chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Cardiac arrest, Concussion, Eye disorder, Haemorrhage
Clinical narrative: On the day I received the Booster Vaccination, I immediately started to bleed once the shot was administered and the lady giving the shot was able to stop the bleeding after a minute. Shortly after I left and I passed out twice resulting in a concussion.  The next month my menstrual cycle came sooner than normal and for the next year and 3 ish months, I had a period every 18 days and constant morning sickness, which included throwing up every morning for months.  In February 2023, I began passing out on a weekly or biweekly basis. I went to a few doctors and no one could quite figure out why.  On March 18, 2023, I had my first seizure and I was taken to Community Hospital to get tests ran. All the results came back normal. I was referred to go to the University hospital where I stayed overnight with a lot more tests and still no answers.  I have had over 250 seizures since March 18. Which has caused trauma to my eye, losing some vision in my left eye, and causing memory issues to occur. On May 15, 2023, I was tested for POTS at Medical Center, where I flat-lined and had a seizure during the test. Since the test I have been diagnosed with a severe case of POTS (Postural orthostatic tachycardia syndrome).  July 2023, I was given an oxymetry test where we found that my oxygen levels were low and I am now sleeping with oxygen.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injury, Laboratory test normal, Loss of consciousness, Memory impairment
Clinical narrative: On the day I received the Booster Vaccination, I immediately started to bleed once the shot was administered and the lady giving the shot was able to stop the bleeding after a minute. Shortly after I left and I passed out twice resulting in a concussion.  The next month my menstrual cycle came sooner than normal and for the next year and 3 ish months, I had a period every 18 days and constant morning sickness, which included throwing up every morning for months.  In February 2023, I began passing out on a weekly or biweekly basis. I went to a few doctors and no one could quite figure out why.  On March 18, 2023, I had my first seizure and I was taken to Community Hospital to get tests ran. All the results came back normal. I was referred to go to the University hospital where I stayed overnight with a lot more tests and still no answers.  I have had over 250 seizures since March 18. Which has caused trauma to my eye, losing some vision in my left eye, and causing memory issues to occur. On May 15, 2023, I was tested for POTS at Medical Center, where I flat-lined and had a seizure during the test. Since the test I have been diagnosed with a severe case of POTS (Postural orthostatic tachycardia syndrome).  July 2023, I was given an oxymetry test where we found that my oxygen levels were low and I am now sleeping with oxygen.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Morning sickness, Oxygen saturation decreased, Postural orthostatic tachycardia syndrome, Seizure
Clinical narrative: On the day I received the Booster Vaccination, I immediately started to bleed once the shot was administered and the lady giving the shot was able to stop the bleeding after a minute. Shortly after I left and I passed out twice resulting in a concussion.  The next month my menstrual cycle came sooner than normal and for the next year and 3 ish months, I had a period every 18 days and constant morning sickness, which included throwing up every morning for months.  In February 2023, I began passing out on a weekly or biweekly basis. I went to a few doctors and no one could quite figure out why.  On March 18, 2023, I had my first seizure and I was taken to Community Hospital to get tests ran. All the results came back normal. I was referred to go to the University hospital where I stayed overnight with a lot more tests and still no answers.  I have had over 250 seizures since March 18. Which has caused trauma to my eye, losing some vision in my left eye, and causing memory issues to occur. On May 15, 2023, I was tested for POTS at Medical Center, where I flat-lined and had a seizure during the test. Since the test I have been diagnosed with a severe case of POTS (Postural orthostatic tachycardia syndrome).  July 2023, I was given an oxymetry test where we found that my oxygen levels were low and I am now sleeping with oxygen.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: On the day I received the Booster Vaccination, I immediately started to bleed once the shot was administered and the lady giving the shot was able to stop the bleeding after a minute. Shortly after I left and I passed out twice resulting in a concussion.  The next month my menstrual cycle came sooner than normal and for the next year and 3 ish months, I had a period every 18 days and constant morning sickness, which included throwing up every morning for months.  In February 2023, I began passing out on a weekly or biweekly basis. I went to a few doctors and no one could quite figure out why.  On March 18, 2023, I had my first seizure and I was taken to Community Hospital to get tests ran. All the results came back normal. I was referred to go to the University hospital where I stayed overnight with a lot more tests and still no answers.  I have had over 250 seizures since March 18. Which has caused trauma to my eye, losing some vision in my left eye, and causing memory issues to occur. On May 15, 2023, I was tested for POTS at Medical Center, where I flat-lined and had a seizure during the test. Since the test I have been diagnosed with a severe case of POTS (Postural orthostatic tachycardia syndrome).  July 2023, I was given an oxymetry test where we found that my oxygen levels were low and I am now sleeping with oxygen.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Burning sensation, Dizziness, Fatigue, Headache
Clinical narrative: neuropathy/ neuropathy (pain and tingling in her feet weakness in arms and legs); aches/pain; weakness in arm and legs; tingling; weakness; sore arm; tired; This serious case was reported by a consumer via call center representative and described the occurrence of neuropathy in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 97Ij7, expiry date 06-AUG-2024) for prophylaxis.   Concurrent medical conditions included migraine.   On 10-JUL-2023, the patient received the 1st dose of Shingrix. In JUL-2023, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: sore arm), tiredness (Verbatim: tired) and weakness (Verbatim: weakness). On 20-JUL-2023, the patient experienced neuropathy (Verbatim: neuropathy/ neuropathy (pain and tingling in her feet weakness in arms and legs)) (serious criteria GSK medically significant), pain (Verbatim: aches/pain), weakness of limbs (Verbatim: weakness in arm and legs) and tingling (Verbatim: tingling). The patient was treated with paracetamol (Tylenol), ibuprofen (Advil) and prednisone. The outcome of the neuropathy was not resolved and the outcome of the pain in arm was not reported (duration 2 days) and the outcome of the tiredness was resolved (duration 2 days) and the outcome of the pain, weakness of limbs, weakness and tingling were not reported.   The reporter considered the neuropathy to be related to Shingrix. It was unknown if the reporter considered the pain in arm, tiredness, pain, weakness of limbs, weakness and tingling to be related to Shingrix.     The company considered the neuropathy to be related to Shingrix. It was unknown if the company considered the pain in arm, tiredness, pain, weakness of limbs, weakness and tingling to be related to Shingrix.   Additional Information: GSK Receipt date: 02-AUG-2023 A reporter reported that Shingles vaccine caused neuropathy. Need help and advice. Reporter was the patient who received her first dose of Shingrix on 10-JUL-2023. She had a sore arm and was tired for 2 days.  She stated that on 20-JUL-2023 she developed neuropathy (pain and tingling in her feet, weakness in arms and legs). She took Tylenol and Advil but it did not help.  The neuropathy was present throughout the body, sometimes it was on the left side, sometimes on the right side, in her arms and legs.  She also had aches and weakness. She went to her primary care physician on Monday 24-JUL-2023. Blood tests were normal and she was put on prednisone. The prednisone worked for the 6 day course. Last night was the first time off of the prednisone and she noticed that the neuropathy was present on her right side.  Patient had a history of migraines but never had neuropathy before receiving Shingrix.  The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neuralgia, Pain in extremity, Paraesthesia
Clinical narrative: neuropathy/ neuropathy (pain and tingling in her feet weakness in arms and legs); aches/pain; weakness in arm and legs; tingling; weakness; sore arm; tired; This serious case was reported by a consumer via call center representative and described the occurrence of neuropathy in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 97Ij7, expiry date 06-AUG-2024) for prophylaxis.   Concurrent medical conditions included migraine.   On 10-JUL-2023, the patient received the 1st dose of Shingrix. In JUL-2023, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: sore arm), tiredness (Verbatim: tired) and weakness (Verbatim: weakness). On 20-JUL-2023, the patient experienced neuropathy (Verbatim: neuropathy/ neuropathy (pain and tingling in her feet weakness in arms and legs)) (serious criteria GSK medically significant), pain (Verbatim: aches/pain), weakness of limbs (Verbatim: weakness in arm and legs) and tingling (Verbatim: tingling). The patient was treated with paracetamol (Tylenol), ibuprofen (Advil) and prednisone. The outcome of the neuropathy was not resolved and the outcome of the pain in arm was not reported (duration 2 days) and the outcome of the tiredness was resolved (duration 2 days) and the outcome of the pain, weakness of limbs, weakness and tingling were not reported.   The reporter considered the neuropathy to be related to Shingrix. It was unknown if the reporter considered the pain in arm, tiredness, pain, weakness of limbs, weakness and tingling to be related to Shingrix.     The company considered the neuropathy to be related to Shingrix. It was unknown if the company considered the pain in arm, tiredness, pain, weakness of limbs, weakness and tingling to be related to Shingrix.   Additional Information: GSK Receipt date: 02-AUG-2023 A reporter reported that Shingles vaccine caused neuropathy. Need help and advice. Reporter was the patient who received her first dose of Shingrix on 10-JUL-2023. She had a sore arm and was tired for 2 days.  She stated that on 20-JUL-2023 she developed neuropathy (pain and tingling in her feet, weakness in arms and legs). She took Tylenol and Advil but it did not help.  The neuropathy was present throughout the body, sometimes it was on the left side, sometimes on the right side, in her arms and legs.  She also had aches and weakness. She went to her primary care physician on Monday 24-JUL-2023. Blood tests were normal and she was put on prednisone. The prednisone worked for the 6 day course. Last night was the first time off of the prednisone and she noticed that the neuropathy was present on her right side.  Patient had a history of migraines but never had neuropathy before receiving Shingrix.  The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Blood test normal, Fatigue, Muscular weakness, Neuropathy peripheral
Clinical narrative: neuropathy/ neuropathy (pain and tingling in her feet weakness in arms and legs); aches/pain; weakness in arm and legs; tingling; weakness; sore arm; tired; This serious case was reported by a consumer via call center representative and described the occurrence of neuropathy in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 97Ij7, expiry date 06-AUG-2024) for prophylaxis.   Concurrent medical conditions included migraine.   On 10-JUL-2023, the patient received the 1st dose of Shingrix. In JUL-2023, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: sore arm), tiredness (Verbatim: tired) and weakness (Verbatim: weakness). On 20-JUL-2023, the patient experienced neuropathy (Verbatim: neuropathy/ neuropathy (pain and tingling in her feet weakness in arms and legs)) (serious criteria GSK medically significant), pain (Verbatim: aches/pain), weakness of limbs (Verbatim: weakness in arm and legs) and tingling (Verbatim: tingling). The patient was treated with paracetamol (Tylenol), ibuprofen (Advil) and prednisone. The outcome of the neuropathy was not resolved and the outcome of the pain in arm was not reported (duration 2 days) and the outcome of the tiredness was resolved (duration 2 days) and the outcome of the pain, weakness of limbs, weakness and tingling were not reported.   The reporter considered the neuropathy to be related to Shingrix. It was unknown if the reporter considered the pain in arm, tiredness, pain, weakness of limbs, weakness and tingling to be related to Shingrix.     The company considered the neuropathy to be related to Shingrix. It was unknown if the company considered the pain in arm, tiredness, pain, weakness of limbs, weakness and tingling to be related to Shingrix.   Additional Information: GSK Receipt date: 02-AUG-2023 A reporter reported that Shingles vaccine caused neuropathy. Need help and advice. Reporter was the patient who received her first dose of Shingrix on 10-JUL-2023. She had a sore arm and was tired for 2 days.  She stated that on 20-JUL-2023 she developed neuropathy (pain and tingling in her feet, weakness in arms and legs). She took Tylenol and Advil but it did not help.  The neuropathy was present throughout the body, sometimes it was on the left side, sometimes on the right side, in her arms and legs.  She also had aches and weakness. She went to her primary care physician on Monday 24-JUL-2023. Blood tests were normal and she was put on prednisone. The prednisone worked for the 6 day course. Last night was the first time off of the prednisone and she noticed that the neuropathy was present on her right side.  Patient had a history of migraines but never had neuropathy before receiving Shingrix.  The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: neuropathy/ neuropathy (pain and tingling in her feet weakness in arms and legs); aches/pain; weakness in arm and legs; tingling; weakness; sore arm; tired; This serious case was reported by a consumer via call center representative and described the occurrence of neuropathy in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 97Ij7, expiry date 06-AUG-2024) for prophylaxis.   Concurrent medical conditions included migraine.   On 10-JUL-2023, the patient received the 1st dose of Shingrix. In JUL-2023, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: sore arm), tiredness (Verbatim: tired) and weakness (Verbatim: weakness). On 20-JUL-2023, the patient experienced neuropathy (Verbatim: neuropathy/ neuropathy (pain and tingling in her feet weakness in arms and legs)) (serious criteria GSK medically significant), pain (Verbatim: aches/pain), weakness of limbs (Verbatim: weakness in arm and legs) and tingling (Verbatim: tingling). The patient was treated with paracetamol (Tylenol), ibuprofen (Advil) and prednisone. The outcome of the neuropathy was not resolved and the outcome of the pain in arm was not reported (duration 2 days) and the outcome of the tiredness was resolved (duration 2 days) and the outcome of the pain, weakness of limbs, weakness and tingling were not reported.   The reporter considered the neuropathy to be related to Shingrix. It was unknown if the reporter considered the pain in arm, tiredness, pain, weakness of limbs, weakness and tingling to be related to Shingrix.     The company considered the neuropathy to be related to Shingrix. It was unknown if the company considered the pain in arm, tiredness, pain, weakness of limbs, weakness and tingling to be related to Shingrix.   Additional Information: GSK Receipt date: 02-AUG-2023 A reporter reported that Shingles vaccine caused neuropathy. Need help and advice. Reporter was the patient who received her first dose of Shingrix on 10-JUL-2023. She had a sore arm and was tired for 2 days.  She stated that on 20-JUL-2023 she developed neuropathy (pain and tingling in her feet, weakness in arms and legs). She took Tylenol and Advil but it did not help.  The neuropathy was present throughout the body, sometimes it was on the left side, sometimes on the right side, in her arms and legs.  She also had aches and weakness. She went to her primary care physician on Monday 24-JUL-2023. Blood tests were normal and she was put on prednisone. The prednisone worked for the 6 day course. Last night was the first time off of the prednisone and she noticed that the neuropathy was present on her right side.  Patient had a history of migraines but never had neuropathy before receiving Shingrix.  The reporter consented to follow up.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, HIBV, DTPPVHBHPB, HIBV, RV5, DTPPVHBHPB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: was accidentally administered with acthib and vaxelis at the same time with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old male patient who was accidentally administered with Hib (Prp/T) Vaccine [Act-Hib] And Vaxelis [Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Hib Vaccine Conj (Menigococcal Protein), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid] at the same time with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus Vaccine Live Reassort Oral 5v (Rotateq) for Prophylactic vaccination.  On 31-Jul-2023, the patient received a dose 2 at a dose of 0.5 ml of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (Frequency: Once; Strength: Standard, expiry date: 06-May-2024 and lot UJ801AA) via intramuscular route in Left Vastus Lateralis for Immunization; on the same day received a unknown dose of suspect VAXELIS not produced by Sanofi Pasteur (formulation Strength, expiry date and lot number: not reported via unknown route in unknown administration site for prophylactic vaccination (immunization) and was accidentally administered at the same time (Extra dose administered) (latency: same day).  Information on the batch number was reuqested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, HIBV, DTPPVHBHPB, HIBV, RV5, DTPPVHBHPB, HIBV
Symptoms: Extra dose administered
Clinical narrative: was accidentally administered with acthib and vaxelis at the same time with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old male patient who was accidentally administered with Hib (Prp/T) Vaccine [Act-Hib] And Vaxelis [Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Hib Vaccine Conj (Menigococcal Protein), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid] at the same time with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus Vaccine Live Reassort Oral 5v (Rotateq) for Prophylactic vaccination.  On 31-Jul-2023, the patient received a dose 2 at a dose of 0.5 ml of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (Frequency: Once; Strength: Standard, expiry date: 06-May-2024 and lot UJ801AA) via intramuscular route in Left Vastus Lateralis for Immunization; on the same day received a unknown dose of suspect VAXELIS not produced by Sanofi Pasteur (formulation Strength, expiry date and lot number: not reported via unknown route in unknown administration site for prophylactic vaccination (immunization) and was accidentally administered at the same time (Extra dose administered) (latency: same day).  Information on the batch number was reuqested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Product storage error
Clinical narrative: temperature excursion - vaccine not viable according to manufacturer; No adverse event; This spontaneous report was received from a physician referring to a 11-year-old female patient.   Her historical vaccines included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) (24-MAY-2016), flu vaccine (14-FEB-2012, 13-NOV-2012, 01-OCT-2018, 25-SEP-2019 and 23-OCT-2020), hepatitis A vaccine (manufacturer unknown) (30-JAN-2014), hepatitis B vaccine (manufacturer unknown) (11-AUG-2011, 17-OCT-2011 and 15-MAY-2012) (captured in MARRS # 2307USA010911), injectable polio vaccine (24-MAY-2016), measles, mumps and rubella (MMR) vaccine (manufacturer unknown) (13-NOV-2012 and 24-MAY-2016), diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) (17-OCT-2011, 14-DEC-2011, 14-FEB-2012 and 13-NOV-2012), pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (17-OCT-2011, 14-DEC-2011, 14-FEB-2012 and 11-SEP-2012), rotavirus vaccine (+) live (+) oral (+) pentavalent (ROTATEQ) (17-OCT-2011, 14-DEC-2011, 14-FEB-2012), diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) vaccine (26-MAY-2022), varicella vaccine (manufacturer unknown) (11-SEP-2012 and 24-MAY-2016). Concomitant therapies included meningococcal vaccine a/c/y/w conj (dip tox)(MENACTRA). The patient's pertinent medical history and drug reactions or allergies were not provided.  On 14-JUN-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot # W011455 and expiration date 11-DEC-2024) (strength, and route of administration were not provided) in the left arm for prophylaxis.   It was reported that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was improper stored (product storage error). The vaccine was stored in clinical practice. According to manufacturer, the vaccine under temperature excursion vaccine was not viable. Alarm believed to be due to sensory issues. Temperatures was monitored with back up logger. The temperature was in range, and new data logger now was in use. The vaccines/waste was being returned in progress. No adverse effects. No prescription drug treatment was required for the experience. The event was reported to health department and manufacturer previously.  This is one of several reports from the same reporter. This is one of two reports for the same patient. ; Sender's Comments:  US-009507513-2307USA010911:Original Case : 2307USA009798
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion - vaccine not viable according to manufacturer; No adverse event; This spontaneous report was received from a physician referring to a 11-year-old female patient.   Her historical vaccines included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) (24-MAY-2016), flu vaccine (14-FEB-2012, 13-NOV-2012, 01-OCT-2018, 25-SEP-2019 and 23-OCT-2020), hepatitis A vaccine (manufacturer unknown) (30-JAN-2014), hepatitis B vaccine (manufacturer unknown) (11-AUG-2011, 17-OCT-2011 and 15-MAY-2012) (captured in MARRS # 2307USA010911), injectable polio vaccine (24-MAY-2016), measles, mumps and rubella (MMR) vaccine (manufacturer unknown) (13-NOV-2012 and 24-MAY-2016), diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) (17-OCT-2011, 14-DEC-2011, 14-FEB-2012 and 13-NOV-2012), pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (17-OCT-2011, 14-DEC-2011, 14-FEB-2012 and 11-SEP-2012), rotavirus vaccine (+) live (+) oral (+) pentavalent (ROTATEQ) (17-OCT-2011, 14-DEC-2011, 14-FEB-2012), diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) vaccine (26-MAY-2022), varicella vaccine (manufacturer unknown) (11-SEP-2012 and 24-MAY-2016). Concomitant therapies included meningococcal vaccine a/c/y/w conj (dip tox)(MENACTRA). The patient's pertinent medical history and drug reactions or allergies were not provided.  On 14-JUN-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot # W011455 and expiration date 11-DEC-2024) (strength, and route of administration were not provided) in the left arm for prophylaxis.   It was reported that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was improper stored (product storage error). The vaccine was stored in clinical practice. According to manufacturer, the vaccine under temperature excursion vaccine was not viable. Alarm believed to be due to sensory issues. Temperatures was monitored with back up logger. The temperature was in range, and new data logger now was in use. The vaccines/waste was being returned in progress. No adverse effects. No prescription drug treatment was required for the experience. The event was reported to health department and manufacturer previously.  This is one of several reports from the same reporter. This is one of two reports for the same patient. ; Sender's Comments:  US-009507513-2307USA010911:Original Case : 2307USA009798
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse effects reported.; The caller said the records state that she received her first dose of RECOMBIVAX HB in October 2012 and then her second dose in August 2013 and then no third dose was recorded.; This spontaneous report was received from a consumer of unknown age and gender referring to himself/herself. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On an unknown date in October 2012, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) therapy type thimerosal-free (RECOMBIVAX HB) intramuscular injection, lot # J000387, expiration date not reported, but upon internal validation established as 07-SEP-2014, administered intramuscularly for prophylaxis (strength, dose were not provided). On an unknown date in August 2013, she received her second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection administered intramuscularly for prophylaxis (strength, dose, lot #, expiration date were not provided) (inappropriate schedule of product administration). No third dose was recorded. The patient said she was unsure if she received a third dose. No additional adverse effects or product quality complaint (PQC) were reported.
Sex: U
Vaccine: MMRV, UNK
Symptoms: Expired product administered, Product preparation issue
Clinical narrative: No additional AE; Caller reported inadvertent administration of expired STERILE DILUENT that was used to reconstitute PROQUAD; Caller reported inadvertent administration of expired STERILE DILUENT that was used to reconstitute PROQUAD; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, or medical history provided.  On 29-JUN-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (strength, dose, anatomical location, lot #, expiry date, and route of administration were not provided), which was inadvertent reconstituted in expired sterile diluent solution for injection/infusion, 1 dose, lot #T029529, expiration date: 16-APR-2023 (strength was not provided) (expired product administered, product preparation issue). No temperature excursion. No symptoms reported. Sterile diluent supported for 12 months post-expiry.  This is one of several reports from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Caller reported inadvertent administration of expired STERILE DILUENT that was used to reconstitute MMR-II; Caller reported inadvertent administration of expired STERILE DILUENT that was used to reconstitute MMR-II; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, or medical history provided.  On 01-JUN-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, dose, anatomical location, lot #, expiry date, and route of administration were not provided), which was inadvertently reconstituted in expired sterile diluent solution for injection/infusion, 1 dose, lot #T029529, expiration date: 16-APR-2023 (strength was not provided) (expired product administered, product preparation issue). No temperature excursion. No symptoms reported. Sterile diluent supported for 12 months post-expiry.  This is one of several reports from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: The caller said the patient received a dose of MMRII on 7/5/2023, aft; No additional adverse event; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. The patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX). Additionally, the patient's pertinent medical history, drug reactions or allergies were not provided.  On 27-JUN-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, one dose, lot number was reported as W039699, which upon internal review was determined to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), expiration date was reported and determined to be valid as 25-MAY-2024, albumin status rHA, administered as prophylaxis (strength, dose, frequency, route of administration, albumin status, and anatomical location was not provided) after a temperature excursion (product storage error) with a temperature of 48.8 degree Fahrenheits for 7 hours and 45 minutes. No adverse event reported.  This is one of the several reports from the same reporter.; Sender's Comments:  US-009507513-2307USA006147:
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No adverse event; Inappropriate schedule of vaccine administered; This spontaneous report was received from a physician referring to a 1-day-old female patient. The patient's pertinent medical history, drug reactions or allergies and concomitant vaccines were not provided.   On 11-AUG-2011, 17-OCT-2011 and 15-MAY-2012, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection (strength, route of administration, exact dose, lot number and expiration date were not provided) for prophylaxis, respectively (inappropriate schedule of product administration for the second and third doses).   This is one of several reports from the same reporter. This is one of two reports for the same patient.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional AE; The patient received an expired dose of VAQTA; This spontaneous report was received from a registered nurse and referred to an 18-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 31-JUL-2023, the patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA), 1 dose, (lot number W003118 has been verified to be a valid lot number, expiration date reported and validated as 13-JUL-2023), as prophylaxis (strength, route of administration and anatomical location were not provided).  No adverse event reported.
Sex: M
Vaccine: HPV9
Symptoms: Product dose omission issue
Clinical narrative: Pharmacist called to report that a 3rd dose of GARDASIL 9 was missed. HCP reports that the missed dose occurred on Jan. 4th, 2021, but has no information available for when the 1st or 2nd dose was delivered. HCP has limited demographics on the patien; This spontaneous report was received from a pharmacist referring to a 42-year-old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       On unknown dates, the patient was vaccinated with the first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, route of administration, lot # and expiration date were not reported).         On 04-JAN-2021, the patient missed the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). There was no information available for when the 1st or 2nd dose were delivered
Age: 1.0
Sex: F
Vaccine: PNC15
Symptoms: No adverse event, Syringe issue
Clinical narrative: No additional AE; the syringe broke cleanly; while needle was still inserted into patient; This spontaneous report was received from a nurse referring to a 1-year-old female patient. The patient had no pertinent medical history, drug reactions/allergies, concurrent conditions or concomitant medications (all reported as "none").       On 03-AUG-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) 0.5 mL / single or four dose series, intramuscular (IM), lot # X005583 with expiration date 10-DEC-2024, for Pneumococcal prevention (strength and anatomical location were not reported). No additional adverse event (AE) was reported. Nurse reported that after administering pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) to the patient, the end of the barrel where the needle screws into the syringe broke cleanly off once administration was completed while needle was still inserted into patient. Nurse stated that the patient involved was not harmed as a result of the syringe breaking and the complete vaccine was administered to the patient. Nurse stated that the syringe in question was disposed of per facility protocol, therefore no sample was available to be retrieved.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: they were diagnosed with COVID last Friday; they were diagnosed with COVID last Friday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "they were diagnosed with COVID last Friday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Aug2023) Unknown results, notes: they took the COVID test yesterday. Clinical course: Caller mentioned they were diagnosed with COVID last Friday and took the COVID test yesterday and was wondering how soon after COVID can they receive a new COVID 19 vaccine to get updated with it and had no current symptoms and was been 7 days since the diagnosis. Caller then added they took a two stage shot and a booster from Pfizer.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he got COVID after being vaccinated; he got COVID after being vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (not ongoing), notes: first time I got COVID without the vaccine it was 2 weeks; "Covid-19" (not ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "he got COVID after being vaccinated". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: third time. Clinical course: Caller requested information on PAXLOVID side effects. He got the Pfizer vaccine he had COVID, this was his third time, his doctor prescribed PAXLOVID he hadn't taken it yet but he was diagnosed on the 1st he was bit nervous about taking this because he did not know everything about it, he just thought number 1 his wife wanted to get pregnant and he didn't want to cause any trouble with the reproduction process, that was a concern, was there any major side effects. He didn't have any health issues, heart disease or cancer, diabetes or people that was normally healthy, do they had any problems with this stuff". Caller confirmed the Pfizer vaccine he got was the COVID-19 vaccine and stated: "He got both shots he didn't have any problems with it, he had no side effects." Caller stated he got COVID after being vaccinated: "he got it for 4 or 5 days, it really didn't last that long but the first time he got COVID without the vaccine it was 2 weeks." Confirmed PAXLOVID use was for a patient over the age of 18.  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: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (2023) Negative; (2023) Negative; (2023) Positive, notes: Positive test with symptoms after two negative tests 48 hours apart. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid  from  25Jul2023 to 29Jul2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known the information available the Causal relation between the events Drug ineffective, Covid-19 and suspect drug cannot be excluded completely
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "recovered" (2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2023) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 25Jul2023 and 29Jul2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300269473 Same patient, different event/drug;
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Jul2023 at 10:15 as dose 6 (booster), single (Lot number: Gj3268) at the age of 71 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Sep2022 at 10:15 as dose 5 (booster), single (Lot number: FP4554), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course : Patient had no allergies. Patient started paxlovid treatment from 27Jul2023 to 31Jul2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300269488 same patient different drug/event;
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm and on 15May2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 04Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 27Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 16Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 24Jul2023 to 28Jul2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "reactive airway disease" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient take paxlovid from 24Jul2023 to 28Jul2023 as COVID 19 Treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.