chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Feeling cold, Feeling hot, Headache, Pyrexia
Clinical narrative: side effects were "worse" with the second shot; headache; fever; shakes; feeling cold; hey woke up in bed and were hot and took all the layers off; This case has been considered invalid as Unspecified AE. Upon follow up 4 (13Jan2022) information, this case become valid as events were added.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). An adult female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Potentially anxiety" (unspecified if ongoing); "loose bone in foot/leg" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Allergies: lavender, reaction(s): "Allergies". Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization.  The following information was reported: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "side effects were "worse" with the second shot"; HEADACHE (non-serious), outcome "unknown", described as "headache"; PYREXIA (non-serious), outcome "unknown", described as "fever"; TREMOR (non-serious), outcome "unknown", described as "shakes"; FEELING COLD (non-serious), outcome "unknown", described as "feeling cold"; FEELING HOT (non-serious), outcome "unknown", described as "hey woke up in bed and were hot and took all the layers off".  Additional Information:Started with a headache for a couple of hours (maybe 2) and then it turned into a fever with shakes that caused them to layer up due to feeling cold. They said they woke up in bed and were hot and took all the layers off, and they implied that was when the effects broke.They said side effects were "worse" with the second shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: side effects were "worse" with the second shot; headache; fever; shakes; feeling cold; hey woke up in bed and were hot and took all the layers off; This case has been considered invalid as Unspecified AE. Upon follow up 4 (13Jan2022) information, this case become valid as events were added.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). An adult female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Potentially anxiety" (unspecified if ongoing); "loose bone in foot/leg" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Allergies: lavender, reaction(s): "Allergies". Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization.  The following information was reported: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "side effects were "worse" with the second shot"; HEADACHE (non-serious), outcome "unknown", described as "headache"; PYREXIA (non-serious), outcome "unknown", described as "fever"; TREMOR (non-serious), outcome "unknown", described as "shakes"; FEELING COLD (non-serious), outcome "unknown", described as "feeling cold"; FEELING HOT (non-serious), outcome "unknown", described as "hey woke up in bed and were hot and took all the layers off".  Additional Information:Started with a headache for a couple of hours (maybe 2) and then it turned into a fever with shakes that caused them to layer up due to feeling cold. They said they woke up in bed and were hot and took all the layers off, and they implied that was when the effects broke.They said side effects were "worse" with the second shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain, Poor quality product administered, Product temperature excursion issue, Pyrexia
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Jan2022 09:37 (Lot number: FJ1620) at the age of 41 years 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: 01), administration date: 29Apr2021, for COVID-19 immunization; Bnt162b2 (Dose: 02, Vaccine Name: COVID-19, Manufacturer: Pfizer, Batch/Lot#: FJ1620, Route: IM, Anatomical Site of Injection: L arm), administration date: 20May2021, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "fever"; FATIGUE (non-serious), outcome "recovered", described as "fatigue"; PAIN (non-serious), outcome "recovered", described as "body aches"; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 04Jan2022 09:37, outcome "unknown", PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome "unknown" and all described as "administered to a patient after several days when it must be administered within 6 hours". Therapeutic measures were not taken as a result of poor quality product administered. Additional event: The patient provide information to the physician when she presented to the office for her daughter's routine visit regarding the reported adverse event(s) with the use of the product. The Pfizer product had a causal effect to the adverse event (s), possible normal expected side effect vs from expired vaccine. Reporter was not willing to be contacted again by Pfizer on the reported adverse event (s). The events did not result in doctor office or urgent care. Vaccines reconstituted and stored in syringe on 31Dec2021. Nurse did not read label on syringe that showed the date and administered the dose on 04Jan2022. She said she didn't recall a label on it and thought it was just drawn up. The Nurse "didn't see" an expiration date and has been reminded to never administer a vaccine without a label. The patient and mother both experienced fever, fatigue, and body aches that they didn't experienced with previous doses. Both recovered without a need to seek medical attention. Follow-up attempts are completed. No further information is expected. Follow-up (07Mar2022): This is a spontaneous follow-up report from a contactable Nurse. This Nurse reported in response to HCP letter sent that included: Updated information included: New Reporter added, Patient Initials and Age added, Historical Vaccines, Vaccine details added, Vaccination facility details added, Event Onset date and Treatment updated, New events added. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk, Illness
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP, for a Pfizer sponsored program (003110). A 1-year-old female patient exposed to the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), via transmammary; both single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had exposure via breast milk (breast-feeding), with outcome of unknown; and illness (sick), with outcome of recovered. Additional information: The patient got sick but got better into two days. The reporter believed she developed some natural immunity through breastfeeding. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report: US-PFIZER INC-202200132872 (patient's mother's case).
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node in neck; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2) (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 1 single), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph node in neck".  Additional information: Swollen lymph node in neck occurred after dose 2 in primary series as well. 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.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Poor quality product administered
Clinical narrative: was administered her 2nd COVID vaccine,  The needle entered her arm, plunger pushed and the my daughter moved, needle came out and I saw liquid run down her arm.; was administered her 2nd COVID vaccine,  The needle entered her arm, plunger pushed and the my daughter moved, needle came out and I saw liquid run down her arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A 6 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 14Jan2022 (Batch/Lot number: unknown) at the age of 6 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 14Jan2022, outcome "unknown" and all described as "was administered her 2nd COVID vaccine,  The needle entered her arm, plunger pushed and the my daughter moved, needle came out and I saw liquid run down her arm.".  Additional information: The technician inserted the same needle to give patient the rest of the dose. Nothing was mentioned of it and patient left. Reporters concern was that his daughter did not get the recommended amount of the vaccine.   Follow-up (07Mar2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: She already received her initial 2 covid vaccines from Pfizer and had a little a tiredness that went away; 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 80 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (ongoing), notes: She also claimed that she may had more arthritis now that she had before. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "She already received her initial 2 covid vaccines from Pfizer and had a little a tiredness that went away". This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Confusional state, Fatigue, Headache, Heart rate increased, Illness
Clinical narrative: felt sick; muscle ache; fatigue; headache; fast heartbeat; slight confusion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; imiquimod (ALDARA), administration date Oct2021 (Batch/Lot number: unknown). 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: ILLNESS (non-serious) with onset Oct2021, outcome "recovered", described as "felt sick"; MYALGIA (non-serious) with onset Oct2021, outcome "recovered", described as "muscle ache"; FATIGUE (non-serious) with onset Oct2021, outcome "recovered", described as "fatigue"; HEADACHE (non-serious) with onset Oct2021, outcome "recovered", described as "headache"; HEART RATE INCREASED (non-serious) with onset Oct2021, outcome "recovered", described as "fast heartbeat"; CONFUSIONAL STATE (non-serious) with onset Oct2021, outcome "recovered", described as "slight confusion". The action taken for imiquimod was dosage permanently withdrawn.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: felt sick; muscle ache; fatigue; headache; fast heartbeat; slight confusion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; imiquimod (ALDARA), administration date Oct2021 (Batch/Lot number: unknown). 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: ILLNESS (non-serious) with onset Oct2021, outcome "recovered", described as "felt sick"; MYALGIA (non-serious) with onset Oct2021, outcome "recovered", described as "muscle ache"; FATIGUE (non-serious) with onset Oct2021, outcome "recovered", described as "fatigue"; HEADACHE (non-serious) with onset Oct2021, outcome "recovered", described as "headache"; HEART RATE INCREASED (non-serious) with onset Oct2021, outcome "recovered", described as "fast heartbeat"; CONFUSIONAL STATE (non-serious) with onset Oct2021, outcome "recovered", described as "slight confusion". The action taken for imiquimod was dosage permanently withdrawn.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: I had my booster recently and since then my blood pressure has been going up consistently; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single 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. The following information was reported: HYPERTENSION (non-serious), outcome "not recovered", described as "I had my booster recently and since then my blood pressure has been going up consistently". Relevant laboratory tests and procedures are available in the appropriate section.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Rhinorrhoea, Sneezing
Clinical narrative: very slight runny nose/Little bit of the drippy nose; tiredness; sneeze; cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) 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: RHINORRHOEA (non-serious), outcome "unknown", described as "very slight runny nose/Little bit of the drippy nose"; FATIGUE (non-serious), outcome "unknown", described as "tiredness"; SNEEZING (non-serious), outcome "unknown", described as "sneeze"; COUGH (non-serious), outcome "unknown", described as "cough".  Additional Information: he was experiencing the signs and symptoms of a very slight runny nose and also tiredness and sometimes he sneeze and cough also. And one of his friend was also experiencing the same signs and symptoms after getting the vaccine. Had all three shots and that the booster shot also. Wanted to know if these are after effects to vaccine.  Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Fatigue, Rhinorrhoea, Sneezing
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. 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: RHINORRHOEA (non-serious), outcome "unknown", described as "very slight runny nose/Little bit of the drippy nose"; FATIGUE (non-serious), outcome "unknown", described as "tiredness"; SNEEZING (non-serious), outcome "unknown", described as "sneeze"; COUGH (non-serious), outcome "unknown", described as "cough". Additional information: It was reported that he was experiencing the signs and symptoms of a very slight runny nose and also tiredness and sometimes he sneeze and cough also. And one of his friends is also experiencing the same signs and symptoms after getting the vaccine. He has had all three shots and that the booster shot also. He wanted to find out if tiredness and little bit of the drippy nose is part of the after effects. He wanted to know if after the shot if this is the after effect. His first shot was get in the year, then he had the second shot, then he had the third shot along the middle of the year. He do not have it with me. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Follow-up (07Mar2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Oral discomfort, SARS-CoV-2 test
Clinical narrative: lip started burning; noticed 3 canker sores on my lower inner lip; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jan2022 12:00 (Batch/Lot number: unknown) at the age of 30 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SUBOXONE. The following information was reported: ORAL DISCOMFORT (non-serious) with onset 29Jan2022, outcome "not recovered", described as "lip started burning"; APHTHOUS ULCER (non-serious) with onset 29Jan2022, outcome "not recovered", described as "noticed 3 canker sores on my lower inner lip". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of oral discomfort, aphthous ulcer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fall, Gait inability, Headache
Clinical narrative: dizzy; trouble breathing; I can''t even walk now; severe rash; severe headache; I walked down the street and I just collapsed/I fall down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) at the age of 60 years as dose 2, single and administered in arm left (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "coughing" (unspecified if ongoing), notes: I was coughing for months, and then I got this shot (further clarification unknown; "COVID-19" (unspecified if ongoing), notes: I had the virus and two days after that I started feeling side effect and they got worse. Concomitant medication(s) included: OMEPRAZOLE; VENLAFAXINE. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; DYSPNOEA (non-serious), outcome "unknown", described as "trouble breathing"; GAIT INABILITY (non-serious), outcome "unknown", described as "I can''t even walk now"; RASH (non-serious), outcome "unknown", described as "severe rash"; HEADACHE (non-serious), outcome "unknown", described as "severe headache"; FALL (non-serious), outcome "unknown", described as "I walked down the street and I just collapsed/I fall down". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, dyspnoea, gait inability, rash, headache, fall.  Additional information: After the shot, the patient tried walking first time after five months and couldn't even do that because the patient was dizzy and had severe rash and muscles and head. And all the doctors told that everything was fine. The patient had two of them, didn't get the booster yet. The patient is going to get the booster. The doctor kept saying that rash will go away but it was really not going away. When the patient had the virus and two days after that started feeling side effect and they got worse. The patient had omeprazole for stomach.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Rash, Weight
Clinical narrative: dizzy; trouble breathing; I can''t even walk now; severe rash; severe headache; I walked down the street and I just collapsed/I fall down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) at the age of 60 years as dose 2, single and administered in arm left (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "coughing" (unspecified if ongoing), notes: I was coughing for months, and then I got this shot (further clarification unknown; "COVID-19" (unspecified if ongoing), notes: I had the virus and two days after that I started feeling side effect and they got worse. Concomitant medication(s) included: OMEPRAZOLE; VENLAFAXINE. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; DYSPNOEA (non-serious), outcome "unknown", described as "trouble breathing"; GAIT INABILITY (non-serious), outcome "unknown", described as "I can''t even walk now"; RASH (non-serious), outcome "unknown", described as "severe rash"; HEADACHE (non-serious), outcome "unknown", described as "severe headache"; FALL (non-serious), outcome "unknown", described as "I walked down the street and I just collapsed/I fall down". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, dyspnoea, gait inability, rash, headache, fall.  Additional information: After the shot, the patient tried walking first time after five months and couldn't even do that because the patient was dizzy and had severe rash and muscles and head. And all the doctors told that everything was fine. The patient had two of them, didn't get the booster yet. The patient is going to get the booster. The doctor kept saying that rash will go away but it was really not going away. When the patient had the virus and two days after that started feeling side effect and they got worse. The patient had omeprazole for stomach.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: PARAESTHESIA (non-serious), outcome "not recovered", described as "pins and needles from my shoulder 2 finger tip". The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Oligomenorrhoea
Clinical narrative: menstrual cycle has increased; menstrual cycle has increased; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female 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: MENSTRUAL DISORDER (non-serious), OLIGOMENORRHOEA (non-serious), outcome "unknown" and all described as "menstrual cycle has increased".  Additional information: Reporter informed that his wife expressed that her menstrual cycle has increased a few days after she got her booster shot. She also mentioned that her sister was having a similar experience.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2022 (Batch/Lot number: unknown) at the age of 39 years as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose administration date: 27Apr2021, dose number: 2, dose vaccine location: Left arm), administration date: 27Apr2021, when the patient was 39 years old, for Covid-19 immunization, reaction(s): "after each dose I have a constant smell of smoke in my nose"; Bnt162b2 (dose administration date: 06Apr2021, time: 12:00 PM, dose number: 1, dose vaccine location: Left arm), administration date: 06Apr2021, when the patient was 39 years old, for Covid-19 immunization, reaction(s): "after each dose I have a constant smell of smoke in my nose". The following information was reported: PAROSMIA (non-serious), outcome "not recovered", described as "constant smell of smoke in my nose/that I did not experience the smell until the day after receiving the booster and has not stopped since". The event "constant smell of smoke in my nose/that I did not experience the smell until the day after receiving the booster and has not stopped since", was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of parosmia. Additional information: By the following day after each dose she have a constant smell of smoke in nose. It was clearly coming from within and not related to the environment. This lasted all the way from the first dose to the second and cleared up months later. Its now been around two months that she did not experience the smell until the day after receiving the booster and has not stopped since. Patient did nor received other vaccine in four weeks. Patient did nor received other medications in two weeks. Patient did not have Covid prior vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, SARS-CoV-2 test
Clinical narrative: constant smell of smoke in my nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Apr2021 (Batch/Lot number: unknown) at the age of 39 years as dose 2, single and administered in arm left, administration date 06Apr2021 12:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAROSMIA (non-serious), outcome "not recovered", described as "constant smell of smoke in my nose". The event "constant smell of smoke in my nose" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of parosmia.  Additional information: Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. It was clearly coming from within and not related to the environment. This lasted all the way from the first dose to the second and cleared up months later. Its been around two months that she did not experience the smell until the day after receiving the booster and has not stopped since.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: menstrual cycle issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female 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: MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "menstrual cycle issues".  Additional Details: She was experienced menstrual cycle issues after the COVID vaccine and would like to talk to someone.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Emphysema
Clinical narrative: Emphysema; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: immunocompromised individuals. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Manufacturer unknown), for COVID-19 Immunization. The following information was reported: EMPHYSEMA (non-serious), outcome "unknown", described as "Emphysema".  Additional information: Caller was asking about the 2nd booster shot for immunocompromised individuals for the Pfizer Covid-19 vaccine. The 1st booster dose 6 months ago (no specific date provided) and he mentioned that he had Emphysema and it was not mentioned if the condition was acquired after getting vaccinated.  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: Electric shock sensation, SARS-CoV-2 test, Therapeutic response unexpected
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2022 (Lot number: FJ6369) at the age of 49 years as dose 3 (booster), single and administration date 21Dec2020 (Lot number: EJ1685) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "an auto immune issue" (unspecified if ongoing). Concomitant medication(s) included: HYDROCODONE; CYMBALTA; NABUMETONE. Vaccination history included: Bnt162b2 (Dose: 2, Lot Number: EL1284, I know my last one was left), administration date: 19Jan2021, when the patient was 49 years old, for Covid-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "believed to have an auto immune issue but felt significantly better after my first and third Pfizer vaccine."; ELECTRIC SHOCK SENSATION (non-serious), outcome "unknown", described as "I am getting electric shocks with my muscles". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Caller is calling about the Pfizer COVID-19 Vaccine just to let you know she gave a call back regarding previous interaction. She has sent online but her main concern is that she was wondering if there are any studies for people who felt better after receiving the vaccine, so she already provided the medical information for her, and she is believed to have an autoimmune issue, but she felt significantly better after the first and the third Pfizer vaccine. Patient stated she actually has some long-term issues for like 20 years, it helped and feel better after her first one and third one and she do not know why but everybody else use to get sick to it, but she tends to get better patient really good for like 23-week. Patient also experienced getting electric shocks with her muscles and all those stuff. Follow-up attempts completed. No further information is expected. The lot/batch number is not available despite the follow-up attempts made.
Sex: U
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: 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 number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "bad flu". Additional information: Patient thanked Pfizer for Covid vaccine which saved life. Patient had just struggled with the equivalent of a bad flu. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "shingles". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunization. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "shingles". Therapeutic measures were taken as a result of herpes zoster.  Additional information: Patient got booster dose. She came down with severe case of a rash and I sent pictures to her dermatologist. Patient reported symptoms of severe case of a rash, his arm, back, breast was horrible painful, she had been so sick that she cannot sleep, skin burns. She did not know if she came in contact with something or spider bit her or something. It was not better, and the pain was like; worst thing she had ever got in her life. It was like somebody was burning her with a lit cigarette and stabbing her with needles that never goes away. It was just absolutely horrible her skin burns and her clothing burns her skin to touch it. It was so terrible, it was my whole left breast, under her arm all the way down my left arm onto my back and it was as big as a saucer in her back. Dermatologist said it was shingles. He sent her prescriptions to go pick up at the drug store. Patient reported that she took Roboc' as cholesterol reducing medicine, that is the generic for 'Crestor' and Maxide for acid reflux it is generic for 'Prilosec'. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, SARS-CoV-2 test positive, Vaccination site pain
Clinical narrative: constant pain at injection site; radiating through my deltoid as well as the same pain; deep ache in both thighs; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Hep b, for Immunization; Flu vaccine, for Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset May2021, outcome "not recovered", described as "constant pain at injection site"; PAIN (non-serious) with onset May2021, outcome "not recovered", described as "radiating through my deltoid as well as the same pain"; PAIN IN EXTREMITY (non-serious) with onset May2021, outcome "not recovered", described as "deep ache in both thighs". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, pain, pain in extremity. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Depression, Emotional disorder
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US159961_OS (RA). A 51 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single 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 number unknown), for COVID-19 immunization. The following information was reported: EMOTIONAL DISORDER (non-serious), outcome "unknown", described as "Emotional for weeks"; DEPRESSION (non-serious), outcome "unknown", described as "Little depression". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: About 3 months after receiving my second dose of the Pfizer Covid vaccine, I began to lose a significant amount of hair; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster),single and (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: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid 19 immunization. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "About 3 months after receiving my second dose of the Pfizer Covid vaccine, I began to lose a significant amount of hair".  Additional Information: About 3 months after receiving my second dose of the Pfizer Covid vaccine, patient began to lose a significant amount of hair. The loss finally subsided 6 months after patient got the second dose. Patient received my booster at the end of November and the hair loss has returned. Patient did not had covid and assumed there was some correlation between the vaccine and my hair- loss.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No  further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP. A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the COVID-19 vaccine (manufacturer unknown), for immunization. The patient developed a rash (rash all over her body), with outcome of unknown. Additional information: A coworker has a rash all over her body. The reporter did not have additional details. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: She is feeling sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 51 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 51 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN., Dose Number:Unknown), for COVID-19 Immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "She is feeling sick".  Additional  information: I am calling about adverse effect, adverse side reaction for COVID booster. I am a Pfizer colleague. I am required by corporate compliance to call if I hear of any adverse effect, that's what I am doing right now also need me to give feedback, it's a way, this is recorded right? Okay, hold on! way too long for me to actually talk to somebody. I gave way too much information. If I was the one that was actually having an adverse event side reaction, I don't think I would like to sit there and 'listen' all that information. Given much information on that recorded robot line that's not what somebody who is feeling sick from the vaccination booster is going to  want to sit there and listen to, okay? Get that feed. So, I guess my sister got the vaccine booster and she is feeling sick. So, there you go. Reporter stated, "Yeah, I mean, I have two report, one is for my sister and one is for her co-worker. I don't have a coworker's name. My sister feels sick, the coworker has a rash all over her body.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Loss of personal independence in daily activities
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2022 (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), administration date: 2021, for COVID-19 immunization, reaction(s): "had Covid"; Bnt162b2 (Dose: 2, single), administration date: 2021, for COVID-19 immunization, reaction(s): "had Covid". The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 03Feb2022, outcome "unknown", described as "booster knocked them out/was reason why not taking part in social activity"; FEELING ABNORMAL (non-serious) with onset 03Feb2022, outcome "unknown", described as "feel bad". Additional information: Do not think literally meant knocked them out unconscious, but that it made them feel bad. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: other people are going through this/he had went to the doctor who tried to tell him it was alopecia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female 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: ALOPECIA (non-serious), outcome "unknown", described as "other people are going through this/he had went to the doctor who tried to tell him it was alopecia".  Additional information: Consumer reported he has had the first two doses and he is having symptoms because of that COVID shot. He says he knows it is from the COVID shot, though he had went to the doctor who tried to tell him it was alopecia, but he knows the COVID shot would have given him a blood disease that gave him alopecia.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.