chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Arthropathy, Chills, Fatigue, Headache, Immunisation
Clinical narrative: Booster dose; Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint fever; Nausea; Feeling unwell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 immunization; Bnt162b2 (Dose 2, single), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster dose"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Injection site pain"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; CHILLS (non-serious), outcome "unknown", described as "Chills"; ARTHROPATHY (non-serious), outcome "unknown", described as "Joint fever"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; MALAISE (non-serious), outcome "unknown", described as "Feeling unwell".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, Vaccination site pain
Clinical narrative: Booster dose; Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint fever; Nausea; Feeling unwell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 immunization; Bnt162b2 (Dose 2, single), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster dose"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Injection site pain"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; CHILLS (non-serious), outcome "unknown", described as "Chills"; ARTHROPATHY (non-serious), outcome "unknown", described as "Joint fever"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; MALAISE (non-serious), outcome "unknown", described as "Feeling unwell".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Pain, Pruritus
Clinical narrative: stinging; burning; like itchy feeling; 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, Solution for injection) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Batch/Lot number: Unknown), for COVID-19 immunization. The following information was reported: PAIN (non-serious), outcome unknown, described as stinging; BURNING SENSATION (non-serious), outcome unknown, described as burning; PRURITUS (non-serious), outcome unknown, described as like itchy feeling.  Additional information: Patient stated that I just had a question about this side effect, and I have had well 3 weeks ago, today had the second one and I am still having, I didn't know how long, I was trying to find out how long the side effect last, is it over a week. Patient also stated that stated It's 'stinging' and burning like itchy feeling and it's been a week ago today. Product details like NDC#, UPC# and Expiration Date and Pharmacy details could not be probed as the consumer was unwilling to file safety report. Hence limited information available over the call. On 18Oct2021 Phone-Out 10:57 AM: 1st attempt by phone to consumer to obtain follow-up information contained on consumer questionnaire. Phone answered by consumer who provided her mailing address details. Consumer questionnaire forwarded to AER reporting mailbox.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the patient.  A 64-year-old female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Lot number: ER8732) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "shingles" (unspecified if ongoing); "ear problems" (unspecified if ongoing), notes: She has never had ear problems in her entire life. Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism (ongoing). Vaccination history included: Zoster vaccine (Dose 1, The first one was kind of nasty and the second one was really nasty. It wasn't anything unusual, it was exactly what they said, the body aches, fever, and everything.), administration date: 2016, for shingles immunization, reaction(s): "body aches", "fever"; Zoster vaccine (Dose 2, The first one was kind of nasty and the second one was really nasty. It wasn't anything unusual, it was exactly what they said, the body aches, fever, and everything.), administration date: 2016, for shingles immunization, reaction(s): "body aches", "fever"; Zoster vaccine (Dose 1, she had her first shingles vaccine years ago and it didn't work), administration date: 2016, for shingles immunization, reaction(s): "it didn't work".  The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "sore arm".  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood pressure measurement, Gait disturbance, Heart rate, Pyrexia
Clinical narrative: Could not walk; Lost control of my urine; Fever; Rash; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administration date 30Apr2021 (Batch/Lot number: unknown) at the age of 52 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "high cholesterol" (unspecified if ongoing); "high pulse rate" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN; MELOXICAM; CHOLECALCIFEROL; METOPROLOL; ATORVASTATIN; TRAMADOL; POTASSIUM; GABAPENTIN; LIDOCAINE; PREMARIN. The following information was reported: GAIT DISTURBANCE (non-serious) with onset 30Apr2021, outcome "recovered" (2021), described as "Could not walk"; URINARY INCONTINENCE (non-serious) with onset 30Apr2021, outcome "recovered" (2021), described as "Lost control of my urine"; PYREXIA (non-serious) with onset 30Apr2021, outcome "recovered" (2021), described as "Fever"; RASH (non-serious) with onset 30Apr2021, outcome "recovered" (2021), described as "Rash". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient's concomitant medication included: lidocaine patch, PREMARIN VAGINAL. On 30Apr2021, it was reported that patient experienced: relapse, could not walk, lost control of my urine, fever, rash.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urinary incontinence
Clinical narrative: Could not walk; Lost control of my urine; Fever; Rash; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administration date 30Apr2021 (Batch/Lot number: unknown) at the age of 52 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "high cholesterol" (unspecified if ongoing); "high pulse rate" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN; MELOXICAM; CHOLECALCIFEROL; METOPROLOL; ATORVASTATIN; TRAMADOL; POTASSIUM; GABAPENTIN; LIDOCAINE; PREMARIN. The following information was reported: GAIT DISTURBANCE (non-serious) with onset 30Apr2021, outcome "recovered" (2021), described as "Could not walk"; URINARY INCONTINENCE (non-serious) with onset 30Apr2021, outcome "recovered" (2021), described as "Lost control of my urine"; PYREXIA (non-serious) with onset 30Apr2021, outcome "recovered" (2021), described as "Fever"; RASH (non-serious) with onset 30Apr2021, outcome "recovered" (2021), described as "Rash". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient's concomitant medication included: lidocaine patch, PREMARIN VAGINAL. On 30Apr2021, it was reported that patient experienced: relapse, could not walk, lost control of my urine, fever, rash.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Lymphadenopathy
Clinical narrative: Pfizer COVID-19 booster shot in left arm; He left arm pit lymph nodes swelled up causing pain.; He left arm pit lymph nodes swelled up causing pain.; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A 40 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (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 1, UNKNOWN MANUFACTURER), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, UNKNOWN MANUFACTURER), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Pfizer COVID-19 booster shot in left arm"; LYMPHADENOPATHY (non-serious), AXILLARY PAIN (non-serious), outcome "unknown" and all described as "He left arm pit lymph nodes swelled up causing pain.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Headache, Influenza like illness, Nasopharyngitis, Productive cough
Clinical narrative: excessive bleeding from her nose; flu like symptoms; having a cold for a couple of days now; Runny nose; She has phlegm; She has a lot of headache; 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 37 year-old female patient received bnt162b2 (BNT162B2), administration date 30Aug2021 (Batch/Lot number: unknown) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EPISTAXIS (non-serious), outcome "unknown", described as "excessive bleeding from her nose"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "having a cold for a couple of days now"; RHINORRHOEA (non-serious), outcome "unknown", described as "Runny nose"; PRODUCTIVE COUGH (non-serious), outcome "unknown", described as "She has phlegm"; HEADACHE (non-serious), outcome "unknown", described as "She has a lot of headache". Relevant laboratory tests and procedures are available in the appropriate section.  Information on lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: excessive bleeding from her nose; flu like symptoms; having a cold for a couple of days now; Runny nose; She has phlegm; She has a lot of headache; 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 37 year-old female patient received bnt162b2 (BNT162B2), administration date 30Aug2021 (Batch/Lot number: unknown) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EPISTAXIS (non-serious), outcome "unknown", described as "excessive bleeding from her nose"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "having a cold for a couple of days now"; RHINORRHOEA (non-serious), outcome "unknown", described as "Runny nose"; PRODUCTIVE COUGH (non-serious), outcome "unknown", described as "She has phlegm"; HEADACHE (non-serious), outcome "unknown", described as "She has a lot of headache". Relevant laboratory tests and procedures are available in the appropriate section.  Information on lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: lost her sense of taste and smell; lost her sense of taste and smell; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative. The reporter is the patient.  A female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "lost her sense of taste and smell".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Serum ferritin, Serum ferritin increased
Clinical narrative: Her ferritin levels almost went up to 600; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1 single), administration date: 19Apr2021, for covid-19 immunization, reaction(s): "sick". The following information was reported: SERUM FERRITIN INCREASED (non-serious), outcome "unknown", described as "Her ferritin levels almost went up to 600". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Her sister also had a really strange reaction with the second shot Pfizer covid vaccine. Her ferritin levels almost went up to 600 which was really bad. States her sister reported this.   Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "Itching".  Additional information: The report relate to study or programme.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Malaise, Pyrexia, Tachycardia
Clinical narrative: Fever; Tachycardia; Feeling lousy; Headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 05Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, She received her first dose on 18Dec2020 and "did not experience anything with that dose".), administration date: 18Dec2020, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fever"; TACHYCARDIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Tachycardia"; MALAISE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Feeling lousy"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Headache". The events "fever", "tachycardia", "feeling lousy" and "headache" were 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 pyrexia, tachycardia.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: My hurts it did that last time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN (non-serious), outcome "unknown", described as "My hurts it did that last time".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Booster; Temperature excursion; Booster shot, they got was in a temperature excursion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2, Solution for injection), administration date 16Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Sep2021, outcome unknown, described as Booster; PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset 16Sep2021, outcome unknown, described as Temperature excursion; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 16Sep2021, outcome unknown, described as Booster shot, they got was in a temperature excursion.  Additional information: About a week later pharmacist called and said the booster shot wife and caller had been in a temperature excursion and wondering if they were having any side effects. Caller said they both had same side effects after boosters as they did after both doses of covid vaccine. Wondering if we have any records on file of the booster they received. Also wants to know if they should be revaccinated. And if booster shot, they got was in a temperature excursion, is that ok.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: temperature excursion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administration date 16Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (2nd dose, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome "unknown", described as "temperature excursion".  Additional information: CDC suggested he calls us. Wife and caller both had both doses of covid vaccine and the booster on 16Sep2021. About a week later pharmacist called and said the booster shot wife and caller had were in a temperature excursion and wondering if they were having any side effects. Caller said they both had same side effects after boosters as they did after both doses of covid vaccine. Wondering if we have any records on file of the booster they received. Also wants to know if they should be revaccinated. And if booster shot, they got was in a temperature excursion, is that ok. Relayed information and transferred. Will fax for AEs.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (24Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abnormal faeces
Clinical narrative: She cares for her  87 yr. old mother who had the first vax and she is asking if it is excreted in stool because she changes her poopy diapers.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 87 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "blood disorder" (unspecified if ongoing), notes: Rare blood disorder; "spleen removed" (unspecified if ongoing), notes: Spleen removed when she was young and was told not to get live vaccinations. The patient's concomitant medications were not reported.  The following information was reported: ABNORMAL FAECES (non-serious) with onset 2021, outcome "unknown", described as "She cares for her 87 yr. old mother who had the first vax and she is asking if it is excreted in stool because she changes her poopy diapers.".  Additional information: After call she mentioned her mother received vax 30 days ago.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fall, Ligament sprain, Swelling
Clinical narrative: sprain; swelling; fell; Some pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 25 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "chronic migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 Immunization. The following information was reported: LIGAMENT SPRAIN (non-serious) with onset 2021, outcome "unknown", described as "sprain"; SWELLING (non-serious) with onset 2021, outcome "unknown", described as "swelling"; FALL (non-serious) with onset 2021, outcome "unknown", described as "fell"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "Some pain".  Additional information: As patient was a sports person got Sprain while working on sports got injury and happened after vaccination. Unsure timeline but believe large space between the two, during the follow up patient experienced swelling initially so they could not tell if it was fracture. They've said it has hurt more than usual in the past couple of days. They are currently in a brace; they will be in a boot for four more weeks for their foot to fully heal. They were given also the option of a hard shoe (cannot remember if can immediately do that or not), reporter mentioned about the potential ligament issue but nothing further, and no new information was updated during the follow-up's.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness
Clinical narrative: typical flu like symptoms; fatigue; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 34 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) at the age of 34 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, administration date: Mar2021, for COVID-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "typical flu like symptoms"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; HEADACHE (non-serious), outcome "unknown", described as "headache". 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) : PFIZER INC-202101655010 same patient/drug, different dose/event
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Vomiting
Clinical narrative: feeling unwell; nausea; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 16:45 (Lot number: FK5618) at the age of 6 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "no" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 18Nov2021 12:00, outcome "recovered" (2021), described as "feeling unwell"; NAUSEA (non-serious) with onset 18Nov2021 12:00, outcome "recovered" (2021), described as "nausea"; VOMITING (non-serious) with onset 18Nov2021 12:00, outcome "recovered" (2021), described as "vomiting". Therapeutic measures were not taken as a result of malaise, nausea, vomiting.  Additional information: Facility type vaccine: Doctor's office/urgent care. The patient did not received any other vaccine in four weeks. The patient did not had covid prior to vaccination and not tested covid post vaccination. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Peripheral swelling
Clinical narrative: calf swelling; the back of her knees felt very tight/back of her knees were tight and her calves were tight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 13:00 (Batch/Lot number: unknown) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Dry eyes" (unspecified if ongoing). Concomitant medication(s) included: PROLIA taken for osteoporosis (ongoing); XIIDRA taken for dry eye (ongoing). Vaccination history included: Bnt162b2 (First Dose, lot number ER8729, administered in left arm), administration date: 09Apr2021, when the patient was 63 years old, for Covid-19 Immunisation; Bnt162b2 (Second Dose , Lot: EW0164, administered in left arm Reaction/event as reported by primary source: Fever, Date of start of reaction/event: Apr2021, Outcome of reaction/event at the time of last observation: RECOVERED/RESOLVED), administration date: 30Apr2021, when the patient was 63 years old, for Covid-19 Immunisation, reaction(s): "Fever", "Chills", "Headache". The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 23Nov2021 17:00, outcome "recovering", described as "calf swelling"; MUSCLE TIGHTNESS (non-serious) with onset 23Nov2021 17:00, outcome "recovering", described as "the back of her knees felt very tight/back of her knees were tight and her calves were tight".  The lot number for [BNT162B2], was not provided and will be requested during follow up. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: experience a severe reaction after first dose underneath her arm.  It is a lymph node.; She complained about the pain under the arm a day later; 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 parent.  A 19 year-old female patient received bnt162b2 (COMIRNATY), administration date Aug2021 (Lot number: EW0178) at the age of 19 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Mar2021, stop date: Mar2021, notes: She was quarantined 08Mar2021 in her dorm. The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovered" (2021), described as "experience a severe reaction after first dose underneath her arm. It is a lymph node."; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "She complained about the pain under the arm a day later".  Additional information: The caller was calling on behalf of her daughter who had Covid 19 in March, received her first dose of Pfizer covid vaccine Aug2021 and experienced a reaction with a lymph node under her arm that resolved with a few days. She complained about the pain under the arm a day later, about the lymph nodes, and it lasted a couple of days and went away. Caller stated her daughter is due for the second dose but isn't sure if she should get it  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got more sick than normal; 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 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03May2021 10:00 (Lot number: EW0164) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Glaucoma" (ongoing), notes: Verbatim: Glaucoma, diagnosed with this condition in her 30's. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Lot Number: ER8732), administration date: 12Apr2021, when the patient was 63 years old, for COVID-19 immunization; Flu (Adverse Event: Feeling a little icky after a flu shot.), reaction(s): "Feeling a little icky". The following information was reported: ILLNESS (non-serious) with onset 03May2021, outcome "recovered", described as "Got more sick than normal". Therapeutic measures were not taken as a result of illness.  Additional Information: The patient's weight (65.77 kg) and height (168 cm) was reported. Patient concomitant medications included antidepressant, anti-anxiety, Glaucoma drops, Heartburn pill (takes this once in a while) and Allergy pill (Start: Unspecified Stop: Unspecified). Patient states that she had the first one and everything was fine.  With the second one she got more sick than normal, stated that she got the second vaccine in the morning, probably around 0800 and started to feel sick that same night. States that she actually probably got the vaccine around 1000.  States she was sick for a long time, probably like a week or so, then recuperated  Now, knowing that the booster dose is something you have to have she was wondering what she should do and states that with how sick she felt after the second one she needs some advice,  The patient denies any labs, testing, or treatments relevant to these events.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Vaccination site pain
Clinical narrative: Swollen lymph nodes in left armpit; a mild headache; Sore Arm at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 16:00 (Lot number: FH8030) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 31Mar2021, when the patient was 43 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 10Mar2021, when the patient was 43 years old, for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 23Nov2021 20:00, outcome "recovering", described as "a mild headache"; VACCINATION SITE PAIN (non-serious) with onset 23Nov2021 20:00, outcome "recovering", described as "Sore Arm at injection site"; LYMPHADENOPATHY (non-serious) with onset 24Nov2021 01:00, outcome "unknown", described as "Swollen lymph nodes in left armpit". Therapeutic measures were not taken as a result of headache, vaccination site pain, lymphadenopathy.  Additional information: Other vaccine in four weeks: No. other medications in two weeks: None. covid prior vaccination: No. covid tested post vaccination: No.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Lymph node pain, Plantar fasciitis
Clinical narrative: painful axial lymph nodes on same side as injection; painful axial lymph nodes on same side as injection; plantar fasciitis flare up; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 12:30 (Lot number: FH8028) at the age of 53 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 Number: 2, Batch/Lot No: ER8737, Location of injection: Arm Left, Vaccine Administration Time: 09:30 AM), administration date: 03Apr2021, when the patient was 53 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6204, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 11Mar2021, when the patient was 53 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Nov2021 12:30, outcome "unknown", described as "booster"; LYMPH NODE PAIN (non-serious), AXILLARY PAIN (non-serious) all with onset 21Nov2021 20:00, outcome "not recovered" and all described as "painful axial lymph nodes on same side as injection"; PLANTAR FASCIITIS (non-serious) with onset 21Nov2021 20:00, outcome "not recovered", described as "plantar fasciitis flare up". Therapeutic measures were not taken as a result of lymph node pain, axillary pain, plantar fasciitis.  Additional information: The most recent COVID-19 vaccine was administered in public health clinic/veterans administration facility. The patient had not received any other vaccine within 4 weeks prior to the covid vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient had No known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site vesicles
Clinical narrative: The blister is gone but a black spot is still there.; blister on left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 (Lot number: EP6955, Expiration Date: Jun2021) at the age of 47 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; CALCIUM. Vaccination history included: Bnt162b2 (First dose: given on 09Mar2021. Lot number: EN6199. Expiry: unknown. NDC: unknown. Given in left arm.), administration date: 09Mar2021, when the patient was 47 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE VESICLES (non-serious) with onset 30Mar2021, outcome "recovered", described as "blister on left arm"; VACCINATION SITE DISCOLOURATION (non-serious), outcome "not recovered", described as "The blister is gone but a black spot is still there.".  Additional Information: Caller stated he took the Pfizer COVID vaccine on 30Mar2021. It was the second dose. He had a blister on left arm. The blister appeared within 1 hour of getting the second dose of the Pfizer COVID vaccine. He got the second dose around 12 PM or 1PM. The blister went away in about 4 or 5 days. Then it became a black spot. The black spot is still there. Today he took the booster shot and they said he needed to call and report it. What does he have to do with the left arm? The black spot is too much. Is there some way for them to send that to his email address? It is looking bad. It has never looked like that. Right now he doesn't know if the booster will do the same. No other vaccines given within 4 weeks except the first dose of the Pfizer COVID vaccine. The patient did not went to emergency room/physician office.  No follow-up attempts are possible. No further information is expected.  Follow-up (30Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Fatigue, Influenza, Influenza A virus test
Clinical narrative: vomiting; fever of 103.2; No appetite; Tired and lethargic/Exhaustion; Tired and lethargic; Positive for flu A; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 15:00 (Lot number: FL0007) at the age of 5 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: FATIGUE (non-serious) with onset 23Nov2021, outcome "recovering", described as "Tired and lethargic/Exhaustion"; LETHARGY (non-serious) with onset 23Nov2021, outcome "recovering", described as "Tired and lethargic"; PYREXIA (non-serious) with onset 23Nov2021 17:00, outcome "recovering", described as "fever of 103.2"; DECREASED APPETITE (non-serious) with onset 23Nov2021, outcome "recovering", described as "No appetite"; VOMITING (non-serious) with onset 24Nov2021 02:30, outcome "recovering", described as "vomiting"; INFLUENZA (non-serious) with onset 23Nov2021, outcome "recovering", described as "Positive for flu A". The events "tired and lethargic/exhaustion", "tired and lethargic", "fever of 103.2", "no appetite", "vomiting" and "positive for flu a" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue, lethargy, pyrexia, decreased appetite, vomiting, influenza.  Additional Information: The patient was tired and lethargic in the morning of 23Nov2021 (day after vaccine). By 5:00 p.m. had a fever of 103.2. No appetite, exhaustion. Went to bed at 6:00 p.m. Awoke at 2:30 a.m. on 24Nov2021 after vomiting. High fever of 102.1. Slept through the rest of the night. Awoke with fever still at 102. Went to pediatrician. No flu shot administered to (name) yet this season.The facility type vaccine was reported as Public Health Clinic/Veterans Administration facility. The patient didn't received any other vaccine in 4 weeks. The patient was not tested positive for Covid prior to vaccination but tested positive post vaccination. No known allergies were reported.  Follow-up attempts are completed. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pyrexia, SARS-CoV-2 antibody test, Vomiting
Clinical narrative: vomiting; fever of 103.2; No appetite; Tired and lethargic/Exhaustion; Tired and lethargic; Positive for flu A; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 15:00 (Lot number: FL0007) at the age of 5 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: FATIGUE (non-serious) with onset 23Nov2021, outcome "recovering", described as "Tired and lethargic/Exhaustion"; LETHARGY (non-serious) with onset 23Nov2021, outcome "recovering", described as "Tired and lethargic"; PYREXIA (non-serious) with onset 23Nov2021 17:00, outcome "recovering", described as "fever of 103.2"; DECREASED APPETITE (non-serious) with onset 23Nov2021, outcome "recovering", described as "No appetite"; VOMITING (non-serious) with onset 24Nov2021 02:30, outcome "recovering", described as "vomiting"; INFLUENZA (non-serious) with onset 23Nov2021, outcome "recovering", described as "Positive for flu A". The events "tired and lethargic/exhaustion", "tired and lethargic", "fever of 103.2", "no appetite", "vomiting" and "positive for flu a" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue, lethargy, pyrexia, decreased appetite, vomiting, influenza.  Additional Information: The patient was tired and lethargic in the morning of 23Nov2021 (day after vaccine). By 5:00 p.m. had a fever of 103.2. No appetite, exhaustion. Went to bed at 6:00 p.m. Awoke at 2:30 a.m. on 24Nov2021 after vomiting. High fever of 102.1. Slept through the rest of the night. Awoke with fever still at 102. Went to pediatrician. No flu shot administered to (name) yet this season.The facility type vaccine was reported as Public Health Clinic/Veterans Administration facility. The patient didn't received any other vaccine in 4 weeks. The patient was not tested positive for Covid prior to vaccination but tested positive post vaccination. No known allergies were reported.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Lymphadenopathy, Pain
Clinical narrative: achy; joints were hurting; had a headache; chills; lymph nodes stayed swollen for a few months; 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 14Jan2021 (Lot number: EK9231) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII, administration date Sep2021. The following information was reported: PAIN (non-serious) with onset 14Jan2021, outcome "recovered" (2021), described as "achy"; ARTHRALGIA (non-serious) with onset 14Jan2021, outcome "recovered" (2021), described as "joints were hurting"; HEADACHE (non-serious) with onset 14Jan2021, outcome "recovered" (2021), described as "had a headache"; CHILLS (non-serious) with onset 14Jan2021, outcome "recovered" (2021), described as "chills"; LYMPHADENOPATHY (non-serious) with onset 14Jan2021, outcome "recovered" (2021), described as "lymph nodes stayed swollen for a few months".  Additional information:  Anatomical Location of Administration of Pfizer vaccine considered as suspect: right arm  Emergency Room was No. Physician Office as no, but had called doctor. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was none within 4 weeks, had flu vaccine in Sep2021. AE(s) following prior vaccinations was none.  No follow-up attempts are possible. No further information is expected.