chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Oral pain, Sialoadenitis, Sjogren's syndrome, Swelling face, Tooth disorder
Clinical narrative: Salivary gland infection; Sjogren's syndrome (mouth inflammation); Sjogren's syndrome (mouth inflammation); Lymph gland infection; Tooth disorder (rancid); Swelling in upper cheeks and ears; Swelling in upper cheeks and ears; Eyes are burning and a little bit dry; Eyes are burning and a little bit dry; Mouth really hurt to me; Flu; This is a spontaneous report from a contactable consumer reporting for herself. A 50-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# CL3302), via an unspecified route of administration, on 01Feb2021, at single dose, for COVID-19 immunisation. Medical history included COVID-19 from Apr2020 to an unknown date, Sjogren's syndrome from 2015 and ongoing (was under control), fibromyalgia, autoimmune disorder, ongoing hormone level abnormal (taking estrogen), ongoing eye disorder. Concomitant medications included ongoing ciclosporin (RESTASIS) for eye disorder, famotidine (PEPCID), albuterol [salbutamol] (unknown manufacturer), ongoing estradiol (ESTROGEN) for hormone level abnormal. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation and experienced pain, asthma and nasal irritation. The patient experienced salivary gland infection (medically significant) in Feb2021 with outcome of unknown, Sjogren's syndrome (mouth inflammation) (medically significant) in Feb2021 with outcome of unknown, lymph gland infection in Feb2021 with outcome of unknown, tooth disorder (rancid) in Feb2021 with outcome of unknown, swelling in upper cheeks and ears in Feb2021 with outcome of unknown, eyes are burning and a little bit dry in Feb2021 with outcome of unknown, mouth really hurt to me in Feb2021 with outcome of unknown, flu in Feb2021 with outcome of unknown. The patient went to the emergency room for Sjogren's syndrome (mouth inflammation) and tooth disorder (rancid). On unknown date the patient underwent lab tests and procedures which included blood electrolytes: unknown results, full blood count: unknown results, investigation: unknown results, monocyte count: normal. Therapeutic measures were taken as a result of the events and included treatment with Salagen and Tylenol. The reporter stated she believed to have a reaction from the vaccine shot.
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Unevaluable event
Clinical narrative: received quadracel in error at age of 2 year (age range for Quadracel was 4-6yrs of age)/no AE; Initial information received on 16-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 year old patient who received quadracel in error at age of 2 year (age range for Quadracel was 4-6yrs of age), while he/she received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] lot number not reported via unknown route in unknown administration site for prophylactic vaccination (product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  A health office received a Quadracel vaccine. The age range for Quadracel was 4-6yrs of age, which means this child received Quadracel in error.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: patients received improperly stored vaccines; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 09-FEB-2021, the patient (also reported as an unknown number of patients) was vaccinated with an improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 1 dose, lot # T032761, expiration date 30-MAY-2022 (exact dose and route of administration were not reported) for prophylaxis. The administered vaccine experienced temperature excursion of 46.9 degrees Fahrenheit for 15 min. Previous temperature excursion included 48.7 degrees Fahrenheit for 3 h 15 min. The digital data logger was involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: T032761; expirationdate: 30-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: HEP
Symptoms: Erythema, Lymphangitis, Malaise, Serum sickness, Urticarial vasculitis
Clinical narrative: lymphangitis; serum sickness; hypocomplementemic vasculitis; This spontaneous report was received from a currently 83-year-old female patient who reported on herself. The patient's medical history included reaction / allergy for tetanus vaccine and for sulfites. No information regarding the patient's concurrent conditions or concomitant medications was not provided.  On an unspecified date in 1990, the patient was vaccinated wit the first and the second doses of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (dose, lot #, expiration date, route of administration were not reported) injection in arm for prophylaxis (reported as "she was working in the intensive care unit (ICU) in Critical Care and 3 physicians were diagnosed with Hepatitis B so the employees were advised to get the vaccine").  On an unspecified date in 1990, reported as after the first two doses, she experienced malaise and "vaccination reaction". On an unspecified date, she received the third dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB). On an unknown date, after the third dose, she developed a red streak from elbow to shoulder area, lymphangitis, and serum sickness. The patient was eventually diagnosed with hypocomplementemic vasculitis. She was on "cortisone/steroids" for approximately 1 year after the reaction to the vaccine (conflicting information, it was also reported that the patient was not given any treatment for adverse event). It was reported that the patient sought medical attention and spoke to several physician. She also had unspecified testing by dermatologist (result not reported). The outcome of the events was reported as recovering.  The causality assessment between the aforementioned events and the suspect vaccine was not provided, however upon internal review, it was considered related to the suspect vaccine.  Upon internal review, the events of lymphangitis and hypocomplementemic vasculitis were determined to be medically significant.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no other adverse event; Improperly stored product administered; This spontaneous report has been received from an office manager and refers to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.  On 20-FEB-2021, the improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 1 dose, lot # s011532 with expiration date 01-DEC-2021 (route of administration, exact dose and frequency were unknown) was administered to a patient (product storage error). The vaccine was stored at -2.7 Celsius degrees for 11 hours and 52 minutes. There was no previous temperature excursions. Digital data logger was involved. No other adverse events 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; devicelotnumber: s011532; expirationdate: 01-DEC-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: M
Vaccine: HPV9
Symptoms: Injection site discolouration, Injection site pain, Injection site swelling
Clinical narrative: some skin discoloration; Injection site swelling; injection site pain; This spontaneous report as received from a physician refers to a 15-year-old male patient. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  On 12-FEB-2021,the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  lot number:16211931 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9); Lot number:16211931 does not match any Company product as confirmed by Lot Verification team, expiration date reported as: 26-JAN-2022) for prophylaxis (dose, and  route were not reported).  It was reported that 2-3 days later, on approximately on 14-FEB-2021 (also reported as on 20-FEB-2021 by the same reporter), he had injection site swelling (Vaccination site swelling) and pain (Vaccination site pain). On 20-FEB-2021, the patient was seen in the office to evaluate injection site swelling. The reporter stated that the site was swollen about 1 cm in diameter, very painful with some skin discoloration, on  20-FEB-2021 (Vaccination site discolouration). No additional adverse event or PQC reported. The patient seek medical attention by office visit. No treatment was given for the events.  The outcome of vaccination site swelling, vaccination site pain  and vaccination site discolouration was not recovered. The causal relationship between the aforementioned event and  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; 9 month old patient was administered VAQTA; This spontaneous report was received from a physician via company representative, referring to a 9-month-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.      On 18-FEB-2021, a 9-month-old patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) (product administered to patient of inappropriate age). No additional adverse event reported.
Sex: F
Vaccine: PPV
Symptoms: Malaise, Peripheral swelling, Skin warm
Clinical narrative: arm swollen; arm was warm; didn't feel well for a long time; This spontaneous report as received from a consumer refers to a 71-year-old female patient.There was no information about the patient's medical history, concurrent conditions or concomitant medication.      On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).         On an unknown date, the patient stated her arm was warm (feeling hot) and swollen and she "did not feel well for a long time (malaise)."  The patient reported she was taking diphenhydramine hydrochloride (BENADRYL) after reaction. No clarifying details were provided.  The outcome of peripheral swelling, malaise and feeling hot is unknown.  The causality assessment for the events was not reported.   This is one of several reports received from the same reporter; Sender's Comments:  US-009507513-2102USA008670:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no other AE's reported; temperature - 7.4 C / the VARIVAX was administered; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 19-FEB-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live VARIVAX 0.5 ml, lot # T021821, expiration date 25-JUN-2022 (route of administration and anatomical location were not provided) for prophylaxis. The administered vaccine was stored in a temperature of -7.4 degrees Celsius (C) for 3 hours and 54 minutes. No previous temperature excursion was reported. Digital data logger was involved.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2102USA008721: US-009507513-2102USA008814:
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: no additional adverse event; three doses of ROTATEQ were administered following a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-FEB-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml once, orally, lot # 1691308, expiration date 28-NOV-2021 for prophylaxis. The vaccine experienced a temperature excursion, however, at the time of reporting, the reporter was waiting for multiple excursion form to be returned so no details were provided. Digital data logger was not involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2102USA008565:
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Swelling
Clinical narrative: soreness at injection; little swelling; little pain; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date for tolerance see case US2021AMR000320).   On 31st December 2020, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced injection site pain, swelling and pain. On an unknown date, the outcome of the injection site pain, swelling and pain were unknown.   It was unknown if the reporter considered the injection site pain, swelling and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccine indication. The patient experienced side effect of soreness at injection, the little swelling and the little pain. The reporter inquired that What should be done to calm these reaction. The information regarding consent to follow up was not reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR000320:1st dose
Sex: U
Vaccine: VARZOS
Symptoms: Multiple allergies
Clinical narrative: had a severe allergies to something in the second dose of Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of multiple allergies in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced multiple allergies. On an unknown date, the outcome of the multiple allergies was unknown.   It was unknown if the reporter considered the multiple allergies to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient him/herself. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient stated that he/she had severe allergies to something in the 2nd dose of Shingrix, The patient wanted to know if he/she should get COVID vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: I have an allergic reaction to the first dose; This case was reported by a consumer via media and described the occurrence of allergic reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient him/herself. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received 1st dose of Shingrix and had allergic reaction.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Large patch of redness at Shingrix injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group  was not reported however captured as adult as per vaccine indication. The patient experienced large patch of redness at Shingrix injection site.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypersomnia, Myalgia, Pain
Clinical narrative: Developed muscular aches; Pain; Headaches; When to bed and slept for ~12 hours; This case was reported by a physician and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain, pain, headache and sleep excessive. On an unknown date, the outcome of the muscle pain, pain, headache and sleep excessive were recovered/resolved.   The reporter considered the muscle pain, pain, headache and sleep excessive to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The physician stated that upon receiving the 2nd dose of Shingrix, the patient developed muscular aches and pain and headache and when to bed and slept for approximately 12 hours and this resolved the next day. The patient was not hospitalized. The physician believed that this was related to the vaccine. The reporter consented to follow-up.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: range of motion is limited; has a hard time sleeping at night due to the pain; immediately experienced a sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th September 2020, the patient received the 1st dose of Shingrix. On 30th September 2020, immediately after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the patient experienced mobility decreased and difficulty sleeping. On an unknown date, the outcome of the pain in arm, mobility decreased and difficulty sleeping were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, mobility decreased and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The patient had his first dose and immediately experienced a sore arm.  The soreness had not resolved and his range of motion was limited.   He said he had a hard time sleeping at night due to the pain. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pruritus
Clinical narrative: Itching for several days; Experienced an allergic reaction; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included multiple allergies.   In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pruritus and allergic reaction. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the pruritus and allergic reaction were recovered/resolved.   It was unknown if the reporter considered the pruritus and allergic reaction to be related to Shingrix.  Additional details were provided as follows: The reporter reported for herself. The age at vaccination was not reported but it could be 74 or 75 years. The reporter stated that, after vaccination with 1st dose, experienced an allergic reaction, had itching for several days. The patient took steroid medication for few days.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021008415:Same reporter. Duplicate case - deleted.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaemia, Chills, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: Felt like she had anemia; Was out of breath; Felt really bad / did not feel better after eating yesterday or after eating breakfast this morning/ have not resolved; Flu-like symptoms; Fever; Chills; Achiness; A lot of fatigue; Headache; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 62-year-old female patient who received Herpes zoster (Shingrix) for an unknown indication.   Concurrent medical conditions included hashimoto's disease.   On 15th January 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 16th January 2021, 1 days after receiving Shingrix, the patient experienced feeling bad, influenza-like symptoms, fever, chills, pain, fatigue and headache. On 19th January 2021, the patient experienced anemia and shortness of breath. The action taken with Shingrix was unknown. On 17th January 2021, the outcome of the influenza-like symptoms, fever, chills, pain and headache were recovered/resolved. On an unknown date, the outcome of the feeling bad, fatigue, anemia and shortness of breath were not recovered/not resolved.   It was unknown if the reporter considered the feeling bad, influenza-like symptoms, fever, chills, pain, fatigue, headache, anemia and shortness of breath to be related to Shingrix.  Additional details were reported as follows: The patient received shingrix vaccine on in the upper left arm at .  She stated that the next she felt really bad with flu-like symptoms, including fever, chills, achiness, a lot of fatigue and headache.  She reported that, they all were gone by on 17th January 2021 and that she felt fine on On 18th January 2021.  She also reported on 19th January 2021, she felt like she had anemia, was out of breath and had fatigue.  She did not feel better after eating day before reporting or after eating breakfast on the day of reporting. These had not resolved. The patient consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Felt like she had anemia; Was out of breath; Felt really bad / did not feel better after eating yesterday or after eating breakfast this morning/ have not resolved; Flu-like symptoms; Fever; Chills; Achiness; A lot of fatigue; Headache; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 62-year-old female patient who received Herpes zoster (Shingrix) for an unknown indication.   Concurrent medical conditions included hashimoto's disease.   On 15th January 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 16th January 2021, 1 days after receiving Shingrix, the patient experienced feeling bad, influenza-like symptoms, fever, chills, pain, fatigue and headache. On 19th January 2021, the patient experienced anemia and shortness of breath. The action taken with Shingrix was unknown. On 17th January 2021, the outcome of the influenza-like symptoms, fever, chills, pain and headache were recovered/resolved. On an unknown date, the outcome of the feeling bad, fatigue, anemia and shortness of breath were not recovered/not resolved.   It was unknown if the reporter considered the feeling bad, influenza-like symptoms, fever, chills, pain, fatigue, headache, anemia and shortness of breath to be related to Shingrix.  Additional details were reported as follows: The patient received shingrix vaccine on in the upper left arm at .  She stated that the next she felt really bad with flu-like symptoms, including fever, chills, achiness, a lot of fatigue and headache.  She reported that, they all were gone by on 17th January 2021 and that she felt fine on On 18th January 2021.  She also reported on 19th January 2021, she felt like she had anemia, was out of breath and had fatigue.  She did not feel better after eating day before reporting or after eating breakfast on the day of reporting. These had not resolved. The patient consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Pruritus
Clinical narrative: middle area of her back started to itch; sensation of little stabbing needles / in the middle of her back; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received in 2018.).   On 3rd October 2018, the patient received Shingrix. On 24th January 2021, 844 days after receiving Shingrix, the patient experienced pruritus and pins and needles. On an unknown date, the outcome of the pruritus and pins and needles were not recovered/not resolved.   It was unknown if the reporter considered the pruritus and pins and needles to be related to Shingrix.  Additional details were provided as follows:  The patient had both doses in 2018. After searching paperwork, the date 3rd October 2018 was found as vaccination date but the reporter was not sure if that was the first dose or second dose date. After receiving Shingrix, the patient experienced the middle area of her back started to itch and the sensation of little stabbing needles presented, and it was under her bra area in the middle of her back. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Rash
Clinical narrative: Dr. diagnosed it as an allergic reaction; RASH ON THE ARM / covered her entire left arm; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. In November 2020, 2 days after receiving Shingrix and an unknown time after starting Zyrtec, the patient experienced allergic reaction and rash. The patient was treated with cetirizine hydrochloride (Zyrtec). On an unknown date, the outcome of the allergic reaction was unknown and the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the allergic reaction and rash to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received 1st dose of Shingrix in unknown arm. After receiving 1st dose of Shingrix, the patient experienced rash covered her entire left arm. The doctor diagnosed it as an allergic reaction. The rash disappeared after one week. The patient reported all possible side effects. The patient became frustrated with the collection of demographics and hung up the phone before transfer to the product team. The patient did not give permission to contact their doctor.    The reporter did not consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity, Tenderness
Clinical narrative: Soreness at injection site; left arm was Sore to the touch; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain and pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were unknown.   It was unknown if the reporter considered the injection site pain and pain in arm to be related to Shingrix.  Additional details were provided as follows:  After receiving 1st dose of Shingrix, the patient experienced soreness at injection site and left arm was sore to the touch. All information was not available. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: experiencing "all of the listed side effects." / not feeling well; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th January 2021, the patient received the 2nd dose of Shingrix. On 28th January 2021, 1 days after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. On 27th January 2021, the patient received 2nd dose of Shingrix. The reporter stated that, she experienced all of the listed side effects and refused to answer any questions as she was not feeling well enough to do so. Limited information was provided. The reporter did not consent to follow up.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Rash, Vomiting
Clinical narrative: Rash on his arm; Sweating; Vomiting; This case was reported by a consumer via call center representative and described the occurrence of sweating in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th January 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 11th January 2021, 12 hrs after receiving Shingrix, the patient experienced sweating and vomiting. On 26th January 2021, the patient experienced rash. On an unknown date, the outcome of the sweating and vomiting were recovered/resolved and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the sweating, vomiting and rash to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The patient stated that, about 12 hours after vaccination, the patient had sweating and vomiting and were resolved. The patient stated that 3 days ago, the patient developed a rash on his arm and was not recovered. The patient did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021022953:same reporter US-GLAXOSMITHKLINE-US2021022954:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Skin disorder
Clinical narrative: A skin issue; This case was reported by a consumer via call center representative and described the occurrence of skin disorder in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced skin disorder. The patient was treated with antibiotics nos (Anti-Biotic (Drug Name Unknown)). On an unknown date, the outcome of the skin disorder was not recovered/not resolved.   It was unknown if the reporter considered the skin disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  Patient received the dose of Shingrix and experienced skin issue. The reporter stated that, he/she was due for the 2nd dose of Shingrix. The patient took anitbiotics for the skin disorder.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the second dose of Shingrix earlier than recommended / first dose was administered on 5-JAN-2021; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 3R45T, expiry date unknown) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 5th February 2021, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional information was provided as follows: The patient received the 2nd dose of Rotarix earlier than the recommended schedule, which led to shortening of vaccination schedule. On 5th January 201, the patient received 1st dose of Shingrix. The reporter consented to follow up. The case is linked with the case number- US2021033003, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021033003:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Swelling face, Throat tightness
Clinical narrative: libs and throat were closing; libs and throat were closing; Swelling on the face; This case was reported by a physician via call center representative and described the occurrence of throat constriction in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced throat constriction (serious criteria life threatening), lip swelling (serious criteria life threatening) and facial swelling (serious criteria life threatening). The patient was treated with steroids nos (Steroids) and antihistamine (Anti Histamine). On an unknown date, the outcome of the throat constriction, lip swelling and facial swelling were recovered/resolved.   It was unknown if the reporter considered the throat constriction, lip swelling and facial swelling to be related to Shingrix.  Additional details were provided as follows: It was reported that the 24 hours after receiving a the first dose of Shingrix the patient experienced swelling on the face, lips and throat were closing, had to go to emergency and received medications steroids and anti-histamines.  The patient was now recovered. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; A spontaneous report was received from a consumer, concerning herself, a 75-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed chills.  The patient's medical history was not provided. Concomitant product use was not provided.  On 15 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot # unknown) in the left arm for prophylaxis of COVID-19 infection.   On 17 Jan 2021, after vaccine administration, since Sunday, the patient started experiencing chills. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event chill was considered not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Ophthalmic herpes zoster
Clinical narrative: Herpes Opthlamic Zoster; A spontaneous report was received from a consumer concerning a 42 years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed Herpes Ophthalmic Zoster/MedDRA PT: Ophthalmic herpes zoster.  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 (Lot #not provided) on an unknown date. On 09 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot #, site of injection and route of administration Not provided) for the prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient was diagnosed with Herpes Ophthalmic Zoster. Treatment details were not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event ; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event Herpes Ophthalmic Zoster was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Gallbladder disorder
Clinical narrative: Gall bladder dysfunction; A spontaneous report was received from a medical assistant concerning a patient of unspecified age and gender, who Moderna's COVID-19 Vaccine (mRNA-1273) and experienced gall bladder dysfunction.     The patient's medical history was not reported. Concomitant product use was not provided by reporter.   On unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.  On an unspecified date, after receiving vaccine, the patient experienced gall bladder dysfunction. Hence, due to this reaction the second dose of vaccine was not administered. Treatment information was not provided.   Action taken to mRNA-1273 in response to event was temporarily withheld.   The outcome of event gall bladder dysfunction was unknown at the time of this report.; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy bone marrow, Blood test, Body temperature, Chills, Computerised tomogram
Clinical narrative: High grade MDS; Multiorgan failure; Pancytopenia; shortness of breath; Inflammatory marker increased; Chills; Fever; Fatigue; A spontaneous report was received from a healthcare provider concerning a 71Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced chills, fever, fatigue, pancytopenia, shortness of breath (dyspnoea),  multi organ failure, and myelodysplastic syndrome (MDS).  The patient's medical history was reported to include Breast Cancer and mastectomy. No relevant concomitant medications were reported.  On 16 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:unkown) intramuscularly for prophylaxis of COVID-19 infection.   On 16 Jan 2021, The patient experienced events like chills, fever, and fatigue.  On an undisclosed date, the patient was admitted to the hospital for shortness of breath. Laboratory details include Bone Marrow biopsy with abnormal results such as showed high grade MDS with 19% blasts. Blood work done with normal results. Body temperature results came out 103 degrees Fahrenheit.  On 30 Jan 2021 the patient experienced worsening shortness of breath and was intubated.  Her IL-6 was very high, and she had profound liver failure. She ended up needing pressors and requiring continuous renal replacement therapy.  Treatment included steroids.  Action taken with mRNA-1273 in response to the events was not applicable.   The patient died on 12 Feb 2021. The cause of death was reported as high grade MDS. An autopsy was planned.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Inflammatory marker increased, Interleukin level, Laboratory test
Clinical narrative: High grade MDS; Multiorgan failure; Pancytopenia; shortness of breath; Inflammatory marker increased; Chills; Fever; Fatigue; A spontaneous report was received from a healthcare provider concerning a 71Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced chills, fever, fatigue, pancytopenia, shortness of breath (dyspnoea),  multi organ failure, and myelodysplastic syndrome (MDS).  The patient's medical history was reported to include Breast Cancer and mastectomy. No relevant concomitant medications were reported.  On 16 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:unkown) intramuscularly for prophylaxis of COVID-19 infection.   On 16 Jan 2021, The patient experienced events like chills, fever, and fatigue.  On an undisclosed date, the patient was admitted to the hospital for shortness of breath. Laboratory details include Bone Marrow biopsy with abnormal results such as showed high grade MDS with 19% blasts. Blood work done with normal results. Body temperature results came out 103 degrees Fahrenheit.  On 30 Jan 2021 the patient experienced worsening shortness of breath and was intubated.  Her IL-6 was very high, and she had profound liver failure. She ended up needing pressors and requiring continuous renal replacement therapy.  Treatment included steroids.  Action taken with mRNA-1273 in response to the events was not applicable.   The patient died on 12 Feb 2021. The cause of death was reported as high grade MDS. An autopsy was planned.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Multiple organ dysfunction syndrome, Myelodysplastic syndrome, Pancytopenia, Pyrexia
Clinical narrative: High grade MDS; Multiorgan failure; Pancytopenia; shortness of breath; Inflammatory marker increased; Chills; Fever; Fatigue; A spontaneous report was received from a healthcare provider concerning a 71Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced chills, fever, fatigue, pancytopenia, shortness of breath (dyspnoea),  multi organ failure, and myelodysplastic syndrome (MDS).  The patient's medical history was reported to include Breast Cancer and mastectomy. No relevant concomitant medications were reported.  On 16 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:unkown) intramuscularly for prophylaxis of COVID-19 infection.   On 16 Jan 2021, The patient experienced events like chills, fever, and fatigue.  On an undisclosed date, the patient was admitted to the hospital for shortness of breath. Laboratory details include Bone Marrow biopsy with abnormal results such as showed high grade MDS with 19% blasts. Blood work done with normal results. Body temperature results came out 103 degrees Fahrenheit.  On 30 Jan 2021 the patient experienced worsening shortness of breath and was intubated.  Her IL-6 was very high, and she had profound liver failure. She ended up needing pressors and requiring continuous renal replacement therapy.  Treatment included steroids.  Action taken with mRNA-1273 in response to the events was not applicable.   The patient died on 12 Feb 2021. The cause of death was reported as high grade MDS. An autopsy was planned.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Inappropriate schedule of product administration, Incorrect dose administered, Syringe issue
Clinical narrative: Allergic reaction; Syringe malfunctioned and the vaccine ran down patients arm/ noticed there was still some vaccine left in the syringe; Syringe malfunctioned and the vaccine ran down patients arm/ noticed there was still some vaccine left in the syringe; Administered another new dose; A spontaneous report was received on 12 FEB 2021 from a pharmacist concerning a 36-years-old, female patient who received second dose of Moderna's COVID-19 vaccine and had syringe malfunctioned and the vaccine ran down patients arm/ noticed there was still some vaccine left in the syringe developed allergic reaction, heart racing, arm was on fire and throat was itchy and was administered another new dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273 on 28 Jan 2021 (LOT number: unknown) for COVID-19 infection prophylaxis. On 28 JAN 2021, patients received second dose of mRNA-1273(BATCH/LOT number: 025J20-2A) in the right upper arm for the prophylaxis of COVID-19 infection.  On 28 JAN 2021, when patient received the vaccine, the syringe was "malfunctioned", and the vaccine ran down patient's arm. Vaccine administrator noticed there was still some vaccine left in the syringe and thought the patient did not receive that dose because it was leaked down patients arm. The patient received another new dose. After receiving vaccine, patient had an allergic reaction, heart racing, arm was on fire and throat was itchy. Treatment for the events provided was diphenhydramine.   Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the event's allergic reaction, heart racing, arm was on fire and throat was were unknown. The outcome of the events syringe malfunctioned, and the vaccine ran down patients arm noticed there was still some vaccine left in the syringe developed and administered another new dose were considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Chills, Computerised tomogram normal, Fatigue, Headache
Clinical narrative: Patient has episode of amnesia possibly cause by seizure. Patient also had headache, chills, fatigue.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Ultrasound Doppler
Clinical narrative: Patient has episode of amnesia possibly cause by seizure. Patient also had headache, chills, fatigue.