chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Disturbance in attention, Headache, Impaired work ability, Influenza like illness, Lethargy
Clinical narrative: Woke next morning with extreme lethargy, headache, flu like symptoms of extreme aches all over body. Had difficulty staying focused or awake. Called out of work.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Somnolence
Clinical narrative: Woke next morning with extreme lethargy, headache, flu like symptoms of extreme aches all over body. Had difficulty staying focused or awake. Called out of work.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: patient reported to pharmacy 2 days after receiving vaccine.  she had a quarter size red circle at the injection site.  she reported that the site was sore but not hot or infected and it was only sore at that spot.  she did not report any illness or fever or other side effects
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Acupuncture, Electrocardiogram, Electroencephalogram, Fatigue, Hair metal test abnormal
Clinical narrative: Day of shot on January 3, 2019 she left doctors and said she felt tired. Later she said she was very sleepy and didn't want to go to softball practice that day. She went to bed. Woke up around midnight throwing up. I thought she had the flu. Didn't go to school rest of week. and missed most days after. Woke up every more with head in the toilet being sick. Was very nausea and complained of feeling like she was run down. After a few weeks of this we started having test.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Hypersensitivity, Loss of personal independence in daily activities, Malaise, Milk allergy, Nausea
Clinical narrative: Day of shot on January 3, 2019 she left doctors and said she felt tired. Later she said she was very sleepy and didn't want to go to softball practice that day. She went to bed. Woke up around midnight throwing up. I thought she had the flu. Didn't go to school rest of week. and missed most days after. Woke up every more with head in the toilet being sick. Was very nausea and complained of feeling like she was run down. After a few weeks of this we started having test.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Somnolence, Vomiting
Clinical narrative: Day of shot on January 3, 2019 she left doctors and said she felt tired. Later she said she was very sleepy and didn't want to go to softball practice that day. She went to bed. Woke up around midnight throwing up. I thought she had the flu. Didn't go to school rest of week. and missed most days after. Woke up every more with head in the toilet being sick. Was very nausea and complained of feeling like she was run down. After a few weeks of this we started having test.
Age: 84.0
Sex: F
Vaccine: FLUA3
Symptoms: Asthenia, Dizziness, Feeling abnormal, Headache, Hypoaesthesia
Clinical narrative: +headache, numbness, shacks, weak, vomited,meakness, dizziness, felt very  weird all over all night,  weak for 2 days
Age: 84.0
Sex: F
Vaccine: FLUA3
Symptoms: Tremor, Vomiting
Clinical narrative: +headache, numbness, shacks, weak, vomited,meakness, dizziness, felt very  weird all over all night,  weak for 2 days
Age: 4.0
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Ear pain, Tinnitus
Clinical narrative: Patient developed ringing in the ears as well as pain in both ears that does not go away. The MMR vaccine information statement sheet reports that ringing in the ears could be a potential adverse reaction.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, X-ray limb normal
Clinical narrative: Pain in left and decreased ROM shoulder after vaccination
Age: 24.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Non adverse event occured
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Oropharyngeal pain
Clinical narrative: Patient woke up with 101 degree temp and sore throat on 11/06/2019.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Vaccine positive rechallenge
Clinical narrative: 4 inches of hot, red, swelling, upper (L) arm Same reaction in 2017 with flu vaccine
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Chills, Erythema, Headache, Injection site swelling
Clinical narrative: patient reported fever chills and headach for 3 days after vaccine given in arm. Reported local reaction starting day after the vaccine-described as warm reddened  ~ 50mm (size of an orange) swelling at site, warm to touch, 0 drainage, pain in upper extremity into arm pit.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Local reaction, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: patient reported fever chills and headach for 3 days after vaccine given in arm. Reported local reaction starting day after the vaccine-described as warm reddened  ~ 50mm (size of an orange) swelling at site, warm to touch, 0 drainage, pain in upper extremity into arm pit.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: patient presented to pharmacy a few weeks after getting vaccine at the pharmacy complaining of right arm pain. states it hurts/she is unable to raise her right arm. She has informed her doctor who thinks it may be a result of nerve damage related to the vaccine
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: patient report 'significant' GI illness including stomach cramping and diarrhea the evening after being vaccinated.
Age: 25.0
Sex: F
Vaccine: SMALL
Symptoms: Axillary pain, Blister, Diarrhoea, Erythema, Headache
Clinical narrative: Patient reports increasing erythema and tenderness with axillary lymphadenopathy starting on Friday (day 9).  Patient reports a 7-10 Burning pain in arm and a dull ache in armpit.  She is self treated with ibuprofen 800mgs 4x per day.  She describes normal progression from papule, to  vesicle, to pustule and no scab. She states mild drainage noted when changing dressing, serous in nature. She describes continued low grade HA not relieved by ibuprofen, but otherwise feels well. She did have 4 loose BMs yesterday but no n/v.  The patient likely presenting with a robust take.
Age: 25.0
Sex: F
Vaccine: SMALL
Symptoms: Lymphadenopathy, Pain, Pain in extremity, Papule, Pustule
Clinical narrative: Patient reports increasing erythema and tenderness with axillary lymphadenopathy starting on Friday (day 9).  Patient reports a 7-10 Burning pain in arm and a dull ache in armpit.  She is self treated with ibuprofen 800mgs 4x per day.  She describes normal progression from papule, to  vesicle, to pustule and no scab. She states mild drainage noted when changing dressing, serous in nature. She describes continued low grade HA not relieved by ibuprofen, but otherwise feels well. She did have 4 loose BMs yesterday but no n/v.  The patient likely presenting with a robust take.
Age: 25.0
Sex: F
Vaccine: SMALL
Symptoms: Robust take following exposure to vaccinia virus, Secretion discharge, Tenderness
Clinical narrative: Patient reports increasing erythema and tenderness with axillary lymphadenopathy starting on Friday (day 9).  Patient reports a 7-10 Burning pain in arm and a dull ache in armpit.  She is self treated with ibuprofen 800mgs 4x per day.  She describes normal progression from papule, to  vesicle, to pustule and no scab. She states mild drainage noted when changing dressing, serous in nature. She describes continued low grade HA not relieved by ibuprofen, but otherwise feels well. She did have 4 loose BMs yesterday but no n/v.  The patient likely presenting with a robust take.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Nausea, Vision blurred
Clinical narrative: Patient's wife states that approx. 2 hours after receiving the vaccine, he started having blurred vision in left eye and feeling dizzy and nauseated. States it has gotten progressively worse now having blurred vision in both eyes.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain
Clinical narrative: significant upper arm edema, more notable than small swelling at the site of injection... soreness reported in one particular spot about 4" away from injection site
Age: 0.08
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Child was given flu vaccine for 6months- to 35 months in error. There was no adverse reaction at this time
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: THE CLIENT DEVELOPED CELLULITIS AFTER RECEIVING A PREVNAR 13 VACCINATION THAT REQUIRED A VISIT TO THE ER AND MEDICAL TREATMENT
Age: 74.0
Sex: F
Vaccine: FLUA3
Symptoms: Laboratory test, Urticaria
Clinical narrative: Beginning approximately 8 hours after the injection was given, the patient complained of hives and welts covering her body from head to toe.  She immediately contacted her primary care provider, was referred to a dermatologist, an allergist and a hematologist. After some testing of the welts, results came back as a super-sensitive reaction to an unknown drug. Her provider suggested she report this Adverse Reaction to the Pharmacist/Pharmacy where the vaccine was given.  It is now 4 weeks later and she is still experiencing symptoms of this severe reaction.
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Flatulence, Haematochezia, Irritability, Nasal congestion, Nasopharyngitis
Clinical narrative: had two diapers with frank blood specks 4 days after rotavirus vaccine on teh 3rd of september.   mom states he was gassy, more fussy after the vaccines.  drinking well, no fever.  she had also started sweet potatoes and wondered if they were the cause.  stopped the sweet potato   no blood for a week, had a small speck of blood on the 14th in a stool  mom had corn the night before, he was again pretty gassy and passed a large stool and lots of "explosive gas"  small noticable speck of blood   mom eats yoghurt, not much milk  says patient has always been a little sensitive to spicey foods, things she eats.   otherwise acting well, normal.  little cold and stuffiness  eating well, happy,  no rash no fever  no change in spit ups   2-3 diapers with blood. initial two temporally related to rotavirus vaccine.  no significant blood or symptoms to suggest intussuception  doubt sweet potatoes as cause  continuing "speck" noted recently--still from the vaccine, ? from small fissure, ? maternal dietary source (most likely is generally dairy)  guaic today is NEGATIVE
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Occult blood negative
Clinical narrative: had two diapers with frank blood specks 4 days after rotavirus vaccine on teh 3rd of september.   mom states he was gassy, more fussy after the vaccines.  drinking well, no fever.  she had also started sweet potatoes and wondered if they were the cause.  stopped the sweet potato   no blood for a week, had a small speck of blood on the 14th in a stool  mom had corn the night before, he was again pretty gassy and passed a large stool and lots of "explosive gas"  small noticable speck of blood   mom eats yoghurt, not much milk  says patient has always been a little sensitive to spicey foods, things she eats.   otherwise acting well, normal.  little cold and stuffiness  eating well, happy,  no rash no fever  no change in spit ups   2-3 diapers with blood. initial two temporally related to rotavirus vaccine.  no significant blood or symptoms to suggest intussuception  doubt sweet potatoes as cause  continuing "speck" noted recently--still from the vaccine, ? from small fissure, ? maternal dietary source (most likely is generally dairy)  guaic today is NEGATIVE
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Facial pain, Lip swelling, Pain, Swelling face
Clinical narrative: I received the flu shot on OCT. 23, 2019, about 5pm. About 2 hours after receiving the shoT, I began experiencing a side effecT, which felt 1/2 like a tootheache, and 1/2 like an infection. There was swelling in my face and upper lip. When pressure was applied to my right upper lip, in the area immediately below my right Nostril opening, there was a lot of pain. The pain was throbbing. The pain got worse as time went on, even thought I was taking Advil. On Oct. 25, after continuous pain, I called my Doctors, FNP office, to report the side effecT. The pain was abouT an 8 on a scaled of 1 to 10. The person I spoke with at FNP clinic Advised me to go to an Urgent Care. I did so the same day, Oct. 25. I was evaluated, and prescribed Amox-clav 875 MG tablets for anti-biotic treatment, and Tramadol 50MG tablets for pain. My face was visibly swollen at that time, and especially in my upper right lip area. I Advised the health care person, FNP, that I had no dental problems. I also told him that this was a side effecT. I also reported the side effecT to the FDA.
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Dyskinesia, Gait disturbance, Headache, Paraesthesia
Clinical narrative: Bilateral arm jerking with tingling. C/O headache & was limping.
Age: 1.0
Sex: M
Vaccine: FLU4, MMR, PNC13, VARCEL
Symptoms: Decreased appetite, Fatigue, Hypersomnia, Pyrexia, Rash
Clinical narrative: Fever 102 next day, RED RASH NECK, TRUNK, FACE tired sleeping a lot decrease appetite
Age: 1.0
Sex: M
Vaccine: FLU4, MMR, PNC13, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Fever 102 next day, RED RASH NECK, TRUNK, FACE tired sleeping a lot decrease appetite
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects; first dose on 15-SEP2-016 (at age 12 years), and second dose on 24-JUL-2019; This spontaneous report as received from a medical assistant to an adolescent patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 15-SEP-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 1 dose, lot # L026602, expiration date 19-OCT-2017 (exact dose, site and route of administration were not provided). On 24-JUL-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 1 dose, lot # R025730, expiration date 18-JUN-2021 (exact dose, site and route of administration were not provided). No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy
Clinical narrative: Chronic inflammatory demyelinating polyneuropathy; Information was received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. No information was provided regarding the pt's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications.  On or about 09-JAN-2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported), as recommended for routine health maintenance and for its intended purpose: the prevention of shingles.   On an unspecified date (reported as "shortly after"), the pt was diagnosed with chronic inflammatory demyelinating polyneuropathy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the pt suffered serious, severe, progressive, permanent and incurable personal injuries that caused physical limitations (physical impairment) not presented prior vaccination; the pt also suffered significant conscious pain and mental anguish, loss of enjoyment of life and emotional distress due to his physical limitations and seriousness of his condition. As a further proximate result, the pt has suffered significant medical expenses, the loss of accumulations and other economic and non-economic damages.  The causality was reported as related and the event was considered to be disabling.   Upon internal review, the pt's chronic inflammatory demyelinating polyneuropathy was determined to be a medically significant event.  Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Vaccination failure
Clinical narrative: poor response to pneumococcal vaccine; This literature marketed report was received form the authors of published article, stated as below, and refers to 51-year-old male patient. The patient's concurrent conditions included thymoma, hypertension, gastro-esophageal reflux, hyperlipidemia, Barret's esophagus and hypogammoglobulinemia (low IgM, IgG subtype deficiency (low IgG1 and IgG3) and absence of circulating B cells, associated with thymoma. The patient had history of blepharitis, childhood otitis media and one cellulitis (requiring intravenous antibiotics thirty years prior). It was reported that recently, the patient underwent resection of a 10 cm thymoma.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose, frequency, route of administration and lot# with expiration date were not reported) for prophylaxis. The patient had poor response to the vaccine and on an unknown date, he was re-vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose, frequency, route of administration and lot# with expiration date were not reported) for prophylaxis. The patient was also vaccinated with recombinant zoster vaccine (strength, dose, frequency, route of administration and lot# with expiration date were not reported).  The outcome of vaccination failure was unknown as follow-up pneumococcal titers were still pending.  The reporter considered vaccination failure to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown).   A copy of the published article has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 75-year-old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2010, he was administered zoster vaccine live (ZOSTAVAX) by a pharmacist. On an unknown date, he was treated by physician for the following injuries resulting from patient's zoster vaccine live (ZOSTAVAX) use: shingles. The outcome of shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: her sister has had shingles even though her sister had the Zostavax vaccine; her sister got shingles twice and they were severe; her sister has had shingles even though her sister had the Zostavax vaccine; her sister got shingles twice and they were severe; This spontaneous report was received from an Advanced Practice Registered Nurse (APRN) and refers to a female patient of unknown age. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On an unknown date, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) for prophylaxis (dose, route, frequency, lot/batch # and expiration date were not reported).   It was reported that the patient had had shingles (herpes zoster) even though she had the zoster vaccine live (ZOSTAVAX) (vaccination failure); she got shingles twice (unknown dates) and they were severe.     The outcome of vaccination failure and herpes zoster was unknown.        The causality assessment between the events and zoster vaccine live (ZOSTAVAX) was not reported.   This one of two reports from the same reporter.; Sender's Comments:  US-9507513-1806USA003205:
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effect; the patient was administered a dose of Pneumovax 23 less than 8 weeks after administration of Prevnar 13; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information regarding the patient's concurrent condition, medical history, drug reactions/allergies and concomitant medications were not provided. On 04-NOV-2019, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) 1 dose (strength, dose #, route of administration were not reported) (lot # R034249 and expiry date reported as 07-AUG-20120) for prophylaxis. It was reported that, the patient was administered with the suspect therapy less than 8 weeks after administration of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) (inappropriate schedule of vaccine administered). No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; one dose of an improperly stored vaccine; This spontaneous report was received from an office manager refers to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant therapies and drug reactions/allergies were unknown. On 06-NOV-2019, the patient was vaccinated with one dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) (therapy type: digital data logger) at a dose 0.5 milliliter per one (route of administration and anatomical location unknown) (lot # S009943 and expiration date:26-JUL-2020) for prophylaxis (product storage error). No adverse effects reported for the patient. The administered dose of the vaccine experienced a temperature excursion of 58.5 degree Fahrenheit for 10 minutes, as recorded by a data logger. The vaccines had no previous temperature excursion. The reporter reported a possible malfunction of the data logger but does not know if the data logger malfunctioned or not.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; Improperly stored dose of varivax; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The medical assistant described on 05-NOV-2019, one improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (product storage error), lot # R030604 with expired date 23-OCT-2020, (strength, dose, route were not reported) for prophylaxis was administered to patient. No adverse effects and no product quality complaint reported.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: inappropriate vaccine schedule; pain/ tender and ached; swelling; redness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of nausea (sick after receiving flu shot, see case US2019AMR199278).   On 15th August 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 15th August 2018, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain, injection site swelling and injection site erythema. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site erythema were resolved with sequelae and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient after 1st dose had injection site painful red, swollen, tender and ached starting on the day of the injection and lasted 2 weeks or beyond. Till the time of reporting, the patient has not receive the 2nd dose which led to  incomplete course of vaccination. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Myalgia
Clinical narrative: Flu like symptoms; Splitting headache; Muscles aches; Chills; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 31st October 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms, headache, muscle pain and chills. On an unknown date, the outcome of the influenza-like symptoms, headache, muscle pain and chills were unknown.   It was unknown if the reporter considered the influenza-like symptoms, headache, muscle pain and chills to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself. The age at vaccination was not reported. At the day of reporting, the patient had flu like symptoms, splitting headache, muscle aches and chills. The patient was inquiring if he could take Advil or something better to treat the events. The patient did not want to share any information.
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Nausea, Vomiting
Clinical narrative: vomiting; nausea; sick; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a adult patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, less than a day after receiving Influenza vaccine, the patient experienced vomiting, nausea and sickness. On an unknown date, the outcome of the vomiting and nausea were recovered/resolved and the outcome of the sickness was unknown.   It was unknown if the reporter considered the vomiting, nausea and sickness to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported but it could be 60 years or 61 years. Ten years before the reporting date, the patient received Flu shot. The patient felt sick. The patient vomited the day she received it and felt slightly nauseous for a couple of days. The reporter did not consent to follow-up. For tolerance of Shingrix, refer case US2019198490.
Sex: F
Vaccine: VARZOS
Symptoms: Swollen tongue
Clinical narrative: tongue swelling; This case was reported by a consumer via call center representative and described the occurrence of swollen tongue in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th June 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced swollen tongue. On an unknown date, the outcome of the swollen tongue was recovered/resolved.   The reporter considered the swollen tongue to be possibly related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient experienced a possible adverse reaction to having the Shingrix vaccine. About 1 to 2 days after receiving the shot, the patient stated that she experienced tongue swelling for about an hour or so.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain in arm; This case was reported by a consumer and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced pain in arm. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that things were going well and patient had more pain. The reporter did not consent to follow up. This case linked with US2019AMR199221, reported for patient's wife.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Skin warm
Clinical narrative: Soreness and pain about 5 inches below the injection site of left arm/ dull pain; Arm feels hot; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th October 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, less than a day after receiving Shingrix, the patient experienced pain in arm and skin warm. On an unknown date, the outcome of the pain in arm and skin warm were unknown.   It was unknown if the reporter considered the pain in arm and skin warm to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. Within 2 to 3 hours after vaccination, the patient experienced soreness and pain about 5 inches below the injection site of left arm. The pain was more at night and arm felt hot. The whole arm felt like it was punched. The whole arm was sore and she felt the presence of soreness more when she massages the arm. There was also dull pain present on the arm when she slept on it. No further details were provided. The reporter did not consent to follow-up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Genital herpes
Clinical narrative: genital herpes vesicles; Not sexually active; This case was reported by a pharmacist via call center representative and described the occurrence of genital herpes in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number BY2Y4, expiry date 13th November 2021) for prophylaxis.   On 11th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than 3 weeks after receiving Shingrix, the patient experienced not sexually active. On 31st October 2019, the patient experienced genital herpes. On an unknown date, the outcome of the genital herpes and not sexually active were unknown.   It was unknown if the reporter considered the genital herpes and not sexually active to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the patient was diagnosed with genital herpes after vaccination. The patient was not sexually active. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of product administration, Peripheral swelling
Clinical narrative: Red arm; Swollen arm; Wrong Route of Administration; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 3RN95, expiry date unknown) for prophylaxis.   On 30th October 2019, the patient received the 2nd dose of Shingrix (subcutaneous). On 30th October 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced erythema of extremities and swelling arm. On an unknown date, the outcome of the erythema of extremities, swelling arm and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the erythema of extremities and swelling arm to be related to Shingrix.  Additional details were provided as follows: The patient presented to the pharmacy with a red, swollen arm. She had received the Shingrix at the pharmacy administered by a different pharmacist. The reporter stated that the reddened area was about 5.5cm away from the shoulder, and 6cm in diameter.  She states it appears the 2nd dose was given subcutaneously, which led to intramuscular formulation administered by other route. The patient reported to pharmacist she did not experience these symptoms after dose 1 of the series. The reporter consented to follow up. No further details were provided at the time of this call.
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: vaccine was given to patient but it had undergone a shipping temperature excursion, no AE; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 58 years old female patient who was vaccinated with a 0.5 mL dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (frequency once) lot UT6686KA via intramuscular route in the right deltoid on 22-Oct-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to incorrect product storage. It was reported that Fluzone Quadrivalent underwent shipping temperature excursion and vaccine was given to patient.  At the time of reporting, no adverse event was reported.  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: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: low fever, sore arm, shivers, aches, headache, tiredness  2 days
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: low fever, sore arm, shivers, aches, headache, tiredness  2 days
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: After 24-36 hours of feeling ill patient noticed a red patch at injection site 3 days later and spoke to dermatologist at scheduled dermotologic  appt and MD noticed redness, swollen and hot to touch. According to patient MD was panicking.  She mentioned it was a cellulitis from getting the shingrix vaccination and prescribed Minocycline. Patient was told to see primary care if redness went beyond a circle in ink.  It did and she saw primary care and MD suggested 24-48 hours decrease of redness. Which is did.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: After 24-36 hours of feeling ill patient noticed a red patch at injection site 3 days later and spoke to dermatologist at scheduled dermotologic  appt and MD noticed redness, swollen and hot to touch. According to patient MD was panicking.  She mentioned it was a cellulitis from getting the shingrix vaccination and prescribed Minocycline. Patient was told to see primary care if redness went beyond a circle in ink.  It did and she saw primary care and MD suggested 24-48 hours decrease of redness. Which is did.
Age: 0.83
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Rash
Clinical narrative: patient developed rash and red skin over whole body.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling abnormal, Headache, Nausea, Pyrexia
Clinical narrative: fever, chills, headache at the base of the skull, nausea and felt awful on 11/7/19
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dizziness, Influenza like illness, Pain
Clinical narrative: I began feeling achy and getting chills at  5:30PM, about two hours after shot was given.  Gradually I started shaking until  I was violently trembling and felt dizzy, which lasted for several hours, until 8:30 PM.  I slept on and off through the night.  When I woke up the next day, I felt very weak, like I had the flu., which lasted through the day and into the next day.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Sleep disorder, Tremor
Clinical narrative: I began feeling achy and getting chills at  5:30PM, about two hours after shot was given.  Gradually I started shaking until  I was violently trembling and felt dizzy, which lasted for several hours, until 8:30 PM.  I slept on and off through the night.  When I woke up the next day, I felt very weak, like I had the flu., which lasted through the day and into the next day.
Age: 1.58
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: The patient's mom called and stated that the child developed a rash on face, chest, back, legs, and private area.  Mom states that "he feels like he has a fever but we don't have a thermometer."  Mom states that Ibuprofen has been given for "fever."  Rash started on 11/7/19.  States that child is eating and drinking ok.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported more pain in right arm initially in right arm vs left arm.  By 11/07/19 there was swelling , redness and warmth moving about 4 inches from deltoid towards the elbow.  Swelling was reduced but patient saw PCP on 11/08/19 and was given the diagnosis of cellulitis and prescribed cephalexin.
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Got flu vaccine during a follow-up visit in the office. Was at appointment with dad. Mom called later in the evening and reported patient had gotten flu vaccine in October during a visit that she attended with him. October vaccine not documented so unsure of lot number.
Age: 0.42
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: SKIN RASHES, FEVER 2 DAYS AFTER RECEIVING PCV13 & Hib vaccine. Given Tylenol and Benadryl Liquid.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Limb discomfort
Clinical narrative: 22 days after receiving influenza vaccination patient complaining that left upper arm is still sore - especially at night if trying to sleep on left side - arm feels "heavy" in the morning. There is no swelling or redness seen. Client has not received any treatment for condition. Stated she has had flu shots in the past but the pain has never lasted this long. Pain is not getting worse but it is not getting better. Writer encouraged client to follow up with her medical provider if pain does not start to improve soon.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, MMR
Symptoms: Accidental exposure to product, Discomfort
Clinical narrative: Child was given MMR vaccine that was meant for brother.  No signs or symptoms at time of vaccination outside of discomfort.  Mother instructed to monitor child for fever.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Hypoaesthesia, Muscular weakness, Pain in extremity, Peripheral coldness
Clinical narrative: I received a flu shot on 10/10/19 at 09:00 in my left arm.  About a week later I started having symptoms with my right arm and hand.  Upon waking, my arm is numb and I couldn't make a fist with my right hand.  I couldn't (this still occurs) squeeze toothpaste onto my toothbrush with my right hand because my hand was weak and it caused a low level of pain.  I took ibuprofen off and on and this has helped with the discomfort. As the day went on I could close my hand into a fist, but I didn't have strength in my hand.  Every day I would check to see if I could close my right hand when I woke up. I thought my symptoms were going away, but on Sunday 11/3/19 in the evening my right hand was so cold and numb, I put a heating pad on my hand.  I noticed the end of my pinky finger was blue from the joint below my nail to the fingertip.  It appeared to be bruised from an injury and my finger was swollen, but I didn't remember injuring the finger.  Today (5 days later) the discoloration and swelling in my pinky is much improved (it is still cold to the touch). I have noticed numbness and tingling in my middle, ring and pinky fingers in the morning while putting on my makeup. I am concerned about the numbness, cold to the touch and tingling in my fingers/right hand.  A co-worker mentioned similar symptoms, so I wanted to document my symptoms.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Skin discolouration
Clinical narrative: I received a flu shot on 10/10/19 at 09:00 in my left arm.  About a week later I started having symptoms with my right arm and hand.  Upon waking, my arm is numb and I couldn't make a fist with my right hand.  I couldn't (this still occurs) squeeze toothpaste onto my toothbrush with my right hand because my hand was weak and it caused a low level of pain.  I took ibuprofen off and on and this has helped with the discomfort. As the day went on I could close my hand into a fist, but I didn't have strength in my hand.  Every day I would check to see if I could close my right hand when I woke up. I thought my symptoms were going away, but on Sunday 11/3/19 in the evening my right hand was so cold and numb, I put a heating pad on my hand.  I noticed the end of my pinky finger was blue from the joint below my nail to the fingertip.  It appeared to be bruised from an injury and my finger was swollen, but I didn't remember injuring the finger.  Today (5 days later) the discoloration and swelling in my pinky is much improved (it is still cold to the touch). I have noticed numbness and tingling in my middle, ring and pinky fingers in the morning while putting on my makeup. I am concerned about the numbness, cold to the touch and tingling in my fingers/right hand.  A co-worker mentioned similar symptoms, so I wanted to document my symptoms.
Age: 43.0
Sex: M
Vaccine: FLUR4
Symptoms: Autopsy, Death
Clinical narrative: Family reported death from unknown cause. Coroners report did not identify cause of death. Patient died driving on the way to work 8 hours after receiving vaccination.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Red, painful, hot to the touch, swollen
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Myalgia, Neuralgia, Skin discolouration
Clinical narrative: Given on 21st September 2019 at approximately 15:30. The arm with the flu shot is experiencing muscle and nerve pain radiating throughout the arm. It is difficult to lift the arm above my head and make a tight fist.   I have observed a darkish blue color on the upper side of hand.
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Vaccination site pain
Clinical narrative: soreness  at vaccination sight
Age: 30.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dizziness, Pruritus, Rash
Clinical narrative: Approximately 1 hour after receiving the FLU shot here, became light headed and dizzy. she was itching and had a rash on her chest. She was escorted to employee health by the Unit Director. from employee health escorted her to the ED for evaluation    While at ED she received 1L NS, solu-medrol 125 mg IV x 1, femotidine IV 20 mg x 1 , and benadryl 25 mg IV x 1
Age: 30.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dizziness, Hypoaesthesia oral, Paraesthesia oral, Pruritus, Rash
Clinical narrative: Approximately 1 hour after receiving the FLU shot here, became light headed and dizzy. she was itching and had a rash on her chest. She was escorted to employee health by the Unit Director. from employee health escorted her to the ED for evaluation    While at ED she received 1L NS, solu-medrol 125 mg IV x 1, femotidine IV 20 mg x 1 , and benadryl 25 mg IV x 1
Age: 32.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: pain, redness, swelling of 2 inch by 3 inch area around injection site of arm that received Boostrix + Menactra with warmth
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Malaise, Myalgia
Clinical narrative: 1- day of swelling at site, 2- second day swelling about 3 inches in diameter then a ring of erythema around the swelling.  general malaise and arthralgia and myalgia intense for one day. 3- third day malaise gone arthralgia and myalgia persisted. 4- the arthralgia and myalgia have persisted but decreased in intensity. 5 now most intermittent myalgia.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Musculoskeletal stiffness
Clinical narrative: Patient has extreme stiff neck/lymph node swelling. Lasted 8 days duration. Could barely turn head. States she has 4 other associates with same reaction.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Swollen tongue, Throat irritation
Clinical narrative: PATIENT EXPERIENCED ITCHY THROAT, AND FELT LIKE THE TONGUE WAS SWOLLEN AFTER 30 MINUTES GETTING THE SHOT PHARMCIST GAVE PATIENT 1 DOSE OF EPIPEN 0.3 MG AND PATIENT FELT BETTER, NO 911 CALL NEEDED
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Injection site pain, Injection site swelling, Insomnia, Mobility decreased
Clinical narrative: 5 hrs after receiving the flu shot in the right arm, pt developed pain and swelling in her right shoulder .  She had pain in shoulder and neck and back.  Hard to move, pt couldn't sleep.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain
Clinical narrative: 5 hrs after receiving the flu shot in the right arm, pt developed pain and swelling in her right shoulder .  She had pain in shoulder and neck and back.  Hard to move, pt couldn't sleep.
Age: 11.0
Sex: M
Vaccine: FLUX
Symptoms: Feeling abnormal, Head injury, Loss of consciousness, Syncope, Visual impairment
Clinical narrative: Fainted, passed out hit his head on the floor about 5 minutes after receiving the vaccine.  Started seeing spots and feeling funny afterwards he has never passed out before or had a reaction to any vaccines so didn't know he was about to pass out.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV5
Symptoms: Barium double contrast, Haematochezia, Intussusception, Irritability, Ultrasound scan
Clinical narrative: Patient became fussy on 10/26/19. In the AM of 10/27/19, she vomited, then had blood in stool. seen in our urgent care clinic. referred by ambulance to Hospital. Diagnosed with an intussusception . this was reduced. observed and discharged home.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Patient became fussy on 10/26/19. In the AM of 10/27/19, she vomited, then had blood in stool. seen in our urgent care clinic. referred by ambulance to Hospital. Diagnosed with an intussusception . this was reduced. observed and discharged home.
Age: 0.83
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site rash, Rash erythematous, Rash papular
Clinical narrative: Erythematous papular rash on posterior upper thighs near gluteal fold and above penis at pubic symphysis. Started 1-2 hours after vaccine. No pain or itching or discomfort. Was improving by the time he was seen again in office 7 days later.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Patient received improperly stored dose of vaccine; This spontaneous report was received from a registered practical nurse and refers to a 12 year old patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 23-SEP-2019, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1637641, expiration date 16-FEB-2022 (dose, frequency, vaccination site and route were not provided), for prophylaxis. No adverse effects reported.  Temperature LOWEST Temperature BELOW 36°F (29F) Time frame 3 days Previous temperature excursion? No