chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bone swelling, Immunisation, Lymphadenopathy
Clinical narrative: Swollen clavicle and lymph nodes; Swollen clavicle and lymph nodes; booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Dec2021 14:15 (Lot number: 33025BP) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Cholesterol" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOVASTATIN taken for blood cholesterol (ongoing); AMLODIPINE taken for blood pressure measurement (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Lot: EL3248, Exp: Unknown, Administered left upper arm), administration date: 03Feb2021, when the patient was 55 years old, for Covid-19 Immunization; Bnt162b2 (Second Dose, Lot: EL9264 , Exp: unknown, Administered left upper arm), administration date: 24Feb2021, when the patient was 55 years old, for Covid-19 Immunization, reaction(s): "Swollen clavicle and lymph nodes", "Swollen clavicle and lymph nodes". The following information was reported: IMMUNISATION (non-serious) with onset 27Dec2021 14:15, outcome "unknown", described as "booster dose"; BONE SWELLING (non-serious), LYMPHADENOPATHY (non-serious) all with onset 28Dec2021, outcome "not recovered" and all described as "Swollen clavicle and lymph nodes".  Additional information: After getting booster shot to Pfizer covid vaccine, patient had a swollen clavicle and lymph nodes which was worsened, and she could not sleep last night due to this. She could not put a bra on that day because it irritated that area. She said same thing happened with second Pfizer covid vaccine also but that was not as severe as this and not this painful. She was on concomitant medication vitamins. No additional vaccines were administered on the same date of the Pfizer suspect. No prior vaccination in last four weeks. Last vaccine was in Feb2021. It was reported that the AE(s) did not require a visit to Emergency Room or physician Office. She only called the doctor's office. She was recommended to go to ER the events got worse.  Follow up attempts are completed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Disorientation, Dizziness, Feeling abnormal, Immunisation
Clinical narrative: feeling dizzy; disoriented; coughing up Phlegm; do not feel right; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 79-year-old female patient received bnt162b2 (BNT162B2), administration date 21Dec2021 (Batch/Lot number: unknown) at the age of 79 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), when the patient was 79 years old, for Covid-19 immunization; Bnt162b2 (DOSE-2), when the patient was 79 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 21Dec2021, outcome "unknown", described as "booster"; DIZZINESS (non-serious), outcome "unknown", described as "feeling dizzy"; DISORIENTATION (non-serious), outcome "unknown", described as "disoriented"; COUGH (non-serious), outcome "unknown", described as "coughing up Phlegm"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "do not feel right".  Additional information: Reporter stated that he and his wife, began feeling dizzy, disoriented and coughing up Phlegm since being administered the Pfizer booster dose and want to know has this been reported by other. After the first and second doses of the vaccine he and his wife had no problems but began to experience symptoms after receiving the booster dose.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101878234 different patient, same drug and event
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Immunisation, Insomnia, Neck pain, Night sweats
Clinical narrative: Sore back and neck; Sore back and neck; night sweats; Booster; fever; insomnia; 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 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "had COVID", start date: 2021, stop date: 2021, notes: I had COVID 3 and a half months ago. The patient's concomitant medications were not reported. Past drug history included: Monoclonal antibodies. Vaccination history included: Covid-19 vaccine (Dose number unknown, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Dec2021, outcome "unknown", described as "Booster"; NECK PAIN (non-serious), BACK PAIN (non-serious) all with onset 28Dec2021, outcome "unknown" and all described as "Sore back and neck"; PYREXIA (non-serious) with onset 27Dec2021, outcome "recovered" (28Dec2021), described as "fever"; INSOMNIA (non-serious) with onset 27Dec2021, outcome "unknown", described as "insomnia"; NIGHT SWEATS (non-serious) with onset 28Dec2021, outcome "unknown", described as "night sweats". Additional Information: Booster COVID vaccine shot received on 27Dec2021 within 12 hours had fever, insomnia. Fever lasted over 30 hours. Also had night sweats & insomnia on second night. Sore back and neck.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Sore back and neck; Sore back and neck; night sweats; Booster; fever; insomnia; 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 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "had COVID", start date: 2021, stop date: 2021, notes: I had COVID 3 and a half months ago. The patient's concomitant medications were not reported. Past drug history included: Monoclonal antibodies. Vaccination history included: Covid-19 vaccine (Dose number unknown, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Dec2021, outcome "unknown", described as "Booster"; NECK PAIN (non-serious), BACK PAIN (non-serious) all with onset 28Dec2021, outcome "unknown" and all described as "Sore back and neck"; PYREXIA (non-serious) with onset 27Dec2021, outcome "recovered" (28Dec2021), described as "fever"; INSOMNIA (non-serious) with onset 27Dec2021, outcome "unknown", described as "insomnia"; NIGHT SWEATS (non-serious) with onset 28Dec2021, outcome "unknown", described as "night sweats". Additional Information: Booster COVID vaccine shot received on 27Dec2021 within 12 hours had fever, insomnia. Fever lasted over 30 hours. Also had night sweats & insomnia on second night. Sore back and neck.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Immunisation
Clinical narrative: I have my Pfizer booster; dizziness; 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 27Dec2021 11:00 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, Dose 1), for COVID-19 Immunization; Covid-19 vaccine (MANUFACTURER UNKNOWN, Dose 2), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Dec2021 11:00, outcome "unknown", described as "I have my Pfizer booster"; DIZZINESS (non-serious) with onset Dec2021, outcome "not recovered", described as "dizziness". The event "dizziness" was evaluated at the physician office visit.  Additional information; Patient reported "I had my Pfizer booster (further clarification unknown, hence suspect captured as unspecified medication) on Monday at 11 o clock and I am having a really bad side effect, The patient went to see my doctor today. But now The patient having this dizziness."   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Tremor
Clinical narrative: Shaking in left hand; Booster; 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 05Dec2021 (Batch/Lot number: unknown) as dose number unknown, (booster) single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (non-serious) with onset 05Dec2021, outcome "unknown", described as "Booster"; TREMOR (non-serious), outcome "unknown", described as "Shaking in left hand".  Additional Information: The report was not related to a study or programme. She then said she has shaking in left hand and unable to confirm if she had that prior. No further details provided.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Loss of personal independence in daily activities
Clinical narrative: she had her booster a week ago today and is still unable to function; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Dec2021 12:00 (Batch/Lot number: unknown) at the age of 23 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "tourette syndrome" (unspecified if ongoing); "mild case /anxiety" (unspecified if ongoing); "depression under control with meds" (unspecified if ongoing); "Allergies:penicillin" (unspecified if ongoing); "trunk rash" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Product=COVID 19, Brand=Pfizer, Lot unknown=True, Lot unknown reason=Not available/provided to reporter at the time of report completion,, Administration date=Apr2021), administration date: Apr2021, for Covid-19 Immunization; Bnt162b2 (DOSE 2, Product=COVID 19, Brand=Pfizer, Lot unknown= True, Lot unknown reason=Not available/provided to reporter at the time of report completion,, Administration date= =May2021,), administration date: May2021, for Covid-19 immunization; Bnt162b2, for Covid-19 Immunization, reaction(s): "severe nausea", "vomiting"; Bnt162b2, for Covid-19 immunization, reaction(s): "Unable to keep any food / drink down". The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021, outcome "unknown", described as "booster"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "she had her booster a week ago today and is still unable to function". The event "she had her booster a week ago today and is still unable to function" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of loss of personal independence in daily activities.  Additional Information: The patient did not receive any vaccine prior to Covid vaccine. The patient did not test positive for Covid post vaccination. Adverse event was treated with IV fluids and anti-nausea medicines.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19, VARZOS
Symptoms: Herpes zoster, Immunisation
Clinical narrative: Booster; Got a terrible case of shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 22Oct2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown, manufacturer unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Oct2021, outcome "unknown", described as "Booster"; HERPES ZOSTER (non-serious) with onset 2021, outcome "unknown", described as "Got a terrible case of shingles".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19, VARZOS
Symptoms: Herpes zoster, Nerve injury, Toxic shock syndrome streptococcal, Vaccination failure
Clinical narrative: Booster; Got a terrible case of shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 22Oct2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown, manufacturer unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Oct2021, outcome "unknown", described as "Booster"; HERPES ZOSTER (non-serious) with onset 2021, outcome "unknown", described as "Got a terrible case of shingles".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use
Clinical narrative: my cousin took the Pfizer booster; The first two shots were Moderna; Off-Label use; sick; The lymph node under her armpit were like swollen for like couple of days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 57 year-old female patient received bnt162b2 (BNT162B2), administration date 28Dec2021 (Batch/Lot number: unknown) as dose unknown number (booster), single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: high blood pressure. The patient's concomitant medications were not reported. Vaccination history included: Moderna vaccine (1st dose, lot#036A21A), for COVID-19 Immunization; Moderna vaccine (2nd dose, lot#019B21A), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 28Dec2021, outcome "unknown", described as "my cousin took the Pfizer booster"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 28Dec2021, outcome "unknown", described as "The first two shots were Moderna"; OFF LABEL USE (non-serious) with onset 28Dec2021, outcome "unknown", described as "Off-Label use"; ILLNESS (non-serious) with onset Dec2021, outcome "unknown", described as "sick"; LYMPHADENOPATHY (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "The lymph node under her armpit were like swollen for like couple of days". Therapeutic measures were not taken as a result of illness, lymphadenopathy.  Additional information: It was reported that my cousin took the Pfizer booster and she had Moderna but then she took the booster and then you know she kind of got sick and her lymph I guess the lymph node under her armpit were like swollen for like couple days.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Mouth swelling
Clinical narrative: Mouth is swollen; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed but manufacturer unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Dec2021, outcome "unknown", described as "booster dose"; MOUTH SWELLING (non-serious), outcome "unknown", described as "Mouth is swollen".  Additional information:This consumer is also the patient who got the Pfizer Covid Vaccine on 30Dec2021. She called to figure out what to do because her mouth is swollen, which is not too bad, just swollen a little. She was trying to figure out how long will this event last; it's not her whole face, just her mouth that is a little swollen. She wanted to know if she can smoke a cigarette, can she drink, she needed to know how long this event will last   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Immunisation, Lymph node pain, Lymphadenopathy
Clinical narrative: Booster; headache; joint soreness; swollen/painful L armpit lymph node; swollen/painful L armpit lymph node; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Dec2021 16:00 (Lot number: 33B0BA) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: JUNEL taken for contraception. Vaccination history included: Bnt162b2 (dose number: 1, lot number: EL0142, administration date: 03Jan2021 in Left arm), administration date: 03Jan2021, when the patient was 26 years old, for Covid-19 immunization; Bnt162b2 (dose number: 2, lot number: EL3247, administration date: 20Jan2021 at 08:30 AM  in Left arm), administration date: 20Jan2021, when the patient was 26 years old, for Covid-19 immunization, reaction(s): "Dose 1 on 03Jan2021 and Dose 2 on 20Jan2021". The following information was reported: IMMUNISATION (non-serious) with onset 30Dec2021, outcome "unknown", described as "Booster"; HEADACHE (non-serious) with onset 30Dec2021, outcome "not recovered", described as "headache"; ARTHRALGIA (non-serious) with onset 30Dec2021, outcome "not recovered", described as "joint soreness"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 30Dec2021, outcome "not recovered" and all described as "swollen/painful L armpit lymph node". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, arthralgia, lymphadenopathy, lymph node pain.  Additional information: On 31Dec2021, patient was tested for covid using nasal swab result of which was negative. Patient had no known allergies. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with covid in the past.  Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Booster; headache; joint soreness; swollen/painful L armpit lymph node; swollen/painful L armpit lymph node; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Dec2021 16:00 (Lot number: 33B0BA) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: JUNEL taken for contraception. Vaccination history included: Bnt162b2 (dose number: 1, lot number: EL0142, administration date: 03Jan2021 in Left arm), administration date: 03Jan2021, when the patient was 26 years old, for Covid-19 immunization; Bnt162b2 (dose number: 2, lot number: EL3247, administration date: 20Jan2021 at 08:30 AM  in Left arm), administration date: 20Jan2021, when the patient was 26 years old, for Covid-19 immunization, reaction(s): "Dose 1 on 03Jan2021 and Dose 2 on 20Jan2021". The following information was reported: IMMUNISATION (non-serious) with onset 30Dec2021, outcome "unknown", described as "Booster"; HEADACHE (non-serious) with onset 30Dec2021, outcome "not recovered", described as "headache"; ARTHRALGIA (non-serious) with onset 30Dec2021, outcome "not recovered", described as "joint soreness"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 30Dec2021, outcome "not recovered" and all described as "swollen/painful L armpit lymph node". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, arthralgia, lymphadenopathy, lymph node pain.  Additional information: On 31Dec2021, patient was tested for covid using nasal swab result of which was negative. Patient had no known allergies. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with covid in the past.  Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19, FLUX, COVID19
Symptoms: Burning sensation, Immunisation, Paraesthesia, Product use issue, Pruritus
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 25-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Dec2021 (Lot number: FJ1620) at the age of 25 years as dose 3, (booster) single for Covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 06Dec2021 (Batch/Lot number: unknown) as dose number unknown, single. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; PEPTO BISMOL [BISMUTH SUBSALICYLATE]. Past drug history included: Corozine prochlorperazine, reaction(s): "Allergies: Corozine prochlorperazine". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0168, Location of injection: Arm Right), when the patient was 24 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0172, Location of injection: Arm Right), when the patient was 24 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Booster"; URTICARIA (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Spontaneous urticaria/body is breaking out into hives/large welts"; PRURITUS (non-serious) with onset 18Dec2021, outcome "not recovered", described as "itchiness"; BURNING SENSATION (non-serious), PARAESTHESIA (non-serious) all with onset 18Dec2021, outcome "not recovered" and all described as "My hands burn and tingle"; SCRATCH (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Scratching at the skin"; PRODUCT USE ISSUE (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Other vaccine same date vaccine date 06Dec2021". Therapeutic measures were not taken as a result of immunisation, urticaria, pruritus, burning sensation, paraesthesia, scratch, product use issue. Additional information: Patient has not received other vaccine in four weeks. Adverse event: Spontaneous urticaria. Patient whole body was breaking out into hives with itchiness moving all over. My hands burn and tingle without any reaction to doing anything. Scratching at the skin causing large welts to form on my skin. Taking a Benadryl has helped, she takes 3 a day. Patient has not suffered from Covid prior vaccination and patient was not tested post vaccination. No known allergies were reported. No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19, FLUX, COVID19
Symptoms: Scratch, Urticaria
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 25-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Dec2021 (Lot number: FJ1620) at the age of 25 years as dose 3, (booster) single for Covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 06Dec2021 (Batch/Lot number: unknown) as dose number unknown, single. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; PEPTO BISMOL [BISMUTH SUBSALICYLATE]. Past drug history included: Corozine prochlorperazine, reaction(s): "Allergies: Corozine prochlorperazine". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0168, Location of injection: Arm Right), when the patient was 24 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0172, Location of injection: Arm Right), when the patient was 24 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Booster"; URTICARIA (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Spontaneous urticaria/body is breaking out into hives/large welts"; PRURITUS (non-serious) with onset 18Dec2021, outcome "not recovered", described as "itchiness"; BURNING SENSATION (non-serious), PARAESTHESIA (non-serious) all with onset 18Dec2021, outcome "not recovered" and all described as "My hands burn and tingle"; SCRATCH (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Scratching at the skin"; PRODUCT USE ISSUE (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Other vaccine same date vaccine date 06Dec2021". Therapeutic measures were not taken as a result of immunisation, urticaria, pruritus, burning sensation, paraesthesia, scratch, product use issue. Additional information: Patient has not received other vaccine in four weeks. Adverse event: Spontaneous urticaria. Patient whole body was breaking out into hives with itchiness moving all over. My hands burn and tingle without any reaction to doing anything. Scratching at the skin causing large welts to form on my skin. Taking a Benadryl has helped, she takes 3 a day. Patient has not suffered from Covid prior vaccination and patient was not tested post vaccination. No known allergies were reported. No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19, FLUX, COVID19
Symptoms: Burning sensation, Chronic spontaneous urticaria, Dyspepsia, Gastrooesophageal reflux disease, Mechanical urticaria
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 25-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Dec2021 (Lot number: FJ1620) at the age of 25 years as dose 3, (booster) single for Covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 06Dec2021 (Batch/Lot number: unknown) as dose number unknown, single. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; PEPTO BISMOL [BISMUTH SUBSALICYLATE]. Past drug history included: Corozine prochlorperazine, reaction(s): "Allergies: Corozine prochlorperazine". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0168, Location of injection: Arm Right), when the patient was 24 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0172, Location of injection: Arm Right), when the patient was 24 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Booster"; URTICARIA (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Spontaneous urticaria/body is breaking out into hives/large welts"; PRURITUS (non-serious) with onset 18Dec2021, outcome "not recovered", described as "itchiness"; BURNING SENSATION (non-serious), PARAESTHESIA (non-serious) all with onset 18Dec2021, outcome "not recovered" and all described as "My hands burn and tingle"; SCRATCH (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Scratching at the skin"; PRODUCT USE ISSUE (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Other vaccine same date vaccine date 06Dec2021". Therapeutic measures were not taken as a result of immunisation, urticaria, pruritus, burning sensation, paraesthesia, scratch, product use issue. Additional information: Patient has not received other vaccine in four weeks. Adverse event: Spontaneous urticaria. Patient whole body was breaking out into hives with itchiness moving all over. My hands burn and tingle without any reaction to doing anything. Scratching at the skin causing large welts to form on my skin. Taking a Benadryl has helped, she takes 3 a day. Patient has not suffered from Covid prior vaccination and patient was not tested post vaccination. No known allergies were reported. No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19, FLUX, COVID19
Symptoms: Nausea, Pain, Pruritus, Scratch, Urticaria
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 25-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Dec2021 (Lot number: FJ1620) at the age of 25 years as dose 3, (booster) single for Covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 06Dec2021 (Batch/Lot number: unknown) as dose number unknown, single. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; PEPTO BISMOL [BISMUTH SUBSALICYLATE]. Past drug history included: Corozine prochlorperazine, reaction(s): "Allergies: Corozine prochlorperazine". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0168, Location of injection: Arm Right), when the patient was 24 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0172, Location of injection: Arm Right), when the patient was 24 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Booster"; URTICARIA (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Spontaneous urticaria/body is breaking out into hives/large welts"; PRURITUS (non-serious) with onset 18Dec2021, outcome "not recovered", described as "itchiness"; BURNING SENSATION (non-serious), PARAESTHESIA (non-serious) all with onset 18Dec2021, outcome "not recovered" and all described as "My hands burn and tingle"; SCRATCH (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Scratching at the skin"; PRODUCT USE ISSUE (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Other vaccine same date vaccine date 06Dec2021". Therapeutic measures were not taken as a result of immunisation, urticaria, pruritus, burning sensation, paraesthesia, scratch, product use issue. Additional information: Patient has not received other vaccine in four weeks. Adverse event: Spontaneous urticaria. Patient whole body was breaking out into hives with itchiness moving all over. My hands burn and tingle without any reaction to doing anything. Scratching at the skin causing large welts to form on my skin. Taking a Benadryl has helped, she takes 3 a day. Patient has not suffered from Covid prior vaccination and patient was not tested post vaccination. No known allergies were reported. No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19, FLUX, COVID19
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 25-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Dec2021 (Lot number: FJ1620) at the age of 25 years as dose 3, (booster) single for Covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 06Dec2021 (Batch/Lot number: unknown) as dose number unknown, single. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; PEPTO BISMOL [BISMUTH SUBSALICYLATE]. Past drug history included: Corozine prochlorperazine, reaction(s): "Allergies: Corozine prochlorperazine". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0168, Location of injection: Arm Right), when the patient was 24 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0172, Location of injection: Arm Right), when the patient was 24 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Booster"; URTICARIA (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Spontaneous urticaria/body is breaking out into hives/large welts"; PRURITUS (non-serious) with onset 18Dec2021, outcome "not recovered", described as "itchiness"; BURNING SENSATION (non-serious), PARAESTHESIA (non-serious) all with onset 18Dec2021, outcome "not recovered" and all described as "My hands burn and tingle"; SCRATCH (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Scratching at the skin"; PRODUCT USE ISSUE (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Other vaccine same date vaccine date 06Dec2021". Therapeutic measures were not taken as a result of immunisation, urticaria, pruritus, burning sensation, paraesthesia, scratch, product use issue. Additional information: Patient has not received other vaccine in four weeks. Adverse event: Spontaneous urticaria. Patient whole body was breaking out into hives with itchiness moving all over. My hands burn and tingle without any reaction to doing anything. Scratching at the skin causing large welts to form on my skin. Taking a Benadryl has helped, she takes 3 a day. Patient has not suffered from Covid prior vaccination and patient was not tested post vaccination. No known allergies were reported. No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Immunisation, SARS-CoV-2 test
Clinical narrative: Shingles outbreak; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Oct2021 (Lot number: FE3590) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "known allergies: Sulfa meds" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Phizer, prev dose brand unknown=False, prev dose lot number=EN6205, prev dose lot unknown=False, prev dose administration date=, 18Mar2021, prev dose dose number=2, prev dose vaccine location=Left arm), administration date: 18Mar2021, when the patient was 68 years old, for COVID-19 immunization; Bnt162b2 (prev dose product=COVID 19, prev dose brand=Phizer, prev dose brand unknown=False, prev dose lot number=EN6201, prev dose lot unknown=False, prev dose administration date=, 24Feb2021, prev dose dose number=1, prev dose vaccine location=Left arm), administration date: 24Feb2021, when the patient was 67 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Oct2021, outcome "recovering", described as "Booster"; HERPES ZOSTER (non-serious) with onset 21Dec2021, outcome "recovering", described as "Shingles outbreak". The event "shingles outbreak" 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 immunisation, herpes zoster.  Additional information: other vaccine in four weeks reported as no. AE treatment received with Antifungal RX. Covid prior vaccination reported as no and Covid tested post vaccination reported as yes.  Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Vaccination site discomfort
Clinical narrative: Discomfort to injection site; vaccine was administered in right forearm; This is a spontaneous report received from a contactable reporter (nurse) from medical information team. The reporter is the patient.  A 79 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), intramuscular, administered in lower forearm right, administration date 06Feb2021 13:00 (Lot number: EL324) at the age of 79 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis", start date: 2010 (ongoing). Family history included: "Increased BP", start date: 2001 (ongoing), notes: Controlled by medication. Concomitant medication(s) included: LISINOPRIL taken for hypertension, start date: 2001 (ongoing); LISINOPRIL HCTZ taken for hypertension, start date: 2001 (ongoing). The following information was reported: VACCINATION SITE DISCOMFORT (non-serious) with onset 06Feb2021 14:00, outcome "unknown", described as "Discomfort to injection site"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 06Feb2021 13:00, described as "vaccine was administered in right forearm". Additional information: The patient's family history also included history of cancer. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: slight / minimal tenderness at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Feb2021 11:50 (Lot number: EL9263) 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: VACCINATION SITE PAIN (non-serious) with onset 05Feb2021, outcome "unknown", described as "slight / minimal tenderness at injection site".  Additional Information: Verbatim and Event Description: The caller and the husband got a 4 weeks schedule for 2nd dose. The Patient reported neither her husband or she had any side effects from either of their vaccination, except slight tenderness at site of injection.  Follow-up (29Mar2021): Patient age at time of vaccination was reported as 70 years. Prior Vaccination within 4 weeks: None. Concomitant drugs was reported as None. Patient Medical History was reported as None. Relevant Test was None. Event Onset date was next day. Seriousness criteria: Not Serious.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Pain
Clinical narrative: Headache; Exhausted; Strange feeling for rest of the week up till today/wiped out; achy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date 08Mar2021 (Lot number: EN6199) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; METHOTREXATE. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "not recovered", described as "Headache"; FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "Exhausted"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "not recovered", described as "Strange feeling for rest of the week up till today/wiped out"; PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "achy". Therapeutic measures were taken as a result of headache, fatigue, feeling abnormal, pain.  Additional information included: Reporter stated, "I got the Pfizer vaccine on Monday and I didn't have much of it an arm soreness or anything that was pretty good but I have an headache and exhausted, strange feeling for rest of the week up till today. So I thought I will check and see about how long does it last?" Reporter confirmed the shot as first shot. Reporter confirmed treatment with Tylenol. Patient reported herself of Mixed ethnicity. She could not remember the rest of her medications. Reporter stated that she got the first dose last Monday and she was still feeling wiped out and achy until now. Caller was asking how long will it last.  No follow-up attempts are possible. No further information is expected.  Follow-up (11Mar2021): This is a follow-up spontaneous report from a Pfizer sponsored program.  Updated information included: narrative was updated.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: He woke up in pain of right hand; 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 (159558). The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 15Mar2021 (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: PAIN IN EXTREMITY (non-serious) with onset 15Mar2021, outcome "not recovered", described as "He woke up in pain of right hand".  Additional information: This report was received via Regulatory Support. Clinical course: The patient who stated he got his first dose of the COVID-19 Vaccine yesterday, 15Mar2021. The caller said last night he had pain in his hand, which was the same arm as he received his first COVID-19 Vaccine in. The event was reported as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Euphoric mood, Pain, Sacroiliitis, X-ray
Clinical narrative: euphoria; little dizziness; felt pain in my side; sacroiliitis; 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 70 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "mini-stroke" (unspecified if ongoing), notes: I had a mini-stroke behind my eye years ago. The patient's concomitant medications were not reported. The following information was reported: EUPHORIC MOOD (non-serious), outcome "recovered" (2021), described as "euphoria"; DIZZINESS (non-serious), outcome "recovered" (2021), described as "little dizziness"; PAIN (non-serious) with onset 14Mar2021, outcome "unknown", described as "felt pain in my side"; SACROILIITIS (non-serious) with onset Mar2021, outcome "unknown", described as "sacroiliitis". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient had received the first dose of the Pfizer COVID vaccine. After getting the first dose patient experienced euphoria and a little dizziness, and felt great after about 2 hours. On Sunday, patient felt pain in her side. she went to the walk-in clinic about it, they did x-rays but thought it was probably a muscle spasm. The x-ray showed sacroiliitis which is inflammation of the joint between my spine and pelvis on the back.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: she noticed puffiness under arm where the injection was received.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Mar2021 14:30 (Lot number: EN6199) at the age of 57 years 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: PERIPHERAL SWELLING (non-serious) with onset 14Mar2021, outcome "recovering", described as "she noticed puffiness under arm where the injection was received."  Additional information: The reporter had her first dose and now she has some puffiness under your arm where she got the shot. The caller wanted to know if that is normal, is it a normal side effect and how long it will be like this. Vaccination Facility Type was at Clinic. No the private Facility was involved. No History of all previous immunization with the Pfizer vaccine considered as suspect. Additional Vaccines Administered on Same Date of the Pfizer Suspect  was none. The patient did not visit Emergency room or Physician's office Prior. Vaccinations (within 4 weeks) and AE(s) following prior vaccinations were none. Family Medical History Relevant to AE was none. Relevant test done were none.  No follow-up attempts are possible. No further information is expected.