chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Complication of pregnancy, Delayed umbilical cord clamping, Delivery, Depression rating scale score
Clinical narrative: Hospitalized - pregnant, Term pregnancy, hospitalized for vaginal delivery;  COVID-19 positive (4,9.22);  Fully vaccinated (no booster)  Hospitalized at Hospital OB:  MD (DC summary, MD - physician, obstetrics)  BRIEF OVERVIEW: Admission Date: 4/9/2022 Discharge Date: 4/11/2022  DETAILS OF HOSPITAL STAY: SUBJECTIVE: Patient is a 24 y.o. G2P2002 female at 39w4d with Estimated Date of Delivery: 4/12/22 who presents today with reported fever and body aches at home.  She has also had some diarrhea.  Presented to triage and tested positive for COVID.  Elected to stay for IOL. Pregnancy has been complicated by recurrent UTIs. PRESENTING PROBLEM:  Term pregnancy [Z34.90] SVD (spontaneous vaginal delivery) [O80] INTRAPARTUM COMPLICATIONS: Medical Problems (from 04/08/22 to present)    No problems associated with this episode.  PROCEDURES PERFORMED: Vaginal delivery  HOSPITAL COURSE: Patient is a 24 y.o. female G2P2002 who wast admitted for IOL due to new diagnosis of COVID at term She was also vaccinated.  She received one cytotec then spontaneously ruptured, making quick progress to 10/+2.  She pushed with 3 ctxs to deliver a liveborn female in a compound presentation with the hand as well as a body cord.  Cord clamping delayed.  Placenta delivered spontaneously and was intact with 3VC.  2nd degree lac repaired with 3-0 vicryl under local anesthesia.  EBL 100cc.  both went home on PPD #2 in stable condition. Covid sxzs improving. Edinburgh Edinburgh Postnatal Depression Scale Total: 4  DELIVERY DETAILS: DELIVERY TYPE: Vaginal, Spontaneous   ESTIMATED DUE DATE: Estimated Date of Delivery: 4/12/22 GESTATIONAL AGE AT DELIVERY: 39w4d  G2P2002 DELIVERY PROVIDER:   ASSISTING PROVIDER(S):   FINDINGS: NEWBORN STATUS: Living  NEWBORN SEX:  girl  Baby Girl A  Delivery Date/Time:    9:40 PM  WEIGHT: 3.23 kg  APGAR:  1 minutes 5 minutes 10 minutes  8  9
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Exposure during pregnancy, Labour induction, Malaise, Pain
Clinical narrative: Hospitalized - pregnant, Term pregnancy, hospitalized for vaginal delivery;  COVID-19 positive (4,9.22);  Fully vaccinated (no booster)  Hospitalized at Hospital OB:  MD (DC summary, MD - physician, obstetrics)  BRIEF OVERVIEW: Admission Date: 4/9/2022 Discharge Date: 4/11/2022  DETAILS OF HOSPITAL STAY: SUBJECTIVE: Patient is a 24 y.o. G2P2002 female at 39w4d with Estimated Date of Delivery: 4/12/22 who presents today with reported fever and body aches at home.  She has also had some diarrhea.  Presented to triage and tested positive for COVID.  Elected to stay for IOL. Pregnancy has been complicated by recurrent UTIs. PRESENTING PROBLEM:  Term pregnancy [Z34.90] SVD (spontaneous vaginal delivery) [O80] INTRAPARTUM COMPLICATIONS: Medical Problems (from 04/08/22 to present)    No problems associated with this episode.  PROCEDURES PERFORMED: Vaginal delivery  HOSPITAL COURSE: Patient is a 24 y.o. female G2P2002 who wast admitted for IOL due to new diagnosis of COVID at term She was also vaccinated.  She received one cytotec then spontaneously ruptured, making quick progress to 10/+2.  She pushed with 3 ctxs to deliver a liveborn female in a compound presentation with the hand as well as a body cord.  Cord clamping delayed.  Placenta delivered spontaneously and was intact with 3VC.  2nd degree lac repaired with 3-0 vicryl under local anesthesia.  EBL 100cc.  both went home on PPD #2 in stable condition. Covid sxzs improving. Edinburgh Edinburgh Postnatal Depression Scale Total: 4  DELIVERY DETAILS: DELIVERY TYPE: Vaginal, Spontaneous   ESTIMATED DUE DATE: Estimated Date of Delivery: 4/12/22 GESTATIONAL AGE AT DELIVERY: 39w4d  G2P2002 DELIVERY PROVIDER:   ASSISTING PROVIDER(S):   FINDINGS: NEWBORN STATUS: Living  NEWBORN SEX:  girl  Baby Girl A  Delivery Date/Time:    9:40 PM  WEIGHT: 3.23 kg  APGAR:  1 minutes 5 minutes 10 minutes  8  9
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Perineal injury, Pyrexia, SARS-CoV-2 test positive, Spontaneous rupture of membranes, Term birth
Clinical narrative: Hospitalized - pregnant, Term pregnancy, hospitalized for vaginal delivery;  COVID-19 positive (4,9.22);  Fully vaccinated (no booster)  Hospitalized at Hospital OB:  MD (DC summary, MD - physician, obstetrics)  BRIEF OVERVIEW: Admission Date: 4/9/2022 Discharge Date: 4/11/2022  DETAILS OF HOSPITAL STAY: SUBJECTIVE: Patient is a 24 y.o. G2P2002 female at 39w4d with Estimated Date of Delivery: 4/12/22 who presents today with reported fever and body aches at home.  She has also had some diarrhea.  Presented to triage and tested positive for COVID.  Elected to stay for IOL. Pregnancy has been complicated by recurrent UTIs. PRESENTING PROBLEM:  Term pregnancy [Z34.90] SVD (spontaneous vaginal delivery) [O80] INTRAPARTUM COMPLICATIONS: Medical Problems (from 04/08/22 to present)    No problems associated with this episode.  PROCEDURES PERFORMED: Vaginal delivery  HOSPITAL COURSE: Patient is a 24 y.o. female G2P2002 who wast admitted for IOL due to new diagnosis of COVID at term She was also vaccinated.  She received one cytotec then spontaneously ruptured, making quick progress to 10/+2.  She pushed with 3 ctxs to deliver a liveborn female in a compound presentation with the hand as well as a body cord.  Cord clamping delayed.  Placenta delivered spontaneously and was intact with 3VC.  2nd degree lac repaired with 3-0 vicryl under local anesthesia.  EBL 100cc.  both went home on PPD #2 in stable condition. Covid sxzs improving. Edinburgh Edinburgh Postnatal Depression Scale Total: 4  DELIVERY DETAILS: DELIVERY TYPE: Vaginal, Spontaneous   ESTIMATED DUE DATE: Estimated Date of Delivery: 4/12/22 GESTATIONAL AGE AT DELIVERY: 39w4d  G2P2002 DELIVERY PROVIDER:   ASSISTING PROVIDER(S):   FINDINGS: NEWBORN STATUS: Living  NEWBORN SEX:  girl  Baby Girl A  Delivery Date/Time:    9:40 PM  WEIGHT: 3.23 kg  APGAR:  1 minutes 5 minutes 10 minutes  8  9
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urinary tract infection, Uterine contractions during pregnancy, Wound closure
Clinical narrative: Hospitalized - pregnant, Term pregnancy, hospitalized for vaginal delivery;  COVID-19 positive (4,9.22);  Fully vaccinated (no booster)  Hospitalized at Hospital OB:  MD (DC summary, MD - physician, obstetrics)  BRIEF OVERVIEW: Admission Date: 4/9/2022 Discharge Date: 4/11/2022  DETAILS OF HOSPITAL STAY: SUBJECTIVE: Patient is a 24 y.o. G2P2002 female at 39w4d with Estimated Date of Delivery: 4/12/22 who presents today with reported fever and body aches at home.  She has also had some diarrhea.  Presented to triage and tested positive for COVID.  Elected to stay for IOL. Pregnancy has been complicated by recurrent UTIs. PRESENTING PROBLEM:  Term pregnancy [Z34.90] SVD (spontaneous vaginal delivery) [O80] INTRAPARTUM COMPLICATIONS: Medical Problems (from 04/08/22 to present)    No problems associated with this episode.  PROCEDURES PERFORMED: Vaginal delivery  HOSPITAL COURSE: Patient is a 24 y.o. female G2P2002 who wast admitted for IOL due to new diagnosis of COVID at term She was also vaccinated.  She received one cytotec then spontaneously ruptured, making quick progress to 10/+2.  She pushed with 3 ctxs to deliver a liveborn female in a compound presentation with the hand as well as a body cord.  Cord clamping delayed.  Placenta delivered spontaneously and was intact with 3VC.  2nd degree lac repaired with 3-0 vicryl under local anesthesia.  EBL 100cc.  both went home on PPD #2 in stable condition. Covid sxzs improving. Edinburgh Edinburgh Postnatal Depression Scale Total: 4  DELIVERY DETAILS: DELIVERY TYPE: Vaginal, Spontaneous   ESTIMATED DUE DATE: Estimated Date of Delivery: 4/12/22 GESTATIONAL AGE AT DELIVERY: 39w4d  G2P2002 DELIVERY PROVIDER:   ASSISTING PROVIDER(S):   FINDINGS: NEWBORN STATUS: Living  NEWBORN SEX:  girl  Baby Girl A  Delivery Date/Time:    9:40 PM  WEIGHT: 3.23 kg  APGAR:  1 minutes 5 minutes 10 minutes  8  9
Age: 5.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient is was overdue for well child check and overdue for vaccines. Pentacle was ordered and administered.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Dental examination, Tinnitus, X-ray
Clinical narrative: Tinnitus
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood urine present, Migraine, Plasmapheresis, Platelet count decreased, Spinal pain
Clinical narrative: Migraine, spinal pain, blood in urine, TTP, hospitalization starting 4/17/2022, began plasma dialysis 4/18/2022
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombotic thrombocytopenic purpura
Clinical narrative: Migraine, spinal pain, blood in urine, TTP, hospitalization starting 4/17/2022, began plasma dialysis 4/18/2022
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing or high buzzing sounds/tinnitus began about an hour to two hours after receiving the vaccine injection. It has continued with varying intensity to this day. I mentioned this to an ENT specialist I saw in May, 2021, and asked if the tinnitus could've resulted from the vaccine, but he could not confirm the potential causality.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Burning and shooting pain on breasts; tingling/pins and needles in shoulder blades and right side of back. Numbness. lol
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Bone pain, Dysstasia, Gait disturbance
Clinical narrative: Moderna 3rd dose Clinic: 4/12/2022, 10am: Moderna lot number 005M21A Systemic reaction: 4/12/2022- Skeletal, joints & muscle aches and pains including whole body. Excruciating pain to walk and bend over. Upper spine pain, hip joints pain, groin pain, lower back pain. 4/13/2022-pain the same. Took Tylenol. 4/14/2023-pain the same, took Tylenol. 4/15/2023-pain minimized, now in right lower back, possibly kidney, and groin area. Excruciating pain to bend the right hip/upper leg. Took Tylenol in the morning and another dose in the evening. 4/16/2022-pain same as 4/15/2022, took Tylenol 4/17/2022 (today) - pain starting to ease up, I can bend over with not as much pain, and I can sit/stand up with not so much pain. Pain is still in lower back and groin on right side. 11am took more Tylenol. I'm going to my doctor Monday for an evaluation.
Sex: F
Vaccine: COVID19
Symptoms: Groin pain, Myalgia, Pain, Pain in extremity, Spinal pain
Clinical narrative: Moderna 3rd dose Clinic: 4/12/2022, 10am: Moderna lot number 005M21A Systemic reaction: 4/12/2022- Skeletal, joints & muscle aches and pains including whole body. Excruciating pain to walk and bend over. Upper spine pain, hip joints pain, groin pain, lower back pain. 4/13/2022-pain the same. Took Tylenol. 4/14/2023-pain the same, took Tylenol. 4/15/2023-pain minimized, now in right lower back, possibly kidney, and groin area. Excruciating pain to bend the right hip/upper leg. Took Tylenol in the morning and another dose in the evening. 4/16/2022-pain same as 4/15/2022, took Tylenol 4/17/2022 (today) - pain starting to ease up, I can bend over with not as much pain, and I can sit/stand up with not so much pain. Pain is still in lower back and groin on right side. 11am took more Tylenol. I'm going to my doctor Monday for an evaluation.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: My ear started ringing 2 days after after taking the third Pfizer dose!
Sex: M
Vaccine: COVID19
Symptoms: Optic ischaemic neuropathy
Clinical narrative: Optic stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was reported that patient didn't have high blood pressure and is on healthy diet. The following information was reported: OPTIC ISCHAEMIC NEUROPATHY (medically significant), outcome "unknown", described as "Optic stroke" occurred a day after receiving the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (003110).  A 64-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown, dose 1), for COVID-19 Immunization. The following information was reported: DEATH (death), outcome "fatal", described as "died". Died three months after her second dose of Pfizer COVID vaccine. The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: died
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: COVID-19; First dose taken on 12-Apr-2021 and second dose on 18-May-2021; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose taken on 12-Apr-2021 and second dose on 18-May-2021) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0220ZIA and 037BZIA) for COVID-19 vaccination.  Patient had no allergies to medications, food, and other products. Patient had no acute illnesses at the time of vaccination and up to one month before. Patient had no chronic or long-standing health conditions Patient did not took prescriptions, over-the-counter medications, dietary supplements, or herbal remedies at time of vaccination.  On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose taken on 12-Apr-2021 and second dose on 18-May-2021). On 15-Oct-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose taken on 12-Apr-2021 and second dose on 18-May-2021) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Oct-2021, SARS-CoV-2 test: positive (Positive) Positive.  Both doses of mRNA-1273 (Moderna COVID-19 Vaccine) was received on arm. It was unknown if there were any other potential causes. No treatment medications were reported.  Company Comment: This is a Spontaneous case concerning a 56-year-old male patient, with no medical history reported, who experienced the unexpected, non-serious, and AESI of COVID-19. The event occurred approximately 5 months after the second dose of mRNA-1273 vaccine. Inappropriate schedule of product administration was noted, as doses were given 36 days apart. SARS-CoV-2 test was performed, with positive result. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-117988 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a 56-year-old male patient, with no medical history reported, who experienced the unexpected, non-serious, and AESI of COVID-19. The event occurred approximately 5 months after the second dose of mRNA-1273 vaccine. Inappropriate schedule of product administration was noted, as doses were given 36 days apart. SARS-CoV-2 test was performed, with positive result. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Cough, Dyspnoea
Clinical narrative: PMhx of moderate persistent asthma, Hx of provoked DVT 10 yrs ago was admitted for worsening dyspnea, cough and chest heaviness over last wk
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal hernia, Abdominal pain, Abscess drainage, Acidosis, Anisocoria
Clinical narrative: pt had covid vaccines.  dx with covid on 1/17/2022, passed on 01/19/2022
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Atrial flutter, Blood ketone body, COVID-19, Colectomy, Computerised tomogram abdomen abnormal
Clinical narrative: pt had covid vaccines.  dx with covid on 1/17/2022, passed on 01/19/2022
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Death, Dyspnoea, Electrocardiogram abnormal, Endotracheal intubation, Enterorrhaphy
Clinical narrative: pt had covid vaccines.  dx with covid on 1/17/2022, passed on 01/19/2022
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Hernia perforation, Hypoxia, Mental status changes, Mydriasis, Pneumoperitoneum
Clinical narrative: pt had covid vaccines.  dx with covid on 1/17/2022, passed on 01/19/2022
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pupillary light reflex tests abnormal, Respiratory symptom, SARS-CoV-2 test positive, Tachycardia, Wound closure
Clinical narrative: pt had covid vaccines.  dx with covid on 1/17/2022, passed on 01/19/2022
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Death
Clinical narrative: pt had covid vaccines.  dx with covid on 1/17/2022, passed on 01/19/2022
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Confusional state, Dysgraphia, Feeling abnormal, Gait disturbance
Clinical narrative: she felt the same pain on her head on the same locations; numbness on her extremities/numbness in hands/numbness in legs; 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 51-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (First booster; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "she felt the same pain on her head on the same locations"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness on her extremities/numbness in hands/numbness in legs".  Additional information: Stated that all three of the doses were Pfizer vaccine and she had them in a hospital clinic. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Grip strength decreased, Headache, Hypoaesthesia, Laboratory test, Magnetic resonance imaging
Clinical narrative: she felt the same pain on her head on the same locations; numbness on her extremities/numbness in hands/numbness in legs; 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 51-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (First booster; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "she felt the same pain on her head on the same locations"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness on her extremities/numbness in hands/numbness in legs".  Additional information: Stated that all three of the doses were Pfizer vaccine and she had them in a hospital clinic. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Memory impairment, Nerve conduction studies, Ocular discomfort, Ophthalmological examination, Visual impairment
Clinical narrative: she felt the same pain on her head on the same locations; numbness on her extremities/numbness in hands/numbness in legs; 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 51-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (First booster; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "she felt the same pain on her head on the same locations"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness on her extremities/numbness in hands/numbness in legs".  Additional information: Stated that all three of the doses were Pfizer vaccine and she had them in a hospital clinic. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anxiety, Confusional state, Feeling abnormal, Gait disturbance, Head discomfort
Clinical narrative: she felt the same pain on her head on the same locations; numbness on her extremities/numbness in hands/numbness in legs; 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 51-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (First booster; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "she felt the same pain on her head on the same locations"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness on her extremities/numbness in hands/numbness in legs".  Additional information: Stated that all three of the doses were Pfizer vaccine and she had them in a hospital clinic. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Hypoaesthesia, Musculoskeletal discomfort, Nausea, Neck pain
Clinical narrative: she felt the same pain on her head on the same locations; numbness on her extremities/numbness in hands/numbness in legs; 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 51-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (First booster; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "she felt the same pain on her head on the same locations"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness on her extremities/numbness in hands/numbness in legs".  Additional information: Stated that all three of the doses were Pfizer vaccine and she had them in a hospital clinic. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Nervous system disorder, Tremor
Clinical narrative: she felt the same pain on her head on the same locations; numbness on her extremities/numbness in hands/numbness in legs; 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 51-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (First booster; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "she felt the same pain on her head on the same locations"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness on her extremities/numbness in hands/numbness in legs".  Additional information: Stated that all three of the doses were Pfizer vaccine and she had them in a hospital clinic. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Hypoaesthesia
Clinical narrative: she felt the same pain on her head on the same locations; numbness on her extremities/numbness in hands/numbness in legs; 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 51-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (First booster; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "she felt the same pain on her head on the same locations"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness on her extremities/numbness in hands/numbness in legs".  Additional information: Stated that all three of the doses were Pfizer vaccine and she had them in a hospital clinic. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she felt the same pain on her head on the same locations; numbness on her extremities/numbness in hands/numbness in legs; 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 51-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (First booster; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "she felt the same pain on her head on the same locations"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness on her extremities/numbness in hands/numbness in legs".  Additional information: Stated that all three of the doses were Pfizer vaccine and she had them in a hospital clinic. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: Caller stated that she has been suffering from sever and extreme fatigue after receiving her 2nd booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2022 as dose 4 (second booster), single (Lot number: FK9894) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EL9261, Expiries: 31May2021, NDC: Unknown, not on the CDC vaccine record card.), administration date: 08Feb2021, when the patient was 79-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot: EM9810, Expiry: 30Jun2021, NDC: Unknown, not on the CDC vaccine record card.), administration date: 03Mar2021, when the patient was 79-year-old, for Covid-19 immunization; BNT162b2 (DOSE 1 (FIRST BOOSTER), SINGLE: , Lot: 301458A, NDC/Expiry: Unknown, not on the CDC vaccine record card.), administration date: 27Sep2021, when the patient was 80-year-old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset Apr2022, outcome "not recovered", described as "Caller stated that she has been suffering from sever and extreme fatigue after receiving her 2nd booster dose". The events "caller stated that she has been suffering from sever and extreme fatigue after receiving her 2nd booster dose" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient on the line regarding Booster dose she got booster shot 20 days ago. She was still suffering from severe fatigue send her to bed. Now she was tried to find somebody who knows. Patient clarified product name as Pfizer Vaccine against the Covid: Product name verified with and documented as provided by reporter. She clarified that she was administered her second booster shot of the Pfizer Vaccine against the Covid on 02Apr2022. She verified that she was still suffering from severe fatigue that sends her to bed which had onset after second booster shot. She was tried to get information on this event relative to the product. She has had complete bloodwork workup and that was fine; her vital signs are all good; no symptoms there of that nature.  Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Fatigue, Vital signs measurement
Clinical narrative: Caller stated that she has been suffering from sever and extreme fatigue after receiving her 2nd booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2022 as dose 4 (second booster), single (Lot number: FK9894) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EL9261, Expiries: 31May2021, NDC: Unknown, not on the CDC vaccine record card.), administration date: 08Feb2021, when the patient was 79-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot: EM9810, Expiry: 30Jun2021, NDC: Unknown, not on the CDC vaccine record card.), administration date: 03Mar2021, when the patient was 79-year-old, for Covid-19 immunization; BNT162b2 (DOSE 1 (FIRST BOOSTER), SINGLE: , Lot: 301458A, NDC/Expiry: Unknown, not on the CDC vaccine record card.), administration date: 27Sep2021, when the patient was 80-year-old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset Apr2022, outcome "not recovered", described as "Caller stated that she has been suffering from sever and extreme fatigue after receiving her 2nd booster dose". The events "caller stated that she has been suffering from sever and extreme fatigue after receiving her 2nd booster dose" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient on the line regarding Booster dose she got booster shot 20 days ago. She was still suffering from severe fatigue send her to bed. Now she was tried to find somebody who knows. Patient clarified product name as Pfizer Vaccine against the Covid: Product name verified with and documented as provided by reporter. She clarified that she was administered her second booster shot of the Pfizer Vaccine against the Covid on 02Apr2022. She verified that she was still suffering from severe fatigue that sends her to bed which had onset after second booster shot. She was tried to get information on this event relative to the product. She has had complete bloodwork workup and that was fine; her vital signs are all good; no symptoms there of that nature.  Follow-up attempts are completed. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count normal, Petechiae, Rash
Clinical narrative: Symmetric petechial rash noted to bilateral medial upper arms; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 5-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 as dose 1, single (Lot number: FL8094) at the age of 5 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PETECHIAE (non-serious) with onset 12Apr2022, outcome "recovering", described as "Symmetric petechial rash noted to bilateral medial upper arms". The event "symmetric petechial rash noted to bilateral medial upper arms" required physician office visit. Therapeutic measures were not taken as a result of petechiae.  Additional Information: Patient did not had covid prior vaccination and was not tested for covid post vaccination.
Age: 5.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Petechiae
Clinical narrative: Symmetric petechial rash noted to bilateral medial upper arms; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 5-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 as dose 1, single (Lot number: FL8094) at the age of 5 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PETECHIAE (non-serious) with onset 12Apr2022, outcome "recovering", described as "Symmetric petechial rash noted to bilateral medial upper arms". The event "symmetric petechial rash noted to bilateral medial upper arms" required physician office visit. Therapeutic measures were not taken as a result of petechiae.  Additional Information: Patient did not had covid prior vaccination and was not tested for covid post vaccination.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: it is extreme cramps on her legs; headache; pain in the arm; excruciating pain on both legs to her belly that she can hardly tolerate; 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.  An 87-year-old female patient received BNT162b2 (BNT162B2), on 13Apr2022 at 17:00 as dose 4 (booster), single (Lot number: SJ9948) at the age of 87 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE: 1, Product details: Stated that for the first dose on 17Mar2021 that the lot was EN6208. Stated that for the second dose on 07Apr2021 that the lot was EW0153. Stated that for the first booster on 30Oct2021 that the lot was SH8028. Stated that all of them were Pfizer shots.), administration date: 17Mar2021, when the patient was 86-year-old, for Covid-19 immunization, reaction(s): "pain in unknown arm"; BNT162b2 (Dose: 2, Product details: Stated that for the first dose on 17Mar2021 that the lot was EN6208. Stated that for the second dose on 07Apr2021 that the lot was EW0153. Stated that for the first booster on 30Oct2021 that the lot was SH8028. Stated that all of them were Pfizer shots.), administration date: 07Apr2021, when the patient was 86-year-old, for Covid-19 immunization, reaction(s): "pain in unknown arm"; BNT162b2 (DOSE: 3 (Booster), Product details: Stated that for the first dose on 17Mar2021 that the lot was EN6208. Stated that for the second dose on 07Apr2021 that the lot was EW0153. Stated that for the first booster on 30Oct2021 that the lot was SH8028. Stated that all of them were Pfizer shots.), administration date: 30Oct2021, when the patient was 87-year-old, for Covid-19 immunization, reaction(s): "pain in unknown arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 14Apr2022, outcome "unknown", described as "excruciating pain on both legs to her belly that she can hardly tolerate"; HEADACHE (non-serious) with onset 14Apr2022, outcome "not recovered"; PAIN IN EXTREMITY (non-serious) with onset 14Apr2022, outcome "recovered" (Apr2022), described as "pain in the arm"; MUSCLE SPASMS (non-serious), outcome "recovered" (Apr2022), described as "it is extreme cramps on her legs". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Stated that the pain only lasted one day with it. Later clarified that the pain in the arm happened on the day of the shots.  No follow-up attempts are possible. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Muscle spasms, Pain in extremity
Clinical narrative: it is extreme cramps on her legs; headache; pain in the arm; excruciating pain on both legs to her belly that she can hardly tolerate; 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.  An 87-year-old female patient received BNT162b2 (BNT162B2), on 13Apr2022 at 17:00 as dose 4 (booster), single (Lot number: SJ9948) at the age of 87 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE: 1, Product details: Stated that for the first dose on 17Mar2021 that the lot was EN6208. Stated that for the second dose on 07Apr2021 that the lot was EW0153. Stated that for the first booster on 30Oct2021 that the lot was SH8028. Stated that all of them were Pfizer shots.), administration date: 17Mar2021, when the patient was 86-year-old, for Covid-19 immunization, reaction(s): "pain in unknown arm"; BNT162b2 (Dose: 2, Product details: Stated that for the first dose on 17Mar2021 that the lot was EN6208. Stated that for the second dose on 07Apr2021 that the lot was EW0153. Stated that for the first booster on 30Oct2021 that the lot was SH8028. Stated that all of them were Pfizer shots.), administration date: 07Apr2021, when the patient was 86-year-old, for Covid-19 immunization, reaction(s): "pain in unknown arm"; BNT162b2 (DOSE: 3 (Booster), Product details: Stated that for the first dose on 17Mar2021 that the lot was EN6208. Stated that for the second dose on 07Apr2021 that the lot was EW0153. Stated that for the first booster on 30Oct2021 that the lot was SH8028. Stated that all of them were Pfizer shots.), administration date: 30Oct2021, when the patient was 87-year-old, for Covid-19 immunization, reaction(s): "pain in unknown arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 14Apr2022, outcome "unknown", described as "excruciating pain on both legs to her belly that she can hardly tolerate"; HEADACHE (non-serious) with onset 14Apr2022, outcome "not recovered"; PAIN IN EXTREMITY (non-serious) with onset 14Apr2022, outcome "recovered" (Apr2022), described as "pain in the arm"; MUSCLE SPASMS (non-serious), outcome "recovered" (Apr2022), described as "it is extreme cramps on her legs". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Stated that the pain only lasted one day with it. Later clarified that the pain in the arm happened on the day of the shots.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acarodermatitis, Biopsy, Blood test, Condition aggravated, Contusion
Clinical narrative: on 02Jan2022, she got infected with COVID-19, probably the omicron variant; on 02Jan2022, she got infected with COVID-19, probably the omicron variant; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 13May2021 as dose 1, single (Lot number: EW0167), in left arm and on 03Jun2021 at 11:00 as dose 2, single (Lot number: ER8729) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID Asymptomatic", start date: Jan2021 (unspecified if ongoing), notes: COVID Asymptomatic did not get any symptoms, she, just did the test because her husband got tested, positive for COVID.; "Menopause" (unspecified if ongoing), notes: Menopause Started like 5-6 years ago. They put her on, low dosage of hormone taking it for 5 years.; "Seasonal allergies" (unspecified if ongoing), notes: Seasonal allergies which of course progressed with, age so instead of 1 medication, started taking 2 then 3, to try to avoid the allergies. Not food allergies, like tree,, grass, pollen; "Iron deficiency" (unspecified if ongoing), notes: Has had this pretty much her whole life., Been on iron pills for this for pretty much like 20-25, years since in her early 40s; "High allergies on multiple unknown medications" (unspecified if ongoing), notes: High allergies on multiple unknown medications for this, for about 10-12 years; condition has been since birth. There were no concomitant medications. Past drug history included: Paxle, reaction(s): "she is allergic to: Paxle", notes: she is allergic to: Paxle. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Jan2022, outcome "unknown" and all described as "on 02Jan2022, she got infected with COVID-19, probably the omicron variant". The event "on 02jan2022, she got infected with covid-19, probably the omicron variant" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy: (unspecified date) developed Spongiotic dermatitis; Blood test: (unspecified date) Unknown Results; Mammogram: (unspecified date) Unknown Results, notes: small lesion in her left breast; SARS-CoV-2 test: (Jan2021) Unknown results, notes: she just did the test; (02Jan2022) Positive, notes: she also tested positive for COVID Omicron; Ultrasound breast: (unspecified date) Unknown Results, notes: small lesion in her left breast.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dermatitis, Eczema, Erythema, Facial discomfort, Hypersensitivity
Clinical narrative: on 02Jan2022, she got infected with COVID-19, probably the omicron variant; on 02Jan2022, she got infected with COVID-19, probably the omicron variant; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 13May2021 as dose 1, single (Lot number: EW0167), in left arm and on 03Jun2021 at 11:00 as dose 2, single (Lot number: ER8729) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID Asymptomatic", start date: Jan2021 (unspecified if ongoing), notes: COVID Asymptomatic did not get any symptoms, she, just did the test because her husband got tested, positive for COVID.; "Menopause" (unspecified if ongoing), notes: Menopause Started like 5-6 years ago. They put her on, low dosage of hormone taking it for 5 years.; "Seasonal allergies" (unspecified if ongoing), notes: Seasonal allergies which of course progressed with, age so instead of 1 medication, started taking 2 then 3, to try to avoid the allergies. Not food allergies, like tree,, grass, pollen; "Iron deficiency" (unspecified if ongoing), notes: Has had this pretty much her whole life., Been on iron pills for this for pretty much like 20-25, years since in her early 40s; "High allergies on multiple unknown medications" (unspecified if ongoing), notes: High allergies on multiple unknown medications for this, for about 10-12 years; condition has been since birth. There were no concomitant medications. Past drug history included: Paxle, reaction(s): "she is allergic to: Paxle", notes: she is allergic to: Paxle. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Jan2022, outcome "unknown" and all described as "on 02Jan2022, she got infected with COVID-19, probably the omicron variant". The event "on 02jan2022, she got infected with covid-19, probably the omicron variant" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy: (unspecified date) developed Spongiotic dermatitis; Blood test: (unspecified date) Unknown Results; Mammogram: (unspecified date) Unknown Results, notes: small lesion in her left breast; SARS-CoV-2 test: (Jan2021) Unknown results, notes: she just did the test; (02Jan2022) Positive, notes: she also tested positive for COVID Omicron; Ultrasound breast: (unspecified date) Unknown Results, notes: small lesion in her left breast.