chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash pruritic, Scar, Tenderness
Clinical narrative: First Shingrix Vaccine was given on Oct. 9, 2019. The only side effect was the severe, severe pain on left arm going down to fingers. Very painful that couldn't even sleep at night & was suffering so much thru entire arm. Second shingrix Vaccine was given on 12/06/2019. This time I asked to inject on the other arm (Right arm.) Same thing; soon after the injection, the pain started. Severe pain on that side from shoulder to hand & fingers & unable to sleep and same as first one it lasted 2 days. On December 10, 2019 I experienced redness & itching on my both palms & forearms up to elbow. half of my both palms at the same time going up on inner side of the arm. My palms were itching so badly, redness, pain was hurting so much gradually. Half of my palms on each side became very Sensitive & painful. I couldn't touch the skin at all, couldn't hold any object & was unable to drive. The pain & rashes and the scaring look of rashes on both arms and both thighs made me go to Emergency Room at Hospital. Was there for hours & they told me it could have been the side effects of the vaccination. While waiting, they gave me the following shot & medications: dexamethasone (DECADRON) 4mg/mL injection 10mg Intramuscular); diphenhydAMIN (BENADRYL) capsule 25mg; famotidine (PEPCID) tablet 20mg. They also did lab test. Was told to use cream & Benedryl at home & prescribing methylPREDNISolone (MEDROL DOSEPAK) 4mg tablet for a week at home. The appearance of these spot on my thighs was so bad, to me looked close to a shingle. If the skin was reacting like that, how the internal organs were affected? For days, I was dealing with it & while the arms & thighs were getting better, my both shins started to show rashes & again spreading to my calf and were so itchy & painful.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: No adverse reaction, pt was found to be pregnant after injection given.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Cellulitis, Chills, Injection site erythema, Injection site swelling
Clinical narrative: 11/16/19 AM had warmth and slight swelling to injection site. Temp 99.6F c/o chills 11/17 increase in redness to 4'2 x 5" 11/18 injection site very warm left message for PCP 11/20 Appt to see PCP dx cellulitis Treated with antibiotic Keflex 11/21 decrease warmth 1/30/20 Update patient completely recovered and rec'd dose #2 without any complications.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: 11/16/19 AM had warmth and slight swelling to injection site. Temp 99.6F c/o chills 11/17 increase in redness to 4'2 x 5" 11/18 injection site very warm left message for PCP 11/20 Appt to see PCP dx cellulitis Treated with antibiotic Keflex 11/21 decrease warmth 1/30/20 Update patient completely recovered and rec'd dose #2 without any complications.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Dyspnoea, Peripheral swelling, Pruritus, Respiratory tract congestion
Clinical narrative: PER ER REPORT 1-25-2020 C/O RAISED AREAS OF SKIN & ITCHING ON THE BILATERAL UPPER EXTREMITIES X 2DAYS ALSO C/O DIZZINESS, CONGESTION & INTERMITTENT SOB X 2DAYS ZYRTEC 10 MG GIVEN
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient experienced no symptomps from previous administered doses; patient who was administrated the first two doses of GARDASIL 9 on unspecified dates over 1 year ago is being administered a third dose of GARDASIL 9 on 1/28/2020; This spontaneous report as received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's concurrent condition, medical history and concomitant medications was provided.  On an unspecified dates (reported as over 1 year ago), the patient was vaccinated with the first two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, frequency, route and site of administration, lot # and expiration date were not provided) for prophylaxis. On 28-JAN-2020, the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R021634, expiration date 08-MAY-2021, intramuscular (strength and site of administration were not provided) for prophylaxis. The patient experienced no symptoms from previous administered doses. The outcome was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Basedow's disease, Blindness, Diplopia, Discomfort
Clinical narrative: vision loss; Graves' disease; Graves' ophthalmopathy; double vision; tremors; fatigue; tachycardia; increased anxiety; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 24-MA-2016R, patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine at a pharmacy for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Within several weeks after receiving zoster vaccine live (ZOSTAVAX) vaccine, patient experienced severe and debilitating injuries, including, but not limited to, double vision, vision loss, tremors, fatigue, tachycardia, increased anxiety, Graves' disease and Graves' ophthalmopathy. All of these injuries were caused by zoster vaccine live (ZOSTAVAX) and resulted in extreme pain, discomfort and medical care and multiple procedures and surgeries. As a direct and proximate result of Company's defective zoster vaccine live (ZOSTAVAX) vaccine, patient suffered severe injuries and disfigurement not present prior to using Company's product, which were directly caused by the zoster vaccine live (ZOSTAVAX) vaccine. Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and disfiguring personal injuries. Further, as a tragic consequence of Company's wrongful conduct, patient suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, patient have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was unknown.  Upon internal review, the events of blindness, endocrine ophthalmopathy and basedow's disease were considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Endocrine ophthalmopathy, Fatigue, Pain, Surgery, Tachycardia
Clinical narrative: vision loss; Graves' disease; Graves' ophthalmopathy; double vision; tremors; fatigue; tachycardia; increased anxiety; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 24-MA-2016R, patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine at a pharmacy for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Within several weeks after receiving zoster vaccine live (ZOSTAVAX) vaccine, patient experienced severe and debilitating injuries, including, but not limited to, double vision, vision loss, tremors, fatigue, tachycardia, increased anxiety, Graves' disease and Graves' ophthalmopathy. All of these injuries were caused by zoster vaccine live (ZOSTAVAX) and resulted in extreme pain, discomfort and medical care and multiple procedures and surgeries. As a direct and proximate result of Company's defective zoster vaccine live (ZOSTAVAX) vaccine, patient suffered severe injuries and disfigurement not present prior to using Company's product, which were directly caused by the zoster vaccine live (ZOSTAVAX) vaccine. Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and disfiguring personal injuries. Further, as a tragic consequence of Company's wrongful conduct, patient suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, patient have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was unknown.  Upon internal review, the events of blindness, endocrine ophthalmopathy and basedow's disease were considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Therapeutic procedure, Tremor
Clinical narrative: vision loss; Graves' disease; Graves' ophthalmopathy; double vision; tremors; fatigue; tachycardia; increased anxiety; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 24-MA-2016R, patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine at a pharmacy for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Within several weeks after receiving zoster vaccine live (ZOSTAVAX) vaccine, patient experienced severe and debilitating injuries, including, but not limited to, double vision, vision loss, tremors, fatigue, tachycardia, increased anxiety, Graves' disease and Graves' ophthalmopathy. All of these injuries were caused by zoster vaccine live (ZOSTAVAX) and resulted in extreme pain, discomfort and medical care and multiple procedures and surgeries. As a direct and proximate result of Company's defective zoster vaccine live (ZOSTAVAX) vaccine, patient suffered severe injuries and disfigurement not present prior to using Company's product, which were directly caused by the zoster vaccine live (ZOSTAVAX) vaccine. Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and disfiguring personal injuries. Further, as a tragic consequence of Company's wrongful conduct, patient suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, patient have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was unknown.  Upon internal review, the events of blindness, endocrine ophthalmopathy and basedow's disease were considered to be medically significant.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenopia, Dysarthria, Dysphagia, Eyelid function disorder, Facial paralysis
Clinical narrative: slurred speech/dysarthria/Moderate dysarthria; Bilateral facial weakness/R facial weakness; dysphagia/difficulty swallowing; difficulty speaking/gargled speech; difficulty chewing; difficulty closing his eyes; eyes feel heavy; unable to raise eyebrows; numb lips; lower extremity weakness; facial neuritis; Bell's palsy/left sided facial droop/Facial droop; Guillain-Barre syndrome; This case was reported by a lawyer and described the occurrence of bell's palsy in a male patient who received Herpes zoster (Shingrix) for herpes zoster.   The initial information was received on 23 January 2020, via medical records(The case was medically confirmed). As per medical records, the patient had ingested Shingrix RZV 50MCG/0.5Ml (the new shingles vaccine 2 shots) for Zoster (shingles) on 22 March 2018. As per medical records, on 20 September 2019 the patient had acute onset left sided facial droop, lower extremity weakness and slurred speech. Bilateral linear enhancement of the facial nerves, probable facial neuritis, slight left facial droop on left side compared to right although the patient states that his entire face is weak and that is difficult for him to close his eyes and moderate dysarthria. As per progress note dated on 25 September 2019 the patient recommended to be addressed at the follow up visit for Bilateral facial weakness, dysarthria and dysphagia and the patient was diagnosis with Bell's palsy. The patient had bilateral linear enhancement at the fundus of the internal auditory canals bilaterally extending into the labyrinthine portions of the facial nerves bilaterally and geniculate ganglia on both sides. The evening prior to admission he noticed a Left facial droop, had difficulty speaking, chewing and swallowing. During his stay in the ER he developed R facial weakness and bilateral idiopathic Bell's palsy. He was still experiencing left sided facial droop with gargled speech. He has difficulty closing his eyes fully and complains that his eyes feel heavy when he tries to open them. Because of recent shingles vaccination 5 days ago, early Guillain-Barre syndrome would be on the differential. The patient was unable to raise eyebrows or smile, numb lips. The patient had difficulty with movement of lips, smiling, scrunching forehead, moving nose and raising eyebrows. The patient was unable to move facial muscles, unable to smile, puff cheeks, raise eyebrows could only move lower lip. The patient had difficulty talking with frozen face, tongue mid line, sensation was intact, left pupil greater than the right and moving all extremities equally. The patient had MRI on 29 September 2019 with impression Bilateral linear enhancement of the facial nerves. Probable facial neuritis.      Lab Comments: The patient had MRI on 29 September 2019 with impression Bilateral linear enhancement of the facial nerves. Probable facial neuritis.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial paresis, Hypoaesthesia oral, Magnetic resonance imaging abnormal, Mastication disorder, Muscular weakness
Clinical narrative: slurred speech/dysarthria/Moderate dysarthria; Bilateral facial weakness/R facial weakness; dysphagia/difficulty swallowing; difficulty speaking/gargled speech; difficulty chewing; difficulty closing his eyes; eyes feel heavy; unable to raise eyebrows; numb lips; lower extremity weakness; facial neuritis; Bell's palsy/left sided facial droop/Facial droop; Guillain-Barre syndrome; This case was reported by a lawyer and described the occurrence of bell's palsy in a male patient who received Herpes zoster (Shingrix) for herpes zoster.   The initial information was received on 23 January 2020, via medical records(The case was medically confirmed). As per medical records, the patient had ingested Shingrix RZV 50MCG/0.5Ml (the new shingles vaccine 2 shots) for Zoster (shingles) on 22 March 2018. As per medical records, on 20 September 2019 the patient had acute onset left sided facial droop, lower extremity weakness and slurred speech. Bilateral linear enhancement of the facial nerves, probable facial neuritis, slight left facial droop on left side compared to right although the patient states that his entire face is weak and that is difficult for him to close his eyes and moderate dysarthria. As per progress note dated on 25 September 2019 the patient recommended to be addressed at the follow up visit for Bilateral facial weakness, dysarthria and dysphagia and the patient was diagnosis with Bell's palsy. The patient had bilateral linear enhancement at the fundus of the internal auditory canals bilaterally extending into the labyrinthine portions of the facial nerves bilaterally and geniculate ganglia on both sides. The evening prior to admission he noticed a Left facial droop, had difficulty speaking, chewing and swallowing. During his stay in the ER he developed R facial weakness and bilateral idiopathic Bell's palsy. He was still experiencing left sided facial droop with gargled speech. He has difficulty closing his eyes fully and complains that his eyes feel heavy when he tries to open them. Because of recent shingles vaccination 5 days ago, early Guillain-Barre syndrome would be on the differential. The patient was unable to raise eyebrows or smile, numb lips. The patient had difficulty with movement of lips, smiling, scrunching forehead, moving nose and raising eyebrows. The patient was unable to move facial muscles, unable to smile, puff cheeks, raise eyebrows could only move lower lip. The patient had difficulty talking with frozen face, tongue mid line, sensation was intact, left pupil greater than the right and moving all extremities equally. The patient had MRI on 29 September 2019 with impression Bilateral linear enhancement of the facial nerves. Probable facial neuritis.      Lab Comments: The patient had MRI on 29 September 2019 with impression Bilateral linear enhancement of the facial nerves. Probable facial neuritis.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuritis, Speech disorder
Clinical narrative: slurred speech/dysarthria/Moderate dysarthria; Bilateral facial weakness/R facial weakness; dysphagia/difficulty swallowing; difficulty speaking/gargled speech; difficulty chewing; difficulty closing his eyes; eyes feel heavy; unable to raise eyebrows; numb lips; lower extremity weakness; facial neuritis; Bell's palsy/left sided facial droop/Facial droop; Guillain-Barre syndrome; This case was reported by a lawyer and described the occurrence of bell's palsy in a male patient who received Herpes zoster (Shingrix) for herpes zoster.   The initial information was received on 23 January 2020, via medical records(The case was medically confirmed). As per medical records, the patient had ingested Shingrix RZV 50MCG/0.5Ml (the new shingles vaccine 2 shots) for Zoster (shingles) on 22 March 2018. As per medical records, on 20 September 2019 the patient had acute onset left sided facial droop, lower extremity weakness and slurred speech. Bilateral linear enhancement of the facial nerves, probable facial neuritis, slight left facial droop on left side compared to right although the patient states that his entire face is weak and that is difficult for him to close his eyes and moderate dysarthria. As per progress note dated on 25 September 2019 the patient recommended to be addressed at the follow up visit for Bilateral facial weakness, dysarthria and dysphagia and the patient was diagnosis with Bell's palsy. The patient had bilateral linear enhancement at the fundus of the internal auditory canals bilaterally extending into the labyrinthine portions of the facial nerves bilaterally and geniculate ganglia on both sides. The evening prior to admission he noticed a Left facial droop, had difficulty speaking, chewing and swallowing. During his stay in the ER he developed R facial weakness and bilateral idiopathic Bell's palsy. He was still experiencing left sided facial droop with gargled speech. He has difficulty closing his eyes fully and complains that his eyes feel heavy when he tries to open them. Because of recent shingles vaccination 5 days ago, early Guillain-Barre syndrome would be on the differential. The patient was unable to raise eyebrows or smile, numb lips. The patient had difficulty with movement of lips, smiling, scrunching forehead, moving nose and raising eyebrows. The patient was unable to move facial muscles, unable to smile, puff cheeks, raise eyebrows could only move lower lip. The patient had difficulty talking with frozen face, tongue mid line, sensation was intact, left pupil greater than the right and moving all extremities equally. The patient had MRI on 29 September 2019 with impression Bilateral linear enhancement of the facial nerves. Probable facial neuritis.      Lab Comments: The patient had MRI on 29 September 2019 with impression Bilateral linear enhancement of the facial nerves. Probable facial neuritis.
Sex: F
Vaccine: PNC13
Symptoms: Limb discomfort
Clinical narrative: Felt like a band around her arm; This is a spontaneous report from a contactable consumer reporting for herself, based on the information received by Pfizer from Merck National Service Center (case # 01453840). A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient felt like a band around her arm on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Patient only received the DTap-IPV components of the Pentacel and need to re-vaccinated/ No AE; Initial and follow up information was received on 28-Jan-2020 and 29-Jan-2020 regarding an unsolicited valid non-serious case received from an other health professional (medical assistant).  This case involves (pediatric) child patient who was administered with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which was inappropriately reconstituted (Product preparation issue).  This case involves (pediatric) child patient who received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ226AA, Exp. Date 04-APR-2021) via unknown route in unknown administration site, on an unknown date that was reconstituted just with diluent and patient just received the DTap-IPV components (Product preparation issue).  Medical history, past medical treatment, vaccination and family history were not provided.  It was an actual medication error case due to inappropriate reconstitution technique.  It was unknown whether the patient had any adverse reactions.   Laboratory details were not 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 and Module VI of the 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: 5.0
Sex: F
Vaccine: DTAPIPVHIB, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received an extra Ipol the same day she received a Pentacel/no AE; Initial information received on 29-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 5 years old female patient who received vaccines a dose of IPV (VERO) [IPOL] even after receiving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] on same day.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  On 16-Dec-2019, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site. On 16-Dec-2019, the patient received a 0.5 ml single dose of suspect IPV (VERO) lot P1F491M via unknown route in the left deltoid.  It was of actual medication error due to extra dose administered.  It was reported that no adverse event was experienced by te patient.  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: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site urticaria, Respiratory distress, Urticaria, Vaccination site swelling
Clinical narrative: 1/27/20 am - large local swelling to vaccine site with hives. Hives spread to the rest of the body. 0 respiratory distress. Allergic urticaria. Zyrtec 5 mg bid Imp. by ENT - avoid T/Dap due to suspected allergic reaction
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Abnormal faeces, Arthralgia, Chills, Lip blister, Malaise
Clinical narrative: Approximately 30 minutes after receiving flu vaccine, chills, general malaise and joint pain, blister on lower lip, night seats, with intermittent chills, nausea, gelatinous stools.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Night sweats
Clinical narrative: Approximately 30 minutes after receiving flu vaccine, chills, general malaise and joint pain, blister on lower lip, night seats, with intermittent chills, nausea, gelatinous stools.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, C-reactive protein increased, Musculoskeletal stiffness, Neck pain, Pain
Clinical narrative: Patient developed neck pain with radiation into both arms and back two days after Shingrix administration. Pt went to ER on 1/29/2020 which resulted in benign work up. Prescribed meloxicam for neck pain. Patient came in to see Dr for follow up on 2/3/2020. Pt was still experiencing neck stiffness at office visit.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient developed neck pain with radiation into both arms and back two days after Shingrix administration. Pt went to ER on 1/29/2020 which resulted in benign work up. Prescribed meloxicam for neck pain. Patient came in to see Dr for follow up on 2/3/2020. Pt was still experiencing neck stiffness at office visit.
Age: 30.0
Sex: F
Vaccine: MMR, RAB, TYP, YF
Symptoms: Dizziness, Ear discomfort, Ear pain, Feeling abnormal, Feeling cold
Clinical narrative: Shots given Saturday afternoon. Had some arm pain throughout that day and Sunday. Monday she woke up and dropped her child off at daycare. On her way to work she felt "weird" and had to pull over into a lot, nauseated. No vomit. Called off work and drove home. Once home she vomited violently x1. Felt shaky, pale, cold and hot flashes, headaches, ear pain/pressure, dizzy/lightheaded, and achy from the chest up.  Went to urgent care at 0830 that morning. Given ibuprofen and medrol pak. Headaches relieved. Woke up in the middle of the night last night shaking uncontrollably with hot and cold flashes. No symptoms since.
Age: 30.0
Sex: F
Vaccine: MMR, RAB, TYP, YF
Symptoms: Headache, Hot flush, Impaired work ability, Influenza A virus test negative, Influenza B virus test
Clinical narrative: Shots given Saturday afternoon. Had some arm pain throughout that day and Sunday. Monday she woke up and dropped her child off at daycare. On her way to work she felt "weird" and had to pull over into a lot, nauseated. No vomit. Called off work and drove home. Once home she vomited violently x1. Felt shaky, pale, cold and hot flashes, headaches, ear pain/pressure, dizzy/lightheaded, and achy from the chest up.  Went to urgent care at 0830 that morning. Given ibuprofen and medrol pak. Headaches relieved. Woke up in the middle of the night last night shaking uncontrollably with hot and cold flashes. No symptoms since.
Age: 30.0
Sex: F
Vaccine: MMR, RAB, TYP, YF
Symptoms: Influenza virus test negative, Middle insomnia, Nausea, Pain, Pain in extremity
Clinical narrative: Shots given Saturday afternoon. Had some arm pain throughout that day and Sunday. Monday she woke up and dropped her child off at daycare. On her way to work she felt "weird" and had to pull over into a lot, nauseated. No vomit. Called off work and drove home. Once home she vomited violently x1. Felt shaky, pale, cold and hot flashes, headaches, ear pain/pressure, dizzy/lightheaded, and achy from the chest up.  Went to urgent care at 0830 that morning. Given ibuprofen and medrol pak. Headaches relieved. Woke up in the middle of the night last night shaking uncontrollably with hot and cold flashes. No symptoms since.
Age: 30.0
Sex: F
Vaccine: MMR, RAB, TYP, YF
Symptoms: Pallor, Tremor, Vomiting
Clinical narrative: Shots given Saturday afternoon. Had some arm pain throughout that day and Sunday. Monday she woke up and dropped her child off at daycare. On her way to work she felt "weird" and had to pull over into a lot, nauseated. No vomit. Called off work and drove home. Once home she vomited violently x1. Felt shaky, pale, cold and hot flashes, headaches, ear pain/pressure, dizzy/lightheaded, and achy from the chest up.  Went to urgent care at 0830 that morning. Given ibuprofen and medrol pak. Headaches relieved. Woke up in the middle of the night last night shaking uncontrollably with hot and cold flashes. No symptoms since.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Back pain, Headache, Neck pain, Pyrexia
Clinical narrative: Fever, back and neck pain, headache, low energy
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose decreased, Fall, Lip injury, Suture insertion
Clinical narrative: Patient states having a severe low blood sugar event during the evening after receiving Shingrix.  Shingrix given around 1:30pm, and event was overnight.  The event caused her to fall and cut her lip.  The lip cut required stiches.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Computerised tomogram, Seizure
Clinical narrative: My supervisor, BSN  received a call from client's family member at 10:52 AM on February 3, 2020, stating client had and episode of a  seizure.  BSN asked client's family member if she was having any difficulty with breathing.  Family member answered no, she is alert now.   BSN directed family member to take client to the ER STAT.  If needed  call 911.  Family member stated they were taking client to ER now. Family member stated that client was doing ok but was  worn out.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Head discomfort, Syncope
Clinical narrative: 12 hours after receiving the flu injection, I got up, had a very heavy feeling in my head and fainted twice.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Sleep disorder
Clinical narrative: Patient experienced pain and burning as the needle was removed from the left arm. The pain has persisted and remained the same since the day of the shot. She experiences pain when lifting arm above head and behind body. She states that sometimes the pain wakes her at night. Patient following up with primary care doctor.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling abnormal, Injection site pain, Injection site swelling, Loss of personal independence in daily activities
Clinical narrative: Hours after receiving the shot,  patient experienced dizziness, sluggishness, whole body aches, foggy thoughts, impaired functioning, and swollen and sore at injection site.  Symptoms continued and she felt very sick for 3 days. On the third day, she went to urgent care and was given Z-pack.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Pain, Sluggishness
Clinical narrative: Hours after receiving the shot,  patient experienced dizziness, sluggishness, whole body aches, foggy thoughts, impaired functioning, and swollen and sore at injection site.  Symptoms continued and she felt very sick for 3 days. On the third day, she went to urgent care and was given Z-pack.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Dysgeusia, Dyskinesia, Feeling hot, Flushing
Clinical narrative: Immediately after vaccination patient had soreness and stiffness at the site of injection.  Five hours later, patient described extreme headache, muscle soreness, and stiffness.  Patient stated that she felt hot but no fever suspected based on touch.  Also, no visible sweating, but some flushing in cheeks.  Majority of pain was bilateral at base of skull.    Patient's mother massaged the neck and base of the skull, some relief experienced.  At midnight, appx. 10 hours after vaccination Patient experienced a seizure that lasted 30-40 seconds in length with a thrashing of arms and legs and loss of consciousness.  Patient reported feeling faint and a metallic taste in her mouth just prior to the seizure.    Mother of patient monitored her all night, call and spoke with RN on Sunday, Feb 2.  Reported symptoms and scheduled a phone call appointment with Dr. for Tuesday (first available).  Spoke with Dr., patient's family concerned that there has been an adverse reaction with the vaccination and Citalopram.  Dr. took copious notes that will be kept in the patient file.  In addition, Dr. stated that she will follow-up with the clinical pharmacist and contact a Neurologist to inquire about any follow-up tests that may need to be completed.  Dr. will get back to the patient's mother via phone call.   Family is to watch for any other side effects and if any other seizure activity occurs, they were told to go to the nearest ER.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Immediate post-injection reaction, Injection site pain, Injection site reaction, Loss of consciousness
Clinical narrative: Immediately after vaccination patient had soreness and stiffness at the site of injection.  Five hours later, patient described extreme headache, muscle soreness, and stiffness.  Patient stated that she felt hot but no fever suspected based on touch.  Also, no visible sweating, but some flushing in cheeks.  Majority of pain was bilateral at base of skull.    Patient's mother massaged the neck and base of the skull, some relief experienced.  At midnight, appx. 10 hours after vaccination Patient experienced a seizure that lasted 30-40 seconds in length with a thrashing of arms and legs and loss of consciousness.  Patient reported feeling faint and a metallic taste in her mouth just prior to the seizure.    Mother of patient monitored her all night, call and spoke with RN on Sunday, Feb 2.  Reported symptoms and scheduled a phone call appointment with Dr. for Tuesday (first available).  Spoke with Dr., patient's family concerned that there has been an adverse reaction with the vaccination and Citalopram.  Dr. took copious notes that will be kept in the patient file.  In addition, Dr. stated that she will follow-up with the clinical pharmacist and contact a Neurologist to inquire about any follow-up tests that may need to be completed.  Dr. will get back to the patient's mother via phone call.   Family is to watch for any other side effects and if any other seizure activity occurs, they were told to go to the nearest ER.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Musculoskeletal stiffness, Myalgia, Seizure
Clinical narrative: Immediately after vaccination patient had soreness and stiffness at the site of injection.  Five hours later, patient described extreme headache, muscle soreness, and stiffness.  Patient stated that she felt hot but no fever suspected based on touch.  Also, no visible sweating, but some flushing in cheeks.  Majority of pain was bilateral at base of skull.    Patient's mother massaged the neck and base of the skull, some relief experienced.  At midnight, appx. 10 hours after vaccination Patient experienced a seizure that lasted 30-40 seconds in length with a thrashing of arms and legs and loss of consciousness.  Patient reported feeling faint and a metallic taste in her mouth just prior to the seizure.    Mother of patient monitored her all night, call and spoke with RN on Sunday, Feb 2.  Reported symptoms and scheduled a phone call appointment with Dr. for Tuesday (first available).  Spoke with Dr., patient's family concerned that there has been an adverse reaction with the vaccination and Citalopram.  Dr. took copious notes that will be kept in the patient file.  In addition, Dr. stated that she will follow-up with the clinical pharmacist and contact a Neurologist to inquire about any follow-up tests that may need to be completed.  Dr. will get back to the patient's mother via phone call.   Family is to watch for any other side effects and if any other seizure activity occurs, they were told to go to the nearest ER.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: patient developed moderately  enlarged, warm,  tender area to left deltoid.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site reaction, Rash, Rash erythematous
Clinical narrative: Patient presented to the pharmacy today, approximately 24 hours after receiving second dose of Shingrix with red rashes on both arms from about armpits to the palms of his hands and around the injection site.  I advised the patient to go to urgent care or primary doctor which he did.  Dr. (urgent care physician) said it was an allergic reaction to the Shingrix and prescribed the patient Prednisone 20mg tablets to take two tablets daily for five days.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Pyrexia
Clinical narrative: tiredness , stomach pain, shivering, fever  this lasted for about 35 hours.
Age: 23.0
Sex: M
Vaccine: JEV1, SMALL, SMALL
Symptoms: Chest pain, Pericarditis, Troponin increased
Clinical narrative: Patient developed chest pain, was hospitalized, and diagnosed with pericarditis
Age: 23.0
Sex: M
Vaccine: JEV1, SMALL, SMALL
Symptoms: Blood creatinine normal, Brain natriuretic peptide normal, C-reactive protein increased, Chest pain, Myocarditis
Clinical narrative: Patient developed chest pain, was hospitalized, and diagnosed with pericarditis
Age: 23.0
Sex: M
Vaccine: JEV1, SMALL, SMALL
Symptoms: Painful respiration, Red blood cell sedimentation rate increased, Troponin increased, Vaccination complication
Clinical narrative: Patient developed chest pain, was hospitalized, and diagnosed with pericarditis
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient was diagnosed with Shingles at office visit today 2/4/2020
Age: 17.0
Sex: M
Vaccine: HEP, HEPA, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Pallor
Clinical narrative: When leaving office, 15 minutes after vaccines were administered. pt felt slightly light headed. Had pt sit down and v/s were taken. VSS HR 74 BP 11/66 RR 18 Sat 100%. Appeared a bit pale but regained full color within seconds. Pt given breakfast bar and apple juice, did not eat all day. 30 minutes after consumption of snacks and being monitored pt states "I feel back to normal". VSS HR 75 BP 115/64 RR 18 Sat 100%. No c/o SOB or any other sign of allergic reaction or acute distress.  Educated mother on s/s to report to MD, verbalized understanding. Pt left clinic with mother ambulatory in stable condition.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: PATIENT CALLED TO SAY THAT THERE WAS SIGNIFICANT REDDISH CIRCLE APPROX THE SIZE OF HER PALM AT THE INJECTION SITE.  IT WAS ALSO WARM TO THE TOUCH.  SHE DID NOT TAKE ANYTHING TO TRY TO REMEDY THE SYMPTOMS AND SAID SHE WAS AWARE THAT SOME HYPERREACTION COULD OCCUR BUT THIS SEEMED 'SIGNIFICANT'.  I RECOMMENDED SHE SEE URGENT CARE TO RULE OUT CELLULITIS NEEDING ANTIBIOTICS.  I CALLED TO FOLLOW UP WITH HER THAT EVENING AND SHE STATED IT APPEARS TO BE RESOLVING A LITTLE BIT.  I RECOMMENDED SHE TAKE IBUPROFEN AND MAYBE BENADRYL IF SHE HAD SOME HANDY AND TO BE SEEN IF NOT RESOLVED OR GETS WORSE IN THE NEXT 24 HOURS.  SHE STATED SHE IS A NURSE AND MOSTLY JUST WANTED THE ADVERSE EVENT REPORTED.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site streaking, Injection site swelling
Clinical narrative: Patient experienced abnormal and excessive swelling of the left upper arm. Started at shoulder, stopped near elbow. This included red streaking. Patient states that she experienced this same reaction with her annual influenza vaccination but thought it was due to poor injection technique. This was discussed prior to administration of Shingrix and patient opted to continue with vaccinations. Notification of this reaction was provided 2/4/20. Presentation of symptoms occurred within 24 hours and lasted >48 hours. Patient never experienced anaphylactic symptoms. Symptoms are now clear.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion
Clinical narrative: PT DESCRIBES THE NEXT DAY A BRUISE AFTER RECEIVING THE SHINGRIX VACCINE
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site rash, Neuralgia, Rash
Clinical narrative: Hours after the Shingrix vaccine, the patient developed a rash around the injection site on left arm. The rash spread over the course of one week throughout arm and to chest and thoracic spine, only on  left side.  The rash was associated with neuropathic pain and the healthcare provider easily identified it as Shingles.  Treatment was initiated 7 days after onset when the patient sought out health care.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Malaise, Pain, Pyrexia
Clinical narrative: Malaise, achy, headache slight fever. 24 hours.
Age: 37.0
Sex: M
Vaccine: HEP, HEPA, TDAP, TYP
Symptoms: Dizziness, Fall, Hyperhidrosis, Hypotension, Unresponsive to stimuli
Clinical narrative: Patient came in to receive 4 travel vaccinations (hep b, Heb a, Dtap, Typhoid). Patient reported on informed content form fainting upon blood draws only. I discussed with patient about only receiving 2 vaccination that day and coming back for the remaining 2 shots. Patient refused suggestion because of time crunch with this trip. I discussed with patient all VIS information for all vaccinations and discussed the follow vaccinations for the hep a and hep b. After administering the hep a and hep b shots I checked with patient on how he was feeling, " he said he felt fine and was ready for the other 2 shots". I proceeded with the remaining  2 vaccinations. Patient felt fine after the 4 shots. I asked him to wait for 15 minutes, that is when he stated" that he felt dizzy and was seeing white" shortly after the patient slumped down into the chair and did not respond to my asking questions. I came back into the pharmacy and got the 2nd pharmacist and called 911. In the patient will call line one of the patients was a paramedic and came in to assist with the patient. Patient was diaphoretic and had low blood pressure but was responsive to the paramedic. The medix crew arrived and took the scene with patient care. Patient recovered without and injuries and refused to go with the medix crew to the hospital. After waiting another 20 minutes patient left the store and stated he was " feeling normal again".
Age: 37.0
Sex: M
Vaccine: HEP, HEPA, TDAP, TYP
Symptoms: Visual impairment
Clinical narrative: Patient came in to receive 4 travel vaccinations (hep b, Heb a, Dtap, Typhoid). Patient reported on informed content form fainting upon blood draws only. I discussed with patient about only receiving 2 vaccination that day and coming back for the remaining 2 shots. Patient refused suggestion because of time crunch with this trip. I discussed with patient all VIS information for all vaccinations and discussed the follow vaccinations for the hep a and hep b. After administering the hep a and hep b shots I checked with patient on how he was feeling, " he said he felt fine and was ready for the other 2 shots". I proceeded with the remaining  2 vaccinations. Patient felt fine after the 4 shots. I asked him to wait for 15 minutes, that is when he stated" that he felt dizzy and was seeing white" shortly after the patient slumped down into the chair and did not respond to my asking questions. I came back into the pharmacy and got the 2nd pharmacist and called 911. In the patient will call line one of the patients was a paramedic and came in to assist with the patient. Patient was diaphoretic and had low blood pressure but was responsive to the paramedic. The medix crew arrived and took the scene with patient care. Patient recovered without and injuries and refused to go with the medix crew to the hospital. After waiting another 20 minutes patient left the store and stated he was " feeling normal again".
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Pyrexia
Clinical narrative: Patient states he had a hard time walking and was starting to get a fever but this was kept down due to tylenol
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Fever and chills
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Haemorrhage, Head injury
Clinical narrative: When I woke up in the morning, I felt nauseous and suddenly I passed out, hitting my head and bleeding from my right eyebrow, I called the rescue, but they told me that I should go to an emergency because the wound required suturing.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Nausea
Clinical narrative: When I woke up in the morning, I felt nauseous and suddenly I passed out, hitting my head and bleeding from my right eyebrow, I called the rescue, but they told me that I should go to an emergency because the wound required suturing.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Pt developed rash on forehead
Age: 2.0
Sex: F
Vaccine: DTAP, FLU3, HEPA, HIBV, MMR, PNC13
Symptoms: Dysstasia, Pain in extremity, Pyrexia
Clinical narrative: Fever 103.5, unable to stand on legs due to pain
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Injection site erythema, Myalgia, Pyrexia
Clinical narrative: Fever, including aching muscles, skin sensitive to touch, lasted a full day. Red around injection site, noticed on day 2 (too concerned with fever on day 1 to notice if it was red then).
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Hyperhidrosis, Hypotonia, Loss of consciousness, Moaning, Muscle contractions involuntary
Clinical narrative: Vaccine administered at 5:38 pm without any prior issues, patient sitting in chair. After 1 minute she asks if she can sit for a while. I respond yes and ask if she is ok. She responds "yes, this happens sometimes, it didn't happen the last time though."  5:40 pm  I offered her water, handed it to her at which time she falls into a slump, becomes diaphoretic,  leans her head back against the wall, closes her eyes, water bottle falls and she clinches her fists and moans.  I support her head against my chest and inform her that she is ok. After 30 seconds she arouses at which time I call my assistant for help.  Apply cool compresses to her neck and head. BP is 100/48 and oxygen is 100%.  After an additional 1-2 minutes she asks if she can move to the exam table to lie down.  We allow her to stand, no symptoms, she takes a few step to the exam table and proceeds to sit of the exam table when she becomes limp and is placed back in the chair.  She becomes diaphoretic but remains alert. 5:55 pm  BP 102/62, oxygen 100%.  Patient provided water to drink.  After 1-2 minutes she transfers to the exam table without incident, legs elevated, drinks water with cool compresses.  Patient remains alert and she is monitored. 6:20 pm BP 123/70 oxygen 100%  patient is alert and oriented x 3 and stable, she is able to stand and walk around the room without incident.  Patient remains in the waiting area for an addition 15 minutes before being discharged