chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Immunisation, Off label use, Product use issue, Tinnitus
Clinical narrative: About 1 week after my Covid booster; I noticed my T had spiked to an uncomfortable level; vaccine received same date: Flu; vaccine received same date: Flu; This is a spontaneous report received from 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 14Oct2021 (Lot number: 30145BA) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 14Oct2021 (Batch/Lot number: unknown) for immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing); "Tinnitus" (unspecified if ongoing), notes: Tinnitus. I have tinnitus but very low with generally no issue. ; "shingles" (unspecified if ongoing), notes: I had shingles about 3 years ago and has never gone away. Concomitant medication(s) included: LATANOPROST; CALCIUM; MAGNESIUM. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL 9269), administration date: 11Feb2021, when the patient was 65 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9262), administration date: 24Jan2021, when the patient was 65 years old, for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 14Oct2021, outcome "unknown" and all described as "vaccine received same date: Flu"; IMMUNISATION (non-serious) with onset 23Oct2021, outcome "unknown", described as "About 1 week after my Covid booster"; TINNITUS (non-serious) with onset 23Oct2021, outcome "not recovered", described as "I noticed my T had spiked to an uncomfortable level". The action taken for influenza vaccine was unknown. Therapeutic measures were not taken as a result of immunisation, tinnitus.  Additional information: Facility where the most recent COVID-19 vaccine was administered as Withheld. Relevant past drug history mentioned as No. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient stated about 1 week after her Covid booster, patient noticed her T had spiked to an uncomfortable level. Patient did not think of any relation to the booster. Patient  thought it was maybe just a spike but after 3 weeks of continual noise, patient asked a relative who experienced T along with some other symptoms. Since the vaccination, the patient has not been tested for COVID-19. Device Date mentioned as 15Nov2021.   Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Heart rate, Heart rate increased, Immunisation
Clinical narrative: Patient states received his COVID-19 vaccine booster; heart rate go up; blood pressure drop; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): RA2021US195563 (RA).  A 68 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 68 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: Covid-19 vaccine (dose number unknown, primary Immunization series complete but unknown manufacturer), for covid-19 immunisation. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Patient states received his COVID-19 vaccine booster"; HEART RATE INCREASED (non-serious), outcome "recovered", described as "heart rate go up"; BLOOD PRESSURE DECREASED (non-serious), outcome "recovered", described as "blood pressure drop". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Taste disorder
Clinical narrative: metallic taste in her mouth; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101620646 (Pfizer inc.).  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 14:30 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "immunization" (unspecified if ongoing). Concomitant medication(s) included: FLU taken for immunisation. Vaccination history included: Bnt162b2 (Dose Number: 01, Administration Date: 19Mar2021, Administration Time: 08:06 am, Anatomical Site: Left arm), administration date: 19Mar2021, for Covid-19 immunization; Bnt162b2 (Dose Number: 02, Administration Date: 09Apr2021, Administration Time: 09:06 am, Anatomical Site: Left arm), administration date: 09Apr2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 11Nov2021 14:30, outcome "unknown", described as "booster"; TASTE DISORDER (non-serious) with onset 11Nov2021 15:07, outcome "not recovered", described as "metallic taste in her mouth".  Additional information: No Other Products, Patient History, Investigation Assessment has been reported. Caller relays that approximately 37-40 minutes after the booster she was in the car and got a metallic taste in her mouth while she was driving. States she looked online and some people describe it like a mouthful of nickels. States she thought something was wrong, she could taste or feel metal in her whole mouth. Caller states she got her booster around 2:30pm and it happened at 3:07pm. Caller relays it didn't prohibit her from eating but she still had it and hoped it was going away and it came back and it's 5 days later. Caller states she went to her dentist yesterday and asked them and they told her they haven't heard of that, not many people have that. States she kept apologizing at the dentist as her mouth felt like metal and she had gotten ready for the appointment. Caller states it has not gone away yet, when it 1st happened 37 minutes after, it was very pronounced and she was overcome by it it came on suddenly. States she told her husband and he couldn't believe it. States something is wrong with her mouth and maybe she has gotten used to it but it's not as pronounced but it's still there, not every minute. The patient was not visited Emergency Room and Physician Office. Patient's Medical History (including any illness at time of vaccination) and Relevant Tests mentioned as None.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Immunisation, Myalgia
Clinical narrative: Booster; Fever; Tiredness; Chills; at the injection site still got a big lump and it still hurts; at the injection site still got a big lump and it still hurts; Feels swollen like the arm side; Headache; Pain; Muscle pain; 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 13Nov2021 (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 (Immunization series complete but unknown manufacturer, Dose 1), for Covid-19 Immunisation; Covid-19 vaccine (Immunization series complete but unknown manufacturer, Dose 2), for Covid-19 Immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 13Nov2021, outcome "unknown", described as "Booster"; SWELLING (non-serious) with onset Nov2021, outcome "unknown", described as "Feels swollen like the arm side"; HEADACHE (non-serious) with onset Nov2021, outcome "not recovered", described as "Headache"; PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "Pain"; MYALGIA (non-serious) with onset Nov2021, outcome "unknown", described as "Muscle pain"; PYREXIA (non-serious) with onset 13Nov2021, outcome "not recovered", described as "Fever"; FATIGUE (non-serious) with onset Nov2021, outcome "not recovered", described as "Tiredness"; CHILLS (non-serious) with onset Nov2021, outcome "unknown", described as "Chills"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE MASS (non-serious) all with onset Nov2021, outcome "not recovered" and all described as "at the injection site still got a big lump and it still hurts".  Additional information: Consumer stated, the patient had received the booster shot 2 days ago and the patient having a lot of side effects. Felt swollen like the arm side. The patient had been running a fever since Saturday, headache, pain, muscle pain. Consumer stated, "the patient having headache, tiredness, Patient have been running on fever for three days since the patient had the vaccine (further clarification unknown hence suspect captured as unspecified vaccine), the booster, the patient got the booster, muscle pain, chills, where the injection site, still got a big lump and it still hurts, too many side effects.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Pyrexia, Vaccination site mass, Vaccination site pain
Clinical narrative: Booster; Fever; Tiredness; Chills; at the injection site still got a big lump and it still hurts; at the injection site still got a big lump and it still hurts; Feels swollen like the arm side; Headache; Pain; Muscle pain; 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 13Nov2021 (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 (Immunization series complete but unknown manufacturer, Dose 1), for Covid-19 Immunisation; Covid-19 vaccine (Immunization series complete but unknown manufacturer, Dose 2), for Covid-19 Immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 13Nov2021, outcome "unknown", described as "Booster"; SWELLING (non-serious) with onset Nov2021, outcome "unknown", described as "Feels swollen like the arm side"; HEADACHE (non-serious) with onset Nov2021, outcome "not recovered", described as "Headache"; PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "Pain"; MYALGIA (non-serious) with onset Nov2021, outcome "unknown", described as "Muscle pain"; PYREXIA (non-serious) with onset 13Nov2021, outcome "not recovered", described as "Fever"; FATIGUE (non-serious) with onset Nov2021, outcome "not recovered", described as "Tiredness"; CHILLS (non-serious) with onset Nov2021, outcome "unknown", described as "Chills"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE MASS (non-serious) all with onset Nov2021, outcome "not recovered" and all described as "at the injection site still got a big lump and it still hurts".  Additional information: Consumer stated, the patient had received the booster shot 2 days ago and the patient having a lot of side effects. Felt swollen like the arm side. The patient had been running a fever since Saturday, headache, pain, muscle pain. Consumer stated, "the patient having headache, tiredness, Patient have been running on fever for three days since the patient had the vaccine (further clarification unknown hence suspect captured as unspecified vaccine), the booster, the patient got the booster, muscle pain, chills, where the injection site, still got a big lump and it still hurts, too many side effects.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Immunisation, Peripheral swelling
Clinical narrative: This is a spontaneous report received from a contactable other HCP. An adult male patient received the 3rd (booster) dose of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st and 2nd dose of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient stated "I have seen two women and one man over 65 years old who got redness and swelling in their arm from shoulder to elbow a few days after getting the Pfizer booster shot." The patient experienced erythema/redness, peripheral swelling/swelling in their arm from shoulder to elbow, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Immunisation, Migraine, Pain in extremity, Swelling
Clinical narrative: GI upset  and vomiting; GI upset  and vomiting; Migraine; Arm pain; Swollen under arm pit; Booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 13Nov2021 12:00 (Lot number: PH8030) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "migraines" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE [AMLODIPINE BESILATE]; LEVOTHYROXINE [LEVOTHYROXINE SODIUM]; RIZATRIPTAN; NURTEC ODT; VITAMIN D [COLECALCIFEROL]; ANAPROX; VIT C; IBUPROFEN. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: Bnt162b2 ([{prev_dose_product=COVID 19,, prev_dose_brand=Pfizer,, prev_dose_lot_number=EP6955,, prev_dose_administrator_route=Intra, muscular, prev_dose_administration_date=25Mar2021,, prev_dose_administration_time=01:00, PM, prev_dose_dose_number=2, prev_dose_vaccine_location=Left, arm}), administration date: 25Mar2021, when the patient was 48 years old, for COVID-19 immunization; Bnt162b2 ({prev_dose_product=COVID 19, prev_dose_brand=Pfizer, prev_dose_lot_number=EL3247, prev_dose_administrator_route=Intra, muscular, prev_dose_administration_date=05Mar2021,, prev_dose_administration_time=01:00, PM, prev_dose_dose_number=1, prev_dose_vaccine_location=Left, arm}]), administration date: 05Mar2021, when the patient was 48 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Nov2021 12:00, outcome "unknown", described as "Booster dose"; ABDOMINAL DISCOMFORT (non-serious), VOMITING (non-serious) all with onset 14Nov2021 10:30, outcome "not recovered" and all described as "GI upset and vomiting"; MIGRAINE (non-serious) with onset 14Nov2021 10:30, outcome "not recovered", described as "Migraine"; PAIN IN EXTREMITY (non-serious) with onset 14Nov2021 10:30, outcome "not recovered", described as "Arm pain"; SWELLING (non-serious) with onset 14Nov2021 10:30, outcome "not recovered", described as "Swollen under arm pit". Therapeutic measures were not taken as a result of abdominal discomfort, vomiting, migraine, pain in extremity, swelling.  Additional information: The patient received other vaccine 4weeks product "SEQIRUS' (lot number: 308456), administered on left arm as dose 1. The patient had no known allergies. The patient had no COVID prior vaccination. Not tested for COVID post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: GI upset  and vomiting; GI upset  and vomiting; Migraine; Arm pain; Swollen under arm pit; Booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 13Nov2021 12:00 (Lot number: PH8030) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "migraines" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE [AMLODIPINE BESILATE]; LEVOTHYROXINE [LEVOTHYROXINE SODIUM]; RIZATRIPTAN; NURTEC ODT; VITAMIN D [COLECALCIFEROL]; ANAPROX; VIT C; IBUPROFEN. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: Bnt162b2 ([{prev_dose_product=COVID 19,, prev_dose_brand=Pfizer,, prev_dose_lot_number=EP6955,, prev_dose_administrator_route=Intra, muscular, prev_dose_administration_date=25Mar2021,, prev_dose_administration_time=01:00, PM, prev_dose_dose_number=2, prev_dose_vaccine_location=Left, arm}), administration date: 25Mar2021, when the patient was 48 years old, for COVID-19 immunization; Bnt162b2 ({prev_dose_product=COVID 19, prev_dose_brand=Pfizer, prev_dose_lot_number=EL3247, prev_dose_administrator_route=Intra, muscular, prev_dose_administration_date=05Mar2021,, prev_dose_administration_time=01:00, PM, prev_dose_dose_number=1, prev_dose_vaccine_location=Left, arm}]), administration date: 05Mar2021, when the patient was 48 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Nov2021 12:00, outcome "unknown", described as "Booster dose"; ABDOMINAL DISCOMFORT (non-serious), VOMITING (non-serious) all with onset 14Nov2021 10:30, outcome "not recovered" and all described as "GI upset and vomiting"; MIGRAINE (non-serious) with onset 14Nov2021 10:30, outcome "not recovered", described as "Migraine"; PAIN IN EXTREMITY (non-serious) with onset 14Nov2021 10:30, outcome "not recovered", described as "Arm pain"; SWELLING (non-serious) with onset 14Nov2021 10:30, outcome "not recovered", described as "Swollen under arm pit". Therapeutic measures were not taken as a result of abdominal discomfort, vomiting, migraine, pain in extremity, swelling.  Additional information: The patient received other vaccine 4weeks product "SEQIRUS' (lot number: 308456), administered on left arm as dose 1. The patient had no known allergies. The patient had no COVID prior vaccination. Not tested for COVID post vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Exposure via skin contact, Immunisation, Underdose, Wrong technique in product usage process
Clinical narrative: a patient came in today for a booster; nurse was a new nurse she injected incorrectly; injecting only like one quarter even less than that of the dose/very small dose less than 0.1ml went in to the arm; rest of it just jugged out to the outside of the skin; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 82 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 16Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown, Manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Nov2021, outcome "unknown", described as "a patient came in today for a booster"; WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) with onset 16Nov2021, outcome "unknown", described as "nurse was a new nurse she injected incorrectly"; UNDERDOSE (non-serious) with onset 16Nov2021, outcome "unknown", described as "injecting only like one quarter even less than that of the dose/very small dose less than 0.1ml went in to the arm"; EXPOSURE VIA SKIN CONTACT (non-serious) with onset 16Nov2021, outcome "unknown", described as "rest of it just jugged out to the outside of the skin".  Additional information: a very small dose less than 0.1ml went in to the arm so rest of it just jugged (sounds like but wasn't able to verify the spelling) out to the outside of the skin". Reporter thinks should re-give another dose because the first one was even less than one fourth. Reporter just wanted to know if there is any advice we can give her. Pfizer covid-19 vaccine confirmed (purple one).  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Myalgia, Paraesthesia, Pyrexia
Clinical narrative: muscle aches; tingling fingertip; Fever; Moderna COVID-19 booster; Moderna COVID-19 booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Mar2021 11:30 (Lot number: EL3247) as dose 1, single and intramuscular, administered in arm left, administration date 25Mar2021 10:10 (Lot number: EP6955) as dose 2, single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), intramuscular, administered in arm left, administration date 14Nov2021 10:00 (Lot number: 071F21A) as dose 3 (booster), single for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: IMMUNISATION (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 14Nov2021 10:00, outcome "unknown" and all described as "Moderna COVID-19 booster"; PYREXIA (non-serious) with onset 14Nov2021 23:00, outcome "recovered" (Nov2021), described as "Fever"; MYALGIA (non-serious) with onset 15Nov2021, outcome "recovered" (Nov2021), described as "muscle aches"; PARAESTHESIA (non-serious) with onset 15Nov2021, outcome "recovered" (15Nov2021), described as "tingling fingertip". Therapeutic measures were not taken as a result of pyrexia, paraesthesia. Therapeutic measures were taken as a result of myalgia. Additional information: The patient received vaccine at pharmacy or drug store. The symptom of tingling fingertips did not occur till the morning of 15Nov2021. The patient received booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious Covid-19 complications). The patient did not receive any prior vaccinations within 4 weeks and the patient did not have any relevant tests or specific relevant test for thromboembolic events with thrombocytopenia. The patient received treatment with acetaminophen due to event myalgia. It was reported that tingle sensation lasted about 15 minutes. Include and hand and fingertips. Only on right hand. No tingle on left hand or finger. It went away by itself.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: She said her son is feeling very weak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 9-year-old male patient received bnt162b2 (COMIRNATY), administration date 2021 (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: ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "She said her son is feeling very weak".  additional information: Consumer stated her 9-year-old son, and 5-year-old daughter received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine at 10 AM. She said her son was feeling very weak. She wants to know what she should give her child to treat the symptoms.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Condition aggravated, Diarrhoea, Immunisation, Pain
Clinical narrative: Booster dose; Stomach pain; vomiting; diarrhea; Pain; Started her period, that probably makes it worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 38 year-old female patient received bnt162b2 (COMIRNATY) (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.  The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster dose"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "Stomach pain"; VOMITING (non-serious), outcome "unknown", described as "vomiting"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; PAIN (non-serious), outcome "unknown", described as "Pain"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Started her period, that probably makes it worse".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Booster dose; Stomach pain; vomiting; diarrhea; Pain; Started her period, that probably makes it worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 38 year-old female patient received bnt162b2 (COMIRNATY) (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.  The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster dose"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "Stomach pain"; VOMITING (non-serious), outcome "unknown", described as "vomiting"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; PAIN (non-serious), outcome "unknown", described as "Pain"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Started her period, that probably makes it worse".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Limb discomfort, Vaccination site pain
Clinical narrative: booster dose; I cannot lift my arm./I have have been icing my arm since I received the vaccine; pain at injection site.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Nov2021 12:00 (Lot number: FJ1611) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Levaquin, reaction(s): "Allergy", notes: known allergies levaquin. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EWb158, Location of injection: Arm Right), administration date: 15Apr2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6205), administration date: 25Mar2021, for COVID-19 immunization.The following information was reported: IMMUNISATION (non-serious) with onset 15Nov2021, outcome "unknown", described as "booster dose"; LIMB DISCOMFORT (non-serious) with onset 15Nov2021, outcome "not recovered", described as "I cannot lift my arm./I have have been icing my arm since I received the vaccine"; VACCINATION SITE PAIN (non-serious) with onset 15Nov2021, outcome "not recovered", described as "pain at injection site.". Therapeutic measures were not taken as a result of events.  Clinical course:The patient had no  covid  prior  to vaccination and not  tested covid post vaccination. No other vaccine  received in four weeks. It was reported that no results in death, life threatening, Caused/prolonged hosp, Disabling/Incapacitating, Congenital anomaly/birth defect. The patient waited 30 minutes after injection. It has been over 24 hours since the patient had the vaccine and she cannot lift her arm. The patient was awakened last night at 3:00am due to pain at injection site. She have been icing on her arm since she received the vaccine.  Follow-up attempts are completed. No further information is expected
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Immunisation, Movement disorder, Pain, Positron emission tomogram
Clinical narrative: has pain on the right side/was reported as worsened; barely able to move the right arm; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Sep2021 (Lot number: 30130817) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included Breast cancer (unspecified if ongoing); Lymph nodes and the cancer taken out (unspecified if ongoing). There were no concomitant medications. Vaccination history included Bnt162b2 (First Dose Covid-19 shot: 01Mar2021, LOT: EN6205, EXP: Unknown, NDC: Unknown, AE(s) following prior vaccinations: None, Anatomical Location: right shoulder, administration date: 01Mar2021, for COVID-19 immunization, reaction(s): "None"; Bnt162b2 (Second Dose Covid-19 shot: 22Mar2021, LOT: D202HNV, EXP: Unknown, NDC: Unknown, AE(s) following prior vaccinations: None, Anatomical Location: right shoulder), administration date: 22Mar2021, for COVID-19 immunization, reaction(s) None. The following information was reported IMMUNISATION (non-serious) with onset 27Sep2021, outcome unknown, described as Booster; PAIN (non-serious) with onset 28Sep2021, outcome not recovered; MOVEMENT DISORDER (non-serious) with onset 28Sep2021, outcome unknown. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, movement disorder.  Patient stated that she took the shot and she had breast cancer. She was in remission and had been using a garment that was supposed to get the water out of her breast. She didn't know that she could not use the garment for 2 weeks. Right now, she had to go through physical therapy to relive the pain that she had on the right side. She stated that she went to occupational therapy. Patient had pain in the right side. It started the next day after she got the shot. It was in her right arm, up and under the breast and the right side of her back, in that area. It was gotten worse, the pain level. She was barely able to move the right arm. She had to massage it with her left hand some times. Patient was taking pain medication, she was taking Percocet. patient was no longer using the garment because it was making it more painful because of the water build up on that side. She did not have her breast removed, she had lymph nodes and the cancer taken out. Patient did not require emergency room and physician office visit. The patient did not have prior vaccinations within 4 weeks. Patient stated that she had to put it on her shorts and put her arm through and wrap it around.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: aches and pains; slight fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Mar2021 (Lot number: EN6205, Expiration Date: 30Jun2021) at the age of 72 years as dose 1, 0.3 ml single and administered in arm right, administration date 17Feb2021 (Lot number: EL9266, Expiration Date: 31May2021) as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Other than she takes injections with Enbrel every couple of weeks for her Rheumatoid Arthritis. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "aches and pains"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "slight fever". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts completed. No further information expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Immunisation, Pain in extremity
Clinical narrative: As she has pain in her left arm; Short term diarrhea; Covid booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer program (002591). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) at the age of 76 years as dose number unknown (booster), single for covid-19 immunisation; influenza vaccine (FLU), administration date Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported IMMUNISATION (non-serious) with onset Nov2021, outcome unknown; PAIN IN EXTREMITY (non-serious), outcome unknown; DIARRHOEA (non-serious), outcome unknown. Therapeutic measures were taken as a result of pain in extremity, diarrhoea.  Patient reports receiving the flu shot last week and the COVID shot the week before and is having side effects like arm pain and short-term diarrhea. Patient is currently prescribed Xeljanz 5 mg as treatment for the events in extremity, diarrhoea.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Immunisation
Clinical narrative: Booster; Hair started falling out; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included Bnt162b2 (Dose 1, Pfizer BioNTech Covid19 Vaccine), for COVID-19 immunisation, reaction(s) Hair started falling out; Bnt162b2 (Dose 2, Pfizer BioNTech COVID19 Vaccine), for COVID-19 immunisation, reaction(s) Hair started falling out. The following information was reported IMMUNISATION (non-serious), outcome unknown; ALOPECIA (non-serious), outcome unknown. The clinical course included she received all three Pfizer BioNTech Covid19 Vaccine doses, but after the first dose she noticed her hair started falling out. After the second dose, her hair started falling out more. Then it stopped and everything seemed ok. Then she got the booster and her hair started falling out again. She has questions. The caller noticed the hair failing about within a month of the first dose. She noticed hair everywhere. Certainly, after the second dose, it was like woah.   The lot number for bnt162b2 was not provided and will be requested during follow-up. Linked Report(s): US-PFIZER INC-202101595915 same reporter/drug/AE, different patients.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use
Clinical narrative: experiencing like its weird like a sac of fluid underneath in the arm pit / in the arm pit is where I feel like just extra fluid; I have like an extra skin; like a swollen lymph node; little sore to touch; My first dose of the COVID-19 Vaccine was Modern and then for the booster I got Pfizer; My first dose of the COVID-19 Vaccine was Modern and then for the booster I got Pfizer; booster I got Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 09:45 (Lot number: PAA173396) at the age of 41 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: Modern (First dose , Lot #:043LZ, I really don't know if it's 0, looks like 0A), for COVID-19 Immunization; Moderna (Second dose: , Lot: 004M20A), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 13Nov2021, outcome "unknown" and all described as "My first dose of the COVID-19 Vaccine was Modern and then for the booster I got Pfizer"; IMMUNISATION (non-serious) with onset 13Nov2021, outcome "unknown", described as "booster I got Pfizer"; BLISTER (non-serious) with onset 14Nov2021, outcome "not recovered", described as "experiencing like its weird like a sac of fluid underneath in the arm pit / in the arm pit is where I feel like just extra fluid"; SKIN DISORDER (non-serious) with onset 14Nov2021, outcome "not recovered", described as "I have like an extra skin"; LYMPHADENOPATHY (non-serious) with onset 14Nov2021, outcome "not recovered", described as "like a swollen lymph node"; PAIN (non-serious) with onset 14Nov2021, outcome "not recovered", described as "little sore to touch". Therapeutic measures were taken as a result of blister, skin disorder, lymphadenopathy, pain. Additional Information:- No prior vaccination (4 weeks), patient received treatment Advil. Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Skin disorder
Clinical narrative: experiencing like its weird like a sac of fluid underneath in the arm pit / in the arm pit is where I feel like just extra fluid; I have like an extra skin; like a swollen lymph node; little sore to touch; My first dose of the COVID-19 Vaccine was Modern and then for the booster I got Pfizer; My first dose of the COVID-19 Vaccine was Modern and then for the booster I got Pfizer; booster I got Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 09:45 (Lot number: PAA173396) at the age of 41 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: Modern (First dose , Lot #:043LZ, I really don't know if it's 0, looks like 0A), for COVID-19 Immunization; Moderna (Second dose: , Lot: 004M20A), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 13Nov2021, outcome "unknown" and all described as "My first dose of the COVID-19 Vaccine was Modern and then for the booster I got Pfizer"; IMMUNISATION (non-serious) with onset 13Nov2021, outcome "unknown", described as "booster I got Pfizer"; BLISTER (non-serious) with onset 14Nov2021, outcome "not recovered", described as "experiencing like its weird like a sac of fluid underneath in the arm pit / in the arm pit is where I feel like just extra fluid"; SKIN DISORDER (non-serious) with onset 14Nov2021, outcome "not recovered", described as "I have like an extra skin"; LYMPHADENOPATHY (non-serious) with onset 14Nov2021, outcome "not recovered", described as "like a swollen lymph node"; PAIN (non-serious) with onset 14Nov2021, outcome "not recovered", described as "little sore to touch". Therapeutic measures were taken as a result of blister, skin disorder, lymphadenopathy, pain. Additional Information:- No prior vaccination (4 weeks), patient received treatment Advil. Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Pain
Clinical narrative: Swollen lymph node in shot arm; General ache; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 (Lot number: FF8841) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Batch/lot number: EL3247, Route of administration: Intramuscular, Anatomical Location: Arm Left, Dose number: 1), administration date: 20Jan2021, when the patient was 54 years old, for COVID-19 immunisation; Bnt162b2 (Batch/lot number: EL3247, Anatomical Location: Arm Left, Dose number: 2), administration date: 12Feb2021, when the patient was 54 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (non-serious) with onset 16Nov2021 05:00, outcome "recovering", described as "Swollen lymph node in shot arm"; PAIN (non-serious) with onset 16Nov2021 05:00, outcome "recovering", described as "General ache". Therapeutic measures were not taken as a result of lymphadenopathy, pain. Additional information: The patient did receive any other vaccines within 4 weeks prior to the COVID vaccine was unknown. The patient did not any other medications the patient received within 2 weeks of vaccination. The patient prior to vaccination was not diagnosed with COVID-19. The patient not has been since the vaccination, tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation
Clinical narrative: This booster had an additional side effect.  Pain in the arm pit.; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient.   A 62-year-old female patient (not pregnant) received bnt162b2 (BNT162B2, solution for injection), administration date 12Nov2021 at 16:30 (Batch/Lot number: unknown) at the age of 62 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included Thyroid cancer (unspecified if ongoing). Concomitant medication(s) included FLU taken for immunization, administration date 15Oct2021. Vaccination history included Bnt162b2, dose 1 for COVID-19 immunization; Bnt162b2, dose 2 for COVID-19 immunization. The following information was reported IMMUNISATION (non-serious) with onset 12Nov2021 16:30, outcome unknown; AXILLARY PAIN (non-serious) with onset 13Nov2021, outcome recovering. Therapeutic measures were not taken as a result of axillary pain. The patient had adverse events normal side effects, but this booster had an additional side effect. Pain in the arm pit. Adverse event start date was on 13Nov2021. The patient has not had treatment AE. The patient has not had tested covid post vaccination. The patient had no known allergies.  Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Pain in extremity
Clinical narrative: Sore arm; Felt a little tired; Third Pfizer vaccine; This is a spontaneous report from a contactable consumer based on information received by Pfizer from regulatory authority (manufacturer control number: US-AMGEN-USASL2021137858). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number 3, single for covid-19 immunisation. Relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE ONE, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE TWO, SINGLE), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 04Nov2021, outcome "unknown", described as "Third Pfizer vaccine"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown", described as "Felt a little tired".  bnt162b2(BNT162B2) is under agreement with regulatory authority.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation, Joint range of motion decreased, Muscle spasms, Myalgia
Clinical narrative: Booster; Joint pain; Muscle pain; I have infringement and I couldn''t rotate it because cuff causing my shoulders; Vaccine triggered my stupid problem with the rotated cuff and infringement; I have the little bit of sinus but it seems to triggered the pain out of the blue; Muscle spasms at the injection site; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster) single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "voice incomprehensive" (unspecified if ongoing); "shoulder movement" (unspecified if ongoing); "voice distortion" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "I have infringement and I couldn''t rotate it because cuff causing my shoulders; Vaccine triggered my stupid problem with the rotated cuff and infringement"; SINUS PAIN (non-serious), outcome "unknown", described as "I have the little bit of sinus but it seems to triggered the pain out of the blue"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "Muscle spasms at the injection site".  Additional information: Patient completed 3 doses of the Pfizer, have joint pain, muscle pain, patient think in September did third dose (Booster dose). Patient was retired other health provider (Hence reporter type captured in the tab). Patient have a problem with whatever have and then infringement and couldn't rotate it because cuff causing my shoulders. I haven't had it because of that I had to retire, so I haven't had this problem in 9 years but when I had the vaccine I have the little bit of sinus but it seems to triggered the pain out of the blue, and I am having little muscle spasms at the injection site. Is it possible that the vaccine triggered my stupid problem with the rotated cuff and infringement because it just it's been going on for a couple of weeks, should not realize that third dose. Will it just, Is this possible that it triggered I haven't had a problem in years, then out of the blue. I was reviewing the side effects and I am having a problem; It really triggered after my booster.  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.