chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Fatigue, Feeding disorder, Nasal dryness
Clinical narrative: Feels sick; 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 19th December 2019, the patient received the 2nd dose of Shingrix. On 20th December 2019, 1 days after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient feels sicks after receiving 2nd dose of Shingrix. No further information was provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: Feels sick; 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 19th December 2019, the patient received the 2nd dose of Shingrix. On 20th December 2019, 1 days after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient feels sicks after receiving 2nd dose of Shingrix. No further information was provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise
Clinical narrative: Feels sick; 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 19th December 2019, the patient received the 2nd dose of Shingrix. On 20th December 2019, 1 days after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient feels sicks after receiving 2nd dose of Shingrix. No further information was provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthma, Chills, Condition aggravated, Feeding disorder, Headache
Clinical narrative: swelling; pain at injection site; redness; itchy; hot to touch; PAINFUL TO TOUCH; able to get out of bed to get a drink; HEAT FLASH; feel cold; Joint pain; Body pain; not feeling well; fatigue; headache; chills; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th December 2019 11:00, the patient received Shingrix. On 20th December 2019, less than a day after receiving Shingrix, the patient experienced headache, chills, fatigue, feeling unwell, activities of daily living impaired, hot flashes, feeling cold, joint pain and general body pain. On 20th December 2019 16:00, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site itching, injection site warmth and tenderness. On an unknown date, the outcome of the extensive swelling of vaccinated limb, chills, injection site pain, fatigue, injection site erythema, injection site itching, injection site warmth, feeling unwell, activities of daily living impaired, hot flashes and feeling cold were recovering/resolving and the outcome of the headache, tenderness and joint pain were not recovered/not resolved and the outcome of the general body pain was unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, headache, chills, injection site pain, fatigue, injection site erythema, injection site itching, injection site warmth, feeling unwell, tenderness, activities of daily living impaired, hot flashes, feeling cold, joint pain and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported The patient started not feeling well 2 hours after receiving the vaccine.   The patient received it at 11:00 am and by 4:00 pm the injection site was painful, red,itchy, swollen and hot to the touch. The swelling grew to the size of a cantaloupe protruding outside her shirt.   The swelling had reduced to the size of an orange.  It was still painful to the touch.   The chills were described as flashed of heat in the face that come and go and make the rest of her body feel cold.  The body pains were less but still present in her joints.  The headache was still present.  At the time of reporting  the patient had been able to get out of bed to get a drink. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: swelling; pain at injection site; redness; itchy; hot to touch; PAINFUL TO TOUCH; able to get out of bed to get a drink; HEAT FLASH; feel cold; Joint pain; Body pain; not feeling well; fatigue; headache; chills; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th December 2019 11:00, the patient received Shingrix. On 20th December 2019, less than a day after receiving Shingrix, the patient experienced headache, chills, fatigue, feeling unwell, activities of daily living impaired, hot flashes, feeling cold, joint pain and general body pain. On 20th December 2019 16:00, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site itching, injection site warmth and tenderness. On an unknown date, the outcome of the extensive swelling of vaccinated limb, chills, injection site pain, fatigue, injection site erythema, injection site itching, injection site warmth, feeling unwell, activities of daily living impaired, hot flashes and feeling cold were recovering/resolving and the outcome of the headache, tenderness and joint pain were not recovered/not resolved and the outcome of the general body pain was unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, headache, chills, injection site pain, fatigue, injection site erythema, injection site itching, injection site warmth, feeling unwell, tenderness, activities of daily living impaired, hot flashes, feeling cold, joint pain and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported The patient started not feeling well 2 hours after receiving the vaccine.   The patient received it at 11:00 am and by 4:00 pm the injection site was painful, red,itchy, swollen and hot to the touch. The swelling grew to the size of a cantaloupe protruding outside her shirt.   The swelling had reduced to the size of an orange.  It was still painful to the touch.   The chills were described as flashed of heat in the face that come and go and make the rest of her body feel cold.  The body pains were less but still present in her joints.  The headache was still present.  At the time of reporting  the patient had been able to get out of bed to get a drink. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain
Clinical narrative: swelling; pain at injection site; redness; itchy; hot to touch; PAINFUL TO TOUCH; able to get out of bed to get a drink; HEAT FLASH; feel cold; Joint pain; Body pain; not feeling well; fatigue; headache; chills; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th December 2019 11:00, the patient received Shingrix. On 20th December 2019, less than a day after receiving Shingrix, the patient experienced headache, chills, fatigue, feeling unwell, activities of daily living impaired, hot flashes, feeling cold, joint pain and general body pain. On 20th December 2019 16:00, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site itching, injection site warmth and tenderness. On an unknown date, the outcome of the extensive swelling of vaccinated limb, chills, injection site pain, fatigue, injection site erythema, injection site itching, injection site warmth, feeling unwell, activities of daily living impaired, hot flashes and feeling cold were recovering/resolving and the outcome of the headache, tenderness and joint pain were not recovered/not resolved and the outcome of the general body pain was unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, headache, chills, injection site pain, fatigue, injection site erythema, injection site itching, injection site warmth, feeling unwell, tenderness, activities of daily living impaired, hot flashes, feeling cold, joint pain and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported The patient started not feeling well 2 hours after receiving the vaccine.   The patient received it at 11:00 am and by 4:00 pm the injection site was painful, red,itchy, swollen and hot to the touch. The swelling grew to the size of a cantaloupe protruding outside her shirt.   The swelling had reduced to the size of an orange.  It was still painful to the touch.   The chills were described as flashed of heat in the face that come and go and make the rest of her body feel cold.  The body pains were less but still present in her joints.  The headache was still present.  At the time of reporting  the patient had been able to get out of bed to get a drink. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Extensive swelling of vaccinated limb, Fatigue, Feeling cold
Clinical narrative: swelling; pain at injection site; redness; itchy; hot to touch; PAINFUL TO TOUCH; able to get out of bed to get a drink; HEAT FLASH; feel cold; Joint pain; Body pain; not feeling well; fatigue; headache; chills; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th December 2019 11:00, the patient received Shingrix. On 20th December 2019, less than a day after receiving Shingrix, the patient experienced headache, chills, fatigue, feeling unwell, activities of daily living impaired, hot flashes, feeling cold, joint pain and general body pain. On 20th December 2019 16:00, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site itching, injection site warmth and tenderness. On an unknown date, the outcome of the extensive swelling of vaccinated limb, chills, injection site pain, fatigue, injection site erythema, injection site itching, injection site warmth, feeling unwell, activities of daily living impaired, hot flashes and feeling cold were recovering/resolving and the outcome of the headache, tenderness and joint pain were not recovered/not resolved and the outcome of the general body pain was unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, headache, chills, injection site pain, fatigue, injection site erythema, injection site itching, injection site warmth, feeling unwell, tenderness, activities of daily living impaired, hot flashes, feeling cold, joint pain and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported The patient started not feeling well 2 hours after receiving the vaccine.   The patient received it at 11:00 am and by 4:00 pm the injection site was painful, red,itchy, swollen and hot to the touch. The swelling grew to the size of a cantaloupe protruding outside her shirt.   The swelling had reduced to the size of an orange.  It was still painful to the touch.   The chills were described as flashed of heat in the face that come and go and make the rest of her body feel cold.  The body pains were less but still present in her joints.  The headache was still present.  At the time of reporting  the patient had been able to get out of bed to get a drink. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Hot flush, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: swelling; pain at injection site; redness; itchy; hot to touch; PAINFUL TO TOUCH; able to get out of bed to get a drink; HEAT FLASH; feel cold; Joint pain; Body pain; not feeling well; fatigue; headache; chills; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th December 2019 11:00, the patient received Shingrix. On 20th December 2019, less than a day after receiving Shingrix, the patient experienced headache, chills, fatigue, feeling unwell, activities of daily living impaired, hot flashes, feeling cold, joint pain and general body pain. On 20th December 2019 16:00, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site itching, injection site warmth and tenderness. On an unknown date, the outcome of the extensive swelling of vaccinated limb, chills, injection site pain, fatigue, injection site erythema, injection site itching, injection site warmth, feeling unwell, activities of daily living impaired, hot flashes and feeling cold were recovering/resolving and the outcome of the headache, tenderness and joint pain were not recovered/not resolved and the outcome of the general body pain was unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, headache, chills, injection site pain, fatigue, injection site erythema, injection site itching, injection site warmth, feeling unwell, tenderness, activities of daily living impaired, hot flashes, feeling cold, joint pain and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported The patient started not feeling well 2 hours after receiving the vaccine.   The patient received it at 11:00 am and by 4:00 pm the injection site was painful, red,itchy, swollen and hot to the touch. The swelling grew to the size of a cantaloupe protruding outside her shirt.   The swelling had reduced to the size of an orange.  It was still painful to the touch.   The chills were described as flashed of heat in the face that come and go and make the rest of her body feel cold.  The body pains were less but still present in her joints.  The headache was still present.  At the time of reporting  the patient had been able to get out of bed to get a drink. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Loss of personal independence in daily activities, Malaise, Pain, Tenderness
Clinical narrative: swelling; pain at injection site; redness; itchy; hot to touch; PAINFUL TO TOUCH; able to get out of bed to get a drink; HEAT FLASH; feel cold; Joint pain; Body pain; not feeling well; fatigue; headache; chills; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th December 2019 11:00, the patient received Shingrix. On 20th December 2019, less than a day after receiving Shingrix, the patient experienced headache, chills, fatigue, feeling unwell, activities of daily living impaired, hot flashes, feeling cold, joint pain and general body pain. On 20th December 2019 16:00, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site itching, injection site warmth and tenderness. On an unknown date, the outcome of the extensive swelling of vaccinated limb, chills, injection site pain, fatigue, injection site erythema, injection site itching, injection site warmth, feeling unwell, activities of daily living impaired, hot flashes and feeling cold were recovering/resolving and the outcome of the headache, tenderness and joint pain were not recovered/not resolved and the outcome of the general body pain was unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, headache, chills, injection site pain, fatigue, injection site erythema, injection site itching, injection site warmth, feeling unwell, tenderness, activities of daily living impaired, hot flashes, feeling cold, joint pain and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported The patient started not feeling well 2 hours after receiving the vaccine.   The patient received it at 11:00 am and by 4:00 pm the injection site was painful, red,itchy, swollen and hot to the touch. The swelling grew to the size of a cantaloupe protruding outside her shirt.   The swelling had reduced to the size of an orange.  It was still painful to the touch.   The chills were described as flashed of heat in the face that come and go and make the rest of her body feel cold.  The body pains were less but still present in her joints.  The headache was still present.  At the time of reporting  the patient had been able to get out of bed to get a drink. The reporter consented to follow up.
Age: 90.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Nightmares; Rapid heartbeat; Some lightheadedness; Anxiety; uncomfortable; Severe aches; Chills; This case was reported by a consumer via call center representative and described the occurrence of pain in a 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on an unknown date, refer case US2019AMR229168) and Flu vaccine (received flu vaccine on an unknown date and had no reaction to the flu vaccine).   On 12th December 2019, the patient received the 2nd dose of Shingrix. In December 2019, less than a day after receiving Shingrix, the patient experienced pain, chills, nightmare, heart rate increased, light headedness, anxiety and discomfort. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain and chills were recovered/resolved and the outcome of the nightmare, heart rate increased, light headedness, anxiety and discomfort were unknown.   It was unknown if the reporter considered the pain, chills, nightmare, heart rate increased, light headedness, anxiety and discomfort to be related to Shingrix.  Additional details were provided as follows: The patient had not had a reaction to the annual flu shot. The patient reported that she received 2nd shot on Thursday had severe aches and chills for 24 hours, nightmares for the past 3 nights with a rapid heartbeat, anxiety and some lightheadedness.  The patient asked she was female if that makes a difference. The patient reported that rapid heart and anxiety was very uncomfortable, not to mention awful nightmares which were very unusual for me. The patient had not had a reaction to the annual flu shot.
Age: 90.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anxiety, Chills, Discomfort, Dizziness, Heart rate increased
Clinical narrative: Nightmares; Rapid heartbeat; Some lightheadedness; Anxiety; uncomfortable; Severe aches; Chills; This case was reported by a consumer via call center representative and described the occurrence of pain in a 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on an unknown date, refer case US2019AMR229168) and Flu vaccine (received flu vaccine on an unknown date and had no reaction to the flu vaccine).   On 12th December 2019, the patient received the 2nd dose of Shingrix. In December 2019, less than a day after receiving Shingrix, the patient experienced pain, chills, nightmare, heart rate increased, light headedness, anxiety and discomfort. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain and chills were recovered/resolved and the outcome of the nightmare, heart rate increased, light headedness, anxiety and discomfort were unknown.   It was unknown if the reporter considered the pain, chills, nightmare, heart rate increased, light headedness, anxiety and discomfort to be related to Shingrix.  Additional details were provided as follows: The patient had not had a reaction to the annual flu shot. The patient reported that she received 2nd shot on Thursday had severe aches and chills for 24 hours, nightmares for the past 3 nights with a rapid heartbeat, anxiety and some lightheadedness.  The patient asked she was female if that makes a difference. The patient reported that rapid heart and anxiety was very uncomfortable, not to mention awful nightmares which were very unusual for me. The patient had not had a reaction to the annual flu shot.
Age: 90.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nightmare, Pain
Clinical narrative: Nightmares; Rapid heartbeat; Some lightheadedness; Anxiety; uncomfortable; Severe aches; Chills; This case was reported by a consumer via call center representative and described the occurrence of pain in a 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on an unknown date, refer case US2019AMR229168) and Flu vaccine (received flu vaccine on an unknown date and had no reaction to the flu vaccine).   On 12th December 2019, the patient received the 2nd dose of Shingrix. In December 2019, less than a day after receiving Shingrix, the patient experienced pain, chills, nightmare, heart rate increased, light headedness, anxiety and discomfort. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain and chills were recovered/resolved and the outcome of the nightmare, heart rate increased, light headedness, anxiety and discomfort were unknown.   It was unknown if the reporter considered the pain, chills, nightmare, heart rate increased, light headedness, anxiety and discomfort to be related to Shingrix.  Additional details were provided as follows: The patient had not had a reaction to the annual flu shot. The patient reported that she received 2nd shot on Thursday had severe aches and chills for 24 hours, nightmares for the past 3 nights with a rapid heartbeat, anxiety and some lightheadedness.  The patient asked she was female if that makes a difference. The patient reported that rapid heart and anxiety was very uncomfortable, not to mention awful nightmares which were very unusual for me. The patient had not had a reaction to the annual flu shot.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient says his arm has been sore, and hurting since the vaccination.  He says it hurts most when he has to raise or lift the left arm.  He says he has not tried anything for the pain.  When showing his arm, it did not appear swollen or discolored.  There were signs of him using cupping, as we were able to see the cupping marks on the upper arm.
Age: 5.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Peripheral swelling
Clinical narrative: Pt with arm swelling seen at Urgent Care and ER and given IV dose antibiotics x 1 and then PO antibiotics, completely resolved.
Age: 5.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Cellulitis, Skin warm, Swelling, Tenderness
Clinical narrative: Pt with arm swelling seen at Urgent Care and ER and given IV dose antibiotics x 1 and then PO antibiotics, completely resolved.
Age: 5.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Peripheral swelling
Clinical narrative: Extreme swelling, skin hot to touch, tender in certain areas,  diagnoses as cellulitis
Age: 5.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Cellulitis, Skin warm, Swelling, Tenderness
Clinical narrative: Extreme swelling, skin hot to touch, tender in certain areas,  diagnoses as cellulitis
Age: 59.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse symptoms reported; inadvertently administered an expired dose of VAQTA; This spontaneous report was received from a medical assistant referring to a currently 59 years old patient of unknown gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On 11-DEC-2019, the patient was inadvertently administered an expired dose of hepatitis a vaccine, inactivated (VAQTA)(lot # R031045, expiration date was 18-NOV-2019)(strength, dose, frequency and route were not reported) for prophylaxis. No adverse symptoms reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; administered one dose of expired pneumovax23; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On 23-DEC-2019, the patient was inadvertently administered one dose of expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route of administration and anatomical location were unknown) with lot # R006465 and expiration date 24-OCT-2019 for prophylaxis. The patient did not experience any symptoms. There was no product quality complaint associated with the case.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No symtoms reported; One patient received GARDASIL 9 that was stored improperly; This spontaneous report was received from a office Manager referring to a 11-year-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant medication were not reported.     On 26-DEC-2019, the patient was inadvertently vaccinated with an improperly stored dose (product storage error) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscular in the left deltoid by prophylaxis (strength, dose, frequency were not provided) (lot # S008154 has been verified to be a valid number; expiration date 20-NOV-2021). The  temperature  excursion was at (36 degrees Fahrenheit (F) to 46 F) 46.2 F, for a time frame of 15 minutes, and (below 36 F) 30.9 F for a time frame of 4 hours and 37 minutes, the previous temperature excursion was (above 46 F) 52.7 F for a timeframe of 30 hours and 37 minutes. It was reported that the call was due to data logger. No symptoms were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling; Redness / Swelling was red; Swelling was warm to the touch; This case was reported by a consumer and described the occurrence of swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling, erythema and skin warm. On an unknown date, the outcome of the swelling, erythema and skin warm were recovered/resolved.   It was unknown if the reporter considered the swelling, erythema and skin warm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not provided, but selected as an adult as per vaccine indication. After vaccination, experienced swelling and redness for 3 weeks and the swelling was red, with a 2 inch diameter, and warm to the touch. The patient asked was this a serious reaction and could receive 2nd dose of Shingrix.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Pyrexia
Clinical narrative: Low Grade Fever; Lower Back Pain; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 29RD5, expiry date 16th April 2022) for prophylaxis.   On 10th December 2019, the patient received Shingrix (intramuscular) .5 ml. On 10th December 2019, less than a day after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced fever and low back pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the low back pain was not recovered/not resolved.   It was unknown if the reporter considered the fever and low back pain to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in the right deltoid and the same day the patient developed a low grade fever and lower back pain.  The pharmacist reported the fever resolved, but the patient still has lower back pain.  The pharmacist believes the patient takes ibuprofen to decrease pain, but the ibuprofen only takes the edge off not providing full relief.  The pharmacist reported the patient tried to go a day without any pain reliever unsuccessfully.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Neuralgia, Vaccination failure
Clinical narrative: Suspected vaccination failure; Experienced Shingles-like reaction; Nerve pain following a dermatome; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and nerve pain. On an unknown date, the outcome of the vaccination failure, shingles and nerve pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and nerve pain to be related to Shingrix and Shingrix.  Additional details were reported as follows: The patient experienced almost shingles-like reaction, nerve pain following a dermatome after receiving Shingrix. The reporter was unable to provide full patient and vaccine details. The reporter Did not consent to follow-up.  The reporter asked about any information on this type of reaction after 2nd dose of Shingrix. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation for herpes zoster were not provided.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: injection site redness; injection site swelling; discomfort; bumps; and itching; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th December 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In December 2019, 2 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site discomfort, injection site rash and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site discomfort, injection site rash and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site discomfort, injection site rash and injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient received dose  of Shingrix and 2 or 3 days later started feeling discomfort, redness, swelling, itching and bumps as the injection site. The follow up consent was granted.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Nausea, Vaccination site bruising, Vaccination site pain
Clinical narrative: Pain from the stem of the shoulder to the elbow worsened; she felt like she was going to throw up, but never did; Vaccination site bruising; Vaccination site rash hot and painful; Vaccination site rash hot and painful; Vaccination site rash hot and painful; Pain and swelling from the stem of the shoulder to the elbow; Pain and swelling from the stem of the shoulder to the elbow; This is a spontaneous report from a contactable consumer (patient's son/daughter). An 82-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (lot# AN8551, Exp Date 13Nov2021, NDC 005-1971-02), via an unspecified route of administration in the right deltoid, on 17Nov2019 morning, at 0.5 ml single, for immunisation. Medical history included diabetes and blood pressure high (took medications). There were no concomitant medications. The patient experienced vaccination site rash hot and painful on 21Nov2019 with outcome of recovered with sequelae on 28Nov2019, vaccination site bruising on 19Dec2019 with outcome of recovering. After redness disappeared the patient experienced pain and swelling from the stem of her shoulder to her elbow in Nov2019 with outcome of not recovered. On an unspecified date the pain from the stem of the shoulder to the elbow worsened. Furthermore, she felt like she was going to throw up, but never did.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Vaccination site rash, Vaccination site warmth
Clinical narrative: Pain from the stem of the shoulder to the elbow worsened; she felt like she was going to throw up, but never did; Vaccination site bruising; Vaccination site rash hot and painful; Vaccination site rash hot and painful; Vaccination site rash hot and painful; Pain and swelling from the stem of the shoulder to the elbow; Pain and swelling from the stem of the shoulder to the elbow; This is a spontaneous report from a contactable consumer (patient's son/daughter). An 82-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (lot# AN8551, Exp Date 13Nov2021, NDC 005-1971-02), via an unspecified route of administration in the right deltoid, on 17Nov2019 morning, at 0.5 ml single, for immunisation. Medical history included diabetes and blood pressure high (took medications). There were no concomitant medications. The patient experienced vaccination site rash hot and painful on 21Nov2019 with outcome of recovered with sequelae on 28Nov2019, vaccination site bruising on 19Dec2019 with outcome of recovering. After redness disappeared the patient experienced pain and swelling from the stem of her shoulder to her elbow in Nov2019 with outcome of not recovered. On an unspecified date the pain from the stem of the shoulder to the elbow worsened. Furthermore, she felt like she was going to throw up, but never did.
Age: 50.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Headache, Injected limb mobility decreased, Nausea, Pain, Peripheral swelling
Clinical narrative: Recieved iMMuNiZatioN iN 12/16/19. Awoke on 12/17/198 at 3:00 AM with Headache, Nausea and Vomiting, and body aches. Right ARM was swolleN aNd hot, and had trouble lifting it. She went to her physician oN 12/17/19 at 6:30 pm. Was told to use a heating pad and Rest. Took off work 12/18/19
Age: 50.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Skin warm, Vomiting
Clinical narrative: Recieved iMMuNiZatioN iN 12/16/19. Awoke on 12/17/198 at 3:00 AM with Headache, Nausea and Vomiting, and body aches. Right ARM was swolleN aNd hot, and had trouble lifting it. She went to her physician oN 12/17/19 at 6:30 pm. Was told to use a heating pad and Rest. Took off work 12/18/19
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: one dose of VARIVAX and one dose of PROQUAD were inadvertently administered to the patient; This spontaneous report as received from a registered nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, drug reactions/allergies and concomitant therapies was not provided.       On 09-DEC-2019, the patient was inadvertently administered varicella virus vaccine live (oka/merck)(VARIVAX) (1 dose, lot# S011952, expiration date 16-APR-2021) subcutaneously  and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) ) rHA (recombinant Human albumin)(1 dose, lot# S007074, expiration date 06-SEP-2020) for prophylaxis (inappropriate schedule of product administration). The outcome of inappropriate schedule of product administration was unknown.
Sex: M
Vaccine: HPV9
Symptoms: Pain
Clinical narrative: the patient experienced "minor soreness and pain"; patient was accidentally given a subcutaneous injection of GARDASIL 9; This spontaneous report was received from a pharmacist and refers to a 39-year-old male patient. The patient had none pertinent medical history, drug reaction or allergy. Concomitant medications included an unspecified quadrivalent flu shot (manufacturer unknown) given on 13-DEC-2019 (reported as "on the same day as" hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)).  On an unspecified date in June 2019 (reported as "6 months ago"), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (reported as "pretty sure" the patient received his first two hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccinations "IM") (exact dose, lot number and expiration date were not provided).  On an unspecified date in 2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly (exact dose, lot number and expiration date were not provided).  On 13-DEC-2019, the patient had his skin pinched and "accidentally given a subcutaneous injection" (also reported as given subcutaneous in error)with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, lot number and expiration date were not provided). It was the last and third dose from a 3 series vaccination with the suspect vaccine.  On 13-DEC-2019, the patient experienced minor soreness and pain. No lab diagnostics or studies were performed and the patient did not seek medical attention.  The outcome of the event of minor soreness and pain was unknown by the reporter.  The relatedness between the event of minor soreness and pain and the suspect vaccine was not provided.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; a patient received an expired dose of PNEUMOVAX; This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. Information about patient's concurrent condition, concomitant medication, medical history, drug allergy/reaction was not reported.  On 18-DEC-2019, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dose number, route, anatomical location was not reported) lot # N023651, expiration date: 20-MAY-2019 for prophylaxis (expired product administered). No known adverse effects were reported. No product quality complaint was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: She felt crappy; This case was reported by a consumer via patient support programs and described the occurrence of feeling bad in a 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, unknown after receiving Shingrix, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: fever; diarrhea; vomiting; This case was reported by a consumer via call center representative and described the occurrence of fever in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of diarrhoea (received 1st dose on an unknown date and experienced fever, headache, malaise, refer case id US2019230529).   On 6th December 2019, the patient received the 2nd dose of Shingrix. In December 2019, less than 2 weeks after receiving Shingrix, the patient experienced fever, vomiting and diarrhea. The patient was treated with paracetamol (Tylenol) and electrolytes nos + glucose (Pedialyte). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, vomiting and diarrhea were recovered/resolved.   It was unknown if the reporter considered the fever, vomiting and diarrhea to be related to Shingrix.  Additional details were received as follows: The patient received second dose of Shingrix, and experienced fever and diarrhea which has lasted for several weeks as well as vomiting that lasted for about 2 days. The patient used tylenol and pedialyte to treat her symptoms. The patient consented to follow up.
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Local injection site reaction; This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Previously administered products included Shingrix (had 1st dose, refe case US2019230531).   On an unknown date, the patient received the 2nd dose of Shingrix and Influenza vaccine Quadrivalent 2019-2020 season at an unknown dose. On an unknown date, unknown after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced injection site reaction. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site reaction was recovered/resolved.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The case was reported by patient's wife. The patient receive dose of Shingrix and high dose of flu vaccine and experienced local injection site reaction that resolved. This case has been linked with cases US2019230531 and US2019AMR231140.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: red; swollen arm; headache; fatigue; achy; sore arm/Arm ache; felt like the flu" for 2 days; This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) (batch number G537F, expiry date unknown) for prophylaxis.   On 6th December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than 2 weeks after receiving Shingrix, the patient experienced influenza-like symptoms, erythema, swelling arm, pain in arm, headache, fatigue and pain. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the erythema, swelling arm, headache, fatigue and pain were unknown and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, erythema, swelling arm, pain in arm, headache, fatigue and pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient exerienced flu like symptoms for 2 days.  The patient also expereinced red, swollen arm, sore arm, headache, fatigue and achy. Arm ache still persisted after 10 days. This case linked with US2019AMR232164, US2019AMR234116 and US2019102453, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: red; swollen arm; headache; fatigue; achy; sore arm/Arm ache; felt like the flu" for 2 days; This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) (batch number G537F, expiry date unknown) for prophylaxis.   On 6th December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than 2 weeks after receiving Shingrix, the patient experienced influenza-like symptoms, erythema, swelling arm, pain in arm, headache, fatigue and pain. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the erythema, swelling arm, headache, fatigue and pain were unknown and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, erythema, swelling arm, pain in arm, headache, fatigue and pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient exerienced flu like symptoms for 2 days.  The patient also expereinced red, swollen arm, sore arm, headache, fatigue and achy. Arm ache still persisted after 10 days. This case linked with US2019AMR232164, US2019AMR234116 and US2019102453, reported by same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: felt like the flu" for 2 days; red; swollen arm; headache; fatigue; achy; sore arm/Arm ache; This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) (batch number 2AH5M, expiry date unknown) for prophylaxis.   On 10th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced influenza-like symptoms, erythema, swelling arm, pain in arm, headache, fatigue and pain. On an unknown date, the outcome of the influenza-like symptoms, erythema, swelling arm, pain in arm, headache, fatigue and pain were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, erythema, swelling arm, pain in arm, headache, fatigue and pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced flu like symptoms, red, swollen arm, sore arm, headache, fatigue and achy. For tolerance of 2nd dose of Shingrix, refer case US2019AMR234116. This case linked with US2019AMR232150 and US2019102453, reported by same reporter.