant) with onset 19Dec2022 at 09:00, outcome "recovering", described as "Guillen Barre Syndrome. The patient was hospitalized for guillain-barre syndrome (hospitalization duration: 19 day(s)). The event "guillen barre syndrome,  required physician office visit and emergency room visit. Therapeutic measures were taken as a result of guillain-barre syndrome. Treatment included Plasma Pharisees, Steroids, Various IV's. Insulin.  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: 60.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillen Barre Syndrome; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Dec2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing). Concomitant medication(s) included: ALPHAGAN; AZOPT [BRINZOLAMIDE]; JANUMET; NEXIUM [ESOMEPRAZOLE SODIUM]. Vaccination history included: Covid-19 vaccine (DOSE: 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE: 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE: 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization. No known allergies, no covid prior vaccination, no covid tested post vaccination. Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks. The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization, medically significant) with onset 19Dec2022 at 09:00, outcome "recovering", described as "Guillen Barre Syndrome. The patient was hospitalized for guillain-barre syndrome (hospitalization duration: 19 day(s)). The event "guillen barre syndrome,  required physician office visit and emergency room visit. Therapeutic measures were taken as a result of guillain-barre syndrome. Treatment included Plasma Pharisees, Steroids, Various IV's. Insulin.  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: 55.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; patient male was supposed to receive 2nd dose of SHINGRIX but was administered VARIVAX vaccine; This spontaneous report was received from a certified medical assistant (CMA) and referred to a 55-year-old male. Information about historical condition and concomitant medication was not reported.  The patient was supposed to receive the second dose of varicella zoster vaccine RGE (CHO) (SHINGRIX) (anatomical location, strength, dose, route, lot number, and expiration date were not reported) for prophylaxis but was administered varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose: 0.5 ml; anatomical location, strength, route, lot number, and expiration date were not reported) for prophylaxis instead on 12-OCT-2022 (Wrong product administered). There was no adverse event.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; Patient was administered improperly stored, seprate PNEUMOVAX 23; This spontaneous report has been received from a office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 23-DEC-2022, the patient was vaccinated with a improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, see event description, lot number W007035 verified as valid, expiration date reported as 23-OCT-2023, and upon internal review established as 20-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided) at a temperature of 55.0 degree Fahrenheit for 153 hours (product storage error).  This is one of several reports from the same reporter.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; Patient was administered improperly stored, separate PNEUMOVAX 23; This spontaneous report has been received from a office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 23-DEC-2022, the patient was vaccinated with a improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, see event description, lot number W007035 verified as valid, expiration date reported as 23-OCT-2023, and upon internal review established as 20-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided) at a temperature of 55.0 degree Fahrenheit for 153 hours (product storage error).  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2301USA007635:02320477
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The nurse reported that the patient did not experience any type of adverse reactions; twins were given an "extra dose" of "varicella" due to receiving the PROQUAD vaccine; This spontaneous report was received from a nurse, referring to a 4-year-old male patient. The patient's concurrent conditions, medical history, concomitant therapy and drug reactions/allergies were not reported.  On 24-JAN-2023, the patient was vaccinated with an "extra dose" of "varicella" due to receiving the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number W029547 has been verified to be a valid lot number, expiration date was reported as 14-MAR-2024, 0.5 milliliter (ml), route and anatomical location were not provided) for prophylaxis (extra dose administered). The patient was on a "catch up" schedule and was administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) that resulted in them receiving a dose of "varicella" that was not needed. It is unknown what the "catch up" schedule was in reference to and how many doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) that patient had received in the past. The patient did not experience any type of adverse reactions (no adverse event).  This was one of two reports from the same reporter.; Sender's Comments:  US-009507513-2301USA009662:
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: received 1st dose approximately 1 year ago and would like to receive 2nd dose today 1/27/23.; no additional adverse events; This spontaneous report was received from a nurse concerning a 19-year-old female patient .  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date (reported as "approximately 1 year ago"), the patient was vaccinated with the firs dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, administered as prophylaxis (strength, lot #, expiry date, and route of administration were not provided), and she wanted to received the second dose on 27-JAN-2023 (also reported as "today") (Inappropriate schedule of product administration). No additional adverse events were reported.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Memory impairment
Clinical narrative: no strength in arms and  legs; extremely dizzy; memory issues; This case was reported by a consumer via call center representative and described the occurrence of strength loss of in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 4KG39, expiry date 17th February 2028) for prophylaxis.   Previously administered products included Shingrix (first dose received on an unknown date).   On 17th January 2023 17:40, the patient received the 2nd dose of Shingrix. On 18th January 2023, 1 days after receiving Shingrix, the patient experienced strength loss of, dizziness and memory disturbance. On 21st January 2023, the outcome of the strength loss of, dizziness and memory disturbance were recovered/resolved.   It was unknown if the reporter considered the strength loss of, dizziness and memory disturbance to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-Jan-2023 Reporter's Comments: This case was self reported by the patient. The patient received 2nd Shingrix shot. In the morning, the patient woke up with no strength in arms & legs, extremely dizzy, memory issues.  The patient experienced no strength in arms & legs, extremely dizzy, memory issues that was resolved. The reporter consented to follow up.
Age: 21.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrix Administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 21-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 19th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 26-Jan-2023 Reporter's comment:  The case was reported by the nurse. The Nurse calls to report an expired dose of Twinrix was administered to a patient. The consent to follow up via email agreed. Additional supportive information: As patient received expired vaccine which led to expired vaccine used. This case is linked with US2023011699 same reporter.; Sender's Comments:  US-GSK-US2023011699:same reporter
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: injection site reaction, redness; injection site swollen; injection site pain; upper back pain; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number D9cb9, expiry date 24th September 2023) for prophylaxis.   On 24th January 2023, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 24th January 2023, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site pain and upper back pain. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site pain were not recovered/not resolved and the outcome of the upper back pain was recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain and upper back pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-JAN-2023 Reporter's Comment: The case was self reported by the patient. The patient received first dose of Shingrix into left arm and just a little while following getting the vaccine, she started having upper back pain and an injection site reaction such as redness, swollen and pain. The patient reported that she was still experiencing these symptoms. The reporter consented to follow up. Additional Supportive Information: Event outcome for upper back pain was kept as recovered as reported in structured field and clarification raised for the same.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Immunisation reaction
Clinical narrative: Had a very strong, not anaphylactic reaction but, strong reaction to the Moderna vaccine; uncomfortability; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Had a very strong, not anaphylactic reaction but, strong reaction to the Moderna vaccine) and DISCOMFORT (uncomfortability) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 prophylaxis.     The patient's past medical history included Cancer (cancer survivor) in 2021. Previously administered products included for Product used for unknown indication: Pfizer (First Shot LOT: EL1283 NDC, EXP: Unknown) on 26-Feb-2021, Pfizer (Second shot LOT: EN6208 NDC and EXP: Unknown) on 19-Mar-2021. Past adverse reactions to the above products included No adverse event with Pfizer; and Sleep excessive with Pfizer.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Had a very strong, not anaphylactic reaction but, strong reaction to the Moderna vaccine) and DISCOMFORT (uncomfortability). At the time of the report, IMMUNISATION REACTION (Had a very strong, not anaphylactic reaction but, strong reaction to the Moderna vaccine) and DISCOMFORT (uncomfortability) outcome was unknown.            No Concomitant medication was reported. Patient had some issues with Moderna and the Pfizer vaccines.  No treatment information was reported.   This case was linked to MODERNATX, INC.-MOD-2023-705591 (E2B Linked Report). This case was linked to MOD-2023-705318 (Patient Link).; Sender's Comments:  MODERNATX, INC.-MOD-2023-705591:Case for Most People
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Got the same symptoms like Dr.) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Got the same symptoms like Dr.). At the time of the report, IMMUNISATION REACTION (Got the same symptoms like Dr.) outcome was unknown.            Concomitant product use was not provided by the reporter.  The patient received Pfizer Covid Vaccine - BNT162b2.  The patient got the same symptoms like the physician.   Treatment information was not provided.   This case was linked to MODERNATX, INC.-MOD-2022-584727 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-584727:Dr. case
Sex: U
Vaccine: COVID19-2
Symptoms: Death
Clinical narrative: She knows of a person who died after the Moderna vaccines; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (She knows of a person who died after the Moderna vaccines) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company comment: This is a spontaneous fatal case regarding a patient of an unknown age and gender, with no reported medical history, who died after receiving a dose of mRNA-1273.222 bivalent vaccine (Original/Omicron BA.4/5). Vaccination date was not provided. Death occurred on an unknown date. Latency cannot be assessed. The cause of death was not reported. It is unknown if an autopsy was performed. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 .222 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-706003, US-MODERNATX, INC.-MOD-2023-706020 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706003:Case for women US-MODERNATX, INC.-MOD-2023-706020:Trackin only case for REPORTER; Reported Cause(s) of Death: Person who died after the Moderna vaccines
Age: 34.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; A dose of Moderna Covid-19 vaccine, Bivalent vaccine was given 2 days beyond BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine, Bivalent vaccine was given 2 days beyond BUD) and NO ADVERSE EVENT (No adverse event) in a 34-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 20-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine, Bivalent vaccine was given 2 days beyond BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine, Bivalent vaccine was given 2 days beyond BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine, Bivalent vaccine was given 2 days beyond BUD).    Concomitant product use was not provided by the reporter.  A dose of Moderna Covid-19 vaccine, Bivalent vaccine was given 2 days beyond BUD.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Therapeutic response unexpected
Clinical narrative: diarrhea has disappeared and has stayed gone for 1 1/2 or 2 years.; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (diarrhea has disappeared and has stayed gone for 1 1/2 or 2 years.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Chronic diarrhea and HIV infection.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (diarrhea has disappeared and has stayed gone for 1 1/2 or 2 years.) and NO ADVERSE EVENT (No adverse event). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (diarrhea has disappeared and has stayed gone for 1 1/2 or 2 years.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for THERAPEUTIC RESPONSE UNEXPECTED (diarrhea has disappeared and has stayed gone for 1 1/2 or 2 years.).    It was reported that patient was fully vaccinated with 2 original, 2 boosters and one variant booster.  Patient was taking medication for chronic diarrhea for a couple of years. When patient received the first shot, diarrhea had disappeared and had stayed gone for 1 1/2 or 2 years. No treatment information was provided.   This case was linked to MOD-2023-705061 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: General physical health deterioration, Illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she has been very sick since she got the vaccine) and GENERAL PHYSICAL HEALTH DETERIORATION (they just want to report that she going to die quickly because she has been very sick since she got the vaccine) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (she has been very sick since she got the vaccine) and GENERAL PHYSICAL HEALTH DETERIORATION (they just want to report that she going to die quickly because she has been very sick since she got the vaccine). At the time of the report, ILLNESS (she has been very sick since she got the vaccine) and GENERAL PHYSICAL HEALTH DETERIORATION (they just want to report that she going to die quickly because she has been very sick since she got the vaccine) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. No treatment drug was reported.   Reporter did not allow further contact
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; Patient realized that they gave the same Bivalent vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient realized that they gave the same Bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 79-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7171B and 052D22A) for COVID-19 prophylaxis.   Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (First Primary monovalent dose, Lot 013L20A & Exp. Date: unknown) on 21-Jan-2021, Moderna COVID-19 Vaccine (2nd Primary monovalent dose, Lot 030M20A & Exp. Date: unknown) on 17-Feb-2021, Moderna COVID-19 Vaccine (First Monovalent Booster dose, Lot 019F21A & Exp. Date unknown) on 26-Oct-2021, Moderna COVID-19 Vaccine (2nd Monovalent Booster dose and Lot 048L21A& Exp. Date: unknown) on 13-Apr-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.   On 26-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Jan-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (Patient realized that they gave the same Bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient realized that they gave the same Bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Patient realized that they gave the same Bivalent vaccine).    No concomitant medications were reported.  Patient told that usually get vaccinated at the local Health Department. Today patient went to a doctor's office and did not have vaccination card with her. When patient came home, realized that they gave the same Bivalent vaccine. Patient feels fine and did not have any side effects.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; office discovered that vaccines in inventory were used past there expiration date/vaccines were administered July 13-21 of 2022/vaccines used by date was July 14 2022; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (office discovered that vaccines in inventory were used past there expiration date/vaccines were administered July 13-21 of 2022/vaccines used by date was July 14 2022) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In July 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (office discovered that vaccines in inventory were used past there expiration date/vaccines were administered July 13-21 of 2022/vaccines used by date was July 14 2022). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (office discovered that vaccines in inventory were used past there expiration date/vaccines were administered July 13-21 of 2022/vaccines used by date was July 14 2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (office discovered that vaccines in inventory were used past there expiration date/vaccines were administered July 13-21 of 2022/vaccines used by date was July 14 2022).    No concomitant medications were provided. No treatment medications were provided. It was reported that the office was aware of 3 patients that had received mention vaccine vials.   This case was linked to US-MODERNATX, INC.-MOD-2023-705204 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-705204:Master case
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse Event; 10 year old came in to get the primary series of Moderna. Instead of giving the primary series they needed, they ended up giving them the bivalent booster shot; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (10 year old came in to get the primary series of Moderna. Instead of giving the primary series they needed, they ended up giving them the bivalent booster shot) and NO ADVERSE EVENT (No Adverse Event) in a 10-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 016H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (10 year old came in to get the primary series of Moderna. Instead of giving the primary series they needed, they ended up giving them the bivalent booster shot). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (10 year old came in to get the primary series of Moderna. Instead of giving the primary series they needed, they ended up giving them the bivalent booster shot) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (10 year old came in to get the primary series of Moderna. Instead of giving the primary series they needed, they ended up giving them the bivalent booster shot).    No concomitant medications were reported. HCP reported a 10 year old came in to get the primary series of Moderna but instead of giving the primary series he needed, they ended up giving him the bivalent booster shot. Patient had no previous Covid vaccines. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (heart attack) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.     It was reported that a patient had a heart attack after taking the Moderna COVID-19 vaccine.   No treatment medications were reported.  Company Comment :This is a spontaneous case concerns an adult female patient of unspecified age, with no relevant medical history reported, who experienced the expected serious (medically significant) AESI event of Myocardial infarction that occurred on unspecified day after a dose of mRNA-1273 bivalent BA4-5 vaccine. Vaccination dose number and vaccination schedule not disclosed. The event outcome was reported unknown. No further information on risk factors, clinical course, relevant medical history, diagnostic investigations, and treatment received were available for review. The benefit-risk relationship of mRNA-1273 bivalent BA4-5 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19-2
Symptoms: Vaccination site movement impairment
Clinical narrative: because I cannot use my arm anymore on my right side. I cannot use it because of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (because I cannot use my arm anymore on my right side. I cannot use it because of Moderna) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (because I cannot use my arm anymore on my right side. I cannot use it because of Moderna). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (because I cannot use my arm anymore on my right side. I cannot use it because of Moderna) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that patient cannot use arm anymore on right side. Patient  cannot use it because of Moderna and has tried over and over for days to get a hold of someone but he couldn't figure any of it.  No treatment medications were reported.