chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling
Clinical narrative: Swollen arm; Pain; 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,SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 2,SINGLE), for Covid-19 Immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Swollen arm"; PAIN (non-serious), outcome "unknown", described as "Pain".   Additional information: When probed for the concern, consumer stated, "I had my third dose (Booster shot) today. Is it ok to take Tylenol?". When probed for any adverse event from the Booster shot, consumer stated, "It is just my arm is swollen, that's why I want to take Tylenol. Can I take Tylenol today? I had this Booster shot at "4:5" today." In response to further question, consumer stated, "I just have some kind of pain and all I want to take Aspirin or Tylenol. Can I take Aspirin or Tylenol? I just have swelling in my arm."   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Blood test, Trichodynia
Clinical narrative: Burning scalp; Very fast hair loss.; 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 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05May2021 (Lot number: EW0179) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:01), administration date: 14Apr2021, when the patient was 60 years old, for COVID-19 immunization. The following information was reported: TRICHODYNIA (non-serious) with onset 2021, outcome "unknown", described as "Burning scalp"; ALOPECIA (non-serious) with onset 2021, outcome "unknown", described as "Very fast hair loss.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of trichodynia, alopecia.  Additional information: Consumer stated he was calling to report side effects after receiving the Pfizer Covid vaccine in May. Consumer stated the side effects began last week but he has not taken any other vaccines and has not changed his lifestyle in any other way. Consumer also stated since his son also experienced the same side effects he figured he should report in case they are related to the vaccine. Consumer stated he does not have a question for Medical Information he would just like to report his side affects. His side effects started last week. He experienced Burning scalp and very fast hair loss. He doesn't know if we can add the notes to this report. his son had the same vaccine in different state same date in May and he got exact same symptoms in Aug. Exactly same symptoms but in Aug. When he got the symptoms last week he was very concerned because definitely it aligns up. They both are not on any medications, they both are very healthy. They have exact same symptoms. That's the son got in Aug and he got it now. So, to him get very concerned. Consumer further stated, So he get any kind of follow up because he need to know if anybody else will have same symptoms. He needs to know that. It's very sad. he need to know anybody else 'has symptoms' but is there a way for him to find out if anybody else reported this kind of side effect?"  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101504353 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Arm numbness; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202101504479 (Pfizer).  A 15 year-old female patient received bnt162b2 (BNT162B2), administration date 02Nov2021 (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 (1st dose), for COVID-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "Arm numbness".  Additional information: Caller stated she had a patient come in that got her vaccine yesterday and was reporting arm numbness. Caller was asking is there any follow up concerns or is this a common effect as its not one she has seen before. This was not a side effect she had encountered before.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Trichodynia
Clinical narrative: very fast hair loss; Burning scalp; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose number unknwon, 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 "very fast hair loss"; TRICHODYNIA (non-serious), outcome "unknown", described as "Burning scalp". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional Information: The patient reported side effects after receiving the Pfizer Covid vaccine in May. The patient reported that the side effects began last week but he has not taken any other vaccines and has not changed his lifestyle in any other way. The patient reported since his son also experienced the same side effects he figured he should report in case they are related to the vaccine.   Follow-up (03Nov2021): This is a Follow-up spontaneous report from a contactable consumer. This consumer reported for a patient (son) that on an unspecified age his son got exact same symptoms; Burning scalp and very fast hair loss. The patient reported that his side effects started last week. He did not know if they can add the notes to this report. The patient reported that his side son had the same vaccine in different state same date in May and he got exact same symptoms in August. Exactly same symptoms but in August. When he got the symptoms last week, he was very concerned because definitely it aligns up. The patient reported that they both are not on any medications (Further clarifications unknown), and they both are very healthy. The patient wanted to notify that his son got exact same symptoms. The patient wanted to know if anybody else will had same symptoms. It's very sad. The patient wanted to know is there a way for him to find out if anybody else reported this kind of side effect.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  Follow-up (06Dec2021): 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101504259 similar report from same reporter
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: After receiving first dose vaccine in left deltoid had left elbow pain; This is a spontaneous report received from a contactable Other HCP. This Other HCP reported for a patient (young individual).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in deltoid left (Batch/Lot number: unknown) as dose 1, single and administered in arm right (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "not recovered", described as "After receiving first dose vaccine in left deltoid had left elbow pain".  Additional information: After receiving first dose vaccine in left deltoid had left elbow pain: The caller is a Nurse Practitioner and reporting a young individual came in after receiving the first dose Pfizer Covid 19 Vaccine in the left deltoid and had left elbow pain.The left elbow pain is persisting for the patient. The patient subsequently received the second dose Pfizer Covid 19 Vaccine in the right arm and had no complications. The patient continues to have left elbow pain. The caller asks is there any way to make the patients feel better? Is the caller the only person reporting this event after receiving the Pfizer Covid 19 Vaccine? Caller states this is the reason she is really calling Pfizer and the caller would prefer to be transferred to USMI. No further information provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Food allergy, Illness
Clinical narrative: I got sick last time; I am allergic to eggs; 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 patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date Mar2021 (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), administration date: 2021, for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "I got sick last time"; FOOD ALLERGY (non-serious) with onset 2021, outcome "unknown", described as "I am allergic to eggs".  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.
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Thinking abnormal
Clinical narrative: having bizarre thoughts and dreams outside of his normal sexual attraction; having bizarre thoughts and dreams outside of his normal sexual attraction; homosexual erotic fantasies exclusively; 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 36 year-old male patient received bnt162b2 (COMIRNATY), administration date Oct2021 (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: THINKING ABNORMAL (non-serious), ABNORMAL DREAMS (non-serious) all with onset Oct2021, outcome "unknown" and all described as "having bizarre thoughts and dreams outside of his normal sexual attraction"; ABNORMAL DREAMS (non-serious) with onset Oct2021, outcome "unknown", described as "homosexual erotic fantasies exclusively". Additional information: Caller is a 36-year-old male who reports receiving his first dose of the Pfizer BioNTech Covid 19 vaccine about 3 weeks ago. He then started having bizarre thoughts and dreams outside of his normal sexual attraction. Caller reports having homosexual erotic fantasies exclusively even though he is married to a woman. Caller seeking information on this side effect would like to know why is having this psychological sexual attraction from the vaccine  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: entire torso rash from neck to thigh. It was itchy; entire torso rash from neck to thigh. It was itchy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Oct2021 16:45 (Lot number: Fh8020) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Celiac" (unspecified if ongoing); "Colitis" (unspecified if ongoing); "allergy" (unspecified if ongoing), notes: Known Allergy : Yes. Concomitant medication(s) included: BUDESONIDE; ROSUVASTATIN CALCIUM. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9264, Location of injection: Arm Right, Vaccine Administration Time: 10:00 PM), administration date: 02Feb2021, when the patient was 70 years old, for Covid- 19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6202, Location of injection: Arm Right, Vaccine Administration Time: 02:30 AM), administration date: 26Feb2021, when the patient was 71 years old, for Covid-19 immunization. The following information was reported: RASH (non-serious), RASH PRURITIC (non-serious) all with onset 24Oct2021 10:00, outcome "recovered" (26Oct2021) and all described as "entire torso rash from neck to thigh. It was itchy". Therapeutic measures were taken as a result of rash, rash pruritic.  Additional information: No other vaccine in four weeks was administered. Patient did not have COVID prior vaccination and COVID was not tested positive post vaccination. On 24Oct2021, entire torso rash from neck to thigh. It was itchy. Patient took Benadryl and it mostly went away after 48 hours, but was slightly itchy for a week.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: I had burning hands; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Sep2021 14:00 (Lot number: fd0810) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Mango skin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BURNING SENSATION (non-serious) with onset 03Oct2021 11:00, outcome "recovered" (06Oct2021), described as "I had burning hands". Therapeutic measures were not taken as a result of burning sensation.  Additional information: Facility type vaccine other was Costco. There was no other vaccine in four weeks. There was no other medications in two weeks. 3 days after the first shot I had burning hands for approximately 2 hours and it went away. There was covid prior vaccination. There was no covid tested post vaccination. known allergies was Mango skin  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Migraine, Myalgia, Pyrexia
Clinical narrative: altered taste; Fever; chills; muscle aches; migraine; exhaustion; pain at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Oct2021 15:00 (Lot number: FH8028) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "HBP" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "migraine" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulfa drugs, reaction(s): "allergy"; Neosporin, reaction(s): "allergy"; Penicillin, reaction(s): "allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6199, Location of injection: Arm Left), administration date: 05Mar2021, when the patient was 60 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EP7533, Location of injection: Arm Left), administration date: 27Mar2021, when the patient was 60 years old, for COVID-19 Immunization; Tetanus, reaction(s): "allergy". The following information was reported: TASTE DISORDER (non-serious) with onset 31Oct2021, outcome "recovering", described as "altered taste"; PYREXIA (non-serious) with onset 31Oct2021, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 31Oct2021, outcome "recovering", described as "chills"; MYALGIA (non-serious) with onset 31Oct2021, outcome "recovering", described as "muscle aches"; MIGRAINE (non-serious) with onset 31Oct2021, outcome "recovering", described as "migraine"; FATIGUE (non-serious) with onset 31Oct2021, outcome "recovering", described as "exhaustion"; VACCINATION SITE PAIN (non-serious) with onset 31Oct2021, outcome "recovering", described as "pain at injection site". Therapeutic measures were not taken as a result of taste disorder, pyrexia, chills, myalgia, migraine, fatigue, vaccination site pain.  Additional information: The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder, Vaccination site pain
Clinical narrative: altered taste; Fever; chills; muscle aches; migraine; exhaustion; pain at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Oct2021 15:00 (Lot number: FH8028) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "HBP" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "migraine" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulfa drugs, reaction(s): "allergy"; Neosporin, reaction(s): "allergy"; Penicillin, reaction(s): "allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6199, Location of injection: Arm Left), administration date: 05Mar2021, when the patient was 60 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EP7533, Location of injection: Arm Left), administration date: 27Mar2021, when the patient was 60 years old, for COVID-19 Immunization; Tetanus, reaction(s): "allergy". The following information was reported: TASTE DISORDER (non-serious) with onset 31Oct2021, outcome "recovering", described as "altered taste"; PYREXIA (non-serious) with onset 31Oct2021, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 31Oct2021, outcome "recovering", described as "chills"; MYALGIA (non-serious) with onset 31Oct2021, outcome "recovering", described as "muscle aches"; MIGRAINE (non-serious) with onset 31Oct2021, outcome "recovering", described as "migraine"; FATIGUE (non-serious) with onset 31Oct2021, outcome "recovering", described as "exhaustion"; VACCINATION SITE PAIN (non-serious) with onset 31Oct2021, outcome "recovering", described as "pain at injection site". Therapeutic measures were not taken as a result of taste disorder, pyrexia, chills, myalgia, migraine, fatigue, vaccination site pain.  Additional information: The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Osteoarthritis, Pain in extremity
Clinical narrative: aggravated osteoarthritis in right hand; soreness in right arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Oct2021 11:00 (Lot number: 30155BA) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA), administered in arm left, administration date 16Oct2021 (Batch/Lot number: unknown) as dose 1, single. The patient's relevant medical history was not reported. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]. Vaccination history included: Bnt162b2 (Dose Number: 1, lot number=EL 3246, vaccine location=Right arm), administration date: 11Jan2021, when the patient was 65 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, lot number=EL 3246, vaccine location=Right arm), administration date: 03Feb2021, when the patient was 65 years old, for Covid-19 immunization. The following information was reported: OSTEOARTHRITIS (non-serious) with onset 16Oct2021 18:00, outcome "recovered" (2021), described as "aggravated osteoarthritis in right hand"; PAIN IN EXTREMITY (non-serious) with onset 16Oct2021 18:00, outcome "recovered" (2021), described as "soreness in right arm". Therapeutic measures were not taken as a result of osteoarthritis, pain in extremity.  Additional information: facility type vaccine: Doctor's office/urgent care. other vaccine in four weeks: No. No covid prior vaccination. No covid tested post vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Muscle twitching
Clinical narrative: The twitching in her eyes and head started around the second dose; 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 30 year-old female patient received bnt162b2 (COMIRNATY), administered in arm, administration date 08Sep2021 (Lot number: EW0179) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "C-section" (unspecified if ongoing), notes: C-section  , last c section was in Jun2020.; "covid", start date: Jun2021 (unspecified if ongoing), notes: she had covid in Jun2021 and lost taste and smell at the time; "lost taste" (unspecified if ongoing), notes: she had covid in Jun2021 and lost taste and smell at the time; "smell at the time" (unspecified if ongoing), notes: she had covid in Jun2021 and lost taste and smell at the time. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:01, Batch/lot number: FA7484  , Anatomical location : injection in arm), administration date: 18Aug2021, when the patient was 30 years old, for COVID-19 immunization, reaction(s): "headache". The following information was reported: MUSCLE TWITCHING (non-serious) with onset 2021, outcome "not recovered", described as "The twitching in her eyes and head started around the second dose". The event "the twitching in her eyes and head started around the second dose" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of muscle twitching.  Additional information: patient had twitching in her eyes and head and she was asking if there can be any nerve damage or if there are people complaining of headache after the vaccine. Patient had headache every week, around 3 days a week, it is really intense, usually above or around temple, not on the temple and there is twitching in her head around the temple.Clarifies the twitching in eyes and head started a month to month and a half ago. She takes Tylenol and Ibuprofen and they are not really working which is why she thinks it is a different kind of head pain. She is thinking maybe this connected or what manifested it but she had 4 C-sections with spinal taps which could be damaging to the nerves., she went a couple of weeks ago to ER and they did a CT scan and found no tumors, nothing stood out . Confirmed she was not admitted  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: By checking my pulse, I discovered irregular heartbeat; my chest felt funny; was unable to work the next day; tired; fever; Achey; chills; no appetite; throbbing headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Sep2021 11:00 (Lot number: EW0168) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypothyroid" (unspecified if ongoing), notes: other medical history: hypothyroid; "penicillin allergy" (unspecified if ongoing), notes: known allergies: penicillin. Concomitant medication(s) included: NP THYROID. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0168, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 23Aug2021, when the patient was 41 years old, for Covid-19 immunization. The following information was reported: HEART RATE IRREGULAR (non-serious) with onset 16Sep2021, outcome "recovered" (18Sep2021), described as "By checking my pulse, I discovered irregular heartbeat"; FATIGUE (non-serious) with onset 15Sep2021 21:00, outcome "recovering", described as "tired"; PYREXIA (non-serious) with onset 15Sep2021 21:00, outcome "recovering", described as "fever"; PAIN (non-serious) with onset 15Sep2021 21:00, outcome "recovering", described as "Achey"; CHILLS (non-serious) with onset 15Sep2021 21:00, outcome "recovering", described as "chills"; DECREASED APPETITE (non-serious) with onset 15Sep2021 21:00, outcome "recovering", described as "no appetite"; HEADACHE (non-serious) with onset 15Sep2021 21:00, outcome "recovering", described as "throbbing headache"; CHEST DISCOMFORT (non-serious) with onset 16Sep2021, outcome "recovering", described as "my chest felt funny"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 16Sep2021, outcome "recovering", described as "was unable to work the next day". Therapeutic measures were not taken as a result of heart rate irregular, fatigue, pyrexia, pain, chills, decreased appetite, headache, chest discomfort, loss of personal independence in daily activities.  Additional Information: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient received multi vitamin and NP Thyroid medications within 2 weeks of vaccination. There were no prolongation for the reported events. The patient did not receive any treatment. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Loss of personal independence in daily activities, Pain, Pyrexia
Clinical narrative: By checking my pulse, I discovered irregular heartbeat; my chest felt funny; was unable to work the next day; tired; fever; Achey; chills; no appetite; throbbing headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Sep2021 11:00 (Lot number: EW0168) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypothyroid" (unspecified if ongoing), notes: other medical history: hypothyroid; "penicillin allergy" (unspecified if ongoing), notes: known allergies: penicillin. Concomitant medication(s) included: NP THYROID. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0168, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 23Aug2021, when the patient was 41 years old, for Covid-19 immunization. The following information was reported: HEART RATE IRREGULAR (non-serious) with onset 16Sep2021, outcome "recovered" (18Sep2021), described as "By checking my pulse, I discovered irregular heartbeat"; FATIGUE (non-serious) with onset 15Sep2021 21:00, outcome "recovering", described as "tired"; PYREXIA (non-serious) with onset 15Sep2021 21:00, outcome "recovering", described as "fever"; PAIN (non-serious) with onset 15Sep2021 21:00, outcome "recovering", described as "Achey"; CHILLS (non-serious) with onset 15Sep2021 21:00, outcome "recovering", described as "chills"; DECREASED APPETITE (non-serious) with onset 15Sep2021 21:00, outcome "recovering", described as "no appetite"; HEADACHE (non-serious) with onset 15Sep2021 21:00, outcome "recovering", described as "throbbing headache"; CHEST DISCOMFORT (non-serious) with onset 16Sep2021, outcome "recovering", described as "my chest felt funny"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 16Sep2021, outcome "recovering", described as "was unable to work the next day". Therapeutic measures were not taken as a result of heart rate irregular, fatigue, pyrexia, pain, chills, decreased appetite, headache, chest discomfort, loss of personal independence in daily activities.  Additional Information: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient received multi vitamin and NP Thyroid medications within 2 weeks of vaccination. There were no prolongation for the reported events. The patient did not receive any treatment. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood oestrogen decreased, Depression, Disturbance in attention, Investigation
Clinical narrative: anxiety; low estrogen; can't sleep; can't focus/can't concentrate; depressed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD21-160641 (Moderna).  A female patient received bnt162b2 (BNT162B2), administration date Apr2021 (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), for COVID-19 immunization. The following information was reported: ANXIETY (non-serious) with onset Apr2021, outcome "unknown", described as "anxiety"; BLOOD OESTROGEN DECREASED (non-serious) with onset Apr2021, outcome "unknown", described as "low estrogen"; SLEEP DISORDER (non-serious) with onset Apr2021, outcome "unknown", described as "can't sleep"; DISTURBANCE IN ATTENTION (non-serious) with onset Apr2021, outcome "unknown", described as "can't focus/can't concentrate"; DEPRESSION (non-serious) with onset Apr2021, outcome "unknown", described as "depressed". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient who believed that she received the Moderna vaccine, stating that since receiving her 2nd dose in Apr2021, she has low estrogen, can't sleep, can't focus, depressed, has anxiety and can't concentrate. She was tested and test proves that she has low estrogen. She went on to state that she is aware of 10 people who experienced the similar reactions. 5 of which are (Withheld) and she is (Withheld) and did not mention the nationality of the other 5. Upon request of date of vaccination and LOT number/EXP Date for the Moderna vaccine, patient realized that she called the wrong number because she received both doses of the Pfizer vaccine. Age was not captured. Limited AE filed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: anxiety; low estrogen; can't sleep; can't focus/can't concentrate; depressed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD21-160641 (Moderna).  A female patient received bnt162b2 (BNT162B2), administration date Apr2021 (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), for COVID-19 immunization. The following information was reported: ANXIETY (non-serious) with onset Apr2021, outcome "unknown", described as "anxiety"; BLOOD OESTROGEN DECREASED (non-serious) with onset Apr2021, outcome "unknown", described as "low estrogen"; SLEEP DISORDER (non-serious) with onset Apr2021, outcome "unknown", described as "can't sleep"; DISTURBANCE IN ATTENTION (non-serious) with onset Apr2021, outcome "unknown", described as "can't focus/can't concentrate"; DEPRESSION (non-serious) with onset Apr2021, outcome "unknown", described as "depressed". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient who believed that she received the Moderna vaccine, stating that since receiving her 2nd dose in Apr2021, she has low estrogen, can't sleep, can't focus, depressed, has anxiety and can't concentrate. She was tested and test proves that she has low estrogen. She went on to state that she is aware of 10 people who experienced the similar reactions. 5 of which are (Withheld) and she is (Withheld) and did not mention the nationality of the other 5. Upon request of date of vaccination and LOT number/EXP Date for the Moderna vaccine, patient realized that she called the wrong number because she received both doses of the Pfizer vaccine. Age was not captured. Limited AE filed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pain in extremity, Pruritus, Rash, Rash macular
Clinical narrative: Rash; Thought it was poison ivy because it is like a blister with water inside; hives; really itchy, all over her face.; arm was sore; blotches on the face; 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 75 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Oct2021 (Batch/Lot number: unknown) at the age of 75 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: 1), for COVID-19 immunization; Bnt162b2 (DOSE: 2), for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset Oct2021, outcome "unknown", described as "Rash"; BLISTER (non-serious) with onset Oct2021, outcome "unknown", described as "Thought it was poison ivy because it is like a blister with water inside"; URTICARIA (non-serious) with onset Oct2021, outcome "unknown", described as "hives"; PRURITUS (non-serious) with onset Oct2021, outcome "unknown", described as "really itchy, all over her face."; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "unknown", described as "arm was sore"; RASH MACULAR (non-serious) with onset Oct2021, outcome "unknown", described as "blotches on the face". Therapeutic measures were taken as a result of rash, blister, urticaria, pruritus, pain in extremity. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Rash; Thought it was poison ivy because it is like a blister with water inside; hives; really itchy, all over her face.; arm was sore; blotches on the face; 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 75 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Oct2021 (Batch/Lot number: unknown) at the age of 75 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: 1), for COVID-19 immunization; Bnt162b2 (DOSE: 2), for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset Oct2021, outcome "unknown", described as "Rash"; BLISTER (non-serious) with onset Oct2021, outcome "unknown", described as "Thought it was poison ivy because it is like a blister with water inside"; URTICARIA (non-serious) with onset Oct2021, outcome "unknown", described as "hives"; PRURITUS (non-serious) with onset Oct2021, outcome "unknown", described as "really itchy, all over her face."; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "unknown", described as "arm was sore"; RASH MACULAR (non-serious) with onset Oct2021, outcome "unknown", described as "blotches on the face". Therapeutic measures were taken as a result of rash, blister, urticaria, pruritus, 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: Myalgia, Pain in extremity
Clinical narrative: Muscle and arm pain; Muscle and arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Oct2021 (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: MYALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 2021, outcome "unknown" and all described as "Muscle and arm pain".  Additional information: Patient got the 2nd dose of the Pfizer COVID vaccine a month ago and was having muscle and arm pain. She did not wish to provide an address, email or date of birth and did not have time to complete report as she was at work. She stated she would call back later. No further details provided. She did not have the lot or expiration to provide today (at the time of report).  Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash, Rash macular, Urticaria
Clinical narrative: we all had this head toll/a rash; hives on the face that is itchy; arm was sore; hives on the face that is itchy; blotches on the face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient (unknown if pregnant) received bnt162b2 (COMIRNATY) (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: RASH (non-serious), outcome "unknown", described as "we all had this head toll/a rash"; URTICARIA (non-serious), PRURITUS (non-serious), outcome "unknown" and all described as "hives on the face that is itchy"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was sore"; RASH MACULAR (non-serious), outcome "unknown", described as "blotches on the face".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient). 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. The patient developed a skin disorder (weird circle on arm), with outcome of unknown. Additional information: Patient and spouse got the Pfizer shot couple of months ago and now have a weird circle on their arms. Follow-up (Nov 17, 2021): This follow-up submitted to notify the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected. Sender's comments: Linked report: US-PFIZER INC-202101512002 (same product and event, different patients).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Emotional distress, Gait disturbance, HIV test negative, Laboratory test normal
Clinical narrative: Rash-like hives on my arms and legs. I haven't been able to use the bathroom without medication. My feet and legs hurt so bad, I can barely walk some days. I have had every test ran on me possible. Everything negative except for a vaginal infection. I am seeing a gastrologist. I have a colonoscopy scheduled. I have been to the emergency room on different occasions. Nobody can figure out what is wrong with me. Some days are worse than others, but definitely has changed my life. I am an emotional wreck. Everyone is looking at me even crazier than before because all my tests are coming back negative. They act like it's been all in my head. It's making it hard to function in life. I've always had psychological problems but this is terrible.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Mental disorder, Pain in extremity, Rash, Treponema test negative
Clinical narrative: Rash-like hives on my arms and legs. I haven't been able to use the bathroom without medication. My feet and legs hurt so bad, I can barely walk some days. I have had every test ran on me possible. Everything negative except for a vaginal infection. I am seeing a gastrologist. I have a colonoscopy scheduled. I have been to the emergency room on different occasions. Nobody can figure out what is wrong with me. Some days are worse than others, but definitely has changed my life. I am an emotional wreck. Everyone is looking at me even crazier than before because all my tests are coming back negative. They act like it's been all in my head. It's making it hard to function in life. I've always had psychological problems but this is terrible.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaginal infection
Clinical narrative: Rash-like hives on my arms and legs. I haven't been able to use the bathroom without medication. My feet and legs hurt so bad, I can barely walk some days. I have had every test ran on me possible. Everything negative except for a vaginal infection. I am seeing a gastrologist. I have a colonoscopy scheduled. I have been to the emergency room on different occasions. Nobody can figure out what is wrong with me. Some days are worse than others, but definitely has changed my life. I am an emotional wreck. Everyone is looking at me even crazier than before because all my tests are coming back negative. They act like it's been all in my head. It's making it hard to function in life. I've always had psychological problems but this is terrible.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vision blurred
Clinical narrative: Patient experienced headache, nausea, vomiting and blurred vision. Patient went to ER on 02/25/2022 for evaluation.
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Lethargy, Pain, Pain in extremity, SARS-CoV-2 antibody test
Clinical narrative: Drastic Hair Loss; Loss of 10-15% Volume of Hair; felt lethargic; arm pain; throbbing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 68 year-old male patient received bnt162b2 (COMIRNATY), administration date 12Oct2021 (Lot number: 30125BA) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: 06Aug2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious) with onset 14Oct2021, outcome "unknown", described as "Drastic Hair Loss; Loss of 10-15% Volume of Hair"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "recovered", described as "arm pain"; PAIN (non-serious) with onset Oct2021, outcome "recovered", described as "throbbing"; LETHARGY (non-serious) with onset 12Oct2021, outcome "unknown", described as "felt lethargic". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller stated to me he received the Pfizer Covid Vaccine on 12Oct2021 and no more than two days later he began to experience drastic hair loss that had never happened before. Caller wanted to know if this was a reported side effect of the vaccine. Caller is a 68 year old male who reports hair loss, 10%-15%, that began no more than two days after receiving his first Pfizer Covid vaccine injection. Caller stated that he had a head full of hair prior to Covid injection and this has never happened before. Caller goes on to explain that around 06Aug2021 he contracted Covid. He began to feel progressively more sick and on 15Aug2021 he had a really bad day, so on 16Aug2021 he was tested for COVID and the test was positive. Caller states he felt bad for approximately 10 more days. Caller says he waited 5 weeks after contracting COVID to receive the Pfizer Covid vaccine and he is not sure if his previously having Covid contributed to his hair loss. Caller states he went to see his doctor yesterday and they decided together to wait on getting the second dose due to his hair loss. Second dose was due on 02Nov2021. Caller also reports experiencing arm pain for two weeks after vaccine injection, that turned into throbbing which lasted for about a week but is gone today. Caller also says he felt lethargic right after vaccine injection with no ambition but that wore off pretty quickly. Caller did not have the expiration date. Caller declined any further demographic information. Response: After review of the prescribing information informed caller that I did not see hair loss as a reported side effect, however these may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials. LAB-1451-12.0 Revised: 29Oct2021  No follow-up attempts are possible. No further information is expected.