chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Palpitations, Rash macular, Syncope, Thrombosis
Clinical narrative: No blood clot but testing shows signs of blood clot; Unable to eat; Chest pains; Red spots; Muscles feel like needles; She has not taken second dose; Fainted; hand turned red; Palpitations; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (No blood clot but testing shows signs of blood clot) and SYNCOPE (Fainted) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), ERYTHEMA (hand turned red) and PALPITATIONS (Palpitations). On an unknown date, the patient experienced THROMBOSIS (No blood clot but testing shows signs of blood clot) (seriousness criterion medically significant), FEEDING DISORDER (Unable to eat), CHEST PAIN (Chest pains), RASH MACULAR (Red spots), MYALGIA (Muscles feel like needles) and INCOMPLETE COURSE OF VACCINATION (She has not taken second dose). At the time of the report, THROMBOSIS (No blood clot but testing shows signs of blood clot), SYNCOPE (Fainted), ERYTHEMA (hand turned red), PALPITATIONS (Palpitations), FEEDING DISORDER (Unable to eat), CHEST PAIN (Chest pains), RASH MACULAR (Red spots), MYALGIA (Muscles feel like needles) and INCOMPLETE COURSE OF VACCINATION (She has not taken second dose) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Coagulation test: signs of blood clot (abnormal) signs of blood clot.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that within 3 minutes of receiving dose, patient's hand turned red and she fainted. Patient was brought to the hospital and was released a couple hours later when palpitations stopped. No medication given to treat symptoms.  The patient was receiving unspecified acid reflux medication.   Company comment Very limited information regarding these events has been provided at this time. Further information has been requested. Company causality for events Thrombosis, Syncope, Erythema, Palpitations, Feeding disorder, Chest pain, Rash macular and Myalgia cannot be excluded, while company causality for Incomplete course of vaccination is assessed as not applicable.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested. Company causality for events Thrombosis, Syncope, Erythema, Palpitations, Feeding disorder, Chest pain, Rash macular and Myalgia cannot be excluded, while company causality for Incomplete course of vaccination is assessed as not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Ectopic pregnancy, Exposure during pregnancy
Clinical narrative: Ectopic pregnancy; Exposure during pregnancy; This spontaneous case was reported by a consumer and describes the occurrence of ECTOPIC PREGNANCY (Ectopic pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ECTOPIC PREGNANCY (Ectopic pregnancy) (seriousness criterion medically significant) and EXPOSURE DURING PREGNANCY (Exposure during pregnancy). At the time of the report, ECTOPIC PREGNANCY (Ectopic pregnancy) outcome was unknown and EXPOSURE DURING PREGNANCY (Exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that she was not pregnant at the time of this report. Relevant concomitant medications were not reported.  Treatment medication was not provided.  Company comment: This report refers to a case of exposure during pregnancy for mRNA-1273 (lot # unknown) with associated AE reported of ectopic pregnancy. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: This report refers to a case of exposure during pregnancy for mRNA-1273 (lot # unknown) with associated AE reported of ectopic pregnancy. Very limited information regarding these events has been provided at this time. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Ulcerative keratitis
Clinical narrative: Corneal ulcers; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ULCERATIVE KERATITIS (Corneal ulcers) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ULCERATIVE KERATITIS (Corneal ulcers) (seriousness criterion medically significant). At the time of the report, ULCERATIVE KERATITIS (Corneal ulcers) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Product dose omission issue
Clinical narrative: currently in the hospital with shingles; shingles after the 1st dose; Too sick to get the 2nd dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (currently in the hospital with shingles; shingles after the 1st dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Too sick to get the 2nd dose). On an unknown date, the patient experienced HERPES ZOSTER (currently in the hospital with shingles; shingles after the 1st dose) (seriousness criterion hospitalization). On 23-Feb-2021, PRODUCT DOSE OMISSION ISSUE (Too sick to get the 2nd dose) had resolved. At the time of the report, HERPES ZOSTER (currently in the hospital with shingles; shingles after the 1st dose) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.       No concomitant medications were reported.  Per the reporter: the patient's doctor said he was too sick to get the second planned dose scheduled 23FEB2021.  No treatment details were reported.  This case concerns a male patient of unknown age who missed second dose. The patient also experienced shingles and due to temporal association between the reported event and the administration of mRNA-1273, causal relationship cannot be excluded. Some vaccines have been known to exacerbate latent herpes zoster in patients Event of missed dose is assessed as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: A follow up received on 25 MAY 2021 has no new information; Sender's Comments: This case concerns a male patient of unknown age who missed second dose. The patient also experienced shingles and due to temporal association between the reported event and the administration of mRNA-1273, causal relationship cannot be excluded. Some vaccines have been known to exacerbate latent herpes zoster in patients Event of missed dose is assessed as not applicable.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Gait inability, Pain in extremity, Pulmonary embolism
Clinical narrative: blood clots in her legs; blood lot traveled to lungs, had a very severe case of blood clots; severe pain in her legs; could not walk; weak; feeling fatigued; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clots in her legs), PULMONARY EMBOLISM (blood lot traveled to lungs, had a very severe case of blood clots) and PAIN IN EXTREMITY (severe pain in her legs) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (severe pain in her legs) (seriousness criterion hospitalization), GAIT INABILITY (could not walk), ASTHENIA (weak) and FATIGUE (feeling fatigued). On 31-Mar-2021, the patient experienced THROMBOSIS (blood clots in her legs) (seriousness criteria hospitalization and medically significant) and PULMONARY EMBOLISM (blood lot traveled to lungs, had a very severe case of blood clots) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 31-Mar-2021 due to PULMONARY EMBOLISM and THROMBOSIS. At the time of the report, THROMBOSIS (blood clots in her legs), PULMONARY EMBOLISM (blood lot traveled to lungs, had a very severe case of blood clots), PAIN IN EXTREMITY (severe pain in her legs), GAIT INABILITY (could not walk), ASTHENIA (weak) and FATIGUE (feeling fatigued) outcome was unknown.            No concomitant and treatment medications were reported.  The patient had no side effects from the first dose of Moderna vaccine.   The patient remained hospitalized at the time of report.  Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Fatigue is consistent with the Known safety profile of the product.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Fatigue is consistent with the Known safety profile of the product.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots in her legs; blood lot traveled to lungs, had a very severe case of blood clots; severe pain in her legs; could not walk; weak; feeling fatigued; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clots in her legs), PULMONARY EMBOLISM (blood lot traveled to lungs, had a very severe case of blood clots) and PAIN IN EXTREMITY (severe pain in her legs) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (severe pain in her legs) (seriousness criterion hospitalization), GAIT INABILITY (could not walk), ASTHENIA (weak) and FATIGUE (feeling fatigued). On 31-Mar-2021, the patient experienced THROMBOSIS (blood clots in her legs) (seriousness criteria hospitalization and medically significant) and PULMONARY EMBOLISM (blood lot traveled to lungs, had a very severe case of blood clots) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 31-Mar-2021 due to PULMONARY EMBOLISM and THROMBOSIS. At the time of the report, THROMBOSIS (blood clots in her legs), PULMONARY EMBOLISM (blood lot traveled to lungs, had a very severe case of blood clots), PAIN IN EXTREMITY (severe pain in her legs), GAIT INABILITY (could not walk), ASTHENIA (weak) and FATIGUE (feeling fatigued) outcome was unknown.            No concomitant and treatment medications were reported.  The patient had no side effects from the first dose of Moderna vaccine.   The patient remained hospitalized at the time of report.  Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Fatigue is consistent with the Known safety profile of the product.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Fatigue is consistent with the Known safety profile of the product.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Platelet count, Platelet count decreased, Product dose omission issue
Clinical narrative: platelet count 3; purple dots on body; Red dots on body; skin was bleeding; tongue blisters; bruising on body, arm, stomach and legs; did not received 2 dose; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED (platelet count 3) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CALCIUM for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PLATELET COUNT DECREASED (platelet count 3) (seriousness criterion hospitalization). On an unknown date, the patient experienced PURPURA (purple dots on body), ERYTHEMA (Red dots on body), SKIN HAEMORRHAGE (skin was bleeding), TONGUE BLISTERING (tongue blisters), CONTUSION (bruising on body, arm, stomach and legs) and PRODUCT DOSE OMISSION ISSUE (did not received 2 dose). The patient was hospitalized from 14-Apr-2021 to 16-Apr-2021 due to PLATELET COUNT DECREASED. The patient was treated with PREDNISONE at a dose of 20 mg. On 16-Apr-2021, PLATELET COUNT DECREASED (platelet count 3) had resolved. At the time of the report, PURPURA (purple dots on body), ERYTHEMA (Red dots on body), SKIN HAEMORRHAGE (skin was bleeding), TONGUE BLISTERING (tongue blisters) and CONTUSION (bruising on body, arm, stomach and legs) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not received 2 dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Platelet count: 3 (Inconclusive) 3.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products also included medication for joint pain. Treatment: Prednisone 20 mg for 10 days, but only took two pills. Patient had her first dose of Moderna COVID19 Vaccine on 02Apr2021 in left deltoid. She was scheduled for the second dose on 30Apr2021, but the doctor told her not to go. Nine days after the vaccine, patient had red, purple small dots on her body. It looked like her skin was bleeding. She had blisters on her tongue. She had bruising all over her body: on her arms, stomach, legs. On 14Apr2021, she went to the hospital because her platelet count was 3. She was discharged  16Apr2021.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Purpura, Skin haemorrhage, Tongue blistering
Clinical narrative: platelet count 3; purple dots on body; Red dots on body; skin was bleeding; tongue blisters; bruising on body, arm, stomach and legs; did not received 2 dose; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED (platelet count 3) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CALCIUM for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PLATELET COUNT DECREASED (platelet count 3) (seriousness criterion hospitalization). On an unknown date, the patient experienced PURPURA (purple dots on body), ERYTHEMA (Red dots on body), SKIN HAEMORRHAGE (skin was bleeding), TONGUE BLISTERING (tongue blisters), CONTUSION (bruising on body, arm, stomach and legs) and PRODUCT DOSE OMISSION ISSUE (did not received 2 dose). The patient was hospitalized from 14-Apr-2021 to 16-Apr-2021 due to PLATELET COUNT DECREASED. The patient was treated with PREDNISONE at a dose of 20 mg. On 16-Apr-2021, PLATELET COUNT DECREASED (platelet count 3) had resolved. At the time of the report, PURPURA (purple dots on body), ERYTHEMA (Red dots on body), SKIN HAEMORRHAGE (skin was bleeding), TONGUE BLISTERING (tongue blisters) and CONTUSION (bruising on body, arm, stomach and legs) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not received 2 dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Platelet count: 3 (Inconclusive) 3.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products also included medication for joint pain. Treatment: Prednisone 20 mg for 10 days, but only took two pills. Patient had her first dose of Moderna COVID19 Vaccine on 02Apr2021 in left deltoid. She was scheduled for the second dose on 30Apr2021, but the doctor told her not to go. Nine days after the vaccine, patient had red, purple small dots on her body. It looked like her skin was bleeding. She had blisters on her tongue. She had bruising all over her body: on her arms, stomach, legs. On 14Apr2021, she went to the hospital because her platelet count was 3. She was discharged  16Apr2021.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Impaired work ability, Myalgia, Pyrexia
Clinical narrative: Chills; preventing the patient from working; Myalgias; Severe fever; This is a spontaneous report from a contactable physician.  The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 02Mar2021, this case now contains all required information to be considered valid.    A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced severe fever for 48 hours, chills, and myalgias preventing the patient from working. The patient recovered from severe fever, however the outcome of the other events was not specified.  According to the reporting physician the above described events were related to BNT162b2 vaccination.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer. A 79-years-old female patient received BNT162B2 (COVID-19 Vaccine, Solution for injection, Lot number: EM9809), dose 2 via an unspecified route of administration, administered in Arm Right on an unspecified date, 10:00 (at the time of 79-years-old) as second dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The vaccination facility type was hospital. The patient previously took prolia for her bones and osteoporosis and historical vaccine as bnt162b2 (Lot Number: FF1283) on 25Jan2021 administered via unspecified route, in arm left as first dose for covid-19 immunisation. The patient had first COVID-19 shot this past Monday. Gets the next one in three weeks. The patient was told information by someone and wants to see if that information was correct. The patient would get Prolia shot on a Monday and that Wednesday would get the second COVID-19 Vaccine. The patient gets Prolia every six months for her bones and osteoporosis. The patient had sore upper arm- put ice on - gone melt day. The outcome of event was unknown. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood cholesterol increased
Clinical narrative: This is a spontaneous report from a contactable nurse (patient herself). A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as unknown single for COVID-19 immunization.  Patient has not taken medications such as Advil and High cholesterol medications a week now and wanted to know how long she should not take these medications before getting the second dose of the vaccine. Patient later stated that she is taking High cholesterol medications a week now and wanted to know how long she should not take these medication before getting the second dose of the vaccine. The outcome of the event was unknown. Information on the lot/batch number has been requested. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered at inappropriate site, Vaccination site erythema, Vaccination site swelling
Clinical narrative: little bulging bump with redness; red allergic bump is a 1-2 cm spot that appeared after 2 days below the injection site;  there is a little bulging bump with redness; feels that her second dose of the covid 19 vaccine was administered improperly; This is a spontaneous report from a contactable consumer (patient's friend). A 34-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number and Expiration date: unknown), dose 2 via an unknown route of administration, in left arm on Jan2021 (at the age of 34 years age of vaccination) as 2nd dose, single dose for covid-19 immunisation and patient received the first dose of bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number and Expiration date: unknown) dose 1 via an unknown route of administration on an unspecified date single dose for COVID-19 immunisation. The patient medical history was unknown. The patient's concomitant medications were not reported. On an unknown date in Jan 2021, the patient's friend reported that, his friend feels that her second dose of the covid 19 vaccine was administered improperly. The injection was administered on the patient's left arm and that the patient felt the medication was not administered properly and she did not fully receive the second dose. She wanted to know if she can repeat the second dose. The reporter experienced the red allergic bump was a 1-2 cm spot that appeared after 2 days below the injection site, there was a little bulging bump with redness on an unknown date in Jan 2021. It was reported that the, patient was concerned as she wanted to be fully vaccinated and if could get another dose. The outcome of events was unknown.   Follow-up (01Feb2021): This is a follow-up spontaneous report from a contactable consumer. Patient information and new event information was added  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Feeling hot, Incorrect route of product administration, Pruritus, Weight
Clinical narrative: little bulging bump with redness; red allergic bump is a 1-2 cm spot that appeared after 2 days below the injection site;  there is a little bulging bump with redness; feels that her second dose of the covid 19 vaccine was administered improperly; This is a spontaneous report from a contactable consumer (patient's friend). A 34-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number and Expiration date: unknown), dose 2 via an unknown route of administration, in left arm on Jan2021 (at the age of 34 years age of vaccination) as 2nd dose, single dose for covid-19 immunisation and patient received the first dose of bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number and Expiration date: unknown) dose 1 via an unknown route of administration on an unspecified date single dose for COVID-19 immunisation. The patient medical history was unknown. The patient's concomitant medications were not reported. On an unknown date in Jan 2021, the patient's friend reported that, his friend feels that her second dose of the covid 19 vaccine was administered improperly. The injection was administered on the patient's left arm and that the patient felt the medication was not administered properly and she did not fully receive the second dose. She wanted to know if she can repeat the second dose. The reporter experienced the red allergic bump was a 1-2 cm spot that appeared after 2 days below the injection site, there was a little bulging bump with redness on an unknown date in Jan 2021. It was reported that the, patient was concerned as she wanted to be fully vaccinated and if could get another dose. The outcome of events was unknown.   Follow-up (01Feb2021): This is a follow-up spontaneous report from a contactable consumer. Patient information and new event information was added  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Sleep deficit
Clinical narrative: Cant sleep; This is a spontaneous report from a contactable consumer. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 29Jan2021 as single dose for COVID-19 immunisation. The patient's medical history included sinus headache on 29Jan2021. The patient's concomitant medications were not reported. The patient had sinus headache on 29Jan2021 before the vaccination and hence he took 500mg Tylenol. Afterwards, the patient had his vaccine dose and realised he made a mistake as he had read online that "it was bad to do and not supposed to take Tylenol before getting the vaccine" and "if the person takes Tylenol or a NSAID it can stop the immune response to the Pfizer vaccine". The patient further clarified that he did not have a reaction of any sort, he had no redness, headache or fatigue. The patient went on to describe that that, "he can't sleep at night thinking about that." The patient wanted to know whether he had to take the vaccine again and was wondering whether having taken Tylenol prior to the shot messed it up. Like in terms of getting the proper response from the vaccine, should he take an extra shot or not. The patient further stated that, the vaccine was perfectly safe, and Pfizer did great. The reporter had classified the events as non-serious. The outcome of the events was unknown.  Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Concussion, Dizziness, Gait disturbance
Clinical narrative: dizziness/When I stand up I can't move right away. I have to wait until the dizziness goes away/dizzy feeling like he a concussion; dizziness/When I stand up I can't move right away. I have to wait until the dizziness goes away/dizzy feeling like he a concussion; dizziness/When I stand up I can't move right away. I have to wait until the dizziness goes away/dizzy feeling like he a concussion; This is a spontaneous report from a contactable consumer (patient) via medical information team. A male patient of 79-year-old received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration (Batch/Lot number was not reported) on 31Jan2021 (reported as yesterday morning (Sunday)) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 31Jan2021 (reported as starting last night), the patient experienced dizziness/when he stands up, can't move right away. He has to wait until the dizziness goes away/dizzy feeling like he a concussion. This morning he was having the dizzy feeling like he a concussion. He wants to know, if this could be a side effect. He sat and waited for 15 minutes after with no reaction. The outcome of all the events was unknown. There was no product quality complaint (PQC) present.  Information on the lot/batch number has been requested.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Neck pain, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 35-year-old non-pregnant female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9262) via unspecified route of administration in left arm on 25Jan2021 at 16:45 (at 35-year-old age) as single dose for COVID-19 immunization. Patient had no allergies to medications, food, or other products or any other medical history. No concomitant medications were reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, patient has been tested for COVID-19. On an unspecified date in Jan2021, patient experienced strong neck pain in the area-on the left side (vaccine was injected in left arm). Two days after experiencing strong neck pain, on 30Jan2021, at 12:00PM, on day 5 after vaccination with 1st dose, patient developed swelling of the left supraclavicular lymph node (3-4 cm in diameter). Possibly also swelling of groin lymph nodes but more minor. On an unspecified date in 2021, swelling in supraclavicular lymph node was not subsiding by day 8-9 after vaccination and was significantly painful. Reporter considered events as non-serious. Due to the events, patient visited doctor or other healthcare professional office/clinic visit. On 25Jan2021, 27Jan2021 and 29Jan2021, patient underwent lab test of COVID-PCR via nasal swab and tested negative. It was unknown if the patient received treatment for the adverse event. Outcome of the events were not resolved.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypotension
Clinical narrative: very low BP; This is a spontaneous report received from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had very low bp (blood pressure). The patient underwent lab tests and procedures which included blood pressure measurement: low. The outcome of the event was unknown.   Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Cardiac disorder, Chills, Cough, Decreased appetite
Clinical narrative: a terrible time sleeping; feet and hands were ice cold; chills; coughing; sneezing; blowing her nose; Felt like she wanted to vomit; Felt short shots in her heart and lungs; Felt short shots in her heart and lungs; Can't eat much food; Feels an erratic short pain on right side of head; Seems like she got the COVID virus for 24 hours and wants to know if that would make her contagious to other people; Seems like she got the COVID virus for 24 hours and wants to know if that would make her contagious to other people; very bizarre dreams; pains underneath her arms; This is a spontaneous report from a contactable consumer (patient herself). A 77-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- UNKNOWN) via an unspecified route of administration on 01Feb2021 (at the age of 77-years-old) as 2nd dose single for COVID-19 immunization. The patient medical history and concomitant medications were not provided. The patient experienced a, had to use tons of blankets to get warm, very bizarre dreams (bizarre experience), pains underneath her arms. On 01Feb2021 experienced terrible time sleeping, feet and hands were ice cold, chills, coughing, sneezing, blowing her nose, felt like she wanted to vomit, felt short shots in her heart and lungs, cannot eat much food, feels an erratic short pain on right side of head. Got the second Pfizer shot on Monday (01Feb2021). Patient was seeing dreams and wild things. Woke up yesterday (02Feb2021) morning and it seemed to dissipate by yesterday noon time. Seems like she got the COVID virus for 24 hours and wants to know if that would make her contagious to other people. Clarified she is referring to the COVID-19 shot. The patient agreed that experienced these symptoms after receiving the second dose of the Pfizer COVID-19 vaccine and they lasted about 24 hours and today patient feels fine. The reporter was concerned that patient may have had COVID, possibly from the vaccine, and wants to know if she was contagious. It was queried if patient had a positive COVID test after receiving the second COVID-19 shot. Patient did not address question and stated she only received the first and second COVID-19 shot. The outcome of the events suspected COVID-19, drug ineffective, pain in extremity, abnormal dreams, sleeping disorder was unknown while for the other events was recovered on 02Feb2021.   Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.   Follow-up attempts have been completed and no further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Headache, Lung disorder, Nausea, Pain in extremity
Clinical narrative: a terrible time sleeping; feet and hands were ice cold; chills; coughing; sneezing; blowing her nose; Felt like she wanted to vomit; Felt short shots in her heart and lungs; Felt short shots in her heart and lungs; Can't eat much food; Feels an erratic short pain on right side of head; Seems like she got the COVID virus for 24 hours and wants to know if that would make her contagious to other people; Seems like she got the COVID virus for 24 hours and wants to know if that would make her contagious to other people; very bizarre dreams; pains underneath her arms; This is a spontaneous report from a contactable consumer (patient herself). A 77-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- UNKNOWN) via an unspecified route of administration on 01Feb2021 (at the age of 77-years-old) as 2nd dose single for COVID-19 immunization. The patient medical history and concomitant medications were not provided. The patient experienced a, had to use tons of blankets to get warm, very bizarre dreams (bizarre experience), pains underneath her arms. On 01Feb2021 experienced terrible time sleeping, feet and hands were ice cold, chills, coughing, sneezing, blowing her nose, felt like she wanted to vomit, felt short shots in her heart and lungs, cannot eat much food, feels an erratic short pain on right side of head. Got the second Pfizer shot on Monday (01Feb2021). Patient was seeing dreams and wild things. Woke up yesterday (02Feb2021) morning and it seemed to dissipate by yesterday noon time. Seems like she got the COVID virus for 24 hours and wants to know if that would make her contagious to other people. Clarified she is referring to the COVID-19 shot. The patient agreed that experienced these symptoms after receiving the second dose of the Pfizer COVID-19 vaccine and they lasted about 24 hours and today patient feels fine. The reporter was concerned that patient may have had COVID, possibly from the vaccine, and wants to know if she was contagious. It was queried if patient had a positive COVID test after receiving the second COVID-19 shot. Patient did not address question and stated she only received the first and second COVID-19 shot. The outcome of the events suspected COVID-19, drug ineffective, pain in extremity, abnormal dreams, sleeping disorder was unknown while for the other events was recovered on 02Feb2021.   Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.   Follow-up attempts have been completed and no further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, Rhinorrhoea, Sleep disorder, Sneezing, Suspected COVID-19
Clinical narrative: a terrible time sleeping; feet and hands were ice cold; chills; coughing; sneezing; blowing her nose; Felt like she wanted to vomit; Felt short shots in her heart and lungs; Felt short shots in her heart and lungs; Can't eat much food; Feels an erratic short pain on right side of head; Seems like she got the COVID virus for 24 hours and wants to know if that would make her contagious to other people; Seems like she got the COVID virus for 24 hours and wants to know if that would make her contagious to other people; very bizarre dreams; pains underneath her arms; This is a spontaneous report from a contactable consumer (patient herself). A 77-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- UNKNOWN) via an unspecified route of administration on 01Feb2021 (at the age of 77-years-old) as 2nd dose single for COVID-19 immunization. The patient medical history and concomitant medications were not provided. The patient experienced a, had to use tons of blankets to get warm, very bizarre dreams (bizarre experience), pains underneath her arms. On 01Feb2021 experienced terrible time sleeping, feet and hands were ice cold, chills, coughing, sneezing, blowing her nose, felt like she wanted to vomit, felt short shots in her heart and lungs, cannot eat much food, feels an erratic short pain on right side of head. Got the second Pfizer shot on Monday (01Feb2021). Patient was seeing dreams and wild things. Woke up yesterday (02Feb2021) morning and it seemed to dissipate by yesterday noon time. Seems like she got the COVID virus for 24 hours and wants to know if that would make her contagious to other people. Clarified she is referring to the COVID-19 shot. The patient agreed that experienced these symptoms after receiving the second dose of the Pfizer COVID-19 vaccine and they lasted about 24 hours and today patient feels fine. The reporter was concerned that patient may have had COVID, possibly from the vaccine, and wants to know if she was contagious. It was queried if patient had a positive COVID test after receiving the second COVID-19 shot. Patient did not address question and stated she only received the first and second COVID-19 shot. The outcome of the events suspected COVID-19, drug ineffective, pain in extremity, abnormal dreams, sleeping disorder was unknown while for the other events was recovered on 02Feb2021.   Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.   Follow-up attempts have been completed and no further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Middle insomnia, Pruritus
Clinical narrative: itchy hands and feet; it woke up her a few times during the night; This is a spontaneous report from a contactable consumer. This 56-year-old female consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection (lot number: EL3249, Expiry date: Unknown) via unspecified route of administration on 02-FEB-2021 10:30 as a single for COVID-19 immunization. Medical history was included rash due to penicillin allergy, COPD, depression, anxiety, muscle spasm, asthma, COPD, itching, sleep disorder, acid reflux, allergy. Concomitant medications were Advair, 100/50mg; on puff twice daily for COPD, ProAir rescue inhaler as needed for Asthma. Baclofen 20mg; take up to three time daily by mouth as needed as she had shoulder issues (Muscle spasm) taking for 5 years or more, Effexor XR 150mg; take once daily by mouth, Famotidine 20mg; take one twice daily by mouth, Trazodone hydrochloride 100mg; take once daily, Omeprazole 20mg; take once daily by mouth, Flonase, 50mg; take one squirt per nostril for an unknown indication. Azelastine HCI daily 137mg; take one spray each nostril daily for Allergy. On 02-FEB-2021 17:00 patient experienced allergy reactions with itchy hands and feet. She took one Benadryl last night and it helped. Mentioned she was taking Benadryl for itching and it wasn't enough, so they added Famotidine which has worked. Outcome of the event was recovering for the event itchy hands and feet and unknown for it woke up her a few times during the night.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphoedema
Clinical narrative: severe lymphedema in both arms; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on an unspecified date as an unspecified dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced severe lymphedema in both arms on an unspecified date. Outcome of the event was unknown.  Information about lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Illness
Clinical narrative: bowel strain; Sunday I went often, but I had to force myself. It hurts to go, it is really hard to go. I feel the urge to go, but I cannot (defecate) I am sitting on toilet now, trying to...; I'm so sick; This is a spontaneous report from a contactable consumer or other non hcp.   A 95-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscularly administered in the left arm on 24Jan2021 (Batch/Lot Number: EL9263) as a single dose for an COVID-19 immunization. The patient past medical history included blood pressure and thyroid. The patient stated that she took medication for her blood pressure and she also takes thyroid medication. Concomitant medication included macrogol 3350 (MIRALAX) and loperamide hydrochloride (IMODIUM A-D). After the administration of vaccine, the patient experienced bowel strain in Jan2021. On Sunday, she went often, but she had to force herself hurts to go and hard to go. She felt urge to go, but she cannot (defecate) she was sitting on toilet now, trying to and she was so sick. She was going to the bathroom off and on throughout the day on Sunday. She clarified that on Monday and Tuesday she couldn't go to the bathroom, she states that "little marble would come out, but it would hurt". She explained this issue with her bowels started on Sunday. She didnt know if this could be caused by the vaccine since she is having so many problems with her bowels. She reported that Miralax but she hasn't been taking it since she got the shot. She hasn't taken the Miralax in about 3 or 4 days because she was normal. She took Imodium A-D because she was going so much on Sunday. Then, Monday and Tuesday she started having a hard time using the bathroom. The event outcome was Unknown.  No further details were provided or obtained.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: rash at the injection site and it was swollen; Pain injection site; stiff arm; rash at the injection site and it was swollen/Swollen arm; This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 10:28 (Batch/Lot Number: EL9262; Expiration Date: May2021) as single dose for COVID-19 immunisation. Medical history included a mild stroke 5 years ago, HIV positive, human immunodeficiency virus, from 15 years ago. Concomitant medication(s) included Abacavir/Lamivudine 600/300mg at once daily by mouth for HIV for 15 years and ongoing; Atazanavir 200 mg at two daily by mouth for HIV for 15 years and ongoing; multivitamin 200mg at one daily by mouth taking for six months and Ongoing; Vitamin D3 1000units at once daily by mouth taking for six months and Ongoing; Aspirin 81 mg at once daily by mouth for stroke taking for year and half and Ongoing. No History of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks). No Family Medical History. The patient had the first dose of the Pfizer COVID 19 vaccine 29Jan2021 at 10.28AM in the left arm and about half an hour later he had pain at the injection site so he went by the house and iced it for 40 minutes, then went to work. His arm was stiff and bothering him all day and when he came home he noticed a rash at the injection site and it was swollen. Now it had cleared up by about two thirds. He did not seek treatment for the rash. The patient was planning to receive the second dose on 19Feb2021 but wanted to know, considering his reaction should he get the second dose. AE(s) did not require a visit to physician or ER. No Relevant test. Outcome of the events rash, stiff arm was recovering; swelling, injection site pain was recovered on 30Jan2021.  Follow-up attempts are completed. No further information is expected.