chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo, Vertigo positional
Clinical narrative: 4-5 days after vaccine developed Vertigo; Diagnosed with BPPV.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Sep2021 11:30 (Lot number: EW0187) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Neck stiffness" (unspecified if ongoing); "Dyspepsia" (unspecified if ongoing). Concomitant medication(s) included: DOXYCYCLINE; TRAZODONE; PEPCID. Past drug history included: Lisinopril, reaction(s): "known allergies: Lisinopril"; Steroids, reaction(s): "known allergies: Steroids". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6206, Location of injection: Arm Left), administration date: 09Mar2021, when the patient was 63 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EP7534, Location of injection: Arm Left), administration date: 30Mar2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: VERTIGO (non-serious) with onset 28Sep2021 08:00, outcome "recovered with sequelae", described as "4-5 days after vaccine developed Vertigo"; VERTIGO POSITIONAL (non-serious) with onset 28Sep2021 08:00, outcome "recovered with sequelae", described as "Diagnosed with BPPV.". The events "4-5 days after vaccine developed vertigo" and "diagnosed with bppv." were evaluated at the physician office visit. Therapeutic measures were taken as a result of vertigo, vertigo positional.  The patient was given Vestibular Therapy as a treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Trazodone 50 mg, Pepcid 30mg, Doxycycline medications within 2 weeks of vaccination. The patient did not have Covid-19 prior vaccination and did not tested for Covid-19 post vaccination. Facility where the most recent COVID-19 vaccine was administered was Public Health Clinic/ Administration facility.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Peripheral swelling
Clinical narrative: red area at the injection site; arm is swollen; 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 71 year-old female patient received bnt162b2 (COMIRNATY), administration date 27Oct2021 (Batch/Lot number: unknown) at the age of 71 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 (1st Dose), for COVID-19 immunization; Bnt162b2 (2nd Dose), for COVID-19 immunization. The following information was reported: INJECTION SITE ERYTHEMA (non-serious) with onset 29Oct2021, outcome "unknown", described as "red area at the injection site"; PERIPHERAL SWELLING (non-serious) with onset 29Oct2021, outcome "unknown", described as "arm is swollen".  Additional information: stated she got the booster dose this past Wednesday. Caller reported she woke up this morning and her arm was swollen and there was a red area at the injection site. Caller stated this did not happen after the first doses. Caller asked stated this specific to getting the booster dose. Caller asked how long will it last. Caller reports that today, her arm is swollen and there is a red spot the size of a dime at the injection site. The patient had no issues with the first two vaccines.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown); both single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced dizziness (head rushes), and felt  abnormal ("when I am settling down to sleep, I feel flares in my head"), with outcome of unknown. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: horrible pain in her shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st), for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "horrible pain in her shoulder". Therapeutic measures were taken as a result of arthralgia.  Additional information: Reporter stated 5 days after receiving the second dose her mother had horrible pain in her shoulder and took Tylenol. Reporter asked if her mother could take Tylenol after receiving the booster dose.   Follow-up: This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Under arm lymph node swelling on the same side as the Covid site injection; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Oct2021 08:00 (Lot number: Ff2590) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 27Oct2021 (Batch/Lot number: unknown) for immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Qw11111), for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: N/a), for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 28Oct2021, outcome "not recovered", described as "Under arm lymph node swelling on the same side as the Covid site injection". Therapeutic measures were not taken as a result of lymphadenopathy. Additional information: Relevant medical history and concurrent conditions were reported none. Relevant past drug history were none. Reaction was allergy. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient received any other vaccines within 4 weeks was flu shot and the patient did not receive any other medications within 2 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior the vaccination. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for adverse events. No hospitalization prolonged. No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Gout, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: prev dose administration date=01May2021, dose number=1/administration date=26Sep2021, dose number=2; gout flare ups in my right foot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Sep2021 12:00 (Lot number: EW0187) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cholesterol" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN SODIUM; LEVOTHYROXIN; CLARITIN [LORATADINE]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0173, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 01May2021, when the patient was 50 years old, for COVID-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 2021, outcome "unknown", described as "prev dose administration date=01May2021, dose number=1/administration date=26Sep2021, dose number=2"; GOUT (non-serious) with onset 2021, outcome "not recovered", described as "gout flare ups in my right foot". The event "gout flare ups in my right foot" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Facility where the most recent COVID-19 vaccine was administered at Public Health Clinic/Veterans Administration facility. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient had been tested for COVID-19 since the vaccination. Patient had not diagnosed with COVID-19 prior to vaccination. Patient had received other medications the patient received within 2 weeks of vaccination was pravastatin sodium, levothyroxin, Claritin. After my 2nd shot, I started having gout flare ups in my right foot. It's been happening once a month. I didn't have any gout issues before the vaccination. Patient had not known allergies. Patient had other medical history was cholesterol, hypothyroid.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash, SARS-CoV-2 test
Clinical narrative: Major major facial breakout that hurts and feels hard to touch; Major major facial breakout that hurts and feels hard to touch; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 22Jun2021 10:00 (Batch/Lot number: unknown) at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA. Vaccination history included: Bnt162b2 (Dose 1, Lot No: Unknown, Location of injection: Arm Right, Vaccine Administration Time: 10:00 AM), administration date: 01Jun2021, when the patient was 30 years old, for COVID-19 immunisation. The following information was reported: PAIN (non-serious), RASH (non-serious) all with onset 23Jun2021, outcome "not recovered" and all described as "Major major facial breakout that hurts and feels hard to touch". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, rash.   Additional information: Patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: After receiving the first vaccine, my menstrual cycle started 4 days early and was lighter than normal.; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 15:00 (Lot number: FC3181) at the age of 35 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 28Aug2021 07:00, outcome "unknown", described as "After receiving the first vaccine, my menstrual cycle started 4 days early and was lighter than normal.". Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No list of any other medications the patient received within 2 weeks of vaccination. Patient knew her body was reacting to this vaccine based off her cycle history and the symptoms she was experiencing. She was regular with a 28 day cycle. Never early. Never late. Patient did not have covid prior vaccination. Post vaccination patient was not tested for COVID. Patient had no known allergies. Device Date: 30Oct2021.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Left Arm Soreness; Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 28Oct2021 16:30 (Batch/Lot number: unknown) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administered in arm right, administration date 28Oct2021 (Batch/Lot number: unknown) as unk, single. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIPITOR; LOVAZA; OZEMPIC; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (Dose Number: 2, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 15Mar2021, when the patient was 56 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 01:30 PM), administration date: 24Feb2021, when the patient was 56 years old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 29Oct2021 12:00, outcome "recovering", described as "Left Arm Soreness"; PYREXIA (non-serious) with onset 29Oct2021 12:00, outcome "recovering", described as "Fever". Therapeutic measures were not taken as a result of pain in extremity, pyrexia.  Additional information: The patient received medications in two weeks with Lipitor, lovaza, ozempic, zyrtec and vitamins. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (02Dec2021)This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pain and swelling at injection location; Pain and swelling at injection location; Swollen lymph node on left side neck area; Tiredness/Fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Oct2021 12:15 (Lot number: PH8028) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Nut and shellfish allergy" (unspecified if ongoing); "Nut and shellfish allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL0140), administration date: 21Dec2020, when the patient was 52 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL1284), administration date: 11Jan2021, when the patient was 52 years old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 28Oct2021 07:00, outcome "recovering" and all described as "Pain and swelling at injection location"; LYMPHADENOPATHY (non-serious) with onset 28Oct2021 07:00, outcome "recovering", described as "Swollen lymph node on left side neck area"; FATIGUE (non-serious) with onset 28Oct2021 07:00, outcome "recovering", described as "Tiredness/Fatigue". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site swelling, lymphadenopathy, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, and it was not fully known list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination patient not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Severely swollen lymph node in left armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Oct2021 08:00 (Lot number: FF2593) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Penicillins" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8729, Location of injection: Arm Left), administration date: 06Apr2021, when the patient was 39 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: El9266), administration date: 17Mar2021, when the patient was 39 years old, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 31Oct2021, outcome "recovering", described as "Severely swollen lymph node in left armpit". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, Prior to vaccination, the patient was diagnosed with COVID-19 was unknown, Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, SARS-CoV-2 test
Clinical narrative: muscle aches; fatigue; headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 28Apr2021 (Lot number: EP6955) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, lot number:EP6955), administration date: 07Apr2021, when the patient was 46 years old, for COVID-19 immunization. The following information was reported: MYALGIA (non-serious) with onset 25Aug2021, outcome "recovered" (2021), described as "muscle aches"; FATIGUE (non-serious) with onset 25Aug2021, outcome "recovered" (2021), described as "fatigue"; HEADACHE (non-serious) with onset 25Aug2021, outcome "recovered" (2021), described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of myalgia, fatigue, headache.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received other medications within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Large red bump very warm to the touch; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Oct2021 19:15 (Lot number: 30155BA) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Severe asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Metoclopramide, reaction(s): "known allergies: Allergy", notes: known allergies: Metoclopramide. Vaccination history included: Bnt162b2 (Dose Number: 2, Single, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 21Feb2021, when the patient was 57 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 02Feb2021, when the patient was 57 years old, for COVID-19 Immunization. The following information was reported: URTICARIA (non-serious) with onset 29Oct2021 14:00, outcome "not recovered", described as "Large red bump very warm to the touch". Therapeutic measures were not taken as a result of urticaria.  Additional information: Facility type vaccine was Pharmacy or Drug Store. The patient had not received any other vaccine in four weeks of vaccination. The event Large red bump very warm to the touch did not resulted in physician visit or emergency room visit. The patient was not diagnosed with Covid-19 prior to vaccination. Since vaccination the patient was not test for Covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Right armpit lymph node is a bit swollen and painful; Right armpit lymph node is a bit swollen and painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Feb2021 (Lot number: EN6201) at the age of 38 years as dose 2, single and administered in arm right, administration date 30Jan2021 (Lot number: EL9262) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing); "Eczema" (unspecified if ongoing); "Contact Dermatitis" (unspecified if ongoing); "Epstein Barr" (unspecified if ongoing), notes: Epstein Barr; "Mitral Valve Prolapse" (unspecified if ongoing); "Known allergies: Nuts" (unspecified if ongoing), notes: known allergies : Food: all nuts; "Known allergies: Sea food" (unspecified if ongoing), notes: known allergies : Food: all seafood; "Known allergies: most fruit" (unspecified if ongoing), notes: known allergies : Food:  most fruit; "Known allergies: Avocados" (unspecified if ongoing), notes: known allergies : Food: avocados. Concomitant medication(s) included: SYMBICORT; B12 [CYANOCOBALAMIN]; IBUPROFEN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; MIRALAX. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 2021, outcome "not recovered" and all described as "Right armpit lymph node is a bit swollen and painful". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain.  Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Dyspnoea, Illness, Pain
Clinical narrative: Diarrhea; Body aches; Chest pain; Difficult breathing; Sick; 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: Bnt162b2 (DOSE: 1), for COVID-19 immunization; Bnt162b2 (DOSE: 2), for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; PAIN (non-serious), outcome "unknown", described as "Body aches"; CHEST PAIN (non-serious), outcome "unknown", described as "Chest pain"; DYSPNOEA (non-serious), outcome "unknown", described as "Difficult breathing"; ILLNESS (non-serious), outcome "unknown", described as "Sick".  Additional Context: Consumer stated, "I just want to report a adverse or side effects to Pfizer Booster shot." Side effect experienced: Consumer stated, "Diarrhea, sick, Body aches, Chest pains, difficult breathing."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (22Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Presyncope, Vertigo positional
Clinical narrative: A week of positional vertigo.; Second shot...day of felt like cloud lifted. 20 after shot...almost blacked out,; Dizzy; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Mar2021 14:00 (Lot number: EN6208) at the age of 64 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Known allergies: compazine for vomiting, reaction(s): "Known Allergies: Compazine", notes: Known Allergies: Compazine; Known allergies: tyramine, reaction(s): "Known Allergies: Tyramine", notes: Known Allergies: Tyramine. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6200, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 26Feb2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: VERTIGO POSITIONAL (non-serious) with onset 20Mar2021, outcome "unknown", described as "A week of positional vertigo."; PRESYNCOPE (non-serious) with onset 20Mar2021, outcome "unknown", described as "Second shot...day of felt like cloud lifted. 20 after shot...almost blacked out,"; DIZZINESS (non-serious) with onset 20Mar2021, outcome "unknown", described as "Dizzy"; DIARRHOEA (non-serious) with onset 20Mar2021, outcome "unknown", described as "Diarrhea". The events "a week of positional vertigo.", "second shot...day of felt like cloud lifted. 20 after shot...almost blacked out,", "dizzy" and "diarrhea" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of vertigo positional, presyncope, dizziness, diarrhoea.  Additional information included: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient received bnt162b2 (BNT162B2), administration date 21Oct2021 (Lot number: Ff8839) at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FF8839), administration date: 30Sep2021, when the patient was 31 years old, for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 24Oct2021, outcome "unknown", described as "Hair loss".  Additional information: Since the vaccination, patient had not been tested for COVID-19. COVID prior vaccination: Yes. If COVID tested post vaccination: No.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pain in extremity
Clinical narrative: headache; She felt like she was hit by a truck; her arm was sore for 3 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US190951.  A 49 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 49 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "her arm was sore for 3 days"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "She felt like she was hit by a truck".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Pain in extremity
Clinical narrative: sore arm; headache; lethargy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD21-157337 (Moderna).  A 50 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 21Apr2021 (Lot number: EW0171) at the age of 49 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single; lot: EW0150, expiration: unknown, ROA: Intramuscular), administration date: 31Mar2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "headache"; LETHARGY (non-serious) with onset 2021, outcome "unknown", described as "lethargy". Therapeutic measures were taken as a result of headache.  Additional information: The patient was treated with Tylenol for headache. She was not immunocompromised. She was told by her doctor not to worry about the dose she received.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic, Vaccination site swelling
Clinical narrative: it is a big elongated elevated red hot itchy rash; I got swollen at the site of shot, a pretty big swelling area; I don''t know if it''s a rash or hives, it is a big elongated elevated red hot itchy rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 26Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for Covid-19 Immunisation; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for Covid-19 Immunisation. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 29Oct2021, outcome "not recovered", described as "I got swollen at the site of shot, a pretty big swelling area"; RASH PRURITIC (non-serious) with onset 29Oct2021, outcome "not recovered", described as "I don''t know if it''s a rash or hives, it is a big elongated elevated red hot itchy rash"; RASH ERYTHEMATOUS (non-serious), outcome "not recovered", described as "it is a big elongated elevated red hot itchy rash".  Additional Information: Patient got the Booster shot on 26Oct2021 at 5 PM and today is Friday 29Oct2021, so 3 days later almost the same time it's 72 hours later, got swollen at the site of shot. Patient got a pretty big swelling area and don't know if it's a rash or hives or what but it is a big elongated elevated red hot itchy rash and it is not going away. Patient didn't have that on the first two shot (first dose and second dose). Just get it on third one (Booster, Covid-19 Vaccine).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count normal, Haematocrit, Hormone level abnormal, Illness
Clinical narrative: Second dose: was sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Mar2021 (Lot number: 5N6199) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypersensitivity" (unspecified if ongoing), notes: Verbatim: Allergy, body is severely sensitive; "she has had swollen eyes from being in a lumber store" (unspecified if ongoing); "can smell chemicals a mile away" (unspecified if ongoing); "had a rash from latex and metal" (unspecified if ongoing); "had a rash from latex and metal" (unspecified if ongoing); "had a reaction to cats" (unspecified if ongoing); "had a reaction to yellow flowers" (unspecified if ongoing); "had a reaction to Hay" (unspecified if ongoing). Concomitant medication(s) included: COZAAR; IBUPROFEN. Past drug history included: Amoxicillin, reaction(s): "gets a rash". Vaccination history included: Bnt162b2 (First Dose: Received 17Feb2021, lot EM1809 or EM7809, NDC and expiration date unknown.), administration date: 17Feb2021, when the patient was 70 years old, for COVID-19 immunization, reaction(s): "didn't feel great after the first dose"; Tetanus shot, administration date: 2020, reaction(s): "little reaction". The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Second dose: was sick". The patient underwent the following laboratory tests and procedures: full blood count normal: perfectly normal; haematocrit: perfectly normal; hormone level abnormal: unknown, notes: it was really different. Additional information: The reporter stated that the event relatedness as related. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient id not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Erythema, Fatigue, Lymphadenopathy
Clinical narrative: Redness and swelling at injection site; Redness and swelling at injection site; Redness and swelling at injection site; very swollen gland in left armpit; low grade fever; aches in joints; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Oct2021 18:00 (Lot number: FG3527) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation; typhoid vaccine polysacch vi (TYPHIM VI), administered in arm left, administration date 14Sep2021 (Lot number: T2A371m) as unk unk, single. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Other medical history: blood pressure; "Known allergies: Yes" (unspecified if ongoing), notes: Known Allergies: Yes. Concomitant medication(s) included: AMLODIPINE; FAMOTIDINE; LARIAM. Vaccination history included: Bnt162b2 (Dose Number: 2, lot number=ER8729, administration time=10:00 AM, vaccine location=Left arm), administration date: 14Apr2021, when the patient was 64 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, lot number=EN6207, administration time=10:00 AM, vaccine location=Left arm, ), administration date: 17Mar2021, when the patient was 64 years old, for Covid-19 Immunization. The following information was reported: VACCINATION SITE REACTION (non-serious), ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 30Oct2021 18:00, outcome "recovering" and all described as "Redness and swelling at injection site"; LYMPHADENOPATHY (non-serious) with onset 30Oct2021 18:00, outcome "recovering", described as "very swollen gland in left armpit"; PYREXIA (non-serious) with onset 30Oct2021 18:00, outcome "recovering", described as "low grade fever"; ARTHRALGIA (non-serious) with onset 30Oct2021 18:00, outcome "recovering", described as "aches in joints"; FATIGUE (non-serious) with onset 30Oct2021 18:00, outcome "recovering", described as "tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site reaction, erythema, vaccination site swelling, lymphadenopathy, pyrexia, arthralgia, fatigue.  Additional information: Facility type vaccine was Pharmacy or Drug store. No covid prior vaccination and was not tested covid post vaccination  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Redness and swelling at injection site; Redness and swelling at injection site; Redness and swelling at injection site; very swollen gland in left armpit; low grade fever; aches in joints; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Oct2021 18:00 (Lot number: FG3527) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation; typhoid vaccine polysacch vi (TYPHIM VI), administered in arm left, administration date 14Sep2021 (Lot number: T2A371m) as unk unk, single. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Other medical history: blood pressure; "Known allergies: Yes" (unspecified if ongoing), notes: Known Allergies: Yes. Concomitant medication(s) included: AMLODIPINE; FAMOTIDINE; LARIAM. Vaccination history included: Bnt162b2 (Dose Number: 2, lot number=ER8729, administration time=10:00 AM, vaccine location=Left arm), administration date: 14Apr2021, when the patient was 64 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, lot number=EN6207, administration time=10:00 AM, vaccine location=Left arm, ), administration date: 17Mar2021, when the patient was 64 years old, for Covid-19 Immunization. The following information was reported: VACCINATION SITE REACTION (non-serious), ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 30Oct2021 18:00, outcome "recovering" and all described as "Redness and swelling at injection site"; LYMPHADENOPATHY (non-serious) with onset 30Oct2021 18:00, outcome "recovering", described as "very swollen gland in left armpit"; PYREXIA (non-serious) with onset 30Oct2021 18:00, outcome "recovering", described as "low grade fever"; ARTHRALGIA (non-serious) with onset 30Oct2021 18:00, outcome "recovering", described as "aches in joints"; FATIGUE (non-serious) with onset 30Oct2021 18:00, outcome "recovering", described as "tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site reaction, erythema, vaccination site swelling, lymphadenopathy, pyrexia, arthralgia, fatigue.  Additional information: Facility type vaccine was Pharmacy or Drug store. No covid prior vaccination and was not tested covid post vaccination  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Lymphoedema, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: I was very weak the next morning; my lymphedema in my left axilla region increased; my right arm that received injection was very sore; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Oct2021 17:30 (Lot number: 30145BA) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Stage 2A cancer left breast" (unspecified if ongoing), notes: Other medical history: Stage 2A cancer left breast, in remission; "Lymphedema left axilla, arm, and scapula" (ongoing). Concomitant medication(s) included: EXEMESTANE; VITAMIN D NOS; FOLIC ACID. Vaccination history included: Bnt162b2 (Dose 1, single, administration time: 05:30 PM , lot number: FC3183, Vaccination site location: Right arm, ), administration date: 17Sep2021, when the patient was 51 years old, for COVID-19 immunization, reaction(s): "headache", "bilateral legs felt heavy", "chest pain", "lump at injection site". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 08Oct2021 20:00, outcome "recovering", described as "my right arm that received injection was very sore"; ASTHENIA (non-serious) with onset 09Oct2021, outcome "recovering", described as "I was very weak the next morning"; LYMPHOEDEMA (non-serious) with onset 08Oct2021 20:00, outcome "recovering", described as "my lymphedema in my left axilla region increased". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphoedema.  Additional information: The patient had no known allergies. patient did not receive other vaccine in four weeks. Prior vaccination, patient had not been tested for Covid-19. post vaccination, patient had tested for Covid-19. Patient received treatment for lymphedema used pump Increased no of times.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood urine present, Fatigue, Malaise, Memory impairment
Clinical narrative: blood in the urine; Incontinence, cannot control his urine; Tiredness; forgetfulness; Feeling unwell; Weak; he is sleepy, he is on bed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 77 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Oct2021 (Lot number: FE3590, Expiration Date: 05Nov2021) at the age of 77 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Verbatim: Diabetic" (unspecified if ongoing), notes: Diabetic; "Verbatim: Blood pressure high" (unspecified if ongoing), notes: Blood pressure high; "Heart" (unspecified if ongoing); "Pacemaker" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; LISINOPRIL taken for hypertension; METOPROLOL taken for cardiac disorder; GLIPIZIDE taken for diabetes mellitus. The following information was reported: BLOOD URINE PRESENT (non-serious) with onset 26Oct2021, outcome "unknown", described as "blood in the urine"; URINARY INCONTINENCE (non-serious) with onset Oct2021, outcome "unknown", described as "Incontinence, cannot control his urine"; FATIGUE (non-serious) with onset Oct2021, outcome "unknown", described as "Tiredness"; MEMORY IMPAIRMENT (non-serious) with onset Oct2021, outcome "unknown", described as "forgetfulness"; MALAISE (non-serious) with onset Oct2021, outcome "unknown", described as "Feeling unwell"; ASTHENIA (non-serious) with onset Oct2021, outcome "unknown", described as "Weak"; SOMNOLENCE (non-serious) with onset Oct2021, outcome "unknown", described as "he is sleepy, he is on bed".  Additional information: The problem right now. No, he didn't have any medication but what he was taking for his reason. For this one complaining asking if taking any medication. No.  Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Urinary incontinence
Clinical narrative: blood in the urine; Incontinence, cannot control his urine; Tiredness; forgetfulness; Feeling unwell; Weak; he is sleepy, he is on bed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 77 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Oct2021 (Lot number: FE3590, Expiration Date: 05Nov2021) at the age of 77 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Verbatim: Diabetic" (unspecified if ongoing), notes: Diabetic; "Verbatim: Blood pressure high" (unspecified if ongoing), notes: Blood pressure high; "Heart" (unspecified if ongoing); "Pacemaker" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; LISINOPRIL taken for hypertension; METOPROLOL taken for cardiac disorder; GLIPIZIDE taken for diabetes mellitus. The following information was reported: BLOOD URINE PRESENT (non-serious) with onset 26Oct2021, outcome "unknown", described as "blood in the urine"; URINARY INCONTINENCE (non-serious) with onset Oct2021, outcome "unknown", described as "Incontinence, cannot control his urine"; FATIGUE (non-serious) with onset Oct2021, outcome "unknown", described as "Tiredness"; MEMORY IMPAIRMENT (non-serious) with onset Oct2021, outcome "unknown", described as "forgetfulness"; MALAISE (non-serious) with onset Oct2021, outcome "unknown", described as "Feeling unwell"; ASTHENIA (non-serious) with onset Oct2021, outcome "unknown", described as "Weak"; SOMNOLENCE (non-serious) with onset Oct2021, outcome "unknown", described as "he is sleepy, he is on bed".  Additional information: The problem right now. No, he didn't have any medication but what he was taking for his reason. For this one complaining asking if taking any medication. No.  Follow-up attempts are completed. No further information is expected.