chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Myalgia, Pruritus, Pyrexia
Clinical narrative: As with many patients during the 2nd dose, on 5/3/21, I had fever, sweats, chills, and muscle pain, But on 5/5/21, I developed a rash and itching on my back and chest. The rash faded by 5/7/21 but the ITCHING continued, all over, esp my face, chest and back and lasted 5/11/2021.  Per my Dr, I was taking Claritin 10mg BID and Benadryl 25mg every 6 hrs to treat the itching with little relief.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: As with many patients during the 2nd dose, on 5/3/21, I had fever, sweats, chills, and muscle pain, But on 5/5/21, I developed a rash and itching on my back and chest. The rash faded by 5/7/21 but the ITCHING continued, all over, esp my face, chest and back and lasted 5/11/2021.  Per my Dr, I was taking Claritin 10mg BID and Benadryl 25mg every 6 hrs to treat the itching with little relief.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Hyperhidrosis, Hypoacusis, Pallor, Presyncope
Clinical narrative: Within 3 minutes of receiving vaccine a vasovagal response is noted to be occurring:  loss of vision, muffled sound, pale face, diaphoretic.  Normal function returned in 15 minutes.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dehydration, Dizziness, Hyperhidrosis
Clinical narrative: Patient felt dizzy and tightness of chest after vaccination. He sweat a lot and claimed he want to lay down. gave him water and orange juice to drink. called the ambulance and they took him to hospital and found out he was dehydrated.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient stated on CDC form and questioned in person if he had received a COVID-19 vaccine.  Patient stated NO.  Moderna vaccine was administered at 10:03 a.m. At 4pm while entering vaccine in state immunization system (MIIX), patient had received 1 dose of Pfizer COVID_19 vaccine on 2/8/21 .  I called patient at 6:30 p.m., he again denied getting a Covid-19 vaccine prior.  Based on MIIX he had received a vaccine of Pfizer and then I administer Moderna on 8/13/21.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Spreading numbness in fingers of the arm receiving the vaccine.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dyspnoea, Sensation of foreign body, Throat irritation
Clinical narrative: Patient reported throat itching, lump in throat at 1738, 20minutes into observation period after first dose of pfizer vaccine. Denied any shortness of breath or difficulty breathing.  Vital signs were initiated at 1744, BP slightly elevated. Water and crackers were provided. Benadryl 25mg IM was offered, patient accepted, administered in Left deltoid at 1745. Patient reported improvement in symptoms at 1751; complete resolutions of symptoms at 1759. Last set of vital signs taken at 1800, blood pressure still slightly elevated, verbalized feeling better and ready to leave. Patient left at 1800 with daughter, stating they would take uber home together. Was educated to follow up with primary heathcare provider and if symptoms return or worsen to seek emergency medical care, patient verbalized understanding.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Heart rate decreased, Sensation of foreign body, Throat irritation
Clinical narrative: Patient reported throat itching, lump in throat at 1738, 20minutes into observation period after first dose of pfizer vaccine. Denied any shortness of breath or difficulty breathing.  Vital signs were initiated at 1744, BP slightly elevated. Water and crackers were provided. Benadryl 25mg IM was offered, patient accepted, administered in Left deltoid at 1745. Patient reported improvement in symptoms at 1751; complete resolutions of symptoms at 1759. Last set of vital signs taken at 1800, blood pressure still slightly elevated, verbalized feeling better and ready to leave. Patient left at 1800 with daughter, stating they would take uber home together. Was educated to follow up with primary heathcare provider and if symptoms return or worsen to seek emergency medical care, patient verbalized understanding.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Feeling hot, Hyperhidrosis
Clinical narrative: After the patient received her first Moderna vaccine, patient was in observation area to be observed for any reactions. At 1515 8/13/21 patient complained about tingling of the lips and stated that she had a hard time breathing with pressure on her chest, and felt hot and diaphoretic. Patient was placed on bed in semi fowlers position, patient was instructed to drink water and juice, ice packs were placed on her back. Blood pressure was taken at 1520, BP 126/88 and heart rate was 93, O2 100%. Patient was then placed in side lying position with support on back, RN supervisor then called 911 because patient was not improving and looked pale and fatigued. A second blood pressure was taken at 1545, BP 101/58 HR 97. Paramedics arrived at 1553 and took patient to hospital.  Patient reported being  over 8 months pregnant with recent history of adverse reaction to Tdap vaccine 6/24/21.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Paraesthesia oral
Clinical narrative: After the patient received her first Moderna vaccine, patient was in observation area to be observed for any reactions. At 1515 8/13/21 patient complained about tingling of the lips and stated that she had a hard time breathing with pressure on her chest, and felt hot and diaphoretic. Patient was placed on bed in semi fowlers position, patient was instructed to drink water and juice, ice packs were placed on her back. Blood pressure was taken at 1520, BP 126/88 and heart rate was 93, O2 100%. Patient was then placed in side lying position with support on back, RN supervisor then called 911 because patient was not improving and looked pale and fatigued. A second blood pressure was taken at 1545, BP 101/58 HR 97. Paramedics arrived at 1553 and took patient to hospital.  Patient reported being  over 8 months pregnant with recent history of adverse reaction to Tdap vaccine 6/24/21.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation
Clinical narrative: First covid vaccine Pfizer and second dose vaccine Moderna
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event, patient was not 12 years old yet. Actual age is 11 years and 11 months old
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Insomnia, Nausea
Clinical narrative: Headache, nausea, insomnia, hot flashes
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Erythema, Induration
Clinical narrative: 8/12/21 Induration 3 inches by 3inches, pain, redness, swelling upon awakening, by 8pm I had chills n fever. On 8/13/21 I continued with all of the above plus, nausea, diarrhea, weakness, body aches. I felt like I was getting COVID all over again. I was Positive for COVID 6/2020 and was still donating convalecent plasma until July 2021, I stop donating because my vein was disappearing. I still had antibodies to  COVID
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Swelling
Clinical narrative: 8/12/21 Induration 3 inches by 3inches, pain, redness, swelling upon awakening, by 8pm I had chills n fever. On 8/13/21 I continued with all of the above plus, nausea, diarrhea, weakness, body aches. I felt like I was getting COVID all over again. I was Positive for COVID 6/2020 and was still donating convalecent plasma until July 2021, I stop donating because my vein was disappearing. I still had antibodies to  COVID
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Fall, Seizure, Syncope
Clinical narrative: Fall; Syncope; Seizure; Trouble breathing
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Fatigue, Lip swelling, Pain
Clinical narrative: Burning in arm right after injection. Lip swelling (lower lip) about 30-45 minutes after injection.  Experienced high fevers (103), intense chills, body aches, and exhaustion for two days.  My husband called the ER and they said to take Tylenol and Ibuprofen and cold baths to reduce fever.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Burning in arm right after injection. Lip swelling (lower lip) about 30-45 minutes after injection.  Experienced high fevers (103), intense chills, body aches, and exhaustion for two days.  My husband called the ER and they said to take Tylenol and Ibuprofen and cold baths to reduce fever.
Age: 32.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Headache, Vaccine positive rechallenge
Clinical narrative: Dizziness, joint pain, severe headache
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Atrial fibrillation, Blood test, Cough, Death
Clinical narrative: Pneumonia or Pneumonitis Weakness Severe hypoxia Cough Atrial fibrillation Dyspnea Death  Progressed from ambulatory to death in 8 days
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoxia, Pneumonia, Pneumonitis
Clinical narrative: Pneumonia or Pneumonitis Weakness Severe hypoxia Cough Atrial fibrillation Dyspnea Death  Progressed from ambulatory to death in 8 days
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chloasma, Platelet count normal, Skin warm, Swelling, Tenderness
Clinical narrative: First vaccination  Large melasma patches on back ( 6 inches in diameter) 2nd vaccination swelling tenderness & warm to touch still on day 3
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: ADMINISTERED SECOND DOSE OF COVID 19 PFIZER VACCINE FROM A BATCH 6 DAYS OUT OF DATE. NO ADVERSE EVENT.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient lied on intake form and said he had never received any moderna doses. after administration and checking cairs it shows he received in jan and feb 2021. no reaction at this time.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pain in jaw, Temporomandibular joint syndrome
Clinical narrative: Severe jaw pain/symptoms of TMJ, brain fog, excessive fatigue and tiredness
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Patient reports tachycardia randomly occurring.  This is occurring when patient is idle and not being active (ie while sleeping at night).  Reports several instances of this.  Patient has had this issue in the past but has been common since the vaccine.  Patient is on heart medication since he has had stents/previous heart attacks.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage, Swelling
Clinical narrative: bleeding and swelling outside of normal reaction to vaccine
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: patient lied on intake form and said he had never received any moderna doses. after administration and checking cairs it shows she received in jan and feb 2021. no reaction at this time and wasn't eligible for 3rd dose when administered.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: DOSE 2 OF COVID 19 PFIZER VACCINE ADMINISTERED WAS 6 DAYS EXPIRED, NO ADVERSE EVENTS AS A RESULT
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Vaccination site inflammation, Vaccination site reaction, Vaccination site warmth
Clinical narrative: Allergy around the vaccine point, inflammation on the zone, fever, the flue.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Musculoskeletal stiffness, Neck pain
Clinical narrative: Achy Neck; Stiff neck; Headache; Shoulders sore; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Achy Neck), MUSCULOSKELETAL STIFFNESS (Stiff neck), HEADACHE (Headache) and ARTHRALGIA (Shoulders sore) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 00B21A) for COVID-19 vaccination.     No medical history was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced NECK PAIN (Achy Neck), MUSCULOSKELETAL STIFFNESS (Stiff neck), HEADACHE (Headache) and ARTHRALGIA (Shoulders sore). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 1 dosage form. On 31-Mar-2021, NECK PAIN (Achy Neck), MUSCULOSKELETAL STIFFNESS (Stiff neck), HEADACHE (Headache) and ARTHRALGIA (Shoulders sore) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant includes high blood pressure medication.  Action taken with mRNA-1273 with the events was considered as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow-up received on 28-jun-2021 which is updated with the information of Concomitant medication and expiry dates for the 1st and 2nd doses.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate, Heart rate increased, Herpes zoster
Clinical narrative: Heart rate was rising; headache; tiredness; shingles; fever; sore arm; swelling; red blotches all over her arm; itchy rash; flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY, SWELLING, RASH MACULAR, RASH PRURITIC, and INFLUENZA LIKE ILLNESS in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included WARFARIN for Anticoagulant therapy, FAMOTIDINE for Gastroesophageal reflux disease, PROBIOTICS for Stomach upset.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY, SWELLING, RASH MACULAR, and RASH PRURITIC. 04-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS and PYREXIA. On 13-Feb-2021, the patient experienced HERPES ZOSTER (shingles). On 04-May-2021, the patient experienced FATIGUE. On an unknown date, the patient experienced HEART RATE INCREASED and HEADACHE. On 05-Feb-2021, INFLUENZA LIKE ILLNESS and PYREXIA had resolved. At the time of the report, PAIN IN EXTREMITY, SWELLING, RASH MACULAR, and RASH PRURITIC had not resolved, HEART RATE INCREASED, HEADACHE, and FATIGUE outcome was unknown and HERPES ZOSTER had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 90 above (High) pulse rate never dropped under 90.         Patient took Tylenol and Benadryl for her treatment. Concomitant medications taken were Vitamin D 5000 units 3 tablets a day, Vitamin B-12 1000mg 1 tablet daily, Vitamin C 750mg Chew 2 a day. On 28Jul2021, patient will have an appointment with the lung specialist to check up on the ground glass cancer 10 years ago. Action taken with mRNA-1273 in response to the events were Not Applicable       Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Patient email id was updated. Drug start date was updated. New adverse event was updated.  Lab data was updated. Concomitant medication was updated
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity, Pyrexia, Rash macular, Rash pruritic
Clinical narrative: Heart rate was rising; headache; tiredness; shingles; fever; sore arm; swelling; red blotches all over her arm; itchy rash; flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY, SWELLING, RASH MACULAR, RASH PRURITIC, and INFLUENZA LIKE ILLNESS in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included WARFARIN for Anticoagulant therapy, FAMOTIDINE for Gastroesophageal reflux disease, PROBIOTICS for Stomach upset.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY, SWELLING, RASH MACULAR, and RASH PRURITIC. 04-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS and PYREXIA. On 13-Feb-2021, the patient experienced HERPES ZOSTER (shingles). On 04-May-2021, the patient experienced FATIGUE. On an unknown date, the patient experienced HEART RATE INCREASED and HEADACHE. On 05-Feb-2021, INFLUENZA LIKE ILLNESS and PYREXIA had resolved. At the time of the report, PAIN IN EXTREMITY, SWELLING, RASH MACULAR, and RASH PRURITIC had not resolved, HEART RATE INCREASED, HEADACHE, and FATIGUE outcome was unknown and HERPES ZOSTER had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 90 above (High) pulse rate never dropped under 90.         Patient took Tylenol and Benadryl for her treatment. Concomitant medications taken were Vitamin D 5000 units 3 tablets a day, Vitamin B-12 1000mg 1 tablet daily, Vitamin C 750mg Chew 2 a day. On 28Jul2021, patient will have an appointment with the lung specialist to check up on the ground glass cancer 10 years ago. Action taken with mRNA-1273 in response to the events were Not Applicable       Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Patient email id was updated. Drug start date was updated. New adverse event was updated.  Lab data was updated. Concomitant medication was updated
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Heart rate was rising; headache; tiredness; shingles; fever; sore arm; swelling; red blotches all over her arm; itchy rash; flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY, SWELLING, RASH MACULAR, RASH PRURITIC, and INFLUENZA LIKE ILLNESS in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included WARFARIN for Anticoagulant therapy, FAMOTIDINE for Gastroesophageal reflux disease, PROBIOTICS for Stomach upset.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY, SWELLING, RASH MACULAR, and RASH PRURITIC. 04-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS and PYREXIA. On 13-Feb-2021, the patient experienced HERPES ZOSTER (shingles). On 04-May-2021, the patient experienced FATIGUE. On an unknown date, the patient experienced HEART RATE INCREASED and HEADACHE. On 05-Feb-2021, INFLUENZA LIKE ILLNESS and PYREXIA had resolved. At the time of the report, PAIN IN EXTREMITY, SWELLING, RASH MACULAR, and RASH PRURITIC had not resolved, HEART RATE INCREASED, HEADACHE, and FATIGUE outcome was unknown and HERPES ZOSTER had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 90 above (High) pulse rate never dropped under 90.         Patient took Tylenol and Benadryl for her treatment. Concomitant medications taken were Vitamin D 5000 units 3 tablets a day, Vitamin B-12 1000mg 1 tablet daily, Vitamin C 750mg Chew 2 a day. On 28Jul2021, patient will have an appointment with the lung specialist to check up on the ground glass cancer 10 years ago. Action taken with mRNA-1273 in response to the events were Not Applicable       Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Patient email id was updated. Drug start date was updated. New adverse event was updated.  Lab data was updated. Concomitant medication was updated
Sex: F
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect product storage in a neonate female patient who received HBV (Engerix B) for prophylaxis.   On 30th July 2021, the patient received the 1st dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.  Additional details provided were as follows: Age at vaccination was not reported. Nurse reported that, the new born received a dose of Engerix B after a temperature excursion where the vaccine was expose to freezing temperatures (8 by 20 to 1.4 degree Celsius for 1hr and 8 by 23 to 26.4 degree Celsius for 4 hrs) The reporter consented to follow-up.; Sender's Comments:  PR-GLAXOSMITHKLINE-PR2021168130:FU deleted
Sex: F
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Vaccine was expose to freezing temperatures; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received HBV (Engerix B) (batch number K329E, expiry date 24th April 2023) for prophylaxis.   On 4th August 2021, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that new born baby received a dose of Engerix B after a temperature excursion where the vaccine was expose to freezing temperatures, which led to incorrect storage of drug. The Engerix B was exposed to temperature minus 1.4 degree Celsius for 1 hours and temperature minus 26.4 degree Celsius for 4 hours. The doctor and mother have authorized to vaccinate this baby. The patient received a new Engerix-B vaccine on 5th August 2021. The reporter consented to follow up. ; Sender's Comments:  PR-GLAXOSMITHKLINE-PR2021167740:Deleted (incorrect Argus ID)
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Clinodactyly, Dyspnoea, Gait inability, Headache, Pyrexia
Clinical narrative: fever; headache; trouble speaking; unable to walk; unable to breath; crooked fingers/ twisted fingers; This is a spontaneous report from a contactable consumer (patient). A 15-years-old male patient received first dose of bnt162b2 (BNT162B2, BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EW0178) via an unspecified route of administration, administered in arm left on 15Jun2021 09:00 as dose 1, single and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EW0186) as dose 2, single for COVID-19 immunization (Age at vaccination 15 years). Medical history included asthma; food allergy Known allergies to the shrimp, sinus disorder. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. On 07Jul2021 01:00 patient experienced fever, headache, trouble speaking, unable to walk, unable to breath and crooked fingers/ twisted fingers. Therapeutic measures were taken as a result of all AE includes treatment with vein treatment solumedrol and Panadol, vendria. AE resulted in Emergency room / department or emergencies. The outcome for all events was recovered on an unspecified date in 2021  Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: fever; headache; trouble speaking; unable to walk; unable to breath; crooked fingers/ twisted fingers; This is a spontaneous report from a contactable consumer (patient). A 15-years-old male patient received first dose of bnt162b2 (BNT162B2, BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EW0178) via an unspecified route of administration, administered in arm left on 15Jun2021 09:00 as dose 1, single and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EW0186) as dose 2, single for COVID-19 immunization (Age at vaccination 15 years). Medical history included asthma; food allergy Known allergies to the shrimp, sinus disorder. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. On 07Jul2021 01:00 patient experienced fever, headache, trouble speaking, unable to walk, unable to breath and crooked fingers/ twisted fingers. Therapeutic measures were taken as a result of all AE includes treatment with vein treatment solumedrol and Panadol, vendria. AE resulted in Emergency room / department or emergencies. The outcome for all events was recovered on an unspecified date in 2021  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: HEP, HEPA, MMR, YF
Symptoms: Limb mass
Clinical narrative: a golf-ball sized ball in arm; This spontaneous report has been received from a consumer in courtesy from Pfizer, referring to a 40 years old (estimated as DOB and AE onset date) female patient. The patient had familial Mediterranean fever (FMF/) but do not present active symptoms (Genetic asymptomatic carrier for Familial Mediterranean Fever) and also frequently suffered from migraines. Also reported that patient's immune system generally reacts strongly to all vaccines. Patient also had ongoing allergy to etodolac (LODINE). Past medical treatment(s) medical treatment(s), vaccination(s) and concomitant was not provided.  In 2019, the patient received a dose of suspect yellow fever vaccine produced by unknown manufacturer, a dose of suspect hepatitis a vaccine (manufacturer unknown), a dose of suspect hepatitis b vaccine (manufacturer unknown) and a dose of suspect measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), all for prophylactic vaccination. Strength, lot number and expiration date for all suspect vaccines were not reported. Route and administration site for all suspect product were unknown.   In 2019, the patient developed a non-serious strong reaction including a golf-ball sized ball in arm (limb mass), in the same year following the vaccinations and on the third Hepatitis A/ Hepatitis B dose. It was unknown if the patient experienced any additional symptoms/events. No laboratory data reported. Steroids as a corrective treatment was received by the patient to bring down the limb mass. At time of reporting, the outcome was unknown for the reported event. There would be no information on the batch number for this case. The causality assessment between all suspect vaccines and the event was not reported.  It was also reported that on 10- MAR-2021 07: 15 AM, the patient, who was 42 years old currently (pregnancy: no), received the most recent coronavirus disease 2019 (COVID-19) (coronavirus disease, two doses) vaccine in Hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and also no any other medications was received within 2 weeks of vaccination. Reported event: for both doses: chills for about an hour (began exactly 3 hours after the shot was administered in both doses). First dose had a hangover-type headache the day after the shot. Second dose the hangover-type headache started the same day as the shot and with much greater intensity. It was day 2 and the headache was still present but with less intensity. Some chills in the morning sporadically. Patient thanked and said let's get rid of this COVID pandemic. She did not received treatment for the adverse event, Prior to vaccination, the patient was not diagnosed with COVID- 19 and since the vaccination, she had not been tested for COVID-19; Vaccine facility information available. Ethnicity information was available. Race information was available (race also reported as unknown).
Age: 42.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE reported; dose of VAQTA with a labeled expiry of 7/11/2021 was inadvertently administered to a patient on 7/13/2021.; This spontaneous report has been received from a medical assistant, referring to a 42 years old patient of unknown gender. The patient's historical condition, current condition and concomitant medication were not reported.    Medical assistant warm transferred for assistance in reporting that a dose of  hepatitis a vaccine, inactivated(VAQTA) (formulation vial, dose: 1 ml, lot#T018670, strength and route were unknown, indication: prophylaxis) with a labeled expiry of 11-JUL-2021 was inadvertently administered to a patient on 13-JUL-2021 (expired product administered). The reporter stated there were no known temperature excursions involved. No additional information was provided, no additional adverse event reported.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no known side effects; an improperly stored (supported) dose of VARlVAX was administered; This spontaneous report was received from a medical assistant referring to a female patient of unknown age. The patient's pertinent medical history, concomitant therapies and drug reaction/allergies were not reported.  On 27-JUL-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis (strength, dose, and route of administration were not reported; lot number T032318 has been verified to be a valid lot number, expiration date was 22-SEP-2022). The vaccine was exposed to minus 12.4 degree Celsius for 1 hour 15 minutes and minus 3.2 degree Celsius for 1 hour 30 minutes, which was detected by a data logger (product storage error). It was reported that the vaccine had a previous temperature excursion at minus 8.6 degree Celsius for 1 hour 40 minutes. No additional adverse events or product quality complaints were reported. No further information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Pain; Chills; Injection site pain; Pyrexia; This case was received via VAERS (Reference number: 0931176) on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Pain), CHILLS (Chills), VACCINATION SITE PAIN (Injection site pain) and PYREXIA (Pyrexia) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol and Hypertension.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PAIN (Pain), CHILLS (Chills), VACCINATION SITE PAIN (Injection site pain) and PYREXIA (Pyrexia). At the time of the report, PAIN (Pain), CHILLS (Chills), VACCINATION SITE PAIN (Injection site pain) and PYREXIA (Pyrexia) had resolved.        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.   Other Meds : calcium, biotin, aspirin, Norvasc, Atorvastatin Symptom Text : fever, soreness at injection site, body aches and chills.  These began approximately 6:30pm night of injection, continued into the next day.  Taking advil every 4 hours and this has helped to stop the fever but the rest of the symptoms continue   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Chest discomfort, Fatigue, Injection site erythema
Clinical narrative: Abdominal pain upper; Back pain; Chest discomfort; Injection site reaction; Musculoskeletal stiffness; Neck pain; Pain in extremity; Injection site pruritus; Injection site erythema; Injection site swelling; Injection site pain; Fatigue; This case was received via VAERS (Reference number: 0933587) on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN UPPER (Abdominal pain upper), BACK PAIN (Back pain), CHEST DISCOMFORT (Chest discomfort), INJECTION SITE REACTION (Injection site reaction) and MUSCULOSKELETAL STIFFNESS (Musculoskeletal stiffness) in a 31-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.     Concurrent medical conditions included Penicillin allergy (Penicillin). Concomitant products included MAGNESIUM, LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), SERTRALINE HYDROCHLORIDE (ZOLOFT) and PROBIOTICS NOS for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced ABDOMINAL PAIN UPPER (Abdominal pain upper), BACK PAIN (Back pain), CHEST DISCOMFORT (Chest discomfort), INJECTION SITE REACTION (Injection site reaction), MUSCULOSKELETAL STIFFNESS (Musculoskeletal stiffness), NECK PAIN (Neck pain), PAIN IN EXTREMITY (Pain in extremity), INJECTION SITE PRURITUS (Injection site pruritus), INJECTION SITE ERYTHEMA (Injection site erythema), INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE PAIN (Injection site pain) and FATIGUE (Fatigue). At the time of the report, ABDOMINAL PAIN UPPER (Abdominal pain upper), BACK PAIN (Back pain), CHEST DISCOMFORT (Chest discomfort), INJECTION SITE REACTION (Injection site reaction), MUSCULOSKELETAL STIFFNESS (Musculoskeletal stiffness), NECK PAIN (Neck pain), PAIN IN EXTREMITY (Pain in extremity), INJECTION SITE PRURITUS (Injection site pruritus), INJECTION SITE ERYTHEMA (Injection site erythema), INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE PAIN (Injection site pain) and FATIGUE (Fatigue) had not resolved.        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 were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Abdominal pain upper; Back pain; Chest discomfort; Injection site reaction; Musculoskeletal stiffness; Neck pain; Pain in extremity; Injection site pruritus; Injection site erythema; Injection site swelling; Injection site pain; Fatigue; This case was received via VAERS (Reference number: 0933587) on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN UPPER (Abdominal pain upper), BACK PAIN (Back pain), CHEST DISCOMFORT (Chest discomfort), INJECTION SITE REACTION (Injection site reaction) and MUSCULOSKELETAL STIFFNESS (Musculoskeletal stiffness) in a 31-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.     Concurrent medical conditions included Penicillin allergy (Penicillin). Concomitant products included MAGNESIUM, LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), SERTRALINE HYDROCHLORIDE (ZOLOFT) and PROBIOTICS NOS for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced ABDOMINAL PAIN UPPER (Abdominal pain upper), BACK PAIN (Back pain), CHEST DISCOMFORT (Chest discomfort), INJECTION SITE REACTION (Injection site reaction), MUSCULOSKELETAL STIFFNESS (Musculoskeletal stiffness), NECK PAIN (Neck pain), PAIN IN EXTREMITY (Pain in extremity), INJECTION SITE PRURITUS (Injection site pruritus), INJECTION SITE ERYTHEMA (Injection site erythema), INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE PAIN (Injection site pain) and FATIGUE (Fatigue). At the time of the report, ABDOMINAL PAIN UPPER (Abdominal pain upper), BACK PAIN (Back pain), CHEST DISCOMFORT (Chest discomfort), INJECTION SITE REACTION (Injection site reaction), MUSCULOSKELETAL STIFFNESS (Musculoskeletal stiffness), NECK PAIN (Neck pain), PAIN IN EXTREMITY (Pain in extremity), INJECTION SITE PRURITUS (Injection site pruritus), INJECTION SITE ERYTHEMA (Injection site erythema), INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE PAIN (Injection site pain) and FATIGUE (Fatigue) had not resolved.        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 were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Abdominal pain upper; Back pain; Chest discomfort; Injection site reaction; Musculoskeletal stiffness; Neck pain; Pain in extremity; Injection site pruritus; Injection site erythema; Injection site swelling; Injection site pain; Fatigue; This case was received via VAERS (Reference number: 0933587) on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN UPPER (Abdominal pain upper), BACK PAIN (Back pain), CHEST DISCOMFORT (Chest discomfort), INJECTION SITE REACTION (Injection site reaction) and MUSCULOSKELETAL STIFFNESS (Musculoskeletal stiffness) in a 31-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.     Concurrent medical conditions included Penicillin allergy (Penicillin). Concomitant products included MAGNESIUM, LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), SERTRALINE HYDROCHLORIDE (ZOLOFT) and PROBIOTICS NOS for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced ABDOMINAL PAIN UPPER (Abdominal pain upper), BACK PAIN (Back pain), CHEST DISCOMFORT (Chest discomfort), INJECTION SITE REACTION (Injection site reaction), MUSCULOSKELETAL STIFFNESS (Musculoskeletal stiffness), NECK PAIN (Neck pain), PAIN IN EXTREMITY (Pain in extremity), INJECTION SITE PRURITUS (Injection site pruritus), INJECTION SITE ERYTHEMA (Injection site erythema), INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE PAIN (Injection site pain) and FATIGUE (Fatigue). At the time of the report, ABDOMINAL PAIN UPPER (Abdominal pain upper), BACK PAIN (Back pain), CHEST DISCOMFORT (Chest discomfort), INJECTION SITE REACTION (Injection site reaction), MUSCULOSKELETAL STIFFNESS (Musculoskeletal stiffness), NECK PAIN (Neck pain), PAIN IN EXTREMITY (Pain in extremity), INJECTION SITE PRURITUS (Injection site pruritus), INJECTION SITE ERYTHEMA (Injection site erythema), INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE PAIN (Injection site pain) and FATIGUE (Fatigue) had not resolved.        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 were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 5 days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient's husband. The age at vaccination was not reported. The patient got the new shingles vaccine and came down with shingles 5 days later. The reporter stated, no vaccine was 100 percent effective, please lie awake at night contemplating that fact for the next 20 years. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Localised infection, Malaise
Clinical narrative: Last one last Dec / Got infection in my arm; Last one last Dec / Still don't feel well; This case was reported by a consumer via(Facebook) interactive digital media and described the occurrence of arm infection in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In December 2020, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than 9 months after receiving Shingles vaccine, the patient experienced arm infection and feeling unwell. On an unknown date, the outcome of the arm infection and feeling unwell were unknown.   It was unknown if the reporter considered the arm infection and feeling unwell to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient stated that, he/she got the 2nd dose in last December and got infection in his/her arm and still did not feel well. The follow-up would not possible as no contact details were available; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR168946:Same reporter. Invalid case.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; had a case of them; This case was reported by a consumer via 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles 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 vaccine, the patient still got shingles. The patient was told that, there was a new vaccine out there at the time of reporting, so he/she would try that one too. 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 of shingles were not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Neuralgia, Pain, Post herpetic neuralgia, Vaccination failure
Clinical narrative: suspected vaccination failure; I had internal shingles; nerve pain/awful pain; 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (original vaccine).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix and Shingrix.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. The patient had the original vaccine and then both the doses of Shingrix, years ago from the date of reporting. After receiving Shingrix, the patient got shingles. The patient reported that, he/she had internal shingles, too.  The patient had most awful pain in his/her entire life. The patient did not even know there was such a thing.  At the time of reporting, the patient was still having nerve pain but tolerable.  The patient's doctor said, he/she might have this pain for the rest of his/her life. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: new two shot vaccine / took the first one / got them; This case was reported by a consumer via(Facebook) interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  The patient's past medical history included shingles (had them when the patient turned 50).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine. This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Additional details were provide are as follows: The case was reported by patient himself/ herself. The age at vaccination was not reported. The patient had shingles when he/she turned 50 and had the first vacation kept getting them. The patient stated that, out of new two shot vaccines, the patient received 1st dose of Shingles vaccine and got shingles again. The patient did not bother with the 2nd dose. The follow up would not be possible as no contact details were available.