chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Migraine, Muscle spasms, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Calves of both my legs cramped up really bad as if I tore my muscles or something; felt tenderness in my left hip area and on opposite arm of the shot; felt tenderness in my left hip area and on opposite arm of the shot; There was random yellow bruising on my arms but they were small; migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 (Lot number: Fh8028) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MUSCLE SPASMS (non-serious) with onset 2022, outcome "recovered with sequelae", described as "Calves of both my legs cramped up really bad as if I tore my muscles or something"; TENDERNESS (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 2022, outcome "recovered with sequelae" and all described as "felt tenderness in my left hip area and on opposite arm of the shot"; CONTUSION (non-serious) with onset 2022, outcome "recovered with sequelae", described as "There was random yellow bruising on my arms but they were small"; MIGRAINE (non-serious) with onset 2022, outcome "recovered with sequelae", described as "migraine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of muscle spasms, tenderness, pain in extremity, contusion, migraine.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Calves of both my legs cramped up really bad as if I tore my muscles or something. Also felt tenderness in my left hip area and on opposite arm of the shot. It lasted about four days. There was random yellow bruising on my arms but they were small. Had a massive migraine as well. No Prior to vaccination, was the patient diagnosed with COVID-19. Yes Since the vaccination, has the patient been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Calves of both my legs cramped up really bad as if I tore my muscles or something; felt tenderness in my left hip area and on opposite arm of the shot; felt tenderness in my left hip area and on opposite arm of the shot; There was random yellow bruising on my arms but they were small; migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 (Lot number: Fh8028) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MUSCLE SPASMS (non-serious) with onset 2022, outcome "recovered with sequelae", described as "Calves of both my legs cramped up really bad as if I tore my muscles or something"; TENDERNESS (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 2022, outcome "recovered with sequelae" and all described as "felt tenderness in my left hip area and on opposite arm of the shot"; CONTUSION (non-serious) with onset 2022, outcome "recovered with sequelae", described as "There was random yellow bruising on my arms but they were small"; MIGRAINE (non-serious) with onset 2022, outcome "recovered with sequelae", described as "migraine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of muscle spasms, tenderness, pain in extremity, contusion, migraine.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Calves of both my legs cramped up really bad as if I tore my muscles or something. Also felt tenderness in my left hip area and on opposite arm of the shot. It lasted about four days. There was random yellow bruising on my arms but they were small. Had a massive migraine as well. No Prior to vaccination, was the patient diagnosed with COVID-19. Yes Since the vaccination, has the patient been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Rash
Clinical narrative: total body rash; joint pain; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lyme disease" (unspecified if ongoing), notes: Underlying history of Lyme disease. The patient's concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "total body rash"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Heart rate irregular, Illness
Clinical narrative: Extremely ill; fever; extreme fatigue; pain; muscle aches; headache; fuzzy head and foggy thinking; feeling like my brain was burning; Erratic heartbeat; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 46-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date Apr2021 (Lot number: EW0161) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "NSAIDS" (unspecified if ongoing), notes: Known allergies: NSAIDS. Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8730, Location of injection: Arm Left), administration date: Mar2021, when the patient was 46 years old, for COVID-19 Immunization, reaction(s): "extreme fatigue", "Fuzzy head and foggy thinking", "feeling absolutely miserable beginning 24 hours after 1st dose", "headache", "Erratic heartbeat", "extremely ill", "could not work", "muscle aches", "pain", "fever". The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "recovered", described as "Extremely ill"; PYREXIA (non-serious) with onset 2021, outcome "recovered", described as "fever"; FATIGUE (non-serious) with onset 2021, outcome "recovered", described as "extreme fatigue"; PAIN (non-serious) with onset 2021, outcome "recovered", described as "pain"; MYALGIA (non-serious) with onset 2021, outcome "recovered", described as "muscle aches"; HEADACHE (non-serious) with onset 2021, outcome "recovered", described as "headache"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "recovered", described as "fuzzy head and foggy thinking"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "recovered", described as "feeling like my brain was burning"; HEART RATE IRREGULAR (non-serious) with onset 2021, outcome "recovered", described as "Erratic heartbeat". The events "extremely ill", "fever", "extreme fatigue", "pain", "muscle aches", "headache", "fuzzy head and foggy thinking", "feeling like my brain was burning" and "erratic heartbeat" 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 illness, pyrexia, fatigue, pain, myalgia, headache, feeling abnormal, feeling abnormal, heart rate irregular.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Extremely ill; fever; extreme fatigue; pain; muscle aches; headache; fuzzy head and foggy thinking; feeling like my brain was burning; Erratic heartbeat; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 46-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date Apr2021 (Lot number: EW0161) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "NSAIDS" (unspecified if ongoing), notes: Known allergies: NSAIDS. Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8730, Location of injection: Arm Left), administration date: Mar2021, when the patient was 46 years old, for COVID-19 Immunization, reaction(s): "extreme fatigue", "Fuzzy head and foggy thinking", "feeling absolutely miserable beginning 24 hours after 1st dose", "headache", "Erratic heartbeat", "extremely ill", "could not work", "muscle aches", "pain", "fever". The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "recovered", described as "Extremely ill"; PYREXIA (non-serious) with onset 2021, outcome "recovered", described as "fever"; FATIGUE (non-serious) with onset 2021, outcome "recovered", described as "extreme fatigue"; PAIN (non-serious) with onset 2021, outcome "recovered", described as "pain"; MYALGIA (non-serious) with onset 2021, outcome "recovered", described as "muscle aches"; HEADACHE (non-serious) with onset 2021, outcome "recovered", described as "headache"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "recovered", described as "fuzzy head and foggy thinking"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "recovered", described as "feeling like my brain was burning"; HEART RATE IRREGULAR (non-serious) with onset 2021, outcome "recovered", described as "Erratic heartbeat". The events "extremely ill", "fever", "extreme fatigue", "pain", "muscle aches", "headache", "fuzzy head and foggy thinking", "feeling like my brain was burning" and "erratic heartbeat" 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 illness, pyrexia, fatigue, pain, myalgia, headache, feeling abnormal, feeling abnormal, heart rate irregular.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Lymphadenopathy, Swelling face
Clinical narrative: slight fullnes in upper arm, neck + bilat axillary; lymph nodes as well; as subtle swelling of L face ceecks + left side of lower jaw; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 52 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 15Dec2021 (Lot number: FJ1420) at the age of 52 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:1st, batch/Lot number: FH8020, Route of administration: Intramuscular, Anatomical site of inj: Right Deltoid), administration date: 23Nov2021, when the patient was 52 years old, for COVID-19 immunization, reaction(s): "Pain swelling at site of vaccine", "Pain swelling at site of vaccine", "Sensation of not being able to swallow food". The following information was reported: CHEST DISCOMFORT (non-serious), outcome "recovered", described as "slight fullnes in upper arm, neck + bilat axillary"; LYMPHADENOPATHY (non-serious), outcome "recovered", described as "lymph nodes as well"; SWELLING FACE (non-serious), outcome "recovered", described as "as subtle swelling of L face ceecks + left side of lower jaw". Additional information: The patient was premediated with waladryl  period to vaccine. The patient has the sensation of not being able to swallow food post vaccine 1 which resolved but did not expressing this with 2 with previous with waladryl. The patient did not taken any other vaccine prior to covid vaccine with in 4 weeks. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Feeling abnormal, Illness, Nausea
Clinical narrative: Nauseated; Chills; Joint pain; Ears ringing; I feel awful/feel so bad; My vision is blurred; I am so sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 13Jan2022 (Lot number: FD7218) 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; unknown manufacturer), for COVID-19 immunization.  The following information was reported: NAUSEA (non-serious) with onset Jan2022, outcome "unknown", described as "Nauseated"; CHILLS (non-serious) with onset Jan2022, outcome "unknown", described as "Chills"; ARTHRALGIA (non-serious) with onset Jan2022, outcome "unknown", described as "Joint pain"; TINNITUS (non-serious) with onset Jan2022, outcome "unknown", described as "Ears ringing"; FEELING ABNORMAL (non-serious) with onset Jan2022, outcome "unknown", described as "I feel awful/feel so bad"; VISION BLURRED (non-serious) with onset Jan2022, outcome "unknown", described as "My vision is blurred"; ILLNESS (non-serious) with onset Jan2022, outcome "unknown", described as "I am so sick".  Additional information: When patient was asked about lot number, they reported Pfizer FD7218 or 51 and don't know.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus, Vision blurred
Clinical narrative: Nauseated; Chills; Joint pain; Ears ringing; I feel awful/feel so bad; My vision is blurred; I am so sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 13Jan2022 (Lot number: FD7218) 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; unknown manufacturer), for COVID-19 immunization.  The following information was reported: NAUSEA (non-serious) with onset Jan2022, outcome "unknown", described as "Nauseated"; CHILLS (non-serious) with onset Jan2022, outcome "unknown", described as "Chills"; ARTHRALGIA (non-serious) with onset Jan2022, outcome "unknown", described as "Joint pain"; TINNITUS (non-serious) with onset Jan2022, outcome "unknown", described as "Ears ringing"; FEELING ABNORMAL (non-serious) with onset Jan2022, outcome "unknown", described as "I feel awful/feel so bad"; VISION BLURRED (non-serious) with onset Jan2022, outcome "unknown", described as "My vision is blurred"; ILLNESS (non-serious) with onset Jan2022, outcome "unknown", described as "I am so sick".  Additional information: When patient was asked about lot number, they reported Pfizer FD7218 or 51 and don't know.  Follow-up attempts completed. No further information expected.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Body height, Rash, SARS-CoV-2 test
Clinical narrative: he develop some rash on his face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 5 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Jan2022 (Lot number: FK5618, Expiration Date: 31May2022) at the age of 5 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot number: FK5618, Expiration date: 04Feb2022, Anatomical site of vaccine administration: Left arm.), administration date: 27Dec2021, when the patient was 5 years old, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 17Jan2022, outcome "unknown", described as "he develop some rash on his face". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash. No follow-up attempts are possible. No further information is expected.  Additional information: Treatment for Adverse Event (Rash): Reporter stated, "I just gave him Zyrtec."
Sex: F
Vaccine: PNC13, UNK
Symptoms: Allergy to vaccine
Clinical narrative: Drug Allergies: Prevnar, Nitrofurantoin; This is a spontaneous report received from a contactable reporter(s) (Physician) for a sponsored program (005570).  A 90 year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose number unknown, single for immunisation; nitrofurantoin (NITROFURANTOIN) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Drug Allergies: Prevnar, Nitrofurantoin". The action taken for nitrofurantoin was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: PNC20
Symptoms: Feeling abnormal, Thinking abnormal
Clinical narrative: I can't even think anymore; I'm having such a bad day; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program (005570). The reporter is the patient.  A patient of unspecified age and gender) received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20) (Batch/Lot number: unknown) as dose number unknown, single. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: THINKING ABNORMAL (non-serious), outcome "unknown", described as "I can't even think anymore"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I'm having such a bad day". The action taken for pneumococcal 20-val conjugate vaccine (diphtheria crm197 protein) was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Lip swelling
Clinical narrative: her lips were fairly large/the initial swelling, her lips go down and the last 5-7 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): GL-011922-1308 (Galderma).  A 46 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) at the age of 46 years as dose number unknown, single for covid-19 immunisation; hyaluronic acid (RESTYLANE), first regimen from 25Jun2021 (Batch/Lot number: unknown) to 25Jun2021 at 0.5 mL single, second regimen from Jul2021 (Batch/Lot number: unknown) to Jul2021 at 0.5 mL single and third regimen from 06Dec2021 (Batch/Lot number: unknown) to 06Dec2021 at 0.1 mL single; botulinum toxin type a (BOTOX), first regimen from Jun2021 (Batch/Lot number: unknown) to Jun2021 and second regimen from Sep2021 (Batch/Lot number: unknown) to Sep2021. Relevant medical history included: "general cleaning" (unspecified if ongoing), notes: No dental procedure other than a general cleaning. Concomitant medication(s) included: ACYCLOVIR [ACICLOVIR]; VENLAFAXINE. The following information was reported: LIP SWELLING (non-serious), outcome "unknown", described as "her lips were fairly large/the initial swelling, her lips go down and the last 5-7 days". The action taken for hyaluronic acid and botulinum toxin type a was unknown.  Additional information: On 25Jun2021, the consumer was injected with Restylane, 0.5 ml in upper and lower lip. The consumer reported that it looked good for a month or so, then nothing. In Jul2021, 0.5 ml Restylane was injected, and again, the consumer reported that it looked good for a month and then nothing. On 06Dec2021, the consumer went to a different doctor, and was injected with 0.1 ml, of Restylane Kysse, and reported that initially, her lips were fairly large, and looked good for 3-4 weeks. Within the last week and half, the consumer reported that it looks like I had nothing done, and that after the initial swelling, her lips go down and the last 5-7 days, dramatic change, went down super. Acyclovir 400 mg daily and Venlafaxine 75 mg daily reported as concomitant medications. No medical history or allergies were reported. The consumer has had Botox in the forehead in Jun2021 and Sep2021. Pfizer Covid vaccination received in Feb2021, no booster. No dental procedure other than a general cleaning.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Alopecia; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  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: ALOPECIA (non-serious), outcome "unknown", described as "Alopecia".  Additional information: Reporter received a call from (Name) (last name and name of practice here) who wanted education on starting a patient of Dr. (Name) on Xeljanz. The patient's diagnosis was Alopecia, (Name) indicated this was caused by the Pfizer Covid- 19 vaccine. (Name) stated the office had reported the side effect to Pfizer Covid compliance. Reporter called Xelsource and inquired about the process to have Xeljanz covered through assistance off label. I did not give any information about the office or patient. I asked if the process is the same as a Medicare patient denial. I called Dr. (Name) office and informed (Name) that the process would be the same as that she does for her Medicare denied patients. Event did not take place after use of the product Xeljanz.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bedridden, Myalgia, SARS-CoV-2 test
Clinical narrative: Had extreme joint pain; Had extreme muscle pain; I was unable to get out of bed or dress myself; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 09:00 (Lot number: FC3181) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Controlled high blood pressure" (unspecified if ongoing), notes: Verbatim: Controlled high blood pressure; "GERD" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; PANTOPRAZOLE; VITAMIN D3; ZINC. The following information was reported: ARTHRALGIA (non-serious) with onset 23Aug2021 01:00, outcome "recovering", described as "Had extreme joint pain"; MYALGIA (non-serious) with onset 23Aug2021 01:00, outcome "recovering", described as "Had extreme muscle pain"; BEDRIDDEN (non-serious) with onset 23Aug2021 01:00, outcome "recovering", described as "I was unable to get out of bed or dress myself". The events "had extreme joint pain", "had extreme muscle pain" and "i was unable to get out of bed or dress myself" 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 arthralgia, myalgia, bedridden.  Additional Information: Three days after first dose Patient had extreme joint and muscle pain. Patient was unable to get out of bed or dress herself. The symptoms gradually got somewhat better over three weeks and then Patient had  2nd dose of vaccine. Following this dose Patient was unable to walk without assistance and had extreme full body muscle and joint pain. Patient was formerly very active, teaching martial arts and personal training. Within three days Patient was reduced to showering and dressing with aid from her spouse. Patient had numerous Dr. appointments, tests and scans and it was concluded that Patient had severe reactive arthritis from the Covid-19 vaccination. This has dramatically affected Patients life in many aspects. Patient have had to be placed on high dose steroids and other medications. The inflammation was so bad in Patients hands and wrists that Patient had to have double carpal tunnel surgery. Patient have been in constant pain for 5 months.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/I got my two shots and years ago I had Shingles; shingles, bad; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient did not care he/she got two Shingles shots and four years ago from reporting date, had shingles. The patient stated shingles was so bad that the patient did not want them again. This case was considered as suspected vaccination failure as details regarding the time to onset and laboratory test confirmation for shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness
Clinical narrative: Experienced flu-like symptoms; Developed a headache; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th February 2022, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. In March 2022, 1 day after receiving Shingrix, the patient experienced influenza-like symptoms and headache. The patient was treated with ibuprofen. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms and headache to be related to Shingrix.  Additional details reported were as follows: This case was reported by the patient for herself.  The patient received Shingrix into the muscle of her left arm.  The first day following the vaccine, the patient experienced flu-like symptoms.  The patient developed a headache on the second day which she treated with Ibuprofen. Flu-like symptoms were resolved but she still had a headache which persisted.  The reporter did not give consent to follow up and to contact healthcare professional. The reporter did not have lot or expiration date.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 2 years ago, never received second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix approximately 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The case was self reported by the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. The patient did not wish to provide name or contact information patient provided limited information. The reporter did not consent to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm is sore and hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm is sore and hurting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (her arm is sore and hurting). At the time of the report, PAIN IN EXTREMITY (her arm is sore and hurting) had not resolved.            Concomitant products were not provided.  Patient stated that she had blood work done and her results are not same as before.  Treatment medications were not reported.   Reporter did not allow further contact
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Pruritus, SARS-CoV-2 antibody test
Clinical narrative: Extreme itching on shoulders, upper arm and neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 (Lot number: EW0167) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: MIRENA. The following information was reported: PRURITUS (non-serious) with onset 01Jun2021, outcome "unknown", described as "Extreme itching on shoulders, upper arm and neck". The event "extreme itching on shoulders, upper arm and neck" was 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 pruritus.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination was Morena IUD. Patient had extreme itching on shoulders,upper arm and neck. The itching began on shoulders and upper arms. The itching started to get unbearable 8/6 and at that time called the doctor. They cannot figure out what it was. Patient got covid 28Dec2021 and at that time the itching moved to front and back neck areas. There was no adverse reaction at the time of the vaccine. Patient did not had a rash and all blood levels are good. Patients covid antibody level is 5812.3 AU/ml. Treatment received for the adverse event was with Creams. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, SARS-CoV-2 test, Vaginal haemorrhage
Clinical narrative: Excessive and frequent vaginal bleeding; Heavy bleeding almost constantly between cycle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PROGESTERONE in two weeks. 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; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown, Unable to locate or read the details, Location of injection: Arm Left), for Covid-19 immunization.  The following information was reported: VAGINAL HAEMORRHAGE (non-serious) with onset 14Nov2021, outcome "not recovered", described as "Excessive and frequent vaginal bleeding"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 14Nov2021, outcome "not recovered", described as "Heavy bleeding almost constantly between cycle". The events "excessive and frequent vaginal bleeding" and "heavy bleeding almost constantly between cycle" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of vaginal haemorrhage, heavy menstrual bleeding.  Additional information: Excessive and frequent vaginal bleeding. Heavy bleeding almost constantly between cycle. Patient did not receive other vaccine in four weeks. The Patient did not have covid prior vaccination. The Patient tested covid post vaccination. Known allergies: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (11Mar2022): 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: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Ear infection, Nasopharyngitis, Rash, SARS-CoV-2 test
Clinical narrative: ear infection; sinus infection; experience extreme joint pain and rashes which seem to be related to a drug allergy; experience extreme joint pain and rashes which seem to be related to a drug allergy; got a head cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 6 year-old male patient received bnt162b2 (BNT162B2), administration date 28Dec2021 (Batch/Lot number: unknown) at the age of 6 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination:Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes; "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 30Dec2021, outcome "recovering", described as "got a head cold"; EAR INFECTION (non-serious), outcome "recovering", described as "ear infection"; SINUSITIS (non-serious), outcome "recovering", described as "sinus infection"; ARTHRALGIA (non-serious), RASH (non-serious), outcome "recovering" and all described as "experience extreme joint pain and rashes which seem to be related to a drug allergy". The events "got a head cold", "ear infection", "sinus infection", "experience extreme joint pain and rashes which seem to be related to a drug allergy" and "experience extreme joint pain and rashes which seem to be related to a drug allergy" 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 nasopharyngitis, ear infection, sinusitis, arthralgia, rash.  Additional Information: if other vaccine in four weeks was no. other medications in two weeks was cephalosporin. Within 2 days of getting his first dose, my son got a head cold and its unknown whether its a reaction to vaccine or not. within 2 weeks of getting the vaccine, my son needed treatment with cephalosporin antibiotics for ear infection and sinus infection. While he is allergic to penicilin he took cephalosporins before and was fine. To-ward the end of the 7 days he began to experience extreme joint pain and rashes which seem to be related to a drug allergy. He took these before and did not have a reaction. I was not sure if it was related to the timing of the vaccine and some immune response. Treatment included steroids and ongoing use of Zyrtec and Benadryl. if covid prior vaccination and if covid tested post vaccination was yes. Device Date : 07Feb2022  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: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: ear infection; sinus infection; experience extreme joint pain and rashes which seem to be related to a drug allergy; experience extreme joint pain and rashes which seem to be related to a drug allergy; got a head cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 6 year-old male patient received bnt162b2 (BNT162B2), administration date 28Dec2021 (Batch/Lot number: unknown) at the age of 6 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination:Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes; "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 30Dec2021, outcome "recovering", described as "got a head cold"; EAR INFECTION (non-serious), outcome "recovering", described as "ear infection"; SINUSITIS (non-serious), outcome "recovering", described as "sinus infection"; ARTHRALGIA (non-serious), RASH (non-serious), outcome "recovering" and all described as "experience extreme joint pain and rashes which seem to be related to a drug allergy". The events "got a head cold", "ear infection", "sinus infection", "experience extreme joint pain and rashes which seem to be related to a drug allergy" and "experience extreme joint pain and rashes which seem to be related to a drug allergy" 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 nasopharyngitis, ear infection, sinusitis, arthralgia, rash.  Additional Information: if other vaccine in four weeks was no. other medications in two weeks was cephalosporin. Within 2 days of getting his first dose, my son got a head cold and its unknown whether its a reaction to vaccine or not. within 2 weeks of getting the vaccine, my son needed treatment with cephalosporin antibiotics for ear infection and sinus infection. While he is allergic to penicilin he took cephalosporins before and was fine. To-ward the end of the 7 days he began to experience extreme joint pain and rashes which seem to be related to a drug allergy. He took these before and did not have a reaction. I was not sure if it was related to the timing of the vaccine and some immune response. Treatment included steroids and ongoing use of Zyrtec and Benadryl. if covid prior vaccination and if covid tested post vaccination was yes. Device Date : 07Feb2022  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: Arthralgia, Discomfort, Pain
Clinical narrative: My elbows just ached; It is extremely uncomfortable and painful.; It is extremely uncomfortable and painful.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) 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: Covid-19 vaccine (Dose: 1, Manufacturer Unknown), for COVID-19 immunization, reaction(s): "no side effects at all". The following information was reported: ARTHRALGIA (non-serious), outcome "not recovered", described as "My elbows just ached"; PAIN (non-serious), DISCOMFORT (non-serious), outcome "not recovered" and all described as "It is extremely uncomfortable and painful.". Therapeutic measures were taken as a result of arthralgia, pain, discomfort.  Additional information: Patient stared that "with my second vaccine I had no side effects in the first 24 hours then suddenly my elbows just ached. I assumed it was from the vaccine but it never stopped and is still just achy, ok, no they just plain hurt all the time". Again, it happened about 24 hours after second vaccine. It is extremely uncomfortable and painful. I am taking either Tylenol or ibuprofen way to much.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nausea
Clinical narrative: Nausea; Headache; Diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4097881-00.  A 41 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) at the age of 41 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at weekly (unk, weekly) for posterior segment of eye anomaly, uveitis, psoriasis, colitis ulcerative. Relevant medical history included: "rheumatoid arthritis" (unspecified if ongoing); "non-infectious intermediate posterior" (unspecified if ongoing); "panuveitis" (unspecified if ongoing); "moderate to severe chronic plaque psoriasis" (unspecified if ongoing); "moderate to severe ulcerative colitis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (It was unknown if patient was enrolled in a COVID 19 Vaccine Trial. On 01Mar2021, she received first dose COVID 19 Vaccine manufactured by Pfizer Biontech), administration date: 01Mar2021, when the patient was 41 years old, for COVID-19 immunization, reaction(s): "upset stomach"; Bnt162b2 (In Mar2021, the patient experienced first vaccine caused upset stomach, headache and fever), administration date: Mar2021, when the patient was 41 years old, for COVID-19 Immunization, reaction(s): "headache"; Bnt162b2, administration date: Mar2021, when the patient was 41 years old, for COVID-19 Immunization, reaction(s): "fever". The following information was reported: NAUSEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Nausea"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Headache"; DIARRHOEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Diarrhea". The action taken for adalimumab was dosage permanently withdrawn.  Additional information: The causality for BNT162B2 was reported as possible for all the events and the causality for Humira was not reported for any of the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Onychoclasis, Trichorrhexis
Clinical narrative: significant hair breakage/loss; significant hair breakage/loss; her toenails becoming brittle, three toe nails break off completely; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2021SA431468.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; dupilumab (DUPILUMAB), subcutaneous since 05May2020 (Batch/Lot number: unknown) at 300 mg for dermatitis atopic. Relevant medical history included: "Thyroid disorder" (unspecified if ongoing), notes: Historical Condition: Thyroid disorder. The patient's concomitant medications were not reported. The following information was reported: TRICHORRHEXIS (non-serious), ALOPECIA (non-serious) all with onset 01Aug2021, outcome "unknown" and all described as "significant hair breakage/loss"; ONYCHOCLASIS (non-serious) with onset 01Aug2021, outcome "unknown", described as "her toenails becoming brittle, three toe nails break off completely". The action taken for dupilumab was unknown.  Additional information: On 01Aug2021, the patient developed a non-serious event 'significant hair breakage/loss' (Latency:1 year 2 months 27 days) following the first dose intake of Dupilumab. On 01Aug2021, the patient developed a non-serious event 'significant hair breakage/loss' (Unknown Latency) following the administration of Pfizer BioNTech Covid-19 Vaccine. It was reported 'patient received her Pfizer covid vaccine around end of Jul, beginning of August. She has noticed significant hair breakage/ loss since that time as well as her toenails becoming brittle. She has had three toe nails break off completely, only changes in her life around that time were getting her Covid shot and possibly starting menopause'.It was not reported if the patient received a corrective treatment for the events significant hair breakage/loss, her toenails becoming brittle, three toe nails break off completely.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.