chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Limb discomfort, Urticaria
Clinical narrative: My right leg near my knee began to burn; Then hives developed. My stomach also developed hives.; My left leg also had pressure in it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 13:15 (Lot number: FD8448) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "known_allergies:broccoli" (unspecified if ongoing); "known_allergies:shrimp" (unspecified if ongoing); "known_allergies:peanuts" (unspecified if ongoing); "known_allergies:coconut" (unspecified if ongoing); "known_allergies:corn, wheat" (unspecified if ongoing); "known_allergies:gluten" (unspecified if ongoing). Concomitant medication(s) included: VITAMINS NOS. The following information was reported: BURNING SENSATION (non-serious) with onset 27Aug2021 13:30, outcome "recovering", described as "My right leg near my knee began to burn"; URTICARIA (non-serious) with onset 27Aug2021 13:30, outcome "recovering", described as "Then hives developed. My stomach also developed hives."; LIMB DISCOMFORT (non-serious) with onset 27Aug2021 13:30, outcome "recovering", described as "My left leg also had pressure in it". Therapeutic measures were not taken as a result of burning sensation, urticaria, limb discomfort.  Prior to vaccination, was the patient was not diagnosed with COVID-19.Since the vaccination, patient has not been tested for COVID. No treatment received, case assessed as non serious  Follow-Up (07Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Incorrect route of product administration
Clinical narrative: She received the Prevnar 13 vaccine subcutaneously and not intramuscularly; Arm is super red; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 39 year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), subcutaneous, administered in arm left, administration date 26Aug2021 (Lot number: CM113) at the age of 39 years as dose 1, single for immunisation; meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), administration date 26Aug2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. Relevant medical history included: "Does not have a spleen/asplenic person" (unspecified if ongoing), notes: asplenic person; "immunocompromised" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 26Aug2021, outcome "unknown", described as "She received the Prevnar 13 vaccine subcutaneously and not intramuscularly"; ERYTHEMA (non-serious) with onset 2021, outcome "unknown", described as "Arm is super red".  Additional information: The patient was asking for the efficacy of the Prevnar-13 vaccine when given subcutaneously and any information on immunocompromised individuals. She also asked if she would have to repeat the dose given that she does not have a spleen and if there are any other side effects she should look for because her arm was super red. Patient was advised to seek medical attention if she feels it's necessary.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Nipple oedema, Nipple pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 44 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Aug2021 13:15 (Lot number: EW0217) at the age of 44 years as dose 2, single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Product=COVID 19, brand=Pfizer,, Lot number=EW0202,, Lot unknown=False,, Administration time=14:00 PM,, Dose number=1,, vaccine location=Left arm, No events reported.), administration date: 23Jul2021, when the patient was 44 years old, for Covid-19 Immunization. The following information was reported: NIPPLE PAIN (non-serious) with onset 14Aug2021 10:00, outcome "recovering", described as "My right nipple in the center only was sore the day after I had my 2nd shot"; NIPPLE OEDEMA (non-serious) with onset 14Aug2021 10:00, outcome "recovering", described as "Tender to touch and looks a little bigger"; INFLAMMATION (non-serious) with onset 14Aug2021 10:00, outcome "recovering", described as "I read can cause inflammation for up to 4 weeks". Therapeutic measures were not taken as a result of nipple pain, nipple oedema, inflammation. Additional information: Prior to vaccination, patient was not diagnosed with COVID, Since the vaccination, patient has been tested for COVID. No treatment was received, Case assessed as non serious. Follow-Up (07Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Insomnia, Nervousness
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Aug2021 19:45 (Lot number: FC3180) at the age of 56 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "HTN" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "Known Allergy: PCN" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lyrica, reaction(s): "Known Allergy: Lyrica". The following information was reported: TREMOR (non-serious) with onset 24Aug2021 12:00, outcome "recovering", described as "Inside and outside tremors and shaking feeling like my heart was racing but wasn't"; INSOMNIA (non-serious) with onset 24Aug2021 12:00, outcome "recovering", described as "Enough to keep me awake"; HEADACHE (non-serious) with onset 24Aug2021 12:00, outcome "recovering", described as "Headache"; VISION BLURRED (non-serious) with onset 24Aug2021 12:00, outcome "recovering", described as "blurry vision"; FATIGUE (non-serious) with onset 24Aug2021 12:00, outcome "recovering", described as "fatigue"; PYREXIA (non-serious) with onset 24Aug2021 12:00, outcome "recovered" (28Aug2021), described as "Temp to 100.4 x 4 days"; PALPITATIONS (non-serious) with onset 24Aug2021 12:00, outcome "recovering", described as "My heart was racing"; NERVOUSNESS (non-serious) with onset 24Aug2021 12:00, outcome "recovering", described as "shaking feeling". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tremor, insomnia, headache, vision blurred, fatigue, pyrexia, palpitations, nervousness. Additional information: Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination nor been tested for COVID-19 since the vaccination. No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia, Tremor, Vision blurred
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Aug2021 19:45 (Lot number: FC3180) at the age of 56 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "HTN" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "Known Allergy: PCN" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lyrica, reaction(s): "Known Allergy: Lyrica". The following information was reported: TREMOR (non-serious) with onset 24Aug2021 12:00, outcome "recovering", described as "Inside and outside tremors and shaking feeling like my heart was racing but wasn't"; INSOMNIA (non-serious) with onset 24Aug2021 12:00, outcome "recovering", described as "Enough to keep me awake"; HEADACHE (non-serious) with onset 24Aug2021 12:00, outcome "recovering", described as "Headache"; VISION BLURRED (non-serious) with onset 24Aug2021 12:00, outcome "recovering", described as "blurry vision"; FATIGUE (non-serious) with onset 24Aug2021 12:00, outcome "recovering", described as "fatigue"; PYREXIA (non-serious) with onset 24Aug2021 12:00, outcome "recovered" (28Aug2021), described as "Temp to 100.4 x 4 days"; PALPITATIONS (non-serious) with onset 24Aug2021 12:00, outcome "recovering", described as "My heart was racing"; NERVOUSNESS (non-serious) with onset 24Aug2021 12:00, outcome "recovering", described as "shaking feeling". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tremor, insomnia, headache, vision blurred, fatigue, pyrexia, palpitations, nervousness. Additional information: Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination nor been tested for COVID-19 since the vaccination. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Rash, SARS-CoV-2 test, Taste disorder
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "smoker" (unspecified if ongoing), notes: he was a smoker for 40 years. The patient's concomitant medications were not reported. The following information was reported: TASTE DISORDER (non-serious), outcome "unknown", described as "had a weekend in which things didn't taste good"; ASTHENIA (non-serious), outcome "unknown", described as "felt a little weak"; RASH (non-serious), outcome "unknown", described as "rashes on his left arm that would come and go". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The reporter stated he was exposed to Covid-19 between the first and second doses of Pfizer Covid-19 vaccine. The reporter stated he was around someone who had a mask on as well as he did and that person tested positive for Covid-19 but he tested negative. Caller stated he had a weekend in which things didn't taste good, felt a little weak, rashes on his left arm that would come and go caller stated he haven't had any rashes in a while. No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dreamy state, Headache, Muscle spasms, Somnolence
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Aug2021 11:00 (Lot number: FC3183) at the age of 37 years as dose 2, single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot number=FA7485, Administration time=03:00 PM, Vaccine location=Left arm), administration date: Aug2021, when the patient was 37 years old, for Covid-19 immunization. The following information was reported: MUSCLE SPASMS (non-serious) with onset 27Aug2021 01:00, outcome "recovering", described as "whole body chills that resembled spasms"; DREAMY STATE (non-serious), SOMNOLENCE (non-serious) all with onset 27Aug2021 01:00, outcome "recovering" and all described as "I was in a dream state and not able to get up or awake from the episode"; CHILLS (non-serious) with onset 27Aug2021 01:00, outcome "recovering", described as "body flailing in what I would describe as whole body chills"; HEADACHE (non-serious) with onset 27Aug2021 01:00, outcome "recovering", described as "While sleeping I developed an intense headache". Therapeutic measures were taken as a result of headache. Additional information: The patient did not have Covid-19 prior vaccination. The patient did not get Covid-19 tested post vaccination. The patient did not have known allergies. The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. The patient mentioned while sleeping he developed an intense headache, followed by his body flailing in what he would describe as whole body chills that resembled spasms. He was in a dream state and not able to get up or awake from the episode. He does not know how long it lasted but he wants to say a few hours. He awoke at 04:00 with a pounding headache for which he took Advil and fell into a deep sleep after that. No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Injection site pain, Myalgia
Clinical narrative: 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 56 year-old male patient received bnt162b2 (BNT162B2), administration date 26Aug2021 (Lot number: FC3184) at the age of 56 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Hypertension" (ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension (ongoing). Vaccination history included: Bnt162b2 (First dose received on 05Aug2021 in the left arm, Lot#FA7485, NDC/Expiry not known), administration date: 05Aug2021, when the patient was 56 years old, for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 26Aug2021, outcome "unknown", described as "chills"; PYREXIA (non-serious) with onset 26Aug2021, outcome "unknown", described as "he took his temperature and he learned he had a fever of 38° C"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain"; INJECTION SITE PAIN (non-serious), outcome "unknown", described as "pain at the injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Follow-Up (07Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 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 56 year-old male patient received bnt162b2 (BNT162B2), administration date 26Aug2021 (Lot number: FC3184) at the age of 56 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Hypertension" (ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension (ongoing). Vaccination history included: Bnt162b2 (First dose received on 05Aug2021 in the left arm, Lot#FA7485, NDC/Expiry not known), administration date: 05Aug2021, when the patient was 56 years old, for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 26Aug2021, outcome "unknown", described as "chills"; PYREXIA (non-serious) with onset 26Aug2021, outcome "unknown", described as "he took his temperature and he learned he had a fever of 38° C"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain"; INJECTION SITE PAIN (non-serious), outcome "unknown", described as "pain at the injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Follow-Up (07Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chest discomfort, Chest pain, Chills
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Aug2021 14:30 (Lot number: EW0172) at the age of 59 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Psoriatic arthropathy" (unspecified if ongoing), notes: Other Medical History: psoriatic arthritis; "Penicillin Allergy" (unspecified if ongoing), notes: Known allergies: Penicillin possibly. Concomitant medication(s) included: HUMIRA, administration date 15Aug2021. The following information was reported: VOMITING (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "Worst case of throwing up I have ever had. Temp of 101. chills, diarrhea, chest pains, cold sweats, headache, every joint in my body hurt 24 hours after the shot lasting about 12 hours, I still can no"; PYREXIA (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "Temp of 101"; CHILLS (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "chills"; DIARRHOEA (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "diarrhea"; CHEST PAIN (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "chest pains"; COLD SWEAT (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "cold sweats"; HEADACHE (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "headache"; ARTHRALGIA (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "every joint in my body hurt"; DYSPNOEA (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "can not take a deep breath"; CHEST DISCOMFORT (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "chest hurting". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vomiting, pyrexia, chills, diarrhoea, chest pain, cold sweat, headache, arthralgia, dyspnoea, chest discomfort. Additional information: The patient received any other vaccines within 4 weeks prior to the COVID vaccine. Vaccine Facility type was Pharmacy or Drug Store. Other medications in two weeks was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. Known allergies to Penicillin possibly. Other medical history reported as psoriatic arthritis. Adverse event did not require a visit to Emergency Room/Physician Office. The patient did not receive any treatment for the event. No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Diarrhoea, Dyspnoea, Headache, Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Aug2021 14:30 (Lot number: EW0172) at the age of 59 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Psoriatic arthropathy" (unspecified if ongoing), notes: Other Medical History: psoriatic arthritis; "Penicillin Allergy" (unspecified if ongoing), notes: Known allergies: Penicillin possibly. Concomitant medication(s) included: HUMIRA, administration date 15Aug2021. The following information was reported: VOMITING (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "Worst case of throwing up I have ever had. Temp of 101. chills, diarrhea, chest pains, cold sweats, headache, every joint in my body hurt 24 hours after the shot lasting about 12 hours, I still can no"; PYREXIA (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "Temp of 101"; CHILLS (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "chills"; DIARRHOEA (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "diarrhea"; CHEST PAIN (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "chest pains"; COLD SWEAT (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "cold sweats"; HEADACHE (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "headache"; ARTHRALGIA (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "every joint in my body hurt"; DYSPNOEA (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "can not take a deep breath"; CHEST DISCOMFORT (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "chest hurting". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vomiting, pyrexia, chills, diarrhoea, chest pain, cold sweat, headache, arthralgia, dyspnoea, chest discomfort. Additional information: The patient received any other vaccines within 4 weeks prior to the COVID vaccine. Vaccine Facility type was Pharmacy or Drug Store. Other medications in two weeks was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. Known allergies to Penicillin possibly. Other medical history reported as psoriatic arthritis. Adverse event did not require a visit to Emergency Room/Physician Office. The patient did not receive any treatment for the event. No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Aug2021 14:30 (Lot number: EW0172) at the age of 59 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Psoriatic arthropathy" (unspecified if ongoing), notes: Other Medical History: psoriatic arthritis; "Penicillin Allergy" (unspecified if ongoing), notes: Known allergies: Penicillin possibly. Concomitant medication(s) included: HUMIRA, administration date 15Aug2021. The following information was reported: VOMITING (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "Worst case of throwing up I have ever had. Temp of 101. chills, diarrhea, chest pains, cold sweats, headache, every joint in my body hurt 24 hours after the shot lasting about 12 hours, I still can no"; PYREXIA (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "Temp of 101"; CHILLS (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "chills"; DIARRHOEA (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "diarrhea"; CHEST PAIN (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "chest pains"; COLD SWEAT (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "cold sweats"; HEADACHE (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "headache"; ARTHRALGIA (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "every joint in my body hurt"; DYSPNOEA (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "can not take a deep breath"; CHEST DISCOMFORT (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "chest hurting". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vomiting, pyrexia, chills, diarrhoea, chest pain, cold sweat, headache, arthralgia, dyspnoea, chest discomfort. Additional information: The patient received any other vaccines within 4 weeks prior to the COVID vaccine. Vaccine Facility type was Pharmacy or Drug Store. Other medications in two weeks was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. Known allergies to Penicillin possibly. Other medical history reported as psoriatic arthritis. Adverse event did not require a visit to Emergency Room/Physician Office. The patient did not receive any treatment for the event. No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Asthenia, Chills, Contusion, Dyspnoea
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Lot number: ER8735) at the age of 36 years as dose 2, single and administered in arm left, administration date 11Jun2021 10:00 (Lot number: ER8735) as dose 1, single for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DYSPNOEA (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "Shortness of breath"; HYPOAESTHESIA (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "numbness in arm & hands"; NAUSEA (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "nausea"; CHILLS (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "shivers without fever"; PALPITATIONS (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "heart palpitations"; GAIT INABILITY (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "unable to walk"; FATIGUE (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "extreme fatigue"; ASTHENIA (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "weakness"; ARTHROPOD BITE (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "ticks around arm"; CONTUSION (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "sensation of bruised under rib cages"; MOVEMENT DISORDER (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "left arm unable to move". Therapeutic measures were not taken as a result of dyspnoea, hypoaesthesia, nausea, chills, palpitations, gait inability, fatigue, asthenia, arthropod bite, contusion, movement disorder. Additional information: The patient did not receive any other vaccine in four weeks of suspect vaccine. No medications were received within two weeks of receiving Covid-19 vaccine. No known allergies. The patient was neither diagnosed with Covid-19 prior vaccination, nor been tested for Covid-19 post vaccination. No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait inability, Hypoaesthesia, Movement disorder, Nausea
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Lot number: ER8735) at the age of 36 years as dose 2, single and administered in arm left, administration date 11Jun2021 10:00 (Lot number: ER8735) as dose 1, single for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DYSPNOEA (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "Shortness of breath"; HYPOAESTHESIA (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "numbness in arm & hands"; NAUSEA (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "nausea"; CHILLS (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "shivers without fever"; PALPITATIONS (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "heart palpitations"; GAIT INABILITY (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "unable to walk"; FATIGUE (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "extreme fatigue"; ASTHENIA (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "weakness"; ARTHROPOD BITE (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "ticks around arm"; CONTUSION (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "sensation of bruised under rib cages"; MOVEMENT DISORDER (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "left arm unable to move". Therapeutic measures were not taken as a result of dyspnoea, hypoaesthesia, nausea, chills, palpitations, gait inability, fatigue, asthenia, arthropod bite, contusion, movement disorder. Additional information: The patient did not receive any other vaccine in four weeks of suspect vaccine. No medications were received within two weeks of receiving Covid-19 vaccine. No known allergies. The patient was neither diagnosed with Covid-19 prior vaccination, nor been tested for Covid-19 post vaccination. No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Lot number: ER8735) at the age of 36 years as dose 2, single and administered in arm left, administration date 11Jun2021 10:00 (Lot number: ER8735) as dose 1, single for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DYSPNOEA (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "Shortness of breath"; HYPOAESTHESIA (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "numbness in arm & hands"; NAUSEA (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "nausea"; CHILLS (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "shivers without fever"; PALPITATIONS (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "heart palpitations"; GAIT INABILITY (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "unable to walk"; FATIGUE (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "extreme fatigue"; ASTHENIA (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "weakness"; ARTHROPOD BITE (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "ticks around arm"; CONTUSION (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "sensation of bruised under rib cages"; MOVEMENT DISORDER (non-serious) with onset 02Jul2021 11:00, outcome "not recovered", described as "left arm unable to move". Therapeutic measures were not taken as a result of dyspnoea, hypoaesthesia, nausea, chills, palpitations, gait inability, fatigue, asthenia, arthropod bite, contusion, movement disorder. Additional information: The patient did not receive any other vaccine in four weeks of suspect vaccine. No medications were received within two weeks of receiving Covid-19 vaccine. No known allergies. The patient was neither diagnosed with Covid-19 prior vaccination, nor been tested for Covid-19 post vaccination. No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 28-year-old female patient (not pregnant) received the 1st dose of BNT162B2 (Comirnaty, batch/lot# FL3180), at the age of 28, in right arm, on Aug 14, 2021, at 08:00, single dose, for COVID-19 immunisation. Medical history included asthma (unspecified if ongoing), and allergy to sulfa drugs. Concomitant medication included: Lo Loestrin FE. The patient reported pain in extremity/arm soreness/pain for about 2 days/difficult to breathe, heaviness on chest, dyspnea/difficult to breathe and chest discomfort/heaviness on chest, onset Aug 14, 2021, with outcome of recovered (Aug 16, 2021). No therapeutic measures taken as a result of pain in extremity, dyspnea and chest discomfort. Additional information: Patient did not take any other vaccine in the past four weeks. Patient did not have COVID-19 prior to vaccination nor test for COVID-19 post vaccination. No follow-up attempts possible. No further information expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Haematoma, Headache, Influenza like illness
Clinical narrative: 1st dose of vaccine, 04Aug, had bleeding on the site of administration; resulting to hematoma on the left arm; experienced flu like symptoms; dry cough; nasal congestion; headache; body ache; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Aug2021 15:00 (Lot number: F87484) at the age of 53 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: VACCINATION SITE HAEMORRHAGE (non-serious), outcome "not recovered", described as "1st dose of vaccine, 04Aug, had bleeding on the site of administration"; HAEMATOMA (non-serious), outcome "not recovered", described as "resulting to hematoma on the left arm"; INFLUENZA LIKE ILLNESS (non-serious), outcome "not recovered", described as "experienced flu like symptoms"; COUGH (non-serious), outcome "not recovered", described as "dry cough"; NASAL CONGESTION (non-serious), outcome "not recovered", described as "nasal congestion"; HEADACHE (non-serious), outcome "not recovered", described as "headache"; PAIN (non-serious), outcome "not recovered", described as "body ache"; FATIGUE (non-serious), outcome "not recovered", described as "fatigue". Therapeutic measures were not taken as a result of vaccination site haemorrhage, haematoma, influenza like illness, cough, nasal congestion, headache, pain, fatigue.   Additional information: Patient did not receive any other vaccines within 4 weeks to the COVID vaccine but received other unspecified medications within 2 weeks of the vaccination. Patient received no treatment for the events and had no known allergies. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain, Vaccination site haemorrhage
Clinical narrative: 1st dose of vaccine, 04Aug, had bleeding on the site of administration; resulting to hematoma on the left arm; experienced flu like symptoms; dry cough; nasal congestion; headache; body ache; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Aug2021 15:00 (Lot number: F87484) at the age of 53 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: VACCINATION SITE HAEMORRHAGE (non-serious), outcome "not recovered", described as "1st dose of vaccine, 04Aug, had bleeding on the site of administration"; HAEMATOMA (non-serious), outcome "not recovered", described as "resulting to hematoma on the left arm"; INFLUENZA LIKE ILLNESS (non-serious), outcome "not recovered", described as "experienced flu like symptoms"; COUGH (non-serious), outcome "not recovered", described as "dry cough"; NASAL CONGESTION (non-serious), outcome "not recovered", described as "nasal congestion"; HEADACHE (non-serious), outcome "not recovered", described as "headache"; PAIN (non-serious), outcome "not recovered", described as "body ache"; FATIGUE (non-serious), outcome "not recovered", described as "fatigue". Therapeutic measures were not taken as a result of vaccination site haemorrhage, haematoma, influenza like illness, cough, nasal congestion, headache, pain, fatigue.   Additional information: Patient did not receive any other vaccines within 4 weeks to the COVID vaccine but received other unspecified medications within 2 weeks of the vaccination. Patient received no treatment for the events and had no known allergies. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Feeling cold, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Aug2021 12:00 (Batch/Lot number: unknown) at the age of 23 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "known allergy: Moderate-Egg white" (unspecified if ongoing); "known allergy: Mild-dairy" (unspecified if ongoing); "known allergy: gluten" (unspecified if ongoing); "known allergy: egg yolk" (unspecified if ongoing); "known allergy: oats" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COUGH (non-serious) with onset 03Aug2021 17:00, outcome "recovered" (2021), described as "Slight cough"; FEELING COLD (non-serious), CHILLS (non-serious) all with onset 03Aug2021 17:00, outcome "recovered" (2021) and all described as "Chills very very cold"; PAIN IN EXTREMITY (non-serious) with onset 03Aug2021 17:00, outcome "recovered" (2021), described as "Very sore arm"; PYREXIA (non-serious) with onset 03Aug2021 17:00, outcome "recovered" (2021), described as "Fever of 101.2 F. Lasting roughly one evening". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of cough, feeling cold, chills, pain in extremity, pyrexia. Additional information: The patient had no Covid-19 prior vaccination and had not tested Covid-19 post vaccination. The patient had no other vaccine in four weeks and no other medications in two weeks. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Aug2021 12:00 (Batch/Lot number: unknown) at the age of 23 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "known allergy: Moderate-Egg white" (unspecified if ongoing); "known allergy: Mild-dairy" (unspecified if ongoing); "known allergy: gluten" (unspecified if ongoing); "known allergy: egg yolk" (unspecified if ongoing); "known allergy: oats" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COUGH (non-serious) with onset 03Aug2021 17:00, outcome "recovered" (2021), described as "Slight cough"; FEELING COLD (non-serious), CHILLS (non-serious) all with onset 03Aug2021 17:00, outcome "recovered" (2021) and all described as "Chills very very cold"; PAIN IN EXTREMITY (non-serious) with onset 03Aug2021 17:00, outcome "recovered" (2021), described as "Very sore arm"; PYREXIA (non-serious) with onset 03Aug2021 17:00, outcome "recovered" (2021), described as "Fever of 101.2 F. Lasting roughly one evening". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of cough, feeling cold, chills, pain in extremity, pyrexia. Additional information: The patient had no Covid-19 prior vaccination and had not tested Covid-19 post vaccination. The patient had no other vaccine in four weeks and no other medications in two weeks. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Feeling cold, Headache
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 12:00 (Batch/Lot number: unknown) at the age of 23 years as dose 2, single and administration date 24Aug2021 12:00 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Moderate-Egg white" (unspecified if ongoing), notes: Moderate-Egg white, Mild-dairy, gluten, egg yolk, oats. There were no concomitant medications. Past drug history included: Mild-dairy for known allergies Mild-dairy, notes: Moderate-Egg white, Mild-dairy, gluten, egg yolk, oats; Egg yolk for known allergies egg yolk, notes: Moderate-Egg white, Mild-dairy, gluten, egg yolk, oats; Oats for known allergies oats, notes: Moderate-Egg white, Mild-dairy, gluten, egg yolk, oats. The following information was reported: CHILLS (non-serious), FEELING COLD (non-serious) all with onset 25Aug2021 16:00, outcome "recovered" and all described as "Chills/shiver freezing for hours. Fever of 102.3 F.  Fever lasted around 2 days (not at 102 F. the entire time, but above 100 F.)"; PYREXIA (non-serious) with onset 25Aug2021 16:00, outcome "recovered", described as "Fever of 102.3 F. Fever lasted around 2 days (not at 102 F the entire time, but above 100 F.)"; COUGH (non-serious) with onset 25Aug2021 16:00, outcome "recovered", described as "Cough"; HEADACHE (non-serious) with onset 25Aug2021 16:00, outcome "recovered", described as "Headache"; PAIN (non-serious) with onset 25Aug2021 16:00, outcome "recovered", described as "soreness, stiffness/pain"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 25Aug2021 16:00, outcome "recovered", described as "stiffness/pain"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 24Aug2021 12:00, outcome "unknown", described as "patient received first dose and 2 dose on 24-AUG-2021 12:00". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, feeling cold, pyrexia, cough, headache, pain, musculoskeletal stiffness. Additional information: No vaccine in four weeks and no medications in two weeks. Patient did not receive any treatment for the adverse event. No Covid-19 prior vaccination and no Covid-19 tested post vaccination. The lot number for bnt162b2 was not provided and will be requested during follow up. Follow-up (07Oct2021): 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: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 12:00 (Batch/Lot number: unknown) at the age of 23 years as dose 2, single and administration date 24Aug2021 12:00 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Moderate-Egg white" (unspecified if ongoing), notes: Moderate-Egg white, Mild-dairy, gluten, egg yolk, oats. There were no concomitant medications. Past drug history included: Mild-dairy for known allergies Mild-dairy, notes: Moderate-Egg white, Mild-dairy, gluten, egg yolk, oats; Egg yolk for known allergies egg yolk, notes: Moderate-Egg white, Mild-dairy, gluten, egg yolk, oats; Oats for known allergies oats, notes: Moderate-Egg white, Mild-dairy, gluten, egg yolk, oats. The following information was reported: CHILLS (non-serious), FEELING COLD (non-serious) all with onset 25Aug2021 16:00, outcome "recovered" and all described as "Chills/shiver freezing for hours. Fever of 102.3 F.  Fever lasted around 2 days (not at 102 F. the entire time, but above 100 F.)"; PYREXIA (non-serious) with onset 25Aug2021 16:00, outcome "recovered", described as "Fever of 102.3 F. Fever lasted around 2 days (not at 102 F the entire time, but above 100 F.)"; COUGH (non-serious) with onset 25Aug2021 16:00, outcome "recovered", described as "Cough"; HEADACHE (non-serious) with onset 25Aug2021 16:00, outcome "recovered", described as "Headache"; PAIN (non-serious) with onset 25Aug2021 16:00, outcome "recovered", described as "soreness, stiffness/pain"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 25Aug2021 16:00, outcome "recovered", described as "stiffness/pain"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 24Aug2021 12:00, outcome "unknown", described as "patient received first dose and 2 dose on 24-AUG-2021 12:00". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, feeling cold, pyrexia, cough, headache, pain, musculoskeletal stiffness. Additional information: No vaccine in four weeks and no medications in two weeks. Patient did not receive any treatment for the adverse event. No Covid-19 prior vaccination and no Covid-19 tested post vaccination. The lot number for bnt162b2 was not provided and will be requested during follow up. Follow-up (07Oct2021): 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.