chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Pain in extremity
Clinical narrative: Pain in left eye; Pain in arm; Headache- front head still hurts; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN, PAIN IN EXTREMITY, and HEADACHE in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN for Diabetes.    On 26-Mar-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 EYE PAIN, PAIN IN EXTREMITY, and HEADACHE. The patient was treated with OXYMETAZOLINE HYDROCHLORIDE ongoing since an unknown date for Headache, at an unspecified dose and frequency; TYLENOL for Headache, at an unspecified dose and frequency; IBUPROFEN for Headache, at an unspecified dose and frequency and NAPROXEN for Headache, at an unspecified dose and frequency. At the time of the report, EYE PAIN and PAIN IN EXTREMITY outcome was unknown and HEADACHE had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Blood cholesterol: 160 (normal). On 10-Apr-2021, Blood glucose: 96 (normal). On 10-Apr-2021, Blood pressure measurement (80-120): 157 (High) Hypertension and 126/60 (normal) 126/60. On 10-Apr-2021, Heart rate: increased (High).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was in the ER for 5 hours and was admitted to the hospital because they wanted to perform some tests.  Patient states she went home and still has headache till today. Her front head still hurts.   This case was linked to US-MODERNATX, INC MOD-2021-080351 (E2B Linked Report). This case was linked to MOD-2021-080351.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: hot to touch; felt like hives; kind of itchy; a red oval on her upper arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA, VACCINATION SITE PRURITUS, VACCINATION SITE URTICARIA, and VACCINATION SITE WARMTH in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition reported). Concomitant products included SIMVASTATIN for an unknown indication.   On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA, VACCINATION SITE PRURITUS, VACCINATION SITE URTICARIA, and VACCINATION SITE WARMTH. On 05-Mar-2021, VACCINATION SITE ERYTHEMA, VACCINATION SITE PRURITUS, VACCINATION SITE URTICARIA, and VACCINATION SITE WARMTH had resolved.            Treatment medication include Zyrtec and cold compresses.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN. At the time of the report, VACCINATION SITE PAIN outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information Heart medications.  Treatment information was not provided.
Sex: U
Vaccine: HPV9, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE; Vaccine expired on 08-JUL-2021 was administered on 21-JUL-2021; This spontaneous report was received from a registered nurse referring to a patient of unspecified age and gender.   No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.   On 21-JUL-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R029515, 0.5 milliliter dose for prophylaxis (route and site of administration were not reported).  The vaccine expired on 08-JUL-2021 (expired product administered).  No adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: No additional AE reported.; Customer reports a patient received VARlVAX intramuscularly 03AUG2021.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not reported.  On 03-AUG-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) which was reconstituted with sterile diluent as prophylaxis, 1 dose, by intramuscular route (concentrations, number of administered dose, vaccination scheme frequency were not reported; lot number T032321 and expiration date 22-SEP-2022) (incorrect route of product administration). No adverse events were reported.  Lot No. T032321 has been verified to be a valid lot number for varicella virus vaccine live (Oka/Merck), expiration date reported as 22-SEP-2022.
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: AMENORRHEA/NOT HAVING PERIOD EVER SINCE VACCINATION; This spontaneous report received from a consumer concerned an adult female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced amenorrhea/not having period ever since vaccination. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from amenorrhea/not having period ever since vaccination. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Platelet count decreased, Thrombosis
Clinical narrative: BLOOD CLOTS; LOW PLATELETS; This spontaneous report was received via social media from the parent of a patient via a company representative and concerned a female of unspecified age, race and ethnicity. The patient's weight height and medical history were not reported. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, route of administration, batch number and expiry date not reported), dose not reported, administered on an unspecified date in APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request the batch number. No concomitant medications were reported. On an unspecified date, the patient was reported to have experienced blood clots and low platelets. The patient visited an emergency room/department or urgent care center for the events on an unspecified date. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The patient had not recovered from blood clots and low platelets. This report was serious (other medically important condition).; Sender's Comments: V0: This spontaneous report received from the parent of a patient via social media platform concerns a female of unspecified age, race, and ethnicity who visited the emergency department for blood clots and low platelets an unknown period of time after receiving the Janssen Covid-19 vaccine. Medical history, concomitant medications, clinical symptoms and signs, diagnostic testing, and corrective treatment were not reported. As of the time of the report, the patient had not recovered. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (per definition from Brighton Collaboration), the relationship of the events to vaccination is considered unclassifiable due to insufficient information. Additional information will be requested if contact information becomes available.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Illness, Pyrexia, Vomiting
Clinical narrative: VERY SICK; VOMITING; 103 FEVER; This spontaneous report received from a parent via a company representative concerned a 20 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced very sick, vomiting, and 103 fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine was not applicable. The outcome of very sick, 103 fever and vomiting was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Insomnia, Neck pain
Clinical narrative: COULDN'T SLEEP; WAS IN SO MUCH PAIN; NECK PAIN; SHOULDER BLADE PAIN; ARM WAS SLIGHTLY SORE; HEADACHE; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced couldn't sleep, was in so much pain, neck pain, shoulder blade pain, arm was slightly sore, headache, and fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from couldn't sleep, was in so much pain, neck pain, shoulder blade pain, arm was slightly sore, headache, and fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: COULDN'T SLEEP; WAS IN SO MUCH PAIN; NECK PAIN; SHOULDER BLADE PAIN; ARM WAS SLIGHTLY SORE; HEADACHE; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced couldn't sleep, was in so much pain, neck pain, shoulder blade pain, arm was slightly sore, headache, and fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from couldn't sleep, was in so much pain, neck pain, shoulder blade pain, arm was slightly sore, headache, and fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Hyperhidrosis, Insomnia
Clinical narrative: ZERO SLEEP; WOOZY; BODY ACHE; SWEAT; FEVER; SLIGHT NAUSEA; SLIGHT HEADACHE; FATIGUE; DISCOMFORT ON THE UPPER ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On AUG-2021, the patient experienced discomfort on the upper arm. On AUG-2021, the patient experienced slight headache. On AUG-2021, the patient experienced fatigue. On 06-AUG-2021, the patient experienced zero sleep. On 06-AUG-2021, the patient experienced woozy. On 06-AUG-2021, the patient experienced body ache. On 06-AUG-2021, the patient experienced sweat. On 06-AUG-2021, the patient experienced fever. On 06-AUG-2021, the patient experienced slight nausea. The action taken with covid-19 vaccine was not applicable. The patient was recovering from discomfort on the upper arm, zero sleep, woozy, fever, body ache, and sweat, and had not recovered from slight nausea, slight headache, and fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort, Nausea, Pain, Pyrexia
Clinical narrative: ZERO SLEEP; WOOZY; BODY ACHE; SWEAT; FEVER; SLIGHT NAUSEA; SLIGHT HEADACHE; FATIGUE; DISCOMFORT ON THE UPPER ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On AUG-2021, the patient experienced discomfort on the upper arm. On AUG-2021, the patient experienced slight headache. On AUG-2021, the patient experienced fatigue. On 06-AUG-2021, the patient experienced zero sleep. On 06-AUG-2021, the patient experienced woozy. On 06-AUG-2021, the patient experienced body ache. On 06-AUG-2021, the patient experienced sweat. On 06-AUG-2021, the patient experienced fever. On 06-AUG-2021, the patient experienced slight nausea. The action taken with covid-19 vaccine was not applicable. The patient was recovering from discomfort on the upper arm, zero sleep, woozy, fever, body ache, and sweat, and had not recovered from slight nausea, slight headache, and fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: very swollen lip; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (very swollen lip) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. V07M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced LIP SWELLING (very swollen lip). At the time of the report, LIP SWELLING (very swollen lip) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Tingling in both hands and arms, more on the left side; Numbness in both hands and arms, more on the left side; Moderate pain; A spontaneous report was received from a consumer concerning a 59-year-old, female patient who developed tingling in both hands and arms/ paraesthesia, numbness in both hands and arms/ hypoesthesia and moderate pain/ pain in extremity.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.      The patient received their first of two planned doses of mrna-1273 (Batch number not provided) on unknown.  On 15 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mrna-1273 (Batch number: 012MZ0A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.    On 15 Feb 2021, patient received second dose of vaccine and experienced events tingling in both hands and arms/ paraesthesia, numbness in both hands and arms/ hypoesthesia and moderate pain/ pain in extremity.  Treatment information was not provided.    The patient received both scheduled doses of mrna-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events tingling in both hands and arms/ paraesthesia, numbness in both hands and arms/ hypoesthesia and moderate pain/ pain in extremity were not reported.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: really bad headache; A spontaneous report was received from a consumer concerning a 69-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273)  experienced really bad headache. Concomitant medications were not reported  No relevant medical history  On 15-FEB- 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: UNKNOWN) intramuscularly  for prophylaxis of COVID-19 infection.    On 15-FEB- 2021, the patient experienced events like really bad headache.  No treatment for the event is reported   Action taken with mRNA-1273 in response to the events was not reported.     The events, headache were considered unknown serious criteria
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Rash
Clinical narrative: hot to the touch/burning; Rash on hip; A spontaneous report was received from a consumer, concerning a female patient of 71 years of age, who received Moderna's COVID-19 vaccine and experienced rash on her hip, hot to touch/burning/ dry skin.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an 17-FEB-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis..  On an 17-FEB-2021, after first dose of vaccine, the patient experienced rash on her hip . On an 18-FEB-2021  the patient experienced hot to touch/burning/ dry skin. No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was unkown.  The outcome of the event, rash on her hip, hot to touch/burning/ dry skin was considered to be not resolved at the time of this report.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Fungal infection, Limb discomfort
Clinical narrative: fungal infection; Arm discomfort; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm discomfort) and FUNGAL INFECTION (fungal infection) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03915120A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Muscle weakness (Muscle problem).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced LIMB DISCOMFORT (Arm discomfort). On an unknown date, the patient experienced FUNGAL INFECTION (fungal infection). The patient was treated with TERBINAFINE (LAMISIL [TERBINAFINE]) at a dose of 250 mg. On 18-Jan-2021, LIMB DISCOMFORT (Arm discomfort) had resolved. At the time of the report, FUNGAL INFECTION (fungal infection) outcome was unknown.            No concomitant medication was reported.; Sender's Comments: Based on the known profile for mRNA1273, a causal relationship between the event of groin infection  and product use is assessed as unlikely.  The event of nausea is consistent with the product safety profile, and temporarily associated with product use and a causal relationship cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body ache and pain all over; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache and pain all over) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Body ache and pain all over). At the time of the report, PAIN (Body ache and pain all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Vaccination site pain
Clinical narrative: TIREDNESS; FLU LIKE SYMPTOMS; BODY ACHES / PAINS; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (TIREDNESS), VACCINATION SITE PAIN (BODY ACHES / PAINS) and INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (BODY ACHES / PAINS). On an unknown date, the patient experienced FATIGUE (TIREDNESS) and INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FATIGUE (TIREDNESS), VACCINATION SITE PAIN (BODY ACHES / PAINS) and INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided by the reporter.  Upon internal review on 05-AUG-2021, age was corrected to 76 years as a discrepancy was noted where the narrative in the source document reported patient DOB with one date;  however in the patient identifier section the patient DOB was reported as a different date. Thus, considered the year (in the patient identifier section) as a typing error and corrected patient DOB with the year as reported in the narrative of the source document.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Lip swelling, Skin induration
Clinical narrative: Bottom lip on left side corner started swelling the size of small bubble/swollen into a big bubble; Lip was hard; Bubble on part of right side of face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIP SWELLING (Bottom lip on left side corner started swelling the size of small bubble/swollen into a big bubble), SKIN INDURATION (Lip was hard) and ACNE (Bubble on part of right side of face) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Diabetes and Environmental allergy. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN), LISINOPRIL, HYDROCHLOROTHIAZIDE, METFORMIN HCL, CETIRIZINE HYDROCHLORIDE (CETRIZINE) and COLECALCIFEROL, MENAQUINONE-7, PHYTOMENADIONE, RETINOL PALMITATE, TOCOPHEROL, TOCOTRIENOLS NOS (VITAMIN D COMPLEX) for an unknown indication.    On 17-Feb-2021 at 1:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced SKIN INDURATION (Lip was hard) and ACNE (Bubble on part of right side of face). On 17-Feb-2021 at 3:45 PM, the patient experienced LIP SWELLING (Bottom lip on left side corner started swelling the size of small bubble/swollen into a big bubble). On 18-Feb-2021, SKIN INDURATION (Lip was hard) had resolved. On 18-Feb-2021 at 9:00 AM, LIP SWELLING (Bottom lip on left side corner started swelling the size of small bubble/swollen into a big bubble) had resolved. At the time of the report, ACNE (Bubble on part of right side of face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: age, race, weight, height of patient, current conditions and allergy added, additional events added
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Erythema, Heart rate, Hypersensitivity, Injection site rash
Clinical narrative: couple of other people came in with the same delayed reaction; Itching/pruritus; Redness/erythema; Arm Rash; Hypersensitivity reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (couple of other people came in with the same delayed reaction), HYPERSENSITIVITY (Hypersensitivity reaction), PRURITUS (Itching/pruritus) and ERYTHEMA (Redness/erythema) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to sulpha-swallen skin, itching). Concomitant products included ALENDRONATE SODIUM (ALENDRONATE) for Osteopenia, CALCIUM, VITAMIN C [ASCORBIC ACID] and FISH OIL for an unknown indication.   On 13-Jan-2021 at 1:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021 at 1:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). On an unknown date, the patient experienced VACCINATION COMPLICATION (couple of other people came in with the same delayed reaction), PRURITUS (Itching/pruritus) and ERYTHEMA (Redness/erythema). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 22-Jan-2021 to 25-Jan-2021 at a dose of 1 dosage form. On 25-Jan-2021, HYPERSENSITIVITY (Hypersensitivity reaction) had resolved. At the time of the report, VACCINATION COMPLICATION (couple of other people came in with the same delayed reaction) had resolved and PRURITUS (Itching/pruritus) and ERYTHEMA (Redness/erythema) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: mmHg (normal) normal. On an unknown date, Heart rate: (normal) normal. On an unknown date, Respiratory rate: (normal) normal.         Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow-up information received on 22-APR-2021. Added second dose details, event outcome, concomitant medications and patient details. On 08-Jun-2021: Follow-up information received on 09-JUN-2021. Added concomitant medication-fish oil and diagnostic results.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Respiratory rate, Vaccination complication
Clinical narrative: couple of other people came in with the same delayed reaction; Itching/pruritus; Redness/erythema; Arm Rash; Hypersensitivity reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (couple of other people came in with the same delayed reaction), HYPERSENSITIVITY (Hypersensitivity reaction), PRURITUS (Itching/pruritus) and ERYTHEMA (Redness/erythema) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to sulpha-swallen skin, itching). Concomitant products included ALENDRONATE SODIUM (ALENDRONATE) for Osteopenia, CALCIUM, VITAMIN C [ASCORBIC ACID] and FISH OIL for an unknown indication.   On 13-Jan-2021 at 1:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021 at 1:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). On an unknown date, the patient experienced VACCINATION COMPLICATION (couple of other people came in with the same delayed reaction), PRURITUS (Itching/pruritus) and ERYTHEMA (Redness/erythema). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 22-Jan-2021 to 25-Jan-2021 at a dose of 1 dosage form. On 25-Jan-2021, HYPERSENSITIVITY (Hypersensitivity reaction) had resolved. At the time of the report, VACCINATION COMPLICATION (couple of other people came in with the same delayed reaction) had resolved and PRURITUS (Itching/pruritus) and ERYTHEMA (Redness/erythema) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: mmHg (normal) normal. On an unknown date, Heart rate: (normal) normal. On an unknown date, Respiratory rate: (normal) normal.         Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow-up information received on 22-APR-2021. Added second dose details, event outcome, concomitant medications and patient details. On 08-Jun-2021: Follow-up information received on 09-JUN-2021. Added concomitant medication-fish oil and diagnostic results.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Musculoskeletal stiffness, Myalgia, Pain, Vaccination site movement impairment
Clinical narrative: couldn't move her arm; so sore; stiff arm; hurt so bad to move the arm; hurt from her shoulder to her elbow; she fell backwards and it has started hurting more to move it since her fall.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move her arm), MYALGIA (so sore), MUSCULOSKELETAL STIFFNESS (stiff arm), VACCINATION SITE PAIN (hurt so bad to move the arm) and PAIN (hurt from her shoulder to her elbow) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included DICLOFENAC POTASSIUM (VOLTAREN ACTI) for an unknown indication.   On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move her arm), MYALGIA (so sore), MUSCULOSKELETAL STIFFNESS (stiff arm), VACCINATION SITE PAIN (hurt so bad to move the arm), PAIN (hurt from her shoulder to her elbow) and FALL (she fell backwards and it has started hurting more to move it since her fall.). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move her arm), MYALGIA (so sore), MUSCULOSKELETAL STIFFNESS (stiff arm), VACCINATION SITE PAIN (hurt so bad to move the arm), PAIN (hurt from her shoulder to her elbow) and FALL (she fell backwards and it has started hurting more to move it since her fall.) outcome was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: couldn't move her arm; so sore; stiff arm; hurt so bad to move the arm; hurt from her shoulder to her elbow; she fell backwards and it has started hurting more to move it since her fall.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move her arm), MYALGIA (so sore), MUSCULOSKELETAL STIFFNESS (stiff arm), VACCINATION SITE PAIN (hurt so bad to move the arm) and PAIN (hurt from her shoulder to her elbow) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included DICLOFENAC POTASSIUM (VOLTAREN ACTI) for an unknown indication.   On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move her arm), MYALGIA (so sore), MUSCULOSKELETAL STIFFNESS (stiff arm), VACCINATION SITE PAIN (hurt so bad to move the arm), PAIN (hurt from her shoulder to her elbow) and FALL (she fell backwards and it has started hurting more to move it since her fall.). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move her arm), MYALGIA (so sore), MUSCULOSKELETAL STIFFNESS (stiff arm), VACCINATION SITE PAIN (hurt so bad to move the arm), PAIN (hurt from her shoulder to her elbow) and FALL (she fell backwards and it has started hurting more to move it since her fall.) outcome was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: tiredness; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of fatigue (tiredness) and injection site pain (soreness at the injection site) in an 87-year-old female patient who received mrna-1273 (Moderna covid-19 vaccine) (batch no. 031l20a) for covid-19 vaccination.     the patient's past medical history included no adverse event (no historical condition reported.). concomitant products included blood thinners, hydrochlorothiazide and atorvastatin calcium (atorvastatin an), blood thinner and acelol.   on 13-feb-2021, the patient received dose of mrna-1273 (Moderna covid-19 vaccine) of (batch no. 031l20a) by (unknown route) at an unspecified dose for prophylaxis of COVID-19 infection.  The action taken with mrna-1273 (Moderna covid-19 vaccine) (unknown) was unknown. No treatment medication was reported.  on 13-feb-2021, the patient experienced fatigue (tiredness) and injection site pain (soreness at the injection site). on 13-feb-2021, injection site pain (soreness at the injection site) had resolved. at the time of the report, fatigue (tiredness) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea
Clinical narrative: diarrhea (golden color) that occur 2-3x a week; Shoulder ache; A spontaneous report was received from a consumer concerning a 89-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Shoulder ache and diarrhea (golden color) that occur 2-3x a week . The patient's medical history was not provided by the reporter. Concomitant medications include Metformin ,digoxin, Hydrochlorothiazide ,Levothyroxine ,propranolol, losartan and acyclovir. She had taken Bismuth Subsalicylate to treat  Stomach relief . On 24 Jan 2021  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A) via intra muscular  in unknown anatomical location for prophylaxis of COVID-19 infection.  After receiving the first dose ,the patient experienced shoulder ache pain for couple of hours . On 26 Jan 2021 patient experienced diarrhea (golden color) that occur 2-3x a week. Diarrhea is still evident.  Action taken with mRNA-1273 in response to the events was not unknown. The events of outcome  shoulder ache was Recovered /Resolved and the outcome of diarrhea was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain, Vaccination site warmth
Clinical narrative: big rump that is warm to the touch; Headache; Pain at the site of injection; A spontaneous report was received from a consumer concerning a female patient of 52 year old, who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced headache,vaccination site pain and big rump that is warm to the touch. The patients medical history was not provided.No relevant Concomitant medications were reported.  On 13 feb 2021,prior to the onset of events, the Patient received their first of two planned dose of mRNA-1273(Lot number: 031M20A) vaccine in the left arm for prophylaxis of COVID-19 infection. On 13-feb-2021,couple of hours later,patient experienced headache,vaccination site pain.  On 20-feb-2021,patient experienced big rump that is warm to the touch. No Treatment information for the event was provided. Action taken with second dose of mRNA-1273 in response to the event was not reported. The outcome for the events headache,vaccination site pain and big rump that is warm to the touch was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: sore arm; red arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and ERYTHEMA (red arm) 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 09-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 PAIN IN EXTREMITY (sore arm) and ERYTHEMA (red arm). At the time of the report, PAIN IN EXTREMITY (sore arm) and ERYTHEMA (red arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Exposure during pregnancy, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Body ache; Vaccine exposure during pregnancy; A spontaneous report was received from a consumer concerning a 38-year-old, female patient who Vaccine exposure during pregnancy, Fever/pyrexia and Body ache/Myalgia.    The patient's medical history was not provided.   Concomitant product includes prenatal vitamins.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 025L20A) on 07 Jan 2021.  On 04 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.   First dose of vaccine was administrated on 07 Jan 2021 and second dose on 04 feb 2021. Patient is received vaccine during the pregnancy. And experienced chills, fever and body ache.  Treatment for the event included Tylenol 500 mg.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events was not reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Flatulence, Oesophageal spasm, Pain, Rash
Clinical narrative: rash; pain; esophagus spasm; sneezing; gas; not feeling like herself; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash), PAIN (pain), OESOPHAGEAL SPASM (esophagus spasm), SNEEZING (sneezing) and FLATULENCE (gas) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history is provided and concomitant drugs are provided.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LIOTHYRONINE SODIUM (CYTOMEL), GUAIFENESIN (MUCINEX), FAMOTIDINE, CYCLOBENZAPRINE, LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), TRANEXAMIC ACID (XANEXTRA), LEVOSALBUTAMOL (LEVOLIN [LEVOSALBUTAMOL]), ACETYLSALICYLIC ACID (BABY ASPIRIN), BUDESONIDE (PULMICORT), MOMETASONE FUROATE (NASONEX), DICLOFENAC POTASSIUM (VOLTAREN ACTI), METRONIDAZOLE (NORITATE) and MINOXIDIL (ROGAINE).    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 08-Feb-2021, the patient experienced OESOPHAGEAL SPASM (esophagus spasm), SNEEZING (sneezing), FLATULENCE (gas) and DISCOMFORT (not feeling like herself). On 15-Feb-2021, the patient experienced RASH (rash) and PAIN (pain). On 09-Feb-2021, OESOPHAGEAL SPASM (esophagus spasm), SNEEZING (sneezing) and FLATULENCE (gas) had resolved. On 10-Feb-2021, DISCOMFORT (not feeling like herself) had resolved. On 22-Feb-2021, PAIN (pain) had resolved. At the time of the report, RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: rash; pain; esophagus spasm; sneezing; gas; not feeling like herself; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash), PAIN (pain), OESOPHAGEAL SPASM (esophagus spasm), SNEEZING (sneezing) and FLATULENCE (gas) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history is provided and concomitant drugs are provided.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LIOTHYRONINE SODIUM (CYTOMEL), GUAIFENESIN (MUCINEX), FAMOTIDINE, CYCLOBENZAPRINE, LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), TRANEXAMIC ACID (XANEXTRA), LEVOSALBUTAMOL (LEVOLIN [LEVOSALBUTAMOL]), ACETYLSALICYLIC ACID (BABY ASPIRIN), BUDESONIDE (PULMICORT), MOMETASONE FUROATE (NASONEX), DICLOFENAC POTASSIUM (VOLTAREN ACTI), METRONIDAZOLE (NORITATE) and MINOXIDIL (ROGAINE).    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 08-Feb-2021, the patient experienced OESOPHAGEAL SPASM (esophagus spasm), SNEEZING (sneezing), FLATULENCE (gas) and DISCOMFORT (not feeling like herself). On 15-Feb-2021, the patient experienced RASH (rash) and PAIN (pain). On 09-Feb-2021, OESOPHAGEAL SPASM (esophagus spasm), SNEEZING (sneezing) and FLATULENCE (gas) had resolved. On 10-Feb-2021, DISCOMFORT (not feeling like herself) had resolved. On 22-Feb-2021, PAIN (pain) had resolved. At the time of the report, RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: extremely red; injection site welt; itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDURATION (injection site welt), INJECTION SITE PRURITUS (itching at the injection site) and INJECTION SITE ERYTHEMA (extremely red) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced INJECTION SITE INDURATION (injection site welt) and INJECTION SITE PRURITUS (itching at the injection site). On 23-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (extremely red). At the time of the report, INJECTION SITE INDURATION (injection site welt), INJECTION SITE PRURITUS (itching at the injection site) and INJECTION SITE ERYTHEMA (extremely red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Muscular weakness, Peripheral swelling, Vaccination site erythema
Clinical narrative: Left arm feels weak; Burning sensation at the center of her back; Swollen left arm; Rash at injection site; Soreness at the injection site; Fatigue; A  spontaneous report was received from a consumer who is a  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue, vaccination site pain, arm swelling, vaccination site erythema, burning sensation on the back, and muscular weakness.  The  patient's medical history was not provided . No relevant concomitant medications were reported.  On 15-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown, route of administration:unknown)  in the left arm for prophylaxis of COVID-19 infection.   On 15-Jan-2021, the patient experienced fatigue and vaccination site pain. On 25-Jan-2021, the patient experienced arm swelling, vaccination site erythema and burning sensation on the back. On 05-Feb-2021, the patient experienced muscular weakness.  Treatment details include Benadryl and Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the events fatigue and  vaccination site pain was considered to be recovered/resolved.  The outcome for the events arm swelling, vaccination site erythema, burning sensation on the back, and muscular weakness was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Left arm feels weak; Burning sensation at the center of her back; Swollen left arm; Rash at injection site; Soreness at the injection site; Fatigue; A  spontaneous report was received from a consumer who is a  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue, vaccination site pain, arm swelling, vaccination site erythema, burning sensation on the back, and muscular weakness.  The  patient's medical history was not provided . No relevant concomitant medications were reported.  On 15-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown, route of administration:unknown)  in the left arm for prophylaxis of COVID-19 infection.   On 15-Jan-2021, the patient experienced fatigue and vaccination site pain. On 25-Jan-2021, the patient experienced arm swelling, vaccination site erythema and burning sensation on the back. On 05-Feb-2021, the patient experienced muscular weakness.  Treatment details include Benadryl and Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the events fatigue and  vaccination site pain was considered to be recovered/resolved.  The outcome for the events arm swelling, vaccination site erythema, burning sensation on the back, and muscular weakness was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.