chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 59 year old consumer received 3 dose series of GARDASIL 9; She had no side effects afer receiving GARDASIL 9; This spontaneous report was received from a 59-years-old female consumer, referring to herself. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not reported.  On unspecified dates, the patient received three doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) as prophylaxis (product administered to patient of inappropriate age). The patient reported she had no side effects after receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) doses.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided.; a patient was administered an improperly stored dose of PROQUAD which was also expired; a patient was administered an improperly stored dose of PROQUAD which was also expired; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about pertinent medical history, drug reactions or allergies was not provided.           On 17-DEC-2019, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R015740, expiration date 02-DEC-2019; dosage detail, strength and route were not reported) for prophylaxis (product storage error and expired product administered). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was reconstituted with properly stored sterile diluent.  Administered doses of vaccine experienced temperature excursion from -14 degrees Celsius (C) to -10 C for 1 hour and 30 minutes. There was previous temperature excursion from -14 C to -10 C for 15 minutes. Digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; lhe patient was administered an improperly stored dose of MMRII; This spontaneous report was received from a medical assisstant referring to a patient of unknown age and gender. Information about pertinent medical history, drug reactions/allergies and concomitant therapies was not provided.    On 17-DEC-2019, the patient was administered an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # S006647 and expiration date 05-MAR-2021; strength, dose and route were not reported) for prophylaxis (product storage error) with sterile diluent was properly stored. No additional adverse event information was provided. The vaccine underwent temperature 9.4 Celsius for a duration of 25 minutes. There was no previous temperature excursion. The call was because of data logger.
Sex: F
Vaccine: VARZOS
Symptoms: Autoimmune disorder, Eye infection staphylococcal, Fatigue, Herpes zoster, Muscle spasms
Clinical narrative: PHN; staph infection in and; autoimmune disease; rashes and shingles on her face, scalp, eyes and other areas of her body; rashes and shingles on her face, scalp, eyes and other areas of her body; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On 27-MAR-2017 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unspecified date in April 2017 (reported as one month after receiving vaccine), patient suffered painful and debilitating rashes and shingles on her face, scalp, eyes and other areas of her body which resulted in multiple outbreaks and a diagnosis of post herpetic neuralgia and staph infection in and around both eyes (date unknown), as a result of zoster vaccine live(ZOSTAVAX). The zoster vaccine live(ZOSTAVAX) also caused other injuries, including but not limited to, muscle spasms, constant itching, scalp, fatigue and pain with one diagnosed as an autoimmune disease. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), patient's symptoms have resulted in the physical injuries identified above and limitations not present prior to using zoster vaccine live(ZOSTAVAX) and caused by the zoster vaccine live(ZOSTAVAX) vaccine. The patient sustained severe and disfiguring personal injuries and suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was not reported.   The reporter considered all the events were serious due to disability. Upon internal review, ophthalmic herpes zoster, staph infection in and around both eyes,  autoimmune disease were determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Pain, Post herpetic neuralgia, Pruritus, Rash
Clinical narrative: PHN; staph infection in and; autoimmune disease; rashes and shingles on her face, scalp, eyes and other areas of her body; rashes and shingles on her face, scalp, eyes and other areas of her body; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On 27-MAR-2017 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unspecified date in April 2017 (reported as one month after receiving vaccine), patient suffered painful and debilitating rashes and shingles on her face, scalp, eyes and other areas of her body which resulted in multiple outbreaks and a diagnosis of post herpetic neuralgia and staph infection in and around both eyes (date unknown), as a result of zoster vaccine live(ZOSTAVAX). The zoster vaccine live(ZOSTAVAX) also caused other injuries, including but not limited to, muscle spasms, constant itching, scalp, fatigue and pain with one diagnosed as an autoimmune disease. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), patient's symptoms have resulted in the physical injuries identified above and limitations not present prior to using zoster vaccine live(ZOSTAVAX) and caused by the zoster vaccine live(ZOSTAVAX) vaccine. The patient sustained severe and disfiguring personal injuries and suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was not reported.   The reporter considered all the events were serious due to disability. Upon internal review, ophthalmic herpes zoster, staph infection in and around both eyes,  autoimmune disease were determined to be medically significant.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects; received 1st dose ofGARDASIL 9 "about 1 and a 1/2 years before 10/1/2019; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported. Approximately on an unknown date in April 2018 (also reported as about one and half years before the second dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)), the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route of administration, anatomical location, lot # and expiration date were unknown) for prophylaxis. On 01-OCT-2019 (about one and half years after the first dose), the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route of administration, anatomical location, lot # and expiration date were unknown) for prophylaxis (inappropriate schedule of product administration). No additional adverse effects reported. There was no product quality complaint associated with the case.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: developed chicken pox from a parent that had shingles; This spontaneous report was received from a nurse prescriber referred to a 2-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. The patient's parent had shingles. On an unknown date, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck) (VARIVAX) for childhood vaccinations (dose, route, lot # and expiry date were not reported). On an unknown date (reported as "bit recent date"), the patient developed chicken pox from the patient who had shingles (recently contracted chicken pox). The reporter stated that, chicken pox was mild. The outcome of the event was not resolved. The reporter did not provide any causality assessment.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; Improperly stored vaccine administered; This spontaneous report as received from a medical assistant (also reported as nurse) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.      On 20-DEC-2019, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # S001338, expiry date : 14-JAN-2021) for prophylaxis. It was reported that the vaccine experienced a temperature excursion of above 47 degrees Fahrenheit / 9 degrees Celsius (55.44 degrees Fahrenheit) for a duration of 5 hours (product storage error). There was no previous temperature excursion. It was reported that this call was due to  a digital data logger.  The patient had no adverse event. There was no product quality complaint involved.
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; VARIVAX administered on 12/15/2016 after MMR Il was administered on 12/5/2016; This spontaneous report was received from a medical assistant 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 05-DEC-2016, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, route of administration, anatomical location, lot # and expiration date were unknown) for prophylaxis. On 15-DEC-2016, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) with lot # M012992 and expiration date 14-MAR-2018 (strength, dose, route of administration and anatomical location were unknown) along with hepatitis a virus vaccine inactivated (HAVRIX) (strength, dose, route of administration, anatomical location, lot # and expiration date were unknown) for prophylaxis and sterile diluent (inappropriate schedule of product administration). No additional adverse effects reported. There was no product quality complaint associated with the case.
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse effect; infant inadvertantly administered Pneumovax23; This spontaneous report was received from a nurse referring to a currently 8 week old female patient. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On 24-DEC-2019, the infant patient was inadvertently vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route of administration and anatomical location were unknown) with lot # S012822 and expiration date 21-FEB-2021 for prophylaxis (product administered to patient of inappropriate age). No additional adverse effects reported. There was no product quality complaint associated with the case.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Injection site pain, Pain
Clinical narrative: hurting a lot at the injection site; minor body aches, pain; fatigue; weakness; This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th November 2019, the patient received Shingrix. In November 2019, less than a day after receiving Shingrix, the patient experienced general body pain, fatigue and weakness. On 29th November 2019, the patient experienced injection site pain. The patient was treated with naproxen. On an unknown date, the outcome of the injection site pain, general body pain, fatigue and weakness were recovered/resolved.   It was unknown if the reporter considered the injection site pain, general body pain, fatigue and weakness to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in the afternoon. Around six or seven hours after vaccination, the patient's arm was hurting a lot at the injection site. He took 2 Naproxen which worked really well at alleviating the pain. It took his pain from a seven or eight to maybe a two or three. On 30th November 2019, in the morning, the patient awoke with minor body aches, pain, fatigue, and weakness. He took two more Naproxen which worked really well and he did not have anything after that.
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Pyrexia
Clinical narrative: feverish; chills; upset stomach; headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th December 2019, the patient received the 2nd dose of Shingrix. On 13th December 2019, 1 days after receiving Shingrix, the patient experienced fever, chills, upset stomach and headache. On an unknown date, the outcome of the fever, chills, upset stomach and headache were unknown.   It was unknown if the reporter considered the fever, chills, upset stomach and headache to be related to Shingrix.  Additional case details were reported as follows: The patient got 2nd Shingrix vaccine about this time on day before reporting. On day of reporting the patient became feverish and had some chills, upset stomach and headache. The patient enquired about how long could he or she expect to feel like this. The permission to follow up was denied.
Sex: F
Vaccine: MENB
Symptoms: Joint range of motion decreased, Pain, Swelling
Clinical narrative: lot of pain; Swelling; Limited range of motion; This case was reported by a other health professional and described the occurrence of pain in a female patient who received Men B NVS (Bexsero) for prophylaxis.   In August 2019, the patient received the 1st dose of Bexsero. On an unknown date, less than 5 months after receiving Bexsero, the patient experienced pain, swelling and joint range of motion decreased. On an unknown date, the outcome of the pain, swelling and joint range of motion decreased were recovered/resolved.   It was unknown if the reporter considered the pain, swelling and joint range of motion decreased to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. After vaccination, the patient experienced a lot of pain and swelling with limited range of motion secondary to pain for 2 weeks following the injection. The patient did not felt comfortable to receive 2nd dose of Shingrix whien went to college. The patient's parent asked if get 2nd dose of shingrix though it has been 4 months and because of patient's condition.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Eye pain
Clinical narrative: pain behind eye; Blister; This case was reported by a pharmacist via call center representative and described the occurrence of pain behind eyes in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain behind eyes and blister. On an unknown date, the outcome of the pain behind eyes and blister were unknown.   It was unknown if the reporter considered the pain behind eyes and blister to be related to Shingrix.  Additional details were received as follows: The patient experienced pain behind eye and a blister.  The reporter did not consent to follow up. For tolerance to 2nd dose refer linked case US2019234407, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Customer reported an AE through an email; This case was reported by a consumer via call center representative and described the occurrence of adverse event 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 adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per the vaccine indication. The patient received dose of Shingrix vaccine and experienced adverse event. No other information was available.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 68-year-old 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, less than 6 months after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be 67 or 68 years. The reporter stated that the patient experienced pain after vaccination. The reporter consented to follow up. For tolerance to 2nd dose refer linked case US2019234370, reported by the same reporter.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Infection, Injection site erythema, Injection site scab, Injection site warmth
Clinical narrative: hot; red; infection; scab; This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 3FJ59, expiry date 27th November 2021) for prophylaxis.   On 20th September 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site warmth, injection site erythema, infection and injection site scab. The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the injection site warmth, injection site erythema and infection were unknown and the outcome of the injection site scab was not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth, injection site erythema, infection and injection site scab to be related to Shingrix.  Additional details were received as follows: The reporter stated that the patient received the 2nd dose of Shingrix and after the injection, the injection site became very red and hot.  The patient was infected and was prescribed antibiotics. The reporter stated that the site scabbed over and the scab were there till time of reporting. The reporter stated that the patient will sometimes bump into something and reaggrevate the site.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Lethargy, Myalgia
Clinical narrative: Right arm was sore at the injection site; Lethargic; Tired; Muscle aches; This case was reported by a consumer via call center representative and described the occurrence of lethargy in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th December 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 7th December 2019, less than a day after receiving Shingrix, the patient experienced lethargy, tiredness and muscle pain. On 9th December 2019, the patient experienced injection site pain. On 8th December 2019, the outcome of the lethargy, tiredness and muscle pain were resolved with sequelae. On 11th December 2019, the outcome of the injection site pain was resolved with sequelae.   It was unknown if the reporter considered the lethargy, tiredness, muscle pain and injection site pain to be related to Shingrix.  Additional details were reported as follows: The patient received the first dose of the Shingrix vaccine and felt lethargic, tired, and had muscle aches. The patient right arm was sore at the injection site. All symptoms have resolved. Reporter gave permission for his physician to be contacted.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Blood pressure increased, Chills, Headache, Pain
Clinical narrative: Upset stomach; headache; shivering; body aches; Blood pressure also increased; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension.   On 12th December 2019, the patient received the 1st dose of Shingrix (intramuscular). On 13th December 2019, 1 days after receiving Shingrix, the patient experienced upset stomach, headache, shivering, general body pain and increased blood pressure. On an unknown date, the outcome of the upset stomach, headache, shivering, general body pain and increased blood pressure were recovering/resolving.   It was unknown if the reporter considered the upset stomach, headache, shivering, general body pain and increased blood pressure to be related to Shingrix.  Additional details were reported as follows: The patient developed upset stomach, headache, shivering, and body aches. The patient stated that her blood pressure also increased. The patient consented to follow up.      Lab Comments: on an unknown date blood pressure was noted
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Erythema, Swelling
Clinical narrative: redness below the injection site; upset stomach the day after the injection; swelling below the injection site; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced erythema, upset stomach and swelling. On an unknown date, the outcome of the erythema and swelling were recovering/resolving and the outcome of the upset stomach was not recovered/not resolved.   It was unknown if the reporter considered the erythema, upset stomach and swelling to be related to Shingrix.  Additional details were received as follows: The patient experienced redness and swelling below the injection site and an upset stomach the day after the injection. The patient did not consent to follow up. This case has been linked to cases US2019AMR234253 and US2019228120, reported by the same reporter.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Headache, Myalgia
Clinical narrative: redness below the injection site; muscle pain throughout his body but mostly in his neck, head and shoulders; headache; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 months ago and felt uncomfortable for a couple of days, refer case US2019AMR231469).   On 8th December 2019, the patient received the 2nd dose of Shingrix. On 9th December 2019, 1 days after receiving Shingrix, the patient experienced erythema of extremities, generalized muscle aches and headache. On an unknown date, the outcome of the erythema of extremities was unknown and the outcome of the generalized muscle aches and headache were recovering/resolving.   It was unknown if the reporter considered the erythema of extremities, generalized muscle aches and headache to be related to Shingrix.  Additional details were reported as follows: The patient experienced redness below the injection site the day after the injection. The patient also experienced a headache and muscle pain throughout his body but mostly in his neck, head and shoulders.  The patient did not consent to follow up. This case has been linked to US2019228122, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Pharyngeal swelling
Clinical narrative: anaphylactic reaction; Swollen throat; This case was reported by a nurse via sales rep and described the occurrence of anaphylactic reaction 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 anaphylactic reaction (serious criteria GSK medically significant) and throat swelling. The patient was treated with Benadryl (nos) (Benadryl). On an unknown date, the outcome of the anaphylactic reaction and throat swelling were unknown.   It was unknown if the reporter considered the anaphylactic reaction and throat swelling to be related to Shingrix.  Additional details were provided as follows: The age of the patient and age at vaccination was not reported. The batch number or expiry date were not provided. The patient experienced swollen throat, possibly an anaphylactic reaction, after receiving Shingrix. The reporter consented to follow up. The patient went to the emergency department and was given Benadryl and later discharged home.
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Exposure during pregnancy, Nausea, Vertigo, Vomiting
Clinical narrative: vertigo; nausea; vomiting; drug exposure during pregnancy; Live birth; dizziness; This is a retrospective pregnancy case. This 31-year-old female subject was enrolled in an open label study. The subject received Boostrix on 17th July 2017, for prophylaxis. The subject received Boostrix at an unknown time during the pregnancy.   On 17th July 2017, less than a day after receiving Boostrix, the subject developed vomiting. Serious criteria included hospitalization. Additional event(s) included dizziness on 17th July 2017, live birth, vertigo with serious criteria of hospitalization, nausea with serious criteria of hospitalization and vaccine exposure during pregnancy. The subject was treated with intravenous fluid (nos) (Intravenous Fluid). The outcome of vomiting was unknown. The outcome(s) of the additional event(s) included vertigo (unknown), nausea (unknown), dizziness (unknown), live birth (unknown) and vaccine exposure during pregnancy (unknown). The pregnancy resulted in a live neonate with no apparent congenital anomaly. After [weeks gestation], the subject gave birth to a [gender] neonate via unknown delivery.   It was unknown if the investigator considered the vomiting, dizziness, vertigo and nausea to be related to Boostrix.   Additional details were provided as follows: The patient received Boostrix vaccine with batch number 594SR and expiry date 8th August 2019, while she was pregnant.  Later that day the patient came back to the office complaining about vomiting and dizziness.  The patient received intravenous fluid and went home.  The patient then came back and was hospitalized for vertigo, nausea and vomiting.  She stayed in the hospital for several days.  The patient delivered a healthy baby. The patient was pregnant again and was debating whether she should get the Boostrix vaccine or not.  The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: swellling; redness; itching; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site swelling (1st dose, refer case US2019AMR235142).   On 20th December 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and injection site itching. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient received dose of shingrix in the right deltoid. after vaccination, the patient had injection site swelling, redness and itching. Additional details were provided as follows: The patient received dose of shingrix in the right deltoid. after vaccination, the patient had injection site swelling, redness and itching.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site inflammation, Injection site swelling, Pain in extremity
Clinical narrative: Inflammation and swelling on the injection site after the first dose of Shingrix.; swelling at injection site; pain on right hip and leg; pain on right hip and leg; This case was reported by a consumer via call center representative and described the occurrence of injection site inflammation in a 66-year-old 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 injection site inflammation, injection site swelling, leg pain and pain in hip. On an unknown date, the outcome of the injection site inflammation, injection site swelling, leg pain and pain in hip were unknown.   It was unknown if the reporter considered the injection site inflammation, injection site swelling, leg pain and pain in hip to be related to Shingrix.  Additional detils were provided as follows: The age at vaccination was not reported. After vaccination, the patient experienced  swelling and inflammation on the injection site and pain on the right hip and leg. The patient was not administered with 2nd dose yet. The patient wanted ti know if  swelling and inflammation on the injection site were normal.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Joint range of motion decreased, Pain, Swelling, X-ray
Clinical narrative: Pain, swelling and bruising for couple of weeks.  Persistent pain for almost two months.  decreased range of motion 2/2 pain
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site warmth, Lymphadenopathy
Clinical narrative: Onset of erythema, warmth and induration from inoculation site to axilla 1 week after vaccine administration.   Axillary lymphadenopathy.  Dx: cellulitis.  Tx:  Setpra DS twice daily for 10 days.  24 hour follow-up with significant improvement.
Age: 23.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Dizziness, Feeling abnormal, Nausea, Pallor, Presyncope
Clinical narrative: 0811 patient came to RN and indicated patient felt like she was going to pass out. Pt in waiting room sitting in chair. Pale and c/o feeling nauseated. Denies breathing difficulty. No facial swelling and no difficulty breathing. Said she felt funny and was going to pass out. Diaphoretic. Assisted to wheel chair and brought to treatment room. Two person lift from W/C to treatment table. C/O fingers and hands tingly and "I'm scared". 0813 BP 84/52 HR 74. Resp 28 supine position. 0816 Lips pink and verbalizes feeling little better. Denies having this occur after any other vaccine. Verbalizes did not eat today. Explained a vaso vagal response to her and instructed for all future vaccines to remind us this occurred and vaccine can be administered lying down. Verbalizes understanding.  0827 BP 92/64. Assisted to slowly sit. c/o mild dizziness when moving into sitting position. Skin remains pink and is warm and dry. Eating lollipop due to not eating anything today.  0828 Denies dizziness.  0834 BP 98/72 Accompanied to waiting room and instructed to sit for 15 min until released by staff. Notify staff if feels funny again. Verbalizes understanding 0850 Denies further dizziness. Skin pink. Warm and dry. Allowed to go home.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Injection site erythema, Injection site swelling, Lip swelling, Pruritus
Clinical narrative: Had flu vaccine administered by Nursing Supervisor in Main Hospital earlier on 10/10/19  - stated she had had flu vaccines in past years with no reactions.  Night shift nursing supervisor noted employee began having "redness and swelling at injection site then progressed to lips swelling  and hives with itching.  Employee became short of breath and noted "throat tight." Supervisor took her to ED where she was treated
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Throat tightness, Urticaria
Clinical narrative: Had flu vaccine administered by Nursing Supervisor in Main Hospital earlier on 10/10/19  - stated she had had flu vaccines in past years with no reactions.  Night shift nursing supervisor noted employee began having "redness and swelling at injection site then progressed to lips swelling  and hives with itching.  Employee became short of breath and noted "throat tight." Supervisor took her to ED where she was treated
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fatigue, Feeling hot, Hyperhidrosis, Ill-defined disorder
Clinical narrative: We do not have the lot number etc. as we are not the administrating provider. Pt reported the illness began Friday with PND, nasal congestion, sinus pressure. Pt reported felt hot, no chills, + sweating, fatigue. Tmax 99.8F. She slept well overnight. Her fatigue is better today. Her appetite is ok. Pt had some fleeting lightheadedness yesterday and body aches. These sx's are all better today.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Nasal congestion, Pain, Paranasal sinus discomfort
Clinical narrative: We do not have the lot number etc. as we are not the administrating provider. Pt reported the illness began Friday with PND, nasal congestion, sinus pressure. Pt reported felt hot, no chills, + sweating, fatigue. Tmax 99.8F. She slept well overnight. Her fatigue is better today. Her appetite is ok. Pt had some fleeting lightheadedness yesterday and body aches. These sx's are all better today.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Myalgia, Oropharyngeal pain, Pyrexia, Vomiting
Clinical narrative: Hospitalized Fever  vomiting  muscle aches and pains from head to toe Sore throat Chest pains
Age: 34.0
Sex: M
Vaccine: FLUC4
Symptoms: Syncope
Clinical narrative: 34 year old male patient received Flucelvax Quadrivalent flu shot on 12/26/19 at 11:42am. Patient fainted after flu shot was administered and immediately the 911/ambulance was called. Patient was evaluated by the 911 paramedics/EMTs and stayed in the pharmacy for 20-30 minutes until he felt better and was able to go home. Upon inquiry after the patient fainted, the patient stated they have not eaten prior to the flu shot and have a history of fainting in the past and feels better after eating foods with sugar in them. Documented in patient's pharmacy profile that they fainted after flucelvax shot.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: @1:48pm, patient is sitting in the chair, alert and verbally responsive with his mom next to him. patient received MGC/HPV/FLU VACCINE . Right after receiving the vaccines, patient stated " i feel light headed". LN assessed the patient, put the head of the chair  down , patient laying down with legs elevated. CODE BLUE was page overhead. Multiple staff came to help assessed the patient . Patient remains alert and verbally responsive but still feeling light headed . @1:50pm, vs 156/102, pulse 75, rr 20, 02 sat 97% ra.  @1:51 vs, 144/95, pulse 64, rr 20 02 sat 97% ra. Patient remains alert and verbally responsive.  @1:54pm, vs 144/95, pulse 78, rr 20 , 02 sat 100% ra. Patient stated " i feel better". Patient is now sitting in the chair, upright position. Staff still monitoring the patient.   @2pm, patient stated, i feel better and i am ready to go. Advised patient to report to his PCC about what happened today after receiving vaccines. Per mother, she already spoke with the doctor and reported .  Patient left the clinic with his mother.
Age: 10.0
Sex: F
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event reported; improperly stored vaccine administered; This spontaneous report was received from a medical assistant and refers to a 10-year-old female patient. No information regarding patient's concurrent conditions, past medical history, concomitant medications, drug reactions or allergies was provided. On 13-NOV-2019, the patient was vaccinated with improperly stored dose of virus vaccine live (oka/merck) (VARIVAX) injection, lot number R006221, expiration date 29-FEB-2020 (exact dose and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse event was reported. Administered dose of vaccine experienced temperature excursion of 36 Fahrenheit degree (F) for 48 hours and 30 minutes. There was no previous temperature excursions. Digital data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: The patient was administered an improperly stored dose of Vaqta; This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported. On 31-OCT-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (Strength, dose, frequency, route and anatomical location were not reported) of lot # S010727 with an expiry date of 26-JUL-2020 for prophylaxis (product storage error). The hepatitis a vaccine, inactivated (VAQTA) underwent a temperature excursion at 31.6 Fahrenheit for a time period of 13 hours and 35 minutes. There was no previous temperature excursion involved. Digital data logger was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle ache; This case was reported by a consumer and described the occurrence of myalgia 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 myalgia. On an unknown date, the outcome of the myalgia was unknown.   It was unknown if the reporter considered the myalgia to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had shingles shot for muscle ache. The reporter was requested to provide consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: headache; aches; chills; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced headache, pain and chills. On an unknown date, the outcome of the headache, pain and chills were unknown.   It was unknown if the reporter considered the headache, pain and chills to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had headache, pain and chills. The patient wants to know how long can expect them to last.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort
Clinical narrative: Upset stomach; This case was reported by a consumer via call center representative and described the occurrence of upset stomach 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 upset stomach. On an unknown date, the outcome of the upset stomach was recovered/resolved.   It was unknown if the reporter considered the upset stomach to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced upset stomach after receiving 2nd dose of Shingrix. The reporter believes this may be due to his mass since he was taller and reportedly weighs 100 pounds more. No more information provided. For tolerence with 2nd dose of Shingrix refer linked case US2019AMR233005. This case has been linked to the case US2019232431, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort
Clinical narrative: Upset stomach; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of abdominal discomfort (for tolerance of 1st dose refer case US2019AMR233004).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced upset stomach. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the upset stomach was recovered/resolved.   It was unknown if the reporter considered the upset stomach to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced upset stomach after receiving 2nd dose of Shingrix. The reporter believes this may be due to his mass since he was taller and reportedly weighs 100 pounds more. No more information provided. This case has been linked to the case US2019232431, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Gastrointestinal haemorrhage, Immediate post-injection reaction, Vomiting
Clinical narrative: Had to be admitted for GI bleed; Began vomiting soon after injection; This case was reported by a physician via sales rep and described the occurrence of gastrointestinal bleeding in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced gastrointestinal bleeding (serious criteria hospitalization and GSK medically significant) and vomiting. On an unknown date, the outcome of the gastrointestinal bleeding and vomiting were unknown.   It was unknown if the reporter considered the gastrointestinal bleeding and vomiting to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix and soon after had vomitting and was admitted for gastrointestinal bleeding. The reporter was consented to follow up.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort
Clinical narrative: felt uncomfortable for a couple of days after the first shot; This case was reported by a consumer via call center representative and described the occurrence of discomfort in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced discomfort. On an unknown date, the outcome of the discomfort was unknown.   It was unknown if the reporter considered the discomfort to be related to Shingrix.  Additional details were received as follows: The patient felt uncomfortable for a couple of days after the first shot. The reporter did not consent to follow up. This case has been linked to US2019228122, reported by the same reporter.
Sex: U
Vaccine: TDAP
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: Guillain Barre after taking the dpt booster; Paralyzed; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant) and paralysis (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome and paralysis were unknown.   It was unknown if the reporter considered the guillain barre syndrome and paralysis to be related to DTPa vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient took the DPT booster shot. The patient got Guillen Barre and was paralyzed. The patient was still recuperating after nine months and advised that, the Whooping Cough vaccine should be get with caution.