chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Blood test, Computerised tomogram, Dizziness, Electroencephalogram
Clinical narrative: Light headedness; Headache/stabbing pain at the front of her head near her temples; 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 17 year-old female patient received bnt162b2 (BNT162B2), administration date 22Dec2021 (Lot number: FE3594) 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: Unknown, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Light headedness"; HEADACHE (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Headache/stabbing pain at the front of her head near her temples". The events "light headedness" and "headache/stabbing pain at the front of her head near her temples" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache.  Additional Information: It was reported that, her 17-year-old daughter received the Pfizer Covid19 Booster shot on 22Dec2021, 2 weeks later her daughter developed headache, light headedness which is intermittent at the beginning then progressed to constant headache. It described as stabbing pain at the front of her head near her temples. it only improves slightly for few hours and then it will go back to intense pain. It was also stated, they were seen 2 neurologists, they were in the emergency room twice, they had multiple testing done. Upon follow-up (16Feb2022) Updated information Included: Reporter address, Lab Test, Dosage Regimens (Lot Number), Event onset Date. It was reported that, it started 7Jan2022 and by 27Jan2022 has not left. States she has had CT, MRI and MRA and just did last night an overnight EEG that they don't have the results for. She relays the pain is the front of her head near her temples and it was a stabbing pain. States it was a 4 when she takes some meloxicam medication and a couple hours later is back to a 7 or 8.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging, Pain assessment
Clinical narrative: Light headedness; Headache/stabbing pain at the front of her head near her temples; 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 17 year-old female patient received bnt162b2 (BNT162B2), administration date 22Dec2021 (Lot number: FE3594) 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: Unknown, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Light headedness"; HEADACHE (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Headache/stabbing pain at the front of her head near her temples". The events "light headedness" and "headache/stabbing pain at the front of her head near her temples" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache.  Additional Information: It was reported that, her 17-year-old daughter received the Pfizer Covid19 Booster shot on 22Dec2021, 2 weeks later her daughter developed headache, light headedness which is intermittent at the beginning then progressed to constant headache. It described as stabbing pain at the front of her head near her temples. it only improves slightly for few hours and then it will go back to intense pain. It was also stated, they were seen 2 neurologists, they were in the emergency room twice, they had multiple testing done. Upon follow-up (16Feb2022) Updated information Included: Reporter address, Lab Test, Dosage Regimens (Lot Number), Event onset Date. It was reported that, it started 7Jan2022 and by 27Jan2022 has not left. States she has had CT, MRI and MRA and just did last night an overnight EEG that they don't have the results for. She relays the pain is the front of her head near her temples and it was a stabbing pain. States it was a 4 when she takes some meloxicam medication and a couple hours later is back to a 7 or 8.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: experienced arm soreness after both doses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 37 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "receiving the first dose, the person who injected the needle (i.e., vaccine) did it "wrong" or "at an angle" and made the arm bleed slightly"; Bnt162b2 (Dose1), for COVID-19 immunization, reaction(s): "experienced arm soreness for the next couple of days/ arm soreness after both doses", "receiving the first dose, the person who injected the needle (i.e., vaccine) did it "wrong" or "at an angle" and made the arm bleed slightly". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "experienced arm soreness after both doses". Additional information: Sister of reporter received the Pfizer COVID-19 booster: Individual experienced vomiting and spiked a high fever, body aches; "felt like she had a stomach virus during the night and one day of flu-like symptoms the next day"; whole body was sore, no localized arm soreness; chills, fever, throwing up. Reporter received Pfizer COVID-19 doses 1 and 2: experienced arm soreness after both doses. When receiving the first dose, the person who injected the needle (i.e., vaccine) did it "wrong" or "at an angle" and made the arm bleed slightly: "went it at an angle" stabbed me a little"; experienced arm soreness for the next couple of days.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Gastroenteritis viral, Influenza like illness, Pain
Clinical narrative: vomiting; spiked a high fever; body aches/whole body was sore; felt like she had a stomach virus; flu-like symptoms; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (173415).  A female patient received bnt162b2 (BNT162B2) (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 (Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "vomiting"; PYREXIA (non-serious), outcome "unknown", described as "spiked a high fever"; PAIN (non-serious), outcome "unknown", described as "body aches/whole body was sore"; GASTROENTERITIS VIRAL (non-serious), outcome "unknown", described as "felt like she had a stomach virus"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu-like symptoms"; CHILLS (non-serious), outcome "unknown", described as "chills". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Sister of reporter had strong side effects after receiving Pfizer Covid-19 Booster. Individual experienced vomiting and spiked a high fever, body aches; "felt like she had a stomach virus during the night and one day of flu-like symptoms the next day"; whole body was sore, no localized arm soreness; chills, fever, throwing up. 37-Year-old female reporter received Pfizer COVID-19 doses 1 and 2: experienced arm soreness after both doses. When receiving the first dose, the person who injected the needle (i.e., vaccine) did it "wrong" or "at an angle" and made the arm bleed slightly: "went it at an angle/" stabbed reporter a little" ; experienced arm soreness for the next couple of days.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: vomiting; spiked a high fever; body aches/whole body was sore; felt like she had a stomach virus; flu-like symptoms; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (173415).  A female patient received bnt162b2 (BNT162B2) (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 (Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "vomiting"; PYREXIA (non-serious), outcome "unknown", described as "spiked a high fever"; PAIN (non-serious), outcome "unknown", described as "body aches/whole body was sore"; GASTROENTERITIS VIRAL (non-serious), outcome "unknown", described as "felt like she had a stomach virus"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu-like symptoms"; CHILLS (non-serious), outcome "unknown", described as "chills". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Sister of reporter had strong side effects after receiving Pfizer Covid-19 Booster. Individual experienced vomiting and spiked a high fever, body aches; "felt like she had a stomach virus during the night and one day of flu-like symptoms the next day"; whole body was sore, no localized arm soreness; chills, fever, throwing up. 37-Year-old female reporter received Pfizer COVID-19 doses 1 and 2: experienced arm soreness after both doses. When receiving the first dose, the person who injected the needle (i.e., vaccine) did it "wrong" or "at an angle" and made the arm bleed slightly: "went it at an angle/" stabbed reporter a little" ; experienced arm soreness for the next couple of days.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Electrocardiogram abnormal, Palpitations, SARS-CoV-2 test
Clinical narrative: abnormal EKG; had a very hard heart beat which is sometimes racing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Mar2021 09:00 (Lot number: EN6206) at the age of 32 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "PCOS" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9266, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 23Feb2021, when the patient was 32 years old, for Covid-19 Immunization.  The following information was reported: ELECTROCARDIOGRAM ABNORMAL (non-serious) with onset 20Mar2021, outcome "not recovered", described as "abnormal EKG"; PALPITATIONS (non-serious) with onset 20Mar2021, outcome "not recovered", described as "had a very hard heart beat which is sometimes racing". The events "abnormal ekg" and "had a very hard heart beat which is sometimes racing" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: electrocardiogram: (unspecified date) abnormal; sars-cov-2 test: (07Jan2022) negative, notes: Nasal swab. Therapeutic measures were taken as a result of electrocardiogram abnormal, palpitations.  Additional information: Therapeutic measures included wearing heart rate monitor & echocardiogram. Prior to the vaccine the patient had no heart issues. The patient now have seen a specialist and may need ablasion surgery. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Any other medications the patient received within 2 weeks of vaccination was Birth control. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pain, Swelling face
Clinical narrative: Soreness; puffy face; headache; flu-like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4541469 (RA).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OCREVUS. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Soreness"; SWELLING FACE (non-serious), outcome "unknown", described as "puffy face"; HEADACHE (non-serious), outcome "unknown", described as "headache"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu-like symptoms".  Additional information: Patient's concurrent condition was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Tooth disorder
Clinical narrative: Her husband is unable to get the 2nd shot and was recommended by his cardiologist because he has a tooth that needs to be worked on; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2) (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: TOOTH DISORDER (non-serious), outcome "unknown", described as "Her husband is unable to get the 2nd shot and was recommended by his cardiologist because he has a tooth that needs to be worked on". The event "her husband is unable to get the 2nd shot and was recommended by his cardiologist because he has a tooth that needs to be worked on" was evaluated at the physician office visit.  Additional information: The reporter wanted to know how much protection one shot can give. She mentioned that her husband was unable to get the 2nd shot and was recommended by his cardiologist because he had a tooth that needed to be worked on.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test, Vomiting
Clinical narrative: nausea; My 6yr. Vomited twice after the first dose and has vomited 11 times since the second dose.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 6 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Jan2022 10:00 (Lot number: FL8094) at the age of 6 years as dose 2 (tris), single and administered in arm left, administration date 03Jan2022 10:00 (Lot number: FL0007) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 07Jan2022 07:00, outcome "not recovered", described as "nausea"; VOMITING (non-serious) with onset 07Jan2022 07:00, outcome "not recovered", described as "My 6yr. Vomited twice after the first dose and has vomited 11 times since the second dose.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nausea, vomiting.  Additional information: Both my children (6yr & 8yr) received their Covid-19 vaccines the same day at the same pharmacy. They both are showing signs of vomiting. Once they vomit they feel fine. They aren't showing any other signs or symptoms of illness. The rest of our family continues to be healthy, but these two kids have been sick since they started with their vaccines. My 6yr. Vomited twice after the first dose and has vomited 11 times since the second dose. My 8yr has vomited 3 times with only the second dose. No other symptoms but nausea and vomiting on and off for both kids. These symptoms have been going on for weeks and the only thing I can trace it back to that they have in common is the vaccine. Nothing has been changed in their diet or medications since they received both doses.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200287282 same reporter drug AE different pt
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea, SARS-CoV-2 test negative, Vomiting
Clinical narrative: nausea; My 8yr has vomited 3 times with only the second dose; these two kids have been sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the parent.  A 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Jan2022 10:00 (Lot number: FL8094) at the age of 9 years as dose 2 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product=COVID 19, prev dose brand=pfizer, prev dose brand unknown=False, prev dose lot number=FL0007, prev dose administration time=10:00 AM, prev dose dose number=1, prev dose vaccine location=Left arm), administration date: 03Jan2022, for COVID-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 14Feb2022 17:00, outcome "not recovered", described as "nausea"; VOMITING (non-serious) with onset 14Feb2022 17:00, outcome "not recovered", described as "My 8yr has vomited 3 times with only the second dose"; ILLNESS (non-serious) with onset 14Feb2022 17:00, outcome "not recovered", described as "these two kids have been sick". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nausea, illness.  Additional information: Patient did not receive any other vaccines within 4 weeks. Patient did not receive any other medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.Reporter stated both my children (6yr and 8yr) received their Covid-19 vaccines on the same day.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200286921 same reporter drug AE different pt
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dry skin, Inappropriate schedule of product administration, Rash erythematous, SARS-CoV-2 test positive
Clinical narrative: my face and hands have gotten progressively worse; my skin is constantly peeling and having red rashes show up; my skin is constantly peeling and having red rashes show up; my face and hands have gotten progressively worse; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Jan2022 12:00 (Lot number: 30130BA) at the age of 21 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 1 diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: HUMALOG; TRESIBA; PHENTERMINE. Vaccination history included: Bnt162b2 (Dose 1, Prev dose lot number= 30130BA, Prev dose administration date=08Sep2021, Prev dose administration time=01:00 PM, Prev dose vaccine location=Right arm), administration date: 08Sep2021, when the patient was 20 years old, for COVID-19 immunization, reaction(s): "My skin on my face and hands dried out ", "peeling and burning". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 27Jan2022 12:00, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; DRY SKIN (non-serious), outcome "not recovered", SKIN EXFOLIATION (non-serious), RASH ERYTHEMATOUS (non-serious), outcome "not recovered" and all described as "my skin is constantly peeling and having red rashes show up"; CONDITION AGGRAVATED (non-serious) with onset 15Feb2022, outcome "not recovered", described as "my face and hands have gotten progressively worse". The events "my face and hands have gotten progressively worse", "my skin is constantly peeling and having red rashes show up", "my skin is constantly peeling and having red rashes show up" and "my face and hands have gotten progressively worse" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of inappropriate schedule of product administration, dry skin, skin exfoliation, rash erythematous, condition aggravated.  Additional information: Patient reported it did not occur until 4 days after initial dose. My skin on my face and hands dried out so bad that it started peeling and burning. Nothing made it better. Still to this day on 15Feb2022 my face and hands have gotten progressively worse. I can not wear any makeup at all because my skin was constantly peeling and having red rashes show up.Patient ad not received any other vaccine in four days. Patient did not had Covid prior vaccination. Patient tested covid  post vaccination. Patient had no known allergies. The event not resulted in doctor or other healthcare professional office/clinic visit.  No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Skin exfoliation
Clinical narrative: my face and hands have gotten progressively worse; my skin is constantly peeling and having red rashes show up; my skin is constantly peeling and having red rashes show up; my face and hands have gotten progressively worse; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Jan2022 12:00 (Lot number: 30130BA) at the age of 21 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 1 diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: HUMALOG; TRESIBA; PHENTERMINE. Vaccination history included: Bnt162b2 (Dose 1, Prev dose lot number= 30130BA, Prev dose administration date=08Sep2021, Prev dose administration time=01:00 PM, Prev dose vaccine location=Right arm), administration date: 08Sep2021, when the patient was 20 years old, for COVID-19 immunization, reaction(s): "My skin on my face and hands dried out ", "peeling and burning". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 27Jan2022 12:00, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; DRY SKIN (non-serious), outcome "not recovered", SKIN EXFOLIATION (non-serious), RASH ERYTHEMATOUS (non-serious), outcome "not recovered" and all described as "my skin is constantly peeling and having red rashes show up"; CONDITION AGGRAVATED (non-serious) with onset 15Feb2022, outcome "not recovered", described as "my face and hands have gotten progressively worse". The events "my face and hands have gotten progressively worse", "my skin is constantly peeling and having red rashes show up", "my skin is constantly peeling and having red rashes show up" and "my face and hands have gotten progressively worse" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of inappropriate schedule of product administration, dry skin, skin exfoliation, rash erythematous, condition aggravated.  Additional information: Patient reported it did not occur until 4 days after initial dose. My skin on my face and hands dried out so bad that it started peeling and burning. Nothing made it better. Still to this day on 15Feb2022 my face and hands have gotten progressively worse. I can not wear any makeup at all because my skin was constantly peeling and having red rashes show up.Patient ad not received any other vaccine in four days. Patient did not had Covid prior vaccination. Patient tested covid  post vaccination. Patient had no known allergies. The event not resulted in doctor or other healthcare professional office/clinic visit.  No follow-up attempts are possible. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus tachycardia
Clinical narrative: sinus tachycardia; 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 20 year-old female patient received bnt162b2 (BNT162B2), administration date 14Aug2021 (Lot number: FA7485) as dose 2, single and administration date 17Jul2021 (Lot number: FA6780) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Robust antibodies" (unspecified if ongoing), notes: my daughter who was actually had Robust antibodies on her prior infection. The patient's concomitant medications were not reported. The following information was reported: SINUS TACHYCARDIA (non-serious), outcome "unknown", described as "sinus tachycardia". The event "sinus tachycardia" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of sinus tachycardia.  Additional information: Caller was asking for how long the Pfizer covid-19 vaccine (gray cap) unpunctured, could be stored in the refrigerator after the deep freeze. Caller ended the call before the agent finish the closing spiel. Caller said, 5 days when it first came out. Caller is referring to the Pfizer covid-19 vaccine (gray cap) storage in the refrigerator. Caller asked if the first two doses of the Pfizer covid-19 vaccine make you sick, is it ok for you to take the booster (Not verified if she was referring to her experience). Reporter called on behalf of daughter. Patient was actually had Robust antibodies on her prior infection, (Further clarification unknown) was coerced to take 2 shots of the emergency use authorization vaccine not the one that was approved by the FDA and she ended up in the emergency room not once but twice and she is now on a beta blockers (Treatment) and was diagnosed with sinus tachycardia and her cardiologist said this was as the result of the drug that medication when she took. When paraphrased the above concern, Reporter also wanted to know what happens now like they were telling, she was only 20 years old, they were saying the school that she goes to says now she needs to get the booster and she was afraid. Treatment: Reporter stated, it was called the beta blocker, Caller did not know the actual brand name, Metoprolol Tartrate 25 mg, twice a day, orally. Well this an ongoing thing now.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes virus infection
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced herpes virus infection (since the COVID-19 vaccination, noticed an increase in herpes outbreaks), with outcome of unknown. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Pain in extremity, Product preparation error
Clinical narrative: sore arm, left deltoid; received  the correct doses from an undiluted Vaccine vial; received  the correct doses from an undiluted Vaccine vial yesterday; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team.  A 5 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 16Feb2022 14:45 (Lot number: FL8095, Expiration Date: 31Mar2022) at the age of 5 years as dose 1, 0.2 ml single for covid-19 immunisation. Relevant medical history included: "allergies" (unspecified if ongoing); "compromised immune status" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "genetic/chromosomal abnormalities" (unspecified if ongoing); "endocrine abnormalities (including diabetes)" (unspecified if ongoing); "endocrine abnormalities (including diabetes)" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: OVERDOSE (non-serious) with onset 16Feb2022 14:45, outcome "unknown", described as "received the correct doses from an undiluted Vaccine vial"; PRODUCT PREPARATION ERROR (non-serious) with onset 16Feb2022 14:45, outcome "unknown", described as "received the correct doses from an undiluted Vaccine vial yesterday"; PAIN IN EXTREMITY (non-serious) with onset 17Feb2022, outcome "not recovered", described as "sore arm, left deltoid".  Additional information: There was no family medical history relevant to AE. Reported they had an error with the Pfizer Pediatric COVID-19 Vaccine. It was administered undiluted. Seriousness criteria caller stated as not serious. He just had a sore arm this morning (at the time of report). No relevant tests. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Relatedness of drug to events 'administered Undiluted Pfizer Pediatric COVID-19 Vaccine' and 'sore arm, left deltoid' was assessed as related.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200291857 same product and event, different patient
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness
Clinical narrative: Today was the latest and the worst.; Have been lightheaded to the point of almost passing out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Jan2022 (Batch/Lot number: unknown) at the age of 67 years 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: Zpak for Known allergies: zpak, notes: Known allergies: zpak. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), for COVID-19 immunization, reaction(s): "Covid test result=Positive", "Covid test result=Positive"; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), for COVID-19 immunization, reaction(s): "Covid test result=Positive", "Covid test result=Positive". The following information was reported: DIZZINESS (non-serious) with onset 24Jan2022, outcome "unknown", described as "Have been lightheaded to the point of almost passing out"; CONDITION AGGRAVATED (non-serious) with onset 17Feb2022, outcome "unknown", described as "Today was the latest and the worst.". Therapeutic measures were not taken as a result of dizziness, condition aggravated.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient has been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin discolouration
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (patient). Case identifier: NUS2022US023693_NC. A 71-year-old male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 71, Dec 2021, single dose, for COVID-19 immunisation. Medical history not reported. Concomitant medication: Ramipril. Vaccination history included the COVID-19 vaccine (primary immunization series complete, manufacturer unknown), for COVID-19 immunization. The patient developed a rash (non-serious), with outcome of recovering; pruritus/itching to his lower extremities below the knee to the ankles, with outcome of recovered and skin discoloration/skin still discolored at the rash site (non-serious), with outcome of not recovered. Therapeutic measures were taken as a result of rash, pruritus and skin discoloration. Additional information: The patient currently using a steroid cream on the rash and improving. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness
Clinical narrative: This is a spontaneous report received from contactable other HCP/consumer or other non-HCP, for a Pfizer sponsored program (060820). A 52-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included unknown dose number of the COVID-19 vaccine (manufacturer unknown), for COVID-19 immunisation. The patient experienced illness (felt sick) and chills (non-serious), with outcome of recovered. Additional information: Patient is taking Ibrance 125mg tablet by mouth daily, skip 4th day for 21 days on and 7 days off in conjunction with anastrozole by mouth as verbally instructed by MD (Nov 2021). Prescription: Ibrance 125mg tablet by mouth daily for 21 days on and 7 days off in conjunction with anastrozole by mouth as prescribed by MD. After the start of therapy, patient received COVID-19 booster vaccine on an unknown date. She felt "sick" and experienced chills (date of onset unknown), causing patient to electively skip one dose of Ibrance due to symptoms. No additional symptoms experienced due to missed dose. Her symptoms have now resolved. MD aware. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Pain
Clinical narrative: could not walk; achy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 53 year-old male patient received bnt162b2 (BNT162B2), administration date 02May2021 (Batch/Lot number: unknown) at the age of 53 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT INABILITY (non-serious), outcome "unknown", described as "could not walk"; PAIN (non-serious), outcome "unknown", described as "achy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, X-ray
Clinical narrative: Whereas arm pain from the first two shots was not felt until later that day and went away in a couple of days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Jan2021 (Lot number: EN5318) as dose 1, single and intramuscular, administered in arm left, administration date 20Feb2021 (Lot number: EN6203) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Whereas arm pain from the first two shots was not felt until later that day and went away in a couple of days". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Whereas arm pain from the first two shots was not felt until later that day and went away in a couple of days, the pain from the booster was immediate and severe. The ongoing pain from this incident has restricted her weight-lifting regime which she used to maintain her health and strength. It disrupted her sleep each night and limited her daily activities. No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus, Vertigo
Clinical narrative: Vertigo; Ringing in ears; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 48 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), for COVID-19 immunization. The following information was reported: VERTIGO (non-serious), outcome "not recovered", described as "Vertigo"; TINNITUS (non-serious), outcome "not recovered", described as "Ringing in ears". The events "vertigo" and "ringing in ears" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vertigo, tinnitus.  Additional Information: The patient did received AE treatment was Physical therapy, prescription drugs for nausea. It was unknown patient have Covid prior vaccination. Covid tested post vaccination and Covid test type of post vaccination was Nasal Swab.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Influenza like illness
Clinical narrative: This is a spontaneous report received from contactable other HCP, for a Pfizer sponsored program (141003). A 57-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had influenza-like illness (flu-like symptoms), and arthralgia (increased joint pain), with outcome of unknown. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Muscular weakness, Pain in extremity, Restlessness
Clinical narrative: Upper right arm and shoulder area feel weak, painful, keeps twitching, feels restless; Upper right arm and shoulder area feel weak, painful, keeps twitching, feels restless; Upper right arm and shoulder area feel weak, painful, keeps twitching, feels restless; Upper right arm and shoulder area feel weak, painful, keeps twitching, feels restless; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Feb2022 17:45 (Lot number: FJ5682) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Major depressive disorder" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE SODIUM; PROZAC. Past drug history included: Meloxicam, reaction(s): "Allergy: Meloxicam", notes: Allergy: Meloxicam. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 33025BD, Location of injection: Arm Right, Vaccine Administration Time: 05:45 PM), administration date: 12Jan2022, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: MUSCULAR WEAKNESS (non-serious), PAIN IN EXTREMITY (non-serious), MUSCLE TWITCHING (non-serious), RESTLESSNESS (non-serious) all with onset 05Feb2022, outcome "not recovered" and all described as "Upper right arm and shoulder area feel weak, painful, keeps twitching, feels restless".  Additional information: The onset time of adverse event was 12:00 AM. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID prior to vaccination and had not been tested COVID post the vaccination. Other medications in two weeks: Levothyroxine, Prozac.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Mild sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Nov2021 16:00 (Lot number: 3R038D) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "Blood clotting", start date: 2016 (ongoing), notes: 2016 and then 22Mar2021(Blood clots in chest), 27Apr2021 test found hereditary clotting condition. Concomitant medication(s) included: AMLODIPINE BESYLATE taken for hypertension (ongoing); LISINOPRIL taken for hypertension (ongoing); JANTOVEN taken for thrombosis, start date: 27Apr2021 (ongoing). Vaccination history included: Bnt162b2 (Dose 1,Time: 14:00,Left arm, Intramuscular, Batch/Lot number: EN6203,Exp date: Jun2021), administration date: 25Feb2021, when the patient was 50 years old, for COVID-19 Immunization, reaction(s): "Sore arm"; Bnt162b2 (Dose 2, Time: 14:00, Right arm, Intramuscular, Batch/Lot number: EN6203,Exp date: Jun2021), administration date: 18Mar2021, when the patient was 50 years old, for COVID-19 Immunization, reaction(s): "Sore arm and back", "Sore arm and back". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Mild sore arm".  Additional information: Patient reported no Prior vaccinations. All 3 doses caused mild sore arm and 2nd dose aggravated back possible blood clot diagnosed week later and month later determined as genetic condition. Other tests include relevant test for thromboembolic events with thrombocytopenia. Antibody test to platelet factor IV on 25Mar2021 showed 138.8. Various lab test was conducted after dose 2 including basic no diff on 25Mar2021, basic metabolic panel on 26Mar2021, US Abdomen limitation on 20Apr2021, Beta 2 glycoprotein on 22Apr2021 which were all normal. On the same date, Cardiolipin auto abs and free light chains showed blood clot and blood clots genetic.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Swelling face
Clinical narrative: Swelling of face is under left eye more close to the nose; now it is going up to my eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in hand left (Lot number: Unknown) at the age of 52 years as dose 3(booster), single for covid-19 immunisation. Relevant medical history included: "Crohn's disease" (unspecified if ongoing), notes: Verbatim: Crohn''s. Concomitant medication(s) included: PENTASA taken for crohn's disease. Vaccination history included: Bnt162b2 (Dose: 1, Manufacturer: Unspecified), for COVID-19 Immunization; Bnt162b2 (Dose: 2nd, Manufacturer: Unspecified, second dose was Mar2020), administration date: Mar2020, when the patient was 51 years old, for COVID-19 Immunization. The following information was reported: SWELLING FACE (non-serious), outcome "unknown", described as "Swelling of face is under left eye more close to the nose"; EYE SWELLING (non-serious), outcome "unknown", described as "now it is going up to my eyes". Therapeutic measures were taken as a result of swelling face, eye swelling.  Additional information: Consumer stated, Yes, yesterday I did booster vaccine Pfizer. It was like around 1PM and today 6PM I starts my swelling of face is under left eye more close to the nose now it is going up to my eyes. Yesterday I received booster because before I did 2 vaccine. Consumer stated, Its, this wasI do not know exactly like 1 meter 65 centimeter and then I have weight that was approximately 65, oh no 60kg, 56kg, no 56 kg. Yeah I think so they gave it me on my Vaccination card it's supposed to be there, it was for Pfizer, it was like FJ6369. Consumer stated, Yes, I was taking Pentasa. I have a Crohn's (Captured as provided). I was taking 15 tablets. Consumer stated, No, It was like my second dose was March 2020. It is over a year ago. I was 51(years) that time. No, I did not do any vaccine prior to 4 weeks. I just took Benadryl. I thought might be it would stop the reaction. I took one tablet of Benadryl.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A female patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FK9896), on Feb 16, 2022, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for immunisation. The patient experienced chest pain and headache, onset Feb 2022, with outcome of unknown. Additional information: Reporter had concerns regarding booster side effects. "My little sister is 18. She got her third dose yesterday and has been having a headache. Also, she said she was kind of having chest pain, which she did not have when she got her second dose. She can breathe fine; but she said she has been having chest pain. Should I give her some medications, is it better to sleep it off or do you recommend I take her to urgent care?" Follow-up attempts completed. No further information expected.