chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Feeling abnormal, Hypertension, Malaise
Clinical narrative: felt terrific; she felt like her old self again after the shot, but nothing really else; a little high blood pressure; 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 77 year-old female patient received bnt162b2 (BNT162B2), administration date 05Feb2021 (Lot number: E12247) at the age of 77 years as dose 1, single and administered in arm right, administration date 25Feb2021 (Lot number: EN6202) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "felt terrific"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "she felt like her old self again after the shot, but nothing really else"; HYPERTENSION (non-serious), outcome "unknown", described as "a little high blood pressure". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Reporter stated she received the 2 doses of the Pfizer Covid vaccine last year. She said all went well, she did feel the shot going in but that was it. Felt like her old self after that. She stated it's alarming to hear that it is possible even though you are fully vaccinated with Pfizer Covid vaccine and still can get the Covid virus. She stated her life was complicated enough; she has not gotten the booster yet and now she was tired of hearing about getting a booster dose. She feels that she is not going to catch anything but stated she was old, so body takes its toll, she still drives and lives alone and feels terrific. The patient was 77 when she received her first vaccine. Then, she went in at 78 years old. In a couple of weeks, she would be 79 years old. Stated she was on the light side but she has always been that way, even in high school. She hasn't been measured in quite a while and she has heard you shrink with age. In general, she was on the short side, maybe 5'1.5''. She hasn't been weighed in several months at the doctors. Reporter made the comment she had a little high blood pressure. When probed to determine if the high blood pressure occurred prior to getting the shot or after, the caller explains it happened after. She didn't have high blood pressure until after the first shot.  The high blood pressure began maybe a couple of months afterwards. She doesn't know 100% but she feels that getting the COVID vaccine didn't have anything to do with the high blood pressure, it's her age. She also has wonderful doctors. No additional vaccines administered on same date of the Pfizer suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s), was applicable. She was overall very happy with Pfizer.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: My arm was extremely sore / has continued to feel sore; I have felt more soreness down my arm and fingers; slow to move; tingling sensation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Dec2021 13:00 (Lot number: FE3594) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Previous Dose Details: , Previous Dose Product=COVID 19, Prev Dose Brand=Pfizer, Prev Dose Brand Unknown=False, Prev Dose Lot Number=EW0217, Prev Dose Lot Unknown=False, Prev Dose Administration Date=09Jun2021,  Prev Dose Dose Number=2, Prev Dose Vaccine Location=Left Arm), administration date: 09Jun2021, when the patient was 28 years old, for Covid-19 immunization; Bnt162b2 (Prev Dose Product=COVID 19, Prev Dose Brand=Pfizer, Prev Dose Brand Unknown=False, Prev Dose Lot Number=EW0168, Prev Dose Lot Unknown=False, Prev Dose Administration Date=11May2021,  Prev Dose Number=1, Prev Dose Vaccine Location=Left Arm), administration date: 11May2021, when the patient was 28 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Dec2021, outcome "not recovered", described as "My arm was extremely sore / has continued to feel sore"; PAIN IN EXTREMITY (non-serious) with onset 17Dec2021, outcome "not recovered", described as "I have felt more soreness down my arm and fingers"; MOBILITY DECREASED (non-serious) with onset 17Dec2021, outcome "not recovered", described as "slow to move"; PARAESTHESIA (non-serious) with onset 17Dec2021, outcome "not recovered", described as "tingling sensation". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, pain in extremity, mobility decreased, paraesthesia.  Additional information: The patient  received a Pfizer booster in (city withheld) at (pharmacy name withheld) at (address withheld).Her arm was extremely sore following the shot and has continued to feel sore. Recently, she had felt more soreness down my arm and fingers. Her arms and fingers have felt sore, slow to move, and at times a tingling sensation. She called the (pharmacy name withheld) and they recommended reported it to you all. The patient did not have any known allergies. The patient did not receive any other medications in two weeks. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Pain in extremity, Paraesthesia, SARS-CoV-2 test
Clinical narrative: My arm was extremely sore / has continued to feel sore; I have felt more soreness down my arm and fingers; slow to move; tingling sensation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Dec2021 13:00 (Lot number: FE3594) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Previous Dose Details: , Previous Dose Product=COVID 19, Prev Dose Brand=Pfizer, Prev Dose Brand Unknown=False, Prev Dose Lot Number=EW0217, Prev Dose Lot Unknown=False, Prev Dose Administration Date=09Jun2021,  Prev Dose Dose Number=2, Prev Dose Vaccine Location=Left Arm), administration date: 09Jun2021, when the patient was 28 years old, for Covid-19 immunization; Bnt162b2 (Prev Dose Product=COVID 19, Prev Dose Brand=Pfizer, Prev Dose Brand Unknown=False, Prev Dose Lot Number=EW0168, Prev Dose Lot Unknown=False, Prev Dose Administration Date=11May2021,  Prev Dose Number=1, Prev Dose Vaccine Location=Left Arm), administration date: 11May2021, when the patient was 28 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Dec2021, outcome "not recovered", described as "My arm was extremely sore / has continued to feel sore"; PAIN IN EXTREMITY (non-serious) with onset 17Dec2021, outcome "not recovered", described as "I have felt more soreness down my arm and fingers"; MOBILITY DECREASED (non-serious) with onset 17Dec2021, outcome "not recovered", described as "slow to move"; PARAESTHESIA (non-serious) with onset 17Dec2021, outcome "not recovered", described as "tingling sensation". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, pain in extremity, mobility decreased, paraesthesia.  Additional information: The patient  received a Pfizer booster in (city withheld) at (pharmacy name withheld) at (address withheld).Her arm was extremely sore following the shot and has continued to feel sore. Recently, she had felt more soreness down my arm and fingers. Her arms and fingers have felt sore, slow to move, and at times a tingling sensation. She called the (pharmacy name withheld) and they recommended reported it to you all. The patient did not have any known allergies. The patient did not receive any other medications in two weeks. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I have been receiving random hives on my inner thigh, across my lower stomach and face swelling; I have been receiving random hives on my inner thigh, across my lower stomach and face swelling; This is a spontaneous report received from 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, administration date 27Dec2021 (Lot number: Fl3198) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Corn" (unspecified if ongoing); "known allergies: Corn and lamb" (unspecified if ongoing). Concomitant medication(s) included: LAMICTAL. Vaccination history included: Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer biotech, prev dose brand unknown: False, prev dose lot number: Er8734, prev dose lot unknown: False, prev dose number: 1), administration date: 09Apr2021, when the patient was 34 years old, for Covid-19 immunization, reaction(s): "covid test date: 11Feb2022 / covid test result: Positive", "covid test date: 11Feb2022 / covid test result: Positive"; Bnt162b2 (Previous dose details:, prev dose product: COVID 19, prev dose brand: Pfizer biotech, prev dose brand unknown: False, prev dose lot number: Ew0176, prev dose lot unknown: False, prev dose number: 2, prev dose vaccine location: Right arm), administration date: 30Apr2021, when the patient was 34 years old, for COVID-19 immunization, reaction(s): "covid test date: 11Feb2022 / covid test result: Positive", "covid test date: 11Feb2022 / covid test result: Positive". The following information was reported: URTICARIA (non-serious), SWELLING FACE (non-serious) all with onset 29Dec2021, outcome "recovered with sequelae" and all described as "I have been receiving random hives on my inner thigh, across my lower stomach and face swelling". The event "i have been receiving random hives on my inner thigh, across my lower stomach and face swelling" and "i have been receiving random hives on my inner thigh, across my lower stomach and face swelling" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urticaria, swelling face.  Additional information: The facility type vaccine was hospital. The patient has not received any other vaccine in four weeks. She received Lamictol in two weeks. Her events recovered with lasting effects as she received treatment with benadryl and steroids. She was not tested positive for covid prior vaccination. On 11Feb2022, she tested positive for covid (Covid test type: Nasal Swab) post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-1 test, Swelling face, Urticaria
Clinical narrative: I have been receiving random hives on my inner thigh, across my lower stomach and face swelling; I have been receiving random hives on my inner thigh, across my lower stomach and face swelling; This is a spontaneous report received from 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, administration date 27Dec2021 (Lot number: Fl3198) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Corn" (unspecified if ongoing); "known allergies: Corn and lamb" (unspecified if ongoing). Concomitant medication(s) included: LAMICTAL. Vaccination history included: Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer biotech, prev dose brand unknown: False, prev dose lot number: Er8734, prev dose lot unknown: False, prev dose number: 1), administration date: 09Apr2021, when the patient was 34 years old, for Covid-19 immunization, reaction(s): "covid test date: 11Feb2022 / covid test result: Positive", "covid test date: 11Feb2022 / covid test result: Positive"; Bnt162b2 (Previous dose details:, prev dose product: COVID 19, prev dose brand: Pfizer biotech, prev dose brand unknown: False, prev dose lot number: Ew0176, prev dose lot unknown: False, prev dose number: 2, prev dose vaccine location: Right arm), administration date: 30Apr2021, when the patient was 34 years old, for COVID-19 immunization, reaction(s): "covid test date: 11Feb2022 / covid test result: Positive", "covid test date: 11Feb2022 / covid test result: Positive". The following information was reported: URTICARIA (non-serious), SWELLING FACE (non-serious) all with onset 29Dec2021, outcome "recovered with sequelae" and all described as "I have been receiving random hives on my inner thigh, across my lower stomach and face swelling". The event "i have been receiving random hives on my inner thigh, across my lower stomach and face swelling" and "i have been receiving random hives on my inner thigh, across my lower stomach and face swelling" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urticaria, swelling face.  Additional information: The facility type vaccine was hospital. The patient has not received any other vaccine in four weeks. She received Lamictol in two weeks. Her events recovered with lasting effects as she received treatment with benadryl and steroids. She was not tested positive for covid prior vaccination. On 11Feb2022, she tested positive for covid (Covid test type: Nasal Swab) post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Chills, Dizziness, Hyperhidrosis, Pyrexia, Tachycardia
Clinical narrative: fever over 100F; Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Mar2022 06:30 (Lot number: Fj4991) at the age of 26 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Attention deficit hyperactivity disorder" (unspecified if ongoing); "Known Allergies: sulfa drugs" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL. Past drug history included: Morphine, reaction(s): "Known Allergies: Morphine". Vaccination history included: Bnt162b2 (Dose 1, lot number=Fk9895, administration time=05:00 PM, vaccine location=Left arm), administration date: 18Feb2022, when the patient was 26 years old, for Covid-19 immunization, reaction(s): "I almost fainted immediately after the first dose/Felt faint for a few days", "my arm and fingers on the left side went numb", "Severe chills", "fever over 100F", "Sore arm".  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever over 100F"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: No other vaccine received in four weeks. Other medications in two weeks: Generic Adderall IR. After second dose, patient had fever over 100F and Sore arm. No loss of touch in arm or hand. Not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: fever over 100F; Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Mar2022 06:30 (Lot number: Fj4991) at the age of 26 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Attention deficit hyperactivity disorder" (unspecified if ongoing); "Known Allergies: sulfa drugs" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL. Past drug history included: Morphine, reaction(s): "Known Allergies: Morphine". Vaccination history included: Bnt162b2 (Dose 1, lot number=Fk9895, administration time=05:00 PM, vaccine location=Left arm), administration date: 18Feb2022, when the patient was 26 years old, for Covid-19 immunization, reaction(s): "I almost fainted immediately after the first dose/Felt faint for a few days", "my arm and fingers on the left side went numb", "Severe chills", "fever over 100F", "Sore arm".  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever over 100F"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: No other vaccine received in four weeks. Other medications in two weeks: Generic Adderall IR. After second dose, patient had fever over 100F and Sore arm. No loss of touch in arm or hand. Not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Contusion, Demyelination, Multiple sclerosis, Pain
Clinical narrative: After 1st dose developed cognitive issues; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) at the age of 50 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: COGNITIVE DISORDER (non-serious) with onset Apr2021, outcome "unknown", described as "After 1st dose developed cognitive issues". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cognitive disorder, Weight
Clinical narrative: After 1st dose developed cognitive issues; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) at the age of 50 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: COGNITIVE DISORDER (non-serious) with onset Apr2021, outcome "unknown", described as "After 1st dose developed cognitive issues". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 59.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Injection site erythema, Injection site pain, Mobility decreased, Neuralgia
Clinical narrative: Abdominal pain, progressively grew worse; Severe pain radiated around torso/Torso pain; Pain with any little movement; This case was reported by a consumer via call center representative and described the occurrence of abdominal pain in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2022, the patient received the 1st dose of Shingrix. In February 2022, 5 hrs after receiving Shingrix, the patient experienced abdominal pain, pain and mobility decreased. On an unknown date, the outcome of the abdominal pain was unknown and the outcome of the pain and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the abdominal pain, pain and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix in February and about 5 hours afterwards the patient started with abdominal pain which progressively grew worse. About 6 hours after the vaccination, the patient started with pain was in a fetal position for the next 6 hours with severe torso pain. The patient stated that this pain radiated around his/her torso with any little movement and lasted for 6 hours before stopping. The patient asked that you have had any others with this reaction. The reporter consented to follow-up.
Age: 59.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: Abdominal pain, progressively grew worse; Severe pain radiated around torso/Torso pain; Pain with any little movement; This case was reported by a consumer via call center representative and described the occurrence of abdominal pain in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2022, the patient received the 1st dose of Shingrix. In February 2022, 5 hrs after receiving Shingrix, the patient experienced abdominal pain, pain and mobility decreased. On an unknown date, the outcome of the abdominal pain was unknown and the outcome of the pain and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the abdominal pain, pain and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix in February and about 5 hours afterwards the patient started with abdominal pain which progressively grew worse. About 6 hours after the vaccination, the patient started with pain was in a fetal position for the next 6 hours with severe torso pain. The patient stated that this pain radiated around his/her torso with any little movement and lasted for 6 hours before stopping. The patient asked that you have had any others with this reaction. The reporter consented to follow-up.
Age: 59.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Mobility decreased, Pain
Clinical narrative: Abdominal pain, progressively grew worse; Severe pain radiated around torso/Torso pain; Pain with any little movement; This case was reported by a consumer via call center representative and described the occurrence of abdominal pain in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2022, the patient received the 1st dose of Shingrix. In February 2022, 5 hrs after receiving Shingrix, the patient experienced abdominal pain, pain and mobility decreased. On an unknown date, the outcome of the abdominal pain was unknown and the outcome of the pain and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the abdominal pain, pain and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix in February and about 5 hours afterwards the patient started with abdominal pain which progressively grew worse. About 6 hours after the vaccination, the patient started with pain was in a fetal position for the next 6 hours with severe torso pain. The patient stated that this pain radiated around his/her torso with any little movement and lasted for 6 hours before stopping. The patient asked that you have had any others with this reaction. The reporter consented to follow-up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm after her second dose of the Moderna Covid-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm after her second dose of the Moderna Covid-19 vaccine.) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm after her second dose of the Moderna Covid-19 vaccine.). At the time of the report, PAIN IN EXTREMITY (sore arm after her second dose of the Moderna Covid-19 vaccine.) outcome was unknown.            No concomitant medications were reported. It was reported that the patient was not immunocompromised and had received her primary Series first two doses of the Moderna Covid-19 vaccine as well as a Primary Dose of the Moderna Covid-19 vaccine.  It was reported that the patient did not remember which arm patient received the first and second vaccination in. No treatment medications were reported.   This case was linked to MOD-2022-521217, MOD-2022-521320 (Patient Link).
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: Cough, Dizziness, Dyspnoea, Heart rate decreased, Heart rate irregular
Clinical narrative: Trouble breathing for 4 months after the booster shot. (3rd shot) Also coughing a lot. Coughing up a lot of mucus. Dizzy, light headed, heart racing at times, low heart rate at other times, and irregular heart beat. 4 months of this. Finely my doctor gave me anti biotics for a week, and I started feeling better. Still not right though. I have no lung capacity. I walk 20 feet, and I'm out of breath. I've never been like this in my life until I took the vaccine. Same thing happened after the second shot. That lasted 2 months before I started feeling normal again.
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: Laboratory test, Palpitations, Pulmonary function test, Secretion discharge
Clinical narrative: Trouble breathing for 4 months after the booster shot. (3rd shot) Also coughing a lot. Coughing up a lot of mucus. Dizzy, light headed, heart racing at times, low heart rate at other times, and irregular heart beat. 4 months of this. Finely my doctor gave me anti biotics for a week, and I started feeling better. Still not right though. I have no lung capacity. I walk 20 feet, and I'm out of breath. I've never been like this in my life until I took the vaccine. Same thing happened after the second shot. That lasted 2 months before I started feeling normal again.
Age: 26.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Dysgeusia, Parosmia
Clinical narrative: THE DAY AFTER VACCINES ADMINISTRATION PT STARTED HAVING A  BAD  TASTE IN THE MOUTH  AND A BAD  SMELL IN HER NOSE WHICH ACCORDING TO HER IS SO DISTINCT. ALL THESE LASTED FOR 2 WEEKS. SHE STILL SMELLS IT UNTIL NOW BUT IT IS NOT AS STRONG
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Immunisation reaction, Parosmia
Clinical narrative: 3 DAYS AFTER VACCINE ADMINISTRATION PT STARTED HAVING BAD TASTE IN THE MOUTH AND SMELL IN THE NOSE WHICH IS TRIGGERED BY THE TASTE AND SMELL OF FOOD. PT IS STILL HAVING THOSE UNTOWARD VACCINE REACTION UP TO THIS TIME
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Dyspnoea, Electric shock sensation, Electrocardiogram normal
Clinical narrative: Started with tingling in arms and hands, then chest pain started. Chest pain has gotten worse. Headaches that travel around head, zapping pain throughout body, stomach issues, tachycardia, shortness of breath, abnormally cold hands and feet,  and brain fog.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Gastrointestinal disorder, Headache, Pain, Paraesthesia
Clinical narrative: Started with tingling in arms and hands, then chest pain started. Chest pain has gotten worse. Headaches that travel around head, zapping pain throughout body, stomach issues, tachycardia, shortness of breath, abnormally cold hands and feet,  and brain fog.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, Platelet count increased, Tachycardia
Clinical narrative: Started with tingling in arms and hands, then chest pain started. Chest pain has gotten worse. Headaches that travel around head, zapping pain throughout body, stomach issues, tachycardia, shortness of breath, abnormally cold hands and feet,  and brain fog.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Mobility decreased, Myalgia, Neuralgia, Tendon pain
Clinical narrative: initial symptoms of rotator cuff pain was followed by axillary and suprascapular nerve pain and numbness resulting with significant loss of function of the left arm. The treatment consists of nonsteroidal anti inflammatory medication and physical therapy. As of 03/26/2022 the treatment continues with partial improvement.
Age: 45.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, Medication error, No adverse event, Product administered to patient of inappropriate age, Product prescribing issue
Clinical narrative: MD ordered a pediatric vaccine to an adult patient; Storage in clinical Practice; No adverse event / not notified of any symptoms or side effects; expired dose of PROQU AD was inadvertently given to a 45-year old adult instead of a child; expired dose of PROQU AD was inadvertently given to a 45-year old adult instead of a child / a pediatric vaccine was given to an adult patient; This spontaneous report was received from a nurse manager and refers to a 45-year-old male patient. No information about his medical history, concomitant medications and concurrent conditions was reported.  On an unknown date, the medical doctor ordered a pediatric measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for an adult patient (product prescribing issue). On 28-FEB-2022, instead of a child, the patient was inadvertently administered with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) lot# T028297, expiration date: 16-FEB-2022 (dose was not provided), subcutaneously in right arm for prophylaxis (expired product administered, product administered to patient of inappropriate age). Additionally, a medication error occurred during storage in clinical practice (product storage error) (also reported the product did not have any temperature excursion and was stored properly, discrepant information). No additional adverse event information was provided, the reporter was not notified of any symptoms or side effects (no adverse event).
Age: 45.0
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: MD ordered a pediatric vaccine to an adult patient; Storage in clinical Practice; No adverse event / not notified of any symptoms or side effects; expired dose of PROQU AD was inadvertently given to a 45-year old adult instead of a child; expired dose of PROQU AD was inadvertently given to a 45-year old adult instead of a child / a pediatric vaccine was given to an adult patient; This spontaneous report was received from a nurse manager and refers to a 45-year-old male patient. No information about his medical history, concomitant medications and concurrent conditions was reported.  On an unknown date, the medical doctor ordered a pediatric measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for an adult patient (product prescribing issue). On 28-FEB-2022, instead of a child, the patient was inadvertently administered with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) lot# T028297, expiration date: 16-FEB-2022 (dose was not provided), subcutaneously in right arm for prophylaxis (expired product administered, product administered to patient of inappropriate age). Additionally, a medication error occurred during storage in clinical practice (product storage error) (also reported the product did not have any temperature excursion and was stored properly, discrepant information). No additional adverse event information was provided, the reporter was not notified of any symptoms or side effects (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC reported; Caller reported the vaccines were administered after the excursion; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history, allergies, drug reactions were not provided. The patient's concomitant therapies included sterile diluent.  On 10-NOV-2021, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) in dose 0.5 ml, (lot # U017140, verified as valid with expiration date 28-NOV-2022, albumin status: rHa) (dose number, route of administration and anatomical location were not reported) for prophylaxis (Product storage error). The temperature to which the vaccine was exposed was 6 Fahrenheit degrees up to 14 Fahrenheit degrees and the time frame was reported as 4 hours and 14 Fahrenheit degrees up to 46 Fahrenheit degrees for 4 hours and 45 minutes. No previous temperature excursions were reported. No additional adverse event was reported (No adverse event). It was unknown if a digital data logger was involved.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2203USA001841: US-009507513-2203USA001716: US-009507513-2203USA001578: US-009507513-2203USA001612: US-009507513-2203USA001617: US-009507513-2203USA001688: US-009507513-2203USA001728: US-009507513-2203USA001890:
Age: 0.75
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE details are available; 9 month old was administered with dose of ROTATEQ; This spontaneous report was received from an office manager and refers to a 9-month-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided.  On 07-MAR-2022 (also reported as today), the patient was vaccinated with 1 dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #1742431, expiration date: 31-JAN-2023 (dose not provided), administered orally for prophylaxis (product administered to patient of inappropriate age). No additional adverse event details were available (no adverse event).
Age: 1.58
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Confirmed wtih caller no other AE occurred.; The caller reported a patient received both PROQUAD and VARIVAX on 09-MAR-2022; This spontaneous report was received from a nurse and refers to a 19-month-old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-MAR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) 1 dose, lot # u009261, expiration date: 19-SEP-2022 (formulation, dose, strength, site and route of administration were not provided) for prophylaxis; and varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, lot # t040418, expiration date: 01-DEC-2022 (formulation, dose, strength, site and route of administration were not provided) for prophylaxis (Inappropriate schedule of product administration). No other adverse event occurred (No adverse event).
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE ocurred; Administered to a patient after a temperature excursion; This spontaneous report was received from an office manager concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided.  On 07-MAR-2022, in March 2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) 1 dose (lot number T033815 with expiration date on 05-OCT-2022) and with varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose (lot number U020239 with expiration date on 28-JUN-2023) both for prophylaxis (route of administration, vaccination scheme frequency and anatomical location were not provided).  Before administration, the doses of the vaccines experienced a temperature excursion on 07-MAR-2022 since they were stored at a temperature of -14 degrees Celsius (C) up to -10 degrees C for the time frame of 30 minutes, from -10 degrees C up to 8 degrees C for 2 hours and 15 minutes, and from 9 degrees C up to 25 degrees C for 20 minutes (product storage error). There was no previous temperature excursion.  No adverse events were reported.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Autoimmune disorder, Autonomic nervous system imbalance, Dizziness, Herpes zoster
Clinical narrative: autonomic dysfunction.; Autoimmune Disease; injection site bump; numbness and tingling in her extremities and her face; numbness and tingling in her extremities and her face; menstrual cycle abnormalities; Abdominal pain; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 17-years-old female patient. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On 07-NOV-2016, the patient was vaccinated with a first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (Lot #, expiration date, dose, route of administration and anatomical location of vaccine were not provided) for preventing cervical cancer.  On an unspecified date, subsequent to the patient vaccination, the patient developed a large bump at the injection site. She also began experiencing heart palpitations, numbness and tingling in her extremities and her face, abdominal pain, menstrual cycle abnormalities, nausea, and dizziness. Additionally, based upon her chronic and severe post-Gardasil symptoms, Plaintiff has been diagnosed with various medical conditions, including, but not limited to, autonomic dysfunction and has Resulted in Her Suffering from Severe, Debilitating, Disabling and Painful Chronic Injuries. At the reporting time, the outcome of the event was unknown.  The reporter considered the events of shingles to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL)  Upon internal review the event of Autoimmune Disease was considered as medically significant.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Injection site swelling, Menstrual disorder, Nausea, Palpitations
Clinical narrative: autonomic dysfunction.; Autoimmune Disease; injection site bump; numbness and tingling in her extremities and her face; numbness and tingling in her extremities and her face; menstrual cycle abnormalities; Abdominal pain; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 17-years-old female patient. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On 07-NOV-2016, the patient was vaccinated with a first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (Lot #, expiration date, dose, route of administration and anatomical location of vaccine were not provided) for preventing cervical cancer.  On an unspecified date, subsequent to the patient vaccination, the patient developed a large bump at the injection site. She also began experiencing heart palpitations, numbness and tingling in her extremities and her face, abdominal pain, menstrual cycle abnormalities, nausea, and dizziness. Additionally, based upon her chronic and severe post-Gardasil symptoms, Plaintiff has been diagnosed with various medical conditions, including, but not limited to, autonomic dysfunction and has Resulted in Her Suffering from Severe, Debilitating, Disabling and Painful Chronic Injuries. At the reporting time, the outcome of the event was unknown.  The reporter considered the events of shingles to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL)  Upon internal review the event of Autoimmune Disease was considered as medically significant.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: autonomic dysfunction.; Autoimmune Disease; injection site bump; numbness and tingling in her extremities and her face; numbness and tingling in her extremities and her face; menstrual cycle abnormalities; Abdominal pain; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 17-years-old female patient. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On 07-NOV-2016, the patient was vaccinated with a first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (Lot #, expiration date, dose, route of administration and anatomical location of vaccine were not provided) for preventing cervical cancer.  On an unspecified date, subsequent to the patient vaccination, the patient developed a large bump at the injection site. She also began experiencing heart palpitations, numbness and tingling in her extremities and her face, abdominal pain, menstrual cycle abnormalities, nausea, and dizziness. Additionally, based upon her chronic and severe post-Gardasil symptoms, Plaintiff has been diagnosed with various medical conditions, including, but not limited to, autonomic dysfunction and has Resulted in Her Suffering from Severe, Debilitating, Disabling and Painful Chronic Injuries. At the reporting time, the outcome of the event was unknown.  The reporter considered the events of shingles to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL)  Upon internal review the event of Autoimmune Disease was considered as medically significant.
Age: 69.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Hepatitis B, Inappropriate schedule of product administration, Pain
Clinical narrative: hepatitis B; little soreness; dates of vaccination: on 19-MAR-2015 and on 05-MAY-2015; This spontaneous report has been received from a lawyer via Plaintiff Fact Sheet (FS), from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 2108USA004335), concerning a 69-year old female patient (pt). The pt's historical vaccinations included influenza vaccine inact split (provided as "influenza split (INFs) virus", administered 3 times) and zoster vaccine live (ZOSTAVAX). Concomitant vaccine included hepatitis a vaccine, inactivated (manufacturer unknown) (information captured in split case # 2203USA006565).  On 19-MAR-2015, the pt was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) (provided as "HAV adult hepatitis B") (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis by a registered nurse. On an unspecified date after administration, the pt experienced vaccine side effect: hepatitis B (reported as "HAV adult hepatitis B"). On 05-MAY-2015, the pt received another dose of the vaccine (inappropriate schedule of product administration). On an unspecified date after another dose with hepatitis b vaccine (recombinant) (manufacturer unknown), the pt experienced vaccine side effect: a little soreness. The outcome of the events was not provided. The causality between the hepatitis b vaccine (recombinant) (manufacturer unknown) and the events was considered to be related.  Upon internal review, the event of hepatitis B was determined to be medically significant.  This is one of 3 linked reports regarding the same patient (cross referenced with # 2203USA006565 and 2108USA004335).; Sender's Comments:  US-009507513-2108USA004335: US-009507513-2203USA006565:
Age: 69.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Pain, Vaccine positive rechallenge
Clinical narrative: hepatitis B; little soreness; dates of vaccination: on 19-MAR-2015 and on 05-MAY-2015; This spontaneous report has been received from a lawyer via Plaintiff Fact Sheet (FS), from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 2108USA004335), concerning a 69-year old female patient (pt). The pt's historical vaccinations included influenza vaccine inact split (provided as "influenza split (INFs) virus", administered 3 times) and zoster vaccine live (ZOSTAVAX). Concomitant vaccine included hepatitis a vaccine, inactivated (manufacturer unknown) (information captured in split case # 2203USA006565).  On 19-MAR-2015, the pt was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) (provided as "HAV adult hepatitis B") (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis by a registered nurse. On an unspecified date after administration, the pt experienced vaccine side effect: hepatitis B (reported as "HAV adult hepatitis B"). On 05-MAY-2015, the pt received another dose of the vaccine (inappropriate schedule of product administration). On an unspecified date after another dose with hepatitis b vaccine (recombinant) (manufacturer unknown), the pt experienced vaccine side effect: a little soreness. The outcome of the events was not provided. The causality between the hepatitis b vaccine (recombinant) (manufacturer unknown) and the events was considered to be related.  Upon internal review, the event of hepatitis B was determined to be medically significant.  This is one of 3 linked reports regarding the same patient (cross referenced with # 2203USA006565 and 2108USA004335).; Sender's Comments:  US-009507513-2108USA004335: US-009507513-2203USA006565:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got shingles; This spontaneous report was received from a consumer of unknown age and gender from a social media post. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.  Approximately in 2012, reported as about 10 years ago, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for prophylaxis (dose, route of administration, lot number and expiration date not reported).         Approximately in 2014 the patient experienced shingles (herpes zoster).      The outcome of herpes zoster and its causal relationship with the vaccine were not reported.