chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: all of the symptoms listed; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2020, the patient received the 2nd dose of Shingrix. In July 2020, less than a day after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was not recovered/not resolved.   It was unknown if the reporter considered the adverse reaction 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 selected as per the vaccine indication. On 8th July 2020 at 7:30 pm, the patient received the 2nd dose of Shingrix. After vaccination the patient experienced adverse events. The patient did not experience fever. The patient asked how long with this last. The callback to patient was made but unsuccessful.
Sex: F
Vaccine: PNC13
Symptoms: Crying, Injected limb mobility decreased, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Redness, heat, pain (not just soreness or stiffness) from site; redness, heat, pain (not just soreness or stiffness) from site; redness, heat, pain (not just soreness or stiffness) from site; A knot the size of a marble popped up to left of injection site; pain ran into her shoulders and she couldn't use or lift the arm; pain ran into her shoulders and she couldn't use or lift the arm; affected her sleeping as she would only be able to get 3-4 hours a night; Crying; 'Normal' stiff arm and heaviness; 'Normal' stiff arm and heaviness; This is a spontaneous report from a contactable consumer, the patient.  A 72-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration in the arm on 04Jun2020 as a single dose for immunisation.  The patient's medical history and concomitant medications were not reported. The patient previously received her flu shot (MANUFACTURER UNKNOWN) every year for immunization and had no side effects.  On an unknown date in 2020, after the vaccination, the patient experienced 'normal' stiff arm and heaviness. On 18Jun2020, 14 days after the vaccination, the patient had redness, heat, pain (not just soreness or stiffness) from site, and a knot the size of a marble popped up to left of injection site. The pain was terrible and it went from aching to excruciating pain. It was reported that the pain ran into her shoulders and she couldn't use or lift the arm. This affected her sleeping as she would only be able to get 3-4 hours a night and she would wake up in the morning crying in pain. The patient saw her physician on 06Jul2020 for the pain and was prescribed prednisone (MANUFACTURER UNKNOWN) which she started on 07Jul2020. The prednisone helped and she was able to sleep through the night. The clinical outcome of the poor quality of sleep was recovering; while that of the 'normal' stiff arm and heaviness; redness, heat, pain (not just soreness or stiffness) from site; a knot the size of a marble popped up to left of injection site, pain ran into her shoulders and she couldn't use or lift the arm, and crying were unknown.   No follow-up attempts are possible; information about lot number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Insomnia, Limb discomfort, Musculoskeletal disorder, Musculoskeletal pain
Clinical narrative: Redness, heat, pain (not just soreness or stiffness) from site; redness, heat, pain (not just soreness or stiffness) from site; redness, heat, pain (not just soreness or stiffness) from site; A knot the size of a marble popped up to left of injection site; pain ran into her shoulders and she couldn't use or lift the arm; pain ran into her shoulders and she couldn't use or lift the arm; affected her sleeping as she would only be able to get 3-4 hours a night; Crying; 'Normal' stiff arm and heaviness; 'Normal' stiff arm and heaviness; This is a spontaneous report from a contactable consumer, the patient.  A 72-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration in the arm on 04Jun2020 as a single dose for immunisation.  The patient's medical history and concomitant medications were not reported. The patient previously received her flu shot (MANUFACTURER UNKNOWN) every year for immunization and had no side effects.  On an unknown date in 2020, after the vaccination, the patient experienced 'normal' stiff arm and heaviness. On 18Jun2020, 14 days after the vaccination, the patient had redness, heat, pain (not just soreness or stiffness) from site, and a knot the size of a marble popped up to left of injection site. The pain was terrible and it went from aching to excruciating pain. It was reported that the pain ran into her shoulders and she couldn't use or lift the arm. This affected her sleeping as she would only be able to get 3-4 hours a night and she would wake up in the morning crying in pain. The patient saw her physician on 06Jul2020 for the pain and was prescribed prednisone (MANUFACTURER UNKNOWN) which she started on 07Jul2020. The prednisone helped and she was able to sleep through the night. The clinical outcome of the poor quality of sleep was recovering; while that of the 'normal' stiff arm and heaviness; redness, heat, pain (not just soreness or stiffness) from site; a knot the size of a marble popped up to left of injection site, pain ran into her shoulders and she couldn't use or lift the arm, and crying were unknown.   No follow-up attempts are possible; information about lot number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal stiffness
Clinical narrative: Redness, heat, pain (not just soreness or stiffness) from site; redness, heat, pain (not just soreness or stiffness) from site; redness, heat, pain (not just soreness or stiffness) from site; A knot the size of a marble popped up to left of injection site; pain ran into her shoulders and she couldn't use or lift the arm; pain ran into her shoulders and she couldn't use or lift the arm; affected her sleeping as she would only be able to get 3-4 hours a night; Crying; 'Normal' stiff arm and heaviness; 'Normal' stiff arm and heaviness; This is a spontaneous report from a contactable consumer, the patient.  A 72-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration in the arm on 04Jun2020 as a single dose for immunisation.  The patient's medical history and concomitant medications were not reported. The patient previously received her flu shot (MANUFACTURER UNKNOWN) every year for immunization and had no side effects.  On an unknown date in 2020, after the vaccination, the patient experienced 'normal' stiff arm and heaviness. On 18Jun2020, 14 days after the vaccination, the patient had redness, heat, pain (not just soreness or stiffness) from site, and a knot the size of a marble popped up to left of injection site. The pain was terrible and it went from aching to excruciating pain. It was reported that the pain ran into her shoulders and she couldn't use or lift the arm. This affected her sleeping as she would only be able to get 3-4 hours a night and she would wake up in the morning crying in pain. The patient saw her physician on 06Jul2020 for the pain and was prescribed prednisone (MANUFACTURER UNKNOWN) which she started on 07Jul2020. The prednisone helped and she was able to sleep through the night. The clinical outcome of the poor quality of sleep was recovering; while that of the 'normal' stiff arm and heaviness; redness, heat, pain (not just soreness or stiffness) from site; a knot the size of a marble popped up to left of injection site, pain ran into her shoulders and she couldn't use or lift the arm, and crying were unknown.   No follow-up attempts are possible; information about lot number cannot be obtained.
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Right arm vaccination injection is red and painful for a patient who was receiving  Trumenba; Right arm vaccination injection is red and painful for a patient who was receiving  Trumenba; This is a spontaneous report based on the information reported to Pfizer by Agency, (Reference#: A202008864) via a non-contactable consumer. A female patient of unspecified age received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose in right arm for immunisation. Medical history and concomitant medications were not reported. An adverse event of right arm vaccination injection site was red and painful was reported for a patient who was receiving product meningococcal group b rlp2086. Outcome of the events was unknown.  No follow-up attempts are possible. Information regarding batch/lot number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of product administration, No adverse event, Wrong product administered
Clinical narrative: administered 0.1 mL dose of Adacel to a patient instead of Tubersol via intradermal route/No AE; Initial information was received on 09-Jul-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 29 year old female patient who administered 0.1 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of TUBERCULIN TEST [TUBERSOL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were none.   On 08-Jul-2020, the patient received a 0.1 mL once dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot C5661AA, expiry date- 08-Aug-2021) via intradermal route in the left arm for prophylactic vaccination.  It was a case of an actual medication error due to wrong product administered.  At the time of report, no adverse event was reported.  Treatment reported in the case were TRIAMCINOLONE, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and FAMOTIDINE (PEPCID [FAMOTIDINE])  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient with the history of Guillain-Barre syndrome received Menactra/ No AE; Initial information was received on 09-Jul-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 17 years old patient who had history of guillain-barre syndrome and still received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (contraindication to vaccination).  The patient's past medical history included Guillain-Barre syndrome. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included third dose of VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  Case details: First the caller states that a patient was given MMR (measles, mumps, and rubella vaccine) and Menactra at the same time and  would like to know if there are any side effects that they should be worried about in regards to the additional vaccine given. After that the caller reported that the consumer did not get a MMR (measles, mumps, and rubella vaccine) but a varicella vaccine on the same day and was wanting to know if the Guillain-Barre syndrome was a contraindication for the varicella vaccine  It was a case of contraindication to vaccination  At a time of reporting no adverse event reported.  There will be no information available on the batch number for this case.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema multiforme, Injection site pain, Injection site swelling
Clinical narrative: ErythemaMultiform & swelling at site of injection, pain
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Fall, Limb injury
Clinical narrative: Patient came with mother to get his 2nd HPV9, waited 15 minutes and fell to the floor on his right side (right arm hit the floor) according to his older brother.  Pt was taken to the treatment room, assessed vital sign and given a box of juice.  Dr. spoke with both patient and mother.
Age: 9.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Papule
Clinical narrative: Patient had erythematous area at left lateral deltoid where Tdap was administered. He denied any fever chills cold or flu symptoms. Patients stated it wasn't sore but did itch. There was also a row of small papules under left breast chest wall. There were no pustule or any true vesicles and the area was non tender. This was all observed on 7/10/2020 two days after immunization was administered.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema multiforme
Clinical narrative: Arthralgia & ErythemaMultiform
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Flushing, Injection site erythema, Injection site warmth
Clinical narrative: Face was flushed and redness and warmth to injection site (R arm) at the 15 minutes mark. Benadryl given, child waited another 10 minutes. When re-checked child's symptoms were resolved.
Sex: F
Vaccine: CHOL, VARCEL
Symptoms: Ear discomfort, Ear swelling, Hypoacusis, Tinnitus
Clinical narrative: SWELLING IN EAR; RINGING IN HER EARS; HARD TO HEAR OUT OF HER EARS; This spontaneous case (PVX2019-1533) report was received from a consumer on 13-Jun-2019. It described a 43-year-old female consumer who experienced the events "ringing in ears", "hard to hear out of ears", and "swelling in ear", after the administration of oral Vaxchora, for cholera and injectable Varicella vaccine (non-company suspect) for chicken pox.  Case report: The consumer took Vaxchora on 10-Jun-2019 and Varicella vaccine on 12-Jun-2019. After that, she experienced ringing in her ears, she was unable to hear out of her ears. She reported that the ringing sound was like "the sound in ear being weird, as if you pop your ear on a plane" but without the pressure experienced while on a plane. She also stated that when she spoke, it would echo, and stated it was similar to "when sinuses affect ears". On 13-Jun-2019, the events had worsened. Additionally, she reported that "getting a funny sensation in the ear, not so much vibrations, but troubled hearing like when your ears clog on the plane". She was prescribed prednisone (6 mg; to be tapered off) to reduce the swelling in the ears and to prevent hearing loss.  The consumer's medical history included ear infection, hypothyroidism, atrial fibrillation, pernicious anemia, and vitiligo .  Concomitant medications included levothyroxine (175 mcg; once in a day) for hypothyroidism, Multaq (dronedarone; 400 mg; twice a day) and metoprolol (25 mg; once in a day) for atrial fibrillation. The past medication included intravenous (IV) iron infusion (about a week ago).  Action taken with Vaxchora and Varicella was unknown.   The consumer had not recovered from the events.  The reporter considered the events unrelated to Vaxchora because until she received the Varicella vaccine, she had no reaction.  Company's Comment: In this case, it was reported that a 43-year-old female consumer experienced the events "ringing in ears", "hard to hear out of ears", and "swelling in ear", after the administration of oral Vaxchora for cholera and injectable Varicella vaccine. Although the events were reported with reasonable time relationship to intake of the Vaxchora vaccine; however, there is also intake of varicella vaccine which is more likely to contribute to these events. Hence, the causality of the events  with Vaxchora is considered as unlikely.; Sender's Comments: Company's Comment: In this case, it was reported that a 43-year-old female consumer experienced the events "ringing in ears", "hard to hear out of ears", and "swelling in ear", after the administration of oral Vaxchora for cholera and injectable Varicella vaccine. Although the events were reported with reasonable time relationship to intake of the Vaxchora vaccine; however, there is also intake of varicella vaccine which is more likely to contribute to these events. Hence, the causality of the events  with Vaxchora is considered as unlikely.
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been downloaded from Agency (US-BEH-2017077107).  This spontaneous report was received from a consumer referring to a 61-year-old male patient. The pertinent concurrent conditions, medical history and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), by subcutaneous route for unknown indication (concentration, number of dose administered, vaccination scheme, frequency, lot number and expiration date were not reported), and on 10-OCT-2016, the patient was vaccinated with influenza virus split virion 3v vaccine inactivated (AFLURIA) at a dose of 0.5 milliliter (ml), by intramuscular route, lot number WT57008 (strength, number of administered dose, vaccination scheme, frequency and expiration date were not reported) for unknown indication.     On 20-OCT-2016, the patient experienced shingles (herpes zoster). The outcome of herpes zoster was not reported.   The causality assessment between both vaccines and the aforementioned event was not reported.  The reporter considered the event was medically significant.
Sex: M
Vaccine: CHOL
Symptoms: Product preparation issue, Wrong technique in product usage process
Clinical narrative: Accidentally mixed the buffer second and the live virus first of the Vaxchora medication, and drank it; Spontaneous report received on 04JAN2020.  A male consumer reported that he "accidentally mixed the buffer second and the live virus first of the Vaxchora medication, and drank it" (PT: Wrong technique in product usage process). He was receiving oral Vaxchora for immunisation. The consumer stated that he got Vaxchora and accidentally mixed the buffer second and the live virus first while preparing the suspension and then drank it. Action taken with Vaxchora with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer accidentally mixed the buffer second and the live virus first of the Vachora medication, and drank it (Wrong technique in drug usage process). Reconstitution of Vaxchora should be done by mixing buffer component first and then the active component. Considering the nature of the event, the causality of the event is assessed as not applicable to Vaxchora.; Sender's Comments: A consumer accidentally mixed the buffer second and the live virus first of the Vachora medication, and drank it (Wrong technique in drug usage process). Reconstitution of Vaxchora should be done by mixing buffer component first and then the active component. Considering the nature of the event, the causality of the event is assessed as not applicable to Vaxchora.
Sex: M
Vaccine: CHOL
Symptoms: Product preparation issue, Wrong technique in product usage process
Clinical narrative: Mixed buffer component of Vaxchora in one glass and mixed the active ingredient in a separate glass and drank one after the other; Spontaneous report received on 14FEB2020.  A nurse reported that a male consumer had "mixed buffer component of Vaxchora in one glass and mixed the active ingredient in a separate glass and drank one after the other" (PT: Wrong technique in product usage process). He received oral Vaxchora for immunisation. Action taken with Vaxchora with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer mixed buffer component of Vaxchora in one glass and mixed the active ingredient in a separate glass and drank one after the other" (Wrong technique in product usage process). Reconstitution of Vaxchora should be done by mixing buffer component into a cup of purified water and then active component should be added into the same cup of water. Considering the nature of the event, the causality of Wrong technique in product usage process is assessed as not applicable to Vaxchora.; Sender's Comments: A consumer mixed buffer component of Vaxchora in one glass and mixed the active ingredient in a separate glass and drank one after the other" (Wrong technique in product usage process). Reconstitution of Vaxchora should be done by mixing buffer component into a cup of purified water and then active component should be added into the same cup of water. Considering the nature of the event, the causality of Wrong technique in product usage process is assessed as not applicable to Vaxchora.
Sex: F
Vaccine: CHOL
Symptoms: Incorrect product formulation administered
Clinical narrative: ADMINISTERED ONLY THE BUFFER PACK OF VAXCHORA; This spontaneous case (PVX2019-1551) report was received from a healthcare professional on 14-Jun-2019. It describes a 42-year-old female consumer who "administered only the buffer pack of Vaxchora". The consumer was receiving Vaxchora for an unknown indication.  Case report: The consumer administered only buffer pack of Vaxchora on 14-Jun-2019.  Action taken with Vaxchora was not applicable.   The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "administered only the buffer pack of Vaxchora" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "administered only the buffer pack of Vaxchora" was considered as not applicable.
Sex: F
Vaccine: CHOL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK VAXCHORA FIVE DAYS BEFORE LEAVING TO ENDEMIC AREA; This spontaneous case report (PVX2019-1649) was received from a consumer on 26-Jun-2019. It describes a 41-year-old female consumer who "took Vaxchora five days before leaving to endemic area". She was receiving Vaxchora (lot number: 7000014) for travelling to endemic area.  Case report: The consumer took Vaxchora on 10-Jun-2019 and left for the endemic area on 15-Jun-2019.  Action taken with Vaxchora was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took Vaxchora five days before leaving to endemic area" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vaxchora five days before leaving to endemic area" was considered as not applicable.
Sex: M
Vaccine: CHOL
Symptoms: Wrong technique in product usage process
Clinical narrative: TOOK A BIG MEAL PRIOR TO TAKING VAXCHORA; This spontaneous case report (PVX2019-1674) was received from a pharmacist on 27-Jun-2019. It describes a 61-year-old male consumer who "took a big meal prior to taking Vaxchora" (product administration error). He was receiving Vaxchora for an unknown indication.  Case report: The consumer had a big meal prior to taking Vaxchora. He took a dose on 26-Jun-2019.  Action taken with Vaxchora with respect to the event was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took a big meal prior to taking Vaxchora" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took a big meal prior to taking Vaxchora" was considered as not applicable.
Sex: M
Vaccine: CHOL, HEP, HEPA, IPV, JEVX, UNK, UNK
Symptoms: Hypersensitivity
Clinical narrative: ALLERGIC REACTION; This spontaneous case report was received from a nurse on 30-Aug-2019. It described a male (18 to 19 year old) consumer who had allergic reaction (PT: Hypersensitivity), after administration of oral Vaxchora (cholera vaccine; company suspect) and Hepatitis A and B vaccine, injectable typhoid vaccine, polio vaccine, measles, mumps, and rubella (MMR vaccine) and Japanese encephalitis vaccine (non-company suspects) for unknown indications.  Case report: The consumer received Vaxchora and other vaccines such as Hepatitis A, Hepatitis B, injectable typhoid, polio, MMR, and Japanese encephalitis and experienced allergic reaction. The Nurse stated that the allergic reaction was not from medications, but the allergic reaction was to food and other things (but did not know exactly what the patient was allergic to). The Nurse stated that the consumer has had past history experiencing similar events.  The Nurse stated that the patient had a lot of allergies and allergic reactions so the caregiver carried an Epi-Pen at all times for her son.  Action taken with Vaxchora, Hepatitis A, Hepatitis B, injectable typhoid, polio, MMR and Japanese encephalitis vaccines with respect to the event was unknown.  The consumer had recovered from the reported event.  The reporter considered the event of allergic reaction was not related to vaccines.  Company comment: In this case,a male consumer had allergic reaction after administration of oral Vaxchora and Hepatitis A and B vaccine, injectable typhoid vaccine, polio vaccine, measles, mumps, and rubella and Japanese encephalitis vaccine . The causal association between the intake of the Vaxchora and the event cannot be ruled out. Hence, the causality of the event with Vivotif is assessed as possible. Also, hypersensitivity is labelled as per Agency. Additionally, co-administration of multiple vaccines and history of allergies also provides an alternative explanation for the reported event.; Sender's Comments: Company comment: In this case,a male consumer had allergic reaction after administration of oral Vaxchora and Hepatitis A and B vaccine, injectable typhoid vaccine, polio vaccine, measles, mumps, and rubella and Japanese encephalitis vaccine . The causal association between the intake of the Vaxchora and the event cannot be ruled out. Hence, the causality of the event with Vivotif is assessed as possible. Also, hypersensitivity is labelled as per Agency. Additionally, co-administration of multiple vaccines and history of allergies also provides an alternative explanation for the reported event.
Sex: F
Vaccine: CHOL
Symptoms: Expired product administered
Clinical narrative: took expired Vaxchora vaccine; This spontaneous case report (PVX2019-2987) was received from a nurse on 05-Dec-2019. It described a 49-year-old female consumer who "took expired Vaxchora vaccine" (PT: Expired product administered) for an unknown indication.  Case report: The consumer took expired Vaxchora (expiry date: Oct 2019) on 05-Dec-2019.  Action taken with Vaxchora with respect to the reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: A consumer took expired Vaxchora vaccine. The expiry date of Vaxchora was in October 2019 and the consumer took the expired Vaxchora on 05-December-2019. Further details of the event was limited. Considering the nature of the event, the causality of the event is assessed as not applicable to Vaxchora.; Sender's Comments: A consumer took expired Vaxchora vaccine. The expiry date of Vaxchora was in October 2019 and the consumer took the expired Vaxchora on 05-December-2019. Further details of the event was limited. Considering the nature of the event, the causality of the event is assessed as not applicable to Vaxchora.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: Visual disturbance; This case was reported by a physician and described the occurrence of visual disturbance in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In April 2020, less than 2 weeks after receiving Shingrix, the patient experienced visual disturbance. On an unknown date, the outcome of the visual disturbance was unknown.   The reporter considered the visual disturbance to be unlikely related to Shingrix.  Additional information was provided as follows: The patient had a reaction to Shingrix as visual disturbances. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020GSK061777:Same patient
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Decreased appetite, Emotional distress, Hypersomnia, Hypotonia, Injection site pain
Clinical narrative: Daughter nursed at about 50% of her normal feeding, slept almost entire 72 hours, very hard to keep awake, limp baby with little flection, took a full 72 hours to recover. After 5 hours of the injection, she started to scream in inconsolable pain at the injection site that would only be soothed with infant tylenol.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Screaming, Somnolence
Clinical narrative: Daughter nursed at about 50% of her normal feeding, slept almost entire 72 hours, very hard to keep awake, limp baby with little flection, took a full 72 hours to recover. After 5 hours of the injection, she started to scream in inconsolable pain at the injection site that would only be soothed with infant tylenol.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: erythema or redness at injection site and surrounding area lasting over 7 days. rash has irregular edges and may be a reaction to injection site barrier bandage.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Confusional state, Dizziness, Feeling hot, Pallor, Posture abnormal
Clinical narrative: Client was wearing a mask due to covid.  Client was asking questions in the lobby for example how big is the needle and does the whole thing go in my arm.  Client appeared nervous due to questions she was asking.  PHN had client seated in a chair.  PHN gave the Tdap first in the right deltoid then HPV in right deltoid at 10:40am.  Then as PHN was giving the MCV4 in the left deltoid client asked am I supposed to feel dizzy.  PHN stayed knelt down by client and watched clients face turn white.  PHN placed both hands on clients arms incase she were to faint.  Client's upper body started convulsing and then her head fainted forward and then back in the chair.  Client then awoke.  Foster mom asked her what her date of birth was and client was confused and could not tell her.  Client then began to throw up.  She reported that she was hot so an icepack and water was given.   Client did not remember what happened to her.  This all happened in a matter of two minutes.  Client and foster mom hung around for about 10 more minutes and when client felt ok they left.  PHN called client about an hour later to see how she was doing.  No other signs/symptoms reported.  Client states that she has never had a seisure or fainted prior to this.  PHN reported incident to PCP.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Seizure, Syncope, Vomiting
Clinical narrative: Client was wearing a mask due to covid.  Client was asking questions in the lobby for example how big is the needle and does the whole thing go in my arm.  Client appeared nervous due to questions she was asking.  PHN had client seated in a chair.  PHN gave the Tdap first in the right deltoid then HPV in right deltoid at 10:40am.  Then as PHN was giving the MCV4 in the left deltoid client asked am I supposed to feel dizzy.  PHN stayed knelt down by client and watched clients face turn white.  PHN placed both hands on clients arms incase she were to faint.  Client's upper body started convulsing and then her head fainted forward and then back in the chair.  Client then awoke.  Foster mom asked her what her date of birth was and client was confused and could not tell her.  Client then began to throw up.  She reported that she was hot so an icepack and water was given.   Client did not remember what happened to her.  This all happened in a matter of two minutes.  Client and foster mom hung around for about 10 more minutes and when client felt ok they left.  PHN called client about an hour later to see how she was doing.  No other signs/symptoms reported.  Client states that she has never had a seisure or fainted prior to this.  PHN reported incident to PCP.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Decreased appetite, Fatigue, Feeling hot, Irritability, Lumbar puncture normal
Clinical narrative: "Felt warm" the evening of May 6 with axillary temp of 99. Temp to 102 rectally on May 7 at 10:30 AM Seen in office at 1800 May 7 with temp of 102.8 (reported to be 103.1 at home). She had been "very irritable" with decreased appetite and and increased fatigue. Presented to ER at Hospital with fever of 105.5 and seizures Stabilized and transferred to different Hospital
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Magnetic resonance imaging brain normal, Procalcitonin increased, Pyrexia, Seizure
Clinical narrative: "Felt warm" the evening of May 6 with axillary temp of 99. Temp to 102 rectally on May 7 at 10:30 AM Seen in office at 1800 May 7 with temp of 102.8 (reported to be 103.1 at home). She had been "very irritable" with decreased appetite and and increased fatigue. Presented to ER at Hospital with fever of 105.5 and seizures Stabilized and transferred to different Hospital
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site hypoaesthesia, Injection site pain, Laboratory test, Sleep disorder
Clinical narrative: Intense pain at injection site, throbbing pain with numbness. Causes sleep interruptions due to pain.
Age: 1.08
Sex: M
Vaccine: HIBV, HPV9, MMR, PNC13, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Called MOC, patient received an HPV instead of a Hep A.
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Per Dr. note on 7/9/2020:  vaccines done on 7/2 (right leg was Hib) - redness at injection site starting yesterday and slightly worsening today.  no fever, no significant pain.  acting well.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: The patient received a varicella vaccine in the subQ space on the back of her right arm. The next day it started itching. The patient returned to employee health on the next day and there was redness and swelling in that area.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Malaise
Clinical narrative: Patient had just received 2 immunizations around 4 pm . Tdap in her left deltoid and Menactra in her right deltoid. Instructed the patient to stay sitting and if she started to feel light headed or dizzy or unwell to lay down. Left the room and within 2 minutes patient's mother came out of the room yelling for help. Staff and I responded. Patient was in the middle of the room lying on her back with her head below our keyboard stand in the room. Staff took patient's oxygen and I went to grab the closest physician. I asked Dr. for help and he went into the room and responded. I stepped out of the room. Staff stayed in with Dr. When patient's PCP Dr. came out of the room I informed her of what happened and that Dr. had went in to check on her. Patient came too shortly after Dr. arrived by the time he had left she was up alert and scared. Dr. briefly informed another Dr. of what happened and Dr. went in with the patient to follow up on the incident.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Swelling face, Urticaria
Clinical narrative: Urticaria, facial swelling
Age: 57.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Blood pressure increased, Lymphadenopathy, Musculoskeletal stiffness, Pain in extremity, Pyrexia
Clinical narrative: Fever of 100.4, achy right arn, swollen lymph nodes under right arm, elevated blood pressure 150/69, stiff neck. Patient felt better after Tylenol/advil. But glands were still a little swollen when she came in 7/14/2020
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: syncope after immunization, waited 30 minutes, syncope resolved.  Patient called 2 hours later to report that syncope had come back and patient was referred to urgent care.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Lethargy, Pyrexia, Vaccine positive rechallenge
Clinical narrative: I had redness and soreness at the injection site which redness spread to approx a 2-inch blob. In the next 24 hours I started to feel lethargic and ran a fever of 101 and laid in bed for a day.  This happened both times I had the shots. The redness and soreness went away in 3-4 days and the fever after 24 hours.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia
Clinical narrative: fatigue and muscle pain
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: fever and chill
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Hyperhidrosis, Myalgia
Clinical narrative: fever and chill
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Cellulitis, Dehydration, Gait inability, Peripheral swelling
Clinical narrative: Patients arm swelled up and she was unable to walk at store(too weak) per her family. They took her to the emergency room to be treated and they said she had cellulitis. They keep her for a couple of days in the hospital. The family stated they said she was dehydrated also. The patients family got her a prescription upon discharge for Keflex 500mg and 1 fluconazole tablet.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypotension, Pyrexia, Urticaria
Clinical narrative: Extreme low blood pressure  Hives Slight fever 99.8
Age: 0.25
Sex: F
Vaccine: PNC13
Symptoms: Crying, Irritability, Pyrexia
Clinical narrative: Baby had fever 101, excessive crying pulse Ox monitor showings 80-85% O2 Sat at the time Baby received within hours, but remained fussy.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Loss of consciousness
Clinical narrative: patient passed out at the front end of the store after receiving vaccine. Did get up and father was contacted (who is a nurse) and agreed she was fine. and she left with the mother
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Periorbital swelling, Rash, Urticaria
Clinical narrative: Patient received Menveo Vaccine at 11AM after receiving vaccine and waiting greater than 15 min office sudden outbreak of urticaria, periorbital swelling and erythema. Mother gave 50mg Benadryl AND RASH decreased. Advised to give 37.5mg Benadryl every 6 hrs for 48 hr. Call back with increased symptoms
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Asthenia, Crying, Dizziness, Incoherent, Limb discomfort
Clinical narrative: pt felt Light headed after vaccination + laid down x 10" then felt better. Dangled Legs For a few minutes then Left office. In car w/Mother started to "not feel well, felt numb" the had LOC x 3-4 minutes per Mom w/Rigidity, jerking at waste. After event pt. started to cry, stated she felt heavy and needed 2 people to assist her out of car into home. Pt continued to state her "body felt heavy + tingly + Remembered shaking." Mother Report ~ 4' after event patient was speaking as if "she were drunk (like after having her wisdom teeth pulled) legs were weak + she needed help with ambulating upstairs. Slept well overnight but did report initially feeling "weird" Upon waking but felt better later in The morning. Hx of anxiety and vasovagal w/Blood work + orthotactic changes subjectively w/ position changes.
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Malaise, Paraesthesia, Tremor
Clinical narrative: pt felt Light headed after vaccination + laid down x 10" then felt better. Dangled Legs For a few minutes then Left office. In car w/Mother started to "not feel well, felt numb" the had LOC x 3-4 minutes per Mom w/Rigidity, jerking at waste. After event pt. started to cry, stated she felt heavy and needed 2 people to assist her out of car into home. Pt continued to state her "body felt heavy + tingly + Remembered shaking." Mother Report ~ 4' after event patient was speaking as if "she were drunk (like after having her wisdom teeth pulled) legs were weak + she needed help with ambulating upstairs. Slept well overnight but did report initially feeling "weird" Upon waking but felt better later in The morning. Hx of anxiety and vasovagal w/Blood work + orthotactic changes subjectively w/ position changes.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination site pain
Clinical narrative: Pt contacted pharmacy stating his (L) cheek is sore. Started a few days after soreness on (L) arm subsided.
Age: 55.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Rash erythematous
Clinical narrative: Redness at injection Site w/swelling. Feverish. Small raised red bumps on upper back and torso. Steroid injection administered 7/13/2020 Kenalog & Decadron
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Blood lactic acid increased, Confusional state, Fall, Full blood count normal, Metabolic function test
Clinical narrative: fell off chair at home, hit head, vomiting, Confused when arrived at ER, DX. Seizure normal labs, CT, neg. tox. screen urine
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Seizure, Toxicologic test normal, Vomiting
Clinical narrative: fell off chair at home, hit head, vomiting, Confused when arrived at ER, DX. Seizure normal labs, CT, neg. tox. screen urine
Age: 62.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: FIVE HOURS AFTER RECEIVING VACCINE PT. REPORTED BY PHONE THAT ARM WAS RED, SWOLLEN AND PAINFUL
Age: 23.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Arthritis, Inflammation, Joint stiffness, Joint swelling
Clinical narrative: left knee was more swollen; right hand swollen; Left knee pain/ right elbow pain; aggreviating her immune response and worsening her rheumatoid arthritis/exacerbation of her arthritis symtoms; right hand, and left knee was more swollen and warm; This case was reported by a other health professional and described the occurrence of swelling of knees in a 23-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included DTP vaccine (received 7 DTP vaccines on unknown dates), DTap vaccine (received  DTap vaccines on unknown dates) and Tdap vaccine (received 1st dose in 2010). Concurrent medical conditions included rheumatoid arthritis. Concomitant products included adalimumab (Humira).   On 30th June 2020, the patient received the 2nd dose of Boostrix. On an unknown date, less than a day after receiving Boostrix, the patient experienced swelling of knees, hand swelling, knee pain, condition aggravated and feeling of warmth. On an unknown date, the outcome of the swelling of knees, hand swelling, knee pain, condition aggravated and feeling of warmth were unknown.   It was unknown if the reporter considered the swelling of knees, hand swelling, knee pain, condition aggravated and feeling of warmth to be related to Boostrix.  Additional details were reported as follows: The patient had a diagnosis of rheumatoid arthritis and was on Humira every 10 days. The patient did not know the name of the previous vaccines. The patient stated that she did not know the name of the 1st Tdap vaccine but the 2nd Tdap vaccine was Boostrix, which was 10 years after the 1st Tdap. The patient received the Boostrix vaccine in the left deltoid muscle.  The patient stated that the Boostrix aggravated her immune response and worsened her rheumatoid arthritis. She stated that within one day, after vaccination, she started to experience exacerbation of her arthritis symptoms in her left knee pain, right elbow pain, right hand, and left knee was more swollen and warm. This case is linked to case US2020118908, reported for same atient.
Age: 23.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Joint warmth
Clinical narrative: left knee was more swollen; right hand swollen; Left knee pain/ right elbow pain; aggreviating her immune response and worsening her rheumatoid arthritis/exacerbation of her arthritis symtoms; right hand, and left knee was more swollen and warm; This case was reported by a other health professional and described the occurrence of swelling of knees in a 23-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included DTP vaccine (received 7 DTP vaccines on unknown dates), DTap vaccine (received  DTap vaccines on unknown dates) and Tdap vaccine (received 1st dose in 2010). Concurrent medical conditions included rheumatoid arthritis. Concomitant products included adalimumab (Humira).   On 30th June 2020, the patient received the 2nd dose of Boostrix. On an unknown date, less than a day after receiving Boostrix, the patient experienced swelling of knees, hand swelling, knee pain, condition aggravated and feeling of warmth. On an unknown date, the outcome of the swelling of knees, hand swelling, knee pain, condition aggravated and feeling of warmth were unknown.   It was unknown if the reporter considered the swelling of knees, hand swelling, knee pain, condition aggravated and feeling of warmth to be related to Boostrix.  Additional details were reported as follows: The patient had a diagnosis of rheumatoid arthritis and was on Humira every 10 days. The patient did not know the name of the previous vaccines. The patient stated that she did not know the name of the 1st Tdap vaccine but the 2nd Tdap vaccine was Boostrix, which was 10 years after the 1st Tdap. The patient received the Boostrix vaccine in the left deltoid muscle.  The patient stated that the Boostrix aggravated her immune response and worsened her rheumatoid arthritis. She stated that within one day, after vaccination, she started to experience exacerbation of her arthritis symptoms in her left knee pain, right elbow pain, right hand, and left knee was more swollen and warm. This case is linked to case US2020118908, reported for same atient.