chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "felt tired"; SOMNOLENCE (non-serious), outcome "unknown", described as "sleepy"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "in pain on the injection site". Additional information: Caller called to ask the duration of time required before getting the 4th dose of the Pfizer vaccine after she took the 3rd dose in late Jul. She also asked if she needs to get it besides getting 3 doses already. During the call, stated that she felt tired, sleepy and in pain on the injection site after getting the first and second doses, while she felt so hot when she took her 3rd, like she was having fever and her hair got curly and frizzy. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Urticaria
Clinical narrative: hives didn't appear until 10 days later [after booster] / has spontaneous hives/get a hive where the table touched her arm/Itching.; red, raised hive; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives didn't appear until 10 days later [after booster] / has spontaneous hives/get a hive where the table touched her arm/Itching.) and ERYTHEMA (red, raised hive) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 046A21A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives didn't appear until 10 days later [after booster] / has spontaneous hives/get a hive where the table touched her arm/Itching.) and ERYTHEMA (red, raised hive). The patient was treated with FEXOFENADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA-D [FEXOFENADINE;PSEUDOEPHEDRINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; FAMOTIDINE (PEPCID AC) for Adverse event, at an unspecified dose and frequency and ALPRAZOLAM (ATARAX [ALPRAZOLAM]) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives didn't appear until 10 days later [after booster] / has spontaneous hives/get a hive where the table touched her arm/Itching.) had not resolved and ERYTHEMA (red, raised hive) outcome was unknown.            No Concomitant medication was reported.  Treatment medication don't stop the hives; they just stop the itching.The patient stated she is currently on Treatment medication.  Patient gave examples of getting hives where she wears her watch, touching her face, and wearing high-collared shirt or where the jeans hit the waist, anywhere that is tight on her skin.   This case was linked to MOD-2022-462294, MOD-2022-462295 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Urticaria
Clinical narrative: hives didn't appear until 10 days later [after booster] / has spontaneous hives/get a hive where the table touched her arm/Itching.; red, raised hive; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives didn't appear until 10 days later [after booster] / has spontaneous hives/get a hive where the table touched her arm/Itching.) and ERYTHEMA (red, raised hive) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 046A21A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives didn't appear until 10 days later [after booster] / has spontaneous hives/get a hive where the table touched her arm/Itching.) and ERYTHEMA (red, raised hive). The patient was treated with FEXOFENADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA-D [FEXOFENADINE;PSEUDOEPHEDRINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; FAMOTIDINE (PEPCID AC) for Adverse event, at an unspecified dose and frequency and ALPRAZOLAM (ATARAX [ALPRAZOLAM]) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives didn't appear until 10 days later [after booster] / has spontaneous hives/get a hive where the table touched her arm/Itching.) had not resolved and ERYTHEMA (red, raised hive) outcome was unknown.            No Concomitant medication was reported.  Treatment medication don't stop the hives; they just stop the itching.The patient stated she is currently on Treatment medication.  Patient gave examples of getting hives where she wears her watch, touching her face, and wearing high-collared shirt or where the jeans hit the waist, anywhere that is tight on her skin.   This case was linked to MOD-2022-462294, MOD-2022-462295 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Administer an entire undiluted purple cap vial; Administer an entire undiluted purple cap vial; Had a temperature of 101; Had a hard time sleeping; Arm hurt; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Jan2022 (Lot number: FJ1614, Expiration Date: 28Feb2022) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose :01, Lot Number: EW0179 , Expiry Date: 31Aug2021, Anatomical Location: Right deltoid), administration date: 10Jun2021, when the patient was 50 years old, for COVID-19 immunization; Bnt162b2 (Dose :02, Lot Number: FA6780, Expiry Date: 01Aug2021, Anatomical Location: Right deltoid), administration date: 08Jul2021, when the patient was 50 years old, for COVID-19 immunization. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 10Jan2022, outcome "unknown" and all described as "Administer an entire undiluted purple cap vial"; PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "Had a temperature of 101"; INSOMNIA (non-serious) with onset Jan2022, outcome "unknown", described as "Had a hard time sleeping"; PAIN IN EXTREMITY (non-serious) with onset Jan2022, outcome "unknown", described as "Arm hurt". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient had medication error (overdose). The stage where medication error occurred was preparation and administration. The contributing factor to the medication error was, healthcare provider thought the vial was ready to go and didn't realize it needed to be mixed, because the nurse usually does the mixing. HCP administered an entire undiluted purple cap vial of booster dose of Pfizer Covid vaccine to the patient. Now they keep the unmixed and ready to go vials in separate places to avoid this from happening again. So far, there were no issues with the patient. No adverse events required to visit to an emergency room or physician's office. The patient did not take any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No additional vaccines were administered on same date of the Pfizer Suspect. No adverse event was reported following prior vaccinations. No relevant tests were performed. The nurse called the patient a day prior to this report and she reported she had a temperature of 101. The patient also said she had a hard time sleeping and getting comfortable because her arm hurt. The nurse felt some of the sleeplessness might be related to anxiety from the overdose event.  Follow up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Insomnia, Overdose, Pain in extremity, Product preparation error
Clinical narrative: Administer an entire undiluted purple cap vial; Administer an entire undiluted purple cap vial; Had a temperature of 101; Had a hard time sleeping; Arm hurt; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Jan2022 (Lot number: FJ1614, Expiration Date: 28Feb2022) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose :01, Lot Number: EW0179 , Expiry Date: 31Aug2021, Anatomical Location: Right deltoid), administration date: 10Jun2021, when the patient was 50 years old, for COVID-19 immunization; Bnt162b2 (Dose :02, Lot Number: FA6780, Expiry Date: 01Aug2021, Anatomical Location: Right deltoid), administration date: 08Jul2021, when the patient was 50 years old, for COVID-19 immunization. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 10Jan2022, outcome "unknown" and all described as "Administer an entire undiluted purple cap vial"; PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "Had a temperature of 101"; INSOMNIA (non-serious) with onset Jan2022, outcome "unknown", described as "Had a hard time sleeping"; PAIN IN EXTREMITY (non-serious) with onset Jan2022, outcome "unknown", described as "Arm hurt". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient had medication error (overdose). The stage where medication error occurred was preparation and administration. The contributing factor to the medication error was, healthcare provider thought the vial was ready to go and didn't realize it needed to be mixed, because the nurse usually does the mixing. HCP administered an entire undiluted purple cap vial of booster dose of Pfizer Covid vaccine to the patient. Now they keep the unmixed and ready to go vials in separate places to avoid this from happening again. So far, there were no issues with the patient. No adverse events required to visit to an emergency room or physician's office. The patient did not take any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No additional vaccines were administered on same date of the Pfizer Suspect. No adverse event was reported following prior vaccinations. No relevant tests were performed. The nurse called the patient a day prior to this report and she reported she had a temperature of 101. The patient also said she had a hard time sleeping and getting comfortable because her arm hurt. The nurse felt some of the sleeplessness might be related to anxiety from the overdose event.  Follow up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Administer an entire undiluted purple cap vial; Administer an entire undiluted purple cap vial; Had a temperature of 101; Had a hard time sleeping; Arm hurt; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Jan2022 (Lot number: FJ1614, Expiration Date: 28Feb2022) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose :01, Lot Number: EW0179 , Expiry Date: 31Aug2021, Anatomical Location: Right deltoid), administration date: 10Jun2021, when the patient was 50 years old, for COVID-19 immunization; Bnt162b2 (Dose :02, Lot Number: FA6780, Expiry Date: 01Aug2021, Anatomical Location: Right deltoid), administration date: 08Jul2021, when the patient was 50 years old, for COVID-19 immunization. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 10Jan2022, outcome "unknown" and all described as "Administer an entire undiluted purple cap vial"; PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "Had a temperature of 101"; INSOMNIA (non-serious) with onset Jan2022, outcome "unknown", described as "Had a hard time sleeping"; PAIN IN EXTREMITY (non-serious) with onset Jan2022, outcome "unknown", described as "Arm hurt". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient had medication error (overdose). The stage where medication error occurred was preparation and administration. The contributing factor to the medication error was, healthcare provider thought the vial was ready to go and didn't realize it needed to be mixed, because the nurse usually does the mixing. HCP administered an entire undiluted purple cap vial of booster dose of Pfizer Covid vaccine to the patient. Now they keep the unmixed and ready to go vials in separate places to avoid this from happening again. So far, there were no issues with the patient. No adverse events required to visit to an emergency room or physician's office. The patient did not take any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No additional vaccines were administered on same date of the Pfizer Suspect. No adverse event was reported following prior vaccinations. No relevant tests were performed. The nurse called the patient a day prior to this report and she reported she had a temperature of 101. The patient also said she had a hard time sleeping and getting comfortable because her arm hurt. The nurse felt some of the sleeplessness might be related to anxiety from the overdose event.  Follow up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest discomfort, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: Breakthrough COVID infection requiring brief hospitalizaton
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Infection, SARS-CoV-2 test positive
Clinical narrative: Breakthrough COVID infection requiring brief hospitalizaton
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Condition aggravated, Muscular weakness, Neuropathy peripheral, Sensory disturbance
Clinical narrative: weakness/difficulty lifting left foot; small fiber neuropathy shocking/stabbing sensations; Difficulty lifting left foot; Shocking/Stabbing sensation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Jan2022 (Lot number: FH8027) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "amyloidosis polyneuropathy including small fiber neuropathy" (unspecified if ongoing), notes: amyloidosis polyneuropathy including small fiber neuropathy; "amyloidosis polyneuropathy including small fiber neuropathy" (unspecified if ongoing), notes: amyloidosis polyneuropathy including small fiber neuropathy. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: ER8737, Location of injection: Arm Left), administration date: 05Apr2021, when the patient was 41 years old, for Covid-19 Immunization; Bnt162b2 (Dose 1, Batch/Lot No: EN6206, Location of injection: Arm Left), administration date: 15Mar2021, when the patient was 41 years old, for Covid-19 Immunization. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 04Jan2022, outcome "not recovered", described as "weakness/difficulty lifting left foot"; SMALL FIBRE NEUROPATHY (non-serious) with onset 04Jan2022, outcome "not recovered", described as "small fiber neuropathy shocking/stabbing sensations"; PAIN (non-serious) with onset 04Jan2022, outcome "not recovered", described as "Difficulty lifting left foot"; SENSORY DISTURBANCE (non-serious) with onset 04Jan2022, outcome "not recovered", described as "Shocking/Stabbing sensation". Therapeutic measures were not taken as a result of muscular weakness, small fibre neuropathy, pain, sensory disturbance.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not diagnosed with COVID-19 since the vaccination. Increase in neuropathy symptoms the next day following vaccine including small fibre neuropathy shocking/stabbing sensations and weakness/difficulty lifting left foot.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Small fibre neuropathy
Clinical narrative: weakness/difficulty lifting left foot; small fiber neuropathy shocking/stabbing sensations; Difficulty lifting left foot; Shocking/Stabbing sensation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Jan2022 (Lot number: FH8027) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "amyloidosis polyneuropathy including small fiber neuropathy" (unspecified if ongoing), notes: amyloidosis polyneuropathy including small fiber neuropathy; "amyloidosis polyneuropathy including small fiber neuropathy" (unspecified if ongoing), notes: amyloidosis polyneuropathy including small fiber neuropathy. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: ER8737, Location of injection: Arm Left), administration date: 05Apr2021, when the patient was 41 years old, for Covid-19 Immunization; Bnt162b2 (Dose 1, Batch/Lot No: EN6206, Location of injection: Arm Left), administration date: 15Mar2021, when the patient was 41 years old, for Covid-19 Immunization. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 04Jan2022, outcome "not recovered", described as "weakness/difficulty lifting left foot"; SMALL FIBRE NEUROPATHY (non-serious) with onset 04Jan2022, outcome "not recovered", described as "small fiber neuropathy shocking/stabbing sensations"; PAIN (non-serious) with onset 04Jan2022, outcome "not recovered", described as "Difficulty lifting left foot"; SENSORY DISTURBANCE (non-serious) with onset 04Jan2022, outcome "not recovered", described as "Shocking/Stabbing sensation". Therapeutic measures were not taken as a result of muscular weakness, small fibre neuropathy, pain, sensory disturbance.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not diagnosed with COVID-19 since the vaccination. Increase in neuropathy symptoms the next day following vaccine including small fibre neuropathy shocking/stabbing sensations and weakness/difficulty lifting left foot.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Pain, Sensory disturbance, Small fibre neuropathy
Clinical narrative: weakness/difficulty lifting left foot; small fiber neuropathy shocking/stabbing sensations; Difficulty lifting left foot; Shocking/Stabbing sensation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Jan2022 (Lot number: FH8027) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "amyloidosis polyneuropathy including small fiber neuropathy" (unspecified if ongoing), notes: amyloidosis polyneuropathy including small fiber neuropathy; "amyloidosis polyneuropathy including small fiber neuropathy" (unspecified if ongoing), notes: amyloidosis polyneuropathy including small fiber neuropathy. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: ER8737, Location of injection: Arm Left), administration date: 05Apr2021, when the patient was 41 years old, for Covid-19 Immunization; Bnt162b2 (Dose 1, Batch/Lot No: EN6206, Location of injection: Arm Left), administration date: 15Mar2021, when the patient was 41 years old, for Covid-19 Immunization. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 04Jan2022, outcome "not recovered", described as "weakness/difficulty lifting left foot"; SMALL FIBRE NEUROPATHY (non-serious) with onset 04Jan2022, outcome "not recovered", described as "small fiber neuropathy shocking/stabbing sensations"; PAIN (non-serious) with onset 04Jan2022, outcome "not recovered", described as "Difficulty lifting left foot"; SENSORY DISTURBANCE (non-serious) with onset 04Jan2022, outcome "not recovered", described as "Shocking/Stabbing sensation". Therapeutic measures were not taken as a result of muscular weakness, small fibre neuropathy, pain, sensory disturbance.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not diagnosed with COVID-19 since the vaccination. Increase in neuropathy symptoms the next day following vaccine including small fibre neuropathy shocking/stabbing sensations and weakness/difficulty lifting left foot.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Headache, Laboratory test, Muscle twitching, Paraesthesia
Clinical narrative: BRAIN FOG (CANNOT THINK OF WHAT SAYING); HEADACHE; EXTREME FATIGUE/EXHAUSTED; TINGLING (TINGLING IN LEGS THAT MOVED TO FEET, ARMS AND WHOLE BODY); MUSCLE TWITCHING; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: thyroid, and other pre-existing medical conditions included: The patient was on thyroid medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: UNKNOWN) dose was not reported, administered on 25-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-SEP-2021, the patient experienced muscle twitching, and tingling (tingling in legs that moved to feet, arms and whole body). On an unspecified date, the patient experienced brain fog (cannot think of what saying), headache, and extreme fatigue/exhausted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling (tingling in legs that moved to feet, arms and whole body), muscle twitching, and extreme fatigue/exhausted, and the outcome of brain fog (cannot think of what saying) and headache was not reported. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Muscle twitching, Paraesthesia
Clinical narrative: BRAIN FOG (CANNOT THINK OF WHAT SAYING); HEADACHE; EXTREME FATIGUE/EXHAUSTED; TINGLING (TINGLING IN LEGS THAT MOVED TO FEET, ARMS AND WHOLE BODY); MUSCLE TWITCHING; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: thyroid, and other pre-existing medical conditions included: The patient was on thyroid medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: UNKNOWN) dose was not reported, administered on 25-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-SEP-2021, the patient experienced muscle twitching, and tingling (tingling in legs that moved to feet, arms and whole body). On an unspecified date, the patient experienced brain fog (cannot think of what saying), headache, and extreme fatigue/exhausted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling (tingling in legs that moved to feet, arms and whole body), muscle twitching, and extreme fatigue/exhausted, and the outcome of brain fog (cannot think of what saying) and headache was not reported. This report was non-serious.
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: vaccines was administered to pediatric patient with out diluent; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202200102693 (Pfizer).  A 7 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 19Jan2022 10:15 (Lot number: FL007) at the age of 7 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Patient did not receive other vaccine in four weeks and unknown if patient received any other medications in two weeks. Covid prior vaccination and covid tested post vaccination was reported as no.  The following information was reported: OVERDOSE (medically significant) with onset 19Jan2022, described as "vaccines was administered to pediatric patient with out diluent". Therapeutic measures were not taken as a result of overdose. It was reported that Agent stated that the caller was a HCP calling in regards to Pfizer Covid Pediatric Vaccine. Agent states the caller stated pediatric patients were inadvertently administered vaccine without diluent. Agent stated the caller says for two patients this was their second dose but for one patient this was the first dose. Agent says callers stated she has already read the CDC guidelines in regards to revaccination and increased risk of side effects, but was unclear if the child who received the vaccine as their first dose should receive the second dose on schedule or if the second dose should be given at all. Agent stated caller has declined reporting at this time but will do at a later time. Caller confirms question with me. Caller stated 3 patients were involved in this adverse event. Patient number 1 was a 7 year old female receiving her second dose, patient number 2 was a 6 year old female receiving her second dose and patient number 3 was a 7 year old male receiving his first dose.ae resulted in none of the above.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and OVERDOSE cannot be completely excluded.
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Overdose
Clinical narrative: vaccines was administered to pediatric patient with out diluent; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202200102693 (Pfizer).  A 7 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 19Jan2022 10:15 (Lot number: FL007) at the age of 7 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Patient did not receive other vaccine in four weeks and unknown if patient received any other medications in two weeks. Covid prior vaccination and covid tested post vaccination was reported as no.  The following information was reported: OVERDOSE (medically significant) with onset 19Jan2022, described as "vaccines was administered to pediatric patient with out diluent". Therapeutic measures were not taken as a result of overdose. It was reported that Agent stated that the caller was a HCP calling in regards to Pfizer Covid Pediatric Vaccine. Agent states the caller stated pediatric patients were inadvertently administered vaccine without diluent. Agent stated the caller says for two patients this was their second dose but for one patient this was the first dose. Agent says callers stated she has already read the CDC guidelines in regards to revaccination and increased risk of side effects, but was unclear if the child who received the vaccine as their first dose should receive the second dose on schedule or if the second dose should be given at all. Agent stated caller has declined reporting at this time but will do at a later time. Caller confirms question with me. Caller stated 3 patients were involved in this adverse event. Patient number 1 was a 7 year old female receiving her second dose, patient number 2 was a 6 year old female receiving her second dose and patient number 3 was a 7 year old male receiving his first dose.ae resulted in none of the above.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and OVERDOSE cannot be completely excluded.
Age: 34.0
Sex: F
Vaccine: COVID19, FLU4, TDAP, COVID19, FLUX, TTOX
Symptoms: Chills, Condition aggravated, Cough, Fatigue, Headache
Clinical narrative: Really bad hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jan2022 14:00 (Batch/Lot number: unknown) at the age of 34 years as dose 1, single for covid-19 immunisation; influenza vaccine (INFLUENZA), administered in arm right, administration date 11Jan2022 (Batch/Lot number: unknown) as dose 1, single; tetanus vaccine (TETANUS VACCINE), administered in arm right, administration date 11Jan2022 (Batch/Lot number: unknown) as dose 1, single. Relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies:CEPHALOSPORINS" (unspecified if ongoing). Concomitant medication(s) included: LAMICTAL; MELATONIN; HYDROXYZINE. Past drug history included: Topamax, reaction(s): "Known allergies: Topamax"; Morphine, reaction(s): "Known allergies: Morphine"; Meloxicam, reaction(s): "Known allergies: Meloxicam"; Trazodone, reaction(s): "Known allergies: Trazodone". The following information was reported: URTICARIA (non-serious) with onset 17Jan2022 12:00, outcome "not recovered", described as "Really bad hives". The event "really bad hives" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of urticaria.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Lamictal, melatonin, hydroxyzine and one a day vitamin within 2 weeks of vaccination. Patient stated that she got the shot and didn't have any side effects or reactions to it that day, but a week later, patient had really bad hives. Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. Reporter classified case as non-serious.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19, FLU4, TDAP, COVID19, FLUX, TTOX
Symptoms: Nasal congestion, Pyrexia, Rhinorrhoea, Urticaria
Clinical narrative: Really bad hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jan2022 14:00 (Batch/Lot number: unknown) at the age of 34 years as dose 1, single for covid-19 immunisation; influenza vaccine (INFLUENZA), administered in arm right, administration date 11Jan2022 (Batch/Lot number: unknown) as dose 1, single; tetanus vaccine (TETANUS VACCINE), administered in arm right, administration date 11Jan2022 (Batch/Lot number: unknown) as dose 1, single. Relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies:CEPHALOSPORINS" (unspecified if ongoing). Concomitant medication(s) included: LAMICTAL; MELATONIN; HYDROXYZINE. Past drug history included: Topamax, reaction(s): "Known allergies: Topamax"; Morphine, reaction(s): "Known allergies: Morphine"; Meloxicam, reaction(s): "Known allergies: Meloxicam"; Trazodone, reaction(s): "Known allergies: Trazodone". The following information was reported: URTICARIA (non-serious) with onset 17Jan2022 12:00, outcome "not recovered", described as "Really bad hives". The event "really bad hives" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of urticaria.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Lamictal, melatonin, hydroxyzine and one a day vitamin within 2 weeks of vaccination. Patient stated that she got the shot and didn't have any side effects or reactions to it that day, but a week later, patient had really bad hives. Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. Reporter classified case as non-serious.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19, FLU4, TDAP, COVID19, FLUX, TTOX
Symptoms: Urticaria
Clinical narrative: Really bad hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jan2022 14:00 (Batch/Lot number: unknown) at the age of 34 years as dose 1, single for covid-19 immunisation; influenza vaccine (INFLUENZA), administered in arm right, administration date 11Jan2022 (Batch/Lot number: unknown) as dose 1, single; tetanus vaccine (TETANUS VACCINE), administered in arm right, administration date 11Jan2022 (Batch/Lot number: unknown) as dose 1, single. Relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies:CEPHALOSPORINS" (unspecified if ongoing). Concomitant medication(s) included: LAMICTAL; MELATONIN; HYDROXYZINE. Past drug history included: Topamax, reaction(s): "Known allergies: Topamax"; Morphine, reaction(s): "Known allergies: Morphine"; Meloxicam, reaction(s): "Known allergies: Meloxicam"; Trazodone, reaction(s): "Known allergies: Trazodone". The following information was reported: URTICARIA (non-serious) with onset 17Jan2022 12:00, outcome "not recovered", described as "Really bad hives". The event "really bad hives" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of urticaria.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Lamictal, melatonin, hydroxyzine and one a day vitamin within 2 weeks of vaccination. Patient stated that she got the shot and didn't have any side effects or reactions to it that day, but a week later, patient had really bad hives. Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. Reporter classified case as non-serious.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Appendicectomy, Appendicitis, Serositis
Clinical narrative: acute appendicitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 20Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer unknown), for COVID-19 immunization.  The following information was reported: APPENDICITIS (medically significant) with onset 2021, outcome "unknown", described as "acute appendicitis". The patient recently in 2021 read about an increase in cases of appendicitis following Covid vaccination. He received his second dose of Pfizer Covid vaccine on 20Apr2021. So he suffered acute appendicitis requiring surgical removal on 25Apr2021. He would appreciate information on where he could report this data for further study. This was not a request for damages, nor it a threat of litigation. He merely wish to report the information for the purposes of further study  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Appendicitis
Clinical narrative: acute appendicitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 20Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer unknown), for COVID-19 immunization.  The following information was reported: APPENDICITIS (medically significant) with onset 2021, outcome "unknown", described as "acute appendicitis". The patient recently in 2021 read about an increase in cases of appendicitis following Covid vaccination. He received his second dose of Pfizer Covid vaccine on 20Apr2021. So he suffered acute appendicitis requiring surgical removal on 25Apr2021. He would appreciate information on where he could report this data for further study. This was not a request for damages, nor it a threat of litigation. He merely wish to report the information for the purposes of further study  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: TINNITUS; This spontaneous report received from a patient concerned a 5 decade old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUN-2021, the patient experienced tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood pressure increased, Blood test, Electrocardiogram, Feeling hot
Clinical narrative: High blood pressure 13 minutes after receiving the booster dose/still having high  blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High blood pressure 13 minutes after receiving the booster dose/still having high  blood pressure) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, the patient experienced HYPERTENSION (High blood pressure 13 minutes after receiving the booster dose/still having high  blood pressure). At the time of the report, HYPERTENSION (High blood pressure 13 minutes after receiving the booster dose/still having high  blood pressure) outcome was unknown.            Patient was on three ongoing concomitant medications (unknown name). Treatment information was not reported.  Patient stated that she had lab test high blood pressure but result were not reported. Patient received the booster dose of the Moderna COVID19 vaccine on 9 Dec 2021 and 13 minutes after she started with a high blood pressure reaction and she had to go to the hospital for this situation.  This is a regulatory authority case concerning  a  61-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious event of Hypertension. The event occurred on the same day after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events were reported as runknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: This is a regulatory authority case concerning  a  61-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious event of Hypertension. The events occurred on the same day after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events were reported as runknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, White coat hypertension
Clinical narrative: High blood pressure 13 minutes after receiving the booster dose/still having high  blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High blood pressure 13 minutes after receiving the booster dose/still having high  blood pressure) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, the patient experienced HYPERTENSION (High blood pressure 13 minutes after receiving the booster dose/still having high  blood pressure). At the time of the report, HYPERTENSION (High blood pressure 13 minutes after receiving the booster dose/still having high  blood pressure) outcome was unknown.            Patient was on three ongoing concomitant medications (unknown name). Treatment information was not reported.  Patient stated that she had lab test high blood pressure but result were not reported. Patient received the booster dose of the Moderna COVID19 vaccine on 9 Dec 2021 and 13 minutes after she started with a high blood pressure reaction and she had to go to the hospital for this situation.  This is a regulatory authority case concerning  a  61-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious event of Hypertension. The event occurred on the same day after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events were reported as runknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: This is a regulatory authority case concerning  a  61-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious event of Hypertension. The events occurred on the same day after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events were reported as runknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.