chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: chills; fever; headaches; aches and pains; flu like symptoms; very bad tiredness; 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 35 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "recovered", described as "chills"; PYREXIA (non-serious), outcome "recovered", described as "fever"; HEADACHE (non-serious), outcome "recovered", described as "headaches"; PAIN (non-serious), outcome "recovered", described as "aches and pains"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "flu like symptoms"; FATIGUE (non-serious), outcome "recovered", described as "very bad tiredness".  Additional information: Reporter stated that, patient received first two doses of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap) and afterwards experienced moderately to severe reactions close to 3 days with the first dose and for the second vaccine, the symptoms were the same, but patient had them for 4 days, which was longer than he expected.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 14:45 (Batch/Lot number: unknown) at the age of 37 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "known allergies: Lemon, Cayenne pepper" (unspecified if ongoing), notes: Verbatim: known allergies: Pork, Lemon, Cayenne pepper, Fish; "known allergies: Latex" (unspecified if ongoing), notes: Verbatim: known allergies: Latex; "Known allergy: Fish" (unspecified if ongoing), notes: Verbatim: known allergies: Pork, Lemon, Cayenne pepper, Fish; "Known allergy-Pork" (unspecified if ongoing). Concomitant medication(s) included: ADVIL; BUDESONIDE. The following information was reported: LYMPH NODE PAIN (non-serious) with onset 04Dec2021 05:45, outcome "not recovered", described as "Pain in left axillary lymph node beginning 15 hours post vaccination"; LYMPHADENOPATHY (non-serious) with onset 05Dec2021 02:45, outcome "not recovered", described as "Large swelling in left axilla and radiating downward beginning 36 hours post vaccination". Therapeutic measures were not taken as a result of lymph node pain, lymphadenopathy. Additional information: It was reported that, the events was non-serious. No other vaccine in four weeks. No Covid prior vaccination. Not tested for Covid post vaccination. Other medical history was none. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: little swelling in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old male patient received bnt162b2 (BNT162B2), administration date 21Mar2021 (Batch/Lot number: unknown) at the age of 18 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE; CONCERTA; FINASTERIDE. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "unknown", described as "little swelling in the arm". Therapeutic measures were not taken as a result of peripheral swelling.  Additional information: Patient stated, "he got his booster this morning at 10 am. He dont know what time you are under in, right now its 2:20 am, so he got his second Pfizer dose back in April and when he had his first dose he was totally fine you know, just little swelling in the arm just like any vaccine will give you (Further clarification unknown) and he got second dose however like almost right away it kind of gave a headache.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: 2 others and they had the same pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "2 others and they had the same pain".  Additional information: Reporter was calling because she has same pain as when she got the shot but more intense and it traveled down her arm, it is almost the exact same pain. Caller notes she spoke with 2 others and they had the same pain. They said they would call; they had the shot in the same arm. Reporter provides no additional information regarding these patients. Reporter had not talked to the doctor yet, she will call if it gets worse. Reporter has pain medication she has been taking for this event. The doctor will probably tell her to call the place she got the shot since she did not get it with her doctors office.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 0.08
Sex: F
Vaccine: COVID19
Symptoms: Crying, Exposure via breast milk, Irritability
Clinical narrative: the baby was fussy all day yesterday and today; Crying; she had a baby and is currently breastfeeding; 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 5 week-old female patient was exposed to bnt162b2 (BNT162B2), transplacental administered in arm left, administration date 07Dec2021 (Lot number: FD0809) as dose 1, single for covid-19 immunisation. The mother's relevant medical history included: "C Section" (unspecified if ongoing), notes: Mode of delivery (e.g. natural birth [i.e., vaginal delivery without medication or anesthesia], cesarean section: C Section; "Full term live birth" (unspecified if ongoing), notes: Pregnancy outcome: check one: Full term live birth. The mother was 1 weeks pregnant at the event onset. The mother is expected to deliver one baby(s). The mother's concomitant medications were not reported. The following information was reported: EXPOSURE VIA BREAST MILK (non-serious) with onset 07Dec2021, outcome "not recovered", described as "she had a baby and is currently breastfeeding"; IRRITABILITY (non-serious) with onset 08Dec2021, outcome "not recovered", described as "the baby was fussy all day yesterday and today"; CRYING (non-serious) with onset 08Dec2021, outcome "not recovered", described as "Crying". The baby was delivered live birth(unspecified), via cesarean route.  Additional Context: Caller reported having her first dose of the vaccine on 07Dec2021. Caller reported on 08Dec2021 having itchiness on her hands and feet. She had a baby on (#) and was currently a breastfeeding; the baby was fussy all day yesterday and today. Caller asked her HCP about the reaction and for treatment recommendations; her HCP recommended she call Pfizer. While reporting for herself, she mentioned she just had a daughter on (#) and she was breastfeeding.  She confirmed she was breastfeeding after she received the vaccine. This report was to capture information about her daughter. She normally does not get vaccines but got it because of her daughter. She then asked if you can pass antibodies through breast milk. She was breastfeeding her daughter. Since then, her daughter has been extremely fussy. She was crying all day yesterday and today. She then stated she cries all the time anyway.     No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101758869 maternal/child case
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Odynophagia, Oropharyngeal discomfort, Pain
Clinical narrative: can''t breathe very well; looks like there''s a clog in his throat; can''t swallow its painful; around his waist is painful; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old male patient received bnt162b2 (BNT162B2), administration date 04Dec2021 (Batch/Lot number: unknown) at the age of 10 years 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: DYSPNOEA (non-serious), outcome "not recovered", described as "can't breathe very well"; OROPHARYNGEAL DISCOMFORT (non-serious), outcome "not recovered", described as "looks like there's a clog in his throat"; ODYNOPHAGIA (non-serious), outcome "not recovered", described as "can't swallow its painful"; PAIN (non-serious), outcome "not recovered", described as "around his waist is painful".  Additional Information: NDC number, Expiry date of Pfizer Covid vaccine was unknown. The caller does not have the patient's vaccination card with him and hence information on lot number and product details were not provided. No information provided on other products, patient history and investigation assessment. Caller calling behalf of patient declines about height and weight. The patient taking Pfizer Covid vaccine to be safe.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus/my husband has the same problem like I have; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "tinnitus/my husband has the same problem like I have".  Additional Information: Caller stated that, after receiving third shot she experienced tinnitus and she confirmed that her husband also experienced the adverse event. Caller also informed that, another patient also had stop to hearing and also he has noise.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Swelling face
Clinical narrative: Face and neck swelling going down into her shoulder; Face and neck swelling going down into her shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 49-year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) at the age of 49 years as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Caller states after first injection she had lymph node swelling under the arm she received the injection), for COVID-19 Immunization, reaction(s): "lymph node swelling". The following information was reported: SWELLING FACE (non-serious), SWELLING (non-serious), outcome "unknown" and all described as "Face and neck swelling going down into her shoulder".  Additional information: The patient stated these symptoms have lasted for 3 months.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Caller states after first injection she had lymph node swelling under the arm she received the injection in; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 49 year-old female 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: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Caller states after first injection she had lymph node swelling under the arm she received the injection in".  Additional Information: Caller confirms question with me and adds that these symptoms have lasted for 3 months. Caller states after first injection she had lymph node swelling under the arm she received the injection in and she is uncertain if these symptoms have anything to do with the vaccine or not but wants to know has anyone else reported whole face swelling.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (30Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Carbohydrate antigen 27.29, Full blood count, Therapeutic response unexpected, Tumour marker decreased
Clinical narrative: 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), intramuscular, administered in arm left, administration date 07Apr2021 (Lot number: EW0151) at the age of 53 years as dose 2, single and intramuscular, administered in arm left, administration date 13Mar2021 (Lot number: EN6204) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: Verbatim: High Blood Pressure; "metastatic breast cancer", start date: Jun2020 (ongoing), notes: She has metastatic breast cancer, monthly injections of Faslodex daily 100mg Verzenio tablets. Concomitant medication(s) included: LISINOPRIL taken for hypertension; VERZENIO taken for breast cancer metastatic (ongoing); FASLODEX taken for breast cancer metastatic (ongoing). The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "unknown", described as "She has metastatic breast cancer, each time she takes the shot her tumor markers goes to normal"; TUMOUR MARKER DECREASED (non-serious) with onset 2021, outcome "recovering", described as "She has metastatic breast cancer, each time she takes the shot her tumor markers goes to normal". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tumour marker decreased. Additional Information: The patient said that it was a good sign for metastatic breast cancer, her tumor markers went to normal. Directly after what was in a week, just few week after and then the next month it went back up, my numbers went up but the vaccine obviously was having some kind of effect on. When she saw her doctor later that month her blood work showed that the tumor markers were normal. Well as close to normal as it had been since she was diagnosed. Dose 3 administered on 03Nov2021 Time: 08:00, Anatomical Site of injection: upper left arm, Route of administration: Intramuscular and Batch/Lot number: FH8028. Vaccination facility type was other. Vaccine was not administered at military facility. No prior vaccinations (within 4 weeks). No specific relevant test for thromboembolic events with thrombocytopenia. This was a positive event after each vaccine including booster my cancer antigen went down to almost normal range and then back up the following month. The vaccine killed off cancer cell in my blood. The patient would like to know why. She would be happy to donate any blood needed for research. Her oncologist checked records of his patients and she was the only one that had this reaction. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash
Clinical narrative: female friend who has had the same "sympathetic" pain and rash in both arms; female friend who has had the same "sympathetic" pain and rash in both arms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), RASH (non-serious), outcome "unknown" and all described as "female friend who has had the same "sympathetic" pain and rash in both arms".  Additional information: Reporter also had some weird sympathetic arm pain and rash on the other arm in the same place. It was weird because since he heard other friends say the same things. No other information about his friends provided.  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
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A 35 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. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Little pain in arm after second shot". Additional information: She got the first shot and had no problems. The second shot she had a little pain in her arm. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101796320 Same patient and drug, different event separated in time.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: the fingers and hands are tingling; she feels very numb; 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 35 year-old female patient received bnt162b2 (BNT162B2), administration date 10Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 2021, for COVID-19 Immunization, reaction(s): "soreness in the arm"; Bnt162b2 (Dose 2), administration date: 2021, for COVID-19 Immunization, reaction(s): "soreness in the arm". The following information was reported: PARAESTHESIA (non-serious) with onset Dec2021, outcome "unknown", described as "the fingers and hands are tingling"; HYPOAESTHESIA (non-serious) with onset Dec2021, outcome "unknown", described as "she feels very numb". The events "the fingers and hands are tingling" and "she feels very numb" were evaluated at the physician office visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Condition aggravated
Clinical narrative: back issue; he aggravated it and he is not concerned as far as the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY), administration date 11Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Back surgery" (unspecified if ongoing), notes: He stated this was an issue before. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: BACK PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "back issue"; CONDITION AGGRAVATED (non-serious) with onset Dec2021, outcome "unknown", described as "he aggravated it and he is not concerned as far as the vaccine".  Additional information: The caller reported he took the booster dose of the Pfizer-BioNTech Covid-19 vaccine on Saturday and has been okay so far. However, he has to possibly take Medrol dose pack because he is having a back issue within the last couple days. He stated this was like prednisone, a steroid type medication. He stated this was an issue before, he has had back surgery. But he aggravated it and he was not concerned as far as the vaccine. He wanted to know if he takes Medrol will it impact the effectiveness of the vaccine or will there be any crazy side effects. If he waits the full 2 weeks to take this, would he had less of a chance of it impacting the effectiveness.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Hypoacusis
Clinical narrative: hearing a sound in her ear; acting crazy; 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 29 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. The following information was reported: HYPOACUSIS (non-serious), outcome "unknown", described as "hearing a sound in her ear"; ABNORMAL BEHAVIOUR (non-serious), outcome "unknown", described as "acting crazy".  Additional information: Reporter was calling about her 29 year-old daughter who received both doses of the purple cap Pfizer Covid-19 vaccine and now is hearing a sound in her ear that sounds like two microphones put together per reporter's daughter. Reporter denies that it was ringing that she hears and was unsure of what her daughter was hearing. Reporter states that her daughter was acting crazy and asking "us if we can hear it?". Reporter stated that she read somewhere that 10% of the people who receive the Pfizer Covid-19 vaccine have the same complaints and her daughter was one of them but nothing happened to the reporter when she got the Pfizer Covid-19 vaccine. Reporter states that her daughter had not contacted her HCP yet about the above complaints. Reporter also stated during the call that there were people who have side effects from the purple cap Pfizer Covid-19 vaccine and they have to live with the side effects for the rest of their lives. Reporter was asking how long will the above complaints last and what can her daughter do to help her with these complaints? Reporter says that after both doses of the Covid Vaccine her daughter is hearing a sound in her ears, like 2 microphones in her ears. Reporter states that her daughter had them listen to see if they could also hear it; reporter could not hear it. Reporter asks how long should this last?  Follow-up attempts completed. No further information is expected.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Pain, Pyrexia
Clinical narrative: Fever; body aches; couldn''t move his neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 9 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Dec2021 (Batch/Lot number: unknown) at the age of 9 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: PYREXIA (non-serious) with onset 04Dec2021 19:30, outcome "recovered" (Dec2021), described as "Fever"; PAIN (non-serious) with onset 04Dec2021, outcome "recovered" (Dec2021), described as "body aches"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "couldn''t move his neck". Therapeutic measures were taken as a result of pyrexia, pain, musculoskeletal discomfort. Additional information: She is calling in reference to Pfizer COVID19 vaccine that her 9 year old had a reaction to. She wanted to report it and the pediatrician recommended she call and speak to someone at Pfizer about recommendation for the second dose after the reaction. Caller states her son had fever for two days and body aches. Then it all moved into his neck and he could not move his neck. The pediatrician had him take 300mg of Advil three times a day for 48 hours and it relieved the pain. The vaccine knocked him out. He was on the couch for two full days. His twin brother was totally fine. fever: her son received first dose of the vaccine on 04Dec2021 and the fever started that evening. His appointment for the vaccine was at 2:45pm so he received it around that time. The fever stared around 7:30PM. It was around bedtime and she thought he didn't look so good. Fever lasted for two days. Body aches: started on 04Dec2021 and lasted a full week. Couldn't move his neck: that was the worst and it stayed for about a week. Reason for no lot number: of COVID19 vaccine: Complainant does not have the product with them at the time of call. COVID19 Vaccine: caller doesn't have her son's vaccination card as it is in the car.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Bedridden
Clinical narrative: Could not get out of bed for 4 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BEDRIDDEN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Could not get out of bed for 4 days". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional Information: The patient reported that she had been having ever since I had the first shot. The patient reported that she was scared to take the second shot. The patient reported that she took the first shot probably seven months ago (not clarified further) and she could not get out of bed for 4 days and she was scared to take the second shot or if she needed to go to Johnson & Johnson, may be that is what should she do, she did not know.  Follow-up (20Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles/ two people who have same side effect as hers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  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 and concomitant medications were not reported. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "shingles/ two people who have same side effect as hers".  Additional Information: Other Products: Not Provided. Patient History: Not Provided. Patient contacted VAERS in September that stated they send it to the manufacturer and caller states it has been 75 days since reported it and patient was wondering if the report was going to the cloud and nobody looks at it? Caller would like to know if the information reported to VAERS is transmitted to Pfizer? Caller states she cannot find any reports of the side effect she had but she personally knows two people in a town of 6000 people that had this side effect. Patient had shingles and knows multiple people who developed shingles after getting the second vaccine or booster and it is only reported in withheld by their government. Patient states Shingles was worse than having Covid. Caller states withheld gave her the vaccine and they will not report anything. Caller states her HCP did not know stuff and mentions her HCP dismissed her as there was no reports of this adverse effect from Pfizer meanwhile many HCPs have seen this. Caller states her HCP was very dismissive when she suggested there was correlation between Shingles and the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101797217 same reporter drug AE, different patient;US-PFIZER INC-202101797783 same reporter drug AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: two people who have same side effect as hers/ She had shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 44 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "two people who have same side effect as hers/ She had shingles".  Additional Information: Caller states she had shingles and knows multiple people who developed shingles after getting the second vaccine or booster and it is only reported in Israel by their government. Caller states Shingles is worse than having Covid. Caller states withheld gave her the vaccine and they will not report anything. Caller states her HCP doesn't know shit and mentions her HCP dismissed her as there was no reports of this adverse effect from Pfizer meanwhile many HCPs have seen this. Caller states her HCP was very dismissive when she suggested there was correlation between Shingles and the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101797217 same reporter drug AE, different patient;US-PFIZER INC-202101797782 same reporter drug AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: extremely sick; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 30Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 Immunization. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "extremely sick".  Additional information:HCP originally wanted to speak with # from Pfizer MI as they got disconnected. However, since #was unavailable, I offered to help her instead. This interaction was a follow up to the original INT- #. 54-year-old female nurse said she had been prediabetic for several years now. She said her numbers were at a 6 for several years. Then after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine, her A1C levels became elevated. HCP wants to know if this was normal. She also mentioned that she and her daughter had the 2nd dose of the vaccine yesterday. Afterwards, her daughter became extremely sick. She, on the other hand, got sick yesterday for the 1st 24 hours. She said her sinus started acting up. She said she was very sick and stayed in bed all day. She had to take Allegra before and after taking the vaccine. However, she said her main concern was her elevated A1C levels. She said she researched Pfizer and found out that because of the symptoms of illness, it can lead to high glucose levels. According to her, it also stated there that one has to be careful with monitoring the glucose levels 48 hours after receiving the vaccine. She said it also says, "dehydrate" and that people with diabetes seem to experience these side effects with high blood sugar levels. Offered a warm transfer to DSU, but HCP said she already spoke with them. Etransmitting; Possible AE duplicate. Response: I told the HCP that upon review of the prescribing information for the Pfizer-BioNTech Covid-19 Vaccine, I found no information about having elevated A1C levels after receiving the vaccine. For that, I referred her to her own HCP for further guidance. However, HCP probed so I offered to escalate her question to secondline. She said she prefers a callback. Escalating to secondline for further research and handling.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain
Clinical narrative: got the pain; she did get shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 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. The following information was reported: PAIN (non-serious), outcome "unknown", described as "got the pain"; HERPES ZOSTER (non-serious), outcome "unknown", described as "she did get shingles".  Additional information : When probed if the concern is with Pfizer COVID-19 2nd dose: Consumer stated that consumer actually talked to his/her friend whose daughter in law had Pfizer 1st and 2nd injections and she not only got the pain but she did get shingles (Further clarifications unknown) so may be those are two things that CDC or you who ever needs to know, because that was the only person consumer talked to was her and it's about her daughter in law so but they should probably know that is the real possibility of that like what people can experience. When probed if consumer has any details about the friend's daughter in law: Consumer stated could tell her to do that but consumer can tell her to report if you think if it is necessary.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Pyrexia, Rash
Clinical narrative: Rash in his shoulder; Fever; 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 male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization. The following information was reported: RASH (non-serious), outcome "recovered", described as "Rash in his shoulder"; PYREXIA (non-serious), outcome "recovered", described as "Fever". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient stated that he lost his card of vaccination which he needs because he was travelling next Sunday and need to prove that he got the vaccination at the airport. He was requested to visit the vaccination centre for the concern. When probed for side effects from the vaccine, consumer stated, " The second one, yes had rash in shoulder and got fever for one day and that's it." Other medications were reported as Prasugal. Lab tests was confirmed as yes, and details was stated as nothing. 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
Symptoms: Fluid retention, Peripheral swelling
Clinical narrative: feel something wrong with my fluids retentions; leg gets swallow in the morning and keep going during the day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 (Lot number: 30135BA) at the age of 34 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Gastritis" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FC3184, Location of injection: Arm Left), administration date: 07Sep2021, when the patient was 34 years old, for COVID-19 immunization; Mmr (Dose-2, Lot Number: T013003, Anatomical location: LD), administration date: 26Aug2021, when the patient was 34 years old. The following information was reported: FLUID RETENTION (non-serious) with onset Oct2021, outcome "not recovered", described as "feel something wrong with my fluids retentions"; PERIPHERAL SWELLING (non-serious) with onset Oct2021, outcome "not recovered", described as "leg gets swallow in the morning and keep going during the day". The events "feel something wrong with my fluids retentions" and "leg gets swallow in the morning and keep going during the day" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of fluid retention, peripheral swelling.  Additional information: Patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID since the vaccination. Patient did not have any known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Dyspnoea
Clinical narrative: Trouble breathing; Chest pain; Felt terrible; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 09Jun2021 (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, single), for COVID-19 Immunization. The following information was reported: DYSPNOEA (non-serious) with onset Jun2021, outcome "unknown", described as "Trouble breathing"; CHEST PAIN (non-serious) with onset Jun2021, outcome "unknown", described as "Chest pain"; ANXIETY (non-serious) with onset Jun2021, outcome "unknown", described as "Felt terrible".  Additional information: Patient had the second dose of the covid vaccine on 9Jun2021. He had some adverse events, had heart issues like trouble breathing, chest pain and felt terrible when he was in a cold place. If in a hot room, his temperature would rise. He experienced a different perception when it comes to temperature. He is worried that the same thing might happen with the booster. He is just trying to figure out if should take the booster shot tomorrow.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Costochondritis, SARS-CoV-2 test
Clinical narrative: Costochondritis diagnosis 2 months after shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 10:00 (Lot number: Ewo171) at the age of 28 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Lot number: Ep7533, Time: 01:15 PM, Location: Left arm), administration date: 31Mar2021, when the patient was 28 years old, for COVID-19 immunization. The following information was reported: COSTOCHONDRITIS (non-serious) with onset 12May2021, outcome "not recovered", described as "Costochondritis diagnosis 2 months after shot". The event "costochondritis diagnosis 2 months after shot" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of costochondritis, which include treatment with physical therapy.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 18:15 (Lot number: F516V) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hemachromtosis knee replacement" (unspecified if ongoing), notes: Note: Hemachromtosis Knee replacement. Concomitant medication(s) included: INFLUENZA; LIPITOR; CLARITIN [LORATADINE]. Past drug history included: Known allergies: no, reaction(s): "Drug Allergy". Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EP7533, Location of injection: Arm Left), administration date: 09Apr2021, when the patient was 53 years old, for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EN6207, Location of injection: Arm Left), administration date: 17Mar2021, when the patient was 53 years old, for Covid-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 13Dec2021 15:00, outcome "not recovered", described as "Ringing in ears". Therapeutic measures were not taken as a result of tinnitus.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: sore arm; tired; achy; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  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 and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown", described as "tired"; PAIN (non-serious), outcome "unknown", described as "achy"; HEADACHE (non-serious), outcome "unknown", described as "headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus, Tympanometry
Clinical narrative: Three days later, I noticed a ringing in my head/tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single and administration date 09Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "unknown", described as "Three days later, I noticed a ringing in my head/tinnitus". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient want to share his coronavirus vaccine experiences and asked for help to bring attention, and hopefully Start a tinnitus support group for people like him, who are suffering in silence because of the side effects of the coronavirus vaccine and this newly discovered dilemma. He was not asking anyone, or any institution for money. He was prepared to pay for local television, radio, and print advertising. Patient was simply asking for a partnership and guidance that will lead to establishing a tinnitus support group that will be able to utilize medical professionals as presenters to help keep the community more informed about the development of tinnitus and the connection to taking the coronavirus vaccine. On 22Mar2021, patient was seen by a physician at withheld ENT and Allergy. Patient was given a hearing test, and tympanometry exam. Afterwards they tried to sell him a hearing aid and explained there was nothing they could do to help him. Patient learned of the connection between being vaccinated and developing tinnitus. On 20Apr2021, He was seen by withheld physician Dr. withheld who told him the exact thing the physician at withheld ENT and Allergy told him, 'No cure, and Patient would have to learn to deal with it.' Patient found this to be disheartening coming from a world-renowned medical university physician. Patient researched the condition, and believe the vaccine saves lives, but He also believe the public should have been made aware of this horrible side effect. A sudden on-set of tinnitus can lead to depression and suicide in some cases. In my research He discovered there are over 10,000 people who have reported the onset of tinnitus to the Centers of Disease Control shortly after taking the coronavirus vaccine. This past Aug, Johnson & Johnson added tinnitus as a potential side-effect to their vaccine, but Pfizer and Moderna have not. This condition is real, and He had certain there are many people in withheld, and throughout the nation who will agree, this condition came about from being vaccinated for COVID -19. The problem is, we are suffering in silence.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.