chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Injection site pain, Peripheral swelling, Pruritus
Clinical narrative: SWELLING IN RIGHT HAND/SWELLING IN THE PALM  AND BACK OF RIGHT HAND; ITCHING IN RIGHT HAND/ ITCHINESS IN THE PALM  AND BACK OF RIGHT HAND; HAVING A LITTLE HEAT TO IT AS WELL; MILD INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa allergy, ragweed allergy, pet dander allergy, molds allergy, and environmental allergy. The patient experienced drug allergy when treated with cefalexin, and cefixime. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 18200096,and  expiry: UNKNOWN) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-AUG-2021, the patient experienced swelling in right hand/swelling in the palm and back of right hand. On 24-AUG-2021, the patient experienced itching in right hand/ itchiness in the palm and back of right hand. On 24-AUG-2021, the patient experienced having a little heat to it as well. On 24-AUG-2021, the patient experienced mild injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in right hand/swelling in the palm and back of right hand, mild injection site pain, itching in right hand/ itchiness in the palm and back of right hand, and having a little heat to it as well. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: ASTHMA; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced asthma, and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of asthma was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210849243-Covid-19 vaccine ad26.cov2.s-Asthma. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Arthralgia, Cough, Diarrhoea, Pain in extremity
Clinical narrative: ACHING JOINTS; COUGHING; STOMACH SWOLLEN UP; DIARRHEA; ARM SORENESS; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, smoker, and blood pressure, and other pre-existing medical conditions included: The patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 07-JUN-2021, the patient experienced arm soreness. On 20-AUG-2021, the patient experienced coughing. On 20-AUG-2021, the patient experienced stomach swollen up. On 20-AUG-2021, the patient experienced diarrhea. On 21-AUG-2021, Laboratory data included: COVID-19 antigen test (NR: not provided) positive for Covid-19 antibodies. On 22-AUG-2021, the patient experienced aching joints. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from coughing, stomach swollen up, diarrhea, and aching joints on AUG-2021, and arm soreness on 08-JUN-2021. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: ACHING JOINTS; COUGHING; STOMACH SWOLLEN UP; DIARRHEA; ARM SORENESS; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, smoker, and blood pressure, and other pre-existing medical conditions included: The patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 07-JUN-2021, the patient experienced arm soreness. On 20-AUG-2021, the patient experienced coughing. On 20-AUG-2021, the patient experienced stomach swollen up. On 20-AUG-2021, the patient experienced diarrhea. On 21-AUG-2021, Laboratory data included: COVID-19 antigen test (NR: not provided) positive for Covid-19 antibodies. On 22-AUG-2021, the patient experienced aching joints. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from coughing, stomach swollen up, diarrhea, and aching joints on AUG-2021, and arm soreness on 08-JUN-2021. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: RAN A LOW GRADE FEVER FOR THE FIRST 24 HOURS; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, and hyperlipidemia. The patient received covid-19 vaccine ad26.cov2.s (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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced ran a low grade fever for the first 24 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ran a low grade fever for the first 24 hours. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pruritus, Skin disorder
Clinical narrative: PAINFUL AND ITCHING BLISTERS ON BOTH HANDS; SPOTS ON LEGS ANKLES ARMS STOMACH WAIST AREA CHEST BACK UP TOWARD THE NECK; ITCHY SPOT; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included: blister. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 21-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-AUG-2021, the patient experienced spots on legs ankles arms stomach waist area chest back up toward the neck. On 22-AUG-2021, the patient experienced itchy spot. On 23-AUG-2021, the patient experienced painful and itching blisters on both hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from spots on legs ankles arms stomach waist area chest back up toward the neck, and itchy spot, and the outcome of painful and itching blisters on both hands was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a consumer concerned multiple patients. No past medical histories or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number were not reported and have been requested. No concomitant medications were reported.  On an unspecified dates, multiple patient developed blood clots. As per the reporter," I am worried about the Janssen vaccine because I heard that 2 or 3 patient had blood clots ranging from ages 18 to 49." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcomes for the multiple patients with blood clots was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210829146.; Sender's Comments: V0: 20210849364-COVID-19 VACCINE AD26.COV2.S-blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: SORE SHOULDER; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) 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 sore shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore shoulder. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Retching, Vomiting
Clinical narrative: DRY HEAVING; VOMITING; This spontaneous report received from a consumer concerned a 52 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no significant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 20-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-AUG-2021, the patient experienced dry heaving. On 24-AUG-2021, the patient experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, and dry heaving. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Headache, Impaired work ability
Clinical narrative: DIARRHEA; UNABLE TO WORK; PAIN IN HIPS AND NECKS; WEAK MUSCLES; HURTING IN BOTH SHOULDERS; HEADACHE; FEELING TIRED; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 19-SEP-2021) dose was not reported, administered on 11-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-AUG-2021, the patient experienced pain in hips and necks. On 12-AUG-2021, the patient experienced weak muscles. On 12-AUG-2021, the patient experienced hurting in both shoulders. On 12-AUG-2021, the patient experienced headache. On 12-AUG-2021, the patient experienced feeling tired. On 13-AUG-2021, the patient experienced unable to work. On 13-AUG-2021, the patient experienced diarrhea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from diarrhea, and had not recovered from headache, pain in hips and necks, feeling tired, weak muscles, hurting in both shoulders, and unable to work. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain
Clinical narrative: DIARRHEA; UNABLE TO WORK; PAIN IN HIPS AND NECKS; WEAK MUSCLES; HURTING IN BOTH SHOULDERS; HEADACHE; FEELING TIRED; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 19-SEP-2021) dose was not reported, administered on 11-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-AUG-2021, the patient experienced pain in hips and necks. On 12-AUG-2021, the patient experienced weak muscles. On 12-AUG-2021, the patient experienced hurting in both shoulders. On 12-AUG-2021, the patient experienced headache. On 12-AUG-2021, the patient experienced feeling tired. On 13-AUG-2021, the patient experienced unable to work. On 13-AUG-2021, the patient experienced diarrhea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from diarrhea, and had not recovered from headache, pain in hips and necks, feeling tired, weak muscles, hurting in both shoulders, and unable to work. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Pyrexia
Clinical narrative: COUGH; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 20-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-AUG-2021, the patient experienced cough. On 22-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cough, and fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Injection site pain, Pain, Pyrexia
Clinical narrative: SORENESS IS ABOUT A 2 FOR A DAY AFTER; NEEDLE PAIN IS MINOR; FEVER GOT UP TO 103; 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 ad26.cov2.s (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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced soreness is about a 2 for a day after, needle pain is minor, and fever got up to 103. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever got up to 103, and the outcome of needle pain is minor and soreness is about a 2 for a day after was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Illness, Injection site pain
Clinical narrative: Fever of 100.4F; Injection site arm hurts a lot; Chills; Feeling sick; Headache; A spontaneous report was received from a physician, who was a female patient who received Moderna's COVID-19 vaccine and experienced feeling sick, fever of 100.4 F, chills, headache, and injection site arm hurts a lot.    The patient's medical history included Covid-19 in March 2020. Concomitant medications were not provided.    On 22 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (Lot 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On the evening of 22 Dec 2020, the patient experienced a fever of 100.4 degrees Fahrenheit.   On 23 Dec 2020, the patient called and stated that her injection site arm hurt a lot. She denied redness at the injection site. She stated she was having side effects including feeling sick, chills, and headache and still felt symptomatic. Treatment included paracetamol.   Action taken with mRNA-1273 in response to the events feeling sick, fever of 100.4 F, chills, headache, and injection site arm hurts a lot, was not reported.   The events, feeling sick, fever of 100.4 F, chills, headache, and injection site arm hurts a lot, were considered not resolved.  The reporter assessed the events, feeling sick, fever of 100.4 F, chills, headache, and injection site arm hurts a lot as related to the study drug.; Reporter's Comments: This case concerns a female patient who experienced events of feeling sick, fever of 100.4 F, chills, headache, and injection site arm hurts a lot. The events occurred 1 day after the first dose of COVID-19 vaccine administration. Due to possible temporal relationship, the events are considered as related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 100.4F; Injection site arm hurts a lot; Chills; Feeling sick; Headache; A spontaneous report was received from a physician, who was a female patient who received Moderna's COVID-19 vaccine and experienced feeling sick, fever of 100.4 F, chills, headache, and injection site arm hurts a lot.    The patient's medical history included Covid-19 in March 2020. Concomitant medications were not provided.    On 22 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (Lot 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On the evening of 22 Dec 2020, the patient experienced a fever of 100.4 degrees Fahrenheit.   On 23 Dec 2020, the patient called and stated that her injection site arm hurt a lot. She denied redness at the injection site. She stated she was having side effects including feeling sick, chills, and headache and still felt symptomatic. Treatment included paracetamol.   Action taken with mRNA-1273 in response to the events feeling sick, fever of 100.4 F, chills, headache, and injection site arm hurts a lot, was not reported.   The events, feeling sick, fever of 100.4 F, chills, headache, and injection site arm hurts a lot, were considered not resolved.  The reporter assessed the events, feeling sick, fever of 100.4 F, chills, headache, and injection site arm hurts a lot as related to the study drug.; Reporter's Comments: This case concerns a female patient who experienced events of feeling sick, fever of 100.4 F, chills, headache, and injection site arm hurts a lot. The events occurred 1 day after the first dose of COVID-19 vaccine administration. Due to possible temporal relationship, the events are considered as related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance test, Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Pregnant and received the Moderna Covid-19 Vaccine today; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received the Moderna Covid-19 Vaccine today) in a 32-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (Socially). Concurrent medical conditions included Penicillin allergy and Hashimoto's thyroiditis (Has not been given any treatment) since 2016. Concomitant products included ONDANSETRON (ZOFRAN [ONDANSETRON]) from 15-Jun-2020 to 23-Jan-2021 for Nausea in pregnancy, PRE NATAL FORMULA from 07-Mar-2020 to an unknown date for Pregnancy.    On 23-Dec-2020 at 1:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 30-Apr-2020 and the estimated date of delivery was 04-Feb-2021. On 23-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received the Moderna Covid-19 Vaccine today). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy. The vaginal delivery occurred, which was reported as Full-term.There was perinatal complications or fetal/infant abnormalities. No abnormalities were noted at 1 month post-partum. On 23-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received the Moderna Covid-19 Vaccine today) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2020, Pregnancy test: positive (Positive) Positive. In July 2020, Ultrasound scan: normal (normal) normal. In September 2020, Ultrasound scan: normal (normal) normal. In November 2020, Glucose tolerance test: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  The patient had one live full term birth.  The estimated date of conception was reported as 30-May-2020. The patient had no maternal history of subfertility and had established prenatal care. There was no complications or acute illness reported during tis pregnancy.   This case was linked to MOD-2020-001339 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: The patient information, pregnancy information and concomitant product dosage information were updated.; Sender's Comments: This is a case of product exposure during pregnancy with no associated adverse events for this female patient. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Aphasia, Depressed level of consciousness, Disturbance in attention, Dysgraphia
Clinical narrative: Problems with concentration, couldn't concentrate; Trouble finding her words, could't speak properly, experience kind of aphasia symptoms; Mind fogginess, brain fog; Hives; Difficulty remembering names; Difficult to do writing tasks; Heart race; nervousness of getting the vaccine; Swallen in the injection site; Redness in the injection site; A spontaneous report was received from a 70-year-old, female consumer who received Moderna's COVID-19 vaccine and developed problems with concentration, could not speak properly, trouble finding her words, brain fog/ mind fogginess, hives, redness and swelling at the injection site, difficult to do writing tasks, difficulty remembering things, increment in heartbeat, heart racing, nervousness of getting the vaccine.   The patient's past medical history, as provided by the reporter, included long lasting, bad side effects following the influenza vaccine. Concomitant medication reported included vitamins.  On 28 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On 28 Dec 2020, four hours after receiving the vaccine, the patient developed problems with concentration, trouble finding her words, mind fogginess, hives, redness and swelling at the injection site, difficult to do writing tasks, difficulty remembering things, increment heart beat.  Treatment for the event included tylenol and ibuprofen.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the events, developed problems with concentration, trouble finding her words, mind fogginess, hives, redness and swelling at the injection site, increment heartbeat were considered as recovered on 30 Dec 2020. At the time of report outcome of the events difficult to do writing tasks, difficulty remembering things was unknown.  The reporter's assessment of causality for the events was not applicable.  Additional information received on 31 Dec 2020: Events updated.  Follow up received on 23Mar2021, included no new information.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Palpitations, Urticaria, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Problems with concentration, couldn't concentrate; Trouble finding her words, could't speak properly, experience kind of aphasia symptoms; Mind fogginess, brain fog; Hives; Difficulty remembering names; Difficult to do writing tasks; Heart race; nervousness of getting the vaccine; Swallen in the injection site; Redness in the injection site; A spontaneous report was received from a 70-year-old, female consumer who received Moderna's COVID-19 vaccine and developed problems with concentration, could not speak properly, trouble finding her words, brain fog/ mind fogginess, hives, redness and swelling at the injection site, difficult to do writing tasks, difficulty remembering things, increment in heartbeat, heart racing, nervousness of getting the vaccine.   The patient's past medical history, as provided by the reporter, included long lasting, bad side effects following the influenza vaccine. Concomitant medication reported included vitamins.  On 28 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On 28 Dec 2020, four hours after receiving the vaccine, the patient developed problems with concentration, trouble finding her words, mind fogginess, hives, redness and swelling at the injection site, difficult to do writing tasks, difficulty remembering things, increment heart beat.  Treatment for the event included tylenol and ibuprofen.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the events, developed problems with concentration, trouble finding her words, mind fogginess, hives, redness and swelling at the injection site, increment heartbeat were considered as recovered on 30 Dec 2020. At the time of report outcome of the events difficult to do writing tasks, difficulty remembering things was unknown.  The reporter's assessment of causality for the events was not applicable.  Additional information received on 31 Dec 2020: Events updated.  Follow up received on 23Mar2021, included no new information.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician assistant and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 34-year-old female patient who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form at an unspecified frequency. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 21-Apr-2021. On 29-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 29-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.            Causality for event Vaccine exposure during pregnancy is not applicable. It was reported the she was am 23 weeks pregnant. As of 30 Dec 2020, she was 24 weeks pregnant.; Sender's Comments: Causality for event Vaccine exposure during pregnancy is not applicable.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersensitivity, Injection site erythema, Musculoskeletal pain, Nausea
Clinical narrative: musculoskeletal pain; itching at injection site; Fever; Nauseating feeling; soreness around injection site; Nerve pain; Delayed allergic reaction; Red itchy wheel; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL PAIN (musculoskeletal pain), NEURALGIA (Nerve pain), HYPERSENSITIVITY (Delayed allergic reaction), INJECTION SITE ERYTHEMA (Red itchy wheel) and FATIGUE (Fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE for Hypothyroidism.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced NEURALGIA (Nerve pain), HYPERSENSITIVITY (Delayed allergic reaction), INJECTION SITE ERYTHEMA (Red itchy wheel) and FATIGUE (Fatigue). On an unknown date, the patient experienced MUSCULOSKELETAL PAIN (musculoskeletal pain), VACCINATION SITE PRURITUS (itching at injection site), PYREXIA (Fever), NAUSEA (Nauseating feeling) and VACCINATION SITE PAIN (soreness around injection site). At the time of the report, MUSCULOSKELETAL PAIN (musculoskeletal pain), NEURALGIA (Nerve pain), HYPERSENSITIVITY (Delayed allergic reaction), INJECTION SITE ERYTHEMA (Red itchy wheel), FATIGUE (Fatigue), VACCINATION SITE PRURITUS (itching at injection site), PYREXIA (Fever), NAUSEA (Nauseating feeling) and VACCINATION SITE PAIN (soreness around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event included ibuprofen 200mg, acetaminophen 350mg and fexofenadine 60mg.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pyrexia, Vaccination site pain, Vaccination site pruritus
Clinical narrative: musculoskeletal pain; itching at injection site; Fever; Nauseating feeling; soreness around injection site; Nerve pain; Delayed allergic reaction; Red itchy wheel; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL PAIN (musculoskeletal pain), NEURALGIA (Nerve pain), HYPERSENSITIVITY (Delayed allergic reaction), INJECTION SITE ERYTHEMA (Red itchy wheel) and FATIGUE (Fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE for Hypothyroidism.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced NEURALGIA (Nerve pain), HYPERSENSITIVITY (Delayed allergic reaction), INJECTION SITE ERYTHEMA (Red itchy wheel) and FATIGUE (Fatigue). On an unknown date, the patient experienced MUSCULOSKELETAL PAIN (musculoskeletal pain), VACCINATION SITE PRURITUS (itching at injection site), PYREXIA (Fever), NAUSEA (Nauseating feeling) and VACCINATION SITE PAIN (soreness around injection site). At the time of the report, MUSCULOSKELETAL PAIN (musculoskeletal pain), NEURALGIA (Nerve pain), HYPERSENSITIVITY (Delayed allergic reaction), INJECTION SITE ERYTHEMA (Red itchy wheel), FATIGUE (Fatigue), VACCINATION SITE PRURITUS (itching at injection site), PYREXIA (Fever), NAUSEA (Nauseating feeling) and VACCINATION SITE PAIN (soreness around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event included ibuprofen 200mg, acetaminophen 350mg and fexofenadine 60mg.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Arm soreness; Really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm soreness) and HEADACHE (Really bad headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm soreness) and HEADACHE (Really bad headache). At the time of the report, VACCINATION SITE PAIN (Arm soreness) and HEADACHE (Really bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up received containsed no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Vaccination site erythema, Vaccination site pain
Clinical narrative: Has a red circle at injection site; red circle at injection site feels like a bruise; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Has a red circle at injection site), VACCINATION SITE PAIN (red circle at injection site feels like a bruise) and RHINORRHOEA (Runny nose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and MULTI VITAMIN & MINERAL.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (red circle at injection site feels like a bruise) and RHINORRHOEA (Runny nose). On 14-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Has a red circle at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Has a red circle at injection site), VACCINATION SITE PAIN (red circle at injection site feels like a bruise) and RHINORRHOEA (Runny nose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included unknown antidepressants.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site discomfort
Clinical narrative: soreness at administration site; Fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE DISCOMFORT (soreness at administration site) and FATIGUE (Fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition reported.).    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 DISCOMFORT (soreness at administration site) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE DISCOMFORT (soreness at administration site) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Headache, Vaccination site pain
Clinical narrative: Light headed; wheezing; pressure in chest; trouble breathing; soreness in vaccinated arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed), WHEEZING (wheezing), CHEST DISCOMFORT (pressure in chest), DYSPNOEA (trouble breathing) and VACCINATION SITE PAIN (soreness in vaccinated arm) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced DIZZINESS (Light headed), WHEEZING (wheezing), CHEST DISCOMFORT (pressure in chest), DYSPNOEA (trouble breathing), VACCINATION SITE PAIN (soreness in vaccinated arm) and HEADACHE (headache). At the time of the report, DIZZINESS (Light headed), WHEEZING (wheezing), CHEST DISCOMFORT (pressure in chest), DYSPNOEA (trouble breathing), VACCINATION SITE PAIN (soreness in vaccinated arm) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.   This case was linked to MOD-2021-043718 (Parent-Child Link).   See case MOD-2021-043718 for details regarding the child case.  Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Outcome and reporter causality of events updated.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Light headed; wheezing; pressure in chest; trouble breathing; soreness in vaccinated arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed), WHEEZING (wheezing), CHEST DISCOMFORT (pressure in chest), DYSPNOEA (trouble breathing) and VACCINATION SITE PAIN (soreness in vaccinated arm) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced DIZZINESS (Light headed), WHEEZING (wheezing), CHEST DISCOMFORT (pressure in chest), DYSPNOEA (trouble breathing), VACCINATION SITE PAIN (soreness in vaccinated arm) and HEADACHE (headache). At the time of the report, DIZZINESS (Light headed), WHEEZING (wheezing), CHEST DISCOMFORT (pressure in chest), DYSPNOEA (trouble breathing), VACCINATION SITE PAIN (soreness in vaccinated arm) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.   This case was linked to MOD-2021-043718 (Parent-Child Link).   See case MOD-2021-043718 for details regarding the child case.  Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Outcome and reporter causality of events updated.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Dry mouth, Lip dry, Thirst
Clinical narrative: thirsty; feels very dehydrated; dry lips and mouth; dry lips and mouth; This spontaneous case was reported by a consumer and describes the occurrence of   in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021 at 9:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.    Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nausea
Clinical narrative: diarrhea; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), HEADACHE (headache) and NAUSEA (nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced DIARRHOEA (diarrhea), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, DIARRHOEA (diarrhea), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Arthropod sting, Asthenia, Muscular weakness, Pain, Pruritus
Clinical narrative: Arm was swollen and itchy/Larger swelling, more itching; Throbbing; Overall weakness of arm; larger swelling, more itching, throbbing; larger swelling, more itching, throbbing; Overall weakness of my arm; larger swelling, more itching, throbbing; Arm was swollen and itchy; FELT LIKE BEE STING; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Arm was swollen and itchy), ARTHROPOD STING (FELT LIKE BEE STING), VACCINATION SITE PRURITUS (Arm was swollen and itchy/Larger swelling, more itching), VACCINATION SITE PAIN (Throbbing) and ASTHENIA (Overall weakness of arm) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Arm was swollen and itchy) and ARTHROPOD STING (FELT LIKE BEE STING). On 19-Jan-2021, the patient experienced SWELLING (larger swelling, more itching, throbbing), PAIN (larger swelling, more itching, throbbing) and MUSCULAR WEAKNESS (Overall weakness of my arm). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Arm was swollen and itchy/Larger swelling, more itching), VACCINATION SITE PAIN (Throbbing), ASTHENIA (Overall weakness of arm) and PRURITUS (larger swelling, more itching, throbbing). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 18-Jan-2021 at an unspecified dose and frequency; PREDNISONE ongoing from 20-Jan-2021 at a dose of 20 milligram twice a day and AMOXICILLIN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Arm was swollen and itchy), ARTHROPOD STING (FELT LIKE BEE STING), VACCINATION SITE PRURITUS (Arm was swollen and itchy/Larger swelling, more itching), VACCINATION SITE PAIN (Throbbing), ASTHENIA (Overall weakness of arm), SWELLING (larger swelling, more itching, throbbing), PRURITUS (larger swelling, more itching, throbbing), PAIN (larger swelling, more itching, throbbing) and MUSCULAR WEAKNESS (Overall weakness of my arm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.