chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Headache, Injection site pain, Pain
Clinical narrative: Starting immediately following the vaccination at 8:15a on 26Jan2021: pain at injection site (moderate) for approximately 36 hours duration.  Starting at 10pm on 26Jan2021 the following AEs were noted: chills (mild) for approximately 2 hours duration, headache (mild) for approximately 24 hours duration, clammy (mild) for approximately 24 hours duration, overall body ache (mild) for approximately 24 hours duration, and feeling of restless leg syndrome, but throughout whole body (moderate) for approximately 12 hours duration. Tylenol was taken twice during the period of 10p 26Jan2021 through 12p 27Jan2021 for symptoms.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Restlessness
Clinical narrative: Starting immediately following the vaccination at 8:15a on 26Jan2021: pain at injection site (moderate) for approximately 36 hours duration.  Starting at 10pm on 26Jan2021 the following AEs were noted: chills (mild) for approximately 2 hours duration, headache (mild) for approximately 24 hours duration, clammy (mild) for approximately 24 hours duration, overall body ache (mild) for approximately 24 hours duration, and feeling of restless leg syndrome, but throughout whole body (moderate) for approximately 12 hours duration. Tylenol was taken twice during the period of 10p 26Jan2021 through 12p 27Jan2021 for symptoms.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Epistaxis, Hyperhidrosis, Injection site erythema
Clinical narrative: Pt experienced fever of 101.6 about 1.5 days later, along with arm swelling 6 inches across and 5 inces down on the night of vaccine, the area is red, hot and hard, chills, sweating, bloody nose, swollen lymph node - tender and visible, and nightmares.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site swelling, Injection site warmth, Lymph node pain, Lymphadenopathy
Clinical narrative: Pt experienced fever of 101.6 about 1.5 days later, along with arm swelling 6 inches across and 5 inces down on the night of vaccine, the area is red, hot and hard, chills, sweating, bloody nose, swollen lymph node - tender and visible, and nightmares.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nightmare
Clinical narrative: Pt experienced fever of 101.6 about 1.5 days later, along with arm swelling 6 inches across and 5 inces down on the night of vaccine, the area is red, hot and hard, chills, sweating, bloody nose, swollen lymph node - tender and visible, and nightmares.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: approximately 15 minutes following administration, pt felt nauseous, diaphoretic and dizzy. pt did not feel sob or chest tightness. Pt escorted to room to lie down. VS obtained
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: 7 days post administration, left arm experienced significant redness, itching, heat and swelling.  The reaction spread for the next 48 hours then dissipated.  The reaction was approximately 6 inches in diameter at its greatest size.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: papular itchy rash on lower back area.  Treated with prednisone 50 mg daily x 5 days, TAC ointment bid, cetirizine 10 mg qd, diphenhydramine 50 mg qhs.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site discolouration, Injection site erythema, Injection site induration
Clinical narrative: Chills, body aches, fatigue...large area of redness, soreness at injection site up to 4 days after. Became 5 inches in diameter with swollen, dark purple spot in the center around the size of a dime.  Now 8 days later, area of injection remains sore, swollen and red.  Small dime size hard lump where injected.  Concerned for vaccination error because the area of injection is lower on the arm than an intramuscular injection into the deltoid typically is.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain, Injection site swelling, Pain, Product administered at inappropriate site
Clinical narrative: Chills, body aches, fatigue...large area of redness, soreness at injection site up to 4 days after. Became 5 inches in diameter with swollen, dark purple spot in the center around the size of a dime.  Now 8 days later, area of injection remains sore, swollen and red.  Small dime size hard lump where injected.  Concerned for vaccination error because the area of injection is lower on the arm than an intramuscular injection into the deltoid typically is.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash to trunk of body & diffuse pruritus
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy to vaccine, Dysgeusia, Dysphagia, Dyspnoea, Erythema
Clinical narrative: 26 minutes after receiving the vaccine I started to get a metallic taste in my throat. I felt my tongue from the back of my throat to the tip of tongue was very tingly. I difficultly swallowing, every time I went to swallow it felt like something was stuck in my throat. Due to me bad allergic reactions in general I took 25 MG of Benadryl prior to be vaccinated. I was instructed to go over to ER, I went to the ER. I was given 50 MG IV of Benadryl they watched me for a few hours and then sent me home. I went home and sleep and was told to take Benadryl every 8 hours. I woke up cause I couldn't breath right. My face and tongue was swollen at this time. There was redness on my face as well. I woke my husband up and he took my back to the hospital. I went back to Hospital. They said it was acute reaction I was having and gave epi-pen in my left thigh. I received Decadron IV push and said it would last 72. I was told to take Benadryl every 6 hours instead of 8 like told the day before. I went home and have been doing that. I have been okay today so far.  A week before getting the vaccine anti-inflammatory diet to help prevent the an allergic reaction.  I am having my tithers drawn in a month
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Swelling face, Swollen tongue, Throat irritation, Vaccination complication
Clinical narrative: 26 minutes after receiving the vaccine I started to get a metallic taste in my throat. I felt my tongue from the back of my throat to the tip of tongue was very tingly. I difficultly swallowing, every time I went to swallow it felt like something was stuck in my throat. Due to me bad allergic reactions in general I took 25 MG of Benadryl prior to be vaccinated. I was instructed to go over to ER, I went to the ER. I was given 50 MG IV of Benadryl they watched me for a few hours and then sent me home. I went home and sleep and was told to take Benadryl every 8 hours. I woke up cause I couldn't breath right. My face and tongue was swollen at this time. There was redness on my face as well. I woke my husband up and he took my back to the hospital. I went back to Hospital. They said it was acute reaction I was having and gave epi-pen in my left thigh. I received Decadron IV push and said it would last 72. I was told to take Benadryl every 6 hours instead of 8 like told the day before. I went home and have been doing that. I have been okay today so far.  A week before getting the vaccine anti-inflammatory diet to help prevent the an allergic reaction.  I am having my tithers drawn in a month
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: 26 minutes after receiving the vaccine I started to get a metallic taste in my throat. I felt my tongue from the back of my throat to the tip of tongue was very tingly. I difficultly swallowing, every time I went to swallow it felt like something was stuck in my throat. Due to me bad allergic reactions in general I took 25 MG of Benadryl prior to be vaccinated. I was instructed to go over to ER, I went to the ER. I was given 50 MG IV of Benadryl they watched me for a few hours and then sent me home. I went home and sleep and was told to take Benadryl every 8 hours. I woke up cause I couldn't breath right. My face and tongue was swollen at this time. There was redness on my face as well. I woke my husband up and he took my back to the hospital. I went back to Hospital. They said it was acute reaction I was having and gave epi-pen in my left thigh. I received Decadron IV push and said it would last 72. I was told to take Benadryl every 6 hours instead of 8 like told the day before. I went home and have been doing that. I have been okay today so far.  A week before getting the vaccine anti-inflammatory diet to help prevent the an allergic reaction.  I am having my tithers drawn in a month
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Nodule, Peripheral swelling, Pruritus
Clinical narrative: Had shot 1-19-2021 with no reaction. On 1-27-2021 woke up with red, warm, tight arm. With arm itchy and swelling and knot size of 4" x 2"
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Skin tightness
Clinical narrative: Had shot 1-19-2021 with no reaction. On 1-27-2021 woke up with red, warm, tight arm. With arm itchy and swelling and knot size of 4" x 2"
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Immediate post-injection reaction, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: The site became sore almost immediately, but definitely  increased as time went on. By that evening the site was rock hard  and swollen approx. 4" diameter, became vey lathargic, dizzy.  These symptoms last x 2days. Then the site remained swollen,  hard and sore x 4-5days.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Lethargy
Clinical narrative: The site became sore almost immediately, but definitely  increased as time went on. By that evening the site was rock hard  and swollen approx. 4" diameter, became vey lathargic, dizzy.  These symptoms last x 2days. Then the site remained swollen,  hard and sore x 4-5days.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Onset: 1/26/21 Redness, swelling to (L) upper arm radiating down (L) arm, warm to touch, itching ordered: Triamcinolone 0.1% lotion, hydroxyzine 25mg QID, for 5 day Xyzal 5mg BID for 7 days
Sex: U
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: [Pfizer-BioNTech] treatment under Emergency Use Authorization(EUA): New (195 vial count size) box from Lot: EL3249 opened and one vial less than expected.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the second injection was later than what the PI for GARDASIL 9 recommens; This spontaneous report was received from the consumer and refers to a 27-year-old patient of unknown gender. The patient's concurrent condition, medical history, concomitant medications, drugs reactions or allergies were not provided.   On unspecified date in January 2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(dose, route of administration, lot # and expiration date were not provided) for prophylaxis. On 02-SEP-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(dose, route of administration, lot # and expiration date were not provided) for prophylaxis and now he wanted to get the third injection. The second injection was later than what the prescribing information (PI) for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) recommended.
Sex: F
Vaccine: HPV9
Symptoms: Skin papilloma
Clinical narrative: After receiving a GARDASIL 9 dose, within 3 days the warts started to disapear and became less painfull; no additional AE reported; This spontaneous report was received from an employee and refers to a 11-year-old female patient. The patient's concurrent condition included warts. The patient's medical history, concomitant medications, drugs reactions or allergies were not provided.   On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(dose, route of administration, lot # and expiration date were not provided) for prophylaxis. A female patient had horrible warts on both her hands, about 40 warts. After receiving ahpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose, within 3 days the warts started to disappear and became less painful. Within 10 days of receiving thehpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), the warts were all gone. No additional adverse events were reported. The outcome of adverse event was not reported.  The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; temperature excursion. Caller states that GARDASIL 9 administered today 12 JAN 2021; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 12-JAN-2021, the patient was vaccinated with with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R025728 was confirmed to be valid, expiration date reported as 15-JUN-2021, but upon internal validation established as 18-JUN-2021 (exact dose, route of administration, anatomical location were not provided) for prophylaxis.  The multiple temperature excursion was 48.2 degrees Fahrenheit (F) (48.2 F) for 7 hours. Previous excursions was 48 F for 5 hours and 8 minutes. The digital data logger was involved. No adverse effects were 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: R025728; expirationdate: 18-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details available/he patient has not experienced any adverse effects from the expired dose; administered a dose of VAQTA on 1/14/2021 that expired on 1/11/2021; This spontaneous report was received from a physician's office manager and refers to a 12-month-old patient. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On 14-JAN-2021, the patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) prefilled syringe, 0.5 ml, lot # S032359 was confirmed to be valid, expiration date was 22-JAN-2021 (route of administration and anatomical location were not reported) for prophylaxis.  The patient did not experienced any adverse effects from the expired dose and the expired product had not had a temperature excursion at any time. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032359; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: HPV4
Symptoms: Infertility female
Clinical narrative: experiencing infertility; This spontaneous report was received from a consumer, who is a patient's parent and refers to a 33-year-old female patient. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On an unknown date in 2001, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  Since an unknown date, the patient was experiencing infertility. It was reported that the patient sought medical attention and received unspecified ovulation pills as a treatment for the event.  No further information was provided. The outcome of infertility was reported as not recovered.  The causality assessment between the event and human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No other AE; patient received VARlVAX after the product was improperly stored; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 19-JAN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dosage form, lot number t010309, expiration date 24-MAR-2022 (route of administration not provided) for prophylaxis. The patient did not experience any other adverse event.  The vaccine underwent a temeprature excursion of -12.8 degrees Celsius (°C) for 9 hours and 6 minutes, with no previous temperature excursions. The call was due to digital data logger.
Age: 0.08
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: No other side effect or issues reported; the patient was given MMR II Jan 6, 2020 and then given VARlVAX on JAN 14, 2020; This spontaneous report was received from a medical assistant referring to a 5-week-old patient of unknown gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 06-JAN-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 1 dosage form (route of administration, lot number and expiration date were not provided), and on 14-JAN-2020 the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), 1 dosage form for prophylaxis. The vaccines were given off schedule. No other side effects were reported.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No other information available; Caller reports administration of ROTATEQ after temperature excursion; This spontaneous report was received from an other health professional referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 13-JAN-2021, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 2 milliliter, oral, lot number 1742457, expiration date reported as 16-FEB-2022, but upon internal validation was determined as 06-JAN-2022 for prophylaxis. No other adverse event was reported.  The vaccine underwent a temperature excursion of 1.3 degrees Celsius (°C) for 19 minutes, with no previous temperature excursions. The call was due to digital data logger.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE reported; nurse reported an improperly stored ROTATEQ was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 20-JAN-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 1 dosage form, orally, lot number 1688829, expiration date 29-NOV-2021 for prophylaxis. No additional adverse events reported.  The vaccines underwent a temperature excursion of 50 degress Fahrenheit (°F) for 1 hour. There were no previous temperature excursions. The call was due to digital data logger.; Sender's Comments:  US-009507513-2101USA010505:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional AE; Involved VAQTA expired on 01/11/2021 and was administered on 01/20/2021.; This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant therapies were not reported.   On 20-JAN-2021, the patient was inadvertently vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) (exact dose, route of administration, anatomical location were not provided), lot number S032359 has been verified to be a valid lot number, expiration date: 11-JAN-2021, for prophylaxis. There was no known temperature excursions. The nurse inquired about need for revaccination. No additional adverse event reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032359; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Cold sweat, Nausea, Pyrexia
Clinical narrative: felt a bit of nausea; clammy; Shivers; felt feverish, but my temp was 97.7; This case was reported by a consumer via interactive digital media and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th November 2020, the patient received the 1st dose of Shingrix. On 1st December 2020, 4 days after receiving Shingrix, the patient experienced nausea, clamminess, shivers and fever. On an unknown date, the outcome of the nausea, clamminess, shivers and fever were unknown.   It was unknown if the reporter considered the nausea, clamminess, shivers and fever to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was selected as adult as per the vaccine indication. The patient received 1st dose of Shingrix and felt a bit of nausea, clammy, shivers and feverish with the temperature 97.7 degree fahrenheit. The reporter was asking if it was consistent to the side effects. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: experienced some lower back pain achy; This case was reported by a consumer and described the occurrence of low back pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th December 2020, the patient received the 2nd dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced low back pain. On an unknown date, the outcome of the low back pain was unknown.   It was unknown if the reporter considered the low back pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingrix and experienced some lower back pain achy and no fever.
Sex: U
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: Arms were so sore; This case was reported by a consumer and described the occurrence of pain in arm in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, 1 day after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   The reporter considered the pain in arm to be possibly related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Age at vaccination was not reported. The patient reported that the patient rolled over the morning after receiving vaccine, the patient's arm was sore. This case is one of 4 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR252425:same reporter US-GLAXOSMITHKLINE-US2020AMR252429:same reporter US-GLAXOSMITHKLINE-US2020AMR252430:same reporter
Sex: U
Vaccine: MEN
Symptoms: Illness
Clinical narrative: I had sickness; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient got over again in 2011 so could go back to college.  The patient received Meningococcal B vaccine and had sickness.  But at least got records of it at the time of reporting.
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Headache
Clinical narrative: headache; fatigue; This case was reported by a physician via sales rep and described the occurrence of headache in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced headache and fatigue. On an unknown date, the outcome of the headache and fatigue were recovered/resolved.   It was unknown if the reporter considered the headache and fatigue to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Age at vaccination was not reported. Physician stated she seen a patient today, on the day of reporting she experienced fatigue and headache for 4 consecutive days and went to the urgent care after received Bexsero. Patient was fine at the time of reporting.  Physician stated that the patient had not received any other vaccines. The reporter did not agree to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia, Tremor
Clinical narrative: fever; feeling shaky; tiredness; body aches; chills; This case was reported by a consumer and described the occurrence of tremor in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 2nd December 2020, the patient received the 2nd dose of Shingrix. On 2nd December 2020, less than a day after receiving Shingrix, the patient experienced tremor, tiredness, general body pain and chills. On 3rd December 2020, the patient experienced fever. On an unknown date, the outcome of the tremor, tiredness, general body pain, chills and fever were not recovered/not resolved.   It was unknown if the reporter considered the tremor, tiredness, general body pain, chills and fever to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient experienced body aches, chills, tiredness, and feeling shaky on the same day the vaccine received. One day after receiving vaccination, the patient awoke with a fever. The reporter stated that, all events have not resolved.  The patient also mentioned that had every side effect listed, but did not go into specific details other than those reported. The reporter did not consent to follo w up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Papule
Clinical narrative: Redness in his arm; Pain / in his arm; Red papule on his arm; This case was reported by a consumer and described the occurrence of erythema of extremities in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced erythema of extremities, pain in arm and papule. On 18th December 2020, the outcome of the papule was recovered/resolved. On an unknown date, the outcome of the erythema of extremities and pain in arm were recovered/resolved.   The reporter considered the erythema of extremities, pain in arm and papule to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix on left arm. The patient does not recall the specific day but he mentioned that vaccination was done at the beginning of November 2020. The patient experienced pain and redness in his arm and 3 weeks later developed a red papule on his arm. The patient wanted to know if red papule was a side effect or not. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: Fever of 100.2; Headache; This case was reported by a consumer and described the occurrence of headache in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th December 2020 14:30, the patient received the 2nd dose of Shingrix (intramuscular). On 22nd December 2020, 4 days after receiving Shingrix, the patient experienced headache. On 23rd December 2020, the patient experienced fever. On an unknown date, the outcome of the headache was unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the headache and fever to be related to Shingrix.  Additional details were provided as follows: Patient reported that she received the 2nd dose of Shingrix and on night patient had headache. Five days after,the patient woke up with headache and a fever of 100.2 degree F also fever went down and the last reading was 96.8 degree F. The patient did not take any anti-fever medications. Patient did not want to share her pharmacy's contact information. The reporter did not consent to follow up.
Sex: U
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: 2 years old patient / received by mistake a dose of Bexsero; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 2-year-old patient who received Men B NVS (Bexsero) (batch number ABXA93AA, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th January 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Nurse reported a patient who received by mistake a dose of Bexsero, they were trying to administer Menactra which led to wrong vaccine administered.  The vaccine was administered on the same day as reported it. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: pain in her arm; This case was reported by a pharmacist and described the occurrence of pain in arm in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 7F33X, expiry date 11th December 2021) and (batch number 9227H, expiry date 28th February 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 30th December 2020, the patient received the 2nd dose of Shingrix. On 30th December 2020, the 2nd dose was an unknown dose. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix on 31th October 2020. The patient did not have any issues with 1st dose. The patient received 2nd dose and experienced pain in her arm. The event was ongoing. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt was 17 years and 8 months old at the time of receiving the first dose; A spontaneous report was received from a physician concerning a 17-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and patient was 17 years and 8 months old at the time of receiving the first dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025L20A) intramuscularly for prophylaxis of COVID-19. The patient was 17 years and 8 months old at the time of receiving the first dose. No side effects to vaccine were reported.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the event, patient was 17 years and 8 months old at the time of receiving the first dose, was resolved on 30 Dec 2020.; Reporter's Comments: This case concerns a 17-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: 025L20A), reporting Product administered to patient of inappropriate age.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: Needle came off and some of the liquid dripped down; Faulty syringe and needle came off; A spontaneous report was received from a pharmacist concerning a male patient who received Moderna's COVID-19 Vaccine, and the needle fell off and some of the liquid dripped down [Incomplete dose administered and Syringe issue].   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 18-Jan-2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   A pharmacist stated that the vaccine had a faulty syringe. She said that while she was depressing the syringe and went to pull away, the needle came off and some of the liquid dripped down.  She reported that the patient is concerned because they are not sure exactly how much of the vaccine he received. The pharmacist wanted to know if the patient needed to receive another dose of the vaccine.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The events the needle fell off and some of the liquid dripped down were considered resolved on 18-Jan-2021.; Reporter's Comments: This report refers to a case of incorrect dose administered and syringe issue for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Accidentally received second dose about 1.5 weeks early; A spontaneous report was received from a health care professional concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine and accidentally received second dose about 1.5 weeks early (inappropriate schedule of product administration).  There were no medical history concomitant medications provided by the reporter.  On 21-Jan-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number was unknown) intramuscularly for prophylaxis of COVID-19 infection.  The HCP stated that, they were currently vaccinating their employees with Moderna's COVID-19 vaccine and on 21-Jan-2021, patient had accidentally received second dose about 1.5 weeks early due to a scheduling error. No additional information was available at the time of this report. No treatment information was provided for the event.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the event accidentally received second dose about 1.5 weeks early (inappropriate schedule of product administration) was considered to be resolved on 21-Jan-2021.; Reporter's Comments: This report refers to a case of a patient who experienced non-serious event of the accidentally received second dose about 1.5 weeks early (inappropriate schedule of product administration) for administration of  mRNA-1273 (lot # unknown, Exp date-unknown). There were no reported AEs associated with the event of accidentally received second dose about 1.5 weeks early (inappropriate schedule of product administration).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Pain in extremity, Peripheral swelling, Product administered at inappropriate site, Rash
Clinical narrative: rash well below deltoid; pain well below the deltoid; Swelling near elbow; swelling well belowthe delotoid; was given the injection below the deltoid; A spontaneous report was received from health care professional concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced was given injection below the deltoid (Product administered at inappropriate site), pain well below the deltoid (Pain in extremity), swelling well below the deltoid (Peripheral swelling), Swelling near elbow (Joint swelling) and rash well below the deltoid (rash).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 08-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 039K20-24) intramuscularly for prophylaxis of COVID-19 infection.   On 08-Jan-2021, the patient stated that she felt the injection was administered wrong. She received the injection below the deltoid and experienced pain well below the deltoid. Swelling started well below the deltoid as well and on 08-Jan-2021. After 11 days on 19-Jan-2021 she was still having swelling, but it was closer to her elbow and off to the side. She also experienced a rash well below deltoid. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, was given injection below the deltoid, was considered resolved on 08-Jan-2021. The outcome of the events, experienced pain well below the deltoid, swelling below the deltoid, swelling near elbow and rash well below the deltoid, was considered unknown.; Reporter's Comments: This case concerns a female patient, who experienced an event of product administered at inappropriate site and a non-serious expected event of peripheral swelling, rash, pain in extremity, joint swelling. There was no AEs associated with product administered at inappropriate site.  The event of peripheral swelling occurred 1 day (same day) after first dose of mRNA-1273, lot # 039K20-24.  The event of rash, and joint swelling occurred 12 days after first dose of mRNA-1273, lot # 039K20-24. The event of pain in extremity occurred on an unspecified date after first dose of mRNA-1273, lot # 039K20-24. Treatment details were not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: inject air into vaccine; A spontaneous report was received from a nurse healthcare provider concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273)    There was no medical history provided. There were no concomitant medications provided.  On an unspecified date, the patient received the first of two planned doses of mRNA-1273 (Batch # unknown), for prophylaxis of COVID-19 infection.   On an unspecified date, the nurse injected air into vaccine. There was no further information provided There was no treatment information provided.  Action taken with mRNA-1273 in response to the event of injected air into vaccine, was not provided.  The outcome for the event of injected air into vaccine was recovered/resolved at the time of this report.; Reporter's Comments: This report refers to a case of Product administration error (nurse injected air into vaccine) for mRNA-1273, lot # not provided.  There were no reported AEs associated with this case of Ppoduct administration error  The reported event is unlisted and company causality was assessed s not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine given to a minor; A spontaneous report was received from a health care professional concerning a minor patient who received Moderna's COVID-19 Vaccine, and vaccine given to a minor (Product administered to patient of inappropriate age).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273.   Vaccine given to a minor. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, vaccine given to a minor was considered resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Incorrect dose administered, Syringe issue
Clinical narrative: Patient was given second full dose; Partial dosage due to syringe leakage; Partial dosage due to syringe leakage; A spontaneous report was received from a nurse concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and the patient was given partial dosage due to syringe leakage and patient was given second full dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14 Jan 2021, around 12:15 PM, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly for prophylaxis of COVID-19 infection. Due to a syringe leak, the patient was given a partial dose. About five minutes later, the patient received a second full dose of mRNA-1273. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The events, patient was given partial dosage due to syringe leakage and patient was given second full dose, were considered resolved on 14 Jan 2021.; Reporter's Comments: This report refers to a case of Product administration error for mRNA-1273 (Lot number: 013L20A). There was incomplete dose administered due to syringe leakage and after 5 minutes another full dose of vaccine was administered. There were no reported AEs with this case of incomplete dose administered, syringe leak and an extra dose administered error.
Sex: M
Vaccine: TYP
Symptoms: Hypersensitivity
Clinical narrative: patient is allergic to typhoid vaccine, had allergic reaction when was young; Initial information received on 19-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer (patient).  This case involves an adult male patient who had allergic reaction(allergic to typhoid vaccine), while he received TYPHOID VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect TYPHOID VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccine.  On an unknown date, the patient developed a non-serious allergic reaction(allergic to typhoid vaccine) (hypersensitivity) unknown latency following the administration of TYPHOID VACCINE.  The reporter wanted to know if COVID 19 vaccine has any of the components of Typhoid vaccine before getting it.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick; Initial information was received on 17-Jan-2021 regarding an unsolicited valid non-serious from a consumer/ non-heath care professional.  This case involves a patient of unknown age who got sick (illness), while being received INFLUENZA VACCINE.  Past medical history, medical treatment(s), past vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (batch number and other dosing details were not reported) at an unknown dose via unknown route and unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after receiving the suspect vaccine, patient was sick (illness).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  Outcome of the event was reported as unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Use to suffer a lot with the flu; Initial information received on 17-Jan-2021 regarding an unsolicited valid non-serious social media case received from a consumer.  This case involves a patient with unknown demographic who used to suffer a lot with the flu (Influenza), while he/she received vaccine INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient used to suffer a lot with the flu (Influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine: Product Name: Product name was not provided. Since this was a public post on the Sanofi it was assuming the consumer was referring to the Sanofi flu vaccine. Author/Reporter Comment: Use to suffer a lot with the flu. Flu shots only focus on the strain they are predicting for that season. Build ones immunity to fight off anything. Just like working out.   Details of laboratory data were not reported.  The patient had stopped taking the flu shots, eating healthy and working with acupuncture as a corrective treatment.  The patient was recovering (much better) from the event, at the time of reporting.  There would be no information available on the batch number for this case.