chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Paraesthesia oral, Swollen tongue
Clinical narrative: 49 year old female with no significant medical history presents to the ED with possible allergic reaction. Patient had to COVID vaccinations at facilitie at 1750 today. She reports lip tingling and tongue swelling, and she was sent to the ED for further evaluation. Patient reports history of reaction to "certain things." She had an "anaphylactic reaction" with a cortisone shot given by orthopedics in her shoulder a few months ago. Patient presented with similar symptoms including tongue swelling and lip swelling. She took a Benadryl and the symptoms resolved. Today symptoms are similar to previous. She was concerned prior to her vaccination about possible allergic reaction, so she took half a 25 mg Benadryl pill prior to vaccination shot. Patient states symptoms have improved. She denies shortness of breath, throat swelling, rash, or other concerns. Allergy to Penicillin and Amoxicillin..
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was injected with the Janssen COVID-19 Vaccine EUA however it is outside of the age guidelines. Patient is 16 years old
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Injection site pain, Myalgia
Clinical narrative: muscle aches at injection site muscle aches upper back/shoulders About 18 hours after injection 101 degree fever for approximately 4 hours General weakness/lack of energy but not extensive enough to actually hinder basic activities
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: muscle aches at injection site muscle aches upper back/shoulders About 18 hours after injection 101 degree fever for approximately 4 hours General weakness/lack of energy but not extensive enough to actually hinder basic activities
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Back pain, Pain, Paraesthesia
Clinical narrative: The patient is a 66 year old female with history of severe arthritis, fibromyalgia, and COPD presenting with lower back pain x 6 days. The patient states she normally has chronic back pain caused by her arthritis, but the current back pain started about 12 hours after she received her first COVID vaccine 6 days ago. She states the pain is acute onset, sudden onset, severe, located in her lower back with the right side being worse than the left. Today she also notes some tingling down the back of both legs. Pain is constant and worse with ambulation and certain movements. She denies any falls or recent trauma. She denies any weakness, saddle anesthesia, or urinary or bowel symptoms. She tried taking ibuprofen and Norco for pain with no relief. She states her back pain is caused by the COVID vaccination.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chest pain, Dizziness, Fatigue, Headache
Clinical narrative: Light headed, nauseous.  2nd day extreme body aches with tiredness, headache and fever. 3rd day body aches and stomach discomfort and pain on right side of chest.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Light headed, nauseous.  2nd day extreme body aches with tiredness, headache and fever. 3rd day body aches and stomach discomfort and pain on right side of chest.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Arm has become red, itchy and warm to the touch.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Urticaria
Clinical narrative: About 11:15am I started with hives on my right arm. I took Benadryl. The hives continued to appear new spots as of 2am.  I was having increased pain throughout the day. I started a fever at 4pm.  4/8/2021
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Arthralgia, Influenza like illness, Injection site pain, Lip swelling
Clinical narrative: Swelling of lips, tongue and neck within 15 minutes of injection.  Was monitored for 30 minutes.  Swelling did not progress and went down throughout the day.  Lost sense of taste for a day.  Arm became very sore the  day after receiving injection.  Felt like I had the flu in that one arm.  Pain was a 7 on 1-10 pain scale with 10 being the worst.   Arm continues to  hurt from 3 inches above elbow up to shoulder joint to this day.  After receiving 2nd shot in right arm on 01/09/2021, the left hurt worse than the right arm.  The right arm did not hurt immediately after the shot like the left one did.  I can pinpoint and place my finger on the place I received both injections still.  Both continue to hurt in the same areas up my forearms.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling, Swollen tongue
Clinical narrative: Swelling of lips, tongue and neck within 15 minutes of injection.  Was monitored for 30 minutes.  Swelling did not progress and went down throughout the day.  Lost sense of taste for a day.  Arm became very sore the  day after receiving injection.  Felt like I had the flu in that one arm.  Pain was a 7 on 1-10 pain scale with 10 being the worst.   Arm continues to  hurt from 3 inches above elbow up to shoulder joint to this day.  After receiving 2nd shot in right arm on 01/09/2021, the left hurt worse than the right arm.  The right arm did not hurt immediately after the shot like the left one did.  I can pinpoint and place my finger on the place I received both injections still.  Both continue to hurt in the same areas up my forearms.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site rash, Pruritus, Rash, Urticaria
Clinical narrative: About 2 days after my second shot of the Pfizer Vaccine, I experienced a rash on the back of my left shoulder and arm, not far from the injection site. It was around the back side of my upper arm and shoulder/arm pit area.  Rash had a hives like look (red bumps) and only on my left side. I also experienced a similar, but smaller rash on the back side of my right knee on day 3 after my second dose. These rashes were very itchy. It is now day 4 post second shot and the rash is still present but appears to be lessening a bit.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Red blood cell abnormality, Skin warm
Clinical narrative: Rash on left, upper arm. 6" diam. Solid red, itches, warm. Slightly fading after 48 hours.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site nodule, Injection site urticaria
Clinical narrative: A wheal reaction with a hard nodule approximately 1.5 inches in diameter at the site of injection.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting and diarrhea. Currently keeping tack of temp and symptoms. Reached out to the first nurse and will reach out to regular family doctor. So far no treatment/office visit needed.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: CHILLS. FATIGUE, HEADACHE, FEVER 101.5 F
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pyrexia, Tinnitus
Clinical narrative: Nausea, ringing in ears so bad I felt like I was going to throw up or pass out.  Felt like I was going to get up I would fall over. Slight fever
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arterial occlusive disease, Arthralgia, Asthenia, Atrial fibrillation, Blood culture
Clinical narrative: Shortness of breath, hypertension, hypoxia, tachycardia, lips and fingers turn blue, high fever, rash, hives, joint pain, whole body aches, left lower leg burning, artery blockages, infection, weakness, dizziness, tunnel vision, sweating, headache, new onset atrial fibrillation with rvr All of the above symptoms first occurred 30 minutes after injection of vaccine The atrial fibrillation occurred 6 days after injection Left lower leg started burning 15 days after injection The artial blockages and thrombus 18 days after injection by medical diagnosis due to instantaneous shut off of blood to left leg
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest X-ray, Computerised tomogram, Dyspnoea, Headache
Clinical narrative: Shortness of breath, hypertension, hypoxia, tachycardia, lips and fingers turn blue, high fever, rash, hives, joint pain, whole body aches, left lower leg burning, artery blockages, infection, weakness, dizziness, tunnel vision, sweating, headache, new onset atrial fibrillation with rvr All of the above symptoms first occurred 30 minutes after injection of vaccine The atrial fibrillation occurred 6 days after injection Left lower leg started burning 15 days after injection The artial blockages and thrombus 18 days after injection by medical diagnosis due to instantaneous shut off of blood to left leg
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypertension, Hypoxia, Infection, Laboratory test
Clinical narrative: Shortness of breath, hypertension, hypoxia, tachycardia, lips and fingers turn blue, high fever, rash, hives, joint pain, whole body aches, left lower leg burning, artery blockages, infection, weakness, dizziness, tunnel vision, sweating, headache, new onset atrial fibrillation with rvr All of the above symptoms first occurred 30 minutes after injection of vaccine The atrial fibrillation occurred 6 days after injection Left lower leg started burning 15 days after injection The artial blockages and thrombus 18 days after injection by medical diagnosis due to instantaneous shut off of blood to left leg
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral vascular disorder, Pyrexia, Rash, Skin discolouration
Clinical narrative: Shortness of breath, hypertension, hypoxia, tachycardia, lips and fingers turn blue, high fever, rash, hives, joint pain, whole body aches, left lower leg burning, artery blockages, infection, weakness, dizziness, tunnel vision, sweating, headache, new onset atrial fibrillation with rvr All of the above symptoms first occurred 30 minutes after injection of vaccine The atrial fibrillation occurred 6 days after injection Left lower leg started burning 15 days after injection The artial blockages and thrombus 18 days after injection by medical diagnosis due to instantaneous shut off of blood to left leg
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Sputum culture, Tachycardia, Thrombosis, Tunnel vision, Ultrasound scan
Clinical narrative: Shortness of breath, hypertension, hypoxia, tachycardia, lips and fingers turn blue, high fever, rash, hives, joint pain, whole body aches, left lower leg burning, artery blockages, infection, weakness, dizziness, tunnel vision, sweating, headache, new onset atrial fibrillation with rvr All of the above symptoms first occurred 30 minutes after injection of vaccine The atrial fibrillation occurred 6 days after injection Left lower leg started burning 15 days after injection The artial blockages and thrombus 18 days after injection by medical diagnosis due to instantaneous shut off of blood to left leg
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Shortness of breath, hypertension, hypoxia, tachycardia, lips and fingers turn blue, high fever, rash, hives, joint pain, whole body aches, left lower leg burning, artery blockages, infection, weakness, dizziness, tunnel vision, sweating, headache, new onset atrial fibrillation with rvr All of the above symptoms first occurred 30 minutes after injection of vaccine The atrial fibrillation occurred 6 days after injection Left lower leg started burning 15 days after injection The artial blockages and thrombus 18 days after injection by medical diagnosis due to instantaneous shut off of blood to left leg
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Feeling abnormal, Pyrexia, Vaccine positive rechallenge
Clinical narrative: On 4/7/21, 17 days after I received the second Moderna shot I experienced after effects similar to what I had the day after the second shot on 3/22/21. Both events lasted two days. Fever, brain fog and weakness.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Pain in extremity, Pyrexia
Clinical narrative: Sore Arm within a few hours  Cold chills fever 7 hours after shot
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Severe body aches, headache, and occasional shivers.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Petechiae
Clinical narrative: Abnormal menstrual bleeding (currently have been spotting for 16 days). Petechiae on hands for first 24 hours after vaccine.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Rash, Urticaria
Clinical narrative: Inner thighs to calf swollen, red, itchy. Looks like hives, large rash.  Had a procedure in November, Venaseal performed by a vascular doctor. Rash is along the vessels that were treated. Reaction 11pm same day, took Benadryl. Rash appears in afternoon and again in evening.  I have photos.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Injection site swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: Extremely swollen injection site. Red, painful.  Fever. Fatigue.  Extremely swollen, painful lymph nodes on same side under arm.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Extremely swollen injection site. Red, painful.  Fever. Fatigue.  Extremely swollen, painful lymph nodes on same side under arm.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Red, hot, itchy bumpy ..swelling up.  very hard.  area where I received the shot. From my shoulder to the bend in my arm.  I also have a headache.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: Red, hot, itchy bumpy ..swelling up.  very hard.  area where I received the shot. From my shoulder to the bend in my arm.  I also have a headache.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: headache; feeling tired; This is a spontaneous report from a contactable consumer based on information received by Pfizer. A 53-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included psoriatic arthropathy. Concomitant medication included etanercept (ENBREL) taken 50mg weekly for psoriatic arthritis. The patient experienced headache, feeling tired on 18Mar2021. The outcome was unknown.   Pfizer is a marketing authorization holder of BNT162B2 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of BNT162B2 has submitted the same report to the regulatory authorities.   No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 0.42
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AEs; a 5 month old child received a dose of PNEUMOV AX 23; This spontaneous report was received from a other health professional refers to a 5-month-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 15-MAR-2021, the patient, at the age of 5 months, was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vial, 1 injection, lot # T024556 with expiration date of 08-JAN-2022 (route of administration was unknown) for prophylaxis. No adverse event was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Incorrect route of product administration, Pain in extremity, Peripheral swelling
Clinical narrative: The patient thinks that the pharmacist hit a nerve/It hurt at soon he put the needle in /Her arm was very painfull and swollen/She felt it went too deep; The patient thinks that the pharmacist hit a nerve/It hurt at soon he put the needle in /Her arm was very painfull and swollen/She felt it went too deep; The patient thinks that the pharmacist hit a nerve/It hurt at soon he put the needle in /Her arm was very painfull and swollen/She felt it went too deep; The patient thinks that the pharmacist hit a nerve/It hurt at soon he put the needle in /Her arm was very painfull and swollen/She felt it went too deep; This spontaneous report was received from a female consumer of unknown age, via Pfizer, referring to herself. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On an unknown date, the patient was vaccinated with the first dose of Zoster Vaccine Live (manufacturer unknown) (also reported as "shingles vaccine") as prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported).   On an unknown date, the patient was vaccinated with the second dose of Zoster Vaccine Live (manufacturer unknown) (also reported as "shingles vaccine") as prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported).   On an unknown date after the second dose, the patient reported that she believed the pharmacist hit a nerve because it hurt as soon as he put the needle in, and it caused her arm to be very painful and swollen. She also reported that she felt the needle went too deep and hit a nerve, and when the needle went in, it felt very different on this second dose than from the first dose (vaccination site nerve damage, vaccination site pain, vaccination site swelling, wrong technique in product usage process).   The outcome of the aforementioned events was unknown, and the causal relationship between the events and vaccination with Zoster Vaccine Live (manufacturer unknown) were not provided.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No additional AE was reported; temperature excursion; This spontaneous report was received from a registered nurse and refers to a 12-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 30-MAR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) for prophylaxis (lot # T001211 was verified to be valid, expiration date reported and established as 12-JAN-2022); (dose, frequency, route of administration and vaccination site were not provided).  The administered dose of vaccine experienced a temperature excursion of 50.7Fahrenheit degrees for 30 minutes. There was no previous temperature excursion. The patient did not experience any additional adverse reactions. Digital Data Logger was involved.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA000462:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: vaccine administered after temperature excursion; No adverse event; This spontaneous report was received from a medical assistant referring to a patient of unknown gender and age.  The reporter did not provide information on the patient's historical drugs or reactions, historical conditions, current conditions and concomitant medications.  On 19-MAR-2021 date the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) (lot number S037820 and expiration date 24-NOV-2021) for prophylaxis. It was reported that the vaccine was administered after temperature excursion (incorrect product storage). It was reported that the vaccine reached a temperature of 11.7 degree Celsius. This excursion had a time frame reported of 75 minutes. No previous excursions were reported and information was provided via data logger. No additional adverse event was reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2104USA000653:
Age: 21.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product formulation administered
Clinical narrative: No additional adverse event reported; 21 year old patient given RECOMBIVAX HB Dialysis Formulation in error; This spontaneous report as received from a pharmacist refers to a 21-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 02-APR-2021, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) dialysis formulation in error, lot # T020448, expiration date 13-APR-2023 (exact dose, route of administration and anatomical location were not reported) for prophylaxis. No additional adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Pruritus, Rash
Clinical narrative: shingles; Information has been received regarding a case in litigation from a lawyer and refers to a patient of unknown age and gender.  No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 09-OCT-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route, lot # and expiration date was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine (date not reported), the patient suffered a vesicular rash on the left abdomen with scattered lesions on the lateral surface with pain, itching, and burning, which was diagnosed as Shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was considered not recovered. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular, Skin lesion
Clinical narrative: shingles; Information has been received regarding a case in litigation from a lawyer and refers to a patient of unknown age and gender.  No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 09-OCT-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route, lot # and expiration date was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine (date not reported), the patient suffered a vesicular rash on the left abdomen with scattered lesions on the lateral surface with pain, itching, and burning, which was diagnosed as Shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was considered not recovered. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: At the time of the call it was "1 year and 3 months" after the scheduled time for her third dose; No additional AE information reported. No  reported; This spontaneous report as received from an unknown age female patient concerning herself. There was no information about the patient's medical history, concurrent conditions or concomitant medication. On an unknown dates, the patient was vaccinated with a first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), 0 .5 milliliter for prophylaxis (route of administration, lot number and expiration date were not reported).  At the time of the call it was "1 year and 3 months" after the scheduled time for her third dose, but she had not received it yet. She was supposed to have received her third dose in June 2020. No additional adverse event information reported
Sex: M
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Sore/ Hurt more than any other previous vaccination / previous flu shots; This case was reported by a pharmacist via sales rep and described the occurrence of pain in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The previous flu shots the patient had received were sore and they hurt. This case has been linked with US2020AMR225312 reported for same patient by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR225312:Shingrix + Flu shot, same patient
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Pyrexia, Recalled product administered, Vaccine positive rechallenge
Clinical narrative: First Shingrix / on March 2020 / second / in February 2021, late due to Covid delays /second dose of Shingrix in March of 2021, not February 2021; patient was injected with recalled Shingrix, Lot 9LH3Y / given after the recall notice; patient was injected with recalled Shingrix, Lot 9LH3Y / given after the recall notice; Upset stomach; fever; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of abdominal discomfort (received 1st dose in March 2020 and experienced upset stomach and fever, refer case-US2021062776).   In February 2021, the patient received the 2nd dose of Shingrix. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced upset stomach, fever and social problem. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the upset stomach and fever were recovered/resolved and the outcome of the social problem was unknown.   It was unknown if the reporter considered the upset stomach and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. 12 hours after vaccination, patient experienced upset stomach and fever which lasted for 2 days. The reporter did not consent to follow up. This case has been linked with US2021062776, reported by same reporter.   Follow up information was provided by consumer on 5th April 2021: The patient stated that, she received her 2nd dose in March 2021 and not in February 2021. The patient was injected with recalled Shingrix, which was given after the recall notice, which led to recalled drug administered and drug dispensing error. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021062776:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Tenderness
Clinical narrative: rash on chest and back; rash on chest and back that is tender when wearing clothes; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th March 2021, the patient received the 2nd dose of Shingrix. In March 2021, less than 2 weeks after receiving Shingrix, the patient experienced rash and tenderness. On an unknown date, the outcome of the rash and tenderness were unknown.   It was unknown if the reporter considered the rash and tenderness to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient has had rash on chest and back for 5 days that was tender when wearing clothes.
Age: 48.0
Sex: U
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: I am 48 and received my first dose of shingrix; This case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 48-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles at the age of 46 years old).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The reporter reported for himself or herself. The reporter received a dose of Shingrix at the age of 48 years old, which led to inappropriate age at vaccine administration. The patient asked questions regarding effectiveness of Shingrix since the patient already suffered with shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pain / very painful / face in pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for himself/herself. Age at the vaccination was not reported, however age group was captured as an adult as per vaccine indication. Patient received Shingles vaccine 2 years ago and experienced pain. It just got over a month of that pain. It was painful.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: A good friend who got the Shingles shot and she got the Shingles/Suspected vaccination failure; A good friend who got the Shingles shot and she got the Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of Suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported.  The patient was reporter's good friend. The patient got Shingles after Shingles shot. The reporter stated it was not good for patient and was terrible. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of Suspected vaccination failure in a patient who received Herpes zoster (Shingle's vaccine).    On an unknown date, the patient received Shingle's vaccine. On an unknown date, 3 years after receiving Shingle's vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingle's vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the patient itself. The patient got Shingles 3 years after vaccination. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; I just got my second shot I had a full blown case of the shingles; it was the worst pain I ever had; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an adult patient who received Herpes zoster (Shingle's vaccine).    Co-suspect products included Herpes zoster (Shingle's vaccine).   On an unknown date, the patient received the 1st dose of Shingle's vaccine and the 2nd dose of Shingle's vaccine. On an unknown date, unknown after receiving Shingle's vaccine and Shingle's vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingle's vaccine and Shingle's vaccine. It was unknown if the reporter considered the pain to be related to Shingle's vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but selected as adult as per the vaccine indication. The patient reported that, he or she got his or her 2nd shot and had a full-blown case of shingles, and it was the worst pain he or she ever had. This case was considered as suspected vaccination failure as details regarding time to onset for target disease (shingles) and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site scar
Clinical narrative: took 2 shots /they are terribleand they do leave scars; This case was reported by a consumer via interactive digital media and described the occurrence of scar in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced scar. On an unknown date, the outcome of the scar was unknown.   It was unknown if the reporter considered the scar to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not provided. The age group was not reported but it was captured as adult as per vaccine indication. The patient took the shot and would not wish them on his or her worse friend, they were terrible and did leave scars just like chicken pox do. The reporter stated that 2 of his or her sister's did not take them but 1 and he or she, did an slept in the same bed till mamma had to make a bed in a chair away from the other kids. The patient had them so bad then shingles 4 years ago. For tolerance of 2nd dose refer case US2021AMR077290.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR077319:same patient
Age: 51.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Abdominal discomfort, Abdominal pain, Abdominal pain upper, Abnormal faeces, Anxiety
Clinical narrative: Tiredness; Sniffles; Chills; Abnormal stools; Constipation in morning; Insomnia exacerbated; Abdominal discomfort; Cough; Sweating; Colon inflammation; Anxiety aggravated; Feeling sad; Fear; Pain stomach; Pain abdominal; Headache; This case was reported by a consumer and described the occurrence of abnormal stools in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included adalimumab (Humira) for crohn's disease and ulcerative colitis.   The patient's past medical history included diarrhea. Concurrent medical conditions included difficulty sleeping.   On an unknown date, the patient received Shingrix. On 17th August 2020, the patient started Humira (subcutaneous) 40 mg at an unknown frequency. In 2020, unknown after receiving Shingrix, the patient experienced headache. In September 2020, the patient experienced abdominal pain. In October 2020, the patient experienced stomach pain. On 21st October 2020, the patient experienced fear, anxiety and feeling sad. In February 2021, the patient experienced colon inflammation. On 2nd March 2021, the patient experienced sweating. On an unknown date, the patient experienced abnormal stools, constipation, tiredness, sniffles, chills, insomnia exacerbated, abdominal discomfort and cough. The action taken with Humira was unknown. On an unknown date, the outcome of the abnormal stools and constipation were recovering/resolving and the outcome of the fear, tiredness, sniffles, chills, sweating, insomnia exacerbated, anxiety, feeling sad, abdominal discomfort, abdominal pain, headache, stomach pain and cough were unknown and the outcome of the colon inflammation was recovered/resolved.   It was unknown if the reporter considered the abnormal stools, constipation, fear, tiredness, sniffles, chills, colon inflammation, sweating, insomnia exacerbated, anxiety, feeling sad, abdominal discomfort, abdominal pain, headache, stomach pain and cough to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. On 17th August 2020, the patient received Humira via subcutaneous. It was unknown if the reporter considered the abnormal stools, constipation, fear, tiredness, sniffles, chills, colon inflammation, sweating, insomnia exacerbated, anxiety, feeling sad, abdominal discomfort, abdominal pain, headache, stomach pain and cough to be related to humira.
Age: 51.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Chills, Colitis, Colonoscopy abnormal, Condition aggravated, Constipation
Clinical narrative: Tiredness; Sniffles; Chills; Abnormal stools; Constipation in morning; Insomnia exacerbated; Abdominal discomfort; Cough; Sweating; Colon inflammation; Anxiety aggravated; Feeling sad; Fear; Pain stomach; Pain abdominal; Headache; This case was reported by a consumer and described the occurrence of abnormal stools in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included adalimumab (Humira) for crohn's disease and ulcerative colitis.   The patient's past medical history included diarrhea. Concurrent medical conditions included difficulty sleeping.   On an unknown date, the patient received Shingrix. On 17th August 2020, the patient started Humira (subcutaneous) 40 mg at an unknown frequency. In 2020, unknown after receiving Shingrix, the patient experienced headache. In September 2020, the patient experienced abdominal pain. In October 2020, the patient experienced stomach pain. On 21st October 2020, the patient experienced fear, anxiety and feeling sad. In February 2021, the patient experienced colon inflammation. On 2nd March 2021, the patient experienced sweating. On an unknown date, the patient experienced abnormal stools, constipation, tiredness, sniffles, chills, insomnia exacerbated, abdominal discomfort and cough. The action taken with Humira was unknown. On an unknown date, the outcome of the abnormal stools and constipation were recovering/resolving and the outcome of the fear, tiredness, sniffles, chills, sweating, insomnia exacerbated, anxiety, feeling sad, abdominal discomfort, abdominal pain, headache, stomach pain and cough were unknown and the outcome of the colon inflammation was recovered/resolved.   It was unknown if the reporter considered the abnormal stools, constipation, fear, tiredness, sniffles, chills, colon inflammation, sweating, insomnia exacerbated, anxiety, feeling sad, abdominal discomfort, abdominal pain, headache, stomach pain and cough to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. On 17th August 2020, the patient received Humira via subcutaneous. It was unknown if the reporter considered the abnormal stools, constipation, fear, tiredness, sniffles, chills, colon inflammation, sweating, insomnia exacerbated, anxiety, feeling sad, abdominal discomfort, abdominal pain, headache, stomach pain and cough to be related to humira.
Age: 51.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Cough, Depressed mood, Fatigue, Fear, Headache
Clinical narrative: Tiredness; Sniffles; Chills; Abnormal stools; Constipation in morning; Insomnia exacerbated; Abdominal discomfort; Cough; Sweating; Colon inflammation; Anxiety aggravated; Feeling sad; Fear; Pain stomach; Pain abdominal; Headache; This case was reported by a consumer and described the occurrence of abnormal stools in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included adalimumab (Humira) for crohn's disease and ulcerative colitis.   The patient's past medical history included diarrhea. Concurrent medical conditions included difficulty sleeping.   On an unknown date, the patient received Shingrix. On 17th August 2020, the patient started Humira (subcutaneous) 40 mg at an unknown frequency. In 2020, unknown after receiving Shingrix, the patient experienced headache. In September 2020, the patient experienced abdominal pain. In October 2020, the patient experienced stomach pain. On 21st October 2020, the patient experienced fear, anxiety and feeling sad. In February 2021, the patient experienced colon inflammation. On 2nd March 2021, the patient experienced sweating. On an unknown date, the patient experienced abnormal stools, constipation, tiredness, sniffles, chills, insomnia exacerbated, abdominal discomfort and cough. The action taken with Humira was unknown. On an unknown date, the outcome of the abnormal stools and constipation were recovering/resolving and the outcome of the fear, tiredness, sniffles, chills, sweating, insomnia exacerbated, anxiety, feeling sad, abdominal discomfort, abdominal pain, headache, stomach pain and cough were unknown and the outcome of the colon inflammation was recovered/resolved.   It was unknown if the reporter considered the abnormal stools, constipation, fear, tiredness, sniffles, chills, colon inflammation, sweating, insomnia exacerbated, anxiety, feeling sad, abdominal discomfort, abdominal pain, headache, stomach pain and cough to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. On 17th August 2020, the patient received Humira via subcutaneous. It was unknown if the reporter considered the abnormal stools, constipation, fear, tiredness, sniffles, chills, colon inflammation, sweating, insomnia exacerbated, anxiety, feeling sad, abdominal discomfort, abdominal pain, headache, stomach pain and cough to be related to humira.
Age: 51.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Hyperhidrosis, Insomnia, Rhinorrhoea
Clinical narrative: Tiredness; Sniffles; Chills; Abnormal stools; Constipation in morning; Insomnia exacerbated; Abdominal discomfort; Cough; Sweating; Colon inflammation; Anxiety aggravated; Feeling sad; Fear; Pain stomach; Pain abdominal; Headache; This case was reported by a consumer and described the occurrence of abnormal stools in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included adalimumab (Humira) for crohn's disease and ulcerative colitis.   The patient's past medical history included diarrhea. Concurrent medical conditions included difficulty sleeping.   On an unknown date, the patient received Shingrix. On 17th August 2020, the patient started Humira (subcutaneous) 40 mg at an unknown frequency. In 2020, unknown after receiving Shingrix, the patient experienced headache. In September 2020, the patient experienced abdominal pain. In October 2020, the patient experienced stomach pain. On 21st October 2020, the patient experienced fear, anxiety and feeling sad. In February 2021, the patient experienced colon inflammation. On 2nd March 2021, the patient experienced sweating. On an unknown date, the patient experienced abnormal stools, constipation, tiredness, sniffles, chills, insomnia exacerbated, abdominal discomfort and cough. The action taken with Humira was unknown. On an unknown date, the outcome of the abnormal stools and constipation were recovering/resolving and the outcome of the fear, tiredness, sniffles, chills, sweating, insomnia exacerbated, anxiety, feeling sad, abdominal discomfort, abdominal pain, headache, stomach pain and cough were unknown and the outcome of the colon inflammation was recovered/resolved.   It was unknown if the reporter considered the abnormal stools, constipation, fear, tiredness, sniffles, chills, colon inflammation, sweating, insomnia exacerbated, anxiety, feeling sad, abdominal discomfort, abdominal pain, headache, stomach pain and cough to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. On 17th August 2020, the patient received Humira via subcutaneous. It was unknown if the reporter considered the abnormal stools, constipation, fear, tiredness, sniffles, chills, colon inflammation, sweating, insomnia exacerbated, anxiety, feeling sad, abdominal discomfort, abdominal pain, headache, stomach pain and cough to be related to humira.
Sex: F
Vaccine: VARZOS
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: Younger patient receiving shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of off label use in a 32-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster (previous epidose prior to the vaccination).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.  Additional details were reported as follows: The age at vaccination was not applicable to this report. The pharmacist inquired about the younger patient receiving the Shingrix vaccine after the recent episode, which led to off label use. The pharmacist wanted to know how long after the shingles episode could the Shingrix be given to the patient. The reporter consented to follow up.