chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna vaccine (NDC 80777-0273-98) lot 039D21A and GTIN 00380777273983 was administered after the beyond date of 10/23/2021. Contacted manufacturer Moderna no need to repeat the dose.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna vaccine (HDC 80777-0273-98) lot 039D21A and GTIN 00380777273983 was administered after the beyond date of 10/23/2021. Contacted manufacturer Moderna no need to repeat the dose.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna vaccine (NDC 80777-0273-98) lot 039D21A and GTIN 00380777273983 was administered after the beyond date of 10/23/2021. Contacted manufacturer Moderna no need to repeat the dose.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna  vaccine  (NDC  80777-0273-98)  lot # 039D21A + GTiN  00380777273983 was administered  after the beyond date of 10/23/2021. Contacted  Manufacturer  Moderna = no need to repeat the dose .
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna vaccine (NDC 80777-0273-98) lot 039D21A and GTIN 00380777273983 was administered after the beyond date of 10/23/2021. Contacted manufacturer Moderna no need to repeat the dose.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: Dizziness,  fatigue that lasted  12/18-12/22 - Pt sought medical attention and started to take  meclizine for the prolonged dizziness Pt says  dizziness continues
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anti-thyroid antibody positive, Contusion, Ear pain, Eye pain
Clinical narrative: First day, loss taste (bland; resolved voer 1 week), heache back of head/skull base not controlled with excedrin (which alwasy helped ha in past), hyperactive insomnia first night. R ear pain. Later October, severe neurological deficits: L face numb, severe pain behind L eye socket w/blurryh vision. L face droop, and groin spasms/pain, bruising in abdomen/calves/thighs. Findings on 11/21 office visit include decrease sensation L face/forehead, hyperflex r knee, decrease sensation LLE lateral, R lat gaze nystagmus, still dealing w/ severe fatigue and L side skull numb/heavy/headache/groin pain w/o help fro excedrin
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis, Fatigue, Groin pain, Head discomfort, Headache
Clinical narrative: First day, loss taste (bland; resolved voer 1 week), heache back of head/skull base not controlled with excedrin (which alwasy helped ha in past), hyperactive insomnia first night. R ear pain. Later October, severe neurological deficits: L face numb, severe pain behind L eye socket w/blurryh vision. L face droop, and groin spasms/pain, bruising in abdomen/calves/thighs. Findings on 11/21 office visit include decrease sensation L face/forehead, hyperflex r knee, decrease sensation LLE lateral, R lat gaze nystagmus, still dealing w/ severe fatigue and L side skull numb/heavy/headache/groin pain w/o help fro excedrin
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperreflexia, Hypersomnia, Hypoaesthesia, Laboratory test, Magnetic resonance imaging head abnormal
Clinical narrative: First day, loss taste (bland; resolved voer 1 week), heache back of head/skull base not controlled with excedrin (which alwasy helped ha in past), hyperactive insomnia first night. R ear pain. Later October, severe neurological deficits: L face numb, severe pain behind L eye socket w/blurryh vision. L face droop, and groin spasms/pain, bruising in abdomen/calves/thighs. Findings on 11/21 office visit include decrease sensation L face/forehead, hyperflex r knee, decrease sensation LLE lateral, R lat gaze nystagmus, still dealing w/ severe fatigue and L side skull numb/heavy/headache/groin pain w/o help fro excedrin
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging spinal abnormal, Muscle spasms, Nervous system disorder, Nystagmus, Sensory loss
Clinical narrative: First day, loss taste (bland; resolved voer 1 week), heache back of head/skull base not controlled with excedrin (which alwasy helped ha in past), hyperactive insomnia first night. R ear pain. Later October, severe neurological deficits: L face numb, severe pain behind L eye socket w/blurryh vision. L face droop, and groin spasms/pain, bruising in abdomen/calves/thighs. Findings on 11/21 office visit include decrease sensation L face/forehead, hyperflex r knee, decrease sensation LLE lateral, R lat gaze nystagmus, still dealing w/ severe fatigue and L side skull numb/heavy/headache/groin pain w/o help fro excedrin
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Sinus disorder, Spinal vascular disorder, Vision blurred
Clinical narrative: First day, loss taste (bland; resolved voer 1 week), heache back of head/skull base not controlled with excedrin (which alwasy helped ha in past), hyperactive insomnia first night. R ear pain. Later October, severe neurological deficits: L face numb, severe pain behind L eye socket w/blurryh vision. L face droop, and groin spasms/pain, bruising in abdomen/calves/thighs. Findings on 11/21 office visit include decrease sensation L face/forehead, hyperflex r knee, decrease sensation LLE lateral, R lat gaze nystagmus, still dealing w/ severe fatigue and L side skull numb/heavy/headache/groin pain w/o help fro excedrin
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna vaccine (ndc 80777-0273-98) lot # 039D21A and GTIN 00380777273983 was administered after the beyond date of 10/23/2021. Contacted manufacturer Moderna = no need to repeat the dose.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Headache, Fever, Nausea Vomiting, chills
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hallucination, olfactory
Clinical narrative: unable to move from bed; shaking; body pain; headache; fever; Two mornings after I woke up with a strong smoke smell(phantosmia); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Apr2021 (Lot number: EW0171) at the age of 24 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Autoimmune disease" (unspecified if ongoing), notes: other medical history: Autoimmune disease; "Allergies: Penicillin" (unspecified if ongoing); "Covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Phenergyn, reaction(s): "Known allergies: Phenergyn", notes: Known allergies: Penicillin phenergyn amoxicillin. The following information was reported: MOVEMENT DISORDER (non-serious) with onset 25Apr2021 08:00, outcome "not recovered", described as "unable to move from bed"; TREMOR (non-serious) with onset 25Apr2021 08:00, outcome "not recovered", described as "shaking"; PAIN (non-serious) with onset 25Apr2021 08:00, outcome "not recovered", described as "body pain"; HEADACHE (non-serious) with onset 25Apr2021 08:00, outcome "not recovered", described as "headache"; PYREXIA (non-serious) with onset 25Apr2021 08:00, outcome "not recovered", described as "fever"; PAROSMIA (non-serious) with onset 25Apr2021 08:00, outcome "not recovered", described as "Two mornings after I woke up with a strong smoke smell(phantosmia)". The events "unable to move from bed", "shaking", "body pain", "headache", "fever" and "two mornings after i woke up with a strong smoke smell(phantosmia)" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of movement disorder, tremor, pain, headache, pyrexia, parosmia.  Additional information: On 25Apr2021, after her first dose she had a strong reaction of shaking, body pain, headache and fever, unable to move from bed. Two mornings after I woke up with a strong smoke smell (phantosmia). This system persisted for 4 months and gradually decreased in frequency but never stopped. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient has not been tested for COVID-19.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Movement disorder, Pain, Parosmia, Pyrexia
Clinical narrative: unable to move from bed; shaking; body pain; headache; fever; Two mornings after I woke up with a strong smoke smell(phantosmia); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Apr2021 (Lot number: EW0171) at the age of 24 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Autoimmune disease" (unspecified if ongoing), notes: other medical history: Autoimmune disease; "Allergies: Penicillin" (unspecified if ongoing); "Covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Phenergyn, reaction(s): "Known allergies: Phenergyn", notes: Known allergies: Penicillin phenergyn amoxicillin. The following information was reported: MOVEMENT DISORDER (non-serious) with onset 25Apr2021 08:00, outcome "not recovered", described as "unable to move from bed"; TREMOR (non-serious) with onset 25Apr2021 08:00, outcome "not recovered", described as "shaking"; PAIN (non-serious) with onset 25Apr2021 08:00, outcome "not recovered", described as "body pain"; HEADACHE (non-serious) with onset 25Apr2021 08:00, outcome "not recovered", described as "headache"; PYREXIA (non-serious) with onset 25Apr2021 08:00, outcome "not recovered", described as "fever"; PAROSMIA (non-serious) with onset 25Apr2021 08:00, outcome "not recovered", described as "Two mornings after I woke up with a strong smoke smell(phantosmia)". The events "unable to move from bed", "shaking", "body pain", "headache", "fever" and "two mornings after i woke up with a strong smoke smell(phantosmia)" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of movement disorder, tremor, pain, headache, pyrexia, parosmia.  Additional information: On 25Apr2021, after her first dose she had a strong reaction of shaking, body pain, headache and fever, unable to move from bed. Two mornings after I woke up with a strong smoke smell (phantosmia). This system persisted for 4 months and gradually decreased in frequency but never stopped. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient has not been tested for COVID-19.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tremor
Clinical narrative: unable to move from bed; shaking; body pain; headache; fever; Two mornings after I woke up with a strong smoke smell(phantosmia); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Apr2021 (Lot number: EW0171) at the age of 24 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Autoimmune disease" (unspecified if ongoing), notes: other medical history: Autoimmune disease; "Allergies: Penicillin" (unspecified if ongoing); "Covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Phenergyn, reaction(s): "Known allergies: Phenergyn", notes: Known allergies: Penicillin phenergyn amoxicillin. The following information was reported: MOVEMENT DISORDER (non-serious) with onset 25Apr2021 08:00, outcome "not recovered", described as "unable to move from bed"; TREMOR (non-serious) with onset 25Apr2021 08:00, outcome "not recovered", described as "shaking"; PAIN (non-serious) with onset 25Apr2021 08:00, outcome "not recovered", described as "body pain"; HEADACHE (non-serious) with onset 25Apr2021 08:00, outcome "not recovered", described as "headache"; PYREXIA (non-serious) with onset 25Apr2021 08:00, outcome "not recovered", described as "fever"; PAROSMIA (non-serious) with onset 25Apr2021 08:00, outcome "not recovered", described as "Two mornings after I woke up with a strong smoke smell(phantosmia)". The events "unable to move from bed", "shaking", "body pain", "headache", "fever" and "two mornings after i woke up with a strong smoke smell(phantosmia)" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of movement disorder, tremor, pain, headache, pyrexia, parosmia.  Additional information: On 25Apr2021, after her first dose she had a strong reaction of shaking, body pain, headache and fever, unable to move from bed. Two mornings after I woke up with a strong smoke smell (phantosmia). This system persisted for 4 months and gradually decreased in frequency but never stopped. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient has not been tested for COVID-19.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Inflammation, Nausea, Parosmia
Clinical narrative: unable to move from bed; shaking; body pain; headache; fever; Two mornings after I woke up with a strong smoke smell(phantosmia); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Apr2021 (Lot number: EW0171) at the age of 24 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Autoimmune disease" (unspecified if ongoing), notes: other medical history: Autoimmune disease; "Allergies: Penicillin" (unspecified if ongoing); "Covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Phenergyn, reaction(s): "Known allergies: Phenergyn", notes: Known allergies: Penicillin phenergyn amoxicillin. The following information was reported: MOVEMENT DISORDER (non-serious) with onset 25Apr2021 08:00, outcome "not recovered", described as "unable to move from bed"; TREMOR (non-serious) with onset 25Apr2021 08:00, outcome "not recovered", described as "shaking"; PAIN (non-serious) with onset 25Apr2021 08:00, outcome "not recovered", described as "body pain"; HEADACHE (non-serious) with onset 25Apr2021 08:00, outcome "not recovered", described as "headache"; PYREXIA (non-serious) with onset 25Apr2021 08:00, outcome "not recovered", described as "fever"; PAROSMIA (non-serious) with onset 25Apr2021 08:00, outcome "not recovered", described as "Two mornings after I woke up with a strong smoke smell(phantosmia)". The events "unable to move from bed", "shaking", "body pain", "headache", "fever" and "two mornings after i woke up with a strong smoke smell(phantosmia)" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of movement disorder, tremor, pain, headache, pyrexia, parosmia.  Additional information: On 25Apr2021, after her first dose she had a strong reaction of shaking, body pain, headache and fever, unable to move from bed. Two mornings after I woke up with a strong smoke smell (phantosmia). This system persisted for 4 months and gradually decreased in frequency but never stopped. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient has not been tested for COVID-19.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hallucination, olfactory
Clinical narrative: Inappropriate schedule of vaccine administered; I noticed that the phantosmia persisted, to this day I smell smoke that is not there several times a week and sometimes all day; It is overwhelming and nauseating; My doctor advised after reading an article with the same side effect that it is inflammation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Jul2021 (Lot number: Ew0180) at the age of 24 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Autoimmune disease" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin, phenergyn, amoxicillin; "COVID" (unspecified if ongoing), notes: if covid prior vaccination:YES. There were no concomitant medications. Past drug history included: Phenergan, reaction(s): "known allergies: phenergyn"; Amoxicillin, reaction(s): "known allergies: Amoxicillin". Vaccination history included: Bnt162b2 (1st dose, Lot/batch no. - EW0171, vaccine_location= left arm), administration date: 17Apr2021, for COVID-19 immunization, reaction(s): "shaking"; Bnt162b2, for COVID-19 immunization, reaction(s): "headache", "unable to move from bed.", "body pain", "strong smoke smell(phantosmia)", "fever". The following information was reported: PAROSMIA (disability) with onset Jul2021, outcome "not recovered", described as "I noticed that the phantosmia persisted, to this day I smell smoke that is not there several times a week and sometimes all day"; NAUSEA (disability) with onset 2021, outcome "not recovered", described as "It is overwhelming and nauseating"; INFLAMMATION (disability) with onset 2021, outcome "not recovered", described as "My doctor advised after reading an article with the same side effect that it is inflammation"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 17Jul2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The events "i noticed that the phantosmia persisted, to this day i smell smoke that is not there several times a week and sometimes all day", "it is overwhelming and nauseating" and "my doctor advised after reading an article with the same side effect that it is inflammation" were evaluated at the physician office visit. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Movement disorder, Pain, Parosmia, Pyrexia
Clinical narrative: Inappropriate schedule of vaccine administered; I noticed that the phantosmia persisted, to this day I smell smoke that is not there several times a week and sometimes all day; It is overwhelming and nauseating; My doctor advised after reading an article with the same side effect that it is inflammation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Jul2021 (Lot number: Ew0180) at the age of 24 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Autoimmune disease" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin, phenergyn, amoxicillin; "COVID" (unspecified if ongoing), notes: if covid prior vaccination:YES. There were no concomitant medications. Past drug history included: Phenergan, reaction(s): "known allergies: phenergyn"; Amoxicillin, reaction(s): "known allergies: Amoxicillin". Vaccination history included: Bnt162b2 (1st dose, Lot/batch no. - EW0171, vaccine_location= left arm), administration date: 17Apr2021, for COVID-19 immunization, reaction(s): "shaking"; Bnt162b2, for COVID-19 immunization, reaction(s): "headache", "unable to move from bed.", "body pain", "strong smoke smell(phantosmia)", "fever". The following information was reported: PAROSMIA (disability) with onset Jul2021, outcome "not recovered", described as "I noticed that the phantosmia persisted, to this day I smell smoke that is not there several times a week and sometimes all day"; NAUSEA (disability) with onset 2021, outcome "not recovered", described as "It is overwhelming and nauseating"; INFLAMMATION (disability) with onset 2021, outcome "not recovered", described as "My doctor advised after reading an article with the same side effect that it is inflammation"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 17Jul2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The events "i noticed that the phantosmia persisted, to this day i smell smoke that is not there several times a week and sometimes all day", "it is overwhelming and nauseating" and "my doctor advised after reading an article with the same side effect that it is inflammation" were evaluated at the physician office visit. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Inappropriate schedule of vaccine administered; I noticed that the phantosmia persisted, to this day I smell smoke that is not there several times a week and sometimes all day; It is overwhelming and nauseating; My doctor advised after reading an article with the same side effect that it is inflammation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Jul2021 (Lot number: Ew0180) at the age of 24 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Autoimmune disease" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin, phenergyn, amoxicillin; "COVID" (unspecified if ongoing), notes: if covid prior vaccination:YES. There were no concomitant medications. Past drug history included: Phenergan, reaction(s): "known allergies: phenergyn"; Amoxicillin, reaction(s): "known allergies: Amoxicillin". Vaccination history included: Bnt162b2 (1st dose, Lot/batch no. - EW0171, vaccine_location= left arm), administration date: 17Apr2021, for COVID-19 immunization, reaction(s): "shaking"; Bnt162b2, for COVID-19 immunization, reaction(s): "headache", "unable to move from bed.", "body pain", "strong smoke smell(phantosmia)", "fever". The following information was reported: PAROSMIA (disability) with onset Jul2021, outcome "not recovered", described as "I noticed that the phantosmia persisted, to this day I smell smoke that is not there several times a week and sometimes all day"; NAUSEA (disability) with onset 2021, outcome "not recovered", described as "It is overwhelming and nauseating"; INFLAMMATION (disability) with onset 2021, outcome "not recovered", described as "My doctor advised after reading an article with the same side effect that it is inflammation"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 17Jul2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The events "i noticed that the phantosmia persisted, to this day i smell smoke that is not there several times a week and sometimes all day", "it is overwhelming and nauseating" and "my doctor advised after reading an article with the same side effect that it is inflammation" were evaluated at the physician office visit. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Inflammation, Nausea, Parosmia
Clinical narrative: Inappropriate schedule of vaccine administered; I noticed that the phantosmia persisted, to this day I smell smoke that is not there several times a week and sometimes all day; It is overwhelming and nauseating; My doctor advised after reading an article with the same side effect that it is inflammation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Jul2021 (Lot number: Ew0180) at the age of 24 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Autoimmune disease" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin, phenergyn, amoxicillin; "COVID" (unspecified if ongoing), notes: if covid prior vaccination:YES. There were no concomitant medications. Past drug history included: Phenergan, reaction(s): "known allergies: phenergyn"; Amoxicillin, reaction(s): "known allergies: Amoxicillin". Vaccination history included: Bnt162b2 (1st dose, Lot/batch no. - EW0171, vaccine_location= left arm), administration date: 17Apr2021, for COVID-19 immunization, reaction(s): "shaking"; Bnt162b2, for COVID-19 immunization, reaction(s): "headache", "unable to move from bed.", "body pain", "strong smoke smell(phantosmia)", "fever". The following information was reported: PAROSMIA (disability) with onset Jul2021, outcome "not recovered", described as "I noticed that the phantosmia persisted, to this day I smell smoke that is not there several times a week and sometimes all day"; NAUSEA (disability) with onset 2021, outcome "not recovered", described as "It is overwhelming and nauseating"; INFLAMMATION (disability) with onset 2021, outcome "not recovered", described as "My doctor advised after reading an article with the same side effect that it is inflammation"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 17Jul2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The events "i noticed that the phantosmia persisted, to this day i smell smoke that is not there several times a week and sometimes all day", "it is overwhelming and nauseating" and "my doctor advised after reading an article with the same side effect that it is inflammation" were evaluated at the physician office visit. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 54-year-old male patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# FC3183), at the age of 54, intramuscularly, left arm, on Aug 29, 2021, at 13:00, single dose, for COVID-19 immunisation. No medical history reported. Concomitant medication(s) included Crestor. The patient reported peri-arthritis, onset Sep 7, 2021, at 08:00, with outcome of recovered (Sep 26, 2021); peripheral swelling, pain in extremity and erythema, all onset Sep 7, 2021, at 10:00,  with outcome of recovering. Patient also stated "10 days after the first shot my left foot, second toe became red, swollen and very painful; suspected it was capsulitis." Therapeutic measures were not taken as a result of peri-arthritis, peripheral swelling, pain in extremity and erythema. No follow-up attempts possible. No further information expected.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pain in extremity, Periarthritis, Peripheral swelling
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 54-year-old male patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# FC3183), at the age of 54, intramuscularly, left arm, on Aug 29, 2021, at 13:00, single dose, for COVID-19 immunisation. No medical history reported. Concomitant medication(s) included Crestor. The patient reported peri-arthritis, onset Sep 7, 2021, at 08:00, with outcome of recovered (Sep 26, 2021); peripheral swelling, pain in extremity and erythema, all onset Sep 7, 2021, at 10:00,  with outcome of recovering. Patient also stated "10 days after the first shot my left foot, second toe became red, swollen and very painful; suspected it was capsulitis." Therapeutic measures were not taken as a result of peri-arthritis, peripheral swelling, pain in extremity and erythema. No follow-up attempts possible. No further information expected.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Headache
Clinical narrative: RBC 4.06; Severe headache still after 8 weeks and it moves around.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Jul2021 16:00 (Lot number: FA7485) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic diastolic HF" (ongoing); "GERD" (unspecified if ongoing); "Mitral valve disorder" (unspecified if ongoing); "Surgical repair mitral valve", start date: Sep2016 (unspecified if ongoing); "R/C heart cath", start date: May2016 (unspecified if ongoing); "COVID-19" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, lot number=EW0198, administration time=03:00 PM, vaccine location=Right arm), administration date: 07Jul2021, when the patient was 56 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 28Jul2021, outcome "recovering", described as "Severe headache still after 8 weeks and it moves around."; RED BLOOD CELL COUNT DECREASED (non-serious) with onset 22Aug2021, outcome "unknown", described as "RBC 4.06". The event "severe headache still after 8 weeks and it moves around." was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache.  Additional information: Prior to vaccination, the patient was diagnosed with COVID-19; and since the vaccination, has been tested for COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that HA (headache) started after 2nd COVID-19 vaccine on 28Jul2021. Patient took headache pill but stated they did nothing. Patient went to ER on 22Aug2021 and had Primary Care Physician (PCP) visit on 03Sep2021. Patient will also see neurology on 28Oct2021. Pain has improved from 9/10 - 3/10 score. HCP was unsure if Pfizer product had a causal effect to the adverse effect.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain assessment, SARS-CoV-2 test
Clinical narrative: RBC 4.06; Severe headache still after 8 weeks and it moves around.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Jul2021 16:00 (Lot number: FA7485) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic diastolic HF" (ongoing); "GERD" (unspecified if ongoing); "Mitral valve disorder" (unspecified if ongoing); "Surgical repair mitral valve", start date: Sep2016 (unspecified if ongoing); "R/C heart cath", start date: May2016 (unspecified if ongoing); "COVID-19" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, lot number=EW0198, administration time=03:00 PM, vaccine location=Right arm), administration date: 07Jul2021, when the patient was 56 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 28Jul2021, outcome "recovering", described as "Severe headache still after 8 weeks and it moves around."; RED BLOOD CELL COUNT DECREASED (non-serious) with onset 22Aug2021, outcome "unknown", described as "RBC 4.06". The event "severe headache still after 8 weeks and it moves around." was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache.  Additional information: Prior to vaccination, the patient was diagnosed with COVID-19; and since the vaccination, has been tested for COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that HA (headache) started after 2nd COVID-19 vaccine on 28Jul2021. Patient took headache pill but stated they did nothing. Patient went to ER on 22Aug2021 and had Primary Care Physician (PCP) visit on 03Sep2021. Patient will also see neurology on 28Oct2021. Pain has improved from 9/10 - 3/10 score. HCP was unsure if Pfizer product had a causal effect to the adverse effect.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: red rash; whole lot of white bumps on her head; 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 42 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Oct2021 09:30 (Lot number: FH8020) at the age of 42 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: HEAD DISCOMFORT (non-serious) with onset 28Oct2021, outcome "recovered" (Nov2021), described as "whole lot of white bumps on her head"; RASH ERYTHEMATOUS (non-serious), outcome "recovered" (Nov2021), described as "red rash". The events "whole lot of white bumps on her head" and "red rash" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of head discomfort, rash erythematous.  Additional Information: It was reported that the patient received the first dose of the purple cap Pfizer Covid-19 vaccine on 27Oct2021 and on 28Oct2021 she developed a fine red rash with a whole lot of white bumps on her head, face, and neck. Patient was scheduled to receive the second dose of the purple cap Pfizer Covid-19 vaccine on 24Nov2021. Patient reported that she has already consulted with her HCP about the above complaints and her HCP prescribed her Benadryl which she did not take because she did not have complaints of itchiness per patient. Patient also reported that her HCP has advised her to not get the second dose of the purple cap Pfizer Covid-19 vaccine but told her to contact Pfizer. Patient reported that it took 1.5 weeks for the above complaints to resolve. Patient was asking for information about receiving the second dose of the purple cap Pfizer Covid-19 vaccine after having complaints of a rash with white bumps after receiving the first dose. Patient reported that the rash began the next day after her 1st dose of the vaccine on 28Oct2021 and it is not ongoing and has completely resolved and it lasted about a week and a half and was located on her face, head and neck. The events did not require a visit to Emergency Room. Prior vaccinations (within 4 weeks), family medical history relevant to AE(s), relevant tests were reported as none.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Head discomfort, Rash erythematous
Clinical narrative: red rash; whole lot of white bumps on her head; 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 42 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Oct2021 09:30 (Lot number: FH8020) at the age of 42 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: HEAD DISCOMFORT (non-serious) with onset 28Oct2021, outcome "recovered" (Nov2021), described as "whole lot of white bumps on her head"; RASH ERYTHEMATOUS (non-serious), outcome "recovered" (Nov2021), described as "red rash". The events "whole lot of white bumps on her head" and "red rash" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of head discomfort, rash erythematous.  Additional Information: It was reported that the patient received the first dose of the purple cap Pfizer Covid-19 vaccine on 27Oct2021 and on 28Oct2021 she developed a fine red rash with a whole lot of white bumps on her head, face, and neck. Patient was scheduled to receive the second dose of the purple cap Pfizer Covid-19 vaccine on 24Nov2021. Patient reported that she has already consulted with her HCP about the above complaints and her HCP prescribed her Benadryl which she did not take because she did not have complaints of itchiness per patient. Patient also reported that her HCP has advised her to not get the second dose of the purple cap Pfizer Covid-19 vaccine but told her to contact Pfizer. Patient reported that it took 1.5 weeks for the above complaints to resolve. Patient was asking for information about receiving the second dose of the purple cap Pfizer Covid-19 vaccine after having complaints of a rash with white bumps after receiving the first dose. Patient reported that the rash began the next day after her 1st dose of the vaccine on 28Oct2021 and it is not ongoing and has completely resolved and it lasted about a week and a half and was located on her face, head and neck. The events did not require a visit to Emergency Room. Prior vaccinations (within 4 weeks), family medical history relevant to AE(s), relevant tests were reported as none.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dental examination, Myalgia, Oral pain, Pain, Teething
Clinical narrative: Sore arm; mouth pain; Neck pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 16Sep2021 (Batch/Lot number: unknown) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "S/P R thyroidectomy for papillary CA", start date: 2007, stop date: 2008, notes: Pertinent details: partial thyroidectomy of R thyroid; "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism, start date: 2008 (ongoing). Vaccination history included: Bnt162b2 (Dose: 01, Anatomical site of injection:  Left Deltoid, Route of administration: Intramuscular, Batch/Lot number: EW0217), administration date: 16Aug2021, when the patient was 41 years old, for COVID-19 Immunization, reaction(s): "Aches", "Severe mouth pain", "I felt like all my teeth were going to fall out". The following information was reported: ARTHRALGIA (non-serious) with onset 16Sep2021, outcome "unknown", described as "Sore arm"; ORAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "mouth pain "; NECK PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Neck pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient family medical history included hypertension: both sides, gout: father, CKD- mother. Patient Received 1st dose of Pfizer 26Aug2021 around 3-4 pm after work. On 26Aug2021 9-10 P patient experienced Mouth/ Tooth pain due to which patient visited to Physician office. Seriousness criteria was Persistent/ Significant disability/ Incapacity. No treatment was received. The event Mouth/ Tooth pain was Recovered with sequelae. Immediate muscular pain as expected. Nighttime onset of mouth/tooth pain on all sides but especially worse on the right upper side. Visual assessment with minor without any indication of inflammation. Persisted for the next 2-3 weeks with reduction in duration from 20-22hr to 6-12 h, keep up at night to sleep. Received 2nd dose 16Sep is Pm without change in onset of mouth pain, by this time pain is dull and on and off 3-4x1week from sharp-throbbing initially. Developed neck pain on right side only shortly after mouth pain from falling this side when sleeping. Neck pain persistent to this dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Toothache
Clinical narrative: Sore arm; mouth pain; Neck pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 16Sep2021 (Batch/Lot number: unknown) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "S/P R thyroidectomy for papillary CA", start date: 2007, stop date: 2008, notes: Pertinent details: partial thyroidectomy of R thyroid; "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism, start date: 2008 (ongoing). Vaccination history included: Bnt162b2 (Dose: 01, Anatomical site of injection:  Left Deltoid, Route of administration: Intramuscular, Batch/Lot number: EW0217), administration date: 16Aug2021, when the patient was 41 years old, for COVID-19 Immunization, reaction(s): "Aches", "Severe mouth pain", "I felt like all my teeth were going to fall out". The following information was reported: ARTHRALGIA (non-serious) with onset 16Sep2021, outcome "unknown", described as "Sore arm"; ORAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "mouth pain "; NECK PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Neck pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient family medical history included hypertension: both sides, gout: father, CKD- mother. Patient Received 1st dose of Pfizer 26Aug2021 around 3-4 pm after work. On 26Aug2021 9-10 P patient experienced Mouth/ Tooth pain due to which patient visited to Physician office. Seriousness criteria was Persistent/ Significant disability/ Incapacity. No treatment was received. The event Mouth/ Tooth pain was Recovered with sequelae. Immediate muscular pain as expected. Nighttime onset of mouth/tooth pain on all sides but especially worse on the right upper side. Visual assessment with minor without any indication of inflammation. Persisted for the next 2-3 weeks with reduction in duration from 20-22hr to 6-12 h, keep up at night to sleep. Received 2nd dose 16Sep is Pm without change in onset of mouth pain, by this time pain is dull and on and off 3-4x1week from sharp-throbbing initially. Developed neck pain on right side only shortly after mouth pain from falling this side when sleeping. Neck pain persistent to this dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Dental examination, Neck pain, Oral pain
Clinical narrative: Sore arm; mouth pain; Neck pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 16Sep2021 (Batch/Lot number: unknown) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "S/P R thyroidectomy for papillary CA", start date: 2007, stop date: 2008, notes: Pertinent details: partial thyroidectomy of R thyroid; "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism, start date: 2008 (ongoing). Vaccination history included: Bnt162b2 (Dose: 01, Anatomical site of injection:  Left Deltoid, Route of administration: Intramuscular, Batch/Lot number: EW0217), administration date: 16Aug2021, when the patient was 41 years old, for COVID-19 Immunization, reaction(s): "Aches", "Severe mouth pain", "I felt like all my teeth were going to fall out". The following information was reported: ARTHRALGIA (non-serious) with onset 16Sep2021, outcome "unknown", described as "Sore arm"; ORAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "mouth pain "; NECK PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Neck pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient family medical history included hypertension: both sides, gout: father, CKD- mother. Patient Received 1st dose of Pfizer 26Aug2021 around 3-4 pm after work. On 26Aug2021 9-10 P patient experienced Mouth/ Tooth pain due to which patient visited to Physician office. Seriousness criteria was Persistent/ Significant disability/ Incapacity. No treatment was received. The event Mouth/ Tooth pain was Recovered with sequelae. Immediate muscular pain as expected. Nighttime onset of mouth/tooth pain on all sides but especially worse on the right upper side. Visual assessment with minor without any indication of inflammation. Persisted for the next 2-3 weeks with reduction in duration from 20-22hr to 6-12 h, keep up at night to sleep. Received 2nd dose 16Sep is Pm without change in onset of mouth pain, by this time pain is dull and on and off 3-4x1week from sharp-throbbing initially. Developed neck pain on right side only shortly after mouth pain from falling this side when sleeping. Neck pain persistent to this dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.