chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Underdose
Clinical narrative: Sick; I half the second shot; This case was reported by a consumer via call center representative and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chemotherapy.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness and underdose. On an unknown date, the outcome of the sickness was not recovered/not resolved and the outcome of the underdose was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.  The patient received half the second shot which led to underdose and patient became sick. The reporter inquired how long did  the sued effects last.
Sex: F
Vaccine: VARZOS
Symptoms: Exfoliative rash, Pruritus, Rash erythematous
Clinical narrative: A few spots were slightly itchy; red scaly spots; red scaly spots; This case was reported by a consumer and described the occurrence of rash scaly in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   In January 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced rash scaly, red rash and pruritus. The patient was treated with cortisone (non-proprietary) (Cortisone Cream), antibiotics nos (Antibiotic Ointment (Unknown Ingredients)), ketoconazole (Ketoconazole Cream) and emollients and protectives (Moisturizer). On an unknown date, the outcome of the rash scaly and red rash were recovered/resolved and the outcome of the pruritus was unknown.   It was unknown if the reporter considered the rash scaly, red rash and pruritus to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix vaccione about a month ago from reporting date and got few random red scaly spots on body. A few spots were slightly itchy. The patient tried cortisone cream, antibiotic ointment, Ketoconazole cream and moisturizer on the spots but nothing seems to affect them. They eventually fade after about 3 weeks. The patient wanted to know whether it was common after receiving shingrix vaccine. This case has been linked with US2020AMR032961, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Musculoskeletal stiffness, Nausea
Clinical narrative: fever; excess chills; The upper arm is swollen all the way to underarm; tiredness; Stiff body /neck; upset stomach; upset stomach with nausea; This case was reported by a consumer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received Shingrix. In February 2020, 2 days after receiving Shingrix, the patient experienced fever, chills, swelling arm, fatigue, stiff neck, upset stomach and nausea. On an unknown date, the outcome of the fever, chills, swelling arm, fatigue, stiff neck, upset stomach and nausea were unknown.   It was unknown if the reporter considered the fever, chills, swelling arm, fatigue, stiff neck, upset stomach and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix and the upper arm was swollen all the way to underarm, excess chills, fever, tiredness, stiff body, neck, upset stomach with nausea.  The reporter wanted to know was this common two days after shot.
Sex: U
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: fever; excess chills; The upper arm is swollen all the way to underarm; tiredness; Stiff body /neck; upset stomach; upset stomach with nausea; This case was reported by a consumer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received Shingrix. In February 2020, 2 days after receiving Shingrix, the patient experienced fever, chills, swelling arm, fatigue, stiff neck, upset stomach and nausea. On an unknown date, the outcome of the fever, chills, swelling arm, fatigue, stiff neck, upset stomach and nausea were unknown.   It was unknown if the reporter considered the fever, chills, swelling arm, fatigue, stiff neck, upset stomach and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix and the upper arm was swollen all the way to underarm, excess chills, fever, tiredness, stiff body, neck, upset stomach with nausea.  The reporter wanted to know was this common two days after shot.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Gout
Clinical narrative: I'm having a gout attack 2 days after Shingrix vaccination; This case was reported by a consumer via call center representative and described the occurrence of gout acute in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 2 days after receiving Shingrix, the patient experienced gout acute. On an unknown date, the outcome of the gout acute was unknown.   It was unknown if the reporter considered the gout acute to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experience acute gout attack 2 days after receiving shingrix vaccine. The patient reported that he or she did not have a gout attack in 20 years and it happened 2 days after Shingrix vaccination. The patient wanted to know whether gout attack was the side effect of shingrix vaccine.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Injection site rash, Injection site warmth
Clinical narrative: warm rash around the injection site; warm rash around the injection site; I am itchy all over; sore achy joints; achy muscle/ sore achy muscle; chills; headache; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 24th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced joint pain, myalgia, chills and headache. On 27th February 2020, the patient experienced injection site rash, injection site warmth and generalized pruritus. On an unknown date, the outcome of the joint pain, myalgia, chills and headache were recovered/resolved and the outcome of the injection site rash, injection site warmth and generalized pruritus were unknown.   It was unknown if the reporter considered the joint pain, myalgia, chills, headache, injection site rash, injection site warmth and generalized pruritus to be related to Shingrix.  Additional details were reported as follows: The patient received 2nd dose of shingrix vaccine 72 hours ago from reporting date and experienced sore achy joints and muscles, chills, headache, which subsided after 48 hours. On 27th February 2020, in morning patient also discovered a warm rash around the injection site and patient felt itchy all over. The patient wanted to know how long these side effects might last
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia, Pruritus
Clinical narrative: warm rash around the injection site; warm rash around the injection site; I am itchy all over; sore achy joints; achy muscle/ sore achy muscle; chills; headache; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 24th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced joint pain, myalgia, chills and headache. On 27th February 2020, the patient experienced injection site rash, injection site warmth and generalized pruritus. On an unknown date, the outcome of the joint pain, myalgia, chills and headache were recovered/resolved and the outcome of the injection site rash, injection site warmth and generalized pruritus were unknown.   It was unknown if the reporter considered the joint pain, myalgia, chills, headache, injection site rash, injection site warmth and generalized pruritus to be related to Shingrix.  Additional details were reported as follows: The patient received 2nd dose of shingrix vaccine 72 hours ago from reporting date and experienced sore achy joints and muscles, chills, headache, which subsided after 48 hours. On 27th February 2020, in morning patient also discovered a warm rash around the injection site and patient felt itchy all over. The patient wanted to know how long these side effects might last
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Headache
Clinical narrative: Upset stomach; soreness in my joints; Headache; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced upset stomach, joint pain and headache. On an unknown date, the outcome of the upset stomach, joint pain and headache were unknown.   It was unknown if the reporter considered the upset stomach, joint pain and headache to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received shingles vaccine and experienced side effects like upset stomach, soreness in joints and headache. The patient wanted to know how long these side effects might last.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: feeling very unwell for a short period of time; This case was reported by a nurse via call center representative and described the occurrence of malaise in a adult 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 malaise. On an unknown date, the outcome of the malaise was recovered/resolved.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. The patient received 1st dose Shingrix and experienced feeling very unwell for a short period of time. As per the reporter, she normally did not experience any untoward event following receipt of vaccines. The reporter declined consent for follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immune system disorder, Psoriasis
Clinical narrative: I broke out in a bumper crop of psoriasis - legs, arms, buttock, female private area, and scalp; My immune system go bonkers from an injection; This case was reported by a consumer and described the occurrence of psoriasis in a 66-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 psoriasis and immune system disorder. On an unknown date, the outcome of the psoriasis and immune system disorder were not recovered/not resolved.   The reporter considered the psoriasis and immune system disorder to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix and she broke out in a bumper crop of psoriasis included legs, arms, buttock, female private area and scalp. She never had psoriasis before and for 5 months this plaque psoriasis was so annoying and it was ugly in her scalp. Her primary physician looked that and mentioned that many do break outs this way. Her immune system went bonkers from an injection. The follow up consent has been requested. This case has been linked with US2020AMR039762 for the same reporter.
Age: 67.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Asthenia, Bedridden, Blood creatine phosphokinase increased, Legionella infection, Legionella test positive
Clinical narrative: rhabdomyolysis; The hospital now suspects that Legionella (test was positive 3/10; severe myalgia / began to complain of muscle pain; began to complain of weakness; bed bound / was unable to get out of the bed without assistance; CK levels were >30,000 / CK levels were >30K for 3 days, they are now down to 20K.; This case was reported by a pharmacist and described the occurrence of rhabdomyolysis in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX-23) for prophylaxis.   The patient's past medical history included liver transplant.   On 29th February 2020, the patient received Shingrix and PNEUMOVAX-23. On 3rd March 2020, 3 days after receiving Shingrix, the patient experienced rhabdomyolysis (serious criteria hospitalization and GSK medically significant), legionella infection (serious criteria hospitalization and GSK medically significant), myalgia (serious criteria hospitalization), weakness (serious criteria hospitalization) and bedridden (serious criteria hospitalization). On 6th March 2020, the patient experienced creatine kinase increased (serious criteria hospitalization). On an unknown date, the outcome of the rhabdomyolysis, legionella infection, myalgia, weakness and bedridden were unknown and the outcome of the creatine kinase increased was recovered/resolved.   It was unknown if the reporter considered the rhabdomyolysis, legionella infection, myalgia, weakness, bedridden and creatine kinase increased to be related to Shingrix.  Additional details were provided as follows: The patient received the vaccine Shingrix and pneumovax-23  at a pharmacy then experienced severe muscle pain ,weakness and unable to get out of the bed without assistance. The patient was transported via ambulance to the hospital on March 2020 and CK levels were greater than 30,000 for the last 3 days, they are now down to 20K. The hospital now suspects that Legionella test was positive was the cause of the rhabdomyolysis. The reporter medically treating him, by attending wanted to see if there were any other case reports of rhabdomyolysis with the vaccine
Age: 67.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Myalgia, Rhabdomyolysis
Clinical narrative: rhabdomyolysis; The hospital now suspects that Legionella (test was positive 3/10; severe myalgia / began to complain of muscle pain; began to complain of weakness; bed bound / was unable to get out of the bed without assistance; CK levels were >30,000 / CK levels were >30K for 3 days, they are now down to 20K.; This case was reported by a pharmacist and described the occurrence of rhabdomyolysis in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX-23) for prophylaxis.   The patient's past medical history included liver transplant.   On 29th February 2020, the patient received Shingrix and PNEUMOVAX-23. On 3rd March 2020, 3 days after receiving Shingrix, the patient experienced rhabdomyolysis (serious criteria hospitalization and GSK medically significant), legionella infection (serious criteria hospitalization and GSK medically significant), myalgia (serious criteria hospitalization), weakness (serious criteria hospitalization) and bedridden (serious criteria hospitalization). On 6th March 2020, the patient experienced creatine kinase increased (serious criteria hospitalization). On an unknown date, the outcome of the rhabdomyolysis, legionella infection, myalgia, weakness and bedridden were unknown and the outcome of the creatine kinase increased was recovered/resolved.   It was unknown if the reporter considered the rhabdomyolysis, legionella infection, myalgia, weakness, bedridden and creatine kinase increased to be related to Shingrix.  Additional details were provided as follows: The patient received the vaccine Shingrix and pneumovax-23  at a pharmacy then experienced severe muscle pain ,weakness and unable to get out of the bed without assistance. The patient was transported via ambulance to the hospital on March 2020 and CK levels were greater than 30,000 for the last 3 days, they are now down to 20K. The hospital now suspects that Legionella test was positive was the cause of the rhabdomyolysis. The reporter medically treating him, by attending wanted to see if there were any other case reports of rhabdomyolysis with the vaccine
Sex: U
Vaccine: VARZOS
Symptoms: Acute motor axonal neuropathy, Guillain-Barre syndrome, Spinal cord compression
Clinical narrative: Guillain-Barre syndrome; Acute motor axonal neuropathy; Spinal cord compression; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information was received on 10 March 2020, via medical records(The case was medically confirmed). As per pharmacy records, the patient had ingested Shingrix 50 MCG SUSR. As per medical records, on 11 July 2018, the patient was in hospital with hospitalization reason as guillain barre syndrome, spinal cord compression and acute motor axonal neuropathy(AMAN).
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash in both arms; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 453LA, expiry date 18th February 2022) for prophylaxis.   On 5th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experienced a rash in both arms which lasted several days. Reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pruritus, Eye swelling, Ocular hyperaemia, Pain, Pyrexia
Clinical narrative: red left eye; hives around left eye; itchy left eye; swollen left eye; Fever; Body ache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included food allergy.   On 13th February 2020, the patient received the 1st dose of Shingrix (intramuscular). In February 2020, less than a week after receiving Shingrix, the patient experienced fever, general body pain, eye pruritus, eye swelling and hives. On an unknown date, the patient experienced eye red. On an unknown date, the outcome of the fever and general body pain were recovered/resolved and the outcome of the eye pruritus, eye swelling, eye red and hives were recovering/resolving.   The reporter considered the fever and general body pain to be related to Shingrix. It was unknown if the reporter considered the eye pruritus, eye swelling, eye red and hives to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix via intramuscularly in the left upper arm (deltoid) experienced a fever and body ache for 1-2 days then resolved.  Three to four days after the vaccine her left eye started to feel itchy and swollen and was red, also there are hives around the left eye. She does not know if this was due to Shingrix or not. She thinks it may be due to a food allergy. The events pertaining to her left eye have not yet resolved. She has given us permission to call only to obtain the lot/exp.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: red left eye; hives around left eye; itchy left eye; swollen left eye; Fever; Body ache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included food allergy.   On 13th February 2020, the patient received the 1st dose of Shingrix (intramuscular). In February 2020, less than a week after receiving Shingrix, the patient experienced fever, general body pain, eye pruritus, eye swelling and hives. On an unknown date, the patient experienced eye red. On an unknown date, the outcome of the fever and general body pain were recovered/resolved and the outcome of the eye pruritus, eye swelling, eye red and hives were recovering/resolving.   The reporter considered the fever and general body pain to be related to Shingrix. It was unknown if the reporter considered the eye pruritus, eye swelling, eye red and hives to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix via intramuscularly in the left upper arm (deltoid) experienced a fever and body ache for 1-2 days then resolved.  Three to four days after the vaccine her left eye started to feel itchy and swollen and was red, also there are hives around the left eye. She does not know if this was due to Shingrix or not. She thinks it may be due to a food allergy. The events pertaining to her left eye have not yet resolved. She has given us permission to call only to obtain the lot/exp.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site extravasation, Injection site swelling, Peripheral swelling, Skin warm
Clinical narrative: swelling in the injection site similar to an infiltration; swelling in the injection site / Swollen injection area; Warm to touch; swell up arms; This case was reported by a consumer via call center representative and described the occurrence of injection site infiltration in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th February 2020, the patient received Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced injection site infiltration, injection site swelling, skin warm and swelling arm. The patient was treated with antibiotics nos, doxycycline and medication unknown (Fluid). On an unknown date, the outcome of the injection site infiltration, injection site swelling, skin warm and swelling arm were unknown.   It was unknown if the reporter considered the injection site infiltration, injection site swelling, skin warm and swelling arm to be related to Shingrix.  Additional case details were reported as follows: The patient developed swelling in the injection site similar to an infiltration. The patient stated that it was of great extension and warm to touch. The patient experienced swollen up arm. The patient did not remember the address of the store, where he received vaccine. The reporter requesting consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin, Pruritus, Urticaria
Clinical narrative: developed whelps on his torso; start to itch; This case was reported by a consumer via call center representative and described the occurrence of welts in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, couple of months after receiving Shingrix and an unknown time after starting Cortison, the patient experienced welts and pruritus. The patient was treated with cortisone acetate (Cortison). On an unknown date, the outcome of the welts and pruritus were unknown.   It was unknown if the reporter considered the welts and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine approximately two years ago and few months after receiving he developed whelps on his torso.  He went to the dermatologist and biopsies were performed.  The dermatologist did not feel that the whelps were related to the Shingrix vaccine.   The reporter described that he has remnants of the whelps on his torso.   When they start to itch he puts cortisone on them. The reporter unable to obtain additional details and reporter was not willing to continue the call.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Joint pain; This case was reported by a pharmacist via call center representative and described the occurrence of joint pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th February 2020, the patient received Shingrix. On 28th February 2020, less than a day after receiving Shingrix, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was unknown.   It was unknown if the reporter considered the joint pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received shingrix vaccine on left deltoid and experienced joint pain. The reporter consented to follow up
Sex: M
Vaccine: HPVX, MNQ, TDAP
Symptoms: Dizziness, Fall, Head injury, Skin laceration, Suture insertion
Clinical narrative: she remembers one other episode where a patient was syncopal after receiving Boostrix, Menveo, and the HPV vaccine; began to feel light-headed; Fell; suffered a head injury /hit his head on the floor /His head "split"; Drug use in unapproved population; This case was reported by a physician via call center representative and described the occurrence of syncope in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis and HPV 16-18 (HPV vaccine) for prophylaxis.   On an unknown date, the patient received Boostrix at an unknown dose, Menveo at an unknown dose and HPV vaccine at an unknown dose. On an unknown date, 15 min after receiving Boostrix, Menveo and HPV vaccine, the patient experienced syncope (serious criteria GSK medically significant), light headedness, fall and head injury. On an unknown date, the outcome of the syncope, light headedness, fall and head injury were unknown.   It was unknown if the reporter considered the syncope, light headedness, fall and head injury to be related to Boostrix, Menveo and HPV vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Boostrix, HPV and Menveo at the same time and suffered a head injury, 15 minutes after the vaccinations and began to feel light-headed and fell and hit his head on the floor. His head split head and the patient was sent to the ER where he got sutured and sent home. The reporter states that this occurred about 2-3 years ago at a different facility and she does not have many additional details at the time of reporting.  Reporter consented to follow up. This case has been linked with case US2020041051, reported by same reporter.
Sex: M
Vaccine: HPVX, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: she remembers one other episode where a patient was syncopal after receiving Boostrix, Menveo, and the HPV vaccine; began to feel light-headed; Fell; suffered a head injury /hit his head on the floor /His head "split"; Drug use in unapproved population; This case was reported by a physician via call center representative and described the occurrence of syncope in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis and HPV 16-18 (HPV vaccine) for prophylaxis.   On an unknown date, the patient received Boostrix at an unknown dose, Menveo at an unknown dose and HPV vaccine at an unknown dose. On an unknown date, 15 min after receiving Boostrix, Menveo and HPV vaccine, the patient experienced syncope (serious criteria GSK medically significant), light headedness, fall and head injury. On an unknown date, the outcome of the syncope, light headedness, fall and head injury were unknown.   It was unknown if the reporter considered the syncope, light headedness, fall and head injury to be related to Boostrix, Menveo and HPV vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Boostrix, HPV and Menveo at the same time and suffered a head injury, 15 minutes after the vaccinations and began to feel light-headed and fell and hit his head on the floor. His head split head and the patient was sent to the ER where he got sutured and sent home. The reporter states that this occurred about 2-3 years ago at a different facility and she does not have many additional details at the time of reporting.  Reporter consented to follow up. This case has been linked with case US2020041051, reported by same reporter.
Age: 67.0
Sex: F
Vaccine: HEPAB
Symptoms: Cellulitis
Clinical narrative: patient was hospitalized for cellulitis after receiving Twinrix; This case was reported by a pharmacist via call center representative and described the occurrence of cellulitis in a 67-year-old female patient who received HAB (Twinrix) (batch number 75C72, expiry date 13th June 2022) for prophylaxis.   On 2nd March 2020, the patient received Twinrix (intramuscular). On 4th March 2020, 2 days after receiving Twinrix, the patient experienced cellulitis (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the cellulitis was unknown.   It was unknown if the reporter considered the cellulitis to be related to Twinrix.  Additional information was provided as follows: The patient was hospitalized for cellulitis after receiving Twinrix.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: had Guillain Barre after receiving the flu shot; This case was reported by a nurse via call center representative and described the occurrence of guillain barre syndrome in a patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Influenza vaccine, the patient had guillain barre syndrome.
Sex: M
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: Pain; This is a spontaneous report from a contactable Other Healthcare Professional via Pfizer Sales Representative. A male patient of unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain on an unspecified date. Event took place after use of product. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: PNC13
Symptoms: Atypical pneumonia
Clinical narrative: Had walking pneumonia in army; This is a spontaneous report from a Pfizer sponsored program from a non-contactable consumer reporting for him/herself.  A patient of unknown age and gender received on an unknown date a single dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) for immunization. Medical history and concomitant medications were not reported. The patient had 3 pneumonia shots including pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on unspecified dates. Additionally, it was reported that the patient received a flu shot on 01Oct2019 for immunization and got Type A influenza on 07Feb2020 that lasted 10 days. On an unknown date, the patient had walking pneumonia. Outcome was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Antinuclear antibody positive, Arthralgia, Arthritis, Borrelia test positive, C-reactive protein increased
Clinical narrative: Began having joint pain 1 week after flu shot and was also unable to move my head due to neck pain. Went to ER with low-grade fever and was sent home. on 9/17/18, returned to the ER due to continued low-grade fever and severe joint pain. Ran a number of tests, the only positive of which was the BORRELIA (LYME) AB IGG/IGM test. My doctor doubts that it was positive at the time, as the next two times it was given on 10/23/18 and 1/15/19. I proceeded to take 3 rounds of dioxycycline for 10 days, then another 10 days, then 3 weeks, running into January. The infectious disease specialist was not sure it was Lyme when I visited her on 1/15/19 (see test above). All tests came back negative, except for the C-Reactive Protein, which was 6.56. Next, I saw a rheumatologist in March, who tested my C-reactive protein again, and i t was over 8. My ANA also came back positive 160:1 with a speckled pattern. This has been tested twice more since then with the same result. My C-reactive protein continues to be steadily above 8, with joint inflammation, rashes, and low-grade fever continuing.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Neck pain, Pyrexia, Rash
Clinical narrative: Began having joint pain 1 week after flu shot and was also unable to move my head due to neck pain. Went to ER with low-grade fever and was sent home. on 9/17/18, returned to the ER due to continued low-grade fever and severe joint pain. Ran a number of tests, the only positive of which was the BORRELIA (LYME) AB IGG/IGM test. My doctor doubts that it was positive at the time, as the next two times it was given on 10/23/18 and 1/15/19. I proceeded to take 3 rounds of dioxycycline for 10 days, then another 10 days, then 3 weeks, running into January. The infectious disease specialist was not sure it was Lyme when I visited her on 1/15/19 (see test above). All tests came back negative, except for the C-Reactive Protein, which was 6.56. Next, I saw a rheumatologist in March, who tested my C-reactive protein again, and i t was over 8. My ANA also came back positive 160:1 with a speckled pattern. This has been tested twice more since then with the same result. My C-reactive protein continues to be steadily above 8, with joint inflammation, rashes, and low-grade fever continuing.
Age: 14.0
Sex: M
Vaccine: HEP, HEPA, HPV9
Symptoms: Dizziness, Nausea, Pallor
Clinical narrative: This patient had come in today for a shot only visit. He was given Hepatitis A, Hepatitis B, and Gardasil injections. A time out was completed and allergies were verified. Mom reported no hx of reactions to vaccines. The patient was asked to remain in clinic for 15 minutes following the injections. They agreed to do so. At 1010, approximately 5 mins post-injection, the accompanying  interpreter approached the nurse at the nurses station and reported that the patient presented with pallor and c/o nausea and dizziness. The nurse responded to the patient room and observed the pallor. The patient also c/o nausea. A cold cloth was placed on the patients neck and he was asked to remain seated. Vitals were 113/71 Pulse 65, Respirations 18 and O2 Sat 98%. The patient had not eaten breakfast. Dr. precepting attending was asked to observe the patient in clinic. He spoke with both the patient and the patients mother briefly. A plan was set in place to give the patient a light snack and have him sit down a while longer to ensure safety until he felt better and could go home. The patient ate the snack and tolerated it well. No vomiting was observed. The pt reported that he felt better after approximately 15-20 more minutes. The patient was sent home.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Inflammation, Swelling, Tenderness
Clinical narrative: inflammation, tenderness, swelling
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Girl vomited after administration; This spontaneous report was received from a physician and refers to a female patient (reported as a girl) of unknown age. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. Family history included brother's vomiting after administration of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) in approximately 2015 (captured in case MARRS# 2002USA007623). On unknown date in approximately 2017 (reported as 2 or 3 years later after brother's vaccination), the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, dose number, lot #, expiration date, route of administration was not reported) for prophylaxis. On unknown date, after the vaccine administration the girl vomited. The outcome of the event was unknown.  The causality assessment between vomiting and suspect therapy was not provided.  This is one of the three cases received from the same reporter.; Sender's Comments:  US-009507513-2002USA009379: US-009507513-2002USA007623:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; administered a dose of VARIVAX that had been improperly stored; This spontaneous report was received from a practice manager referring to a patient of unknown age and gender. Information about patient's concurrent condition, medical history, drug allergy/reaction was not reported.  On 10-MAR-2020, the patient was inadvertently vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # S021322, expiry date: 09-JUL-2021 for prophylaxis (strength, dose number, anatomical location, route was not reported) (product storage error). It was reported that the vaccine was exposed to a temperature of -8.3 degree Celsius for a time frame of 24 minutes. There was no previous temperature excursion reported. Data logger was involved. The vaccine was reconstituted with properly stored sterile diluent. No adverse events were reported. No product quality complaint was involved.
Sex: M
Vaccine: HEP, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reports; one male patient was administered improperly stored RECOMBIVAX and ROTATEQ.; This spontaneous report was received from a vaccine coordinator referring to a 10 weeks old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 12-MAR-2020 the patient was vaccinated with improperly stored of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) 5/0.5 microgram/milliliter (lot # R028529, expiration date 09-JUN-2021; dose, frequency and route were not reported) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1658255, expiration date 07-FEB-2021, orally; dose and frequency were not reported) for prophylaxis (product storage error).  The administered doses of the vaccines experienced a temperature/time frame at below 2 Degree Celsius (?). On 02-MAR-2020 it was 0.8 C for 5 hours and 9 minutes, on 04-MAR-2020 it was 0.9 C for 11 hours and on 05-MAR-2020 it was -1.3 C for 9 hours and 29 minutes. Previous temperature excursion was at above 9°C 9.3 C for 3 hours 33 minutes on 25-FEB-2020 and below 2°C (0.8 C) for 11 hours 39 minutes on 03-MAR-2020. The digital data logger was involved. No additional adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; the patient was administered an improperly stored dose of MMRII; Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies were not provided. Concomitant medication included sterile diluent (STERILE DILUENT) (lot number R001254, expiration date 20-SEP-2020) that was properly stored.      On 26-FEB-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) Albumin status rHA (recombinant Human albumin) (lot number R030813, expiration date 24-OCT-2020; route, strength, dose and frequency unknown) for prophylaxis (product storage error).   The storage temperature of the vaccine was above 47 degrees Fahrenheit (54.5 degrees Fahrenheit) for a time frame of 2 hours 25 minutes. There was no previous temperature excursion. The call was because of a data logger. No additional adverse event information was reported.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Pt presented on 3/12/2020 (the day after vaccine was given) with red, very warm, somewhat firm skin, about 5-6 inches up and down, and about 3 inches wide on left deltoid. Pt was prescribed Clindamycin for left arm cellulitis. Pt presented the following day 3/13/2020 with increased erythema and induration about 10cm by 6cm. Cont'd Clindamycin, Benadryl, Ibuprofen, and cool compress as needed.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Sleep apnoea syndrome
Clinical narrative: My daughter stopped breathing in her sleep 4 times the night of the dtap vaccine. She continues to randomly stop breathing in her sleep.  She never had issues with breathing before the dtap vaccine. When she stops breathing we have to pick her up and move her around or startle her to get her back breathing again. We have seen 4 different doctors about this and only 1 is willing to help me investigate this problem. We are now waiting for our appointment with a pediatric pulmonologist. The last doctor we seen referred us to them and said we need to have a sleep study done also so we are waiting for all of that to take place.
Age: 56.0
Sex: M
Vaccine: UNK
Symptoms: Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Swelling at injection site, sever pain in the left arm, low grade fever during the day and elevated at night.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse event reported; one dose of improperly stored VARIVAX was administered to the patient; This spontaneous report as received from an office manager refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.  On 11-MAR-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot# S025608, expiration date: 18-AUG-2021 (strength and route of administration were not provided) for prophylaxis. The sterile diluent used to reconstitute the vaccine was stored properly.  The varicella virus vaccine live (oka/merck)(VARIVAX) was stored in a temperature -8.3 Celsius degrees for 24 minutes as recorded by digital data logger. No previous excursion was noted. No additional adverse event reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no symptoms were reported; altered dosing schedule; This spontaneous report was received from a nurse practitioner refers to a female patient of unknown age. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies and concomitant medications were not reported.  On 01-AUG-2019, 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) injection in vial, (strength and route of administration were not reported), (lot # R009614 and expiry date 30-NOV-2020 verified to be valid) for prophylaxis. On 18-DEC-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) injection in vial, (strength and route of administration were not reported), (lot # R009615 and expiry date 07-DEC-2020 verified to be valid) for prophylaxis. The patient was scheduled to get her third dose on 13-MAR-2020. No symptoms were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: flu like symptoms; fever; chills; tired; body aches; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male 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 influenza-like symptoms, fever, chills, tiredness and general body pain. On an unknown date, the outcome of the influenza-like symptoms, fever, chills, tiredness and general body pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms, fever, chills, tiredness and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the salesman, reported that, after vaccination experienced influenza-like symptoms, fever, chills, tiredness and general body pain. The reporter planned for 2nd dose on a friday. This case linked with case US2020037903, reported by same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Neck pain
Clinical narrative: Swelling, significant at injection site.  Patient also described neck pain that went away with time
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chest X-ray normal, Influenza like illness, Pollakiuria, Pyrexia
Clinical narrative: Flu like symptoms, fever, urinary tract infection symptoms of having to urinate frequently but no pain or blood, right side of back hurt like it did a few weeks before shot when I had fluid in my lung
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Urine analysis normal
Clinical narrative: Flu like symptoms, fever, urinary tract infection symptoms of having to urinate frequently but no pain or blood, right side of back hurt like it did a few weeks before shot when I had fluid in my lung
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Urinary tract infection, Urine analysis abnormal
Clinical narrative: See report submitted on first shot in series #189158. After second shot - Urinary tract infection day after shot, put on nitrofurinan for five days, infection cleared up but recurred two weeks later, on Cipro now but getting switched to nitrofurinan again as that is supposed to clear it up
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I have received all of the HPV vaccines. HPV 1_ 08/06/2007 HPV 2_ 10/08/2007 HPV 3_ 05/05/2008