chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenitis
Clinical narrative: swelling of lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENITIS (swelling of lymph nodes) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENITIS (swelling of lymph nodes). At the time of the report, LYMPHADENITIS (swelling of lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Rhinorrhoea
Clinical narrative: Runny nose; Dry cough; This spontaneous case was reported by an other health care professional and describes the occurrence of RHINORRHOEA (Runny nose) and COUGH (Dry cough) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Runny nose) and COUGH (Dry cough). At the time of the report, RHINORRHOEA (Runny nose) and COUGH (Dry cough) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.   Reporter did not allow further contact
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pyrexia, Rash, Urticaria
Clinical narrative: injection site reaction; Rash seems like hives or welts, like 30 of them of each hand and they look like mosquito bites; joint pain; headaches; Rash on the back of both hands; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (injection site reaction), URTICARIA (Rash seems like hives or welts, like 30 of them of each hand and they look like mosquito bites), RASH (Rash on the back of both hands), ARTHRALGIA (joint pain) and HEADACHE (headaches) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: FLU. Past adverse reactions to the above products included No adverse event with FLU.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (low grade fever). On 08-Dec-2021, the patient experienced RASH (Rash on the back of both hands). On an unknown date, the patient experienced VACCINATION SITE REACTION (injection site reaction), URTICARIA (Rash seems like hives or welts, like 30 of them of each hand and they look like mosquito bites), ARTHRALGIA (joint pain) and HEADACHE (headaches). The patient was treated with IBUPROFEN at a dose of 2 cycles 40mg. In November 2021, PYREXIA (low grade fever) had resolved. At the time of the report, VACCINATION SITE REACTION (injection site reaction), URTICARIA (Rash seems like hives or welts, like 30 of them of each hand and they look like mosquito bites), RASH (Rash on the back of both hands), ARTHRALGIA (joint pain) and HEADACHE (headaches) outcome was unknown.            Concomitant product use was not provided by the reporter.    Patient reported he Flu vaccine at the same as the booster   This case was linked to MOD-2021-407187, MOD-2021-407184 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: injection site reaction; Rash seems like hives or welts, like 30 of them of each hand and they look like mosquito bites; joint pain; headaches; Rash on the back of both hands; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (injection site reaction), URTICARIA (Rash seems like hives or welts, like 30 of them of each hand and they look like mosquito bites), RASH (Rash on the back of both hands), ARTHRALGIA (joint pain) and HEADACHE (headaches) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: FLU. Past adverse reactions to the above products included No adverse event with FLU.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (low grade fever). On 08-Dec-2021, the patient experienced RASH (Rash on the back of both hands). On an unknown date, the patient experienced VACCINATION SITE REACTION (injection site reaction), URTICARIA (Rash seems like hives or welts, like 30 of them of each hand and they look like mosquito bites), ARTHRALGIA (joint pain) and HEADACHE (headaches). The patient was treated with IBUPROFEN at a dose of 2 cycles 40mg. In November 2021, PYREXIA (low grade fever) had resolved. At the time of the report, VACCINATION SITE REACTION (injection site reaction), URTICARIA (Rash seems like hives or welts, like 30 of them of each hand and they look like mosquito bites), RASH (Rash on the back of both hands), ARTHRALGIA (joint pain) and HEADACHE (headaches) outcome was unknown.            Concomitant product use was not provided by the reporter.    Patient reported he Flu vaccine at the same as the booster   This case was linked to MOD-2021-407187, MOD-2021-407184 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Insomnia, Peripheral swelling, Rash, Rash pruritic
Clinical narrative: The following day her arm was swollen; She could not breathe; Rashes all over her body/ she still has all this rashes over her; She has rashes all over her body and can't sleep at night because it's very itchy; She has rashes all over her body and can't sleep at night because it's very itchy; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (She has rashes all over her body and can't sleep at night because it's very itchy), RASH PRURITIC (She has rashes all over her body and can't sleep at night because it's very itchy), PERIPHERAL SWELLING (The following day her arm was swollen), DYSPNOEA (She could not breathe) and RASH (Rashes all over her body/ she still has all this rashes over her) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced INSOMNIA (She has rashes all over her body and can't sleep at night because it's very itchy), RASH PRURITIC (She has rashes all over her body and can't sleep at night because it's very itchy) and RASH (Rashes all over her body/ she still has all this rashes over her). 17-Feb-2021, the patient experienced DYSPNOEA (She could not breathe). On 18-Feb-2021, the patient experienced PERIPHERAL SWELLING (The following day her arm was swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 17-Feb-2021 for Breathing difficult, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) on 17-Feb-2021 for Breathing difficult, at an unspecified dose and frequency. At the time of the report, INSOMNIA (She has rashes all over her body and can't sleep at night because it's very itchy), RASH PRURITIC (She has rashes all over her body and can't sleep at night because it's very itchy) and RASH (Rashes all over her body/ she still has all this rashes over her) had not resolved and PERIPHERAL SWELLING (The following day her arm was swollen) and DYSPNOEA (She could not breathe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Patient stated that she can't take the second dose and afraid of it.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A patient potentially received an expired Moderna vaccine past 24 hours in room temperature.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient potentially received an expired Moderna vaccine past 24 hours in room temperature.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient potentially received an expired Moderna vaccine past 24 hours in room temperature.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient potentially received an expired Moderna vaccine past 24 hours in room temperature.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.  A vial was potentially left in room temperature for more than 24 hours.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Skin wound, Vaccination site erythema
Clinical narrative: the skin was right off, right down to the bloody arm/ The skin is like ripped off/ there is no skin/You can see where the skin came off; A red raw perfect circle/ There was a round circle, a light pink place around that. at the injection site.; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WOUND (the skin was right off, right down to the bloody arm/ The skin is like ripped off/ there is no skin/You can see where the skin came off), VACCINATION SITE ERYTHEMA (A red raw perfect circle/ There was a round circle, a light pink place around that. at the injection site.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Johnson and Johnson (Batch Number:1805022) on 15-Mar-2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson.    On 27-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced SKIN WOUND (the skin was right off, right down to the bloody arm/ The skin is like ripped off/ there is no skin/You can see where the skin came off). an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (A red raw perfect circle/ There was a round circle, a light pink place around that. at the injection site.). The patient was treated with BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN [BACITRACIN ZINC;NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. On 27-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, SKIN WOUND (the skin was right off, right down to the bloody arm/ The skin is like ripped off/ there is no skin/You can see where the skin came off) outcome was unknown and VACCINATION SITE ERYTHEMA (A red raw perfect circle/ There was a round circle, a light pink place around that. at the injection site.) had not resolved.            It was reported that patient felt burning sensation when she applied cortisone on the wound.  No concomitant medications were reported.  Three to four days after the booster dose, patient saw a red raw perfect circle at the injection site which was not big.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: arm was red at the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (arm was red at the injection site.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (arm was red at the injection site.). At the time of the report, VACCINATION SITE ERYTHEMA (arm was red at the injection site.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided. Treatment information was not provided. This case was linked to MOD-2021-407238, MOD-2021-407239 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired moderna vaccines administered to 11 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccines administered to 11 patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccines administered to 11 patients). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccines administered to 11 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.  The HCP (nurse) who stated that 11 expired doses were administered to patients. The caller stated that it was mixed doses of the expired vaccines that were administered to 11 patients on 07-Dec-2021. Dose administered after 30-day Use By Date or after manufacturer date of expiry. Number of doses/vials 11 doses administered to 11 patients. The vial did not undergo any temperature excursions
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: I was shaking a lot; chills; a low grade temperature; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (I was shaking a lot), CHILLS (chills) and PYREXIA (a low grade temperature) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced TREMOR (I was shaking a lot), CHILLS (chills) and PYREXIA (a low grade temperature). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, TREMOR (I was shaking a lot), CHILLS (chills) and PYREXIA (a low grade temperature) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported.   This case was linked to MOD-2021-407226, MOD-2021-407239 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Delayed chronic hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Delayed chronic hives) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (Delayed chronic hives). At the time of the report, URTICARIA (Delayed chronic hives) outcome was unknown.            The patient stated that she was on concomitant medications for years. Treatment medications reported were Anti-Histamines.   This case was linked to MOD-2021-407240, MOD-2021-407115 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeling cold, Hyperhidrosis, Hypersensitivity, Pain in extremity
Clinical narrative: feels like cold; and sweating; a lot of itchiness in his chest.; last night his arm started to hurt; had like a red Little weal ("Ronchita roja"); had an allergic reaction after taking the Tylenol:; he's having a Little bit of fever, it is almost 38°C; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feels like cold), HYPERHIDROSIS (and sweating), PRURITUS (a lot of itchiness in his chest.), PAIN IN EXTREMITY (last night his arm started to hurt) and ERYTHEMA (had like a red Little weal ("Ronchita roja")) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-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 08-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 FEELING COLD (feels like cold), HYPERHIDROSIS (and sweating), PRURITUS (a lot of itchiness in his chest.), PAIN IN EXTREMITY (last night his arm started to hurt), ERYTHEMA (had like a red Little weal ("Ronchita roja")), HYPERSENSITIVITY (had an allergic reaction after taking the Tylenol:) and PYREXIA (he's having a Little bit of fever, it is almost 38°C). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING COLD (feels like cold), HYPERHIDROSIS (and sweating), PRURITUS (a lot of itchiness in his chest.), PAIN IN EXTREMITY (last night his arm started to hurt), ERYTHEMA (had like a red Little weal ("Ronchita roja")), HYPERSENSITIVITY (had an allergic reaction after taking the Tylenol:) and PYREXIA (he's having a Little bit of fever, it is almost 38°C) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 38 (abnormal) Result: Patient reported little bit of fever, it is almost 38°C.         Concomitant product use was not provided by the reporter.   Treatment information provided was took Tylenol, acetaminophen, to feel better Patient reported after taking Tylenol had like a red Little weal ("Ronchita roja")
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia
Clinical narrative: feels like cold; and sweating; a lot of itchiness in his chest.; last night his arm started to hurt; had like a red Little weal ("Ronchita roja"); had an allergic reaction after taking the Tylenol:; he's having a Little bit of fever, it is almost 38°C; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feels like cold), HYPERHIDROSIS (and sweating), PRURITUS (a lot of itchiness in his chest.), PAIN IN EXTREMITY (last night his arm started to hurt) and ERYTHEMA (had like a red Little weal ("Ronchita roja")) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-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 08-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 FEELING COLD (feels like cold), HYPERHIDROSIS (and sweating), PRURITUS (a lot of itchiness in his chest.), PAIN IN EXTREMITY (last night his arm started to hurt), ERYTHEMA (had like a red Little weal ("Ronchita roja")), HYPERSENSITIVITY (had an allergic reaction after taking the Tylenol:) and PYREXIA (he's having a Little bit of fever, it is almost 38°C). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING COLD (feels like cold), HYPERHIDROSIS (and sweating), PRURITUS (a lot of itchiness in his chest.), PAIN IN EXTREMITY (last night his arm started to hurt), ERYTHEMA (had like a red Little weal ("Ronchita roja")), HYPERSENSITIVITY (had an allergic reaction after taking the Tylenol:) and PYREXIA (he's having a Little bit of fever, it is almost 38°C) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 38 (abnormal) Result: Patient reported little bit of fever, it is almost 38°C.         Concomitant product use was not provided by the reporter.   Treatment information provided was took Tylenol, acetaminophen, to feel better Patient reported after taking Tylenol had like a red Little weal ("Ronchita roja")
Sex: U
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: "It was just my period came a week early and was heavy"; "It was just my period came a week early and was heavy"; This spontaneous case was reported by an other health care professional and describes the occurrence of MENSTRUATION IRREGULAR ("It was just my period came a week early and was heavy") and HEAVY MENSTRUAL BLEEDING ("It was just my period came a week early and was heavy") in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUATION IRREGULAR ("It was just my period came a week early and was heavy") and HEAVY MENSTRUAL BLEEDING ("It was just my period came a week early and was heavy"). At the time of the report, MENSTRUATION IRREGULAR ("It was just my period came a week early and was heavy") and HEAVY MENSTRUAL BLEEDING ("It was just my period came a week early and was heavy") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: cortisone shot 2 days after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (cortisone shot 2 days after vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced VACCINATION COMPLICATION (cortisone shot 2 days after vaccine). At the time of the report, VACCINATION COMPLICATION (cortisone shot 2 days after vaccine) outcome was unknown. Not Provided    Concomitant medication was not provided. The caller did not have enough information to indicate what the cortisone shot was given for.   Reporter did not allow further contact
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A little sore arm after first shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A little sore arm after first shot) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (A little sore arm after first shot). On 10-Jan-2021, PAIN IN EXTREMITY (A little sore arm after first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-407441, MOD-2021-407436 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site pain
Clinical narrative: some achiness at the site of the vaccination; she had a 102 fever for a day; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (some achiness at the site of the vaccination) and PYREXIA (she had a 102 fever for a day) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (some achiness at the site of the vaccination) and PYREXIA (she had a 102 fever for a day). On 04-Mar-2021, PYREXIA (she had a 102 fever for a day) had resolved. At the time of the report, VACCINATION SITE PAIN (some achiness at the site of the vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 102 (High) 102 Fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had no concomitant medication.  The patient did not use any medication to treat the symptoms.   This case was linked to MOD-2021-407803, MOD-2021-407826.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle contractions involuntary
Clinical narrative: 4 days after the booster shoot she started experiencing some fasciculations; This spontaneous case was reported by a physician and describes the occurrence of MUSCLE CONTRACTIONS INVOLUNTARY (4 days after the booster shoot she started experiencing some fasciculations) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MUSCLE CONTRACTIONS INVOLUNTARY (4 days after the booster shoot she started experiencing some fasciculations). At the time of the report, MUSCLE CONTRACTIONS INVOLUNTARY (4 days after the booster shoot she started experiencing some fasciculations) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was not using any concomitant medication.  The patient did not use any medication to treat the symptoms.   This case was linked to MOD-2021-407803, MOD-2021-407825 (Patient Link).
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Feeling abnormal, Pain, Pain in extremity
Clinical narrative: pain in his shoulder and wrist; pain in his shoulder and knees,hips,; spread to his lower back,; The pain got significantly worse last night; Feels like Crap; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in his shoulder and wrist), ARTHRALGIA (pain in his shoulder and knees,hips,), BACK PAIN (spread to his lower back,), PAIN (The pain got significantly worse last night) and FEELING ABNORMAL (Feels like Crap) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Leukemia and Hypertension. Concomitant products included AMRUBICIN for an unknown indication.    On 05-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Dec-2021, the patient experienced PAIN IN EXTREMITY (pain in his shoulder and wrist), ARTHRALGIA (pain in his shoulder and knees,hips,), BACK PAIN (spread to his lower back,), PAIN (The pain got significantly worse last night) and FEELING ABNORMAL (Feels like Crap). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in his shoulder and wrist), ARTHRALGIA (pain in his shoulder and knees,hips,), BACK PAIN (spread to his lower back,), PAIN (The pain got significantly worse last night) and FEELING ABNORMAL (Feels like Crap) had not resolved.            Concomitant medications include amrubicin, blood pressure pill and medications for his diabetes. Treatment include, Heating pad. His doctor instructed him to stop taking the amrubicin 3 days before receiving the booster dose of the Moderna vaccine. He has started taking his amrubicin again today.   This case was linked to MOD-2021-406936 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Joint range of motion decreased
Clinical narrative: Couldn't lift her right arm; Had a flare up on my right arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Jul2021 (Formulation: solution for injection, Batch/Lot number: unknown) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Scoliosis" (unspecified if ongoing), notes: scoliosis which is, curvature of the spine and had surgery for that at 17.; "Arthritis" (unspecified if ongoing), notes: she was 17; "Musculoskeletal conditions" (unspecified if ongoing), notes: She says after having that when she was 55 she had, musculoskeletal issues that she takes medication for.; "Rheumatoid arthritis" (unspecified if ongoing); "surgery" (unspecified if ongoing), notes: Scoliosis (From:, Unknown To: Unspecified) Additional Information for, Other Conditions: Caller says she was diagnosed wit hthis when she was 17 and had surgery for it when she, was 17; "shrinking" (unspecified if ongoing), notes: every year she is shrinking, but recently she was five feet, four and a half inches, tall. The patient took concomitant medications. The following information was reported: ARTHRITIS (non-serious) with onset 2021, outcome "unknown", described as "Had a flare up on my right arm"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset Jul2021, outcome "unknown", described as "Couldn't lift her right arm". The event "had a flare up on my right arm" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of arthritis. Additional information: The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: Experiencing common arm pain like severe arm pain to a point where I can't touch it and I can hardly lift my arm; firstly I didn't feel anything and then it slowly has gone worse; Having severe Diarrhea and it's making 3 times everything after an hour; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Sep2021 11:00 (Lot number: FD8448) at the age of 27 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing), notes: Verbatim: ADHD; "Cold sores" (unspecified if ongoing), notes: Verbatim: Cold sores. Concomitant medication(s) included: ADDERALL taken for attention deficit hyperactivity disorder; ACICLOVIR taken for oral herpes. The following information was reported: DIARRHOEA (non-serious) with onset 11Sep2021, outcome "unknown", described as "Having severe Diarrhea and it's making 3 times everything after an hour"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Experiencing common arm pain like severe arm pain to a point where I can't touch it and I can hardly lift my arm; firstly I didn't feel anything and then it slowly has gone worse". Therapeutic measures were not taken as a result of diarrhoea, pain in extremity.  Additional Information: I am calling because I think I am having symptoms from getting (first dose) Covid-19 Vaccine today around 11 am, it is now 8:37 pm. I don't know an hour after I receive Vaccine, I have been experiencing Diarrhea and it's making 3 times everything after an hour, I am having severe Diarrhea. One other side effect that I am experiencing common is arm pain, but it is like severe arm pain to a point where I can't touch it and I can hardly lift my arm. I never had such a severe arm pain with any vaccine ever. It started when I first got the vaccine, firstly I didn't feel anything and then it slowly has gone worse throughout the day. I am sure it is probably normal, but I just thought otherwise I don't have any symptoms like fever or nausea or anything.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: with my 1st shot, i got a severe headache within 10 minutes; Shot site soreness.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 59-year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Sep2021 14:30 (Lot number: FC3184) at the age of 59 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Fibromyalgia", start date: 13Mar2017 (ongoing), notes: Pertinent Details: Chronic pain; "Neuropathy", start date: 13Mar2017 (ongoing), notes: Pertinent Details: Chronic-entire body neck down; "Hypothyroid", start date: 1976 (ongoing), notes: Pertinent Details: Hashimotos- allergic to thyroid replacement. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 07Sep2021 14:35, outcome "recovered" (Sep2021), described as "with my 1st shot, i got a severe headache within 10 minutes"; VACCINATION SITE PAIN (non-serious) with onset 07Sep2021 14:35, outcome "recovered" (Sep2021), described as "Shot site soreness.". Therapeutic measures were taken as a result of headache, vaccination site pain  Additional information: Vaccination facility type: Pharmacy or Drug store. With 1st shot, I got a severe headache within 10 minutes, that lasted for 5 days. And shot site soreness. Just thought you should keep track of side effects. Patient was treated with NSAIDS for headache and vaccination site pain. Patient did not receive any other vaccines within 4 weeks of vaccination.  Follow-up attempts completed. No further information expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Pain in extremity
Clinical narrative: was looking at the card and the card says it expired on 31 Jul 21; It looks like that''s the expiry on the sticker on card; right arm still sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101751980 (Pfizer).  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Oct2021 10:00 (Lot number: ER8734, Expiration Date: 31Jul2021) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "carpel surgery", start date: Oct2021 (ongoing), notes: carpel surgery on left wrist; "Type 2 Diabetes" (unspecified if ongoing); "Allergy" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), administration date: 16Mar2021, when the patient was 66 years old, for COVID-19 immunization; Bnt162b2 (DOSE: 2), administration date: 06Apr2021, when the patient was 66 years old, for COVID-19 immunization. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 12Oct2021, outcome "not recovered", described as "was looking at the card and the card says it expired on 31 Jul 21; It looks like that''s the expiry on the sticker on card"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "unknown", described as "right arm still sore".  Additional information:No other vaccines given the same day and no problems with vaccines in the past. States he did get the high dose flu shot in either Sept or early Oct 2021, but unable to provide the NDC, Lot, or expiry. No further details provided. No Emergency Room and Physician Office visit. Patient's Medical History (including any illness at time of vaccination)? Type 2 Diabetes. Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: Type 2 diabetes  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Palpitations, SARS-CoV-2 test
Clinical narrative: Severe cough; heart palpitations; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Jan2021 08:00 AM (Batch/Lot number: unknown) at the age of 34 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Severe Cough" (unspecified if ongoing), notes: other medical history: Severe Cough; "allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Vaccine Administration Time: 09:00 AM), for COVID-19 immunization. The following information was reported: PALPITATIONS (non-serious) with onset Jan2021, outcome "recovered with sequelae", described as "heart palpitations"; COUGH (non-serious) with onset Aug2021, outcome "recovered with sequelae", described as "Severe cough". The events "heart palpitations" and "severe cough" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of palpitations, cough. Additional information: Patient had no covid prior vaccination, No ther vaccine in four weeks. Felt heart Palpitations on the day of vaccination and continuous severe cough after 6 months of vaccination from Aug to till date.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up..
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle twitching
Clinical narrative: Muscle spasms / severe spasming 10-15 times a day, slowly got better; twitching in right forearm within hours of 2nd dose.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Apr2021 (Batch/Lot number: unknown) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 7534, Location of injection: Arm Left), administration date: 26Mar2021, when the patient was 52 years old, for COVID-19 Immunization. The following information was reported: MUSCLE SPASMS (non-serious) with onset 16Apr2021, outcome "recovering", described as "Muscle spasms / severe spasming 10-15 times a day, slowly got better"; MUSCLE TWITCHING (non-serious) with onset 16Apr2021, outcome "recovering", described as "twitching in right forearm within hours of 2nd dose.". Therapeutic measures were not taken as a result of muscle spasms, muscle twitching.  Additional information: It was reported that patient had not received any other vaccine in four weeks. It was reported that Muscle spasms/twitching in right forearm within hours of 2nd dose. Started severe spasming 10-15 times a day, slowly got better. Spasming was less severe but t multiple times a day for several months. Now mild and several times a week. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient was not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: covid vaccine has made me sick for 7 months; This is a spontaneous report received from a contactable reporter for a Pfizer sponsored program (005570). The reporter is the patient. A patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: illness, outcome unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "flu like symptoms".  Additional information: The patient had flu like symptoms for a couple days and she was fine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.