chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, Immunisation, SARS-CoV-2 test
Clinical narrative: Had appendicitis; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient (not pregnant) received BNT162b2 (BNT162B2), administered in arm left, administration date 10Nov2021 12:00 (Lot number: Fh8028) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE SODIUM; PRAVASTATIN; FAMOTIDINE; CLONAZEPAM. The patient did not receive other vaccine within four weeks. The patient did not have covid before vaccination. The patient had no known allergy. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: En6208, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 17Mar2021, when the patient was 75 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: En6201, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 22Feb2021, when the patient was 75 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (hospitalization); APPENDICITIS (hospitalization) with onset 14Dec2021, outcome "recovering", described as "Had appendicitis". The patient had lower right abdominal pain for 2 days, since 14Dec2021. She went to urgent care on 15Dec2021. She had appendicitis. She went hospital and had the appendectomy evening of 15Dec2021.The patient was hospitalized for immunisation, appendicitis (start date: 15Dec2021, discharge date: 16Dec2021, hospitalization duration: 1 day(s)). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (15Dec2021) negative.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Investigation, Optic neuritis, Vision blurred
Clinical narrative: optic neuritis; Booster; blurry vision in my left eye; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Nov2021 10:45 (Lot number: FH8028) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Prev dose product=COVID 19,, Prev dose brand=Pfizer BioNTech,, Prev dose brand unknown=False,, Prev dose lot number=EW0182,, Prev dose lot unknown=False,, Prev dose administration date=13May2021, Prev dose dose number=2,, Prev dose vaccine location=Left arm), administration date: 13May2021, when the patient was 39 years old, for COVID-19 Immunization; Bnt162b2 (Prev dose product=COVID 19,, Prev dose brand=Pfizer BioNTech,, Prev dose brand unknown=False,, Prev dose lot number=ER8736,, Prev dose lot unknown=False,, Prev dose administration date=22Apr2021, Prev dose dose number=1,, Prev dose vaccine location=Left arm), administration date: 22Apr2021, when the patient was 39 years old, for Covid-19 immunization. The following information was reported: OPTIC NEURITIS (non-serious) with onset 26Nov2021 08:00, outcome "not recovered", described as "optic neuritis"; IMMUNISATION (non-serious) with onset 26Nov2021 08:00, outcome "not recovered", described as "Booster"; VISION BLURRED (non-serious) with onset 26Nov2021 08:00, outcome "not recovered", described as "blurry vision in my left eye". The patient has blurry vision in left eye. Diagnosis by a Neuro Ophthalmologist and tests performed indicate it's a case of optic neuritis. The events "optic neuritis" and "blurry vision in my left eye" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: investigation: case of optic neuritis, notes: Its a case of optic neuritis. Therapeutic measures were not taken as a result of optic neuritis, immunisation, vision blurred. The patient did not have covid prior vaccination, and was not covid tested post vaccination.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Hyperhidrosis, Influenza like illness, Nasopharyngitis
Clinical narrative: very sore all over the body/ soreness; Chills(Very cold for several hours, could not get warm); Chills(Very cold for several hours, could not get warm); coughing; numbness at injection site of left arm; left hand still hurts; sneezing; shaking; sweating; flu like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 14:00 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "Fibroid tumors (low blood count)" (unspecified if ongoing); "Fibroid tumors (low blood count)" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, administration date 02Nov2021; LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE. The following information was reported: PAIN (non-serious) with onset 01Dec2021 08:00, outcome "recovering", described as "very sore all over the body/ soreness"; CHILLS (non-serious), NASOPHARYNGITIS (non-serious) all with onset 01Dec2021 08:00, outcome "recovering" and all described as "Chills(Very cold for several hours, could not get warm)"; COUGH (non-serious) with onset 01Dec2021 08:00, outcome "recovering", described as "coughing"; VACCINATION SITE HYPOAESTHESIA (non-serious) with onset 01Dec2021 08:00, outcome "recovering", described as "numbness at injection site of left arm"; PAIN IN EXTREMITY (non-serious) with onset 01Dec2021 08:00, outcome "recovering", described as "left hand still hurts"; SNEEZING (non-serious) with onset 01Dec2021 08:00, outcome "recovering", described as "sneezing"; TREMOR (non-serious) with onset 01Dec2021 08:00, outcome "recovering", described as "shaking"; HYPERHIDROSIS (non-serious) with onset 01Dec2021 08:00, outcome "recovering", described as "sweating"; INFLUENZA LIKE ILLNESS (non-serious) with onset 01Dec2021 08:00, outcome "recovering", described as "flu like symptoms". Therapeutic measures were not taken as a result of pain, chills, nasopharyngitis, cough, vaccination site hypoaesthesia, pain in extremity, sneezing, tremor, hyperhidrosis, influenza like illness.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have known allergies. The events were reported as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Sneezing, Tremor, Vaccination site hypoaesthesia
Clinical narrative: very sore all over the body/ soreness; Chills(Very cold for several hours, could not get warm); Chills(Very cold for several hours, could not get warm); coughing; numbness at injection site of left arm; left hand still hurts; sneezing; shaking; sweating; flu like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 14:00 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "Fibroid tumors (low blood count)" (unspecified if ongoing); "Fibroid tumors (low blood count)" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, administration date 02Nov2021; LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE. The following information was reported: PAIN (non-serious) with onset 01Dec2021 08:00, outcome "recovering", described as "very sore all over the body/ soreness"; CHILLS (non-serious), NASOPHARYNGITIS (non-serious) all with onset 01Dec2021 08:00, outcome "recovering" and all described as "Chills(Very cold for several hours, could not get warm)"; COUGH (non-serious) with onset 01Dec2021 08:00, outcome "recovering", described as "coughing"; VACCINATION SITE HYPOAESTHESIA (non-serious) with onset 01Dec2021 08:00, outcome "recovering", described as "numbness at injection site of left arm"; PAIN IN EXTREMITY (non-serious) with onset 01Dec2021 08:00, outcome "recovering", described as "left hand still hurts"; SNEEZING (non-serious) with onset 01Dec2021 08:00, outcome "recovering", described as "sneezing"; TREMOR (non-serious) with onset 01Dec2021 08:00, outcome "recovering", described as "shaking"; HYPERHIDROSIS (non-serious) with onset 01Dec2021 08:00, outcome "recovering", described as "sweating"; INFLUENZA LIKE ILLNESS (non-serious) with onset 01Dec2021 08:00, outcome "recovering", described as "flu like symptoms". Therapeutic measures were not taken as a result of pain, chills, nasopharyngitis, cough, vaccination site hypoaesthesia, pain in extremity, sneezing, tremor, hyperhidrosis, influenza like illness.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have known allergies. The events were reported as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: Tonic Clonic Seizure  26hrs. after the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2, Solution for injection), administered in arm left, administration date 20Dec2021 14:30 (Lot number: fl8095) at the age of 10 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "Microcephaly" (unspecified if ongoing); "Autism" (unspecified if ongoing); "Chorioretinal lacunes" (unspecified if ongoing); "Lacunes" (unspecified if ongoing); "KIF11" (unspecified if ongoing). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included: DIMETAPP [BROMPHENIRAMINE MALEATE;PHENYLEPHRINE HYDROCHLORIDE;PHENYLPROPANOLAMINE HYDROCHLORIDE]. The following information was reported: GENERALISED TONIC-CLONIC SEIZURE (hospitalization, disability, medically significant, life threatening) with onset 21Dec2021 16:00, outcome "recovering", described as "Tonic Clonic Seizure  26hrs. after the vaccine". The patient was hospitalized for generalised tonic-clonic seizure (hospitalization duration: 1 day(s)). The event "tonic clonic seizure  26hrs. after the vaccine" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of generalised tonic-clonic seizure. Clinical course: Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Hypertension, Immunisation, Paraesthesia
Clinical narrative: I developed pain around my heart; blood pressure was high; tingling pins and needles sensation in my face, starting with the left side of my face and neck and (10 hours later) including my right side of my face as well as parts of my head, my ears and my neck; Booster; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 51-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in arm left, administration date 17Dec2021 11:15 (Lot number: FD7218) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0180, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 16Jun2021, when the patient was 51 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0178, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 26May2021, when the patient was 51 years old, for COVID-19 Immunization. The following information was reported: ANGINA PECTORIS (medically significant) with onset 22Dec2021 01:00, outcome "not recovered", described as "I developed pain around my heart"; IMMUNISATION (non-serious) with onset 17Dec2021 11:15, outcome "unknown", described as "Booster"; HYPERTENSION (non-serious) with onset 22Dec2021 01:00, outcome "not recovered", described as "blood pressure was high"; PARAESTHESIA (non-serious) with onset 22Dec2021 01:00, outcome "not recovered", described as "tingling pins and needles sensation in my face, starting with the left side of my face and neck and (10 hours later) including my right side of my face as well as parts of my head, my ears and my neck". The events "i developed pain around my heart", "blood pressure was high" and "tingling pins and needles sensation in my face, starting with the left side of my face and neck and (10 hours later) including my right side of my face as well as parts of my head, my ears and my neck" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of angina pectoris, hypertension, paraesthesia. Prior to the vaccination, the patient was not diagnosed with COVID-19.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.  Follow-Up (27DEC2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Illness, Immunisation, Pyrexia
Clinical narrative: booster; She got sick, with fever, no sense of taste and smell; She got sick, with fever, no sense of taste and smell; She got sick, with fever, no sense of taste and smell; She got sick, with fever, no sense of taste and smell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Aug2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.   Vaccination history included: Bnt162b2 (Dose: 01, tested positive for covid after receiving the vaccine), for Covid-19 immunization, reaction(s): "tested positive for covid after receiving the vaccine"; Bnt162b2 (Dose: 02, tested positive for covid after receiving the vaccine), for Covid-19 immunization, reaction(s): "tested positive for covid after receiving the vaccine".  The following information was reported: IMMUNISATION (non-serious) with onset 15Aug2021, outcome "unknown", described as "booster"; ILLNESS (non-serious), PYREXIA (non-serious), AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 2021, outcome "unknown" and all described as "She got sick, with fever, no sense of taste and smell".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Blood test, Cardiac disorder, Cardiac stress test, Chest X-ray
Clinical narrative: chest pain; could feel her heart faltering; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Aug2021 10:00 (Lot number: FC3181) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hashimoto''s" (unspecified if ongoing); "interstitial cystitis" (unspecified if ongoing). The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. Concomitant medications included: SYNTHROID; CYTOMEL; GLUTAMINE [ALANYL GLUTAMINE]; OMEGA 3 6 9 [FISH OIL]. Past drug history included: Propoxyphene, reaction(s): "allergies", notes: Known allergies: propoxyphene. The following information was reported: CHEST PAIN (medically significant) with onset 14Aug2021 18:00, outcome "recovering", described as "chest pain"; CARDIAC DISORDER (non-serious) with onset 14Aug2021 18:00, outcome "recovering", described as "could feel her heart faltering". The events "chest pain" and "could feel her heart faltering" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: angiogram: (2021) nothing worse showed on the scans; blood test: (Aug2021) nothing urgent was happening; cardiac stress test: (2021) nothing worse showed on the scans; chest x-ray: (Aug2021) nothing urgent was happening; echocardiogram: (2021) nothing worse showed on the scans. Therapeutic measures were taken as a result of chest pain, cardiac disorder. The patient started having chest pain the day after the shot was given. It got steadily worse, and the patient went to the ER 4 days later. They did a chest xray and bloodwork and nothing urgent was happening, so sent the patient instructions to follow up with her primary care doctor. The patient did a video chat with the primary care doctor and she was advised to take 800mg ibuprofen 3x/day for a week and to call back if she was not better. After a week, the patient was not better, she was worse (it now hurt severely when she bent forward, and all the time she had chest pain, and when she walked her dog she could feel her heart faltering. It was so scary. The patient went in to the see the doctor and she prescribed colchicine and indomethacin and an urgent referral to a cardiologist. The patient was able to see the cardiologist 3 days later, she ordered a stress test, an echocardiogram and a heart ct scan. Nothing worse showed on the scans so the patient stayed on the colchicine and switched from indomethacin to ibuprofen. The patient took those medications every day for 3 months and towards the end of the 3rd month the chest pain went away.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Echocardiogram
Clinical narrative: chest pain; could feel her heart faltering; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Aug2021 10:00 (Lot number: FC3181) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hashimoto''s" (unspecified if ongoing); "interstitial cystitis" (unspecified if ongoing). The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. Concomitant medications included: SYNTHROID; CYTOMEL; GLUTAMINE [ALANYL GLUTAMINE]; OMEGA 3 6 9 [FISH OIL]. Past drug history included: Propoxyphene, reaction(s): "allergies", notes: Known allergies: propoxyphene. The following information was reported: CHEST PAIN (medically significant) with onset 14Aug2021 18:00, outcome "recovering", described as "chest pain"; CARDIAC DISORDER (non-serious) with onset 14Aug2021 18:00, outcome "recovering", described as "could feel her heart faltering". The events "chest pain" and "could feel her heart faltering" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: angiogram: (2021) nothing worse showed on the scans; blood test: (Aug2021) nothing urgent was happening; cardiac stress test: (2021) nothing worse showed on the scans; chest x-ray: (Aug2021) nothing urgent was happening; echocardiogram: (2021) nothing worse showed on the scans. Therapeutic measures were taken as a result of chest pain, cardiac disorder. The patient started having chest pain the day after the shot was given. It got steadily worse, and the patient went to the ER 4 days later. They did a chest xray and bloodwork and nothing urgent was happening, so sent the patient instructions to follow up with her primary care doctor. The patient did a video chat with the primary care doctor and she was advised to take 800mg ibuprofen 3x/day for a week and to call back if she was not better. After a week, the patient was not better, she was worse (it now hurt severely when she bent forward, and all the time she had chest pain, and when she walked her dog she could feel her heart faltering. It was so scary. The patient went in to the see the doctor and she prescribed colchicine and indomethacin and an urgent referral to a cardiologist. The patient was able to see the cardiologist 3 days later, she ordered a stress test, an echocardiogram and a heart ct scan. Nothing worse showed on the scans so the patient stayed on the colchicine and switched from indomethacin to ibuprofen. The patient took those medications every day for 3 months and towards the end of the 3rd month the chest pain went away.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: Had slight itching of scalp and feet / 01-Jan-2022 until today is less itchy/itching decreased; Skin writing/dermatographia; Consistent hives rash/ Hives show up consistently for up to 30 min around the body/Red welts; This spontaneous case was reported by a consumer and describes the occurrence of MECHANICAL URTICARIA (Skin writing/dermatographia), URTICARIA (Consistent hives rash/ Hives show up consistently for up to 30 min around the body/Red welts) and PRURITUS (Had slight itching of scalp and feet / 01-Jan-2022 until today is less itchy/itching decreased) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 06FF21A, 006B21A and 014M20A) for COVID-19 vaccination.     Concomitant products included VITAMIN D NOS and SPIRONOLACTONE for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced MECHANICAL URTICARIA (Skin writing/dermatographia) and URTICARIA (Consistent hives rash/ Hives show up consistently for up to 30 min around the body/Red welts). On 17-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (Had slight itching of scalp and feet / 01-Jan-2022 until today is less itchy/itching decreased). The patient was treated with LORATADINE at a dose of 10 milligram. At the time of the report, MECHANICAL URTICARIA (Skin writing/dermatographia) and URTICARIA (Consistent hives rash/ Hives show up consistently for up to 30 min around the body/Red welts) outcome was unknown and PRURITUS (Had slight itching of scalp and feet / 01-Jan-2022 until today is less itchy/itching decreased) was resolving.            No medical history provided by the reporter.  Patient went to urgent care treatment included anti itch cream.  18-DEC-25-DEC-2021 patient had consistent hives rash, skin writing, dermatographia.  Patient had no allergy.   This case was linked to MOD-2022-438540, MOD-2022-438572 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Tinnitus
Clinical narrative: Booster; extremely loud ringing in my ears; muscle aches; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 22Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "no adverse effect"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "no adverse effect". The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021, outcome "unknown", described as "Booster"; TINNITUS (non-serious) with onset 22Dec2021, outcome "not recovered", described as "extremely loud ringing in my ears"; MYALGIA (non-serious) with onset 22Dec2021, outcome "unknown", described as "muscle aches"; FATIGUE (non-serious) with onset 22Dec2021, outcome "unknown", described as "fatigue". The event "extremely loud ringing in my ears" was evaluated at the physician office visit. As the patient reported: the patient received the covid booster mid-day last Wednesday. Later that day had extremely loud ringing in my ears (tinnitus) along with muscle aches and fatigue. The patient had no side effects with the first two shots. Felt somewhat better two days later but the tinnitus is awful. Zero improvement. The patient called doctor and was told people were having the tinnitus issue. However, when the patient asked if they would be reporting it to the CDC, they said No. Clearly this IS a side effect and consumers need this info.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria
Clinical narrative: Urticaria Dermatographia / Hives all over my body/ itchiness; This spontaneous case was reported by a consumer and describes the occurrence of MECHANICAL URTICARIA (Urticaria Dermatographia / Hives all over my body/ itchiness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.  No Medical History information was reported.   On 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MECHANICAL URTICARIA (Urticaria Dermatographia / Hives all over my body/ itchiness). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 10 milligram. At the time of the report, MECHANICAL URTICARIA (Urticaria Dermatographia / Hives all over my body/ itchiness) had not resolved.     It was reported that 10 days after receiving the Booster shot of Moderna vaccine, patient experienced adverse event hives all over the body and it continued . Patient had medical appointment and was prescribed with steroids for 5days . Patient took Zyrtec10mg anti-histamine that seemed to stop the itchiness but it was still there at the time of report .  No concomitant information provided by the reporter
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Drug delivery system malfunction, Feeling cold, Headache, Incorrect dose administered
Clinical narrative: BODY ACHES; CHILLS; FEELING COLD; HEADACHE; SORENESS AT INJECTION SITE; NUMBNESS AT INJECTION SITE/NUMBNESS FROM ELBOW TO HAND ON INJECTED ARM; POSSIBLE ADMINISTRATION OF MORE THAN RECOMMENDED DOSE; NEEDLE ASSEMBLY DETACHED; ADMINISTERED SLIGHTLY LESS THAN THE ACTUAL DOSE/ONLY 0.1ML HAD BEEN ADMINISTERED; This spontaneous report received from a parent concerned a 22 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, seasonal allergy and pet allergy. The patient previously received with covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin not reported, batch number: 1805025 and expiry: unknown) dose was not reported, 1 total, administered on 17-MAR-2021 for prophylactic vaccination (dose number in series 1). It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s. The patient received booster of covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A and expiry: unknown) dose was not reported,1 total, administered at right arm on 27-DEC-2021 for prophylactic vaccination (dose number in series 2).  No concomitant medications were reported.  On 27-DEC-2021 at the time of vaccination, the patient felt water running down arm as the needle detached from the syringe (needle assembly detached) and according to nurse's clinical judgement, only 0.1ml had been administered (dose number in series 2). The patient was administered another dose of the same vaccine (unknown whether it was the same vial/LOT) into the same arm. On 27-DEC-2021, the patient experienced soreness and numbness at injection site starting at moment of administration. The patient's mother asked the details about incident and pharmacist said that, they had administered slightly less than the actual dose. Pharmacy team insisted that, it was not their fault and that needles were very cheap quality. The patient's mother was concerned, that her daughter could have received more than the recommended dose (coded as inappropriate dose of drug administered). Patient complained of numbness without mobility loss from elbow to hand on the same arm that started the same day. No swelling or hot to touch.(dose number in series 2) On 28-DEC-2021 04:45 hours, patient complained of chills, body aches, very bad headache but no fever as per reporter but the patient stated that, she felt really cold. (dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, body aches, headache, feeling cold, soreness at injection site, and numbness at injection site/numbness from elbow to hand on injected arm, and the outcome of possible administration of more than recommended dose, needle assembly detached and administered slightly less than the actual dose/only 0.1ml had been administered was not reported. This report was non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypoaesthesia, Injection site pain, Pain, Underdose
Clinical narrative: BODY ACHES; CHILLS; FEELING COLD; HEADACHE; SORENESS AT INJECTION SITE; NUMBNESS AT INJECTION SITE/NUMBNESS FROM ELBOW TO HAND ON INJECTED ARM; POSSIBLE ADMINISTRATION OF MORE THAN RECOMMENDED DOSE; NEEDLE ASSEMBLY DETACHED; ADMINISTERED SLIGHTLY LESS THAN THE ACTUAL DOSE/ONLY 0.1ML HAD BEEN ADMINISTERED; This spontaneous report received from a parent concerned a 22 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, seasonal allergy and pet allergy. The patient previously received with covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin not reported, batch number: 1805025 and expiry: unknown) dose was not reported, 1 total, administered on 17-MAR-2021 for prophylactic vaccination (dose number in series 1). It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s. The patient received booster of covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A and expiry: unknown) dose was not reported,1 total, administered at right arm on 27-DEC-2021 for prophylactic vaccination (dose number in series 2).  No concomitant medications were reported.  On 27-DEC-2021 at the time of vaccination, the patient felt water running down arm as the needle detached from the syringe (needle assembly detached) and according to nurse's clinical judgement, only 0.1ml had been administered (dose number in series 2). The patient was administered another dose of the same vaccine (unknown whether it was the same vial/LOT) into the same arm. On 27-DEC-2021, the patient experienced soreness and numbness at injection site starting at moment of administration. The patient's mother asked the details about incident and pharmacist said that, they had administered slightly less than the actual dose. Pharmacy team insisted that, it was not their fault and that needles were very cheap quality. The patient's mother was concerned, that her daughter could have received more than the recommended dose (coded as inappropriate dose of drug administered). Patient complained of numbness without mobility loss from elbow to hand on the same arm that started the same day. No swelling or hot to touch.(dose number in series 2) On 28-DEC-2021 04:45 hours, patient complained of chills, body aches, very bad headache but no fever as per reporter but the patient stated that, she felt really cold. (dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, body aches, headache, feeling cold, soreness at injection site, and numbness at injection site/numbness from elbow to hand on injected arm, and the outcome of possible administration of more than recommended dose, needle assembly detached and administered slightly less than the actual dose/only 0.1ml had been administered was not reported. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Arthritis, Asthenia, Tendonitis
Clinical narrative: Arthralgias, weakness, Achilles tendinitis. Acute L knee arthritis Symptoms lasted 72 hrs. then improved but returned 12/25/21 and continued
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness, Pain
Clinical narrative: Left-arm weak; numbness and persistent pain radiate to fingers and both hips to legs; numbness and persistent pain radiate to fingers and both hips to legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Apr2021 (Lot number: ER8737) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hep C" (unspecified if ongoing), notes: Resolved. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8732, Location of injection: Arm Left), administration date: 27Mar2021, when the patient was 60 years old, for COVID-19 Immunization. The following information was reported: MUSCULAR WEAKNESS (disability) with onset 24Apr2021, outcome "not recovered", described as "Left-arm weak"; PAIN (disability), HYPOAESTHESIA (disability) all with onset 24Apr2021, outcome "not recovered" and all described as "numbness and persistent pain radiate to fingers and both hips to legs". The events "left-arm weak", "numbness and persistent pain radiate to fingers and both hips to legs" and "numbness and persistent pain radiate to fingers and both hips to legs" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of muscular weakness, pain, hypoaesthesia. It was reported that the patient had not received any other vaccines within 4 weeks prior to the COVID vaccine and patient had not received any List of other medications within 2 weeks of vaccination. It was reported that Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient was not been tested for COVID-19.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Coagulopathy, Deep vein thrombosis, Peripheral swelling, Thrombosis
Clinical narrative: 3 blood clots in my left calf.; verified DVT; swelling in my left calf; Blood work indicated blood clotting; This is a spontaneous report received from contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 58-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 09:00 (Batch/Lot number: unknown) at the age of 58 years as dose 2, single for covid-19 immunization. The patient had no relevant medical history. Concomitant medication(s) included: AMLODIPINE BESILATE; FENOFIBRATE; GLUCOSAMINE & MSM; B6. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6202, Location of injection: Arm Right, Vaccine Administration Time: 11:00 AM), administration date: 09Mar2021, when the patient was 58 years old, for COVID-19 immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. After the vaccination patient has not been tested for COVID-19. The following information was reported: THROMBOSIS (medically significant, life threatening) with onset 08Apr2021 18:00, outcome "recovered with sequelae", described as "3 blood clots in my left calf."; DEEP VEIN THROMBOSIS (medically significant, life threatening) with onset 08Apr2021 18:00, outcome "recovered with sequelae", described as "verified DVT"; PERIPHERAL SWELLING (life threatening) with onset 07Apr2021 18:00, outcome "recovered with sequelae", described as "swelling in my left calf"; COAGULOPATHY (life threatening) with onset 07Apr2021 18:00, outcome "recovered with sequelae", described as "Blood work indicated blood clotting". The events "3 blood clots in my left calf.", "verified dvt", "swelling in my left calf" and "blood work indicated blood clotting" were evaluated at the physician office visit and emergency room visit. The patient had his second COVID-19 vaccine on March 30, 2021. Had to go to the ER on April 07, 2021 for swelling in left calf. Blood work indicated blood clotting. Went back for Ultrasound April 08, 2021, which verified DVT, 3 blood clots in left calf.  The patient underwent the following laboratory tests and procedures: blood test: (07Apr2021) blood clotting; ultrasound scan: (08Apr2021) dvt, notes: Ultrasound April 08, 2021, which verified DVT, 3 blood clots in my left calf. Therapeutic measures were taken as a result of thrombosis, deep vein thrombosis, peripheral swelling, coagulopathy included Apixaban.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: 3 blood clots in my left calf.; verified DVT; swelling in my left calf; Blood work indicated blood clotting; This is a spontaneous report received from contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 58-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 09:00 (Batch/Lot number: unknown) at the age of 58 years as dose 2, single for covid-19 immunization. The patient had no relevant medical history. Concomitant medication(s) included: AMLODIPINE BESILATE; FENOFIBRATE; GLUCOSAMINE & MSM; B6. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6202, Location of injection: Arm Right, Vaccine Administration Time: 11:00 AM), administration date: 09Mar2021, when the patient was 58 years old, for COVID-19 immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. After the vaccination patient has not been tested for COVID-19. The following information was reported: THROMBOSIS (medically significant, life threatening) with onset 08Apr2021 18:00, outcome "recovered with sequelae", described as "3 blood clots in my left calf."; DEEP VEIN THROMBOSIS (medically significant, life threatening) with onset 08Apr2021 18:00, outcome "recovered with sequelae", described as "verified DVT"; PERIPHERAL SWELLING (life threatening) with onset 07Apr2021 18:00, outcome "recovered with sequelae", described as "swelling in my left calf"; COAGULOPATHY (life threatening) with onset 07Apr2021 18:00, outcome "recovered with sequelae", described as "Blood work indicated blood clotting". The events "3 blood clots in my left calf.", "verified dvt", "swelling in my left calf" and "blood work indicated blood clotting" were evaluated at the physician office visit and emergency room visit. The patient had his second COVID-19 vaccine on March 30, 2021. Had to go to the ER on April 07, 2021 for swelling in left calf. Blood work indicated blood clotting. Went back for Ultrasound April 08, 2021, which verified DVT, 3 blood clots in left calf.  The patient underwent the following laboratory tests and procedures: blood test: (07Apr2021) blood clotting; ultrasound scan: (08Apr2021) dvt, notes: Ultrasound April 08, 2021, which verified DVT, 3 blood clots in my left calf. Therapeutic measures were taken as a result of thrombosis, deep vein thrombosis, peripheral swelling, coagulopathy included Apixaban.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Immunisation, Myocarditis, SARS-CoV-2 test
Clinical narrative: Myocarditis; Strong chest pain; Booster Dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Dec2021 (Lot number: 330308D) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: other medical history: No. There were no concomitant medications. Vaccination history included: Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose brand unknown=False, Prev dose lot number=EW0162, Prev dose lot unknown=False, Prev dose administration date=28Apr2021, Prev dose dose number=2, Prev dose vaccine location=Left arm), administration date: 28Apr2021, when the patient was 29 years old, for COVID-19 immunization; Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose brand unknown=False, Prev dose lot number=ER8734, Prev dose lot unknown=False, Prev dose administrationdate=02Apr2021, Prev dose dose number=1, Prev dose vaccine location=Left arm), administration date: 02Apr2021, when the patient was 29 years old, for COVID-19 immunization. The following information was reported: MYOCARDITIS (Medically significant and hospitalization) with onset 21Dec2021 03:00, outcome "recovering", described as "Myocarditis"; CHEST PAIN (Medically significant and hospitalization) with onset 21Dec2021 03:00, outcome "recovering", described as "Strong chest pain, Immunisation (Medically significant and hospitalization) with onset 17Dec2021, outcome "unknown", describes as Booster dose. The patient was hospitalized for myocarditis, chest pain (hospitalization duration: 2 day(s)). The events "myocarditis" and "strong chest pain" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Dec2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of myocarditis, chest pain. reported as Prescription medications (unspecified).  Clinical information: Strong chest pain diagnosed as Myocarditis after being admitted to the hospital for 2 days. It was reported that, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown, Prior to vaccination, if the patient was diagnosed with COVID-19. Since the vaccination, the patient has been not tested for COVID-19. Reported as no known allergies.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Muscle spasms, Myalgia
Clinical narrative: Severe cramping in both calf muscles; general muscle pain in both legs; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 66-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Aug2021 (Lot number: FA6780) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: SILDENAFIL CITRATE. Past drug history included: Cipro, reaction(s): "Allergy". The following information was reported: MUSCLE SPASMS (medically significant) with onset 29Aug2021, outcome "recovering", described as "Severe cramping in both calf muscles"; MYALGIA (non-serious) with onset 29Aug2021, outcome "recovering", described as "general muscle pain in both legs". The events "severe cramping in both calf muscles" and "general muscle pain in both legs" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: covid-19: positive, notes: if covid prior vaccination: Yes. Therapeutic measures were not taken as a result of muscle spasms, myalgia. Clinical course: severe cramping in both calf muscles along with general muscle pain in both legs. The patient was not tested for Covid-19 post vaccination. The patient has no other vaccine in four weeks.; Sender's Comments: Based on temporal relationship the possibility of causal association between the event muscle spasms and other reported events and the suspect drug BNT162B2 cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Immunisation
Clinical narrative: Bell's Palsy on my left side of my face; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Dec2021 14:15 (Lot number: Fg3527) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose number=2, lot number-Ew0165, administration time-02:00 PM, vaccine location=Left arm), administration date: 30Apr2021, when the patient was 54 years old, for COVID-19 immunisation; Bnt162b2 (lot number-Ew0162,administration time-01:00 PM, dose number- 1, vaccine location-Left arm), administration date: 09Apr2021, when the patient was 54 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 09Dec2021 14:15, outcome "unknown", described as "Booster"; BELL'S PALSY (medically significant) with onset 20Dec2021 09:00, outcome "recovering", described as "Bell's Palsy on my left side of my face". The event "bell's palsy on my left side of my face" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of bell's palsy with 7-day treatment of Prednisone and lubricant eye.  Clinical course: The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. The patient did not have Covid prior vaccination. The patient was not tested for Covid post vaccination. The patient did not have known allergies.   No follow-up attempts are possible. No further information is expected.