chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lymphadenopathy, Peripheral swelling, Rash, Rash pruritic
Clinical narrative: swollen fingers in both of her hands; rash itched; numb fingers in both of her hands; rash all over her body; swollen lymph node in her left breast; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen fingers in both of her hands), RASH PRURITIC (rash itched), HYPOAESTHESIA (numb fingers in both of her hands), RASH (rash all over her body) and LYMPHADENOPATHY (swollen lymph node in her left breast) in a female 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 PERIPHERAL SWELLING (swollen fingers in both of her hands), RASH PRURITIC (rash itched), HYPOAESTHESIA (numb fingers in both of her hands), RASH (rash all over her body) and LYMPHADENOPATHY (swollen lymph node in her left breast). At the time of the report, PERIPHERAL SWELLING (swollen fingers in both of her hands), RASH PRURITIC (rash itched), HYPOAESTHESIA (numb fingers in both of her hands), RASH (rash all over her body) and LYMPHADENOPATHY (swollen lymph node in her left breast) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported.  No treatment medications were reported.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Rash pruritic, Vaccination site reaction
Clinical narrative: salmon colored rash on her arm which itches; Covid Arm in her left arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (salmon colored rash on her arm which itches) and VACCINATION SITE REACTION (Covid Arm in her left arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced RASH PRURITIC (salmon colored rash on her arm which itches) and VACCINATION SITE REACTION (Covid Arm in her left arm). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) at an unspecified dose and frequency and TRIAMCINOLONE ACETONIDE at a dose of 0.1 percent. At the time of the report, RASH PRURITIC (salmon colored rash on her arm which itches) had not resolved and VACCINATION SITE REACTION (Covid Arm in her left arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant information was not provided.  Patient received the Moderna Covid-19 vaccine in her left arm shoulder deltoid muscle.  The patient experienced COVID arm in her left arm. The patient specifically reported a salmon colored rash on her arm which itches. The rash got better and then it was flares up again. The patient experienced no other side effects.  Patient went to see her primary care physician and a dermatologist. The dermatologist prescribed Allegra and Triamcinolone acetonide ointment 0.1percentage.  Patient planned to see a Rheumatologist.   This case was linked to MOD-2022-485635, MOD-2022-485647 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Burning sensation, Hypoaesthesia, Rash
Clinical narrative: salmon colored rash on her arm which itches; Covid Arm in her left arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (salmon colored rash on her arm which itches) and VACCINATION SITE REACTION (Covid Arm in her left arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced RASH PRURITIC (salmon colored rash on her arm which itches) and VACCINATION SITE REACTION (Covid Arm in her left arm). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) at an unspecified dose and frequency and TRIAMCINOLONE ACETONIDE at a dose of 0.1 percent. At the time of the report, RASH PRURITIC (salmon colored rash on her arm which itches) had not resolved and VACCINATION SITE REACTION (Covid Arm in her left arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant information was not provided.  Patient received the Moderna Covid-19 vaccine in her left arm shoulder deltoid muscle.  The patient experienced COVID arm in her left arm. The patient specifically reported a salmon colored rash on her arm which itches. The rash got better and then it was flares up again. The patient experienced no other side effects.  Patient went to see her primary care physician and a dermatologist. The dermatologist prescribed Allegra and Triamcinolone acetonide ointment 0.1percentage.  Patient planned to see a Rheumatologist.   This case was linked to MOD-2022-485635, MOD-2022-485647 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site reaction, X-ray
Clinical narrative: Clear white line running through the deltoid muscle at the injection.; Ever since his booster shot his deltoid muscle has been hurting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Clear white line running through the deltoid muscle at the injection.) and MYALGIA (Ever since his booster shot his deltoid muscle has been hurting ) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01721A, 0481A21A and 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoarthritis (In his hands, feet, and back - not the arm.). Concomitant products included CELECOXIB (CELEBREX), TRAZODONE, TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) and PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE (MIRAPEX) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (Ever since his booster shot his deltoid muscle has been hurting ). On an unknown date, the patient experienced VACCINATION SITE REACTION (Clear white line running through the deltoid muscle at the injection.). At the time of the report, VACCINATION SITE REACTION (Clear white line running through the deltoid muscle at the injection.) outcome was unknown and MYALGIA (Ever since his booster shot his deltoid muscle has been hurting ) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2022, X-ray: white line running through deltoid muscle (abnormal) There is a clear white line running through the deltoid muscle at the injection.         Patient's weight was reported as 170 with an unknown unit. Patients date birth was reported as 22 Oct 1900.  Patient had no reactions with his first or second shot.  No treatment medication details was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Vaccination complication
Clinical narrative: second case of "Moderna Arm" after her second dose in her left arm; salmon colored rash which itches.; rash gets better and then flares up again; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (second case of "Moderna Arm" after her second dose in her left arm), RASH PRURITIC (salmon colored rash which itches.) and RASH (rash gets better and then flares up again) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION COMPLICATION (second case of "Moderna Arm" after her second dose in her left arm), RASH PRURITIC (salmon colored rash which itches.) and RASH (rash gets better and then flares up again). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and TRIAMCINOLONE ACETONIDE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (second case of "Moderna Arm" after her second dose in her left arm), RASH PRURITIC (salmon colored rash which itches.) and RASH (rash gets better and then flares up again) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2022-485571, MOD-2022-485647 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia, Paraesthesia, Peripheral swelling, Pruritus
Clinical narrative: Covid arm on both her left and right arms/Covid arm extends to her hands and fingers; Fingers are swollen; Itching in her fingers; Burning in her fingers; Tingling in her fingers; Numbness in her fingers/Due to the numbness in her fingers the patient is having trouble writing.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Covid arm on both her left and right arms/Covid arm extends to her hands and fingers), PERIPHERAL SWELLING (Fingers are swollen), PRURITUS (Itching in her fingers), BURNING SENSATION (Burning in her fingers) and PARAESTHESIA (Tingling in her fingers) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced VACCINATION COMPLICATION (Covid arm on both her left and right arms/Covid arm extends to her hands and fingers), PERIPHERAL SWELLING (Fingers are swollen), PRURITUS (Itching in her fingers), BURNING SENSATION (Burning in her fingers), PARAESTHESIA (Tingling in her fingers) and HYPOAESTHESIA (Numbness in her fingers/Due to the numbness in her fingers the patient is having trouble writing.). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and TRIAMCINOLONE ACETONIDE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Covid arm on both her left and right arms/Covid arm extends to her hands and fingers), PERIPHERAL SWELLING (Fingers are swollen), PRURITUS (Itching in her fingers), BURNING SENSATION (Burning in her fingers), PARAESTHESIA (Tingling in her fingers) and HYPOAESTHESIA (Numbness in her fingers/Due to the numbness in her fingers the patient is having trouble writing.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.   This case was linked to MOD-2022-485571, MOD-2022-485635, MOD-2022-485155 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Covid arm on both her left and right arms/Covid arm extends to her hands and fingers; Fingers are swollen; Itching in her fingers; Burning in her fingers; Tingling in her fingers; Numbness in her fingers/Due to the numbness in her fingers the patient is having trouble writing.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Covid arm on both her left and right arms/Covid arm extends to her hands and fingers), PERIPHERAL SWELLING (Fingers are swollen), PRURITUS (Itching in her fingers), BURNING SENSATION (Burning in her fingers) and PARAESTHESIA (Tingling in her fingers) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced VACCINATION COMPLICATION (Covid arm on both her left and right arms/Covid arm extends to her hands and fingers), PERIPHERAL SWELLING (Fingers are swollen), PRURITUS (Itching in her fingers), BURNING SENSATION (Burning in her fingers), PARAESTHESIA (Tingling in her fingers) and HYPOAESTHESIA (Numbness in her fingers/Due to the numbness in her fingers the patient is having trouble writing.). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and TRIAMCINOLONE ACETONIDE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Covid arm on both her left and right arms/Covid arm extends to her hands and fingers), PERIPHERAL SWELLING (Fingers are swollen), PRURITUS (Itching in her fingers), BURNING SENSATION (Burning in her fingers), PARAESTHESIA (Tingling in her fingers) and HYPOAESTHESIA (Numbness in her fingers/Due to the numbness in her fingers the patient is having trouble writing.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.   This case was linked to MOD-2022-485571, MOD-2022-485635, MOD-2022-485155 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: started chemo for an unknown reason; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (started chemo for an unknown reason) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 VACCINATION COMPLICATION (started chemo for an unknown reason). At the time of the report, VACCINATION COMPLICATION (started chemo for an unknown reason) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment included Chemotherapy.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: immunocompromised patient received booster dose instead of full 3rd dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (immunocompromised patient received booster dose instead of full 3rd dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   In November 2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (immunocompromised patient received booster dose instead of full 3rd dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (immunocompromised patient received booster dose instead of full 3rd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  No treatment medication were provided.  The patient was on active chemotherapy.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rashes on one half of her body, the leg and the arm, she does not remember which side.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes on one half of her body, the leg and the arm, she does not remember which side.) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Lactose) and Inflammatory bowel disease (takes Linzess to treat this illness) since 2018. Concomitant products included LINACLOTIDE (LINZESS) from 2018 to an unknown date for Inflammatory bowel disease.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced RASH (Rashes on one half of her body, the leg and the arm, she does not remember which side.). At the time of the report, RASH (Rashes on one half of her body, the leg and the arm, she does not remember which side.) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment Information were provided by the reporter.  Patient experienced rashes on one half of her body, the leg and the arm and she does not remember which side. This rash appeared a couple days after the vaccine was administered. Patient consulted her schools medical facility and the rash went away without medication a couple days after.   This case was linked to MOD-2022-486107, MOD-2022-486076 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: April 6 lymph node on L clavicle swelled; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 (Lot number: EN6204, Expiration Date: Jun2021) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Exercise induced asthma" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "Scoliosis" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; TYLENOL. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 06Apr2021, outcome "recovering", described as "April 6 lymph node on L clavicle swelled". The event "april 6 lymph node on l clavicle swelled" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: April 6 lymph node on L clavicle swelled, reduced by April 15. April 26 painful swelling in R armpit. Pain has continued for 4 days, extending into muscles of R arm. April 28 lymph node on R clavicle swelled. Other medications in two weeks: Birth Control. Facility type vaccine: Pharmacy or Drug Store. The patient had no other vaccine in four weeks, not diagnosed with COVID prior to vaccination and not tested for COVID since vaccination. Patient had no allergies.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Nausea, Paraesthesia
Clinical narrative: Tingling face; Tingling arm injection arm; Nauseous; weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 11Feb2021 15:00 (Lot number: EN9587) as dose 1, single and intramuscular, administered in arm left, administration date 04Mar2021 15:00 (Lot number: EN6199) as dose 2, single for covid-19 immunisation. Relevant medical history included: "viral Asthma" (unspecified if ongoing), notes: viral. Family history included: "Latex" (unspecified if ongoing); "environmental" (unspecified if ongoing); "foods" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Zpack, reaction(s): "Allergies"; Prevacid, reaction(s): "Allergies". Vaccination history included: Flu block (Anatomical site of injection: Left arm, two weeks and two days prior to first doe), administration date: 23Feb2021, when the patient was 50 years old, for immunization. The following information was reported: PARAESTHESIA (non-serious) with onset 11Mar2021 16:30, outcome "recovered" (25Mar2021), described as "Tingling face"; PARAESTHESIA (non-serious) with onset 11Mar2021, outcome "recovered" (11Mar2021), described as "Tingling arm injection arm"; NAUSEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Nauseous"; ASTHENIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "weakness". The events "tingling face" and "tingling arm injection arm" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of paraesthesia, paraesthesia.  Additional information included as almost immediately she was nauseous. They started monitoring me 30 minutes tingling right arm (elbow to solder), 45 minutes while arm kept moving to drank water , tingling's stopped at 60 minutes went to drive home from Apt. Face tingles started at 1 hr 30 min on right side of face started mid face ear to nose, spread to chin, forehead right eye, 5 days mild weakness at mouth bottom lip and right cheek by eye. Resolved at day 14, functions had returned to normal.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Apr2021 13:15 (Lot number: ER8T34) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Acute asthma" (unspecified if ongoing), notes: Verbatim: Acute asthma; "covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: LEXAPRO; FLONASE ALLERGY RELIEF; ALBUTEROL SULFATE. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 05Apr2021 13:15, outcome "unknown", described as "swollen lymph nodes".  Additional information: patient had covid prior vaccination. No covid tested post vaccination. No Known allergies. Patient had reactions 48 hours after first dose with need for inhaler and swollen lymph nodes. No other vaccine in four weeks.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache
Clinical narrative: headache; chills; weakness; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 16:45 (Lot number: Ew0173) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (product=COVID 19, brand:Pfizer, administration time 04:30 AM, dose number:1, vaccine location: Left leg), administration date: 06Apr2021, when the patient was 39 years old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 30Apr2021 02:00, outcome "not recovered", described as "headache"; CHILLS (non-serious) with onset 30Apr2021 02:00, outcome "not recovered", described as "chills"; ASTHENIA (non-serious) with onset 30Apr2021 02:00, outcome "not recovered", described as "weakness".  Therapeutic measures were not taken as a result of headache, chills, asthenia.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female 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: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph nodes".  Additional Information: a doctor said it is likely a vaccine side effect and she works with a woman who still has swollen lymph nodes three months after getting the vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: Menstrual cycle delayed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 10:15 (Lot number: EW0151) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "migraine headache" (unspecified if ongoing); "allergen induced asthma" (unspecified if ongoing), notes: allergen induced. Concomitant medication(s) included: IBUPROFEN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: MENSTRUATION DELAYED (non-serious) with onset Apr2021, outcome "recovering", described as "Menstrual cycle delayed". Therapeutic measures were taken as a result of menstruation delayed.  Additional information: Reported menstrual cycle delayed by 12 days after first shot. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received ibuprofen, zyrtec within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not have relevant past drug history. Patient received treatment as ibuprofen and vitamins. The event was assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pruritus, Pruritus
Clinical narrative: itching all over; inside her ears and head to toe; itching all over; inside her ears and head to toe; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.   A 58-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Aug2021 15:00 (Batch/Lot number: unknown) at the age of 58 years as dose 1, single for covid-19 immunization. Relevant medical history included: "severe allergic reactions in the past" (unspecified if ongoing), notes: severe allergic reactions in the past; "chronic adult parvo B19 or fifths disease" (unspecified if ongoing), notes: about two year ago and it gives you arthritis symptoms; "Fibromyalgia" (unspecified if ongoing), notes: from many years; "allergies" (unspecified if ongoing), notes: from years ago; "she has food allergies too" (unspecified if ongoing), notes: she has food allergies too; "she doesn't eat strawberries" (unspecified if ongoing), notes: she doesn't eat strawberries; "autoimmune issues" (unspecified if ongoing); "pollen allergy" (unspecified if ongoing); "Grass allergy" (unspecified if ongoing); "Allergy to trees" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Epinephrine shot (epinephrine shot), for severe allergic reactions; Cortisone shot (cortisone shot), for severe allergic reactions; Ppsd 23 (2nd dose, Caller reports she had the second dose of the PPSD 23 two weeks prior to the Pfizer COVID 19 vaccine, Vaccine Name:  PPSD 23, Manufacturer: unknown, Lot Number: unknown, Route, Anatomical Location: not provided, No. of Previous Doses: one), administration date: Aug2021, for immunization; Ppsd 23 (her previous dose of PPSD was 6 months earlier.), administration date: Feb2021, for immunization. The following information was reported: PRURITUS (non-serious), EAR PRURITUS (non-serious) all with onset 27Aug2021, outcome "recovering" and all described as "itching all over; inside her ears and head to toe". Therapeutic measures were taken as a result of pruritus, ear pruritus.   Additional information: The patient did not receive any previous immunization and did not receive any Additional Vaccines on Same Date of the Pfizer Suspect. The patient got the vaccination on Tuesday (24AUG2021). lot number as either IC3180 or FC3180; then on Friday night she started itching all over; inside her ears and head to toe and if she scratches, she has a whelph come up. Now the itching was on and off; she thinks it may be improved. PCP has given her hydroxyzine for itching and it helps when she takes it. Right now, she was not itching. The patient had itching like this years ago when she had a real bad allergy attack. she was allergic to everything, to all the outside, pollen, trees, grass. she has food allergies too and she doesn't eat strawberries. No lab tests were done.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Urticaria
Clinical narrative: Blotches; Hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202101190943 (Pfizer).  A 19 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Aug2021 10:00 (Batch/Lot number: unknown) at the age of 19 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: RASH MACULAR (non-serious) with onset 13Aug2021 10:00, outcome "unknown", described as "Blotches"; URTICARIA (non-serious) with onset 13Aug2021 10:00, outcome "unknown", described as "Hives". The events "blotches" and "hives" were evaluated at the physician office visit. Therapeutic measures were taken as a result of rash macular, urticaria.  Additional information: The reporter reported that, blotches on her arms and legs went away, but then comes back. She has had six or seven episodes of 4x4 blotches on her arms and legs. She wants to know what to do about the blotches. She also wanted to know what to do about the second shot. It was located on both arms and legs and not at the site where the vaccine was given. The patient was taking to Urgent Care. She was told to take Benadryl and she did. Reporter also went back to the pharmacy, where the patient got the shot. They also told the patient should take Benadryl. The patient did not take brand Benadryl, patient took drug store brand Benadryl and not real Benadryl, (Lot: P122897, Exp: Nov 2022), Chewable Tablet, 25mg. The patient received Vaccination at Facility Type: Pharmacy/Drug Store. The patient did not Administered any additional Vaccines on Same Date of the Pfizer Suspect. Patient received no other vaccines within 4 weeks PRIOR to the COVID-19 vaccine with no adverse events prior vaccinations. The reporter did the Product Complaint and mentioned patient had hives/blotches after getting the vaccine, patient has tried the drug store Brand Benadryl. The reporter stated that, patient was experiencing hives in blotches that come and go in several different episodes. It was not like a pimple but blotches on her forearms that appeared in her bottoms and her wrists that went down in her forearm and the palm of her hand. It is kind of hot and hard. And appeared mostly in the upper part of her body. One time 4 came out when it was usually 1. She also mentioned that she doesn't think of it as a sever allergic reaction as they appeared slowly about 5 days after each. Reporter was asking what she should do next as she was on Benadryl as per her doctor advice. Reporter wanted to know if many has reported this events and the percentage.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Decreased appetite, Feeling abnormal
Clinical narrative: Started feeling really bad like after the vaccine; Like 40 minutes after the vaccine she starts with the coughing; She got chilling; She got fever; She got a pain all over her body; She got a headache; She do not want to eat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female 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: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Started feeling really bad like after the vaccine"; COUGH (non-serious), outcome "unknown", described as "Like 40 minutes after the vaccine she starts with the coughing"; CHILLS (non-serious), outcome "unknown", described as "She got chilling"; PYREXIA (non-serious), outcome "unknown", described as "She got fever"; PAIN (non-serious), outcome "unknown", described as "She got a pain all over her body"; HEADACHE (non-serious), outcome "unknown", described as "She got a headache"; DECREASED APPETITE (non-serious), outcome "unknown", described as "She do not want to eat". The events "started feeling really bad like after the vaccine", "like 40 minutes after the vaccine she starts with the coughing", "she got chilling", "she got fever", "she got a pain all over her body", "she got a headache" and "she do not want to eat" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated that the patient after receiving the shot (Pfizer COVID 19 Vaccine) had side effects. She got 2 weeks and she is with a side effect, not recovered. Reporter stated, she got the vaccine at 4:30, she felt bad like at 6 O'clock she started feeling really bad like after the vaccine. When confirmed if reporter wanted to know if coughing is the side effect from the COVID 19 Vaccine or not, Reporter added, "No, I am sure it was from the Pfizer vaccine because she was really well and now she started coughing, she was perfect just like 40 minute after the vaccine she started coughing, and she got chilling, fever, pain all over her body, headache and do not want to eat. Next day it was more bad, they took her to the doctor and doctor said it's a virus, but reporter stated that they know it's not the virus because it started after the vaccine. By Tuesday she felt more bad, they took her to the emergency room the last Saturday. The last doctor spoke to her said that's the side effect for the vaccine (further clarification unknown). The reporter stated that the other concern was she got it for like 2 weeks with the same side effects.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Started feeling really bad like after the vaccine; Like 40 minutes after the vaccine she starts with the coughing; She got chilling; She got fever; She got a pain all over her body; She got a headache; She do not want to eat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female 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: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Started feeling really bad like after the vaccine"; COUGH (non-serious), outcome "unknown", described as "Like 40 minutes after the vaccine she starts with the coughing"; CHILLS (non-serious), outcome "unknown", described as "She got chilling"; PYREXIA (non-serious), outcome "unknown", described as "She got fever"; PAIN (non-serious), outcome "unknown", described as "She got a pain all over her body"; HEADACHE (non-serious), outcome "unknown", described as "She got a headache"; DECREASED APPETITE (non-serious), outcome "unknown", described as "She do not want to eat". The events "started feeling really bad like after the vaccine", "like 40 minutes after the vaccine she starts with the coughing", "she got chilling", "she got fever", "she got a pain all over her body", "she got a headache" and "she do not want to eat" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated that the patient after receiving the shot (Pfizer COVID 19 Vaccine) had side effects. She got 2 weeks and she is with a side effect, not recovered. Reporter stated, she got the vaccine at 4:30, she felt bad like at 6 O'clock she started feeling really bad like after the vaccine. When confirmed if reporter wanted to know if coughing is the side effect from the COVID 19 Vaccine or not, Reporter added, "No, I am sure it was from the Pfizer vaccine because she was really well and now she started coughing, she was perfect just like 40 minute after the vaccine she started coughing, and she got chilling, fever, pain all over her body, headache and do not want to eat. Next day it was more bad, they took her to the doctor and doctor said it's a virus, but reporter stated that they know it's not the virus because it started after the vaccine. By Tuesday she felt more bad, they took her to the emergency room the last Saturday. The last doctor spoke to her said that's the side effect for the vaccine (further clarification unknown). The reporter stated that the other concern was she got it for like 2 weeks with the same side effects.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Very bad allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). A female 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: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Very bad allergic reaction". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Pain in extremity
Clinical narrative: Coughing; Arm soreness; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US150245_NS.  A 38 year-old female 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: COUGH (non-serious), outcome "unknown", described as "Coughing"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm soreness"; HEADACHE (non-serious), outcome "unknown", described as "Headache".  Additional Information : Patient reported she had put off doses due to Covid Vaccine and experienced coughing, arm soreness and headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthma, Blood test, Chest X-ray, Electrocardiogram
Clinical narrative: Asthma; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization. The following information was reported: ASTHMA (non-serious) with onset Apr2021, outcome "unknown", described as "Asthma". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Since receiving the 2nd Pfizer vaccine in Apr2021, the patient had been diagnosed with Asthma. The patient never had it it before. Never have had lung breathing issues. Not sure what to do about this. The patient had chest x-rays, ekg, blood tests and not impacting the heart. The patient need someone to contact to discuss further.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: bloody sinus drainage; Nose bleed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Sep2021 (Batch/Lot number: unknown) at the age of 20 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Scoliosis (corrected)" (unspecified if ongoing); "SMA" (unspecified if ongoing); "hypoglycemia" (unspecified if ongoing); "Anemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Arm Right), administration date: 01Sep2021, for COVID-19 immunization. The following information was reported: EPISTAXIS (non-serious) with onset 22Sep2021 21:30, outcome "recovering", described as "bloody sinus drainage"; EPISTAXIS (non-serious) with onset 22Sep2021 21:30, outcome "recovering", described as "Nose bleed". Therapeutic measures were not taken as a result of epistaxis, epistaxis.  Additional Information: Prior to vaccination, patient was not diagnosed with Covid-19. Since the vaccination, patient has not been tested for Covid-19. Patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. Other medications the patient received within 2 weeks of vaccination: Pristiq 100mg, vyvanse 40mg, Nikki, probiotics.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye swelling, Fatigue, Ocular hyperaemia, Swelling
Clinical narrative: I'm feeling a little tired; red in her face; around her eye is swollen; around her eye is swollen and red; swelling; 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. Other Case identifier(s): US-PFIZER INC-202101294991 (Pfizer).  A 65 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 23Sep2021 (Batch/Lot number: unknown) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "allergies to shellfish" (unspecified if ongoing); "Allergies: mold" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset Sep2021, outcome "unknown", described as "I'm feeling a little tired"; ERYTHEMA (non-serious) with onset Sep2021, outcome "unknown", described as "red in her face"; EYE SWELLING (non-serious) with onset Sep2021, outcome "unknown", described as "around her eye is swollen"; OCULAR HYPERAEMIA (non-serious) with onset Sep2021, outcome "unknown", described as "around her eye is swollen and red"; SWELLING (non-serious) with onset Sep2021, outcome "unknown", described as "swelling".  Additional information:She received her second Covid 19 vaccine on 22Sep2021 so it's been almost a week or a week and a day and at the time she received the Covid 19 vaccine she didn't had any problems. But now her eyes, around her eyes were swollen and red and the swelling was really bad and she was red in her face. She was asking if this was a side effect. She reports she was born with allergies to shellfish and mold. She was not sure if she was allergic to eggs because she does not eat a lot of eggs. Her face was red and her eyes were very swollen and around her eyes it was red in each eye.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (27Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.