chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: Mild soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Mar2021 (Lot number: EN6198) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 09Mar2021, outcome "recovered" (11Mar2021), described as "Mild soreness". No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101812560 similar report from same reporter
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Vomiting
Clinical narrative: Mild soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Mar2021 (Lot number: EN6198) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 09Mar2021, outcome "recovered" (11Mar2021), described as "Mild soreness". No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101812560 similar report from same reporter
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: Mild soreness; Had vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Mar2021 (Lot number: EN6208) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Mild Soreness", start date: 09Mar2021, stop date: 11Mar2021, notes: Recovered. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose no:1, lot: EN6198, Route of administration: Right arm), administration date: 08Mar2021, when the patient was 42 years old, for COVID-19 Immunization. The following information was reported: VOMITING (non-serious) with onset 30Mar2021, outcome "recovered" (31Mar2021), described as "Had vomiting"; PAIN (non-serious) with onset 31Mar2021, outcome "recovered" (02Apr2021), described as "Mild soreness". Additional information: The vomiting was only within 24 hours and then felt completely fine and never reported the vomiting because the patient knew nausea was a side effect. By the following day, 31Mar2012 the patient felt good except mild soreness. The patient stated that she recovered completely from vomiting. stated that the soreness began the following day and lasting for three days was what occurred after receiving both the first and second dose Pfizer Covid Vaccine and recovered completely from the soreness.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101812560 similar report from same reporter
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Vomiting
Clinical narrative: Mild soreness; Had vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Mar2021 (Lot number: EN6208) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Mild Soreness", start date: 09Mar2021, stop date: 11Mar2021, notes: Recovered. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose no:1, lot: EN6198, Route of administration: Right arm), administration date: 08Mar2021, when the patient was 42 years old, for COVID-19 Immunization. The following information was reported: VOMITING (non-serious) with onset 30Mar2021, outcome "recovered" (31Mar2021), described as "Had vomiting"; PAIN (non-serious) with onset 31Mar2021, outcome "recovered" (02Apr2021), described as "Mild soreness". Additional information: The vomiting was only within 24 hours and then felt completely fine and never reported the vomiting because the patient knew nausea was a side effect. By the following day, 31Mar2012 the patient felt good except mild soreness. The patient stated that she recovered completely from vomiting. stated that the soreness began the following day and lasting for three days was what occurred after receiving both the first and second dose Pfizer Covid Vaccine and recovered completely from the soreness.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101812560 similar report from same reporter
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Lymphadenopathy, Pain in extremity
Clinical narrative: With the first dose, she only had arm pain. With the second dose, she  had the same arm pain in the same arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27May2021 (Lot number: EW0177) at the age of 45 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 (First dose of the COVID-19 vaccine , Lot Number / Expiry Date: ER8135/ Unknown, Route, Anatomical Location: Left arm), administration date: 06May2021, when the patient was 45 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "With the first dose, she only had arm pain. With the second dose, she  had the same arm pain in the same arm".  Additional information: The patient started doing lymphatic draining massages and used a hot water bag on there to get the swelling down. The swelling was so big she couldn't move her arm. She was in a lot of pain and discomfort. With the second dose, she had the same arm pain in the same arm as her first dose. She confirmed that she had all three doses in her left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200004034 similar report from same reporter
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: With the first dose, she only had arm pain. With the second dose, she  had the same arm pain in the same arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27May2021 (Lot number: EW0177) at the age of 45 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 (First dose of the COVID-19 vaccine , Lot Number / Expiry Date: ER8135/ Unknown, Route, Anatomical Location: Left arm), administration date: 06May2021, when the patient was 45 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "With the first dose, she only had arm pain. With the second dose, she  had the same arm pain in the same arm".  Additional information: The patient started doing lymphatic draining massages and used a hot water bag on there to get the swelling down. The swelling was so big she couldn't move her arm. She was in a lot of pain and discomfort. With the second dose, she had the same arm pain in the same arm as her first dose. She confirmed that she had all three doses in her left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200004034 similar report from same reporter
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Allergy to vaccine, Arthralgia, Pyrexia, Swelling, Urticaria
Clinical narrative: Severe joint swelling; entire body covered in 3 inch thick hives, high fever, severe fatigue. It?s 8 weeks later and I?m still getting new hives and experiencing swelling in various joints.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Joint swelling, Pyrexia, Urticaria
Clinical narrative: Severe joint swelling; entire body covered in 3 inch thick hives, high fever, severe fatigue. It?s 8 weeks later and I?m still getting new hives and experiencing swelling in various joints.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: ADMITTED TO HOSPITAL
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Peripheral coldness
Clinical narrative: Feet and hands are cold; Stomach is a little upset; Bones in arm feel like they are about to burst and break: pain is in the injection arm, the left arm; can't move the arm; Bones in arm feel like they are about to burst and break; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 27Dec2021 17:15 (Lot number: FJ1611) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Osteoporosis" (ongoing), notes: Patient history: Osteoporosis, Additional Information for Other Conditions: Diagnosed six years ago; "covid-19" (unspecified if ongoing), notes: Three weeks ago, she was positive for COVID-19. There were no concomitant medications. The following information was reported: BONE PAIN (non-serious) with onset 27Dec2021, outcome "not recovered", described as "Bones in arm feel like they are about to burst and break"; PERIPHERAL COLDNESS (non-serious) with onset 28Dec2021, outcome "not recovered", described as "Feet and hands are cold"; ABDOMINAL DISCOMFORT (non-serious) with onset 28Dec2021, outcome "not recovered", described as "Stomach is a little upset"; PAIN IN EXTREMITY (non-serious) with onset 27Dec2021, outcome "not recovered", described as "Bones in arm feel like they are about to burst and break: pain is in the injection arm, the left arm"; VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious) with onset 27Dec2021, outcome "unknown", described as "can't move the arm".  Additional information: no other products used by patient. Patient's feet and hands were cold states everyone was warming up her hands and feet. Three weeks ago, she was positive for covid-19. She doesn't know if that makes a different. She didn't receive anything or any medication for testing positive for covid-19. All she did was take house medication for the aches and pains. Rest of her medical conditions are unknown; she doesn't have it with her. She is home in bed. Feet are freezing. Can't move her left arm at all. No additional vaccines administered on same date of the pfizer suspect. Ae(s) did not require a visit to emergency room and physician office. She has never taken a vaccine. Doesn't believe in vaccines. Had to take the covid-19 vaccine for her job. Has never taken a vaccine prior to the first dose covid-19 vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Bone pain, Pain in extremity, Peripheral coldness, Vaccination site movement impairment
Clinical narrative: Feet and hands are cold; Stomach is a little upset; Bones in arm feel like they are about to burst and break: pain is in the injection arm, the left arm; can't move the arm; Bones in arm feel like they are about to burst and break; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 27Dec2021 17:15 (Lot number: FJ1611) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Osteoporosis" (ongoing), notes: Patient history: Osteoporosis, Additional Information for Other Conditions: Diagnosed six years ago; "covid-19" (unspecified if ongoing), notes: Three weeks ago, she was positive for COVID-19. There were no concomitant medications. The following information was reported: BONE PAIN (non-serious) with onset 27Dec2021, outcome "not recovered", described as "Bones in arm feel like they are about to burst and break"; PERIPHERAL COLDNESS (non-serious) with onset 28Dec2021, outcome "not recovered", described as "Feet and hands are cold"; ABDOMINAL DISCOMFORT (non-serious) with onset 28Dec2021, outcome "not recovered", described as "Stomach is a little upset"; PAIN IN EXTREMITY (non-serious) with onset 27Dec2021, outcome "not recovered", described as "Bones in arm feel like they are about to burst and break: pain is in the injection arm, the left arm"; VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious) with onset 27Dec2021, outcome "unknown", described as "can't move the arm".  Additional information: no other products used by patient. Patient's feet and hands were cold states everyone was warming up her hands and feet. Three weeks ago, she was positive for covid-19. She doesn't know if that makes a different. She didn't receive anything or any medication for testing positive for covid-19. All she did was take house medication for the aches and pains. Rest of her medical conditions are unknown; she doesn't have it with her. She is home in bed. Feet are freezing. Can't move her left arm at all. No additional vaccines administered on same date of the pfizer suspect. Ae(s) did not require a visit to emergency room and physician office. She has never taken a vaccine. Doesn't believe in vaccines. Had to take the covid-19 vaccine for her job. Has never taken a vaccine prior to the first dose covid-19 vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Immunisation, Pain in extremity, Product administered at inappropriate site
Clinical narrative: They had the shooting pain down arms and legs because they have a bad back; They had the shooting pain down arms and legs because they have a bad back; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team.  A 72 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 04Apr2021 (Batch/Lot number: unknown) at the age of 71 years as dose 2, single and intramuscular, administration date 06Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Open heart surgery", start date: Jun2014 (unspecified if ongoing), notes: He has had open heart surgery 7-8 years ago.; "Blood pressure" (unspecified if ongoing), notes: He is on heart medications, blood pressure medication, and a pain pill. The patient took concomitant medications. Past drug history included: Varicella (cpox) for IMMUNIZATION. Vaccination history included: Influenza quad adjuvante, administration date: 09Nov2021, for IMMUNIZATION; Influenza quad adjuvante, administration date: 15Dec2020, for IMMUNIZATION; Dtap/ td/ tdap, for IMMUNIZATION; Pneumococcal, for IMMUNIZATION. The following information was reported: BACK PAIN (non-serious), PAIN (non-serious), outcome "unknown" and all described as "They had the shooting pain down arms and legs because they have a bad back".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: They had the shooting pain down arms and legs because they have a bad back; They had the shooting pain down arms and legs because they have a bad back; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team.  A 72 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 04Apr2021 (Batch/Lot number: unknown) at the age of 71 years as dose 2, single and intramuscular, administration date 06Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Open heart surgery", start date: Jun2014 (unspecified if ongoing), notes: He has had open heart surgery 7-8 years ago.; "Blood pressure" (unspecified if ongoing), notes: He is on heart medications, blood pressure medication, and a pain pill. The patient took concomitant medications. Past drug history included: Varicella (cpox) for IMMUNIZATION. Vaccination history included: Influenza quad adjuvante, administration date: 09Nov2021, for IMMUNIZATION; Influenza quad adjuvante, administration date: 15Dec2020, for IMMUNIZATION; Dtap/ td/ tdap, for IMMUNIZATION; Pneumococcal, for IMMUNIZATION. The following information was reported: BACK PAIN (non-serious), PAIN (non-serious), outcome "unknown" and all described as "They had the shooting pain down arms and legs because they have a bad back".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Pain
Clinical narrative: They had the shooting pain down arms and legs because they have a bad back; They had the shooting pain down arms and legs because they have a bad back; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team.  A 72 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 04Apr2021 (Batch/Lot number: unknown) at the age of 71 years as dose 2, single and intramuscular, administration date 06Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Open heart surgery", start date: Jun2014 (unspecified if ongoing), notes: He has had open heart surgery 7-8 years ago.; "Blood pressure" (unspecified if ongoing), notes: He is on heart medications, blood pressure medication, and a pain pill. The patient took concomitant medications. Past drug history included: Varicella (cpox) for IMMUNIZATION. Vaccination history included: Influenza quad adjuvante, administration date: 09Nov2021, for IMMUNIZATION; Influenza quad adjuvante, administration date: 15Dec2020, for IMMUNIZATION; Dtap/ td/ tdap, for IMMUNIZATION; Pneumococcal, for IMMUNIZATION. The following information was reported: BACK PAIN (non-serious), PAIN (non-serious), outcome "unknown" and all described as "They had the shooting pain down arms and legs because they have a bad back".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: bad swelling at my left collar bone; bad swelling in my left arm at the injection site; Bad puffiness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received BNT162B2, administered in arm left, administration date 09Jan2022 12:00 (Lot number: FL3198, Expiry Date: Unknown) at the age of 34 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; AMITRIPTYLINE; TYLENOL; OMEPRAZOLE. Vaccination history included: BNT162B2 (Dose 1, Single, Batch/Lot No: FE3594, Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 19Dec2021, when the patient was 34 years old, for Covid-19 immunization. The following information was reported: SWELLING (non-serious) with onset 10Jan2022 04:00, outcome "not recovered", described as "bad swelling at my left collar bone"; VACCINATION SITE SWELLING (non-serious) with onset 10Jan2022 04:00, outcome "not recovered", described as "bad swelling in my left arm at the injection site"; SWELLING (non-serious) with onset 10Jan2022 04:00, outcome "not recovered", described as "Bad puffiness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of swelling, vaccination site swelling, swelling. Additional Information: Patient did not received did not received other vaccine in four week. Patient did not received Covid prior vaccination. Patient tested Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Swelling, Vaccination site swelling
Clinical narrative: bad swelling at my left collar bone; bad swelling in my left arm at the injection site; Bad puffiness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received BNT162B2, administered in arm left, administration date 09Jan2022 12:00 (Lot number: FL3198, Expiry Date: Unknown) at the age of 34 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; AMITRIPTYLINE; TYLENOL; OMEPRAZOLE. Vaccination history included: BNT162B2 (Dose 1, Single, Batch/Lot No: FE3594, Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 19Dec2021, when the patient was 34 years old, for Covid-19 immunization. The following information was reported: SWELLING (non-serious) with onset 10Jan2022 04:00, outcome "not recovered", described as "bad swelling at my left collar bone"; VACCINATION SITE SWELLING (non-serious) with onset 10Jan2022 04:00, outcome "not recovered", described as "bad swelling in my left arm at the injection site"; SWELLING (non-serious) with onset 10Jan2022 04:00, outcome "not recovered", described as "Bad puffiness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of swelling, vaccination site swelling, swelling. Additional Information: Patient did not received did not received other vaccine in four week. Patient did not received Covid prior vaccination. Patient tested Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Covid vaccine monitoring documentation. PT admission 1/15/22 ? 1/19/22. COVID-19, mRNA, LNP-S, PF, 30 mcg/0.3 mL dose (PFIZER) 02/28/2021 PFIZER, INC lot EN6198. COVID-19, mRNA, LNP-S, PF, 30 mcg/0.3 mL dose (PFIZER) 3/21/2021 PFIZER, INC lot EN6199.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Covid vaccine monitoring documentation. PT admission 1/15/22 ? 1/19/22. COVID-19, mRNA, LNP-S, PF, 30 mcg/0.3 mL dose (PFIZER) 02/28/2021 PFIZER, INC lot EN6198. COVID-19, mRNA, LNP-S, PF, 30 mcg/0.3 mL dose (PFIZER) 3/21/2021 PFIZER, INC lot EN6199.
Age: 73.0
Sex: M
Vaccine: PPV, PNC20
Symptoms: Erythema, Infection, Pain in extremity, Swelling
Clinical narrative: He is complaining that the right arm where he received the shot is sore, and turned dark red.; He is complaining that the right arm where he received the shot is sore, and turned dark red.; His right arm also,  feels hot, stiff, and tight; His right arm also,  feels hot, stiff, and tight; His right arm also,  feels hot, stiff, and tight; This is a spontaneous report received from a contactable Consumer. The reporter is the patient.  A 72 year-old male patient received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20), administration date 04Feb2022 (Batch/Lot number: unknown) at the age of 73 years as unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION SITE DISCOLOURATION (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "He is complaining that the right arm where he received the shot is sore, and turned dark red."; FEELING HOT (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious), MUSCULOSKELETAL DISORDER (non-serious), outcome "unknown" and all described as "His right arm also,  feels hot, stiff, and tight".  Additional information: patient had the shot on Friday afternoon. He was complaining that the right arm where he received the shot was sore, and turned dark red. He put marks around it and it has spread around his whole arm, almost like an old fashion measles shot.  His right arm also, feels hot, stiff, and tight. Patient was told that it would be sore by the pharmacist. Stated that on Saturday that the area was sore and turned red so he put marks to see if it got bigger. Stated that it spread all the way across his arm. Stated that the injection site was red and dark red like an old fashioned small pox vaccine is. Stated that is what it looked like.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: M
Vaccine: PPV, PNC20
Symptoms: Feeling hot, Musculoskeletal disorder, Musculoskeletal stiffness, Vaccination site discolouration, Vaccination site pain
Clinical narrative: He is complaining that the right arm where he received the shot is sore, and turned dark red.; He is complaining that the right arm where he received the shot is sore, and turned dark red.; His right arm also,  feels hot, stiff, and tight; His right arm also,  feels hot, stiff, and tight; His right arm also,  feels hot, stiff, and tight; This is a spontaneous report received from a contactable Consumer. The reporter is the patient.  A 72 year-old male patient received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20), administration date 04Feb2022 (Batch/Lot number: unknown) at the age of 73 years as unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION SITE DISCOLOURATION (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "He is complaining that the right arm where he received the shot is sore, and turned dark red."; FEELING HOT (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious), MUSCULOSKELETAL DISORDER (non-serious), outcome "unknown" and all described as "His right arm also,  feels hot, stiff, and tight".  Additional information: patient had the shot on Friday afternoon. He was complaining that the right arm where he received the shot was sore, and turned dark red. He put marks around it and it has spread around his whole arm, almost like an old fashion measles shot.  His right arm also, feels hot, stiff, and tight. Patient was told that it would be sore by the pharmacist. Stated that on Saturday that the area was sore and turned red so he put marks to see if it got bigger. Stated that it spread all the way across his arm. Stated that the injection site was red and dark red like an old fashioned small pox vaccine is. Stated that is what it looked like.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Blood pressure measurement, Breast tenderness, Cardiac disorder, Chest discomfort
Clinical narrative: Breast tenderness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Dec2021 (Lot number: 301358M) as dose 2, single and administered in arm left, administration date 08Oct2021 12:00 (Lot number: EVV0185) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BREAST TENDERNESS (non-serious) with onset 2021, outcome "not recovered", described as "Breast tenderness".  Additional information: Caller stated that she has three other women that have had breast tenderness from this. Patient had breast tenderness and well after 1st shot of vaccine. Two month later, patient still have tenderness that was uncomfortable, many other who patient talked have this pain. More importantly, patient had heart issues for 4 weeks after the 2nd dose. patient felt pain in chest that was severe. There were nights when I felt live I was going to die in my sleep. Had to see cardiologist. I know other people who had same.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101878634 Same reporter/ drug/ event for different patients.;US-PFIZER INC-202101878670 Same reporter/ drug/ event for different patients.;US-PFIZER INC-202101877385 Same reporter/ drug/ event for different patients.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Inappropriate schedule of product administration, Insomnia
Clinical narrative: Breast tenderness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Dec2021 (Lot number: 301358M) as dose 2, single and administered in arm left, administration date 08Oct2021 12:00 (Lot number: EVV0185) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BREAST TENDERNESS (non-serious) with onset 2021, outcome "not recovered", described as "Breast tenderness".  Additional information: Caller stated that she has three other women that have had breast tenderness from this. Patient had breast tenderness and well after 1st shot of vaccine. Two month later, patient still have tenderness that was uncomfortable, many other who patient talked have this pain. More importantly, patient had heart issues for 4 weeks after the 2nd dose. patient felt pain in chest that was severe. There were nights when I felt live I was going to die in my sleep. Had to see cardiologist. I know other people who had same.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101878634 Same reporter/ drug/ event for different patients.;US-PFIZER INC-202101878670 Same reporter/ drug/ event for different patients.;US-PFIZER INC-202101877385 Same reporter/ drug/ event for different patients.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast tenderness
Clinical narrative: Breast tenderness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Dec2021 (Lot number: 301358M) as dose 2, single and administered in arm left, administration date 08Oct2021 12:00 (Lot number: EVV0185) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BREAST TENDERNESS (non-serious) with onset 2021, outcome "not recovered", described as "Breast tenderness".  Additional information: Caller stated that she has three other women that have had breast tenderness from this. Patient had breast tenderness and well after 1st shot of vaccine. Two month later, patient still have tenderness that was uncomfortable, many other who patient talked have this pain. More importantly, patient had heart issues for 4 weeks after the 2nd dose. patient felt pain in chest that was severe. There were nights when I felt live I was going to die in my sleep. Had to see cardiologist. I know other people who had same.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101878634 Same reporter/ drug/ event for different patients.;US-PFIZER INC-202101878670 Same reporter/ drug/ event for different patients.;US-PFIZER INC-202101877385 Same reporter/ drug/ event for different patients.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Arrhythmia; I have numbness in my right arm and fingertips; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 21Feb2022 16:30 (Lot number: Fj5683) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Arrhythmia- still performing test" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "covid" (unspecified if ongoing). No other vaccine in four weeks. Prior to vaccination, the patient was diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. Concomitant medication(s) received within two weeks included: NAPROXEN [NAPROXEN SODIUM]; CYCLOBENZAPRINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: El8982, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 09Feb2021, when the patient was 40 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: El3249, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 19Jan2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: ARRHYTHMIA (medically significant) with onset 21Feb2022 16:45, outcome "not recovered", described as "Arrhythmia"; HYPOAESTHESIA (non-serious) with onset 21Feb2022 16:45, outcome "not recovered", described as "I have numbness in my right arm and fingertips". The events "arrhythmia" and "i have numbness in my right arm and fingertips" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of arrhythmia, hypoaesthesia.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arrhythmia, Hypoaesthesia
Clinical narrative: Arrhythmia; I have numbness in my right arm and fingertips; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 21Feb2022 16:30 (Lot number: Fj5683) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Arrhythmia- still performing test" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "covid" (unspecified if ongoing). No other vaccine in four weeks. Prior to vaccination, the patient was diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. Concomitant medication(s) received within two weeks included: NAPROXEN [NAPROXEN SODIUM]; CYCLOBENZAPRINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: El8982, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 09Feb2021, when the patient was 40 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: El3249, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 19Jan2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: ARRHYTHMIA (medically significant) with onset 21Feb2022 16:45, outcome "not recovered", described as "Arrhythmia"; HYPOAESTHESIA (non-serious) with onset 21Feb2022 16:45, outcome "not recovered", described as "I have numbness in my right arm and fingertips". The events "arrhythmia" and "i have numbness in my right arm and fingertips" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of arrhythmia, hypoaesthesia.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Alopecia totalis, Cardiac disorder
Clinical narrative: Her hair fell out after taking the 2nd dose of the Pfizer vaccine/having issues with the 2nd dose; Eyelashes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (002591). The reporter is the patient.  A 71-year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 71 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 (1st Dose), administration date: 2021, when the patient was 71 years old, for COVID-19 Immunization. The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "unknown", described as "Her hair fell out after taking the 2nd dose of the Pfizer vaccine/having issues with the 2nd dose"; EYE DISORDER (non-serious) with onset 2021, outcome "unknown", described as "Eyelashes". Therapeutic measures were taken as a result of alopecia, eye disorder.  Additional Information: Attempted transfer from Withheld with Support Services CEP 2591. Transfer agent has a patient on the other line who indicated that she needed Xeljanz and she takes it to help her eyelashes and her hair fell out after taking the 2nd dose of the Pfizer vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Eye disorder
Clinical narrative: Her hair fell out after taking the 2nd dose of the Pfizer vaccine/having issues with the 2nd dose; Eyelashes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (002591). The reporter is the patient.  A 71-year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 71 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 (1st Dose), administration date: 2021, when the patient was 71 years old, for COVID-19 Immunization. The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "unknown", described as "Her hair fell out after taking the 2nd dose of the Pfizer vaccine/having issues with the 2nd dose"; EYE DISORDER (non-serious) with onset 2021, outcome "unknown", described as "Eyelashes". Therapeutic measures were taken as a result of alopecia, eye disorder.  Additional Information: Attempted transfer from Withheld with Support Services CEP 2591. Transfer agent has a patient on the other line who indicated that she needed Xeljanz and she takes it to help her eyelashes and her hair fell out after taking the 2nd dose of the Pfizer vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Excessive and consistent vaginal bleeding since 11Dec2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Nov2021 15:00 (Lot number: FH8027) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8733, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 30Mar2021, when the patient was 46 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6706, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 09Mar2021, when the patient was 46 years old, for COVID-19 immunization. The following information was reported: VAGINAL HAEMORRHAGE (medically significant) with onset 11Dec2021 10:00, outcome "not recovered", described as "Excessive and consistent vaginal bleeding since 11Dec2021". The event "excessive and consistent vaginal bleeding since 11dec2021" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Jan2022) positive. Therapeutic measures were taken as progesterone treatment as result of vaginal haemorrhage.  Clinical course: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. No prolonged hospitalization.  Follow-up attempts completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Vaginal haemorrhage
Clinical narrative: Excessive and consistent vaginal bleeding since 11Dec2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Nov2021 15:00 (Lot number: FH8027) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8733, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 30Mar2021, when the patient was 46 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6706, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 09Mar2021, when the patient was 46 years old, for COVID-19 immunization. The following information was reported: VAGINAL HAEMORRHAGE (medically significant) with onset 11Dec2021 10:00, outcome "not recovered", described as "Excessive and consistent vaginal bleeding since 11Dec2021". The event "excessive and consistent vaginal bleeding since 11dec2021" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Jan2022) positive. Therapeutic measures were taken as progesterone treatment as result of vaginal haemorrhage.  Clinical course: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. No prolonged hospitalization.  Follow-up attempts completed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: No adverse event reported. Pt may have received expired vaccine and this is why Pharmacy has me reporting this as a VAERS.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: No adverse event reported. Pt may have received expired vaccine and this is why Pharmacy has me reporting this as a VAERS.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Urticaria
Clinical narrative: Urticaria rash started on 1/29/22 and since that time has developed dermatographism.on her upper back.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: My right side since the morning of 03/14/2022 is numb, especially my mouth area, the corner, and jaw area, and I have a severe headache that started the 03/15/2022.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported.; expired dose; This spontaneous report was received from registered nurse, referring to a 50-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 25-FEB-2022, the patient was vaccinated with expired pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (0.5 ml, lot # S029542, expiration date 10-JUN-2021, strength and route were not provided) for prophylaxis (expired product administered) in the office. No other information given. No additional adverse events reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE details; administered an expired dose of MMR-II; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 28-FEB-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human albumin (M-M-R II) 0.5 milliliter, lot #S036664, expiration date: 14-NOV-2021 (Expired product administered) (strength, dose number, site and route of administration were not provided) for prophylaxis.  No adverse events were reported (No adverse event).