chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (aches) and CHILLS (Chills). At the time of the report, PAIN (aches) and CHILLS (Chills) outcome was unknown.            The reporter reported that his grandson received a second shot of vaccine and experienced aches and chills. No concomitant medications were provided by the reporter Treatment information was not provided by the reporter   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: some discomfort shoulder pain in the upper arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (some discomfort shoulder pain in the upper arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025620A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (some discomfort shoulder pain in the upper arm). On 19-Jan-2021, VACCINATION SITE PAIN (some discomfort shoulder pain in the upper arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vaccination site pain
Clinical narrative: Feeling a little light-headed; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling a little light-headed) and VACCINATION SITE PAIN (Sore arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced DIZZINESS (Feeling a little light-headed) and VACCINATION SITE PAIN (Sore arm). On 09-Jan-2021, DIZZINESS (Feeling a little light-headed) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment related information has been reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: Not feeling well/didn't feel very well for 24hrs; headache/wicked headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well/didn't feel very well for 24hrs) and HEADACHE (headache/wicked headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Not feeling well/didn't feel very well for 24hrs) and HEADACHE (headache/wicked headache). At the time of the report, MALAISE (Not feeling well/didn't feel very well for 24hrs) and HEADACHE (headache/wicked headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up received and events: headache(wicked headache) and malaise(didn't feel very well for 24 hrs) have been updated.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Vaccination site pain
Clinical narrative: not feeling completely normal; general weakness; injection site is sore to touch; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (not feeling completely normal), ASTHENIA (general weakness) and VACCINATION SITE PAIN (injection site is sore to touch) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced FEELING ABNORMAL (not feeling completely normal), ASTHENIA (general weakness) and VACCINATION SITE PAIN (injection site is sore to touch). At the time of the report, FEELING ABNORMAL (not feeling completely normal), ASTHENIA (general weakness) and VACCINATION SITE PAIN (injection site is sore to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's medical history was not provided. Concomitant medications was not reported.  This case concerns a 88 year old male subject with, who experienced the unlisted events of feeling abnormal and asthenia. The events occurred 1 day  after first dose of IP. No action was taken with IP. The event´s outcome were unknown on 16 Apr 2021. The events were considered possible related to IP in agreement with the reporter due to temporal association.   Reporter did not allow further contact; Sender's Comments: This case concerns a 88 year old male subject with, who experienced the unlisted events of feeling abnormal and asthenia. The events occurred 1 day  after first dose of IP. No action was taken with IP. The event´s outcome were unknown on 16 Apr 2021. The events were considered possible related to IP in agreement with the reporter due to temporal association.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: Hard to touch around the injection site; Redness around the injection site; Soreness, tenderness and hard to touch around the injection site and hurt to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hard to touch around the injection site), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE PAIN (Soreness, tenderness and hard to touch around the injection site and hurt to touch) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Acid reflux (oesophageal). Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Acid reflux (oesophageal), ATENOLOL and AMLODIPINE BESILATE (NORVASC) for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Hard to touch around the injection site), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE PAIN (Soreness, tenderness and hard to touch around the injection site and hurt to touch). At the time of the report, VACCINATION SITE INDURATION (Hard to touch around the injection site), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE PAIN (Soreness, tenderness and hard to touch around the injection site and hurt to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient did not received any treatment but going to take a diphenhydramine.  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; 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Pruritus, Urticaria
Clinical narrative: feels very itchy; systemic hives over her whole body from her neck to her toes; flare up; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (feels very itchy), URTICARIA (systemic hives over her whole body from her neck to her toes) and CONDITION AGGRAVATED (flare up) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH RELIEF) for an unknown indication.    No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH RELIEF) (unknown route) at an unspecified dose. On 08-Jan-2021, the patient experienced PRURITUS (feels very itchy), URTICARIA (systemic hives over her whole body from her neck to her toes) and CONDITION AGGRAVATED (flare up). At the time of the report, PRURITUS (feels very itchy), URTICARIA (systemic hives over her whole body from her neck to her toes) and CONDITION AGGRAVATED (flare up) 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.; 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site nodule, Vaccination site warmth
Clinical narrative: Nodule size of a quarter on the injection site; Injection site warm to touch; Injection site red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (Nodule size of a quarter on the injection site), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE WARMTH (Injection site warm to touch) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011620A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE NODULE (Nodule size of a quarter on the injection site), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE WARMTH (Injection site warm to touch). At the time of the report, VACCINATION SITE NODULE (Nodule size of a quarter on the injection site), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE WARMTH (Injection site warm to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: Hives at injection site was lumpy; Hives at the inejction site; Hives at injection site stings and hurt; itchiness/Itchy at the injection site; soreness on day of injection; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (soreness on day of injection), VACCINATION SITE PRURITUS (itchiness/Itchy at the injection site), VACCINATION SITE URTICARIA (Hives at the inejction site), VACCINATION SITE MASS (Hives at injection site was lumpy) and VACCINATION SITE PAIN (Hives at injection site stings and hurt) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness on day of injection). On 10-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness/Itchy at the injection site). On 11-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Hives at the inejction site), VACCINATION SITE MASS (Hives at injection site was lumpy) and VACCINATION SITE PAIN (Hives at injection site stings and hurt). On 08-Jan-2021, VACCINATION SITE PAIN (soreness on day of injection) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itchiness/Itchy at the injection site), VACCINATION SITE URTICARIA (Hives at the inejction site), VACCINATION SITE MASS (Hives at injection site was lumpy) and VACCINATION SITE PAIN (Hives at injection site stings and hurt) 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 was not reported. The patient experienced soreness on day of injection and was fine that Friday. However, on Sunday,10-Jan-2021 she experienced itchiness and on Monday, 11-Jan-2021, she developed hives, it was lumpy, itchy, stings and hurt. The patient only showered and used ice packs to relieve the symptoms and was currently at the doctor's office at the time of report.; 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: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L26A and 032L20A) for COVID-19 vaccination.  The patient's past medical history included Migraine (Chronic Migraines). Concurrent medical conditions included Polycystic ovarian syndrome. Concomitant products included LEVOMILNACIPRAN HYDROCHLORIDE (FETZIMA), LAMOTRIGINE (LAMICTAL), LIRAGLUTIDE (SAXENDA), BOTULINUM TOXIN TYPE A (BOTOX) and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 10-Jan-2021, PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Body temperature: 102 abnormal (High) 102.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jan-2021: Followup received on 11-Jan-2021. Address was added, patient details were added, past medical history was mentioned, concomitant medication were updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Hives; Itchy area of injection; hot to touch; Redness at site for injection; Soreness at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at site for injection), VACCINATION SITE PAIN (Soreness at site of injection), URTICARIA (Hives), VACCINATION SITE PRURITUS (Itchy area of injection) and VACCINATION SITE WARMTH (hot to touch) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at site for injection) and VACCINATION SITE PAIN (Soreness at site of injection). On 11-Jan-2021, the patient experienced URTICARIA (Hives), VACCINATION SITE PRURITUS (Itchy area of injection) and VACCINATION SITE WARMTH (hot to touch). On 05-Jan-2021, VACCINATION SITE ERYTHEMA (Redness at site for injection) and VACCINATION SITE PAIN (Soreness at site of injection) had resolved. At the time of the report, URTICARIA (Hives) and VACCINATION SITE WARMTH (hot to touch) outcome was unknown and VACCINATION SITE PRURITUS (Itchy area of injection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. Treatment details include ice pack, Benadryl cream, hydrocortisone cream.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: Vomiting; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) and HEADACHE (Headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomiting) and HEADACHE (Headaches). At the time of the report, VOMITING (Vomiting) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment medications were not provided by reporter.   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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: injection site hard; injection site warm to touch; injection site red in a perfect square; injection site started itching; bruising at injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Jan-2021 and was forwarded to Moderna on 14-Jan-2021.    A spontaneous report was received from a consumer (United States) concerning a 22 year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed bruising, itching, redness, warmth, and hardness at the injection site.   The patient's medical history and relevant concomitant medications were not reported.   On 04 Jan 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient experienced bruising at the injection site on 05 Jan 2021.  On 07 Jan 2021 the patient developed itching at the injection site and on 08 Jan 2021 the patient developed warmth, redness, and hardness at the injection site.  A doctor prescribed an anti-inflammatory medication and the patient was advised to treat the events with a cold compress and diphenhydramine.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events bruising, itching, redness, warmth, and hardness at the injection site were not reported.  Reporter causality for the events was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: pregnant patient received the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant patient received the vaccine) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20/2A) for COVID-19 vaccination.     Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and PRENATAL VITAMINS [ASCORBIC ACID;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;ERGOCALCIFEROL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL PALMITATE;RIBOFLAVIN;THIAMINE MONONITRATE] for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 20-Jun-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnant patient received the vaccine). At the time of the report, EXPOSURE DURING PREGNANCY (pregnant patient received the vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided  This is a case of vaccine exposure during pregnancy with no associated AEs for this 38 year old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy; Reporter's Comments: This is a case of vaccine exposure during pregnancy with no associated AEs for this 38 year old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Feeling hot, Pain, Pain in extremity
Clinical narrative: feeling dizzy; worried I will fall; feeling too hot; Pain in arm; body aches; A spontaneous report was received from a consumer  concerning a 36-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain in arm,bodyaches,feeling dizzy,anxiety and feeling too hot. .   The patient's medical history, as provided by the reporter, included allergy to pollen. Concomitant medications reported included birth control,vitamin and Claritin for allergies to pollen.  On  11 Jan 2021  prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: unknown)  in the left arm for prophylaxis of COVID-19 infection.   On 11 Jan 2021 , prior to receiving mRNA-1273, the patient felt  pain in arm,bodyaches and on 12 Jan 2021 feeling dizzy,anxiety and feeling too hot. Treatment for the events was unknown. Action taken with mRNA-1273 in response to the events was not reported.   The  outcome of the events pain in arm,bodyaches,feeling dizzy,anxiety and feeling too hot was unknown.; 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: Dizziness
Clinical narrative: Lightheadedness; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Lightheadedness) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced DIZZINESS (Lightheadedness). At the time of the report, DIZZINESS (Lightheadedness) 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 product use was not provided by the reporter. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Red itchy bumps on her arm ,back, face, chest, legs, elbows, hands, feet; Red itchy bumps on her arm ,back, face, chest, legs, elbows, hands, feet; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Red itchy bumps on her arm ,back, face, chest, legs, elbows, hands, feet) and ERYTHEMA (Red itchy bumps on her arm ,back, face, chest, legs, elbows, hands, feet) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PRURITUS (Red itchy bumps on her arm ,back, face, chest, legs, elbows, hands, feet) and ERYTHEMA (Red itchy bumps on her arm ,back, face, chest, legs, elbows, hands, feet). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) at an unspecified dose and frequency and RANITIDINE HYDROCHLORIDE (ZANTAC) at an unspecified dose and frequency. At the time of the report, PRURITUS (Red itchy bumps on her arm ,back, face, chest, legs, elbows, hands, feet) and ERYTHEMA (Red itchy bumps on her arm ,back, face, chest, legs, elbows, hands, feet) 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 for the events included OTC benadryl, pepcid, steroids and zantac.; 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: 13.0
Sex: U
Vaccine: HPV9, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reported vaccines were exposed to high and low temperatures. Caller reported GARDASIL 9 (lot T025370 exp 12/1/2022) was administered to a patient.; This spontaneous report was received from a health care professional (also reported as "office manager") and refers to a 13-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and alergies were not reported.      On 07-JUL-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number T025370, which has been verified to be valid, the expiration date was reported and validated as 01-DEC-2022), as prophylaxis (product storage error) (dose, dose number, route of administration, and anatomical site of vaccination were not provided).  The suspect vaccine was stored at a temperature above 46 degrees Fahrenheit (F) (49.7 F, for a time frame of 1 hour and 47 F for a time frame 20 minutes), below 36 degrees F (33.9 F, for a time frame of 15 hours, 35..1 F for a time frame of 30 minutes, 35.5 F for a time frame of 1 hour, and 35 F for a time frame of 1 hour). No previous temperature excursion was reported. No digital logger was involved. No additional adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T025370; expirationdate: 01-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; an expired dose of PNEUMOVAX 23 was administered; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 07-JUL-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S034299, expiration date 01-JUL-2021 (dose, route of administration and anatomical location were not reported) for prophylaxis. There had been no prior temperature excursion for the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). There was no additional adverse event reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S034299; expirationdate: 01-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2107USA006841: US-009507513-2107USA006618:
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: syncope episode; This spontaneous report was received from a medical assistant, referring to a 12-year-old male patient.  Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.       On 30-JUL-2021, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose: 0.5 ml, lot # 1621926, expiration date was reported and validated as 28-NOV-2021) intramuscular for prophylaxis.    On the same day, the patient experienced syncope episode. The patient was in the doctor's office when it occurred. No treatment was provided only the patient's vitals were taken when he woke from the syncope episode. The patient fully recovered before leaving the doctor's office on the same day. Therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was also reported as continued.  The causality assessment between the event syncope episode and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, syncope episode was determined to be medically significant. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621926; expirationdate: 28-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE; an expired dose of PROQUAD was inadvertently administered; This spontaneous report was received from an office manager regarding a 4-year-old patient whose gender was not specified. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medication, and drug reactions or allergies was provided.  On 04-AUG-2021, the patient was inadvertently administered an expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) (lot number S017246 has been verified to be valid, expiration date reported and validated as 01-DEC-2020) (administered dose, dose number, vaccination scheme frequency, route of administration, and anatomical location of vaccination were not reported) for prophylaxis (expired product administered). The reporter was inquiring if the administered dose was a supported valid dose. No other adverse events (AE) were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: I'm down for 3 days; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the shingles shot and was down for 3 days. The patient had ever shot with no side effects.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: so sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was not recovered/not resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient for himself/herself. The age at vaccination was not reported. The patient got a shot and was so sick. The patient was doctored for 9 years and 9 months and would always had the results of what it did to him/her. It was horrible. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got second one/ 8 months later.; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date, 8 months before 2nd dose).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details provided were as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient was expected to receive the 2nd shot 2 to 6 months after, but he/she did not really followed through and received 2nd dose 8 months later which led to lengthening of vaccination schedule and asked to start over again as in next year it would be 3 years. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Nausea
Clinical narrative: Got 2nd 2 days ago. I had bad headache; Got 2nd 2 days ago. I had / nausea; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 3rd August 2021, the patient received the 2nd dose of Shingles vaccine. In August 2021, less than a week after receiving Shingles vaccine, the patient experienced headache and nausea. On an unknown date, the outcome of the headache and nausea were unknown.   It was unknown if the reporter considered the headache and nausea to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingle vaccine 2 days before the date of reporting. The patient experienced bad headache and nausea. No further information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Nerve injury, Vaccination failure
Clinical narrative: Suspected Vaccination failure; got shingles on the bottom of my feet / suffer for a long time with it being on my feet; nerve damage in both feet; my left foot is numb I suffer every day; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, nerve damage and numbness in feet. The patient was treated with vicks vaporub nos (Vicks Salve (Nos)). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving and the outcome of the nerve damage and numbness in feet were not recovered/not resolved.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine. It was unknown if the reporter considered the nerve damage and numbness in feet to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles shot, the patient got shingles on the bottom of his/her feet. The patient suffered for a long time with it being on his/her feet. Both feet it took a long time to heal. The patient's friend asked, what happened to his/her feet and he/she told her, he/she did not know. She said, go and get some Vicks salve and the patient did and they started healing pretty fast.  The patient's doctor put him/her on everything tried to heal but nothing worked. And after all of it, no one told the patient it was from the shot, but he/she knew it was. Later, the patient went back to his/her doctor and said he/she had the shingles and he took at him/she and said yes you were right. At the time of reporting, the patient was suffered with nerve damage in both feet do to this, his/her left foot was numb, and he/she suffered every day. The patient suggested to be careful about taking shot. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Peripheral swelling, Pyrexia
Clinical narrative: fever; swelling in arm; chills; redness in arm; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd June 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 22nd June 2021, less than a day after receiving Shingrix, the patient experienced fever, swelling arm, chills and erythema of extremities. On an unknown date, the outcome of the fever, swelling arm, chills and erythema of extremities were recovered/resolved.   It was unknown if the reporter considered the fever, swelling arm, chills and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The case was reported by the husband of the patient. The patient got her first Shingrix vaccine in an unknown arm and experienced fever, swelling in arm, chills, and redness in arm.  For the tolerance of the 2nd dose of Shingrix, refer case US2021AMR166370. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR166370:Same reporter
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dyspnoea, Hypersensitivity, Pain in extremity, Pyrexia
Clinical narrative: Elevated blood pressure; allergic reactions; Fever; rash from head to toe/ Full body rash; Blurred vision; Struggling to breath /  trouble breathing; Pain in left arm; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 56-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2016-2017 season) (batch number C54L3, expiry date 30th June 2017) for prophylaxis.   Previously administered products included Fluarix with an associated reaction of pyrexia (received a dose on 19th October 2015 with batch number 33FF2 and expiry date 30th June 2016 also experienced rash, refer case US2021AMR166737).   On 30th November 2016, the patient received Fluarix Quadrivalent 2016-2017 season (intramuscular). On 30th November 2016, less than a day after receiving Fluarix Quadrivalent 2016-2017 season, the patient experienced allergic reaction, fever, generalized rash, blurred vision, dyspnea and pain in arm. On 1st December 2016, the patient experienced increased blood pressure. The patient was treated with intravenous fluid (nos) (Iv Therapy (Nos)). Rechallenge with Fluarix Quadrivalent 2016-2017 season was positive. On an unknown date, the outcome of the allergic reaction, fever, generalized rash, blurred vision, dyspnea, pain in arm and increased blood pressure were recovered/resolved.   It was unknown if the reporter considered the allergic reaction, fever, generalized rash, blurred vision, dyspnea, pain in arm and increased blood pressure to be related to Fluarix Quadrivalent 2016-2017 season.  Additional details were provided as follows: This case was reported by the patient herself. The patient received Fluarix Quadrivalent 2016-2017 season in the right deltoid and experienced pain in her left arm, struggling for air, blurred vision, rash from head to toe and a fever. The next day, the patient went back to work and experienced trouble breathing and elevated blood pressure. She was sent to the emergency room where she received IV medications. She wanted to get a Covid-19 vaccine, but her allergist was concerned because of an allergic reactions she had to Fluarix in the past. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR166737:
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Vision blurred
Clinical narrative: Elevated blood pressure; allergic reactions; Fever; rash from head to toe/ Full body rash; Blurred vision; Struggling to breath /  trouble breathing; Pain in left arm; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 56-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2016-2017 season) (batch number C54L3, expiry date 30th June 2017) for prophylaxis.   Previously administered products included Fluarix with an associated reaction of pyrexia (received a dose on 19th October 2015 with batch number 33FF2 and expiry date 30th June 2016 also experienced rash, refer case US2021AMR166737).   On 30th November 2016, the patient received Fluarix Quadrivalent 2016-2017 season (intramuscular). On 30th November 2016, less than a day after receiving Fluarix Quadrivalent 2016-2017 season, the patient experienced allergic reaction, fever, generalized rash, blurred vision, dyspnea and pain in arm. On 1st December 2016, the patient experienced increased blood pressure. The patient was treated with intravenous fluid (nos) (Iv Therapy (Nos)). Rechallenge with Fluarix Quadrivalent 2016-2017 season was positive. On an unknown date, the outcome of the allergic reaction, fever, generalized rash, blurred vision, dyspnea, pain in arm and increased blood pressure were recovered/resolved.   It was unknown if the reporter considered the allergic reaction, fever, generalized rash, blurred vision, dyspnea, pain in arm and increased blood pressure to be related to Fluarix Quadrivalent 2016-2017 season.  Additional details were provided as follows: This case was reported by the patient herself. The patient received Fluarix Quadrivalent 2016-2017 season in the right deltoid and experienced pain in her left arm, struggling for air, blurred vision, rash from head to toe and a fever. The next day, the patient went back to work and experienced trouble breathing and elevated blood pressure. She was sent to the emergency room where she received IV medications. She wanted to get a Covid-19 vaccine, but her allergist was concerned because of an allergic reactions she had to Fluarix in the past. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR166737:
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Menveo vaccine/ expiration date 3/2021/ was given; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA354A, expiry date 31st March 2021) for prophylaxis.   On 4th August 2021, the patient received the 1st dose of Menveo. On 4th August 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: Reporter was vaccine coordinator and her title was Lawyer. Menveo vaccine was given to a patient which was already expired on 31st March 2021. The reporter consented to follow up by email.