chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: SWELLING (non-serious), outcome "unknown", described as "Unknown if consumer was experiencing swelling".Additional information: The patient asked if swelling was one of the side effect, 'natural' swelling and stated that the patient was just calling to find that out. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Respiratory disorder
Clinical narrative: Respiratory  issues; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), administration date: 2021, for Covid-19 immunization. The following information was reported: RESPIRATORY DISORDER (non-serious) with onset 2021, outcome "unknown", described as "Respiratory  issues".  Additional information included: The patient had higher risk because of respiratory issues.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 20.0
Sex: M
Vaccine: PPV
Symptoms: Joint swelling, Pyrexia
Clinical narrative: swelling up of the arm; High fever; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 21-year-old male patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), administration date 2020 (lot number: unknown) at the age of 20-years as dose number unknown, single for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling up of the arm" and PYREXIA (non-serious), outcome "unknown", described as "High fever". Additional information: The patient received the vaccine about a year and a half ago.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: MENB
Symptoms: Erythema, Nausea, Pain, Pyrexia, Swelling
Clinical narrative: Nauseous day 1; fever; Swelling/ lasting for 3+ days; redness/ lasting for 3+ days; pain lasting for 3+ days; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a Pfizer sales representative. The reporter is the patient.  A patient (no qualifiers provided) received meningococcal group b rlp2086 (TRUMENBA) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING (non-serious), outcome "recovered", described as "Swelling/ lasting for 3+ days"; ERYTHEMA (non-serious), outcome "recovered", described as "redness/ lasting for 3+ days"; PAIN (non-serious), outcome "recovered", described as "pain lasting for 3+ days"; NAUSEA (non-serious), outcome "unknown", described as "Nauseous day 1"; PYREXIA (non-serious), outcome "unknown", described as "fever". The patient experienced swelling, redness, pain lasting for 3+ days. Nauseous day 1 with fever. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Allergy to metals
Clinical narrative: since then I've been dealing with some health issues including being recently diagnosed with a severe gold allergy; 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 38 year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), administration date 2019 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGY TO METALS (non-serious), outcome "unknown", described as "since then I've been dealing with some health issues including being recently diagnosed with a severe gold allergy".  Additional information: Patient got the vaccine at the end of 2019 and since then had been dealing with some health issues including being recently diagnosed with a severe gold allergy. Patient requested the same for the Pfizer covid vaccine as well.  No follow-up attempts are possible. No further information is expected.  Follow up (21Dec2021): This follow up report is being submitted to amend previously reported information: (To recode Prevnar 13 to the vaccine combination product.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Incorrect dose administered, Migraine, Overdose
Clinical narrative: Headache; Trouble catching her breath; like a migraine and light made it hurt worse; the patient was administered the entire vial as one dose; the patient was administered the entire vial as one dose; This is a spontaneous report from a Pfizer sponsored program via a contactable Nurse reported for a patient. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FC3182, Expiration date: Oct2021) via an unspecified route of administration, administered in left deltoid on 22Sep2021 at 15:00 pm (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient did not have any medical history. The patient's concomitant medications were not reported. No additional vaccines were administered on the same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Sep2021 at 15:00 PM, the patient was given overdose as incorrect dose was administered and on 23Sep2021, the patient experienced headache, dyspnoea and migraine. It was reported that On 22Sep2021 around 15:00 pm, the patient was given a Pfizer BioNtech COVID 19 vaccine dose, the vial was diluted with the correct 1.8 ml of diluent but the patient was administered the entire vial as one dose. RMA (Registered Medical Assistant) gave an entire vial as a single dose to a patient. The vial was diluted with single dose of dilution. It was confirmed that there was only one patient involved. The patient received six doses instead of one because there were six per vial. The patient received the entire vial as a single dose. AE required visit to Physician Office for headache, dyspnoea and migraine. Please clarify the type of medication error.  overdose. Please provide the stage of medication error (e.g., prescribing, dispensing, preparation and administration). Administration. Please provide contributing factors to the medication error. The medical assistant thought it was a single dose vial so drew up entire vial and administered to the patient. Yesterday morning the patient had bad headache which felt like a migraine and light made it hurt worse. She also had trouble catching her breath, and was brought into the doctor office for monitoring. Her O2 was fine, however. Headache was not a intense today but still there. The breathing issues are much better today. On an unknown date, patient underwent laboratory test oxygen saturation (O2), and results were normal. The patient had reported previously that the headaches had been getting better. Outcome for the events headache and dyspnoea was recovering and for other events were unknown.  Follow Up (24Sep2021): This is a spontaneous follow up report. Added additional events and outcome.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation
Clinical narrative: Headache; Trouble catching her breath; like a migraine and light made it hurt worse; the patient was administered the entire vial as one dose; the patient was administered the entire vial as one dose; This is a spontaneous report from a Pfizer sponsored program via a contactable Nurse reported for a patient. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FC3182, Expiration date: Oct2021) via an unspecified route of administration, administered in left deltoid on 22Sep2021 at 15:00 pm (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient did not have any medical history. The patient's concomitant medications were not reported. No additional vaccines were administered on the same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Sep2021 at 15:00 PM, the patient was given overdose as incorrect dose was administered and on 23Sep2021, the patient experienced headache, dyspnoea and migraine. It was reported that On 22Sep2021 around 15:00 pm, the patient was given a Pfizer BioNtech COVID 19 vaccine dose, the vial was diluted with the correct 1.8 ml of diluent but the patient was administered the entire vial as one dose. RMA (Registered Medical Assistant) gave an entire vial as a single dose to a patient. The vial was diluted with single dose of dilution. It was confirmed that there was only one patient involved. The patient received six doses instead of one because there were six per vial. The patient received the entire vial as a single dose. AE required visit to Physician Office for headache, dyspnoea and migraine. Please clarify the type of medication error.  overdose. Please provide the stage of medication error (e.g., prescribing, dispensing, preparation and administration). Administration. Please provide contributing factors to the medication error. The medical assistant thought it was a single dose vial so drew up entire vial and administered to the patient. Yesterday morning the patient had bad headache which felt like a migraine and light made it hurt worse. She also had trouble catching her breath, and was brought into the doctor office for monitoring. Her O2 was fine, however. Headache was not a intense today but still there. The breathing issues are much better today. On an unknown date, patient underwent laboratory test oxygen saturation (O2), and results were normal. The patient had reported previously that the headaches had been getting better. Outcome for the events headache and dyspnoea was recovering and for other events were unknown.  Follow Up (24Sep2021): This is a spontaneous follow up report. Added additional events and outcome.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Maternal exposure during pregnancy, Pain
Clinical narrative: Maternal exposure during pregnancy (Delivery Date 15Dec2021); First night of second dose I was fatigued; had a headache; body aches; fever; violent chills; My whole body was shaking; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Sep2021 11:15 (Batch/Lot number: unknown) at the age of 31 years as dose 2, single for covid-19 immunisation. Date of last menstrual period: 14Mar2021. The patient was 27 weeks pregnant at the time of exposure to bnt162b2. The patient was 27 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 15Dec2021. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Proprietary medicinal product name: Pfizer   , Batch/lot number: Unknown    , Anatomical Location : Arm Left   , Dose Number : 1, administration time=10:30 AM), administration date: 24Aug2021, for COVID-19 immunisation. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 20Sep2021 16:00, outcome "not recovered", described as "Maternal exposure during pregnancy (Delivery Date 15Dec2021)"; FATIGUE (non-serious) with onset 20Sep2021 16:00, outcome "not recovered", described as "First night of second dose I was fatigued"; HEADACHE (non-serious) with onset 20Sep2021 16:00, outcome "not recovered", described as "had a headache"; PAIN (non-serious) with onset 20Sep2021 16:00, outcome "not recovered", described as "body aches"; PYREXIA (non-serious) with onset 20Sep2021 16:00, outcome "not recovered", described as "fever"; CHILLS (non-serious) with onset 20Sep2021 16:00, outcome "not recovered", described as "violent chills"; TREMOR (non-serious) with onset 20Sep2021 16:00, outcome "not recovered", described as "My whole body was shaking". Therapeutic measures were not taken as a result of maternal exposure during pregnancy, fatigue, headache, pain, pyrexia, chills, tremor.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Maternal exposure during pregnancy (Delivery Date 15Dec2021); First night of second dose I was fatigued; had a headache; body aches; fever; violent chills; My whole body was shaking; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Sep2021 11:15 (Batch/Lot number: unknown) at the age of 31 years as dose 2, single for covid-19 immunisation. Date of last menstrual period: 14Mar2021. The patient was 27 weeks pregnant at the time of exposure to bnt162b2. The patient was 27 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 15Dec2021. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Proprietary medicinal product name: Pfizer   , Batch/lot number: Unknown    , Anatomical Location : Arm Left   , Dose Number : 1, administration time=10:30 AM), administration date: 24Aug2021, for COVID-19 immunisation. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 20Sep2021 16:00, outcome "not recovered", described as "Maternal exposure during pregnancy (Delivery Date 15Dec2021)"; FATIGUE (non-serious) with onset 20Sep2021 16:00, outcome "not recovered", described as "First night of second dose I was fatigued"; HEADACHE (non-serious) with onset 20Sep2021 16:00, outcome "not recovered", described as "had a headache"; PAIN (non-serious) with onset 20Sep2021 16:00, outcome "not recovered", described as "body aches"; PYREXIA (non-serious) with onset 20Sep2021 16:00, outcome "not recovered", described as "fever"; CHILLS (non-serious) with onset 20Sep2021 16:00, outcome "not recovered", described as "violent chills"; TREMOR (non-serious) with onset 20Sep2021 16:00, outcome "not recovered", described as "My whole body was shaking". Therapeutic measures were not taken as a result of maternal exposure during pregnancy, fatigue, headache, pain, pyrexia, chills, tremor.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Inappropriate schedule of product administration, Menstrual disorder, Overdose
Clinical narrative: periods for four months now; They were very painful and heavy cycles; They were very painful and heavy cycles; Overdose; inappropriate schedule of vaccine administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 22Mar2021 (Lot number: EN6206) as dose 1, single and administration date 22Mar2021 (Lot number: ER8734) as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypothyroidism" (unspecified if ongoing); "Hashimoto's  Disease" (unspecified if ongoing); ""breakthrough" bleeding as they had been so light", start date: 2018 (unspecified if ongoing), notes: By 2019-2020 my periods could be classified as, "breakthrough" bleeding as they had been so light. The patient took concomitant medications. The following information was reported: OVERDOSE (non-serious) with onset 22Mar2021, outcome "unknown", described as "Overdose"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 22Mar2021, outcome "unknown", described as "inappropriate schedule of vaccine administered"; MENSTRUAL DISORDER (non-serious) with onset 20Jun2021, outcome "unknown", described as "periods for four months now"; HEAVY MENSTRUAL BLEEDING (non-serious), DYSMENORRHOEA (non-serious) all with onset 20Jun2021, outcome "unknown" and all described as "They were very painful and heavy cycles". Therapeutic measures were not taken as a result of menstrual disorder, heavy menstrual bleeding, dysmenorrhoea.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications (not specified) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient had no known allergy. It was reported that since 2018 Patient had routinely had light periods with few symptoms or pain. Her cycles were slowing down in both flow, and it was normal to skip one month occasionally. By 2019-2020 her periods could be classified as "breakthrough" bleeding as they had been so light. After her vaccination in Mar, she went three months with no period. That was not too alarming, given her age. (So, no periods Mar, Apr, or May.) Since then, she has had periods for four months now. (Jun, Jul, Aug, and Sep.) They were very painful and heavy cycles.   No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dyspepsia, Dyspnoea, Nausea, Pain
Clinical narrative: Short breath; Sever stomach cramps; Sever stomach cramps and Burning; Body aches; Nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Sep2021 (Lot number: EW0180) at the age of 67 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: PRILOSEC; FLU VACCINE VII, administration date 15Sep2021. Past drug history included: Augmentin, reaction(s): "Known_allergies: Augmentin", notes: known allergies: Augmentin. The following information was reported: DYSPNOEA (non-serious) with onset 24Sep2021 13:00, outcome "not recovered", described as "Short breath"; ABDOMINAL PAIN UPPER (non-serious) with onset 24Sep2021 13:00, outcome "not recovered", described as "Sever stomach cramps"; DYSPEPSIA (non-serious) with onset 24Sep2021 13:00, outcome "not recovered", described as "Sever stomach cramps and Burning"; PAIN (non-serious) with onset 24Sep2021 13:00, outcome "not recovered", described as "Body aches"; NAUSEA (non-serious) with onset 24Sep2021 13:00, outcome "not recovered", described as "Nausea". BEACHES (non-serious) with onset 24Sep2021 13:00, outcome "not recovered". Therapeutic measures were not taken as a result of dyspnoea, abdominal pain upper, dyspepsia, pain, nausea and beaches. No Covid prior vaccination. No Covid tested post vaccination. The patient did not provide information to Other HCP regarding the reported adverse event(s) with the use of the product. Additional information: The patient was not pregnant during the vaccination. Patient did not receive treatment for the event. Patient had been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nose bleed that started about 1.5 hrs after vaccination.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 24Sep2021 16:30 (Lot number: FF2588) at the age of 15 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "epistaxis", start date: 24Sep2019, stop date: 24Sep2021. There were no concomitant medications. The following information was reported: EPISTAXIS (non-serious) with onset 24Sep2021 18:10, outcome "recovered" (24Sep2021), described as "Nose bleed that started about 1.5 hrs after vaccination.". Therapeutic measures were not taken as a result of epistaxis.  Additional information: The patient did not take other medications in four weeks. prior vaccination, the patient was not diagnosed with Covid-19 and post vaccination, the patient had not been tested for Covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic, SARS-CoV-2 test
Clinical narrative: Itchy rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 14 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 11:00 (Lot number: Ew0169) at the age of 14 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Reactive airway disease" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (dose number=1, lot number=Ew0150, administration time=11:00 AM, vaccine location=Left arm), administration date: 22Jul2021, when the patient was 14 years old, for Covid-19 immunization. The following information was reported: RASH PRURITIC (non-serious) with onset 25Aug2021, outcome "not recovered", described as "Itchy rash". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of rash pruritic.  Additional information:Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks. The patient did not had any other medications the patient received within 2 weeks of vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait inability
Clinical narrative: Debilitating pain in the join of my left knee.; Unable to walk; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Aug2021 16:00 (Lot number: FC3181) at the age of 68 years as dose 2, single and administered in arm right, administration date 30Jul2021 16:00 (Lot number: FC7484) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic obstructive pulmonary disease" (unspecified if ongoing); "Known allergies: Contrast Dye" (unspecified if ongoing), notes: Known allergies: Contrast dye. There were no concomitant medications. The following information was reported: ARTHRALGIA (non-serious) with onset 06Aug2021, outcome "not recovered", described as "Debilitating pain in the join of my left knee."; GAIT INABILITY (non-serious) with onset 06Aug2021, outcome "not recovered", described as "Unable to walk". Therapeutic measures were not taken as a result of arthralgia, gait inability.  Additional information: The patient had debilitating pain in the join of her left knee. Felt like a needle is being stabbed in the tissue part of knee joint. It was excruciating pain and she was unable to walk during episodes. She never had this before covid shot. The patient was administered COVID-19 vaccine in a pharmacy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medication within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. The patient did not receive any treatment. The device date was 26Sep2021.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Hypoaesthesia, Swelling
Clinical narrative: Redness of skin on the ankles; mild swelling; mild warmth/slight warmth in the area; mild heat swelling; slight numbness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Sep2021 11:00 (Lot number: FF2588) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious) with onset 23Sep2021 16:00, outcome "not recovered", described as "Redness of skin on the ankles"; SWELLING (non-serious) with onset 23Sep2021 16:00, outcome "not recovered", described as "mild swelling"; FEELING HOT (non-serious) with onset 23Sep2021 16:00, outcome "not recovered", described as "mild warmth/slight warmth in the area"; FEELING HOT (non-serious) with onset 23Sep2021 16:00, outcome "not recovered", described as "mild heat swelling"; HYPOAESTHESIA (non-serious) with onset 23Sep2021 16:00, outcome "not recovered", described as "slight numbness". Therapeutic measures were not taken as a result of erythema, swelling, feeling hot, feeling hot, hypoaesthesia.   Additional information: No other vaccine in four weeks. No Covid tested post vaccination. No known allergies. patient had covid prior vaccination.    No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: Chronic headaches; migraines; Fatigue; shortness of breath; Disorientation; dizziness; Neurological symptoms (numbing in various parts of body, including face and lips; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 09:15 (Lot number: EW0164) at the age of 34 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "Chronic headaches"; MIGRAINE (non-serious) with onset 2021, outcome "not recovered", described as "migraines"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "Fatigue"; DYSPNOEA (non-serious) with onset 2021, outcome "not recovered", described as "shortness of breath"; DISORIENTATION (non-serious) with onset 2021, outcome "not recovered", described as "Disorientation"; DIZZINESS (non-serious) with onset 2021, outcome "not recovered", described as "dizziness"; HYPOAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "Neurological symptoms (numbing in various parts of body, including face and lips". It was unknown if therapeutic measures were taken as a result of headache, migraine, fatigue, dyspnoea, disorientation, dizziness, hypoaesthesia.  Additional information: Chronic headaches & migraines. Fatigue and shortness of breathe. Disorientation & dizziness. Neurological symptoms (numbing in various parts of body, including face and lips). All of these symptoms occurring to various degrees for the last 5+ months. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. Other medications in two weeks was reported as not applicable.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Migraine
Clinical narrative: Chronic headaches; migraines; Fatigue; shortness of breath; Disorientation; dizziness; Neurological symptoms (numbing in various parts of body, including face and lips; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 09:15 (Lot number: EW0164) at the age of 34 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "Chronic headaches"; MIGRAINE (non-serious) with onset 2021, outcome "not recovered", described as "migraines"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "Fatigue"; DYSPNOEA (non-serious) with onset 2021, outcome "not recovered", described as "shortness of breath"; DISORIENTATION (non-serious) with onset 2021, outcome "not recovered", described as "Disorientation"; DIZZINESS (non-serious) with onset 2021, outcome "not recovered", described as "dizziness"; HYPOAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "Neurological symptoms (numbing in various parts of body, including face and lips". It was unknown if therapeutic measures were taken as a result of headache, migraine, fatigue, dyspnoea, disorientation, dizziness, hypoaesthesia.  Additional information: Chronic headaches & migraines. Fatigue and shortness of breathe. Disorientation & dizziness. Neurological symptoms (numbing in various parts of body, including face and lips). All of these symptoms occurring to various degrees for the last 5+ months. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. Other medications in two weeks was reported as not applicable.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Immunisation, Pruritus, Vaccination site rash
Clinical narrative: received his third Pfizer shot; Has got a rash on his hands bad; Where I got the injection on that arm I have a little bit of a rash; I have it in between all of fingers that just burns; itches like crazy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Sep2021 (Lot number: FC3181) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TAMULOSIN. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization; Bnt162b2 (2nd dose), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "received his third Pfizer shot"; VACCINATION SITE RASH (non-serious), outcome "unknown", described as "Has got a rash on his hands bad; Where I got the injection on that arm I have a little bit of a rash"; BURNING SENSATION (non-serious), outcome "unknown", described as "I have it in between all of fingers that just burns"; PRURITUS (non-serious), outcome "unknown", described as "itches like crazy".  Additional information: This is the second case out of 2 cases in which reporter is reporting for her husband (Patient). Reporter stated, "On 20Sep2021 received his third Pfizer shot and the first day had a little red lump where the vaccine was inserted, the next day the rash spread to about six inches across his arm, the following day he got a bad rash on his stomach, and from there it continued growing and now have a rash behind knees the following days he got rash behind his knees and today his whole body is filled with the rash, that's severely itching." Reaction/event as reported by primary source: Has got a rash on his hands bad; Where I got the injection on that arm, I have a little bit of a rash and then I have it in between all of fingers that just burns and itches like crazy.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Body height, Eye pain
Clinical narrative: I got sick; my arm/feet/ legs hurts; Neck pain; Eye pain; Back pain; Knee pain; I feel so weak; tooth pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old patient received bnt162b2 (BNT162B2), administered in arm right (Lot number: 3014SDA) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "take' them for my headache" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN] taken for headache. The following information was reported: ILLNESS (non-serious), outcome "not recovered", described as "I got sick"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "my arm/feet/ legs hurts"; NECK PAIN (non-serious), outcome "not recovered", described as "Neck pain"; EYE PAIN (non-serious), outcome "not recovered", described as "Eye pain"; BACK PAIN (non-serious), outcome "not recovered", described as "Back pain"; ARTHRALGIA (non-serious), outcome "not recovered", described as "Knee pain"; ASTHENIA (non-serious), outcome "not recovered", described as "I feel so weak"; TOOTHACHE (non-serious), outcome "not recovered", described as "tooth pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of illness, pain in extremity, neck pain, eye pain, back pain, arthralgia, asthenia, toothache.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Neck pain, Pain in extremity, Toothache, Weight
Clinical narrative: I got sick; my arm/feet/ legs hurts; Neck pain; Eye pain; Back pain; Knee pain; I feel so weak; tooth pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old patient received bnt162b2 (BNT162B2), administered in arm right (Lot number: 3014SDA) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "take' them for my headache" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN] taken for headache. The following information was reported: ILLNESS (non-serious), outcome "not recovered", described as "I got sick"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "my arm/feet/ legs hurts"; NECK PAIN (non-serious), outcome "not recovered", described as "Neck pain"; EYE PAIN (non-serious), outcome "not recovered", described as "Eye pain"; BACK PAIN (non-serious), outcome "not recovered", described as "Back pain"; ARTHRALGIA (non-serious), outcome "not recovered", described as "Knee pain"; ASTHENIA (non-serious), outcome "not recovered", described as "I feel so weak"; TOOTHACHE (non-serious), outcome "not recovered", described as "tooth pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of illness, pain in extremity, neck pain, eye pain, back pain, arthralgia, asthenia, toothache.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: I am having a reaction, rash on my right arm; it itch a lot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 21Sep2021 (Lot number: FC3182) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "I am having a reaction, rash on my right arm"; PRURITUS (non-serious), outcome "unknown", described as "it itch a lot".  Additional information: Patient was the reporter and informed about the Pfizer Medical Information and provided with the number and requested to dial the option 3 and informed about timings as 8 AM to 8 PM from Monday to Friday.Further probing could not be done as the reporter was not willing to complete the report. Hence, limited information available over the call.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Coordination abnormal, Immunisation, Malaise, Pyrexia
Clinical narrative: booster; I had fever; and I just felt horrible and at last sit a few hours; I was so weak; I couldn''t get up, hardly get stand up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization; Bnt162b2 (Dose 2), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; PYREXIA (non-serious), outcome "unknown", described as "I had fever"; MALAISE (non-serious), outcome "unknown", described as "and I just felt horrible and at last sit a few hours"; ASTHENIA (non-serious), outcome "unknown", described as "I was so weak"; COORDINATION ABNORMAL (non-serious), outcome "unknown", described as "I couldn''t get up, hardly get stand up".  Additional information: Consumer stated, "Yes, I got my third vaccination, let me see, day before yesterday about 3 O'clock in the afternoon and I was fine until about 4 O'clock in the morning. I went to the bathroom, and I was so weak, I couldn't get up, hardly get stand up and I had fever and I just felt horrible and at last sit a few hours. I had, I live alone or maybe 83 years old. So, I had to call my daughter to come and help me and I just felt weak most of the day and but today I feel better. (General statement) I just thought, they want to know about side effects. The follow-up (07Oct2021) is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Nodule, Pain, Swelling
Clinical narrative: I have nodules on my armpit; lumps kind of like swollen up; it's kind of full of pain till now; I am concern about it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in hand right, administration date 24Sep2021 (Lot number: FC3184, Expiration Date: 07Oct2021) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart burn" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE taken for burning sensation; LISINOPRIL taken for blood pressure abnormal. Vaccination history included: Bnt162b2 (First Dose,, location: left arm, Expiration date: 28Sep2021), administration date: 03Sep2021, when the patient was 49 years old, for Covid-19 immunization. The following information was reported: NODULE (non-serious), outcome "unknown", described as "I have nodules on my armpit"; SWELLING (non-serious), outcome "unknown", described as "lumps kind of like swollen up"; PAIN (non-serious), outcome "unknown", described as "it's kind of full of pain till now"; ANXIETY (non-serious), outcome "unknown", described as "I am concern about it".  Additional information: Patient took 1st shot 3 weeks ago and 2nd shot on Friday so, she thinks from the second shot, she was having this reaction. Consumer stated, "So you want me to call my provider and check on what they going to say." Consumer was advised for to call doctor in case of any emergency and for query consumer was requested to call Medical Information.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Pain, Pyrexia
Clinical narrative: Fever; Feeling bad; Feeling achy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feeling bad"; PAIN (non-serious), outcome "unknown", described as "Feeling achy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Rash
Clinical narrative: DOSE 3 (BOOSTER); I had a rash as a side effect of the COVID booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1 single), for Covid-19 Immunization; Bnt162b2 (Dose 2 single), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "DOSE 3 (BOOSTER)"; RASH (non-serious), outcome "unknown", described as "I had a rash as a side effect of the COVID booster".  Additional information: Consumer stated, "Yes and I was wondering if you have any information suggestion as what to do about the rash." Consumer was informed about the role of  Drug Safety and  Medical Information Department. Consumer hung up abruptly. Further probing could not be done. Hence, limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: Swollen left eye lid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Sep2021 10:45 (Batch/Lot number: unknown) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sinusitis" (unspecified if ongoing). Concomitant medication(s) included: FLONASE. Vaccination history included: Bnt162b2 (DOSE 1), administration date: 02Sep2021, when the patient was 50 years old, for COVID-19 Immunization. The following information was reported: SWELLING OF EYELID (non-serious) with onset 23Sep2021 11:15, outcome "recovered" (Sep2021), described as "Swollen left eye lid". Therapeutic measures were not taken as a result of swelling of eyelid.  Additional information: Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient not tested for COVID-19. Patient received other medications in two weeks was Flonase. No known allergies was reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast tenderness, Fatigue, Headache, Nausea
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Sep2021 15:30 (Lot number: FC3184) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "fertility issues" (unspecified if ongoing), notes: Fertility issues prior to the vaccine which causes me to not ovulate and rarely bleeding. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Product=COVID 19, lot number=FC3184, lot unknown=False, dose number=1), administration date: 30Aug2021, when the patient was 34 years old, for Covid-19 immunization, reaction(s): "spotting".The following information was reported: VULVOVAGINAL DISCOMFORT (non-serious) with onset 24Sep2021, outcome "unknown", described as "a lot of pressure in both of my ovaries but especially on my left side"; VAGINAL HAEMORRHAGE (non-serious) with onset 24Sep2021, outcome "unknown", described as "spotting"; ARTHRITIS (non-serious) with onset 24Sep2021, outcome "unknown", described as "joint pain in my wrist elbow's meals"; NAUSEA (non-serious) with onset 24Sep2021, outcome "unknown", described as "a little nauseous"; HEADACHE (non-serious) with onset 24Sep2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset 24Sep2021, outcome "unknown", described as "fatigue"; BREAST TENDERNESS (non-serious) with onset 24Sep2021, outcome "unknown", described as "breast tenderness as well as being able  able to fill my blood pump through my body".No follow-up attempts are possible. No further information is expected.