chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: HAD NOT SEPARATED THE VACCINE DOSE FROM MEALS BY MORE THAN AN HOUR; This spontaneous case report was received from a physician (PVX2019-436) on 15-Feb-2019. The report describes a 53-year-old adult female consumer who "had not separated the vaccine dose from meals by more than an hour". The consumer was receiving Vivotif for an unknown indication.   It was reported that the consumer took the first dose of Vivotif on 08-Feb-2019 and the last dose on 14-Feb-219. The physician stated that the consumer ate food within an hour of taking Vivotif.  The action taken with Vivotif with respect to the event "had not separated the vaccine dose from meals by more than an hour" was not applicable.  The clinical outcome of the event "had not separated the vaccine dose from meals by more than an hour" was unknown.  Company's Comment: The causality of the event "had not separated the vaccine dose from meals by more than an hour" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "had not separated the vaccine dose from meals by more than an hour" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK TWO UNREFRIGERATED DOSES; This spontaneous case report was received from a pharmacist (PVX2019-438) on 15-Feb-2019. The report describes a 48-year-old adult female consumer who "took two unrefrigerated doses". The consumer was receiving oral Vivotif (one capsule every other day) for typhoid prophylaxis.  It was reported that the consumer picked up Vivotif on 10-Feb-2019 and left it unrefrigerated. She then took two unrefrigerated dose on 12-Feb-2019 and 14-Feb-2019, respectively.  The action taken with Vivotif with respect to the event "took two unrefrigerated doses" was not applicable.  The clinical outcome of the event "took two unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: TOOK THE FIRST DOSE OF VIVOTIF IMMEDIATELY AFTER EATING; A spontaneous case report was received from a caregiver on 19-Feb-2019 for two consumers.  Based on the information obtained from the caregiver, two individual case safety reports PVX201902-000134 (PVX2019-457; husband) and PVX201902-000135 (PVX2019-458, daughter) were created and cross-linked in the database.  The report describes a 15-year-old female consumer who "took the first dose of Vivotif immediately after eating". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.   It was reported that the consumer took the first dose of Vivotif immediately after eating on 19-Feb-2019.  The action taken with Vivotif with respect to the event "took the first dose of Vivotif immediately after eating" was not applicable.  The clinical outcome of the event "took the first dose of Vivotif immediately after eating" was unknown.  Company's Comment: The causality of the event "took the first dose of Vivotif immediately after eating" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took the first dose of Vivotif immediately after eating" was considered as not applicable US-PaxVax Berna GmbH-PVX201902-000134:
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK TWO DOSES IN A ROW; This spontaneous case report was received from a nurse (PVX2019-465) on 20-Feb-2019. The report describes a 32-year-old adult female consumer who "took two doses in a row". The consumer was receiving Vivotif for an unknown indication.   It was reported that the consumer took two doses in a row. The doses were taken on Monday (18-Feb-2019) and Tuesday (19-Feb-2019).  The action taken with Vivotif with respect to the event "took two doses in a row" was not applicable.  The clinical outcome of the event "took two doses in a row" was unknown.  Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: TOOK THIRD DOSE OF VIVOTIF 3 DAYS LATER; This spontaneous case report was received from a pharmacist (PVX2019-470) on 20-Feb-2019. The report describes an adult male consumer who "took third dose of Vivotif 3 days later". The consumer was receiving oral Vivotif capsule (one dose every other day) (lot number: 3003239) for typhoid prophylaxis.   It was reported that the consumer took Vivotif doses incorrectly. The doses were taken on 12-Feb-2019, 14-Feb-2019, 18-Feb-2019, and 20-Feb-2019, respectively.  The action taken with Vivotif with respect to the event "took third dose of Vivotif 3 days later" was not applicable.  The clinical outcome of the event "took third dose of Vivotif 3 days later" was unknown.  Company's Comment: The causality of the event "took third dose of Vivotif 3 days later" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took third dose of Vivotif 3 days later" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK TWO UNREFRIGERATED DOSE; This spontaneous case report was received from a consumer (PVX2019-480) on 21-Feb-2019. The report describes a 21-year-old male consumer who "took two unrefrigerated dose". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer took two unrefrigerated doses of Vivotif.  The action taken with Vivotif with respect to the event "took two unrefrigerated dose" was not applicable.  The clinical outcome of the event took "took two unrefrigerated dose" was unknown.  Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK UNREFRIGERATED DOSES; This spontaneous case report was received from a physician (consumer's mother) (PVX2019-491) on 25-Feb-2019. The report described a male consumer who "took unrefrigerated doses". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer left Vivotif out of the refrigerator for at least 3 to 5 days and then he took three doses.  The action taken with Vivotif with respect to the event "took unrefrigerated doses" was not applicable.  The clinical outcome of the event "took unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: TOOK UNREFRIGERATED DOSES; This spontaneous case report was received from a pharmacist (PVX2019-504) on 25-Feb-2019. The report described a female consumer who "took unrefrigerated doses". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer left Vivotif out of the refrigerator for 8 days and then, she took all the doses.   The action taken with Vivotif with respect to the event "took unrefrigerated doses" was not applicable.  The clinical outcome of the event "took unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Rash
Clinical narrative: BUMPY RASH; This spontaneous case was received from a nurse on 16-May-2019. It describes a male consumer who had bumpy rash, after the administration of Vivotif for an unknown indication.  Case report: A consumer had bumpy rash, after the administration of the first and second dose of Vivotif. Later, the consumer took Benadryl (diphenhydramine) for treatment.  Action taken with Vivotif was unknown.  The consumer had recovered from the event.  Company's Comment: In this case, it was reported that the consumer had bumpy rash, after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, rash is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had bumpy rash, after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, rash is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.
Sex: U
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: Ive had canker sores all my life / I think you know about another thing it seems to work for! / It been 4 months now If this works for everybody you mightve come up something you accidentally didnt kn; This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic drug effect in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 4 months after receiving Shingrix, the patient experienced unexpected therapeutic drug effect. On an unknown date, the outcome of the unexpected therapeutic drug effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic drug effect to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had two shots to protect against shingles  The patient had canker sores all my life nothing seems to really work when was younger and went to for help when was in a service and then had gone to nothing worked since second shot of shingrix have not had one canker sore. The patient drink orange juice pop and take ibuprofen which it always make them worse and still have none The patient asked  If this works for everybody might have come up something accidentally did not know would work.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Magnetic resonance imaging, Pain in extremity, Periarthritis, Sleep disorder
Clinical narrative: Arm pain with movement beginning 2 days after administration, worsening with time. Significant decreased range of motion by late November/increased pain now constant. PCP prescribed physical therapy. went to 4 sessions, but too painful to continue. Saw Ortho PA in Jan/Feb & received steroid injection with no relief. By this time I was in severe pain, interfered with sleep and had little use of my arm. Ordered MRI-referred me an Orthopedist who diagnosed adhesive capsulitis. Recently had procedure :hydrodilation of capsule and manipulation and am now currently in physical therapy 3 times weekly.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray limb
Clinical narrative: Arm pain with movement beginning 2 days after administration, worsening with time. Significant decreased range of motion by late November/increased pain now constant. PCP prescribed physical therapy. went to 4 sessions, but too painful to continue. Saw Ortho PA in Jan/Feb & received steroid injection with no relief. By this time I was in severe pain, interfered with sleep and had little use of my arm. Ordered MRI-referred me an Orthopedist who diagnosed adhesive capsulitis. Recently had procedure :hydrodilation of capsule and manipulation and am now currently in physical therapy 3 times weekly.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Peripheral swelling, Skin warm
Clinical narrative: Pt visited the emergency room on 3/13/2020 with swollen, hot arm.  It was reported to me that the swelling was from shoulder to wrist.  Pt reports diagnosis of cellulitis.  Pt was treated outpatient.
Age: 15.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Arthralgia, Dyspnoea, Myalgia, Pain, Pyrexia
Clinical narrative: barely breathing; swelling; aches; every joint and muscle ached; every joint and muscle ached; fever; This spontaneous report was derived from an online article posted on social media platform received via vendor and refers to a 15-year-old female patient. The patient's concurrent conditions and concomitant therapies were not reported. Her medical history included flu vaccine (unspecified) to which she had no ill side effects.  On 25-AUG-2009, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (route of administration, formulation, anatomical location, lot# and expiry date were not reported) for prophylaxis and with influenza virus vaccine (unspecified) nasal spray (dose, lot# and expiry date were not reported) for prophylaxis.   On the same day, a few hours after receiving a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), she developed aches, fever and swelling. By midnight, the patient was barely breathing and every joint and muscle in her body ached. Her mother drove her to the hospital, where they were met by the patient's pediatrician. There was nothing that could have been done for her, other than to give pain medication (unspecified) and make her comfortable.  The outcome of the events was unknown.  The reporter did not provide causality assessment between the events and the suspect vaccines.  This is one of three reports from the same source.; Sender's Comments:  US-009507513-2004USA003737: US-009507513-2004USA006822:
Age: 15.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Swelling
Clinical narrative: barely breathing; swelling; aches; every joint and muscle ached; every joint and muscle ached; fever; This spontaneous report was derived from an online article posted on social media platform received via vendor and refers to a 15-year-old female patient. The patient's concurrent conditions and concomitant therapies were not reported. Her medical history included flu vaccine (unspecified) to which she had no ill side effects.  On 25-AUG-2009, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (route of administration, formulation, anatomical location, lot# and expiry date were not reported) for prophylaxis and with influenza virus vaccine (unspecified) nasal spray (dose, lot# and expiry date were not reported) for prophylaxis.   On the same day, a few hours after receiving a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), she developed aches, fever and swelling. By midnight, the patient was barely breathing and every joint and muscle in her body ached. Her mother drove her to the hospital, where they were met by the patient's pediatrician. There was nothing that could have been done for her, other than to give pain medication (unspecified) and make her comfortable.  The outcome of the events was unknown.  The reporter did not provide causality assessment between the events and the suspect vaccines.  This is one of three reports from the same source.; Sender's Comments:  US-009507513-2004USA003737: US-009507513-2004USA006822:
Age: 0.17
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: inappropriate age at vaccine administration; No adverse symptoms reported; This spontaneous report was received from a nurse concerning to a 2-month-old patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 10-APR-2020, the patient was accidentally vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dose and route of administration not reported; lot number  S022912 has been verified to be a valid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (therapy type rHA) (PROQUAD), expiration date not reported, but upon internal review established as 19-JAN-2021) due to human error for prophylaxis. No adverse symptoms were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Basal ganglia stroke, Confusional state, Hemiparesis, Ischaemic stroke
Clinical narrative: left basal ganglia ischemic cerebrovascular accident; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On or around 26-NOV-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), patient suffered left sided weakness and confusion. She was hospitalized and diagnosed with left basal ganglia ischemic cerebrovascular accident. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using the vaccine. Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of cerebral ischaemia was reported as not recovered/not resolved. The reporter considered cerebral ischaemia to be related to Zoster Vaccine Live (ZOSTAVAX).     Left basal ganglia ischemic cerebrovascular accident was considered to be disabling.  Upon internal review, left basal ganglia ischemic cerebrovascular accident was considered to be medically significant.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Haematoma, Injection site joint movement impairment, Injection site pain
Clinical narrative: The patient reported pain on 10/21 at the injection site. She was evaluated, diagnosed with a hematoma , given medication for pain. She then came back on 11/13/2019 stating  that she had not improved and had limited mobility in her R shoulder. She was referred to Physical Therapy.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure- admitted to hospital. Treated with antipyretics.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Intensive care
Clinical narrative: Patient went to the hospital to receive treatment. According to the mother she was admitted into the ICU
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Hyperaesthesia
Clinical narrative: Nerve sensitivity in 4" band around left side rib cage starting from beneath breast to 4 inches lower. 180 degree wrap around the torso. Feeling of spot bruising in this area every few inches. Skin sensitive to the touch of clothing.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Needle issue
Clinical narrative: patient received Pedvax Hib at age 2 mos and at age 4 mos. Pedvax Hib dose #3 is recommended to be administered over 12 mos of age.  Also pediarix was only partially administered. Needle came off of syringe during admin. Parent and staff agree that little to no vaccine actually was injected. Dose will be repeated ASAP.
Age: 2.0
Sex: M
Vaccine: DTAPIPV, HEPA, HIBV, MMRV
Symptoms: Wrong product administered
Clinical narrative: Patient is 2 years old. Should have gotten Dtap #4 however received Kinrix which contains dtap and ipv. No reaction.
Age: 28.0
Sex: F
Vaccine: HIBV
Symptoms: Asthenia, Injected limb mobility decreased, Injection site pain, Injection site swelling, Joint injection
Clinical narrative: Intense right shoulder pain starting 2 hours after vaccine with weakness, lose of movement.  Continued pain  and difficulty moving arm 10 days  after shot.  Improved pain with Tylenol #3, minimal swelling noted at shoulder joint., but with continued loss of motion.   Had joint injection from ortho to increase range of motion and decrease pain on 4/22/2020.  Continuing to monitor.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: left thigh and the redness is about 5 in X 4 in, hot to touch, swollen and painful.
Sex: F
Vaccine: HEP
Symptoms: Autism spectrum disorder, CDKL5 deficiency disorder, Constipation, Death, Electroencephalogram
Clinical narrative: Severe reflux and absence Seizures started between 2-4 weeks of age.  Sandifer Syndrome was ruled out, she was treated for reflux and eventually did a series of EEGs. Diagnosed with epilepsy and started on Kepra. She was vaccinated per the CDC guidelines despite having epilepsy and symptoms continued to worsen. She received further diagnoses of CDKL5, infantile Spasms, and a large number of severe autism spectrum symptoms.
Sex: F
Vaccine: HEP
Symptoms: Epilepsy, Gait inability, Gastrooesophageal reflux disease, Infantile spasms, Laboratory test
Clinical narrative: Severe reflux and absence Seizures started between 2-4 weeks of age.  Sandifer Syndrome was ruled out, she was treated for reflux and eventually did a series of EEGs. Diagnosed with epilepsy and started on Kepra. She was vaccinated per the CDC guidelines despite having epilepsy and symptoms continued to worsen. She received further diagnoses of CDKL5, infantile Spasms, and a large number of severe autism spectrum symptoms.
Sex: F
Vaccine: HEP
Symptoms: Petit mal epilepsy, Speech disorder developmental
Clinical narrative: Severe reflux and absence Seizures started between 2-4 weeks of age.  Sandifer Syndrome was ruled out, she was treated for reflux and eventually did a series of EEGs. Diagnosed with epilepsy and started on Kepra. She was vaccinated per the CDC guidelines despite having epilepsy and symptoms continued to worsen. She received further diagnoses of CDKL5, infantile Spasms, and a large number of severe autism spectrum symptoms.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Patient received Tdap vaccine 04/22/2020. Patient c/o pain at time of injection at injection site. Patient states after she got home 04/22/2020 around 11:30 it was hurting really bad, so she took some Tylenol. Patient texted this RN at 12:33PM 04/23/2020 stating that she took Tylenol around 0830 this morning due to pain in her right arm that radiates down to her right hand and up to her neck, shoulder and back. She took Motrin around 1030 as the pain continued. She messaged RN that is was still hurting at 12:33PM 04/23/2020.  She states she feels "a little sickish." She denies fevers. Patient states the injection site is swollen about the size of her palm.  Patient states her arm feels like it's on fire. FNp was notified about this event and recommended ice. RN notified patient to apply ice.
Age: 61.0
Sex: U
Vaccine: HEP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling in right upper arm to elbow crease. he also received Pneumoccocal vaccine at the same time.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: vaccine expiration date 4/02/2022 & Dilutant 4MT3A/Exp 5/20/2022. Next morning felt achy and tired.  By 3pm, had 102 fever, disseminated rash on forehead and down arms, discreet bumps on thorax, inner left thigh, dry cough and nausea.   Patient contacted pharmacist via phone and was encouraged to call doctor and was told that they were not sure whether could receive the 2nd shot.   Rash lasted through Sunday.  Fever would spike around 100-101 at 3pm every afternoon for 12 days.   Patient took Ibuprofen but only when pain was high--took only 1 time every 3rd day.  Even now patient gets temperature spikes on afternoon periodically. It is hay fever season so it could be related to that as well. Patient has not spoken to doctor
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: vaccine expiration date 4/02/2022 & Dilutant 4MT3A/Exp 5/20/2022. Next morning felt achy and tired.  By 3pm, had 102 fever, disseminated rash on forehead and down arms, discreet bumps on thorax, inner left thigh, dry cough and nausea.   Patient contacted pharmacist via phone and was encouraged to call doctor and was told that they were not sure whether could receive the 2nd shot.   Rash lasted through Sunday.  Fever would spike around 100-101 at 3pm every afternoon for 12 days.   Patient took Ibuprofen but only when pain was high--took only 1 time every 3rd day.  Even now patient gets temperature spikes on afternoon periodically. It is hay fever season so it could be related to that as well. Patient has not spoken to doctor
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Apnoea, Crying, Diarrhoea, Respiratory arrest, Resuscitation
Clinical narrative: That evening I found him unresponsive and not breathing in his crib. I gave resuscitation breaths to get him responsive. The following day he was irritable, cried constantly, vomited and had diarrhea. This continued for 2 months. From the night of his vaccinations, when I gave resuscitation breaths, he has had Apnea.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Screaming, Unresponsive to stimuli, Vomiting
Clinical narrative: That evening I found him unresponsive and not breathing in his crib. I gave resuscitation breaths to get him responsive. The following day he was irritable, cried constantly, vomited and had diarrhea. This continued for 2 months. From the night of his vaccinations, when I gave resuscitation breaths, he has had Apnea.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, warm skin @ injection site
Age: 55.0
Sex: U
Vaccine: FLUC4
Symptoms: Abdominal pain, Antimitochondrial antibody normal, Anxiety, Epstein-Barr virus test positive, Fatigue
Clinical narrative: Myalgias, fatigue started first. Endo thought might be Hashimoto's but test negative. AMA, RF neg. EBV positive. She developed anxiety (panic attacks). Any activity seems to make symptoms worse. Doesn't sleep well. Tried Cymbalta but didn't help. Tried amitriptyline. Saw neuro + rheumatology - no answers. ER for abd pain - no acute process (3/13/19). 3/19 - pt remembered she had flush of right before this started. Saw Endo in April, 2019 - no change. Not thyroid.
Age: 55.0
Sex: U
Vaccine: FLUC4
Symptoms: Myalgia, Panic attack, Poor quality sleep, Rheumatoid factor negative, Thyroid function test normal
Clinical narrative: Myalgias, fatigue started first. Endo thought might be Hashimoto's but test negative. AMA, RF neg. EBV positive. She developed anxiety (panic attacks). Any activity seems to make symptoms worse. Doesn't sleep well. Tried Cymbalta but didn't help. Tried amitriptyline. Saw neuro + rheumatology - no answers. ER for abd pain - no acute process (3/13/19). 3/19 - pt remembered she had flush of right before this started. Saw Endo in April, 2019 - no change. Not thyroid.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: The patient states he experienced hives from his shins down when he first received the vaccine. Now he is experiencing itching at night time only on his legs.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: I was given the shingrix shot to prevent any future risks of getting shingles.  Two months went by and after that my right lower extremity began to get a rash which became extremely painful. I didn't know what it could be so I contacted my doctor and they verified that it was shingles. I am suffering from pain ever since the shingles appeared. I try to keep thinking that the pain will go away but at this point hasn't and do not feel that it ever will.
Sex: F
Vaccine: TYP
Symptoms: Pruritus, Urticaria
Clinical narrative: ITCHING; FULL BODY HIVES; This spontaneous case report (818937-1) was extracted through VAERS database on 27-Sep-2019. The case was reported by a consumer via health authority. The report describes a 24-year-old female consumer who experienced full body hives (PT: Urticaria) and itching on legs and head (PT: Pruritus), after administration of oral Vivotif (lot number: 3003183) for an unknown indication.  Case report: The consumer took the first dose of Vivotif either on 09-Aug-2017 or 10-Aug-2017, after getting the yellow fever vaccine on an unknown date. On 15-Aug-2017, she took the fourth dose of Vivotif and experienced itching on her legs and head. She took Benadryl (diphenhydramine) for treatment which helped, but the hives just moved to a different location such as on stomach and legs. Thus, she took another dose of Benadryl in the next morning. She was prescribed steroids and allergy medication to control it. All the hives went away slowly after 1.5 weeks.  Concomitant medications included yellow fever vaccine (injection).  Action taken with Vivotif with respect to reported events was not applicable.  The consumer had recovered from the reported events.  Company's Comment: In this case, it was reported that the consumer experienced full body hives and itching on legs and head after intake of 4th dose Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible. Also, itching and hives are labelled as per CCDS.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer experienced full body hives and itching on legs and head after intake of 4th dose Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible. Also, itching and hives are labelled as per CCDS.
Age: 1.42
Sex: F
Vaccine: MMR, MMR, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects reported; one patient was administered a properly stored but expired dose of M-M-R II; This spontaneous report as received from a medical assistant refers to a 17-month-old female patient. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.     On 14-APR-2020, the patient was vaccinated with a properly stored but expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection (lot number: R010474, expiration date: 10-APR-2020; dose and route of administration were not provided) reconstituted with properly stored sterile diluent (lot number: S013898, expiration date: 05-MAR-2022). No additional adverse effects were reported.
Sex: M
Vaccine: HPV9
Symptoms: Pain in extremity
Clinical narrative: the patient's arm was sore for a little bit of time; the patient's arm was sore for a little bit of time; This spontaneous report was received from the patient's mother referring to an 11-year-old male patient. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. His concomitant medications included and unspecified influenza virus vaccine (unspecified)(reported as "QUAD RIV ALET PF"); an unspecified diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid; and meningococcal acyw conj vaccine (crm197)(MENVEO).      On 03-DEC-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), 1 shot in the arm, for prophylaxis (strength, route of administration, lot # and expiration date were not reported). On the same date, the patient's arm was sore for a little bit of time (skin lesion and pain in extremity). It was stated that the patient did not  receive any medical attention or received any treatment for the events. On the same date, the patient recovered from the events.  The causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site pain
Clinical narrative: shivering; flu like symptoms; soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingles vaccine) for an unknown indication.   On 15th April 2020, the patient received the 2nd dose of Shingles vaccine. In April 2020, less than a day after receiving Shingles vaccine, the patient experienced injection site pain. On 16th April 2020, the patient experienced shivering and influenza-like symptoms. On an unknown date, the outcome of the injection site pain, shivering and influenza-like symptoms were unknown.   It was unknown if the reporter considered the injection site pain, shivering and influenza-like symptoms to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not provided. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The patient received Shingrix vaccine in the evening and experienced pain at injection site. On the day of reporting at 11 am, the patient experienced shivering, the patient asked if was truly a side effect or perhaps the onset of flu-like symptom associated with Covid-19
Sex: F
Vaccine: JEV1
Symptoms: Urticaria
Clinical narrative: Hives - started on her lower legs; The following information was received from a nurse on 29 July 2019.  A female received her second dose of IXIARO (Japanese encephalitis vaccine, batch number not reported) on an unknown date.  After administration she experienced hives starting on her lower legs.  Outcome was not reported.; Sender's Comments: Causality assessed as possible related, given the kind of event and time to onset (after administration).
Age: 37.0
Sex: U
Vaccine: JEV1
Symptoms: Dizziness, Hypoaesthesia
Clinical narrative: Faint feeling; Numb sensation in arm; The following information was received from a nurse on 05 Aug 2019.  A vaccinee (no further identifiers provided) received first dose of IXIARO (Japanese encephalitis vaccine, batch number not reported) on an unknown date.  The vaccinee experienced numb sensation in arm and faint feeling which subsided in approximately five minutes.  ---  Follow up 1 received on 12 Aug 2019.  Relevant vaccinee information included initials and date of birth.   Batch number of IXIARO (JEV18G84E) was provided.; Sender's Comments: Though information is scant, causality is assessed as possibly related, given the nature of the events reported, known for IXIARO.
Sex: F
Vaccine: JEV1
Symptoms: Dyspnoea, Influenza like illness, Pyrexia
Clinical narrative: Flu like symptoms; Labored breathing; Fever; The following information was received from a pharmacist on 06 Aug 2019.  A female received her first dose of IXIARO (Japanese encephalitis vaccine, batch number not reported) on an unknown date.  She experienced some flu like symptoms, fever and labored breathing in the days following the initial dose. The outcome of all events was not reported.; Sender's Comments: Causality assessed as possible related given the kind of events.
Age: 15.0
Sex: F
Vaccine: JEV1
Symptoms: Headache, Rash
Clinical narrative: Rash on abdomen; Headache; The following information was received from an employee of doctor's office on 09 Aug 2019.  A 15 year old female received one dose of IXIARO (Japanese encephalitis vaccine, batch number not reported) on 23 July 2019.  She had a history of headaches.  After administration she experienced headache for three days. Approximately one week after administration she experienced rash on abdomen, which did not resolve by time of report.  ---  Follow up received from a consumer on 12 Aug 2019.  Vaccinee identifiers and date of birth were provided. The batch number (JEV18G84E) of IXIARO was also reported.; Sender's Comments: Causality assessed as possible given the kind of events, however the time to onset (one week) for rash is too long for an immediate allergic reaction and might be indicative for a delayed-type hypersensitivity.  ---  Causality assessment not changed, as no new information concerning the assessment was received.
Sex: M
Vaccine: JEV1
Symptoms: Rash
Clinical narrative: Small bumps on leg and side; The following information was received from a healthcare professional on 20 Aug 2019.  A male received one dose of a Japanese encephalitis vaccine (batch number not reported) on an unknown day.  On the next day he experienced small bumps on his leg and side. Outcome was not reported.  ---  Follow up information was received from a healthcare professional on 23 Aug 2019.  Vaccinee initials and date of birth as well as batch number JEV18G84E were provided [batch number confirmed IXIARO as suspect drug]; Sender's Comments: Causality assessed as possible given the kind of event, which is well known and time to onset (next day).  ---  Causality assessment not changed, as no new information concerning the assessment was provided.
Sex: F
Vaccine: JEV1
Symptoms: Pain
Clinical narrative: Vaccination hurts for days; The following information was received from a consumer via social media on 28 Nov 2019.  A female vaccinee received a dose of IXIARO (Japanese encephalitis vaccine, batch number not reported) on 28 Nov 2019.   It was described that it has hurt for days after vaccination.  No further information available; Sender's Comments: Causality assessed as possible related, given the kind of events. However, time to onset for an adequate assessment is missing.
Age: 69.0
Sex: F
Vaccine: JEV1
Symptoms: Blood glucose normal, Unevaluable event
Clinical narrative: Blood sugar increased from 70 to 99 after vaccination; The following information was received from a nurse on 12 Dec 2019.  A 69 year old female received one dose of IXIARO (Japanese encephalitis vaccine, batch number not reported) on 02 Dec 2019.  Co-suspect vaccine included one dose of Hepatitis B vaccine on 04 Dec 2019.   Before vaccination, her fasting blood sugar level was 70 and after receiving both vaccines, the blood sugar increased up to 99.   ---  Follow up information 1 received on 20 Dec 2019.  No reply received to follow up request, hence lost to follow up.; Sender's Comments: Causality assessed as not related, as there is no pathological mechanism known for an inactivated vaccine to cause elevated blood sugar levels. Additionally exact time to onset is missing as well as the description of blood measure method (e.g. fasting) after vaccination.  ---  Causality assessment not changed, as no new information was received.
Age: 69.0
Sex: M
Vaccine: JEV1, UNK
Symptoms: Blood glucose increased
Clinical narrative: Increased blood sugar level up to 141 after vaccination; The following information was received from a nurse on 12 Dec 2019.  A 69 year old male received one dose of IXIARO (Japanese encephalitis vaccine, batch number not reported) on 02 Dec 2019.  Co-suspect vaccine included one dose of Hepatitis B vaccine on 04 Dec 2019.   Before vaccination, his fasting blood sugar level was 91 to 96 and after receiving both vaccines the blood sugar increased up to 141.   ---  Follow up information 1 received on 20 Dec 2019.  No reply to follow up request received, hence lost to follow up.; Sender's Comments: Causality assessed as not related, as there is no pathological mechanism known for an inactivated vaccine to cause elevated blood sugar levels. Additionally, the exact time to onset is missing, as well as the description of blood measure method (e.g. fasting) after vaccination.  ---  Causality assessment not changed as no new information was received.
Age: 6.0
Sex: M
Vaccine: JEV1
Symptoms: Malaise, Pyrexia, Streptococcus test negative
Clinical narrative: Fever; Sick with Strep; The following information was received from a nurse on 26 Feb 2020.  A 6 year old male received one dose of IXIARO (Japanese encephalitis vaccine, batch number not reported) about one month ago [calculated as Jan 2020]. He has been sick with Strep since vaccination and recovered on an unknown date. At time of reporting, he experienced fever, but outcome was not reported.  No further information available.; Sender's Comments: Causality assessed as not related, as inactivated vaccines do not cause bacterial infections and the time to onset for the event fever is not plausible (one month after vaccination) and can be seen in the context of the streptococcal infection. Reporter most likely suspected IXIARO to cause only the fever as adverse event.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Sore arm, low grade fever, chills,  tired, achy muscles .
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Throat tightness
Clinical narrative: Patient was given injection and 10 min after started itching and throat closing. Patient received epi, Benadryl, nebulizers all within 30min was transported to ER due to not getting better.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Skin discolouration
Clinical narrative: PT HAS BLACK AND BLUE ARM AND SORE TO MOVE.  STARTED THE DAY OF THE SHOT. HAS APPLIED ICE
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Electroencephalogram normal, Laboratory test, Loss of consciousness, Pallor, Seizure
Clinical narrative: During vaccination of Men B patient collapse started seizing, regained consciousness briefly them starting having another seizure. O2 given as he started becoming pale. Sats >99, vs stable. Was transported to ER by ambulance. VSS 162/94 P 74 @ 1158, @ 1200 hrs VSS 121/78 P 63 sats 99% patient conscious alert and oriented to person and place. Patient sats remained > 99% on P/A @ 1204 EMS arrived transferred to stretcher and transported to hospital @1215 approx. has a hx of seizures was last seen by neurologist in 2015 was not put on any meds at that time as the EEG was normal.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Syncope
Clinical narrative: During vaccination of Men B patient collapse started seizing, regained consciousness briefly them starting having another seizure. O2 given as he started becoming pale. Sats >99, vs stable. Was transported to ER by ambulance. VSS 162/94 P 74 @ 1158, @ 1200 hrs VSS 121/78 P 63 sats 99% patient conscious alert and oriented to person and place. Patient sats remained > 99% on P/A @ 1204 EMS arrived transferred to stretcher and transported to hospital @1215 approx. has a hx of seizures was last seen by neurologist in 2015 was not put on any meds at that time as the EEG was normal.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: adverse event; Information has been received via pharmacy records, concerning a case in litigation and refers to currently 70-year-old male patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. On 24-JUL-2013, the patient was dispensed with zoster vaccine live (ZOSTAVAX) 19400 UN solution, at the pharmacy (date of administration, dose, route of administration, lot # and expiry date were not specified). On an unknown date, the patient experienced an unspecified adverse event in association with zoster vaccine live (ZOSTAVAX). The outcome of the event was unknown. The causality was related.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza
Clinical narrative: 2-3 weeks of flu symptoms that persisted much worse than ever before.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Electroencephalogram normal, Febrile convulsion, Generalised tonic-clonic seizure, Magnetic resonance imaging brain normal, Postictal state
Clinical narrative: Received vaccines 4/20/2020. Later that afternoon/evening, developed a generalized tonic clonic seizure. Lasted about 1 minute, post-ictal x 20-30 minutes after. Temperature taken at time of seizure and was 97.8. A few hours later was 100.2, never got higher. No other viral symptoms, no further temperature elevations. Fully back to baseline within a few hours. Has had 5 febrile seizures (each in setting of fever 101 or greater) in the past. Had normal brain MRI and EEG in 2/2020.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Pyrexia
Clinical narrative: Received vaccines 4/20/2020. Later that afternoon/evening, developed a generalized tonic clonic seizure. Lasted about 1 minute, post-ictal x 20-30 minutes after. Temperature taken at time of seizure and was 97.8. A few hours later was 100.2, never got higher. No other viral symptoms, no further temperature elevations. Fully back to baseline within a few hours. Has had 5 febrile seizures (each in setting of fever 101 or greater) in the past. Had normal brain MRI and EEG in 2/2020.
Sex: F
Vaccine: HPV4
Symptoms: Acquired epidermolysis bullosa, Food allergy
Clinical narrative: food allergies; auto immune disease (Epidermolysis Bullosa Acquista (EBA)); This spontaneous report was received from a consumer (patient's mother) via a company representative and refers to a female patient of unknown age. Her pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, lot number and expiration date were not reported). On an unknown date approximately in 2017 (reported as about 3 years ago), the patient developed a rare autoimmune disease called Epidermolysis Bullosa Acquista (EBA). On an unknown date, she also developed food allergies that she had never had before. The outcome of the events was not reported. The reporter considered EBA to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), as she believed that the trigger of the disease was from receiving the vaccine. The relatedness between the event of food allergies and the suspect therapy was not reported.  Upon internal review, the event of EBA was considered to be medically significant.