chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymph node pain, Lymphadenopathy, Vaccination site pain
Clinical narrative: slight soreness on Left bicep at injection site; Third Shot - Swollen and tender lymph nodes on the Left axillary area began 24-30 hours after injection. (same side as injection arm) slight soreness on Left bicep at injection site; Swollen and tender lymph nodes on the Left axillary area began 24-30 hours after injection. (same side as injection arm); Third Shot; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Dec2021 21:30 (Lot number: 33030bd) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included ACCUTANE. No Past drug history included. Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot Number: EM9009, Location of injection: Arm Left, Vaccine Administration Time: 10:00, Left arm completely numb, sore, and unable to move for 24 hours, pain diminished after 72 hours.), administration date: 11Feb2021, for Covid-19 immunization, reaction(s): Left arm completely numb; Bnt162b2 (Dose 1, Batch/Lot Number: el8982, Location of injection: Arm Left, Vaccine Administration Time: 08:00, only slight bruise pain at injection site), administration date: 21Jan2021, for Covid-19 Immunization, reaction(s) pain at injection site. The following information was reported IMMUNISATION (non-serious) with onset 05Dec2021 21:30, outcome unknown, described as Third Shot; VACCINATION SITE PAIN (non-serious) with onset 07Dec2021 06:00, outcome not recovered; LYMPHADENOPATHY (non-serious) with onset 07Dec2021 06:00, outcome not recovered, described as same side as injection arm; LYMPH NODE PAIN (non-serious) with onset 07Dec2021 06:00, outcome not recovered. Therapeutic measures were not taken as a result of vaccination site pain, lymphadenopathy, and lymph node pain.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient reported had not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not tested for COVID-19. Patient had no other symptoms with the dose 3 vaccine.  Follow-up attempts are completed. No further information is expected.   No follow-up attempts are possible. No further information is expected. Linked Report(s) US-PFIZER INC-202101796151 similar report from same reporter; US-PFIZER INC-202101796133 similar report from same reporter.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 35 year-old female patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose 1, single and administration date 2021 (Batch/Lot number: unknown) as dose 2, 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 2021, outcome "unknown", described as "soreness in the arm".  Additional information: Caller was a father reporting that her 35 year old daughter received the booster shot of Pfizer bioNtech covid vaccine 10 months after the primary series. She didn't show much side effects after the first and second dose only some soreness in the arm. But after getting the booster on Friday her arm has been very numb she feels very numb in the fingers and hands were tingling. It has already been 6 days and this feeling doesn't go away.  Follow-up attempts are completed; The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Immunisation, Paraesthesia
Clinical narrative: she got the booster dose, 10 months after her second shot; Arm tingling; fingers are numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 35 year-old female patient 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 (First Dose, She got the first shot and had no problems), for COVID-19 Immunization; Bnt162b2 (Second Dose), for COVID-19 immunization, reaction(s): "little pain in her arm".  The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "she got the booster dose, 10 months after her second shot"; PARAESTHESIA (non-serious), outcome "unknown", described as "Arm tingling"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "fingers are numb".  Additional Information: Consumer (Parent) reported that his daughter (patient) got the first shot and had no problems. The second shot she had a little pain in her arm. On Friday she got the booster dose, 10 months after her second shot. Since Friday her arm has been tingling and her fingers are numb. She called her doctor, but her doctor is not sure what is going on.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101796270 Same patient and drug, different event separated in time
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Pain in extremity, Vaccination site pain
Clinical narrative: a lump under my left arm pit the size of a lemon and also on the left side of my neck by my shoulder; arm pain; pain got better but still has lumps there; booster; 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 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Dec2021 (Lot number: FJ1620) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "UTI" (unspecified if ongoing), notes: was on antibiotics for a previous UTI. The patient took concomitant medications. 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) with onset 12Dec2021, outcome "unknown", described as "booster"; LYMPHADENOPATHY (non-serious) with onset 14Dec2021, outcome "not recovered", described as "a lump under my left arm pit the size of a lemon and also on the left side of my neck by my shoulder"; PAIN IN EXTREMITY (non-serious) with onset 13Dec2021, outcome "recovering", described as "arm pain"; VACCINATION SITE PAIN (non-serious) with onset 13Dec2021, outcome "recovering", described as "pain got better but still has lumps there". Therapeutic measures were taken as a result of lymphadenopathy, pain in extremity, vaccination site pain.  Additional information: Patient stated that she had no issue with the first two doses of the vaccines, product information for first two not provided.  The patient stated that she received her Pfizer BTC vaccine (purple cap formula) booster dose on 12Dec2021 and "then on Tuesday, yesterday, she had a lump under her left arm pit  the size of a lemon and also on the left side of neck by shoulder. Caller stated this lump was soft and felt like it was fluid filled. The patient told pharmacist she had pain, was on antibiotics for a previous UTI, asked pharmacy if she could take tylenol for the pain while on the antibiotics and stated she took two Tylenol and pain got better but still has lumps there.   No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Peripheral swelling
Clinical narrative: significant swelling under her arm, on the arm she got the shot; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 17 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 (Lot number: 3313084) at the age of 17 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: 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 10Dec2021, outcome "unknown", described as "booster"; PERIPHERAL SWELLING (non-serious) with onset 12Dec2021, outcome "recovering", described as "significant swelling under her arm, on the arm she got the shot". Therapeutic measures were taken as a result of peripheral swelling.  Additional information: Patient received the treatment for the event "significant swelling under her arm, on the arm" as Ibuprofen.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Headache, Immunisation, Influenza like illness, Pain in extremity
Clinical narrative: booster; Flu like symptoms; arm pain; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3, booster (single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Unknown manufacturer), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain"; HEADACHE (non-serious), outcome "unknown", described as "headache".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Headache, Influenza like illness
Clinical narrative: booster; Flu like symptoms; arm pain; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3, booster (single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Unknown manufacturer), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain"; HEADACHE (non-serious), outcome "unknown", described as "headache".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: booster; Flu like symptoms; arm pain; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3, booster (single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Unknown manufacturer), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain"; HEADACHE (non-serious), outcome "unknown", described as "headache".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site swelling
Clinical narrative: dose number: 3; Swollen at  the site of injection.; 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) (Lot number: FF2589) 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: EL3247), for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "dose number: 3"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Swollen at  the site of injection."  Follow-Up (21Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Diarrhoea
Clinical narrative: Diarrhea/My diarrhea symptoms are anywhere from 3-8 times per day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Feb2021 (Lot number: EN6203 6121) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing); "High Blood pressure" (unspecified if ongoing), notes: High Blood pressure; "High Cholesterol" (unspecified if ongoing); "Diabetic" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; PROPRANOLOL; LISINOPRIL; OMEPRAZOLE. Past drug history included: Ibuprofen, reaction(s): "Known allergies: Ibuprofen". Vaccination history included: Bnt162b2 (Dose number: 1, lot number: EL9262 5121, vaccine location: Left arm), administration date: 06Feb2021, for COVID-19 immunization, reaction(s): "No adverse effect". The following information was reported: DIARRHOEA (non-serious) with onset 28Aug2021, outcome "not recovered", described as "Diarrhea/My diarrhea symptoms are anywhere from 3-8 times per day". The event "diarrhea/my diarrhea symptoms are anywhere from 3-8 times per day" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of diarrhoea.  Additional information: Patient received dose: 3, lot number: 301358A, vaccine location: Left arm), administration date: 01Oct2021, for COVID-19 immunization.The patient did not  receive any other vaccines within 4 weeks prior to the COVID vaccine. I did not have adverse effects from either of the first two doses of the Covid vaccines. Diarrhea has continued even after my booster shot (3rd overall shot). Prior to vaccination, the patient was not diagnosed with COVID-19.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: schedule today as her 2nd Pediatric dose; one person tested COVID positive; they need to quarantine for 10 days; I told him not to send him in today; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) for a Pfizer sponsored program (159558).  A female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Lot number: FL0007) 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: EXPOSURE TO SARS-COV-2 (non-serious), outcome "unknown", described as "schedule today as her 2nd Pediatric dose; one person tested COVID positive; they need to quarantine for 10 days; I told him not to send him in today".  Additional information- Transferring agent stated that, They have a caller on other line, she is a pharmacist, who has a patient who is supposed to get the 2nd dose today but the patient's school send them home since another kid tested positive (Further clarifications unknown) but the patient is not showing any symptoms. When asked if Pharmacist wants to report or had medical query, Pharmacist stated, the dad calling us her daughter, his daughter has schedule today as her 2nd Pediatric dose, its been three week so today was her 2nd dose however today she was send home from school, her school he thought its like whole classroom or something either whole classroom or the whole school he was not sure like one person tested COVID positive (Further clarifications unknown) and so they send them home and they need to quarantine for 10 days, he said that she doesn't have any sign of the symptoms (Further clarifications unknown).
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Immunisation
Clinical narrative: booster; joint pain; fatigue; felt run down a little; 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 48-year-old female patient received bnt162b2 (BNT162B2), administration date 14Dec2021 (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), for Covid-19 immunization; Bnt162b2 (Dose=2), for Covid-19 immunization; Flu shot (she felt unwell after receiving her flu shot), reaction(s): "felt unwell". The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021, outcome "unknown", described as "booster"; ARTHRALGIA (non-serious) with onset Dec2021, outcome "unknown", described as "joint pain"; FATIGUE (non-serious) with onset Dec2021, outcome "unknown", described as "fatigue"; ASTHENIA (non-serious) with onset Dec2021, outcome "unknown", described as "felt run down a little".  Additional information: 48-year-old female consumer said she and her 48-year-old husband received the booster dose of the Pfizer-BioNTech Covid-19 Vaccine on Tuesday afternoon. She said she personally had mild joint pain, fatigue, and felt run down. Her husband, on the other hand, had more severe symptoms such as pain, fatigue, pain at the injection site, and under his arm. She said his underarms were swollen. She said she is more concerned about the pain and swelling under her husband's arm. Consumer wants to know if they should be concerned about this, if this has been reported before, and if this is a common side effect of the booster dose. She also said that her husband also got a little sick yesterday (just like how she felt unwell after receiving her flu shot), and today he still feels run down. Reason for no lot number: of third dose of the Pfizer covid vaccine: Caller unwilling to complete the report. The report is cross referenced to report ID: The caller was calling regarding her husband; they both got the booster shot Tuesday afternoon. Yesterday both of them had side effects. The caller had milder side effects- joint pain, fatigue, and felt run down a little. The caller clarifies and confirms that she is talking about the third dose of the Pfizer covid vaccine when she says booster dose. They had the listed effects that you could have. The caller and the patient didn't have any side effects outside of the 4-5 common side effects that you have after the booster.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Immunisation, Myalgia
Clinical narrative: Hives all over body; nausea; joints and muscles aches; joints and muscles aches; headache; dizziness; dose received 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 53 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Dec2021 10:45 (Lot number: FF8839) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: BENADRYL. Vaccination history included: Bnt162b2 (Dose Number: 2, previous dose details, prev dos product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: EP6955, prev dose lot unknown: False, prev dose administrator route: Intra muscular, prev dose administration date: 14Apr2021, prev dose dose number: 2, prev dose vaccine location: Left arm), administration date: 14Apr2021, when the patient was 53 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: EP6955, prev dose lot unknown: False, prev dose administrator route: Intra muscular, prev dose administration date: 24Mar2021, prev dose dose number: 1, prev dose vaccine location: Left arm), administration date: 24Mar2021, when the patient was 53 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 10:45, outcome "unknown", described as "dose received 3"; URTICARIA (non-serious) with onset 15Dec2021 23:30, outcome "unknown", described as "Hives all over body"; NAUSEA (non-serious) with onset 15Dec2021 23:30, outcome "unknown", described as "nausea"; ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset 15Dec2021 23:30, outcome "unknown" and all described as "joints and muscles aches"; HEADACHE (non-serious) with onset 15Dec2021 23:30, outcome "unknown", described as "headache"; DIZZINESS (non-serious) with onset 15Dec2021 23:30, outcome "unknown", described as "dizziness". The events "hives all over body", "nausea", "joints and muscles aches", "joints and muscles aches", "headache" and "dizziness" were evaluated at the emergency room visit. It was unknown if therapeutic measures were taken as a result of urticaria, nausea, arthralgia, myalgia, headache, dizziness.  Additional information: Reportedly, no other vaccine were administered in four weeks. Known allergies were reported as none. The patient did not have covid prior vaccination. The patient was not covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Urticaria
Clinical narrative: Hives all over body; nausea; joints and muscles aches; joints and muscles aches; headache; dizziness; dose received 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 53 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Dec2021 10:45 (Lot number: FF8839) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: BENADRYL. Vaccination history included: Bnt162b2 (Dose Number: 2, previous dose details, prev dos product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: EP6955, prev dose lot unknown: False, prev dose administrator route: Intra muscular, prev dose administration date: 14Apr2021, prev dose dose number: 2, prev dose vaccine location: Left arm), administration date: 14Apr2021, when the patient was 53 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: EP6955, prev dose lot unknown: False, prev dose administrator route: Intra muscular, prev dose administration date: 24Mar2021, prev dose dose number: 1, prev dose vaccine location: Left arm), administration date: 24Mar2021, when the patient was 53 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 10:45, outcome "unknown", described as "dose received 3"; URTICARIA (non-serious) with onset 15Dec2021 23:30, outcome "unknown", described as "Hives all over body"; NAUSEA (non-serious) with onset 15Dec2021 23:30, outcome "unknown", described as "nausea"; ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset 15Dec2021 23:30, outcome "unknown" and all described as "joints and muscles aches"; HEADACHE (non-serious) with onset 15Dec2021 23:30, outcome "unknown", described as "headache"; DIZZINESS (non-serious) with onset 15Dec2021 23:30, outcome "unknown", described as "dizziness". The events "hives all over body", "nausea", "joints and muscles aches", "joints and muscles aches", "headache" and "dizziness" were evaluated at the emergency room visit. It was unknown if therapeutic measures were taken as a result of urticaria, nausea, arthralgia, myalgia, headache, dizziness.  Additional information: Reportedly, no other vaccine were administered in four weeks. Known allergies were reported as none. The patient did not have covid prior vaccination. The patient was not covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Immunisation
Clinical narrative: Booster; 6 patients received the Pfizer COVID-19 vaccine adult formulation (purple cap)- booster dose past the expiry date; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program.  A 75 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 10Dec2021 10:00 (Lot number: FE3592, Expiration Date: 03Dec2021) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Lot: Unknown, Expiry: Unknown, NDC: Unknown), administration date: 05Feb2021, when the patient was 74 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2, Lot: Unknown, Expiry: Unknown, NDC: Unknown), administration date: 25Feb2021, when the patient was 74 years old, for COVID-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 10Dec2021 10:00, outcome "unknown", described as "Booster"; EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 10Dec2021 10:00, outcome "unknown", described as "6 patients received the Pfizer COVID-19 vaccine adult formulation (purple cap)- booster dose past the expiry date".  Additional Information: This report is for patient 1 of 6. Patient received the vaccine on 10Dec2021 as a booster dose; expiration date was 03Dec2021. A contactable other Hcp reported similar events for six patients. This is 1st of 6 reports. This other HCP reported for a patient stated 6 doses of the booster Pfizer Covid vaccine was given out of expiration date, for the purple The patient did not visit Emergency Room or Physician Office. The patient was not hospitalized. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 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): None, prior vaccinations: None, Patient's Medical History, Family Medical History Relevant, Relevant Tests: none.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101806366 same reporter/drug/AE with different patient.;US-PFIZER INC-202101806368 same reporter/drug/AE with different patient;US-PFIZER INC-202101806367 same reporter/drug/AE with different patient;US-PFIZER INC-202101806369 same reporter/drug/AE with different patient;US-PFIZER INC-202101806370 same reporter/drug/AE with different patient
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Condition aggravated, Discomfort, Headache, Immunisation
Clinical narrative: booster; pain from the booster dose; felling congested, not well; felling congested, not well; discomfort; running nose; lethargic; headaches; more uncomfortable pain; 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 68 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "chronic pain" (unspecified if ongoing), notes: she has chronic pain from her mid-30s diagnosed with fibromyalgia; "fibromyalgia" (unspecified if ongoing), notes: she has chronic pain from her mid-30s diagnosed with fibromyalgia. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; PAIN (non-serious), outcome "unknown", described as "pain from the booster dose"; NASAL CONGESTION (non-serious), MALAISE (non-serious), outcome "unknown" and all described as "felling congested, not well"; DISCOMFORT (non-serious), outcome "unknown", described as "discomfort"; RHINORRHOEA (non-serious), outcome "unknown", described as "running nose"; LETHARGY (non-serious), outcome "unknown", described as "lethargic"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "more uncomfortable pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain.  additional information: Caller said that she had no symptoms with the first 2 doses.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Lethargy, Malaise, Nasal congestion, Pain
Clinical narrative: booster; pain from the booster dose; felling congested, not well; felling congested, not well; discomfort; running nose; lethargic; headaches; more uncomfortable pain; 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 68 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "chronic pain" (unspecified if ongoing), notes: she has chronic pain from her mid-30s diagnosed with fibromyalgia; "fibromyalgia" (unspecified if ongoing), notes: she has chronic pain from her mid-30s diagnosed with fibromyalgia. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; PAIN (non-serious), outcome "unknown", described as "pain from the booster dose"; NASAL CONGESTION (non-serious), MALAISE (non-serious), outcome "unknown" and all described as "felling congested, not well"; DISCOMFORT (non-serious), outcome "unknown", described as "discomfort"; RHINORRHOEA (non-serious), outcome "unknown", described as "running nose"; LETHARGY (non-serious), outcome "unknown", described as "lethargic"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "more uncomfortable pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain.  additional information: Caller said that she had no symptoms with the first 2 doses.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: booster; pain from the booster dose; felling congested, not well; felling congested, not well; discomfort; running nose; lethargic; headaches; more uncomfortable pain; 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 68 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "chronic pain" (unspecified if ongoing), notes: she has chronic pain from her mid-30s diagnosed with fibromyalgia; "fibromyalgia" (unspecified if ongoing), notes: she has chronic pain from her mid-30s diagnosed with fibromyalgia. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; PAIN (non-serious), outcome "unknown", described as "pain from the booster dose"; NASAL CONGESTION (non-serious), MALAISE (non-serious), outcome "unknown" and all described as "felling congested, not well"; DISCOMFORT (non-serious), outcome "unknown", described as "discomfort"; RHINORRHOEA (non-serious), outcome "unknown", described as "running nose"; LETHARGY (non-serious), outcome "unknown", described as "lethargic"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "more uncomfortable pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain.  additional information: Caller said that she had no symptoms with the first 2 doses.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation, Lymphadenopathy, Pain in extremity
Clinical narrative: swollen lymph nodes in his left armpit; sore shoulder; arm and shoulder soreness; booster Pfizer Biontech COVID-19 shot; 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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Dec2021 (Lot number: FJ8762) 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 (First Dose: 21Apr2021 , Lot: Unknown), administration date: 21Apr2021, for Covid-19 immunization, reaction(s): "Arm and Shoulder Soreness", "Arm and Shoulder Soreness"; Bnt162b2 (Second Dose: 18May2021 , Lot: Unknown), administration date: 18May2021, for Covid-19 immunization, reaction(s): "Arm and Shoulder Soreness", "Arm and Shoulder Soreness", "Knocked him out the day after, it felt like a bad case of the flu and lasted that day and the next day he felt 50% better and the next day 80-90% better and then he was fine". The following information was reported: IMMUNISATION (non-serious) with onset 13Dec2021, outcome "unknown", described as "booster Pfizer Biontech COVID-19 shot"; LYMPHADENOPATHY (non-serious) with onset 15Dec2021, outcome "recovering", described as "swollen lymph nodes in his left armpit"; ARTHRALGIA (non-serious) with onset 14Dec2021, outcome "recovered" (16Dec2021), described as "sore shoulder"; PAIN IN EXTREMITY (non-serious) with onset 14Dec2021, outcome "recovered" (16Dec2021), described as "arm and shoulder soreness". Therapeutic measures were taken as a result of immunisation, lymphadenopathy, arthralgia, pain in extremity.  Additional information: The patient had sore shoulder that had already gone away and wanted to know how long would the side effects last. NDC number and expiry date was unknown. There were no other products and no investigation assessments done. The age and age at vaccination was over 50 years-old. The patient got his shot on Monday, 13Dec2021 and his shoulder was sore Tuesday, and he noticed the swollen lymph nodes in his arm pit the next day. The arm and shoulder soreness was just like the other 2 times, it last for 2 days. The patient was treated with Advil and stated that it was basically sore to the touch, if he was not touching it, there was no pain, but if he moved the muscles a certain way, he felt it. There were no additional vaccine administered on same date of the pfizer suspect. The time of onset of the adverse event was the next day. There was no emergency or physician office visit for any adverse event. The patient did not take any vaccinations within 4 weeks. There was no family medical history or relevant tests done.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101807340 same patient/drug, different AE and dose.;US-PFIZER INC-202101807341 same patient/drug, different AE and dose.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Illness, Immunisation, Peripheral swelling
Clinical narrative: booster; sick from the vaccine; redness of the arm; arm is still swollen and red; The lot number for bnt162b2 was not provided and will be requested during follow up. This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 77 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Dec2021 13:30 (Batch/Lot number: unknown) at the age of 77 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, lotno:ER8733), for Covid-19 Immunization; Bnt162b2 (dose:2, lot no:EWO162), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; ERYTHEMA (non-serious) with onset 13Dec2021, outcome "not recovered", described as "redness of the arm"; PERIPHERAL SWELLING (non-serious) with onset 13Dec2021, outcome "not recovered", described as "arm is still swollen and red"; ILLNESS (non-serious), outcome "not recovered", described as "sick from the vaccine ".  Additional information: The patient's sister called to know if this is a normal side. The patient has had swelling and redness of the arm from day 1 until today which is 16Dec2021 and it has been 4 days. The patient's sister stated that she herself was going to get the booster vaccine because it has been 8 months for the caller but is not getting it if this is what happens and stats she has heard stories about the booster that are not good. The reporter stated Pfizer Booster vaccine was administered to the patient's right arm and that is the same arm with the reported events; states the symptoms began right away and the patient was in bed the next day and was sick from the vaccine and that is ongoing and the same as when it began regarding the redness and swelling of her right arm. The reporter stated the patient has been using ice on the arm. Caller stated she had to get her glasses on to read the patient's vaccine card and does not know if the patient got her vaccines before or after the caller herself and does not remember and thinks it was after the caller and took a photo of the card.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Pain in extremity
Clinical narrative: booster; Tiredness; arm soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 34 year-old male patient 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: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness". 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: Asthenia, Dizziness, Seizure
Clinical narrative: Seizure, dizziness, weakness
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Both joint muscle in my thumbs ached
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Discomfort, Headache, Lymphadenopathy
Clinical narrative: Extremely sore arm, swollen lymph nodes in arm, neck on side of shot and through out body, fever, chills, headache, pressure in face
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Extremely sore arm, swollen lymph nodes in arm, neck on side of shot and through out body, fever, chills, headache, pressure in face
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Patients arm  was itching.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia areata
Clinical narrative: Developed alopecia areata around end of aug 2021 for the first time. There is no family history or previous history of this condition. Have been treated with monthly steroid injection since nov 2021, yet the affected area keeps growing.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Gait inability, Motor dysfunction, Muscle spasms, Pain
Clinical narrative: Severe rigors, to which I suspected I was having a seizure (first time in my life). Loss of motor function and shaking so vigorously that I experienced moderate-to-severe cramping in my neck, lower back, and hips. Unable to walk, difficulty speaking. Blacking out in peripheral vision (experiencing tunnel vision). Was in process of calling an ambulance, but after approximately 5 minutes, symptoms subsided. The following morning, I was sore, but largely asymptomatic.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure, Speech disorder, Tremor, Tunnel vision
Clinical narrative: Severe rigors, to which I suspected I was having a seizure (first time in my life). Loss of motor function and shaking so vigorously that I experienced moderate-to-severe cramping in my neck, lower back, and hips. Unable to walk, difficulty speaking. Blacking out in peripheral vision (experiencing tunnel vision). Was in process of calling an ambulance, but after approximately 5 minutes, symptoms subsided. The following morning, I was sore, but largely asymptomatic.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Arthralgia, Back pain, Dysphagia, Neck pain
Clinical narrative: Difficulty swallowing, pain in the left neck, left shoulder, left hand, left lower quadrant, across lower back and left knee
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Difficulty swallowing, pain in the left neck, left shoulder, left hand, left lower quadrant, across lower back and left knee
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event observed after 15 minute of injection.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cerebral palsy, Dyspnoea, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Covid19 breakthrough.  1st vaccine received on 03/02/2021.  84 y/o with PMHX of AS,CHF,Pacemaker, DM, COPD, HTN, HLD, mod AS, Pulm emboli/dvt presents with 4 day hx of CP and worsening SOB.  Started on low dose steroids.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Myalgia, Neck pain
Clinical narrative: First started getting chills at 9 PM on the day I received the vaccine. I was running a low grade fever as well. The next morning I was feeling muscle soreness/aches, neck pain, head pain, and my left lymph node under my armpit was swollen. The following day I had a headache and the swollen lymph node persisted. The following day, only the swollen lymph node persisted. It is currently 5 days since my vaccination and the only remaining symptom is my swollen lymph node, although the swelling has decreased each day slowly. I did not take any medication to alleviate the symptoms.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: First started getting chills at 9 PM on the day I received the vaccine. I was running a low grade fever as well. The next morning I was feeling muscle soreness/aches, neck pain, head pain, and my left lymph node under my armpit was swollen. The following day I had a headache and the swollen lymph node persisted. The following day, only the swollen lymph node persisted. It is currently 5 days since my vaccination and the only remaining symptom is my swollen lymph node, although the swelling has decreased each day slowly. I did not take any medication to alleviate the symptoms.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Severe arm pain, fever over 100 degrees
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in right ear started just days after receiving the Pfizer booster.  The tinnitus has become progressively worst, lasting most of the day, every day.  I never had this problem before.  I do not have high blood pressure or any other medical issues. I am normal weight. I received the first two Pfizer vaccines at the clinic  on 19 Mar 2021 and 9 Apr 2021. The booster I received at the pharmacy locally.  I received a flu vaccine in early Oct 2021 (don't recall the date) at the same clinic.  I never had any adverse reactions to the flu vaccine in all my years of getting it.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Headache, Immunisation, Pain in extremity
Clinical narrative: booster; tiredness; Elevated temperature (100.4); arm soreness; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 31-year-old female patient 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: Covid-19 vaccine (Dose 1 Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2 Unknown Manufacturer), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021, outcome "unknown", described as "booster"; FATIGUE (non-serious) with onset 16Dec2021, outcome "unknown", described as "tiredness"; PYREXIA (non-serious) with onset 16Dec2021, outcome "unknown", described as "Elevated temperature (100.4)"; PAIN IN EXTREMITY (non-serious) with onset 16Dec2021, outcome "unknown", described as "arm soreness"; HEADACHE (non-serious) with onset 16Dec2021, outcome "unknown", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.