chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Pain in extremity, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: 0.3mL dose of the vaccine was given to a 9-year old patient; 0.3mL dose of the vaccine was given to a 9-year old patient; Low grade fever; Sore arm; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program.  A 9 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Feb2022 (Lot number: FL3209, Expiration Date: Jun2022) at the age of 9 years as dose 1 (tris), 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 04Feb2022, outcome "unknown" and all described as "0.3mL dose of the vaccine was given to a 9-year old patient"; PYREXIA (non-serious) with onset Feb2022, outcome "unknown", described as "Low grade fever"; PAIN IN EXTREMITY (non-serious) with onset Feb2022, outcome "unknown", described as "Sore arm". No follow-up attempts are possible. No further information is expected.  Additional information:  Caller was calling regarding the Pfizer covid 19 purple cap vaccine. Caller stated that a 0.3mL dose of the vaccine was given to a 9-year old patient last Friday, 04Feb2022. Caller was asking if there was information on how long to wait to give the second dose, or if a second dose was still needed. Caller was asking if there would be any complication that would arise from the patient have a higher-than-authorized dose?  Follow-up (08Feb2022, 09Feb2022): This is a follow-up spontaneous report from a Pfizer sponsored program. A contactable pharmacist reported for a 9-year-old female patient that: Updated information: New reporter was added. Patient initials, DOB, age, ethnicity was added. Relevant medical history was added. Vaccination start, stop date, lot number, expiry date, anatomical location was added. Events was added. Concomitant therapy was added.  Details: NDC number of Covid vaccine: 59267-1000-1. No investigation assessment. Patient height and weight was unknown.Caller states this dose was given to the patient on 04Feb2021, wants to know when the patient should get her second dose. States she called to check on the patient, states she just has a low grade fever and sore arm from the shot that was reported to the caller by her parents but states she is fine other than that. Email address is confirmed with the caller.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Urticaria
Clinical narrative: his lips swelled up almost three times the normal; he had welts all over; 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 parent.  A 9 year-old male patient received bnt162b2 (BNT162B2), administration date 07Feb2022 (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: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: LIP SWELLING (non-serious) with onset 07Feb2022, outcome "not recovered", described as "his lips swelled up almost three times the normal"; URTICARIA (non-serious) with onset 07Feb2022, outcome "unknown", described as "he had welts all over". The events "his lips swelled up almost three times the normal" and "he had welts all over" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of lip swelling, urticaria. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: Patient received the second dose yesterday of the vaccine. Reporter wanted to advise that 2 hours after the vaccine his lips swelled up almost three times the normal size and he had welts all over. This did not happen with the first vaccine. We took him to urgent care and they gave him a steroid. Today he is still swollen in those areas. Can you advise what are components of the vaccine? We need to get in contact with his pediatrician with the information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (15Mar2022): 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: M
Vaccine: COVID19
Symptoms: Fatigue, Product administered to patient of inappropriate age
Clinical narrative: Tired; received the wrong dosage of my booster shot. I got a juvenille dosage; 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 74 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 31Jan2022 10:00 (Batch/Lot number: unknown) as dose 3 (booster) (tris), single for covid-19 immunisation; bnt162b2 (BNT162B2), administration date 02Feb2022 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes # 2", start date: 2015 (ongoing), notes: Ongoing; "Kidney stones", start date: 2007 (ongoing), notes: Ongoing. Concomitant medication(s) included: TAMSULOSIN, start date: 2015 (ongoing); FINASTERIDE, start date: 2015 (ongoing); EMPAGLIFLOZIN taken for diabetes mellitus, start date: 2021 (ongoing). Vaccination history included: Covid-19 vaccine (Dose:1, Time:11:00 EST, Anatomical location of injection: left shoulder, Batch/ Lot No: EM9809), administration date: 17Feb2021, when the patient was 74 years old, for COVID-19 immunization; Bnt162b2 (Dose:2, Anatomical location of injection: left shoulder, Batch/ Lot No: EN6199), administration date: 10Mar2021, when the patient was 74 years old, for COVID-19 Immunization. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 31Jan2022 10:00, outcome "unknown", described as "received the wrong dosage of my booster shot. I got a juvenille dosage ; FATIGUE (non-serious) with onset 01Feb2022, outcome "unknown", described as "Tired".  Additional information: Patient received the wrong dosage of booster shot, got a juvenille dosage. Patient was notified of the error and 2 days later got the adult dosage. Patient enquires if there is anything I should be concerned about because of the extra dosage.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever; Chills; Body aches; Joint pain; Headache very severe; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Feb2022 15:45 (Lot number: 33130BA) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing); "Chronic pain" (unspecified if ongoing); "depression" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose number=2, product=COVID 19, brand=Pfizer, lot number=EW0180, administration date=23Jun2021, vaccine location=Left arm), administration date: 23Jun2021, when the patient was 61 years old, for COVID-19 immunization; Bnt162b2 (Dose number=1, product=COVID 19, brand=Pfizer, lot number=EW0167, administration date=09May2021, vaccine location=Left arm), administration date: 09May2021, when the patient was 61 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 09Feb2022, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 09Feb2022, outcome "recovering", described as "Chills"; PAIN (non-serious) with onset 09Feb2022, outcome "recovering", described as "Body aches"; ARTHRALGIA (non-serious) with onset 09Feb2022, outcome "recovering", described as "Joint pain"; HEADACHE (non-serious) with onset 09Feb2022, outcome "recovering", described as "Headache very severe". Therapeutic measures were not taken as a result of pyrexia, chills, pain, arthralgia, headache.  Additional information: No other vaccine in four weeks, Patient took other medications in two weeks, Patient was not diagnosed with COVID prior vaccination, Patient was not tested for COVID post vaccination and No Known allergies.  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: Pain, SARS-CoV-2 test
Clinical narrative: Right side lower pain ever since. It comes and goes very frequently; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 27 year-old female patient (not pregnant) received BNT162b2 (BNT162B2), administered in arm left, administration date 26Oct2021 (Lot number: 301558A) at the age of 27 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "cherry allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 27Oct2021, outcome "not recovered", described as "Right side lower pain ever since. It comes and goes very frequently". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain. Additional information: The first dose of Pfizer COVID-19 vaccine (Batch/Lot No: FJ1611) was reported as administered on 17Nov2021 02:00PM in arm. The second dose of Pfizer COVID-19 vaccine  (Batch/Lot No: 301558A) was reported as administered on 26Oct2021 in left arm. The case was reported as non-serious. It was reported as not resulting in death, no life threatening, not causing/ prolonging hospitalization, no disabling/ incapacitation or no congenital anomaly/ birth defect.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Diarrhoea, Joint stiffness
Clinical narrative: diahrea; Fever up to 102; uncontrollable chills; muscle aches and contraction; muscle aches and contraction; joint aches and stiffness; joint aches and stiffness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Feb2022 12:15 (Lot number: FM0698) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Psoriatic Arthritis" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: COSENTYX; CITALOPRAM; AMLODIPINE BESYLATE; ROPINIR. Past drug history included: Iodine, reaction(s): "known allergies: iodine". Vaccination history included: Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose brand unknown=False, Prev dose lot number=EW0170, Prev dose lot unknown=False, Prev dose administration date=01Jul2021, Prev dose number=2, Prev dose vaccine location=Left arm), administration date: 01Jun2021, when the patient was 49 years old, for COVID-19 immunization; Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose brand unknown=False, Prev dose lot number=EW0170, Prev dose lot unknown=False, Prev dose administration date= 11May2021, Prev dose number=1, Prev dose vaccine location=Left arm), administration date: 11May2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 12Feb2022 22:00, outcome "not recovered", described as "diahrea"; PYREXIA (non-serious) with onset 12Feb2022 22:00, outcome "not recovered", described as "Fever up to 102"; CHILLS (non-serious) with onset 12Feb2022 22:00, outcome "not recovered", described as "uncontrollable chills"; MYALGIA (non-serious), MUSCLE CONTRACTIONS INVOLUNTARY (non-serious) all with onset 12Feb2022 22:00, outcome "not recovered" and all described as "muscle aches and contraction"; ARTHRALGIA (non-serious), JOINT STIFFNESS (non-serious) all with onset 12Feb2022 22:00, outcome "not recovered" and all described as "joint aches and stiffness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of diarrhoea, pyrexia, chills, myalgia, muscle contractions involuntary, arthralgia, joint stiffness. No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle contractions involuntary, Myalgia, Pyrexia
Clinical narrative: diahrea; Fever up to 102; uncontrollable chills; muscle aches and contraction; muscle aches and contraction; joint aches and stiffness; joint aches and stiffness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Feb2022 12:15 (Lot number: FM0698) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Psoriatic Arthritis" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: COSENTYX; CITALOPRAM; AMLODIPINE BESYLATE; ROPINIR. Past drug history included: Iodine, reaction(s): "known allergies: iodine". Vaccination history included: Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose brand unknown=False, Prev dose lot number=EW0170, Prev dose lot unknown=False, Prev dose administration date=01Jul2021, Prev dose number=2, Prev dose vaccine location=Left arm), administration date: 01Jun2021, when the patient was 49 years old, for COVID-19 immunization; Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose brand unknown=False, Prev dose lot number=EW0170, Prev dose lot unknown=False, Prev dose administration date= 11May2021, Prev dose number=1, Prev dose vaccine location=Left arm), administration date: 11May2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 12Feb2022 22:00, outcome "not recovered", described as "diahrea"; PYREXIA (non-serious) with onset 12Feb2022 22:00, outcome "not recovered", described as "Fever up to 102"; CHILLS (non-serious) with onset 12Feb2022 22:00, outcome "not recovered", described as "uncontrollable chills"; MYALGIA (non-serious), MUSCLE CONTRACTIONS INVOLUNTARY (non-serious) all with onset 12Feb2022 22:00, outcome "not recovered" and all described as "muscle aches and contraction"; ARTHRALGIA (non-serious), JOINT STIFFNESS (non-serious) all with onset 12Feb2022 22:00, outcome "not recovered" and all described as "joint aches and stiffness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of diarrhoea, pyrexia, chills, myalgia, muscle contractions involuntary, arthralgia, joint stiffness. No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Condition aggravated, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; pain/soreness getting progressively worse for 4 days; the felt internal hives; burning sensation and felt like every nerve in my body was on fire for 3 days; soreness getting progressively worse for 4 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01May2021 09:00 (Lot number: EW0173) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies:Penicillin" (unspecified if ongoing); "history of Atrial fib" (unspecified if ongoing), notes: history of Atrial fib; "seizure disorder" (unspecified if ongoing), notes: seizure disorder -- 32 years seizure free. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine; Biaxin, reaction(s): "Known allergies: Biaxin", notes: Known allergies: Biaxin. The following information was reported: PYREXIA (non-serious) with onset 01May2021 09:00, outcome "recovered" (May2021), described as "fever"; PAIN (non-serious) with onset 01May2021 09:00, outcome "recovered" (May2021), described as "pain/soreness getting progressively worse for 4 days"; URTICARIA (non-serious) with onset 01May2021 09:00, outcome "recovered" (May2021), described as "the felt internal hives"; BURNING SENSATION (non-serious) with onset 01May2021 09:00, outcome "recovered" (May2021), described as "burning sensation and felt like every nerve in my body was on fire for 3 days"; CONDITION AGGRAVATED (non-serious) with onset 01May2021 09:00, outcome "recovered" (May2021), described as "soreness getting progressively worse for 4 days". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain, urticaria, burning sensation, condition aggravated. Additional information: The patient did not receive any other vaccine within 4 weeks prior to covid vaccine. The patient did not receive any other medication within 2 weeks prior to covid vaccine. Prior to vaccination the patient was not diagnosed with covid-19. Since vaccination the patient has not been tested for Covid-19. No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: fever; pain/soreness getting progressively worse for 4 days; the felt internal hives; burning sensation and felt like every nerve in my body was on fire for 3 days; soreness getting progressively worse for 4 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01May2021 09:00 (Lot number: EW0173) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies:Penicillin" (unspecified if ongoing); "history of Atrial fib" (unspecified if ongoing), notes: history of Atrial fib; "seizure disorder" (unspecified if ongoing), notes: seizure disorder -- 32 years seizure free. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine; Biaxin, reaction(s): "Known allergies: Biaxin", notes: Known allergies: Biaxin. The following information was reported: PYREXIA (non-serious) with onset 01May2021 09:00, outcome "recovered" (May2021), described as "fever"; PAIN (non-serious) with onset 01May2021 09:00, outcome "recovered" (May2021), described as "pain/soreness getting progressively worse for 4 days"; URTICARIA (non-serious) with onset 01May2021 09:00, outcome "recovered" (May2021), described as "the felt internal hives"; BURNING SENSATION (non-serious) with onset 01May2021 09:00, outcome "recovered" (May2021), described as "burning sensation and felt like every nerve in my body was on fire for 3 days"; CONDITION AGGRAVATED (non-serious) with onset 01May2021 09:00, outcome "recovered" (May2021), described as "soreness getting progressively worse for 4 days". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain, urticaria, burning sensation, condition aggravated. Additional information: The patient did not receive any other vaccine within 4 weeks prior to covid vaccine. The patient did not receive any other medication within 2 weeks prior to covid vaccine. Prior to vaccination the patient was not diagnosed with covid-19. Since vaccination the patient has not been tested for Covid-19. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral, SARS-CoV-2 test, Swelling
Clinical narrative: swollen left armpit; swollen left FOREARM; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2022 10:45 (Lot number: FL3209) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER0732, Location of injection: Arm Left, Vaccine Administration Time: 03:15 PM), administration date: 25Mar2021, for COVID-19 immunization, reaction(s): "Inappropriate schedule of vaccine administered"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EM9809, Location of injection: Arm Left, Vaccine Administration Time: 05:30 PM), administration date: 02Feb2021, for COVID-19 immunization. The following information was reported: SWELLING (non-serious) with onset 05Jan2022, outcome "recovered", described as "swollen left armpit"; OEDEMA PERIPHERAL (non-serious) with onset 05Jan2022, outcome "not recovered", described as "swollen left FOREARM". The events "swollen left armpit" and "swollen left forearm" were 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 swelling, oedema peripheral. Additional information  No other vaccine in four weeks, No Other vaccine in two weeks. No covid prior vaccination. The swollen armpit subsided, the left forearm has not even after 40 days since the covid booster.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: sweet & salty taste on my tongue; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 15Nov2021 (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: DYSGEUSIA (non-serious) with onset 2021, outcome "unknown", described as "sweet & salty taste on my tongue".  Additional information: the patient received the Pfizer COVID vaccine on 15Nov2021. Beginning the day after, the patient had a sweet & salty taste on tongue/in mouth ever since. The patient no longer drunk water due to the awful taste in mouth and have had to turn to unhealthy alternatives (soda) to get liquids in.  The lot number for bnt162b2 was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea
Clinical narrative: her cycle has been stretching over a period of up to Two months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 28Oct2021 (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; MANUFACTUERER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for Covid-19 Immunization. The following information was reported: OLIGOMENORRHOEA (non-serious), outcome "unknown", described as "her cycle has been stretching over a period of up to Two months". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Swelling
Clinical narrative: swollen lymphnodes after booster dose/ left chain auxiliary lymph swelling;  significant pain and swelling in left supraclavicular node;  significant pain and swelling in left supraclavicular node; This is a spontaneous report received from contactable reporter(s) (Pharmacist and Consumer or other non HCP).  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Dec2021 15:00 (Lot number: FS1620) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Time: 07:35 AM, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot Number: EL3248), administration date: 27Jan2021, when the patient was 38 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Time: 07:45 AM, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot Number: EN6200), administration date: 17Feb2021, when the patient was 38 years old, for COVID-19 immunization; Flu vaccine (Route: IM, Anatomical site of injection: Left arm), administration date: 21Nov2021, when the patient was 39 years old, for immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 23Dec2021, outcome "recovered", described as "swollen lymphnodes after booster dose/ left chain auxiliary lymph swelling"; PAIN (non-serious), SWELLING (non-serious) all with onset 23Dec2021, outcome "recovered" and all described as " significant pain and swelling in left supraclavicular node". Therapeutic measures were not taken as a result of lymphadenopathy. Additional information  Patient provide information to HCP regarding the reported event(s) with the use of product. HCP considered the Pfizer product had a casual effect to the adverse event. No Relevant Test. No Specific relevant test for thromboembolic events with thrombocytopenia.  Comments/Narrative: 1 day after injection significant pain and swelling in left supraclavicular node that persisted for 10 days with desending left chain auxiliary lymph swelling 3-4 days' post injection but resolved in 1-2 days.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Chills, Headache, Nausea
Clinical narrative: Severe body aches; Severe headache; Fever  highest 103.2; Shaking chills; Shaking chills; Nausea; Stomach pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Feb2022 10:30 (Batch/Lot number: unknown) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "arthritis" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "I was diagnosed with Covid 19", start date: 28Dec2020 (unspecified if ongoing), notes: I was diagnosed with Covid 19 28Dec2020. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, dose administration time: 12:00 PM, dose vaccine location: Left arm, dose product: COVID 19, dose brand: Pfizer, dose lot unknown reason: Unable to locate or read the details), administration date: 01Apr2021, when the patient was 51 years old, for Covid-19 immunization, reaction(s): "Dosage 1: 14Mar2020, Dosage 2: 01Apr2021", "Dosage 1: 14Mar2020, Dosage 2: 01Apr2021"; Bnt162b2 (Dose Number: 1, dose administration time: 02:00 PM, dose vaccine location: Left arm, dose product: COVID 19, dose brand: Pfizer, dose lot unknown reason: Unable to locate or read the details), administration date: 14Mar2020, when the patient was 51 years old, for Covid-19 immunization, reaction(s): "14Mar2020, Dosage 2: 01Apr2021", "14Mar2020, Dosage 2: 01Apr2021". The following information was reported: PAIN (non-serious) with onset 12Feb2022 17:00, outcome "not recovered", described as "Severe body aches"; HEADACHE (non-serious) with onset 12Feb2022 17:00, outcome "not recovered", described as "Severe headache"; PYREXIA (non-serious) with onset 12Feb2022 17:00, outcome "not recovered", described as "Fever highest 103.2"; TREMOR (non-serious), CHILLS (non-serious) all with onset 12Feb2022 17:00, outcome "not recovered" and all described as "Shaking chills"; NAUSEA (non-serious) with onset 12Feb2022 17:00, outcome "not recovered", described as "Nausea"; ABDOMINAL PAIN UPPER (non-serious) with onset 12Feb2022 17:00, outcome "not recovered", described as "Stomach pain". The events "severe body aches", "severe headache", "fever highest 103.2", "shaking chills", "shaking chills", "nausea" and "stomach pain" were 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 pain, headache, pyrexia, tremor, chills, nausea, abdominal pain upper.  Additional information included: Patient had a strong response to all 3 doses. She was diagnosed with Covid 19 on 28Dec2020. The third dose received on 12Feb2022 was the worst. 3 days now Saturday 12Feb Sunday 13Feb Monday 14Feb Tuesday 15Feb events still continued.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: Severe body aches; Severe headache; Fever  highest 103.2; Shaking chills; Shaking chills; Nausea; Stomach pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Feb2022 10:30 (Batch/Lot number: unknown) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "arthritis" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "I was diagnosed with Covid 19", start date: 28Dec2020 (unspecified if ongoing), notes: I was diagnosed with Covid 19 28Dec2020. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, dose administration time: 12:00 PM, dose vaccine location: Left arm, dose product: COVID 19, dose brand: Pfizer, dose lot unknown reason: Unable to locate or read the details), administration date: 01Apr2021, when the patient was 51 years old, for Covid-19 immunization, reaction(s): "Dosage 1: 14Mar2020, Dosage 2: 01Apr2021", "Dosage 1: 14Mar2020, Dosage 2: 01Apr2021"; Bnt162b2 (Dose Number: 1, dose administration time: 02:00 PM, dose vaccine location: Left arm, dose product: COVID 19, dose brand: Pfizer, dose lot unknown reason: Unable to locate or read the details), administration date: 14Mar2020, when the patient was 51 years old, for Covid-19 immunization, reaction(s): "14Mar2020, Dosage 2: 01Apr2021", "14Mar2020, Dosage 2: 01Apr2021". The following information was reported: PAIN (non-serious) with onset 12Feb2022 17:00, outcome "not recovered", described as "Severe body aches"; HEADACHE (non-serious) with onset 12Feb2022 17:00, outcome "not recovered", described as "Severe headache"; PYREXIA (non-serious) with onset 12Feb2022 17:00, outcome "not recovered", described as "Fever highest 103.2"; TREMOR (non-serious), CHILLS (non-serious) all with onset 12Feb2022 17:00, outcome "not recovered" and all described as "Shaking chills"; NAUSEA (non-serious) with onset 12Feb2022 17:00, outcome "not recovered", described as "Nausea"; ABDOMINAL PAIN UPPER (non-serious) with onset 12Feb2022 17:00, outcome "not recovered", described as "Stomach pain". The events "severe body aches", "severe headache", "fever highest 103.2", "shaking chills", "shaking chills", "nausea" and "stomach pain" were 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 pain, headache, pyrexia, tremor, chills, nausea, abdominal pain upper.  Additional information included: Patient had a strong response to all 3 doses. She was diagnosed with Covid 19 on 28Dec2020. The third dose received on 12Feb2022 was the worst. 3 days now Saturday 12Feb Sunday 13Feb Monday 14Feb Tuesday 15Feb events still continued.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pain, Urinary incontinence
Clinical narrative: Permanrnt lot of pain for some reason/It had gave me a severe permanent pain and I cannot get up as normal as I can; it''s soaking because not only that but it''s making uncontrollable urination, uncontrollable water comes out of your body; Very severe stomach pain. This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 19Feb2022 (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) with onset Feb2022, outcome "unknown", described as "Permanrnt lot of pain for some reason/It had gave me a severe permanent pain and I cannot get up as normal as I can"; URINARY INCONTINENCE (non-serious) with onset Feb2022, outcome "unknown", described as "it''s soaking because not only that but it''s making uncontrollable urination, uncontrollable water comes out of your body"; ABDOMINAL PAIN UPPER (non-serious) with onset Feb2022, outcome "unknown", described as "Very severe stomach pain .".  The patient stated, "Yes, It's like, it might be the product that the patient received yesterday, gave permanent lot of pain for some reason and the patient can't get on bed due to COVID19 injection (hence captured as covid19 vaccine; further clarification unknown, hence Pfizer was not checked) that, It had gave the patient a severe permanent pain and the patient cannot get up as normal as the patient can and the patient just want to report that. The patient wanted to people who are not aware of, the patient was not aware of the symptoms or after effects or after injection patient just want to have, the patient do not know what is It. That's all the patient have for today. Some biscuit or some water cold or some of(incomplete sentence) that's all the patient have for today (further not clarified, hence not captured in tab). The patient just like to report, patient have a very severe stomach pain. The patient stated that shirt torn right now and it's soaking because not only that but it's making uncontrollable urination, uncontrollable water comes out of your body . The patient don't know it's too much in body or injection caused that.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Headache, Magnetic resonance imaging, SARS-CoV-2 test
Clinical narrative: Severe headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 17Nov2021 15:30 (Lot number: FH8027) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Yogurt" (unspecified if ongoing), notes: Known allergies: Yogurt. Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0158, Location of injection: Arm Left, Vaccine Administration Time: 16:00 PM), administration date: 21Apr2021, when the patient was 68 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8734, Location of injection: Arm Left, Vaccine Administration Time: 17:00 PM), administration date: 31Mar2021, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 14Jan2022 13:30, outcome "recovering", described as "Severe headache". The event "severe headache" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache.  Additional information: The patient was not pregnant during the vaccination. The most recent COVID-19 vaccine was administered in Pharmacy or Drug Store Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had been tested COVID-19. The patient received treatment for the adverse events with Toradal shots, muscle relaxer, gabapentin.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal discomfort, Rhinorrhoea
Clinical narrative: had a runny nose and the tip of her nose is sore to the touch; had a runny nose and the tip of her nose is sore to the touch; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, administration date 07Feb2022 (Batch/Lot number: unknown) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing); "Psoriatic arthritis" (ongoing); "Atrial fibrillation" (ongoing). Concomitant medication(s) included: ENBREL taken for rheumatoid arthritis, psoriatic arthropathy; HUMIRA. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: RHINORRHOEA (non-serious), NASAL DISCOMFORT (non-serious) all with onset 07Feb2022, outcome "unknown" and all described as "had a runny nose and the tip of her nose is sore to the touch".  Additional information: The patient stated that she had her booster COVID shot on Monday 07Feb 2022 and since getting it she had a runny nose and the tip of her nose was sore to the touch. She stated she doesn't feel bad but has just had a runny nose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lyme disease, Pain in extremity
Clinical narrative: Caller reports having a sore arm and being tired after the first dose; Caller reports having a sore arm and being tired after the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Lot number: EN6208, Expiration Date: 30Jun2021) at the age of 61 years as dose 1 , single for covid-19 immunisation. Relevant medical history included: "muscle skeletal problem" (unspecified if ongoing), notes: from Whiplash years ago; "degenerating disc", start date: 2001 (unspecified if ongoing), notes: degenerating disc in my neck and back,  take the magnesium and I see the chiropractor. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "Caller reports having a sore arm and being tired after the first dose". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, pain in extremity. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200332997 similar report from same reporter
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Menstrual disorder, SARS-CoV-2 test, Ultrasound scan
Clinical narrative: I had my period two times, two weeks apart; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 14Apr2021 (Lot number: EW0153) at the age of 27 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER2613, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 24Mar2021, when the patient was 27 years old, for Covid-19 immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 23Apr2021 12:00, outcome "recovered" (Nov2021), described as "I had my period two times, two weeks apart". The event "i had my period two times, two weeks apart" 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 menstrual disorder. No follow-up attempts are possible. No further information is expected.  Additional information: The patient have always had a very regular and normal period since I was 12. The month of my second Covid shot she had This is extremely unusual for my body so she asked friends (approximately 20 women), and they all said they've had issues with their period since getting vaccinated too. She went to my doctor and she said she's had numerous women come to her with this issue as well. We followed up with blood work and an ultrasound and my period two times, two weeks apart. This continued for 6 months, ending in this past November.  there is no other explanation for this abnormal bleeding other than a possible correlation to the vaccine. Due to this experience, I have not gotten the booster even though I want to. But I fear that the vaccine could make this occur again, and even affect my fertility. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2), administration date Aug2021 (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: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction". The event "allergic reaction" was evaluated at the physician office visit.  Additional information: The reporter stated that her fiance (patient) who had his first dose of the Pfizer Biontech COVID-19 vaccine on Aug2021. He had a slight reaction and was advised not to get the second dose. However, after going to multiple doctors and getting multiple tests it has been deemed that the vaccine was not the cause of the allergic reaction and was able to proceed with the second dose. The reporter asked if he needs to restart the whole series over again or is he able to get his second dose this far out.  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: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Did my COVID rapid and PCR (both positive); Did my COVID rapid and PCR (both positive); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 15:45 (Lot number: 301458A) at the age of 37 years as dose 3 (booster), single, administered in arm left, administration date 08Mar2021 08:45 (Lot number: EN6203) as dose 2, single and administered in arm left, administration date 15Feb2021 13:00 (Lot number: EL9267) as dose 1, single for covid-19 immunisation. Relevant medical history included: "minor gastrointestinal discomfort" (unspecified if ongoing); "constipation" (unspecified if ongoing); "received PRK eye surgery", start date: 11Jan2021 (unspecified if ongoing), notes: received PRK eye surgery. No known allergies were reported. The patient took concomitant medications. Past drug history included: Prednisone, start date: 2021, for weakened my first vaccination. The following information was reported: VACCINATION FAILURE (medically significant) with onset 05Mar2022, outcome "unknown", COVID-19 (medically significant) with onset 05Mar2022, outcome "not recovered" and all described as "Did my COVID rapid and PCR (both positive)". The event "did my COVID rapid and pcr (both positive)" and "did my COVID rapid and pcr (both positive)" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Mar2022) positive; (05Mar2022) positive. Therapeutic measures were taken as a result of covid-19.