chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: had first Menactra dose on 11-Aug-2018 and received second dose on 29-Jul-2022 with no reported  adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 15 years old male patient who had first menactra dose on 11-Aug-2018 and received second dose on 29-Jul-2022 with no reported  adverse event, for the vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Aug-2018, the patient received first dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, with an unknown formulation and strength, ( lot number and expiry date: not reported)  in unknown administration site for immunization. On 29-Jul-2022 he also received the second  dose of the same vaccine  with an unknown batch number in unknown administration site. Information for batch number has been requested   The nurse reported the patient had first menactra dose on 11-Aug-2018 and received second dose on 29-Jul-2022 with no reported  adverse event (inappropriate schedule of product administration) 3 years 11 months 18 days following the first dose administration and (latency: same day) following the second dose administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. The patient would turn 16 years old in a month  Action taken : Not applicable.  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: DTAPIPV, UNK
Symptoms: Extra dose administered, No adverse event, Product preparation error
Clinical narrative: Pentacel had been reconstituted with Quadracel and administered to a patient with no reported adverse event; pentacel had been reconstituted with quadracel and administered to a patient withno adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient and it was reported that  Pentacel had been reconstituted with Quadracel and administered to a patient with no reported adverse event and the vaccines involved were DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Jul-2022, the patient received fourth dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, at dose of 0.5 ml once ( lot: UJ673AA ; expiry date: 27-Apr-2023) via intramuscular route in the left thigh for immunization.   On 28-JUL-2022 the Pentacel had been reconstituted with Quadracel  (lot and expiry date: not reported) and administered to a patient with no reported adverse event (product preparation error) (extra dose administered) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE and DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE. Quadracel was administered accidentally   Action taken : not applicable.  Outcome: unknown   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: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of pentacel being administered with no reported adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 15 months old female patient who was administered expired dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine (Pentacel) 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 measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination; and varicella zoster vaccine (Varicella vaccine) for Prophylactic vaccination.  On 29-Jul-2022, the patient received suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE at a dose of 0.5 ml total (lot UJ527AA, expiry date: 22-Jul-2022, lot: U6986AA, expiry date: 22-Jul-2022) via intramuscular route in unknown administration site for immunisation.  On 29-Jul-2022 the expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Pentacel) was being administered with no reported adverse event (expired product administered)to the patient (same day latency).  Action taken: Not applicable.  Outcome: Unknown for the event expired dose of pentacel being administered with no reported adverse 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: 0.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: patient was only given the liquid component of Pentacel, it was not reconstituted with Acthib with no reported adverse event; patient was only given the liquid component of Pentacel, it was not reconstituted with Acthib with no reported adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. (GMI number: 01213528)  This case involves a 3-month-old female patient was only given the liquid component of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel], it was not reconstituted with acthib 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 Hepatitis B vaccine for Prophylactic vaccination; Rotavirus Vaccine for Prophylactic vaccination; and Pneumococcal Vaccine CONJ (pcv 13) for Prophylactic vaccination.  On 20-Jul-2022, the patient received suspect Pentacel vaccine only liquid component at dose 0.5ml once (lot U6970bb) via intramuscular route in the left thigh for Immunization no reported adverse event (product preparation error, single component of a two-component product administered, same day latency).  It was reported that "Caller states that a patient was only given the liquid component of Pentacel. It was not reconstituted with Acthib. Do we give a repeat dose or just give Acthib?"  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for both events.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: vaccines being administered post excursion, with no reported adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient to whom vaccine was  being administered post excursion, with no reported adverse event , and it involved vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   The reporter stated that the condition was 31.5F for 1 hour and 58 a refrigerator malfunction (not human error). The product was not supported by the extended stability data.   On 13-Jul-2022, the patient received a  dose of 0.5 ml of  suspect HIB (PRP/T) VACCINE, with an unknown formulation and strength, ( lot: UJ604AAA; expiry date: 29-Oct-2022)  via intramuscular route in the right thigh for immunization.  It was reported that on 13-Jul-2022, the  vaccine was  being administered post excursion, with no reported adverse event (poor quality product administered) (latency: same day) following the administration of HIB (PRP/T) VACCINE.  Action taken : not applicable.  Outcome: unknown  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: 0.58
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: ACT-HIB vaccine which had expired on 11-Jul-2022 was administered to a patient with no reported adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 months old female patient and it was reported that HIB (PRP/T) VACCINE [ACT-HIB] vaccine which had expired on 11-Jul-2022 was administered to a patient 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 DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX).   On 29-Jul-2022, the patient received a  dose of 0.5 ml of suspect HIB (PRP/T) VACCINE, (frequency: once), with an unknown formulation and strength ( lot: UJ521AAA ; expiry date: 11-Jul-2022) (diluent lot: U6999AB ; expiry date: 11-Jul-2022)  via intramuscular route in the left vastus lateralis for immunization.  It was reported that an Act-hib vaccine which had expired on 11-Jul-2022 was administered to a patient with no reported adverse event (Expired product administered) (onset date: 29-Jul-2022; latency: same day)   Action taken : Not applicable.  Outcome: Unknown   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.
Sex: M
Vaccine: HIBV, IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion involving IPOL and ACTHIB, both of which were administered twice post excursion with no reported adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old male patient and reported stated that there was a temperature excursion involving IPV (VERO) [IPOL] and HIB (PRP/T) VACCINE [ACT-HIB], both of which were administered twice post excursion with no reported adverse event.   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.  On 12-Jul-2022, the patient received a 0.5ml dose of suspect IPV (VERO) (formulation, strength was unknown, lot V1A121M and expiry date was unknown) via intramuscular route in the right deltoid for Immunization. Information regarding batch and expiry date was requested. On 12-Jul-2022, the patient received an unknown dose of suspect HIB (PRP/T) VACCINE (strength, formulation, lot number and expiry date were unknown) via unknown route in unknown administration site for Immunization. Information regarding batch and expiry date was requested.  On 12-Jul-2022 the patient developed a non-serious event of temperature excursion involving ipol and acthib, both of which were administered twice post excursion with no reported adverse event (poor quality product administered) (latency: same day). The condition was 31.5F for 1 hour and 58 minutes due to a refrigerator malfunction (not human error). Neither of the products were supported by the extended stability data.  Action taken : not applicable.  Outcome: Unknown  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.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: Trumenba was the required vaccine and administering that instead of the MENACTRA, with no reported adverse event; Initial information received on 01-Aug-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age male patient to whom TRUMENBA was the required vaccine and administering that instead of the MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], with no reported adverse event.      The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date the patient developed a non-serious event to whom trumenba (dose, strength, formulation, batch and expiry date was unknown) was the required vaccine and administering that instead of the menactra (dose, strength, formulation, batch and expiry date was unknown), with no reported adverse event (wrong product administered) (latency: same day)for Immunization. The Pharmacist asks if Trumenba and Menactra can both be given to the patient, or if they need to wait to give the Menactra.  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Poor quality product administered, Product preparation error
Clinical narrative: administered Pentacel that was mixed with Quadracel instead of the Pentacel diluent with no reported adverse event; administered Pentacel that was mixed with Quadracel instead of the Pentacel diluent with no reported adverse event; Initial information received on 01-Aug-2022 regarding an unsolicited valid non-serious case received from a physician. GMI number: 01215828  This case involves Infant female patient who was administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] that was mixed with quadracel instead of the pentacel diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received Suspect Pentacel Vaccine mixed with quadracel instead of the Pentacel diluent at dose 0.5 ml once (lot UJ660AA, expiry: 25-Feb-2023) via unknown route in unknown administration site for immunization with no reported adverse event (product preparation error, poor quality product administered).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for both events.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 8.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: administered an expired dose of IPOL with no reported AE; Initial information received on 01-Aug-2022 regarding an unsolicited valid  non-serious case received from other health professional.  This case involves a 8 years old male patient who was administered an expired dose of ipol with no reported ae while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  On 27-Jul-2022, the patient received a 3rd dose of suspect IPV (VERO) at an unknown dose (lot T1D482M, expiry date: 25-Jul-2022) via intramuscular route in the right arm for immunisation.  On 27-Jul-2022 the patient was administered an expired dose of ipol with no reported ae (expired product administered) same day latency following the administration of IPV (VERO).  Action taken: Not applicable.  Outcome: Unknown for the event administered an expired dose of ipol with no reported ae.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: administered expired menactra with no reported adverse event; Initial information received on 02-Aug-2022 regarding an unsolicited valid non-serious case received from health professional. (GMI number: 01217750)  This case is linked to case A200410725.  This case involves a 17-year-old female patient who had administered expired Meningococcal A-C-Y-W135 (D CONJ) Vaccine [Menactra] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 26-Jul-2022, the patient administered expired Menactra vaccine 0.5 ml once lot U6952AA via unknown route in the right arm for Immunization with no reported adverse event (expired product administered, latency same day).  It was reported that Office manager report a MA administered expired MENACTRA. She states no side effects have been noted. She would like to know if the patient needs to be re-dosed.   Action taken: Not applicable.  At time of reporting, the outcome was Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Adacel was given to a 4 year old with no reported adverse event; Initial information received on 02-Aug-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 4 years old male patient to whom DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] was given to a 4 year old 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 HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for Prophylactic vaccination.  On 02-Aug-2022, the patient received a  fifth dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, with an unknown formulation and strength, at dose of 0.5 ml (frequency: once) ( lot: U7271AA ; expiry date: 12-Jan-2024) via intramuscular route in the right thigh for immunization.  It was reported that Adacel was given to a 4 year old with no reported adverse event (product administered to patient of inappropriate age) (latency: same day)  Action taken : not applicable.  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: vaccine was administered to a patient post excursion with no reported adverse event; ADACEL was giving after experiencing several temperature (over 72 hours) excursions with 54° FAHRENHEIT with no reported adverse event; Initial information received on 02-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Infant of unknown gender who was administered vaccine post excursion with no reported adverse event and  adacel was giving after experiencing several temperature (over 72 hours) excursions with 54° fahrenheit with no reported adverse event ,while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported  at  a dose of 0.5ml via intramuscular route at an unknown administration site for immunization.  On 04-Jul-2022, the reporter stated that adacel was giving after experiencing several temperature (over 72 hours) excursions with 54° fahrenheit with no reported adverse event (product temperature excursion issue).  On an unknown date, the patient developed a non-serious event of vaccine was administered post excursion with no reported adverse event  (poor quality product administered) ( latency: same day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the events.   Outcome: unknown for both events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: medication error due to PENTACEL being given to a 6 year old instead of DAPTACEL with no reported adverse event; medication error due to PENTACEL being given to a 6 year old instead of DAPTACEL with no reported adverse event; Initial information received on 02-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 years old male patient who had medication error due to DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] being given to a 6 year old instead of daptacel 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 POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE) for Prophylactic vaccination; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination; and TUBERCULIN PPD (TUBERSOL) for Prophylactic vaccination.  On 02-Aug-2022, the patient received a 0.5ml 1X(once) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (strength, formulation was unknown, lot C5840AA and expiry date: 03-Jun-2023) via intramuscular route in the right deltoid.  On 02-AUG-2022 the patient developed a non-serious event of medication error due to pentacel being given to a 6 year old instead of daptacel with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) (Latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Urticaria
Clinical narrative: PATIENT VACCINATED AT 1130; MOM RETURNED AT 1345 C/O HIVES AND COUGH.  MOM STATED SHE GAVE BENADRYL RIGHT BEFORE RETURNING TO CLINIC. SPO2: 95% DR. SPOKE W/ PARENTS AND OBSERVED PT, LISTENED TO LUNGS AND HEART.  PT STATED HE'S NO LONGER COUGHING AND DOES NOT HAVE ANY SOB OR DIFFICULTY BREATHING.  WILL CONTINUE TO MONITOR.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Electroencephalogram, Generalised tonic-clonic seizure
Clinical narrative: 2 Grand Mal seizures next day
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site swelling, Rash
Clinical narrative: low grade temp (100F), rash on cheeks and legs, swelling at injection site
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Exercise tolerance decreased, Fatigue, Feeling abnormal, Full blood count normal
Clinical narrative: Fatigue, Brain Fog, Lethargy that doesn't go away, becoming SOB more quickly, was fit and active and now it's harder to be active and fit as I was ever since the vaccine no treatment because no one takes these complaints seriously
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lethargy, Metabolic function test abnormal
Clinical narrative: Fatigue, Brain Fog, Lethargy that doesn't go away, becoming SOB more quickly, was fit and active and now it's harder to be active and fit as I was ever since the vaccine no treatment because no one takes these complaints seriously
Age: 27.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Spoke with patient regarding symptoms. Per patient symptoms presented on 8/1/22. Patient states had a raised bump, itchiness, and tenderness at the injection site. Patient states contacted primary physician on 8/3/2022 to make primary care physician aware of symptoms. Per patient primary care physician stated symptoms were normal after receiving the Jynneos Vaccine and would take about 3 weeks to heal. Patient states no longer has itching and tenderness. Patient currently states only has raised bump at injection site. Patient encourage to follow up with primary care physician regarding any other symptoms. Patient verbalized understanding.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; PEDVAX HIB and ROTATQ administered after temperature excursion; This spontaneous report was received from a nurse referring to a patient of unspecified age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies was provided.  On 25-JUL-2022, the patient was vaccinated with haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (lot # U039951, expiration date: 22-JUN-2024, dose, strength, vaccination scheme frequency, and anatomical location were not reported) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot # W004502), expiration date: 09-OCT-2023, dose, strength, and vaccination scheme frequency were not reported) for prophylaxis after a temperature excursion (temperature: 23.8 degree Celsius (C); time frame: 9 hours 45 minutes) (product storage error). It was reported there was no previous temperature excursion. No additional adverse event was reported (no adverse event).
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Neck pain, Pain in extremity
Clinical narrative: Headache; Sore neck; Sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced headache, neck pain and pain in arm. On an unknown date, the outcome of the headache, neck pain and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the headache, neck pain and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-Aug-2022 Reporter's Comments: This case was reported by patient's wife via interactive digital media. The reporter stated that the patient received the 2nd Shingrix shot on Friday and was still had headache, sore neck and sore arm. The reporter wanted to know if this was common. Additional Supportive Information: The follow-up would not be possible as no contact details were available.
Age: 39.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Genital lesion, Insomnia, Malaise, Monkeypox, Psychotic disorder
Clinical narrative: After both vaccines I got extremely ill, issues sleeping - could not fall asleep, April at the age of 40 I had my first psychotic break, as of today I am in the hospital for ?monkeypox?  liaisons on and a rounding genitals ? the seepage smells like a warm penny
Age: 39.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Skin infection, Wound complication
Clinical narrative: After both vaccines I got extremely ill, issues sleeping - could not fall asleep, April at the age of 40 I had my first psychotic break, as of today I am in the hospital for ?monkeypox?  liaisons on and a rounding genitals ? the seepage smells like a warm penny
Age: 59.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Red swollen itchy spot where shot was given.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Fall, Injection site pruritus, Limb injury
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Dizzy, lighteadedness. Patient begin to fall backwards. scraped hand-Mild, Additional Details: After patient received vaccination, patient felt dizzy, light-headed and started to falling. Patient hit and scratched hand on display. Patient was evaluated by nurse practitioner from clinic and felt fine after sitting down for 10 minutes. No bruising or swelling at injection site, patient was just shaken
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site pain, Neck pain, Pain
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: patient reports since vaccine administration she has had pain in the arm radiating up the neck and is unable to move arm as usual; pt was referred to md for clinical evaluation
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Fever-Medium
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Infection, Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient evaluated by PCP who determined she had an infection and started on antibiotics, but didn't think related to the vaccine injection per mother's report.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Pain
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: Shoulder pain that is dull and constant.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Erythema, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: fever, chills, sore arm, reddness on arm and hot
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Amniorrhoea, Anticoagulant therapy, COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: Pt was on gestational week 37w4d when she presented to Labor and Delivery Triage for leaking of fluid. She was not ruptured on exam and her cervix was FT/T/P. However, on arrival to triage, she was saturating 92-95% on room air. She was positive for COVID-19 on 1/5. She was admitted for oxygen management and treatment of COVID-19 symptoms. She was started on 4L oxygen via nasal cannula to maintain saturations >95%. She was started on Remdesivir, Decadron, and vitamins. She was switched from Lovenox to Heparin. While in the hospital, she was on 0 to 4L NC in order to maintain her saturations. On 1/8, she was noted to maintaining her oxygen saturations >95% on room air and was feeling better. She was reassessed at that time and was stable for discharge home. She  scheduled induction of labor on 1/14/2022.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia areata
Clinical narrative: Patient 1 month after 2nd injection developed Alopecia Areata, had patches of hair loss on exam, less than 25% of hair loss. We are currently treating her with Intralesional steroid injections and topical steroid medication to her scalp twice daily. She has not completely regrown her hair yet, but is still ongoing with treatment.
Age: 86.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: COVID-19, COVID-19 pneumonia, Dehydration, Dyspnoea, Fatigue
Clinical narrative: Discharge Provider: MD Primary Care Provider: MD Admission Date: 7/31/2022 Discharge Date: Aug 4, 2022  PRESENTING PROBLEM: Hypoxia  COVID-19  Pneumonia due to COVID-19 virus    HOSPITAL COURSE:   Patient is an 87-year-old female with a past medical history with rheumatoid arthritis on methotrexate comes in with shortness of breath and fatigue.  She was found to have COVID-19, she was not hypoxic but very dehydrated.  She was started on low-dose Decadron and remdesivir and responded well.  She worked with PT/OT and did if finding.  Recommendation was home physical therapy which was set up.  Patient's septic workup was negative.  She tolerated diet well.  Hemodynamically stable for discharge
Age: 86.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Hypoxia, Laboratory test normal
Clinical narrative: Discharge Provider: MD Primary Care Provider: MD Admission Date: 7/31/2022 Discharge Date: Aug 4, 2022  PRESENTING PROBLEM: Hypoxia  COVID-19  Pneumonia due to COVID-19 virus    HOSPITAL COURSE:   Patient is an 87-year-old female with a past medical history with rheumatoid arthritis on methotrexate comes in with shortness of breath and fatigue.  She was found to have COVID-19, she was not hypoxic but very dehydrated.  She was started on low-dose Decadron and remdesivir and responded well.  She worked with PT/OT and did if finding.  Recommendation was home physical therapy which was set up.  Patient's septic workup was negative.  She tolerated diet well.  Hemodynamically stable for discharge
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Mobility decreased, Pain in extremity
Clinical narrative: I had a little tenderness and soreness in my arm for a couple of days. It was difficult to raise my arm. I tested positive for COVID-19 on 05/09/2022. My symptoms started on 05/07/2022 respiratory problems, bad cough, difficult to talk and very tired.  I called our doctors office and was put in  touch with a COVID-19 specialist. They prescribed Paxlovid.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory disorder, SARS-CoV-2 test positive, Speech disorder, Tenderness
Clinical narrative: I had a little tenderness and soreness in my arm for a couple of days. It was difficult to raise my arm. I tested positive for COVID-19 on 05/09/2022. My symptoms started on 05/07/2022 respiratory problems, bad cough, difficult to talk and very tired.  I called our doctors office and was put in  touch with a COVID-19 specialist. They prescribed Paxlovid.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Asymptomatic COVID-19, Bladder catheterisation, Fall, Hypercapnia
Clinical narrative: Pt presented to the ED on 11/5 with CC of generalized weakness which has been getting worse and with frequent falls . She was admitted for Hypercarbia. During her hospital stay she received treatment for her DX, in addition to multiple comorbidities.   Plan was discharge to rehab facility however, pt's roommate in hospital came back positive for COVID 19.  Patient tested positive for COVID-19, was asymptomatic.  Patient did have some mild hypoxia but this was likely secondary bacterial pneumonia was started on Levaquin with good effect.   Her oxygen requirement has improved and has been weaned to 4 L.     Rehab facility delayed transfer,  would like pt monitored and afebrile for 72 hours prior to initiating prior authorization again for placement.  Pt started spiking fevers over the past 48 hours.  Suspect because she was retaining urine as since foley placed the fevers have resolved.   She was discharged  November 29, 2021 in stable condition.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, Lumbar spinal stenosis, Multimorbidity, Pneumonia bacterial, Pyrexia
Clinical narrative: Pt presented to the ED on 11/5 with CC of generalized weakness which has been getting worse and with frequent falls . She was admitted for Hypercarbia. During her hospital stay she received treatment for her DX, in addition to multiple comorbidities.   Plan was discharge to rehab facility however, pt's roommate in hospital came back positive for COVID 19.  Patient tested positive for COVID-19, was asymptomatic.  Patient did have some mild hypoxia but this was likely secondary bacterial pneumonia was started on Levaquin with good effect.   Her oxygen requirement has improved and has been weaned to 4 L.     Rehab facility delayed transfer,  would like pt monitored and afebrile for 72 hours prior to initiating prior authorization again for placement.  Pt started spiking fevers over the past 48 hours.  Suspect because she was retaining urine as since foley placed the fevers have resolved.   She was discharged  November 29, 2021 in stable condition.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Urinary retention
Clinical narrative: Pt presented to the ED on 11/5 with CC of generalized weakness which has been getting worse and with frequent falls . She was admitted for Hypercarbia. During her hospital stay she received treatment for her DX, in addition to multiple comorbidities.   Plan was discharge to rehab facility however, pt's roommate in hospital came back positive for COVID 19.  Patient tested positive for COVID-19, was asymptomatic.  Patient did have some mild hypoxia but this was likely secondary bacterial pneumonia was started on Levaquin with good effect.   Her oxygen requirement has improved and has been weaned to 4 L.     Rehab facility delayed transfer,  would like pt monitored and afebrile for 72 hours prior to initiating prior authorization again for placement.  Pt started spiking fevers over the past 48 hours.  Suspect because she was retaining urine as since foley placed the fevers have resolved.   She was discharged  November 29, 2021 in stable condition.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray normal, Cough, Dyspnoea, Electrocardiogram normal
Clinical narrative: Discharge Provider: Private, DO Primary Care Provider at Discharge: Private, MD Admission Date: 7/30/2022 Discharge Date: 8/1/2022 HOSPITAL COURSE: Patient is a 19 y.o. woman with a history significant for chronic lung disease of infancy, Moebius syndrome, Pierre Robin sequence, and adrenal insufficiency who presented to ED on 7/30/22 with 1 day history of sore throat, nonproductive cough, body aches, SOB and a positive home COVID test. In the ED, she was tachycardiac with HR 120, tachypnea > 30 and afebrile. EKG was insignificant and chest X-ray showed no acute cardiopulmonary abnormalities. She was given fluids, one dose of remdesivir in the ED, and started on hydrocortisone 15 mg q6h as part of her stress dosing regimen for adrenal insufficiency. She was admitted and management was continued on the medicine floors. Admission remained uncomplicated and patient's respiratory status improved. Two doses of remdesivir were administered during admission. Patient and mother were informed that the course of monoclonal antibodies could be completed in outpatient infusion clinics if needed. On 8/1/22, patient was medically and vitally stable for discharge.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, SARS-CoV-2 test positive, Tachycardia, Tachypnoea
Clinical narrative: Discharge Provider: Private, DO Primary Care Provider at Discharge: Private, MD Admission Date: 7/30/2022 Discharge Date: 8/1/2022 HOSPITAL COURSE: Patient is a 19 y.o. woman with a history significant for chronic lung disease of infancy, Moebius syndrome, Pierre Robin sequence, and adrenal insufficiency who presented to ED on 7/30/22 with 1 day history of sore throat, nonproductive cough, body aches, SOB and a positive home COVID test. In the ED, she was tachycardiac with HR 120, tachypnea > 30 and afebrile. EKG was insignificant and chest X-ray showed no acute cardiopulmonary abnormalities. She was given fluids, one dose of remdesivir in the ED, and started on hydrocortisone 15 mg q6h as part of her stress dosing regimen for adrenal insufficiency. She was admitted and management was continued on the medicine floors. Admission remained uncomplicated and patient's respiratory status improved. Two doses of remdesivir were administered during admission. Patient and mother were informed that the course of monoclonal antibodies could be completed in outpatient infusion clinics if needed. On 8/1/22, patient was medically and vitally stable for discharge.
Age: 26.0
Sex: M
Vaccine: FLUC4
Symptoms: Feeling cold, Hyperhidrosis, Hypotension, Pallor
Clinical narrative: Blood pressure low (86/65) Heart Rate 89 Respirations 16 ; Became very cold and sweaty for 12 minutes and pale;  After 12 minute he was pink, dry and was alert and oriented the entire time.  He drunk fluids and at some chicken tenders and was discharge from the pharmacy at 6:30 pm.  He called when he got home at 6:40 pm and was doing great
Age: 96.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Memory impairment, Pneumonia
Clinical narrative: Admission Date: 7/30/2022 Discharge Date: 8/1/2022  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Weakness [R53.1] COVID-19 [U07.1]   HOSPITAL COURSE: 97-year-old male in his normal state of health presented to the emergency room with weakness.  He also has noted progressive memory issues per the son.  This did seem to go on from last several weeks to months.  He also had a friend who was exposed to that had COVID and was hospitalized.  During hospitalization he did very well.   Hospital course: He was treated for community-acquired pneumonia and did very well. His mental status was back to baseline by the next am. He was evaluated by case management and PT and recommended some PT. Family arranged for him to go to assisted living. He never required treatment for Covid, but I did discuss Paxlovid with the patient and son
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chronic obstructive pulmonary disease, Fatigue, Hypoxia, Malaise
Clinical narrative: Discharge Provider: Private MD Primary Care Provider: None Physician, DO Admission Date: 7/31/2022 Discharge Date: Aug 2, 2022 PRESENTING PROBLEM: Hypoxia [R09.02]- Chronic obstructive pulmonary disease, unspecified COPD type (HCC) [J44.9]- Acute respiratory disease due to COVID-19 virus [U07.1, J06.9]- COVID-19 [U07.1]. HOSPITAL COURSE: Patient's symptoms of respiratory distress, fatigue, malaise are into a resolved by day 2 of admission. Feeling very much back to baseline functional status. Is wanting to go home at this time. Understands need to continue steroid course and follow-up outpatient with PCP for further optimization of his chronic obstructive pulmonary disease as well.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory disorder, Respiratory distress
Clinical narrative: Discharge Provider: Private MD Primary Care Provider: None Physician, DO Admission Date: 7/31/2022 Discharge Date: Aug 2, 2022 PRESENTING PROBLEM: Hypoxia [R09.02]- Chronic obstructive pulmonary disease, unspecified COPD type (HCC) [J44.9]- Acute respiratory disease due to COVID-19 virus [U07.1, J06.9]- COVID-19 [U07.1]. HOSPITAL COURSE: Patient's symptoms of respiratory distress, fatigue, malaise are into a resolved by day 2 of admission. Feeling very much back to baseline functional status. Is wanting to go home at this time. Understands need to continue steroid course and follow-up outpatient with PCP for further optimization of his chronic obstructive pulmonary disease as well.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID POSITIVE PT VACCINATED ADMISSION TO HOSPITAL