chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 90.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal
Clinical narrative: Felt wobbly; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Felt wobbly) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. SLTHC and SU91C) for COVID-19 prophylaxis.     The patient had no allergies and had no previous Diagnosis of Covid.  The patient also reported that they had no other medical conditions and was a healthy individual. The patient did not received any vaccination within 1 month of Covid-19 Vaccines.  The patient's past medical history included Kidney stones (Kidney Stones removed 35 years ago). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Headache, CYANOCOBALAMIN (B-12) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Felt wobbly). At the time of the report, FEELING ABNORMAL (Felt wobbly) outcome was unknown.            The patient stated after their primary vaccination series the patient felt wobbly.  It was also reported that the patient was unsure about lot numbers.   No treatment information was provided.   This case was linked to MOD-2022-588507 (Patient Link).
Age: 90.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fall, Feeling abnormal, Muscular weakness, Myalgia
Clinical narrative: Felt wobbly; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Felt wobbly) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. SLTHC and SU91C) for COVID-19 prophylaxis.     The patient had no allergies and had no previous Diagnosis of Covid.  The patient also reported that they had no other medical conditions and was a healthy individual. The patient did not received any vaccination within 1 month of Covid-19 Vaccines.  The patient's past medical history included Kidney stones (Kidney Stones removed 35 years ago). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Headache, CYANOCOBALAMIN (B-12) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Felt wobbly). At the time of the report, FEELING ABNORMAL (Felt wobbly) outcome was unknown.            The patient stated after their primary vaccination series the patient felt wobbly.  It was also reported that the patient was unsure about lot numbers.   No treatment information was provided.   This case was linked to MOD-2022-588507 (Patient Link).
Age: 90.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal
Clinical narrative: fell 3 times/feels like i can fall over the floor and fall forward; muscles are weak; he feels unstable; dizziness; muscles are sore; This spontaneous case was reported by a patient and describes the occurrence of FALL (fell 3 times/feels like i can fall over the floor and fall forward), MUSCULAR WEAKNESS (muscles are weak), FEELING ABNORMAL (he feels unstable), DIZZINESS (dizziness) and MYALGIA (muscles are sore) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. SLTHC and SU91C) for COVID-19 prophylaxis.     The patient's past medical history included Kidney stones (removal of kidney stones 35 years ago.). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Headache, CYANOCOBALAMIN (B-12) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-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 FALL (fell 3 times/feels like i can fall over the floor and fall forward), MUSCULAR WEAKNESS (muscles are weak), FEELING ABNORMAL (he feels unstable), DIZZINESS (dizziness) and MYALGIA (muscles are sore). At the time of the report, FALL (fell 3 times/feels like i can fall over the floor and fall forward), MUSCULAR WEAKNESS (muscles are weak), FEELING ABNORMAL (he feels unstable), DIZZINESS (dizziness) and MYALGIA (muscles are sore) had not resolved.            The patient had no other medical conditions and was a healthy individual. The patient had not received any vaccination within 1 month of Covid-19 Vaccines.  No treatment medications were reported.   This case was linked to MOD-2022-588363 (Patient Link).
Age: 90.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fall, Feeling abnormal, Muscular weakness, Myalgia
Clinical narrative: fell 3 times/feels like i can fall over the floor and fall forward; muscles are weak; he feels unstable; dizziness; muscles are sore; This spontaneous case was reported by a patient and describes the occurrence of FALL (fell 3 times/feels like i can fall over the floor and fall forward), MUSCULAR WEAKNESS (muscles are weak), FEELING ABNORMAL (he feels unstable), DIZZINESS (dizziness) and MYALGIA (muscles are sore) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. SLTHC and SU91C) for COVID-19 prophylaxis.     The patient's past medical history included Kidney stones (removal of kidney stones 35 years ago.). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Headache, CYANOCOBALAMIN (B-12) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-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 FALL (fell 3 times/feels like i can fall over the floor and fall forward), MUSCULAR WEAKNESS (muscles are weak), FEELING ABNORMAL (he feels unstable), DIZZINESS (dizziness) and MYALGIA (muscles are sore). At the time of the report, FALL (fell 3 times/feels like i can fall over the floor and fall forward), MUSCULAR WEAKNESS (muscles are weak), FEELING ABNORMAL (he feels unstable), DIZZINESS (dizziness) and MYALGIA (muscles are sore) had not resolved.            The patient had no other medical conditions and was a healthy individual. The patient had not received any vaccination within 1 month of Covid-19 Vaccines.  No treatment medications were reported.   This case was linked to MOD-2022-588363 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Bacterial gingivitis
Clinical narrative: Gum infection/Bacterial infection; This spontaneous case was reported by a patient and describes the occurrence of BACTERIAL GINGIVITIS (Gum infection/Bacterial infection) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 025B21A and 012A21A) for COVID-19 prophylaxis.     Concomitant products included LISINOPRIL and SIMVASTATIN for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACTERIAL GINGIVITIS (Gum infection/Bacterial infection). The patient was treated with CEFALEXIN SODIUM (CEPHALEXIN [CEFALEXIN SODIUM]) for Gum infection, at a dose of 500 milligram. At the time of the report, BACTERIAL GINGIVITIS (Gum infection/Bacterial infection) had not resolved.            The patient did not have positive covid test or diagnosis. Patient had no allergies.  The patient received 3 doses of the moderna vaccine, 2 primary series doses and 1st booster dose in recommended time frame.  The patient stated that his dentist put him on a broad-spectrum antibiotic called Cephalexin 500mg for 10 days for a gum infection. The patient stated that the infection was still on going and stated that it was a bacterial infection.   This case was linked to MOD-2021-057994 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 19Jan2021 and  2nd dose on 24Feb2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 19Jan2021 and  2nd dose on 24Feb2021) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A2(Z)1A and 037K2(Z)0A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Losartan), Diabetes and Blood pressure high.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 19Jan2021 and  2nd dose on 24Feb2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 19Jan2021 and  2nd dose on 24Feb2021) outcome was unknown.            Patient concomitant medications included diabetic and high blood pressure medications even before first dose of Moderna vaccine. Patient had no positive COVID test or diagnosis. Treatment information was not provided.   This case was linked to MOD-2022-588456 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Product storage error; Received expired booster dose beyond 12 hours after puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond 12 hours after puncture) and PRODUCT STORAGE ERROR (Product storage error) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond 12 hours after puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond 12 hours after puncture) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   She states that 1 booster syringe of Moderna COVID-19 vaccine (0.25ml) was pre drawn at another pharmacy and delivered to their facility on 17-MAY-2022 and on same day vial was initially stored in the refrigerator, time was not known. On transport the syringe was in a cooler with ice without a thermometer. She was not sure of the exact transport time. At the receiving facility, immediately after transport, the syringe  was placed in the refrigerator. The syringe had a pre written expiration date of 6 hours. She does not have the exact time of the source vial puncture. The syringe was used to administered to 1 patient on 22-MAY-2022.  Vial was first punctured date and time was reported as unknown.   The vial stored post puncture was One pre-filled syringe (0.25 ml booster dose) on transport was in a cooler with ice and without thermometer. After transport completed, the syringe was placed in the Refrigerator.  Vial underwent any temperature excursions was reported as unknown.  The syringe was exposed to refrigerated temperature for 4 days prior to administering.  No concomitant medication were reported.   No treatment drug were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2022: Follow up document contain Lot Number was updated.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Mild reactions after 1st primary dose; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Mild reactions after 1st primary dose) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included Deep vein thrombosis (10 Years ago had Deep vein thrombosis which was resolved.).    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Mild reactions after 1st primary dose). At the time of the report, IMMUNISATION REACTION (Mild reactions after 1st primary dose) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       It was reported that the patient's age was over 65. Patient did not take Blood thinners anymore. No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2022-588876, MOD-2022-588877 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaginal haemorrhage
Clinical narrative: about 1 week later she experienced very heavy vaginal bleeding; she did not considered normal for her; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (about 1 week later she experienced very heavy vaginal bleeding) and FEELING ABNORMAL (she did not considered normal for her) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VAGINAL HAEMORRHAGE (about 1 week later she experienced very heavy vaginal bleeding). an unknown date, the patient experienced FEELING ABNORMAL (she did not considered normal for her). At the time of the report, VAGINAL HAEMORRHAGE (about 1 week later she experienced very heavy vaginal bleeding) had resolved and FEELING ABNORMAL (she did not considered normal for her) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Patient was in her late 20s and received her first Moderna dose for COVID 19, about 1 week later she experienced very heavy vaginal bleeding that she did not consider normal for her. It lasted more than 3 weeks. After she visited her Primary provider, He said that it was probably the Moderna Vaccine who caused the vaginal bleeding. The patient was due for her 2nd dose but she was not comfortable getting it because of the issue mentioned before. No concomitant medications details were reported. No treatment medications details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Mobility decreased, Rash
Clinical narrative: She was unable to go down; Rashes on her chest and arm; She had allergic reactions; This spontaneous case was reported by a non-health professional and describes the occurrence of MOBILITY DECREASED (She was unable to go down), RASH (Rashes on her chest and arm) and HYPERSENSITIVITY (She had allergic reactions) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (She was unable to go down), RASH (Rashes on her chest and arm) and HYPERSENSITIVITY (She had allergic reactions). At the time of the report, MOBILITY DECREASED (She was unable to go down), RASH (Rashes on her chest and arm) and HYPERSENSITIVITY (She had allergic reactions) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment information were provided.  The patient received first Moderna Vaccine and had allergic reactions and rashes on chest and arm. The patient was unable to go down.   The patient was afraid to receive second shot. The patient was not a trial participant.  Was reported as 2694.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Nasal congestion, Taste disorder
Clinical narrative: sensation of numbness in one part of the roof of her mouth; She is also now complaining that her nose is suddenly stuffy; she is now complaining of odd taste in her mouth; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPOAESTHESIA ORAL (sensation of numbness in one part of the roof of her mouth), NASAL CONGESTION (She is also now complaining that her nose is suddenly stuffy) and TASTE DISORDER (she is now complaining of odd taste in her mouth) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 2) and Pfizer (the patient was given Pfizer for their primary series :Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.  On 14-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2022, the patient experienced HYPOAESTHESIA ORAL (sensation of numbness in one part of the roof of her mouth) and TASTE DISORDER (she is now complaining of odd taste in her mouth). 14-Jun-2022, the patient experienced NASAL CONGESTION (She is also now complaining that her nose is suddenly stuffy). At the time of the report, HYPOAESTHESIA ORAL (sensation of numbness in one part of the roof of her mouth), NASAL CONGESTION (She is also now complaining that her nose is suddenly stuffy) and TASTE DISORDER (she is now complaining of odd taste in her mouth) had not resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient complained of odd taste in her mouth and sensation of numbness in one part of the roof of her mouth just after 30 minutes after administration of booster of Moderna COVID-19 vaccine. No treatment details were reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Influenza like illness, Pruritus, Rash, Skin reaction
Clinical narrative: itchy; red; she experienced a delayed skin reaction; rash 8 days later; large red hives on back; she kind of felt fluy for 24 hours; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itchy), ERYTHEMA (red), INFLUENZA LIKE ILLNESS (she kind of felt fluy for 24 hours), SKIN REACTION (she experienced a delayed skin reaction) and RASH (rash 8 days later) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder (when she was younger). Concomitant products included LISINOPRIL for an unknown indication.    On 02-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2022, the patient experienced PRURITUS (itchy), ERYTHEMA (red), SKIN REACTION (she experienced a delayed skin reaction), RASH (rash 8 days later) and URTICARIA (large red hives on back). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (she kind of felt fluy for 24 hours). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy) had not resolved, ERYTHEMA (red), SKIN REACTION (she experienced a delayed skin reaction) and RASH (rash 8 days later) outcome was unknown, INFLUENZA LIKE ILLNESS (she kind of felt fluy for 24 hours) had resolved and URTICARIA (large red hives on back) was resolving.            On 02-Apr-2022, the patient received a second booster dose (Lot: 001M21A) of Moderna vaccine.  Reported that 8 days later she experienced a delayed skin reaction and got a rash 8 days later, and it started with large red hives on back, they were red and itchy. It was like that for 2 days. Then for 11 to 12 days they were beginning to get smaller and smaller, but it kept itching. She reports she had an autoimmune disease when she was younger, so she thought that is why she had the delayed skin reaction. She reports she was worried what booster dose to get in the Fall. Reported that no reaction to the other doses.  Treatment included cold wet wash cloth.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: itchy; red; she experienced a delayed skin reaction; rash 8 days later; large red hives on back; she kind of felt fluy for 24 hours; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itchy), ERYTHEMA (red), INFLUENZA LIKE ILLNESS (she kind of felt fluy for 24 hours), SKIN REACTION (she experienced a delayed skin reaction) and RASH (rash 8 days later) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder (when she was younger). Concomitant products included LISINOPRIL for an unknown indication.    On 02-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2022, the patient experienced PRURITUS (itchy), ERYTHEMA (red), SKIN REACTION (she experienced a delayed skin reaction), RASH (rash 8 days later) and URTICARIA (large red hives on back). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (she kind of felt fluy for 24 hours). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy) had not resolved, ERYTHEMA (red), SKIN REACTION (she experienced a delayed skin reaction) and RASH (rash 8 days later) outcome was unknown, INFLUENZA LIKE ILLNESS (she kind of felt fluy for 24 hours) had resolved and URTICARIA (large red hives on back) was resolving.            On 02-Apr-2022, the patient received a second booster dose (Lot: 001M21A) of Moderna vaccine.  Reported that 8 days later she experienced a delayed skin reaction and got a rash 8 days later, and it started with large red hives on back, they were red and itchy. It was like that for 2 days. Then for 11 to 12 days they were beginning to get smaller and smaller, but it kept itching. She reports she had an autoimmune disease when she was younger, so she thought that is why she had the delayed skin reaction. She reports she was worried what booster dose to get in the Fall. Reported that no reaction to the other doses.  Treatment included cold wet wash cloth.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Body temperature, Chest X-ray, Computerised tomogram thorax
Clinical narrative: With the first one she didn't feel good, low grade fever and aches and pains; With the first one she didn't feel good, low grade fever and aches and pains; States that with each dose the symptoms were worse than the one before and this last one she was in the ER; diagnosed with costochondritis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 11Feb2021 at 15:00 as dose 1, single (Lot number: EN9581), in right arm, on 04Mar2021 at 15:00 as dose 2, single (Lot number: EN6199), in right arm and on 13Nov2021 at 19:00 as dose 3 (booster), single (Lot number: FH8030) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "breast cancer" (unspecified if ongoing), notes: Breast cancer diagnosed 12 years ago; "High cholesterol" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension (ongoing); SINGULAIR taken for hypersensitivity; ROSUVASTATIN taken for blood cholesterol (ongoing); MONTELUKAST taken for hypersensitivity (ongoing); DYMISTA taken for hypersensitivity; AZELASTINE taken for hypersensitivity. The following information was reported: PYREXIA (non-serious), PAIN (non-serious), outcome "not recovered" and all described as "With the first one she didn't feel good, low grade fever and aches and pains"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "States that with each dose the symptoms were worse than the one before and this last one she was in the ER"; COSTOCHONDRITIS (non-serious), outcome "unknown", described as "diagnosed with costochondritis". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of condition aggravated, costochondritis.  Follow-up attempts are completed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previous information: Amended the made case as valid. updated narrative information.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Costochondritis, Electrocardiogram, Pain, Pyrexia
Clinical narrative: With the first one she didn't feel good, low grade fever and aches and pains; With the first one she didn't feel good, low grade fever and aches and pains; States that with each dose the symptoms were worse than the one before and this last one she was in the ER; diagnosed with costochondritis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 11Feb2021 at 15:00 as dose 1, single (Lot number: EN9581), in right arm, on 04Mar2021 at 15:00 as dose 2, single (Lot number: EN6199), in right arm and on 13Nov2021 at 19:00 as dose 3 (booster), single (Lot number: FH8030) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "breast cancer" (unspecified if ongoing), notes: Breast cancer diagnosed 12 years ago; "High cholesterol" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension (ongoing); SINGULAIR taken for hypersensitivity; ROSUVASTATIN taken for blood cholesterol (ongoing); MONTELUKAST taken for hypersensitivity (ongoing); DYMISTA taken for hypersensitivity; AZELASTINE taken for hypersensitivity. The following information was reported: PYREXIA (non-serious), PAIN (non-serious), outcome "not recovered" and all described as "With the first one she didn't feel good, low grade fever and aches and pains"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "States that with each dose the symptoms were worse than the one before and this last one she was in the ER"; COSTOCHONDRITIS (non-serious), outcome "unknown", described as "diagnosed with costochondritis". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of condition aggravated, costochondritis.  Follow-up attempts are completed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previous information: Amended the made case as valid. updated narrative information.
Sex: U
Vaccine: PNC13
Symptoms: Device breakage
Clinical narrative: broken dosage of Prevnar 13  received / One syringe arrived broken; This is a spontaneous report received from contactable reporter (Other HCP and Consumer or other non HCP) from product quality group and medical information team.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Lot number: EW2018, Expiration Date: 31Oct2023) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "broken dosage of Prevnar 13 received / One syringe arrived broken". Additional information: NDC: 0005-1971-01. Description of complaint: Received 1 box of 10 and 1 of the syringes arrived broken but the packaging was sealed and intact. Product strength and count size dispensed: 1 Prevnar 13 syringe. The sample of the product is available to be returned, already got notified of prepaid mailer. No patient involvement. She did not even finish opening the package. Prevnar 13V PFS Suspensions 0.5mlx10 Broken/Cracked/Leaking Prior To Use. Called reporter and requested photos, initial mailer sent. Reporter clarified that the syringe was broken upon opening it. For a broken syringe nozzle for Prevnar 13V PFS, this event assessment is reportable.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache
Clinical narrative: headache; stomachaches; This is a spontaneous report received from contactable reporter(s) (Pharmacist and Consumer or other non HCP) from medical information team.  A 10-year-old patient received BNT162b2 (BNT162B2), on 01Jun2022 as dose 3, (booster) single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single), administration date: 11Jan2022, for COVID-19 immunization; BNT162b2 (Dose 2, single), administration date: 01Feb2022, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomachaches". Additional information: Patient is immune-competent.   The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Rash erythematous, Rash pruritic, Swelling
Clinical narrative: Itchy red rash with slight swelling and no bumps developed on several parts of body (primarily on hands but also on eyes, ears, legs, and belly) followed within 10 min by vomiting and within 20 min by chills and extreme fatigue. No fever present. Child was given 5 ml of Children's Zyrtec (5 mg Cetirizine HCl) and slept for one hour. After awakening, all symptoms were resolved. Symptoms and timing (about 48 hrs after) of post-vaccination adverse event were similar to mother's symptoms and timing upon receiving her Covid-19 vaccinations.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Itchy red rash with slight swelling and no bumps developed on several parts of body (primarily on hands but also on eyes, ears, legs, and belly) followed within 10 min by vomiting and within 20 min by chills and extreme fatigue. No fever present. Child was given 5 ml of Children's Zyrtec (5 mg Cetirizine HCl) and slept for one hour. After awakening, all symptoms were resolved. Symptoms and timing (about 48 hrs after) of post-vaccination adverse event were similar to mother's symptoms and timing upon receiving her Covid-19 vaccinations.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Shingles - rash and pain on lower back and buttocks, identified by dermatologist and treated with valtrex
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Overdose, Product preparation error, Vaccination site pain
Clinical narrative: fatigue; injection site pain; given 0.3mL even thought it was supposed to be 0.2mL; Received dose of vaccination that was not diluted; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team.  A 10-year-old female patient received BNT162b2 (BNT162B2), on 04Jun2022 as dose 3 (booster), 0.3ml single (Lot number: FL2757, Expiration Date: 03Aug2022) at the age of 10 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (manufacture unknown , Primary series vaccination), for covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 04Jun2022, outcome "unknown"; VACCINATION SITE PAIN (non-serious) with onset 04Jun2022, outcome "unknown", described as "injection site pain". PRODUCT PREPARATION ERROR (non-serious) with onset 04Jun2022, outcome "unknown", described as "Received dose of vaccination that was not diluted";OVERDOSE (non-serious) with onset 04Jun2022, outcome "unknown", described as "given 0.3mL even thought it was supposed to be 0.2mL"; Therapeutic measures were not taken as a result of fatigue, vaccination site pain. Additional information: The pharmacist calling to report that they vaccinated a ten-year-old female with the correct orange cap formulation, but it was not diluted. This was the booster dose. The patient was given 0.3mL even thought it was supposed to be 0.2mL.After follow up with patients parent, patient had injection site pain and fatigue. States the patient has improved. Reporter stated that It was just an error, not the fault of the packaging or the vaccine.He doesn't think any medications would have contributed to the injection site pain or fatigue, if she take any he doesn't think it's relevant.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Limb immobilisation, Musculoskeletal stiffness
Clinical narrative: 5 days after that I can't move. I can't move my left arm; no muscle ache but 24 hours after I had my last shot a month ago and then my left shoulder, I had surgery and I had arthritis in that (History) and it has started getting stiff; every joint in my body hurts, it really hurts bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "I had surgery" (unspecified if ongoing), notes: I had surgery; "I had arthritis in that (History)" (unspecified if ongoing), notes: I had arthritis in that (History). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (My first 3 shots, no reactions whatsoever, dose 3), for Covid-19 immunization; Bnt162b2 (My first 3 shots, no reactions whatsoever, dose 2), for Covid-19 immunization; Bnt162b2 (My first 3 shots, no reactions whatsoever, dose 1), for Covid-19 immunization. The following information was reported: LIMB IMMOBILISATION (non-serious), outcome "unknown", described as "5 days after that I can't move. I can't move my left arm"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "no muscle ache but 24 hours after I had my last shot a month ago and then my left shoulder, I had surgery and I had arthritis in that (History) and it has started getting stiff"; ARTHRALGIA (non-serious), outcome "unknown", described as "every joint in my body hurts, it really hurts bad".  Additional information: When paraphrased the concern, consumer stated, "This has been going on for a month alright. I have now, till date I have done all my shots. My first 3 shots, no reactions whatsoever. I didn't even had a scratch, no muscle ache but 24 hours after I had my last shot a month ago and then my left shoulder, I had surgery and I had arthritis in that (History) and it has started getting stiff and then 5 days after that I can't move. I can't move my left arm and it seems like every joint in my body hurts, it really hurts bad. I called where I got the shot at and they said talk to your doctor and doctor said call Pfizer."  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Congenital foot malformation
Clinical narrative: Possible bone fusion or Tarsal Coalition; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 10-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: CONGENITAL FOOT MALFORMATION (medically significant), outcome "not recovered", described as "Possible bone fusion or Tarsal Coalition". The action taken for adalimumab was unknown.  The reporter considered "possible bone fusion or tarsal coalition" related to BNT162b2.Causality as per reporter (Drug/Vaccine): Possible  No follow-up attempts are Needed. Information on Lot/Batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that suspect drug contributed to the reported  event.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) in response to mail trail sent regarding confirmation of below mentioned query. The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 12Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant) all with onset 08Jun2022, outcome "unknown" and all described as "had a positive PCR test for COVID-19". Description of Event: Myself, is fully vaccinated and boosted (12Feb2022) and had a positive PCR test for COVID-19 on 08Jun2022. [Query]: Please help to confirm which vaccine you received as you did not provide the information of the brand or manufacture. [Response]: All 3 of my doses were manufactured by Pfizer. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jun2022) Positive. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Jan2021 at 13:00 as dose number unknown, single (Lot number: EL3248) at the age of 76 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "back pain" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Vancomycin, reaction(s): "Known allergies: yes, vancomycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: The patient was treated with Anti-viral (COVID 19 Treatment, Brand: Pfizer, Lot number: FM9992) drugs from 08Jun2022 to 08Jun2022,, with indication was Treatment of COVID-19. No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Nurse). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Nov2021 at 02:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 19Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Spleenectomy" (unspecified if ongoing). Known allergies were not reported. There were no concomitant medications received in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (30Apr2022) negative, notes: was negative then and for three days; (01May2022) negative; (02May2022) negative; (02May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient's husband tested positive on 30Apr2022 so she took a test, was negative then and for three days. On 02May2022 had Covid symptoms and tested positive. Mod severe symptoms. Called Health Dept. for Paxlovid and started on 07May2022. Symptoms diminishing until today 09May2022 and then return of symptom with nausea and diarrhoea and fatigue the worst. Paxlovid (lot number:GA1189), treatment start date: 23May2022, treatment stop date: 28May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 12-year-old male patient received BNT162b2 (BNT162B2), on 08Jun2022 at 13:00 as dose 3 (booster), single (Lot number: FM9992) at the age of 12 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: QUILLICHEW ER. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: FL0007, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 11Dec2021, when the patient was 11-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: FK5127, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 20Nov2021, when the patient was 11-year-old, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 09Jun2022 at 14:00, outcome "unknown". Therapeutic measures were not taken as a result of chills.  Additional information: The patient had no known allergies. The patient did not receive COVID prior vaccination and had not been COVID tested post vaccination. The patient did not receive other vaccine in four weeks.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59-year-old patient received BNT162b2 (BNT162B2, solution for injection), on 16Jan2020 at 16:00 as dose 1, single (Lot number: EL8982), in left arm, on 02Feb2021 at 14:00 as dose 2, single (Lot number: EM9810), in right arm, on 01Sep2021 at 14:00 as dose 3 (booster), single (Lot number: FW0217), in left arm and on 30Mar2022 at 14:00 as dose 4 (booster), single (Lot number: FK9729) at the age of 58 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "known allergies: Shrimp, lobster, crab" (unspecified if ongoing), notes: known allergies: Shrimp, lobster, crab. Concomitant medication(s) included: SYMBICORT; GABAPENTIN; ALLOPURINOL; OMEPRAZOLE; LOSARTAN; AMLODIPINE; PRO-AIR; AFRIN [OXYMETAZOLINE HYDROCHLORIDE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Indication Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Additional information: The patient did take other medication in 2 weeks. Brand Paxlovid was used for treatment start date was 29May2022, Treatment stop date was 03Jun2022 for Indication of Treatment of COVID-19. Other medication in 2 weeks include conmeds of Pro Air RespiClick inhaler, Symbicort inhaler, Gabapentin, Allopurinol, Omeprazole, Losartan, Amlodipine, Afrin nose spray, other medication in 2 weeks start date was 29May2022, and stop date was 09Jun2022. (as reported not specified for which) No adverse conditions were reported for the Covid-19 treatment, no treatment.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in right arm for Covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "shellfish" (unspecified if ongoing), notes: known allergies Shell fish; "red dye" (unspecified if ongoing), notes: known allergies red dye; "Idiopathic intracranial hypertension" (unspecified if ongoing); "Hasimoto's" (unspecified if ongoing), notes: Hasimoto's; "chronic back pain" (unspecified if ongoing); "degenerative disk disease" (unspecified if ongoing), notes: degenerative disk disease; "fibromyalgia" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: allergies. Concomitant medication(s) included: TYLENOL; ACETAZOLAMIDE ER; CITALOPRAM. Past drug history included: Brevital, reaction(s): "Known allergies: Brevital", notes: Known allergies: Brevital. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected Covid-19. Clinical information: The patient received other medications in two weeks included Tylenol 3, Citalopram and Acetazolamide ER. Antiviral details: The drug Paxlovid (Lot number: GA8778) started on 05Jun2022 and stopped on 09Jun2022 was taken for indication as treatment of COVID-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.