chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Breaking out with some rashes, little red rashes that itch like crazy; Still getting the rashes, they pop up here, pop up there and they itch like crazy; Breaking out with some rashes, little red rashes that itch like crazy; Still getting the rashes, they pop up here, pop up there and they itch like crazy; Breaking out with some rashes, little red rashes that itch like crazy; Still getting the rashes, they pop up here, pop up there and they itch like crazy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 76-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Aug2021 (Lot number: FC3181) at the age of 76 years as dose 2, single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Lot Number: FA7485, Time: 10 AM) for Covid-19 Immunisation. The following information was reported: RASH PRURITIC (non-serious), RASH ERYTHEMATOUS (non-serious), RASH (non-serious) all with onset 19Aug2021, outcome "not recovered" and all described as "Breaking out with some rashes, little red rashes that itch like crazy, Still getting the rashes, they pop up here, pop up there and they itch like crazy". Therapeutic measures were not taken as a result of rash pruritic, rash erythematous, rash.  Additional details: Patient received the first dose around 10 o' clock. Patient reported that she got both doses before 12 o' clock and it was in the morning. Patient reported some of the rashes are big rashes marks. Patient did not receive any prior vaccinations (within 4 weeks). Patient reported other medical conditions and other medications as "No, just normal stuff" which was not clarified further. Patient still experienced the rashes and itching. Patient never had this experience before.  Follow-up (03Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dysmenorrhoea, Heavy menstrual bleeding, Inappropriate schedule of product administration, Migraine
Clinical narrative: same thing as before heavy bleeding/menstrual cycle changed to heavy flows after the vaccine; After my second dose, my menstrual cycle was two weeks earlier; horrible menstrual cramps; lower back pain; migraines; Dose number=1 Administration date=19Mar2021/ dose number: 2 vaccine date:19Mar2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Mar2021 (Lot number: EW0162) at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "mild back aches" (unspecified if ongoing), notes: This never happens with me usually its none to mild back aches.; "birth control" (unspecified if ongoing), notes: Although I was on birth control pill and I always get my period on time. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Product COVID 19, brand=Pfizer,, Lot number: EP7534,, Vaccine location=Left arm,, Dose number=1), administration date: 19Mar2021, when the patient was 31 years old, for COVID-19 immunisation, reaction(s): "my menstrual cycle was late two weeks", "had horrible cramps which never happens". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 19Mar2021, outcome "unknown", described as "Dose number=1 Administration date=19Mar2021/ dose number: 2 vaccine date:19Mar2021"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 27Mar2021, outcome "unknown", described as "same thing as before heavy bleeding/menstrual cycle changed to heavy flows after the vaccine"; POLYMENORRHOEA (non-serious) with onset 27Mar2021, outcome "unknown", described as "After my second dose, my menstrual cycle was two weeks earlier"; DYSMENORRHOEA (non-serious) with onset 27Mar2021, outcome "unknown", described as "horrible menstrual cramps"; BACK PAIN (non-serious) with onset 27Mar2021, outcome "unknown", described as "lower back pain"; MIGRAINE (non-serious) with onset 27Mar2021, outcome "unknown", described as "migraines". Therapeutic measures were not taken as a result of heavy menstrual bleeding, polymenorrhoea, dysmenorrhoea, back pain, migraine.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: same thing as before heavy bleeding/menstrual cycle changed to heavy flows after the vaccine; After my second dose, my menstrual cycle was two weeks earlier; horrible menstrual cramps; lower back pain; migraines; Dose number=1 Administration date=19Mar2021/ dose number: 2 vaccine date:19Mar2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Mar2021 (Lot number: EW0162) at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "mild back aches" (unspecified if ongoing), notes: This never happens with me usually its none to mild back aches.; "birth control" (unspecified if ongoing), notes: Although I was on birth control pill and I always get my period on time. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Product COVID 19, brand=Pfizer,, Lot number: EP7534,, Vaccine location=Left arm,, Dose number=1), administration date: 19Mar2021, when the patient was 31 years old, for COVID-19 immunisation, reaction(s): "my menstrual cycle was late two weeks", "had horrible cramps which never happens". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 19Mar2021, outcome "unknown", described as "Dose number=1 Administration date=19Mar2021/ dose number: 2 vaccine date:19Mar2021"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 27Mar2021, outcome "unknown", described as "same thing as before heavy bleeding/menstrual cycle changed to heavy flows after the vaccine"; POLYMENORRHOEA (non-serious) with onset 27Mar2021, outcome "unknown", described as "After my second dose, my menstrual cycle was two weeks earlier"; DYSMENORRHOEA (non-serious) with onset 27Mar2021, outcome "unknown", described as "horrible menstrual cramps"; BACK PAIN (non-serious) with onset 27Mar2021, outcome "unknown", described as "lower back pain"; MIGRAINE (non-serious) with onset 27Mar2021, outcome "unknown", described as "migraines". Therapeutic measures were not taken as a result of heavy menstrual bleeding, polymenorrhoea, dysmenorrhoea, back pain, migraine.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore throat; Cough; Fever; body ache; sore in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date 18Aug2021 (Lot number: FC3181) at the age of 47 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19Aug2021, outcome "not recovered", described as "sore in the arm"; OROPHARYNGEAL PAIN (non-serious) with onset 21Aug2021, outcome "not recovered", described as "Sore throat"; COUGH (non-serious) with onset 21Aug2021, outcome "not recovered", described as "Cough"; PYREXIA (non-serious) with onset 21Aug2021, outcome "not recovered", described as "Fever"; PAIN (non-serious) with onset 21Aug2021, outcome "not recovered", described as "body ache". Therapeutic measures were taken as a result of pain in extremity, oropharyngeal pain, cough, pyrexia, pain.  Additional information: The reporter stated, "Yes, I had the vaccine last Wednesday and it was like the first two days nothing wrong just sore in the arm you know to be expected since Saturday night had been having sore throat, cough and fever and not going away". Reporter stated, "the second one was supposed to be on 08Sep". Reporter confirmed that the start of adverse event was on Saturday evening. When asked about the expiration date, the reporter stated, "It doesn't say that's all they wrote on it they wrote Pfizer and then FC3181 that's it". About treatment, the reporter stated, "I was just been taking Ibuprofen, started on Saturday. I took 400-600 because I had body ache so sometimes I take 3". She stated "probably about twice" as frequency. She was still taking ibuprofen, she stated, "Yes, I took some this morning as I woke up with a fever". No patient history or other products reported. Investigation assessment reported as no.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Gait disturbance, Pain in extremity, Peripheral swelling
Clinical narrative: I in same night when I wake up I found my right foot inflated, red color, and very painful. I could not walk next day, because my food joints were every painful; I in same night when I wake up I found my right foot inflated, red color, and very painful. I could not walk next day, because my food joints were every painful; I in same night when I wake up I found my right foot inflated, red color, and very painful. I could not walk next day, because my food joints were every painful; I in same night when I wake up I found my right foot inflated, red color, and very painful. I could not walk next day, because my food joints were every painful; I in same night when I wake up I found my right foot inflated, red color, and very painful. I could not walk next day, because my food joints were every painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Jun2021 (Lot number: ew0180) at the age of 35 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PERIPHERAL SWELLING (non-serious), ERYTHEMA (non-serious), PAIN IN EXTREMITY (non-serious), GAIT DISTURBANCE (non-serious), ARTHRALGIA (non-serious) all with onset 17Jun2021 10:00, outcome "not recovered" and all described as "I in same night when I wake up I found my right foot inflated, red color, and very painful. I could not walk next day, because my food joints were every painful". Therapeutic measures were taken as a result of peripheral swelling, erythema, pain in extremity, gait disturbance, arthralgia.  Additional information: The patient did not receive other vaccine in four weeks. The patient had not covid prior vaccination. The patient had not covid tested post vaccination. The patient received colchicine 0.6MG and prednisone 10MG as treatment medication.  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Head discomfort, Headache, Pain
Clinical narrative: chills; feeling really really cold; headache; a little bit of body ache; fever; head hurts; body is aching; 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 18 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Aug2021 (Lot number: EW0173) at the age of 18 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1 Covid 19 vaccine , Lot # EW0173, Anatomical Location: right arm , Date: 02Aug2021, Age at Immunization if date not available: 18), administration date: 02Aug2021, when the patient was 18 years old, for covid-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 25Aug2021, outcome "not recovered", described as "chills"; FEELING COLD (non-serious) with onset 25Aug2021, outcome "not recovered", described as "feeling really really cold"; HEADACHE (non-serious) with onset 25Aug2021, outcome "not recovered", described as "headache"; PAIN (non-serious) with onset 25Aug2021, outcome "not recovered", described as "a little bit of body ache"; PYREXIA (non-serious) with onset 25Aug2021, outcome "not recovered", described as "fever"; HEAD DISCOMFORT (non-serious) with onset 25Aug2021, outcome "not recovered", described as "head hurts"; PAIN (non-serious) with onset 25Aug2021, outcome "not recovered", described as "body is aching". Therapeutic measures were taken as a result of chills, feeling cold, headache, pain, pyrexia, head discomfort, pain.  Additional Information: No illness at time of vaccination. No prior vaccination (within 4 weeks). No relevant test reported. CONS - use of fever reducing drugs and pain relievers. Product Complaint: Description of complaint: She states her chills are really bad, she has a fever, her head hurts and her body is aching. She is taking Ibuprofen and that's calming it down a little bit but not taking it all away. Ibuprofen 200mg NDC 49035-912-12 Expiry Apr2024 P124831.  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: chills; feeling really really cold; headache; a little bit of body ache; fever; head hurts; body is aching; 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 18 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Aug2021 (Lot number: EW0173) at the age of 18 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1 Covid 19 vaccine , Lot # EW0173, Anatomical Location: right arm , Date: 02Aug2021, Age at Immunization if date not available: 18), administration date: 02Aug2021, when the patient was 18 years old, for covid-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 25Aug2021, outcome "not recovered", described as "chills"; FEELING COLD (non-serious) with onset 25Aug2021, outcome "not recovered", described as "feeling really really cold"; HEADACHE (non-serious) with onset 25Aug2021, outcome "not recovered", described as "headache"; PAIN (non-serious) with onset 25Aug2021, outcome "not recovered", described as "a little bit of body ache"; PYREXIA (non-serious) with onset 25Aug2021, outcome "not recovered", described as "fever"; HEAD DISCOMFORT (non-serious) with onset 25Aug2021, outcome "not recovered", described as "head hurts"; PAIN (non-serious) with onset 25Aug2021, outcome "not recovered", described as "body is aching". Therapeutic measures were taken as a result of chills, feeling cold, headache, pain, pyrexia, head discomfort, pain.  Additional Information: No illness at time of vaccination. No prior vaccination (within 4 weeks). No relevant test reported. CONS - use of fever reducing drugs and pain relievers. Product Complaint: Description of complaint: She states her chills are really bad, she has a fever, her head hurts and her body is aching. She is taking Ibuprofen and that's calming it down a little bit but not taking it all away. Ibuprofen 200mg NDC 49035-912-12 Expiry Apr2024 P124831.  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Cough, Dizziness, Feeling abnormal, Muscular weakness
Clinical narrative: Back ache; Dizziness; Body heaviness; Cough; Muscle weakness; Fever 101; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 (Lot number: Fc3184) at the age of 12 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing); "ADHD" (ongoing); "Anxiety" (ongoing); "Allergy to dust" (unspecified if ongoing); "Allergy to pollen" (unspecified if ongoing). Concomitant medication(s) included: MELATONIN; CHLORPHENIRAMINE MALEATE; MULTIVITAMIN. Past drug history included: Lactose, reaction(s): "Allergy to lactose". Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer-, BioNTech, lot_number=Ew0186,, administration_date=31Jul2021,, dose_number=1,, vaccine_location=Left arm), administration date: 31Jul2021, when the patient was 12 years old, for COVID-19 immunisation. The following information was reported: BACK PAIN (non-serious) with onset 25Aug2021, outcome "not recovered", described as "Back ache"; DIZZINESS (non-serious) with onset 25Aug2021, outcome "not recovered", described as "Dizziness"; FEELING ABNORMAL (non-serious) with onset 25Aug2021, outcome "not recovered", described as "Body heaviness"; COUGH (non-serious) with onset 25Aug2021, outcome "not recovered", described as "Cough"; MUSCULAR WEAKNESS (non-serious) with onset 25Aug2021, outcome "not recovered", described as "Muscle weakness"; PYREXIA (non-serious) with onset 25Aug2021, outcome "not recovered", described as "Fever 101". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of back pain, dizziness, feeling abnormal, cough, muscular weakness, pyrexia.  Additional information: Patient had administered most recent Covid-19 vaccine in other facility. Patient did not received any other medication within 4 weeks prior to the Covid-19 vaccine. Patient was received treatment with Acetaminophen. Patient had not diagnose with Covid-19 prior to vaccination. Patient was not tested for Covid-19 since Vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Back ache; Dizziness; Body heaviness; Cough; Muscle weakness; Fever 101; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 (Lot number: Fc3184) at the age of 12 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing); "ADHD" (ongoing); "Anxiety" (ongoing); "Allergy to dust" (unspecified if ongoing); "Allergy to pollen" (unspecified if ongoing). Concomitant medication(s) included: MELATONIN; CHLORPHENIRAMINE MALEATE; MULTIVITAMIN. Past drug history included: Lactose, reaction(s): "Allergy to lactose". Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer-, BioNTech, lot_number=Ew0186,, administration_date=31Jul2021,, dose_number=1,, vaccine_location=Left arm), administration date: 31Jul2021, when the patient was 12 years old, for COVID-19 immunisation. The following information was reported: BACK PAIN (non-serious) with onset 25Aug2021, outcome "not recovered", described as "Back ache"; DIZZINESS (non-serious) with onset 25Aug2021, outcome "not recovered", described as "Dizziness"; FEELING ABNORMAL (non-serious) with onset 25Aug2021, outcome "not recovered", described as "Body heaviness"; COUGH (non-serious) with onset 25Aug2021, outcome "not recovered", described as "Cough"; MUSCULAR WEAKNESS (non-serious) with onset 25Aug2021, outcome "not recovered", described as "Muscle weakness"; PYREXIA (non-serious) with onset 25Aug2021, outcome "not recovered", described as "Fever 101". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of back pain, dizziness, feeling abnormal, cough, muscular weakness, pyrexia.  Additional information: Patient had administered most recent Covid-19 vaccine in other facility. Patient did not received any other medication within 4 weeks prior to the Covid-19 vaccine. Patient was received treatment with Acetaminophen. Patient had not diagnose with Covid-19 prior to vaccination. Patient was not tested for Covid-19 since Vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: throat started hurting; terrible headache; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 (Lot number: FC3182) at the age of 21 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 24Aug2021, outcome "recovering", described as "throat started hurting"; HEADACHE (non-serious) with onset 24Aug2021, outcome "recovered" (25Aug2021), described as "terrible headache"; PYREXIA (non-serious) with onset 24Aug2021, outcome "not recovered", described as "fever". Therapeutic measures were taken as a result of oropharyngeal pain, headache. Additional Information:The patient had not received any other vaccines within 4 weeks prior to the COVID vaccinePatient recently got the first dose of the Pfizer vaccine on Friday. Patient clarified as the covid 19 vaccination. Patient had vaccination on Friday and thought after 2 to 3 days it would be over with. Patient went to work on Monday and worked overnight. At 1 o'clock her throat started hurting. Patient got off at 5 and once patient came home went to the store to get Nyquil thought it was a regular sore throat. woke up around 10 or 11 in the morning and patient had a terrible headache. It felt like someone had been banging her against her head and her throat felt ten times worse.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Bruise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONTUSION (non-serious), outcome "unknown", described as "Bruise".  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: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain in extremity, Pyrexia, Swelling
Clinical narrative: 30 hours after shot I have a sore and swollen armpit.; Fever of 101 17 hours after shot; 30 hours after shot I have a sore and swollen armpit.; sore arm and exhaustion.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Aug2021 19:30 (Lot number: FD8448) at the age of 42 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (product =COVID 19, brand= Pfizer, lot number=FC3180, lot unknown=False, administration date= 03Aug2021, administration time=05:00 PM, dose number=1, vaccine location=Right arm), administration date: 03Aug2021, when the patient was 42 years old, for COVID-19 immunisation. The following information was reported: SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 25Aug2021 11:00, outcome "recovering" and all described as "30 hours after shot I have a sore and swollen armpit."; PYREXIA (non-serious) with onset 25Aug2021 11:00, outcome "recovering", described as "Fever of 101 17 hours after shot"; FATIGUE (non-serious) with onset 25Aug2021 11:00, outcome "recovering", described as "sore arm and exhaustion.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of swelling, pyrexia, pain in extremity, fatigue.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received no medication within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Reported as no known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Fever; Chills; nausea; tiredness; joint aches; swollen lymph nodes; feeling unwell; Headaches; Injection site swelling; Injection site pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Aug2021 18:00 (Lot number: FD8448) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lupus" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing); "ARB's allergy" (unspecified if ongoing), notes: known allergies: ARB's. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (lot number: ER8733, administration time: 10:00 AM, dose number: 1, vaccine location: Right arm), administration date: 27Mar2021, for COVID-19 Immunisation. The following information was reported: PYREXIA (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "Chills"; NAUSEA (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "nausea"; FATIGUE (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "tiredness"; ARTHRALGIA (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "joint aches"; LYMPHADENOPATHY (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "swollen lymph nodes"; MALAISE (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "feeling unwell"; HEADACHE (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "Headaches"; VACCINATION SITE SWELLING (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "Injection site swelling"; VACCINATION SITE PAIN (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "Injection site pain".  Additional information: Other medical history: Lupus. This was patients (booster) vaccine. Previously fully vaccinated. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. She was not tested for COVID-19 after the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Fever; Chills; nausea; tiredness; joint aches; swollen lymph nodes; feeling unwell; Headaches; Injection site swelling; Injection site pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Aug2021 18:00 (Lot number: FD8448) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lupus" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing); "ARB's allergy" (unspecified if ongoing), notes: known allergies: ARB's. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (lot number: ER8733, administration time: 10:00 AM, dose number: 1, vaccine location: Right arm), administration date: 27Mar2021, for COVID-19 Immunisation. The following information was reported: PYREXIA (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "Chills"; NAUSEA (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "nausea"; FATIGUE (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "tiredness"; ARTHRALGIA (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "joint aches"; LYMPHADENOPATHY (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "swollen lymph nodes"; MALAISE (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "feeling unwell"; HEADACHE (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "Headaches"; VACCINATION SITE SWELLING (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "Injection site swelling"; VACCINATION SITE PAIN (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "Injection site pain".  Additional information: Other medical history: Lupus. This was patients (booster) vaccine. Previously fully vaccinated. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. She was not tested for COVID-19 after the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Decreased appetite, Fatigue, Formication
Clinical narrative: Progressive severe joint and muscle pain; Progressive severe joint and muscle pain; Headache; Backache; severe neck pain; shoulders immobility; extreme  fatigue; unable to sleep; diminished appetite; twitching; skin crawling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Feb2021 10:45 (Lot number: EL9264) at the age of 67 years as dose 2, single and administered in arm right, administration date 13Jan2021 10:00 (Lot number: El1283) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: BUPROPION; TRAZODONE; FLUOXETINE; LAMOTRIGINE; D3. The following information was reported: ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset 01Mar2021, outcome "not recovered" and all described as "Progressive severe joint and muscle pain"; HEADACHE (non-serious) with onset 01Mar2021, outcome "not recovered", described as "Headache"; BACK PAIN (non-serious) with onset 01Mar2021, outcome "not recovered", described as "Backache"; NECK PAIN (non-serious) with onset 01Mar2021, outcome "not recovered", described as "severe neck pain"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 01Mar2021, outcome "not recovered", described as "shoulders immobility"; FATIGUE (non-serious) with onset 01Mar2021, outcome "not recovered", described as "extreme  fatigue"; INSOMNIA (non-serious) with onset 01Mar2021, outcome "not recovered", described as "unable to sleep"; DECREASED APPETITE (non-serious) with onset 01Mar2021, outcome "not recovered", described as "diminished appetite"; MUSCLE TWITCHING (non-serious) with onset 01Mar2021, outcome "not recovered", described as "twitching"; FORMICATION (non-serious) with onset 01Mar2021, outcome "not recovered", described as "skin crawling". The events "progressive severe joint and muscle pain", "progressive severe joint and muscle pain", "headache", "backache", "severe neck pain", "shoulders immobility", "extreme  fatigue", "diminished appetite", "twitching" and "skin crawling" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of arthralgia, myalgia, headache, back pain, neck pain, musculoskeletal discomfort, fatigue, insomnia, decreased appetite, muscle twitching, formication. additional information :patient not received other vaccine in four weeks, patient take other medications in two weeks (Bupropion, trazadobe, fluoxetine, lamotrigine, D3, lasi), on 12jul2021 patient undergo covid test (Nasal swab) and result of test is negative. No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Insomnia, Muscle twitching, Musculoskeletal discomfort, Myalgia
Clinical narrative: Progressive severe joint and muscle pain; Progressive severe joint and muscle pain; Headache; Backache; severe neck pain; shoulders immobility; extreme  fatigue; unable to sleep; diminished appetite; twitching; skin crawling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Feb2021 10:45 (Lot number: EL9264) at the age of 67 years as dose 2, single and administered in arm right, administration date 13Jan2021 10:00 (Lot number: El1283) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: BUPROPION; TRAZODONE; FLUOXETINE; LAMOTRIGINE; D3. The following information was reported: ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset 01Mar2021, outcome "not recovered" and all described as "Progressive severe joint and muscle pain"; HEADACHE (non-serious) with onset 01Mar2021, outcome "not recovered", described as "Headache"; BACK PAIN (non-serious) with onset 01Mar2021, outcome "not recovered", described as "Backache"; NECK PAIN (non-serious) with onset 01Mar2021, outcome "not recovered", described as "severe neck pain"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 01Mar2021, outcome "not recovered", described as "shoulders immobility"; FATIGUE (non-serious) with onset 01Mar2021, outcome "not recovered", described as "extreme  fatigue"; INSOMNIA (non-serious) with onset 01Mar2021, outcome "not recovered", described as "unable to sleep"; DECREASED APPETITE (non-serious) with onset 01Mar2021, outcome "not recovered", described as "diminished appetite"; MUSCLE TWITCHING (non-serious) with onset 01Mar2021, outcome "not recovered", described as "twitching"; FORMICATION (non-serious) with onset 01Mar2021, outcome "not recovered", described as "skin crawling". The events "progressive severe joint and muscle pain", "progressive severe joint and muscle pain", "headache", "backache", "severe neck pain", "shoulders immobility", "extreme  fatigue", "diminished appetite", "twitching" and "skin crawling" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of arthralgia, myalgia, headache, back pain, neck pain, musculoskeletal discomfort, fatigue, insomnia, decreased appetite, muscle twitching, formication. additional information :patient not received other vaccine in four weeks, patient take other medications in two weeks (Bupropion, trazadobe, fluoxetine, lamotrigine, D3, lasi), on 12jul2021 patient undergo covid test (Nasal swab) and result of test is negative. No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, SARS-CoV-2 test
Clinical narrative: Progressive severe joint and muscle pain; Progressive severe joint and muscle pain; Headache; Backache; severe neck pain; shoulders immobility; extreme  fatigue; unable to sleep; diminished appetite; twitching; skin crawling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Feb2021 10:45 (Lot number: EL9264) at the age of 67 years as dose 2, single and administered in arm right, administration date 13Jan2021 10:00 (Lot number: El1283) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: BUPROPION; TRAZODONE; FLUOXETINE; LAMOTRIGINE; D3. The following information was reported: ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset 01Mar2021, outcome "not recovered" and all described as "Progressive severe joint and muscle pain"; HEADACHE (non-serious) with onset 01Mar2021, outcome "not recovered", described as "Headache"; BACK PAIN (non-serious) with onset 01Mar2021, outcome "not recovered", described as "Backache"; NECK PAIN (non-serious) with onset 01Mar2021, outcome "not recovered", described as "severe neck pain"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 01Mar2021, outcome "not recovered", described as "shoulders immobility"; FATIGUE (non-serious) with onset 01Mar2021, outcome "not recovered", described as "extreme  fatigue"; INSOMNIA (non-serious) with onset 01Mar2021, outcome "not recovered", described as "unable to sleep"; DECREASED APPETITE (non-serious) with onset 01Mar2021, outcome "not recovered", described as "diminished appetite"; MUSCLE TWITCHING (non-serious) with onset 01Mar2021, outcome "not recovered", described as "twitching"; FORMICATION (non-serious) with onset 01Mar2021, outcome "not recovered", described as "skin crawling". The events "progressive severe joint and muscle pain", "progressive severe joint and muscle pain", "headache", "backache", "severe neck pain", "shoulders immobility", "extreme  fatigue", "diminished appetite", "twitching" and "skin crawling" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of arthralgia, myalgia, headache, back pain, neck pain, musculoskeletal discomfort, fatigue, insomnia, decreased appetite, muscle twitching, formication. additional information :patient not received other vaccine in four weeks, patient take other medications in two weeks (Bupropion, trazadobe, fluoxetine, lamotrigine, D3, lasi), on 12jul2021 patient undergo covid test (Nasal swab) and result of test is negative. No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on backs of both hands.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Aug2021 12:00 (Lot number: Fc3183) at the age of 42 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "ME/CFS" (unspecified if ongoing), notes: Other medical history: ME/CFS, Hashimotos, migraines, arthritis; "Hashimoto's" (unspecified if ongoing), notes: Other medical history: ME/CFS, Hashimotos, migraines, arthritis; "migraines" (unspecified if ongoing), notes: Other medical history: ME/CFS, Hashimotos, migraines, arthritis; "arthritis" (unspecified if ongoing), notes: Other medical history: ME/CFS, Hashimotos, migraines, arthritis. The patient's concomitant medications were not reported. Past drug history included: Vancomycin, reaction(s): "Known allergies: Vancomycin", notes: Known allergies: Vancomycin. The following information was reported: RASH (non-serious) with onset 24Aug2021, outcome "not recovered", described as "Rash on backs of both hands.".  Additional information: The patient was not tested COVID prior vaccination. The patient was not tested COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Breast pain, Dizziness, Inflammation, Myalgia
Clinical narrative: 15 hours after dose 2, lightheaded.; Left arm pain for both doses.; Breast pain since dose 1; continued inflammation since dose 1; 15 hours after dose 2, sudden muscle pain; 15 hours after dose 2, sudden bone pain; 15 hours after dose 2, nauseous; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Aug2021 15:30 (Lot number: FA7484) at the age of 25 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 03Aug2021, outcome "recovering", described as "15 hours after dose 2, lightheaded."; PAIN IN EXTREMITY (non-serious) with onset 03Aug2021, outcome "recovering", described as "Left arm pain for both doses."; BREAST PAIN (non-serious) with onset 03Aug2021, outcome "recovering", described as "Breast pain since dose 1"; INFLAMMATION (non-serious) with onset 03Aug2021, outcome "recovering", described as "continued inflammation since dose 1"; MYALGIA (non-serious) with onset 03Aug2021, outcome "recovering", described as "15 hours after dose 2, sudden muscle pain"; BONE PAIN (non-serious) with onset 03Aug2021, outcome "recovering", described as "15 hours after dose 2, sudden bone pain"; NAUSEA (non-serious) with onset 03Aug2021, outcome "recovering", described as "15 hours after dose 2, nauseous". Therapeutic measures were not taken as a result of dizziness, pain in extremity, breast pain, inflammation, myalgia, bone pain, nausea.  Additional information: The vaccine was administered in a pharmacy. The patient did not have any other vaccine in four weeks. The patient did not have covid prior to vaccination nor was tested since vaccination. The patient had no known allergies.   Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: 15 hours after dose 2, lightheaded.; Left arm pain for both doses.; Breast pain since dose 1; continued inflammation since dose 1; 15 hours after dose 2, sudden muscle pain; 15 hours after dose 2, sudden bone pain; 15 hours after dose 2, nauseous; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Aug2021 15:30 (Lot number: FA7484) at the age of 25 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 03Aug2021, outcome "recovering", described as "15 hours after dose 2, lightheaded."; PAIN IN EXTREMITY (non-serious) with onset 03Aug2021, outcome "recovering", described as "Left arm pain for both doses."; BREAST PAIN (non-serious) with onset 03Aug2021, outcome "recovering", described as "Breast pain since dose 1"; INFLAMMATION (non-serious) with onset 03Aug2021, outcome "recovering", described as "continued inflammation since dose 1"; MYALGIA (non-serious) with onset 03Aug2021, outcome "recovering", described as "15 hours after dose 2, sudden muscle pain"; BONE PAIN (non-serious) with onset 03Aug2021, outcome "recovering", described as "15 hours after dose 2, sudden bone pain"; NAUSEA (non-serious) with onset 03Aug2021, outcome "recovering", described as "15 hours after dose 2, nauseous". Therapeutic measures were not taken as a result of dizziness, pain in extremity, breast pain, inflammation, myalgia, bone pain, nausea.  Additional information: The vaccine was administered in a pharmacy. The patient did not have any other vaccine in four weeks. The patient did not have covid prior to vaccination nor was tested since vaccination. The patient had no known allergies.   Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: he had a sore arm after his vaccine; Rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 05Feb2021 (Lot number: EM9809) as dose 2, single and administered in arm right, administration date 15Jan2021 (Lot number: EL3302) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "he had a sore arm after his vaccine"; RASH (non-serious) with onset Aug2021, outcome "not recovered", described as "Rash". Therapeutic measures were not taken as a result of pain in extremity. Therapeutic measures were taken as a result of rash.  Additional Information: The patient stated that this was with both doses. The patient stated that with first dose that it was so sore that he was unable to lay on his arm. The patient stated that with the second dose that he could lay on his arm. The patient stated that the it was the right arm with the first dose. The patient stated that it was unknown arm with second dose. Treatment received for event rash by aspirin, Diclofenac Sodium, Topical gel 1% to rub on it.  No follow-up attempts are possible. No further information is expected.