chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: ''after 2nd dose had pain in arm, chills, and tiredness for about 30-40 hours''.; ''after 2nd dose had pain in arm, chills, and tiredness for about 30-40 hours''.; ''after 2nd dose had pain in arm, chills, and tiredness for about 30-40 hours''.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Mar2021 10:45 (Lot number: EN6208) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Haital Hernia" (ongoing); "osteoporosis" (ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose number:1, Time: 01:00 AM, Anatomical site of injection: arm left, Route of administration: Intramuscular, Batch/Lot number: EN6200), administration date: 27Feb2021, when the patient was 70 years old, for COVID-19 immunization, reaction(s): "Euphoria", "high pitched buzz in right ear", "Nausea", "very mild pain in vaccine spot". The following information was reported: PAIN IN EXTREMITY (non-serious), CHILLS (non-serious), FATIGUE (non-serious) all with onset 2021, outcome "unknown" and all described as "''after 2nd dose had pain in arm, chills, and tiredness for about 30-40 hours''.". Therapeutic measures were taken as a result of pain in extremity. Therapeutic measures were not taken as a result of chills, fatigue.  Additional information: Vaccine facility type was reported as other facility. After 1st dose she had euphoria for 1-2 hours, then high pitched buzz in right ear for several minutes, then nausea for cca half hour. Next day had very mild pain in vaccine spot. Took 2X 1/2 Tylenol and pain ointment with magnesium for achy pain. Nothing really serious. Prior Vaccinations (within 4 weeks) was reported as None. The reporter assessed the events as non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Insomnia, Myalgia
Clinical narrative: Severe Insomnia. Have no slept in 3 days. I have body aches, chills, sweats, muscle pain, severe nausea at night and in the morning with occasional vomiting. Severe headaches, mainly in the right temp; body aches; Severe Insomnia. Have no slept in 3 days. I have body aches, chills, sweats, muscle pain, severe nausea at night and in the morning with occasional vomiting. Severe headaches, mainly in the right temp; sweats; Muscle pain; Severe Insomnia. Have no slept in 3 days. I have body aches, chills, sweats, muscle pain, severe nausea at night and in the morning with occasional vomiting. Severe headaches, mainly in the right temp; occasional vomiting; Severe headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2, Solution for injection), administered in arm left, administration date 29May2021 11:00 (Lot number: Ew0217) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Severe anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious), CHILLS (non-serious), NAUSEA (non-serious) all with onset 02Jun2021 06:00, outcome "not recovered" and all described as "Severe Insomnia. Have no slept in 3 days. I have body aches, chills, sweats, muscle pain, severe nausea at night and in the morning with occasional vomiting. Severe headaches, mainly in the right temp"; PAIN (non-serious) with onset 02Jun2021 06:00, outcome "not recovered", described as "body aches"; HYPERHIDROSIS (non-serious) with onset 02Jun2021 06:00, outcome "not recovered", described as "sweats"; MYALGIA (non-serious) with onset 02Jun2021 06:00, outcome "not recovered", described as "Muscle pain"; VOMITING (non-serious) with onset 02Jun2021 06:00, outcome "not recovered", described as "occasional vomiting"; HEADACHE (non-serious) with onset 02Jun2021 06:00, outcome "not recovered", described as "Severe headaches". Therapeutic measures were not taken as a result of insomnia, pain, chills, hyperhidrosis, myalgia, nausea, vomiting, headache.  Additional information: Severe Insomnia. Have no slept in 3 days. I have body aches, chills, sweats, muscle pain, severe nausea at night and in the morning with occasional vomiting. Severe headaches, mainly in the right temple.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: Severe Insomnia. Have no slept in 3 days. I have body aches, chills, sweats, muscle pain, severe nausea at night and in the morning with occasional vomiting. Severe headaches, mainly in the right temp; body aches; Severe Insomnia. Have no slept in 3 days. I have body aches, chills, sweats, muscle pain, severe nausea at night and in the morning with occasional vomiting. Severe headaches, mainly in the right temp; sweats; Muscle pain; Severe Insomnia. Have no slept in 3 days. I have body aches, chills, sweats, muscle pain, severe nausea at night and in the morning with occasional vomiting. Severe headaches, mainly in the right temp; occasional vomiting; Severe headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2, Solution for injection), administered in arm left, administration date 29May2021 11:00 (Lot number: Ew0217) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Severe anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious), CHILLS (non-serious), NAUSEA (non-serious) all with onset 02Jun2021 06:00, outcome "not recovered" and all described as "Severe Insomnia. Have no slept in 3 days. I have body aches, chills, sweats, muscle pain, severe nausea at night and in the morning with occasional vomiting. Severe headaches, mainly in the right temp"; PAIN (non-serious) with onset 02Jun2021 06:00, outcome "not recovered", described as "body aches"; HYPERHIDROSIS (non-serious) with onset 02Jun2021 06:00, outcome "not recovered", described as "sweats"; MYALGIA (non-serious) with onset 02Jun2021 06:00, outcome "not recovered", described as "Muscle pain"; VOMITING (non-serious) with onset 02Jun2021 06:00, outcome "not recovered", described as "occasional vomiting"; HEADACHE (non-serious) with onset 02Jun2021 06:00, outcome "not recovered", described as "Severe headaches". Therapeutic measures were not taken as a result of insomnia, pain, chills, hyperhidrosis, myalgia, nausea, vomiting, headache.  Additional information: Severe Insomnia. Have no slept in 3 days. I have body aches, chills, sweats, muscle pain, severe nausea at night and in the morning with occasional vomiting. Severe headaches, mainly in the right temple.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraine headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 04Mar2021 17:00 (Batch/Lot number: unknown) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Autoimmune disease , Lupus like high ANA" (ongoing), notes: Onset date: Childhood; "Autoimmune disease , Lupus like high ANA" (ongoing), notes: Onset date: Childhood; "Breast Cancer", start date: Nov2012, stop date: Jan2013, notes: Pertinent details: No recurrence; "High blood pressure" (unspecified if ongoing); "Anxiety" (unspecified if ongoing), notes: Anxiety + treatment for flares; "Hot flashes" (unspecified if ongoing); "Sleep aid" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension, start date: 2020 (ongoing); DIAZEPAM taken for anxiety, start date: Oct1996 (ongoing); ESTRADIOL taken for hot flush, sleep disorder, start date: Jun2019 (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Time: Approx. 2:00 pm PST, Anatomical site of injection: left shoulder (Arm), Route of administration: intramuscular, Lot/Batch number: EL9265), administration date: 07Feb2021, for COVID-19 Immunisation, reaction(s): "Numbness in left hand, arm", "Numbness in lower leg", "Numbness in bottom of feet". The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "migraine headaches". The event "migraine headaches" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of migraine.  Additional information: The four weeks after 2nd dose, patient started to get migraine headaches. The patient had the worst headache patient had ever had mostly on left side of head + face. patient went to emergency on 30Mar2021, was treated + released. Had been taking Tylenol everyday since.  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: Chills, Headache, Insomnia, Menstruation irregular, Nasopharyngitis
Clinical narrative: 10days earlier menstruation; Cold symptoms; Body chills; Fever; Headache; Aches; Insomnia; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism since and unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHYROID) for unknown indication, from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date, the patient experienced 10 days earlier menstruation. On an unknown date, 12 hours after the second dose, the patient experienced body chills, fever, headache, aches, insomnia that occurred for 3 days and felt cold symptoms and was in bed for 3 days. The patient should have taken Tylenol right after the shot as it mitigated the symptoms a lot. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events and included paracetamol (TYLENOL) on an unknown date and unknown if ongoing. The clinical outcome of the events 10 days early menstruation, body chills, fever, headache, aches, insomnia and cold symptoms was resolved on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination Facility Country added, Duration for AE "body chills, fever, headache, aches, insomnia" added as 3 days.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: 10days earlier menstruation; Cold symptoms; Body chills; Fever; Headache; Aches; Insomnia; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism since and unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHYROID) for unknown indication, from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date, the patient experienced 10 days earlier menstruation. On an unknown date, 12 hours after the second dose, the patient experienced body chills, fever, headache, aches, insomnia that occurred for 3 days and felt cold symptoms and was in bed for 3 days. The patient should have taken Tylenol right after the shot as it mitigated the symptoms a lot. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events and included paracetamol (TYLENOL) on an unknown date and unknown if ongoing. The clinical outcome of the events 10 days early menstruation, body chills, fever, headache, aches, insomnia and cold symptoms was resolved on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination Facility Country added, Duration for AE "body chills, fever, headache, aches, insomnia" added as 3 days.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Fever; chills; nausea; sweating; SOB; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 17-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jun2021 17:30 (Batch/Lot number: unknown) at the age of 17 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Product: COVID 19, Lot unknown: True, Lot unknown reason: Unable to locate or read the details, Administration date: 17May2021, Administration time: 05:30 PM, Dose number: 1, Vaccine location: Left arm), administration date: 17May2021, when the patient was 17 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 15Jun2021 20:00, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 15Jun2021 20:00, outcome "not recovered", described as "chills"; NAUSEA (non-serious) with onset 15Jun2021 20:00, outcome "not recovered", described as "nausea"; HYPERHIDROSIS (non-serious) with onset 15Jun2021 20:00, outcome "not recovered", described as "sweating"; DYSPNOEA (non-serious) with onset 15Jun2021 20:00, outcome "not recovered", described as "SOB". Therapeutic measures were not taken as a result of pyrexia, chills, nausea, hyperhidrosis, dyspnoea.  Additional information: The patient did not receive any other vaccine in four weeks of covid-19 vaccine. The patient received other medications (unspecified) within two weeks of covid vaccine. The patient was neither diagnosed with covid prior vaccination, nor been tested for covid post vaccination. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: was sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  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: MALAISE (non-serious), outcome "unknown", described as "was sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Lymphadenopathy
Clinical narrative: Left lymph node in jaw swollen and couldn't bite or chew on left side; Left lymph node in jaw swollen and couldn't bite or chew on left side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Mar2021 15:00 (Lot number: EN6207) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Acid Reflux" (unspecified if ongoing); "Blood thinner" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS taken for blood disorder, start date: 15Apr2020 (ongoing); ATORVASTATIN taken for blood cholesterol, start date: 15Apr2020 (ongoing); LISINOPRIL taken for blood pressure measurement, start date: 2018 (ongoing); OMEPRAZOLE taken for gastrooesophageal reflux disease, start date: 12Dec2020 (ongoing). The following information was reported: LYMPHADENOPATHY (non-serious), JOINT STIFFNESS (non-serious) all with onset 16Mar2021 07:00, outcome "recovering" and all described as "Left lymph node in jaw swollen and couldn't bite or chew on left side". Therapeutic measures were taken as a result of lymphadenopathy, joint stiffness.  Additional information: The treatment for events lymphadenopathy, joint stiffness with tylenol and cold compression. No prior vaccination within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Pain
Clinical narrative: Slight rise in temperature; Body aches; This is a spontaneous report received from a contactable reporter(Consumer). The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) at the age of 70 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN, start date: 2015 (ongoing). Vaccination history included: Bnt162b2 (Dose 1;Time of Onset: 15:00), for COVID-19 immunisation, reaction(s): "Slight itch", "Redness at injection site", "Rash itch around injection site", "Rash itch around injection site". The following information was reported: BODY TEMPERATURE INCREASED (non-serious), outcome "recovered", described as "Slight rise in temperature"; PAIN (non-serious), outcome "recovered", described as "Body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of body temperature increased, pain. Additional information: Time of Onset of Body ache, slight rise in temperature was 14:00 No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021122500 Same patient and drug, Different dose and event
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: aches in right hand; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 86 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Jan2021 (Batch/Lot number: unknown) at the age of 86 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIPITOR [ATORVASTATIN]; METOPROLOL; SYNTHROID; SPIRONOLACTONE; ALLEGRA. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20Jan2021, outcome "recovered" (2021), described as "aches in right hand". Therapeutic measures were not taken as a result of pain in extremity.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: sore arm at injection site; headache; tired feeling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old male patient received bnt162b2 (BNT162B2), administration date 19Feb2021 (Lot number: EN6200) at the age of 76 as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Excedrin for headache, notes: Took Excedrin 5 hours before 1st dose on 29Jan2021, The headache was before the 1st dose, Not after. Vaccination history included: Bnt162b2 (1st dose, Lot number: EL3247), administration date: 29Jan2021, for COVID-19 immunisation; Bnt162b2, for COVID-19 immunisation, reaction(s): "slight headache", "injection site sore arm". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "sore arm at injection site"; HEADACHE (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "headache"; FATIGUE (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "tired feeling".  Additional information: It was reported that, patient did not take any pain medicine before receiving the 2nd vaccine injection on 19Feb2021. At this point, stated that did not have any significant adverse reactions/events from either the 1st or 2nd COVID-19 Pfizer vaccine injections. Specifically, all had after the 1st shot was an injection site sore arm for a day and a slight headache, which could have been from earlier that morning, as stated above. The 2nd shot gave me a sore arm at the injection site, a headache and a tired feeling, all of which went away after 24-36 hours. To sum up, all of these side effects were mild and short lasting. Event experienced: He took Excedrin, before the first dose of covid vaccine. Took Excedrin 5 hours before 1st dose on 29Jan2021 and experienced Headache. The headache was before the 1st dose, Not after.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: General body aches; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 07May2021 10:00 (Lot number: EW0176, Expiration Date: 31Aug2021) at the age of 57 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SINGULAIR taken for mechanical urticaria (ongoing); XYZAL taken for mechanical urticaria (ongoing); ALLEGRA taken for mechanical urticaria (ongoing); PRAVACHOL taken for hypercholesterolaemia (ongoing); PRINIVIL taken for hypertension (ongoing); ZESTRIL taken for hypertension (ongoing); LOPRESSOR taken for hypertension (ongoing); TOPROL XL taken for hypertension (ongoing); ASPIRIN [ACETYLSALICYLIC ACID] (ongoing); BIOTIN taken for hair texture abnormal, skin discomfort, nail discomfort (ongoing); PRE & PROBIOTIC taken for routine health maintenance (ongoing). Vaccination history included: Bnt162b2 (Dose: 01 of covid vaccine, Time: 13:00, Site and route of injection: , Anatomical site if injection: Right upper arm, Route of administration: Intramuscular, Batch/Lot number: EP7533), administration date: 16Apr2021, when the patient was 57 years old, for COVID-19 immunization, reaction(s): "No reaction reported". The following information was reported: PAIN (non-serious) with onset 08May2021 08:00, outcome "recovered" (May2021), described as "General body aches"; FATIGUE (non-serious) with onset 08May2021 08:00, outcome "recovered" (May2021), described as "Fatigue". Therapeutic measures were not taken as a result of pain, fatigue.  Additional Information: Patient took ongoing concomitant medication bladder probiotics taken orally for bladder protection. Patient took Aspirin (Acetylsalicylic acid) for CV Protection. No prior vaccinations. No family medical history relevant to AE(s). No relevant tests were done.  Follow-up attempts have been completed and no further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cyst
Clinical narrative: 2 breast cysts on the right breast.; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200009733 (Pfizer), US-PFIZER INC-202200004220 (Pfizer).  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 25Mar2021 (Batch/Lot number: unknown) at the age of 26 years as dose 2, single and administered in arm right, administration date 21Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BREAST CYST (non-serious) with onset 07Jul2021, outcome "not recovered", described as "2 breast cysts on the right breast.". The event "2 breast cysts on the right breast." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of breast cyst.  Additional Information: Additional information: After receiving my two vaccine doses, I developed a breast cyst which was very concerning for me in the beginning given that it was on the same side that I received both doses of vaccines. Patient stated that he did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Patient reported that he did not receive any other medications received within 2 weeks prior to the vaccination and Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Psoriasis Developed 2 weeks after 2nd vaccination. First appeared behind right ear then on legs and arms.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110). The reporter is the patient.  A 75 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 24May2021 09:30 (Lot number: EW0168) at the age of 75 years as dose 2, single for covid-19 immunisation. No patient's relevant medical history was reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE: 1, 3  May I got my first shot of vaccine, Time: 9AM, Anatomical site of injection: Upper left arm, Route of administration: Intramuscular, Lot no: ER8731), administration date: 03May2021, for covid 19 immunization. The following information was reported: PSORIASIS (non-serious) with onset 14Jun2021, outcome "unknown", described as "Psoriasis Developed 2 weeks after 2nd vaccination. First appeared behind right ear then on legs and arms.". Therapeutic measures were not taken as a result of psoriasis.   Additional information: Customer Verbatim: I am no 76 and on 3 May I got my first shot of vaccine and then 24May the second and then 3 weeks later I developed psoriasis which I have never had before you have a cure for that. On 20Nov2021 at 09:00 am Patient received dose 3 on upper left arm intramuscularly (FG3527).Vaccination facility type was Pharmacy or Drug store, and vaccine was not administered at military facility. There were No Prior vaccination, no concomitant drugs and no patients medical history.   No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site erythema, Vaccination site pain
Clinical narrative: Hurt. Large red circle days later; Hurt. Large red circle days later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 20Apr2021 (Batch/Lot number: unknown) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing), notes: Migraine in past; "preeclampsia" (unspecified if ongoing), notes: Had preeclampsia. Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE]. Past drug history included: Avelox, reaction(s): "Known allergies: Avelox". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 20Apr2021, outcome "unknown" and all described as "Hurt. Large red circle days later". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: My arm still does not function; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Mar2021 (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: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "My arm still does not function".  Additional information: Patient was asking where patient report side effects of vaccine. Was there any type of form for that. Patients arm till does not functions like it did. Patient got a shot in March.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Impaired work ability, Malaise
Clinical narrative: I am unable to perform my job; headaches; excessive sweating; fatigue; overall feeling sick 24/7; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose 2, single and 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: IMPAIRED WORK ABILITY (non-serious), outcome "unknown", described as "I am unable to perform my job"; HEADACHE (non-serious), outcome "not recovered", described as "headaches"; HYPERHIDROSIS (non-serious), outcome "not recovered", described as "excessive sweating"; FATIGUE (non-serious), outcome "not recovered", described as "fatigue"; MALAISE (non-serious), outcome "not recovered", described as "overall feeling sick 24/7".  Additional Information: The patient had the Pfizer flu shot on 30Dec2021. The side effects with this vaccine are closely related to the symptoms of the Pfizer Covid 19 vaccines patient received in Oct2021 and Nov2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased
Clinical narrative: has mobility issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administration date 06Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid virus", start date: 2021 (unspecified if ongoing), notes: Caller had the Covid virus in Mar2021 or Apr2021, and was hospitalized for Covid, but is home now. The patient's concomitant medications were not reported. The following information was reported: MOBILITY DECREASED (non-serious) with onset Dec2021, outcome "unknown", described as "has mobility issues".  Additional information: The reporter was reporting about the Pfizer Covid vaccine, about her second dose. Reporter was unable to get her second dose, because she is homebound and has mobility issues. Reporter was due for her second vaccine on the 28Dec2021, but agent cannot verify the month. Later she stated that she was due for her vaccine on 27Dec2021. Reporter stated her healthcare provider called and said because the office was closed, she could then get the vaccine on 28Dec2021. She and her husband had their first dose of vaccine on 06Dec2021, her husband needs his second vaccine as well. She needed assistance in obtaining a second dose for herself and her husband.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: believes she is allergic to the ingredients in the covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "She has a myriad of allergies to medications/She is allergic to all antibiotics" (unspecified if ongoing); "allergic to foods" (unspecified if ongoing); "Myasthenia Gravis" (unspecified if ongoing); "Allergy to Dye" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Heparin toxins, reaction(s): "Allergy-Heparin Toxin", notes: Verbatim: Heparin Toxin. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "believes she is allergic to the ingredients in the covid vaccine".  Additional information: The Patient believes she is allergic to the ingredients in the covid vaccine. She was 76 years old. She had a myriad of allergies to medications. She was allergic to all antibiotics except for Vancomycin, she had to be given Vancomycin in the hospital via infusion and even that upsets her Myasthenia Gravis. She could not have any bowel preps. She was allergic to foods, dyes, and heparin toxins.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Inappropriate schedule of product administration
Clinical narrative: dose number=1, 08Sep2021;dose number=2, 14Nov2021; it started falling out to the point that you can see my scalp now through my hair.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Nov2021 (Batch/Lot number: unknown) at the age of 72 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATENOLOL; ATORVASTATIN; AMITRIPTINE; ALENDRONATE. Vaccination history included: Bnt162b2 (Dose Number: 1 , Batch/Lot No: FC3184 , Location of injection: Arm Left), administration date: 08Sep2021, when the patient was 72 years old, for Covid-19 Immunization, reaction(s): "Hair loss"; Flu (Anatomical location: arm right), administration date: 08Sep2021.  The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "not recovered", described as "it started falling out to the point that you can see my scalp now through my hair."; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 14Nov2021, outcome "unknown", described as "dose number=1, 08Sep2021;dose number=2, 14Nov2021". The event "it started falling out to the point that you can see my scalp now through my hair." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of alopecia.  Additional information: The patient had many with the first dose which she reported at that time. Shortly after her hair started falling out. Then after the second dose it started falling out to the point that it can see her scalp through her hair. Since the vaccination, the patient did not tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diffuse alopecia
Clinical narrative: dose number=1, 08Sep2021;dose number=2, 14Nov2021; it started falling out to the point that you can see my scalp now through my hair.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Nov2021 (Batch/Lot number: unknown) at the age of 72 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATENOLOL; ATORVASTATIN; AMITRIPTINE; ALENDRONATE. Vaccination history included: Bnt162b2 (Dose Number: 1 , Batch/Lot No: FC3184 , Location of injection: Arm Left), administration date: 08Sep2021, when the patient was 72 years old, for Covid-19 Immunization, reaction(s): "Hair loss"; Flu (Anatomical location: arm right), administration date: 08Sep2021.  The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "not recovered", described as "it started falling out to the point that you can see my scalp now through my hair."; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 14Nov2021, outcome "unknown", described as "dose number=1, 08Sep2021;dose number=2, 14Nov2021". The event "it started falling out to the point that you can see my scalp now through my hair." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of alopecia.  Additional information: The patient had many with the first dose which she reported at that time. Shortly after her hair started falling out. Then after the second dose it started falling out to the point that it can see her scalp through her hair. Since the vaccination, the patient did not tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Blood test, Computerised tomogram, Magnetic resonance imaging neck
Clinical narrative: Had a lost of taste and smell; Had a lost of taste and smell; Tingling in his hands and legs; Trembling inside his muscles/electricity through his muscles; Trembling inside his muscles/electricity through his muscles; COVID toes and fingers; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 46-year-old male patient received bnt162b2 (COMIRNATY), administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single and administration date Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Contracted COVID", start date: Oct2020 (unspecified if ongoing), notes: Mild and not hospitalized. The patient's concomitant medications were not reported. The following information was reported: AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 2021, outcome "not recovered" and all described as "Had a lost of taste and smell"; PARAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "Tingling in his hands and legs"; MUSCLE DISCOMFORT (non-serious), TREMOR (non-serious) all with onset 2021, outcome "not recovered" and all described as "Trembling inside his muscles/electricity through his muscles"; RASH (non-serious) with onset 2021, outcome "not recovered", described as "COVID toes and fingers". The events "had a lost of taste and smell", "had a lost of taste and smell", "tingling in his hands and legs", "trembling inside his muscles/electricity through his muscles", "trembling inside his muscles/electricity through his muscles" and "covid toes and fingers" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient contracted covid in Oct2020 and received Pfizer vaccines in Jan2021. He was also "boosted". The case of covid was mild and he was not hospitalized. He has had continuing problems since having covid and the vaccines" and that he was scheduled to see a neurologist in a long covid clinic. He has had a lost of taste and smell, "covid toes and fingers", tingling in his hands and legs, "trembling inside his muscles", "electricity through his muscles", he spent a night in the ER, had a "CAT scan" and a "MRI of his neck", and blood work. He began to recover his sense of smell and taste when he lost it again after the booster dose. The reporter said they "don't know" if his symptoms were from "this vaccine or COVID". Caller asked if there was a way to access reports filed about tingling and numbness. Caller commented that she "couldn't glean anything" from the material she read online, including the prescribing information, which is why called. Caller said she is wondering if there is any information on accessing risks post study.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Muscle discomfort, Paraesthesia, Rash, Tremor
Clinical narrative: Had a lost of taste and smell; Had a lost of taste and smell; Tingling in his hands and legs; Trembling inside his muscles/electricity through his muscles; Trembling inside his muscles/electricity through his muscles; COVID toes and fingers; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 46-year-old male patient received bnt162b2 (COMIRNATY), administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single and administration date Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Contracted COVID", start date: Oct2020 (unspecified if ongoing), notes: Mild and not hospitalized. The patient's concomitant medications were not reported. The following information was reported: AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 2021, outcome "not recovered" and all described as "Had a lost of taste and smell"; PARAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "Tingling in his hands and legs"; MUSCLE DISCOMFORT (non-serious), TREMOR (non-serious) all with onset 2021, outcome "not recovered" and all described as "Trembling inside his muscles/electricity through his muscles"; RASH (non-serious) with onset 2021, outcome "not recovered", described as "COVID toes and fingers". The events "had a lost of taste and smell", "had a lost of taste and smell", "tingling in his hands and legs", "trembling inside his muscles/electricity through his muscles", "trembling inside his muscles/electricity through his muscles" and "covid toes and fingers" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient contracted covid in Oct2020 and received Pfizer vaccines in Jan2021. He was also "boosted". The case of covid was mild and he was not hospitalized. He has had continuing problems since having covid and the vaccines" and that he was scheduled to see a neurologist in a long covid clinic. He has had a lost of taste and smell, "covid toes and fingers", tingling in his hands and legs, "trembling inside his muscles", "electricity through his muscles", he spent a night in the ER, had a "CAT scan" and a "MRI of his neck", and blood work. He began to recover his sense of smell and taste when he lost it again after the booster dose. The reporter said they "don't know" if his symptoms were from "this vaccine or COVID". Caller asked if there was a way to access reports filed about tingling and numbness. Caller commented that she "couldn't glean anything" from the material she read online, including the prescribing information, which is why called. Caller said she is wondering if there is any information on accessing risks post study.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk, Lactation disorder, Off label use, Product use issue
Clinical narrative: Off-label use; Drug use in unapproved population; undetectable levels in breast milk; milk changed to blue/green color; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A female patient 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: OFF LABEL USE (non-serious), outcome "unknown", described as "Off-label use"; PRODUCT USE ISSUE (non-serious), outcome "unknown", described as "Drug use in unapproved population"; EXPOSURE VIA BREAST MILK (non-serious), outcome "unknown", described as "undetectable levels in breast milk"; LACTATION DISORDER (non-serious), outcome "unknown", described as "milk changed to blue/green color". Additional information: The reporter reported as non-serious. Caller would like to obtain some general breastfeeding information and read that some mom breast milk changed to blue/green colour, but nothing was mentioned in how long that lasted or the composition of it. Also, the majority of case studies have found undetectable levels in breast milk.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.