chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Eye swelling
Clinical narrative: Received vaccines on 10/09/2019, when awaking on 10/10/2019 her eyes were swollen shut, unable to open that day. Patient used ice to help control swelling. She started improving 10/14/2019 and today, 10/15/2019 is much better, able to see and only looks like she has bags under her eyes and still slightly swollen on upper eyelids.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Computerised tomogram normal, Diplopia, Eyelid ptosis, Headache, IIIrd nerve paralysis
Clinical narrative: HISTORY: (1) November 27, 2018 called the eye Dr. - Horrible Headaches - Left eye was drooping - (also called Retina Dr) (2) November 28th : Went for eye check up - Dr suggested testing -  prescribed: Valtrex, Neurontyn, + topical Durezol drops. (3) November 29th : Pain increased - double vision starting - eye drooping further - went to Emergency Room at Medical Center. They suggested CT scans and MRI. (CT scan had already been done the day before) came back normal. (4) December 3rd : office visit with Dr - he tentatively diagnosed 3rd cranial nerve palsy - (5) December 5th 2 MRI's were done, they came back normal - (no growths or tumors.) (6) December 7th office visit with Dr - his diagnosis was : Pupil Sparing non compression partial third nerve palsy. (A) Continue with Neurontin - ( times per day). (B) Put patch on the eye glasses to aid with double vision. (7) December 17th Dr suggested neuro ophthalmologist visit. (8) January 3rd office visit with Dr, neuro othamologist he agreed with Dr's diagnosis-+ suggested a timeline of 3-6 months for spontaneous recovery. (9) Condition lasted for 3 1/2 months til March 11, 2019-> eye not 100% yet. Doctors mentioned in the previous page time line are: (1) Eye doctor (office visits were on :) 11/28.2018 11/30/2018 12/03/2018 12/07/2018 12/17/2018 Jan 3, 2019
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Magnetic resonance imaging normal
Clinical narrative: HISTORY: (1) November 27, 2018 called the eye Dr. - Horrible Headaches - Left eye was drooping - (also called Retina Dr) (2) November 28th : Went for eye check up - Dr suggested testing -  prescribed: Valtrex, Neurontyn, + topical Durezol drops. (3) November 29th : Pain increased - double vision starting - eye drooping further - went to Emergency Room at Medical Center. They suggested CT scans and MRI. (CT scan had already been done the day before) came back normal. (4) December 3rd : office visit with Dr - he tentatively diagnosed 3rd cranial nerve palsy - (5) December 5th 2 MRI's were done, they came back normal - (no growths or tumors.) (6) December 7th office visit with Dr - his diagnosis was : Pupil Sparing non compression partial third nerve palsy. (A) Continue with Neurontin - ( times per day). (B) Put patch on the eye glasses to aid with double vision. (7) December 17th Dr suggested neuro ophthalmologist visit. (8) January 3rd office visit with Dr, neuro othamologist he agreed with Dr's diagnosis-+ suggested a timeline of 3-6 months for spontaneous recovery. (9) Condition lasted for 3 1/2 months til March 11, 2019-> eye not 100% yet. Doctors mentioned in the previous page time line are: (1) Eye doctor (office visits were on :) 11/28.2018 11/30/2018 12/03/2018 12/07/2018 12/17/2018 Jan 3, 2019
Age: 65.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Fatigue, Feeling abnormal, Feeling cold, Headache, Injection site erythema
Clinical narrative: Oct. 18 Fri evening pain in right arm at the site to rival a hornet sting. 5 days latter pain, redness, swelling where shot was given in right arm, foggy feeling fatigue, headache, chills, itchy at sight, arm still hurts 13 days latter.
Age: 65.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Oct. 18 Fri evening pain in right arm at the site to rival a hornet sting. 5 days latter pain, redness, swelling where shot was given in right arm, foggy feeling fatigue, headache, chills, itchy at sight, arm still hurts 13 days latter.
Sex: U
Vaccine: HEP, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored vaccine administered; No adverse effect; This spontaneous report was received from a medical assistant regarding unspecified patients of unknown demographics. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date (also reported as on multiple unspecified dates), the patients were vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (Strength, dose, frequency and anatomical location were not reported) intramuscularly of lot # R016791 with an expiry date of 16-APR-2020 for prophylaxis and hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (Strength, dose, frequency and anatomical location were not reported) intramuscularly of lot # R007212 with an expiry date of 04-NOV-2020 for prophylaxis (Product storage error). No adverse effects were reported. It was reported that the vaccine was exposed to a temperature of 1.4 Celsius (C) for a time frame of 10 minutes. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  Follow-up information was received from a office manager on 01-NOV-2019. A call was placed to the medical assistant, but the pharmacist was no longer worked in the office. The phone was then transferred to the office manager who stated that there was no new information concerning the report and additionally there were no patient identifiers.  This is a non-valid case due to lack of patient identifiers.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse efects reported; patient received dose of PNEUMOVAX 23 that was improperly stored; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history or concomitant medications was provided.  On 01-OCT-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S012246 and expiration date: 10-FEB-2020 (exact dose, frequency and route of administration were not reported) for prophylaxis. No adverse effects were reported.  The vaccine was stored in 68 Fahrenheit (F) for 8 hours. There was a previous temperature excursion in 57 F for 2 hours. The improper storage was recorded by Digital Data Logger.
Age: 7.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; one dose of improperly stored MMR II was inadvertently administered; This spontaneous report was received from a medical assistant referring to a 7 year-old patient of unknown gender. The patient's pertinent medical history, concurrent condition and drug reactions/allergies were not reported. Concomitant therapy included diluent. On 07-OCT-2019, the patient was inadvertently vaccinated with one dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (data logger) (lot # R028003 with expiry date of 01-OCT-2020) (strength, anatomical location and route were not reported) constituted with properly stored diluent for prophylaxis. No adverse effects were reported. It was reported that the vaccine was exposed to a temperature above 47 degree fahrenheit for a time frame of 10 hours. There was no previous temperature excursion reported. No product quality complaint (PQC) was associated with this report.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Severe fever; Body aches; Shivering; Pain in joints; This case was reported by a consumer and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose on an unknown date, refer case US2019AMR195115).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, general body pain, shivering and joint pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, general body pain, shivering and joint pain were unknown.   It was unknown if the reporter considered the fever, general body pain, shivering and joint pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's husband. The age at vaccination was not reported. The patient experienced severe fever, body aces, shivering and pain in joints.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Pain, Pyrexia
Clinical narrative: Severe fever; Body aches; Shivering; Pain in joints; This case was reported by a consumer and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fever, general body pain, shivering and joint pain. On an unknown date, the outcome of the fever, general body pain, shivering and joint pain were recovered/resolved.   It was unknown if the reporter considered the fever, general body pain, shivering and joint pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's husband. The age at vaccination was not reported. The patient experienced severe fever, body aches ,shivering ,pain in joints. For tolerance to next dose of Shingrix, refer case US2019AMR195110.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: fever; Chills; muscle acts; This case was reported by a consumer via call center representative and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th October 2019, the patient received Shingrix. In October 2019, less than a day after receiving Shingrix, the patient experienced chills and muscle pain. On an unknown date, the patient experienced fever. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the chills, muscle pain and fever were not recovered/not resolved.   It was unknown if the reporter considered the chills, muscle pain and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had the vaccine late afternoon and felt fine.  It was reported that 12 to 15 hours after receiving the vaccine the patient felt chilled with muscle aches and fever.  The patient didn't have any gastrointestinal symptoms. The patient asked how long will this last?
Age: 57.0
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus
Clinical narrative: arm is a little painful; itchy; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 57-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced pain in arm and itchy upper limbs. On an unknown date, the outcome of the pain in arm and itchy upper limbs were unknown.   It was unknown if the reporter considered the pain in arm and itchy upper limbs to be related to Shingrix.  Additional details were provided as follows: On Wednesday from the date of reporting, the patient received Shingrix. The patient felt ok but the arm was a little painful and itchy. The patient asked do it need to worry. The patient referred to his/her doctor for treatment of painful and itchy arm. The patient was satisfied with the information provided by the representative, and stated that usually, the patient did not have the reaction to vaccine however this was unusual.
Sex: M
Vaccine: RAB, RAB
Symptoms: Dizziness, Headache, Product administration error
Clinical narrative: wrong reconsttitution; Headache; Dizziness; This case was reported by a consumer via call center representative and described the occurrence of headache in a male patient who received Rabies NVS (RabAvert) for prophylaxis.    On an unknown date, the patient received RabAvert at an unknown dose. On an unknown date, unknown after receiving RabAvert, the patient experienced drug administration error. On an unknown date, the outcome of the drug administration error was unknown.  Additional details were received as follows: The age at vaccination was not reported. Caller states he the patient received pre exposure vaccine and had been reactivated or not effective because it was not given immediately after reconstitution. He states it was given about 10 minutes after reconstitution. This led to drug administration error. He was referred to his physician. HCP not asked.  AE report filed after call ended, as caller concerned about reactivation of vaccine.   Follow up information received from consumer on 25st October 2019 as follows: On 19th October 2019, the patient received the 1st dose of RabAvert (intramuscular) 1 ml with batch number ARBA171A, expiry date 31st July 2022 in right arm.  In October 2019, less than a week after receiving RabAvert, the patient experienced headache and dizziness.  In October 2019, the outcome of the headache and dizziness were resolved.  It was unknown if the reporter considered the headache and dizziness to be related to RabAvert.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Insomnia, Pyrexia
Clinical narrative: redness at injection site; fever; pain at the injection site; hard time sleeping; tired; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 3HT5J, expiry date 26th January 2022) for prophylaxis.   On 24th October 2019, the patient received Shingrix 1 ml. On 24th October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, difficulty sleeping and tiredness. On 25th October 2019, the patient experienced injection site erythema and fever. On an unknown date, the outcome of the injection site erythema, injection site pain, difficulty sleeping, tiredness and fever were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, difficulty sleeping, tiredness and fever to be related to Shingrix.  Additional details were provided as follows: The day before the reporting date, the patient received Shingrix. The patient felt painful at the injection site and also felt tired last night. The patient had time sleeping because it was painful at the injection site. On the reporting date, 1 day after receiving Shingrix, the patient saw that it was red at the injection site and she had fever about 100.3 degree F. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Burning sensation, Chills, Dizziness, Headache
Clinical narrative: itching; burning; shingles; stomach ache; shiver; headache; dizziness; muscle ache; Rash; Injection site pain; red; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax vaccine  with an associated reaction of herpes zoster (Shingles many years ago and had Zostavax vaccine many years back).   On 23rd October 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, less than a week after receiving Shingrix, the patient experienced injection site pain, rash and erythema. On 24th October 2019, the patient experienced shingles, stomach pain, shivers, headache, dizziness and muscle pain. On 25th October 2019, the patient experienced burning sensation. On an unknown date, the patient experienced pruritus. On an unknown date, the outcome of the shingles, injection site pain, stomach pain, shivers, headache, dizziness, muscle pain, rash, burning sensation, pruritus and erythema were unknown.   It was unknown if the reporter considered the shingles, injection site pain, stomach pain, shivers, headache, dizziness, muscle pain, rash, burning sensation, pruritus and erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in left arm and experience stomach ache, shiver, headache, dizziness, muscle ache. The injection site was painful with redness but she states about 2 inches below the injection site also it is slightly red with itching. She stated at the time of reporting she started to experience burning sensation from the left side of her back to the left breast, and stating she was feeling that she might be getting the shingles. No blisters observed at this time. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site pain, Injection site rash, Myalgia
Clinical narrative: itching; burning; shingles; stomach ache; shiver; headache; dizziness; muscle ache; Rash; Injection site pain; red; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax vaccine  with an associated reaction of herpes zoster (Shingles many years ago and had Zostavax vaccine many years back).   On 23rd October 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, less than a week after receiving Shingrix, the patient experienced injection site pain, rash and erythema. On 24th October 2019, the patient experienced shingles, stomach pain, shivers, headache, dizziness and muscle pain. On 25th October 2019, the patient experienced burning sensation. On an unknown date, the patient experienced pruritus. On an unknown date, the outcome of the shingles, injection site pain, stomach pain, shivers, headache, dizziness, muscle pain, rash, burning sensation, pruritus and erythema were unknown.   It was unknown if the reporter considered the shingles, injection site pain, stomach pain, shivers, headache, dizziness, muscle pain, rash, burning sensation, pruritus and erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in left arm and experience stomach ache, shiver, headache, dizziness, muscle ache. The injection site was painful with redness but she states about 2 inches below the injection site also it is slightly red with itching. She stated at the time of reporting she started to experience burning sensation from the left side of her back to the left breast, and stating she was feeling that she might be getting the shingles. No blisters observed at this time. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: itching; burning; shingles; stomach ache; shiver; headache; dizziness; muscle ache; Rash; Injection site pain; red; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax vaccine  with an associated reaction of herpes zoster (Shingles many years ago and had Zostavax vaccine many years back).   On 23rd October 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, less than a week after receiving Shingrix, the patient experienced injection site pain, rash and erythema. On 24th October 2019, the patient experienced shingles, stomach pain, shivers, headache, dizziness and muscle pain. On 25th October 2019, the patient experienced burning sensation. On an unknown date, the patient experienced pruritus. On an unknown date, the outcome of the shingles, injection site pain, stomach pain, shivers, headache, dizziness, muscle pain, rash, burning sensation, pruritus and erythema were unknown.   It was unknown if the reporter considered the shingles, injection site pain, stomach pain, shivers, headache, dizziness, muscle pain, rash, burning sensation, pruritus and erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in left arm and experience stomach ache, shiver, headache, dizziness, muscle ache. The injection site was painful with redness but she states about 2 inches below the injection site also it is slightly red with itching. She stated at the time of reporting she started to experience burning sensation from the left side of her back to the left breast, and stating she was feeling that she might be getting the shingles. No blisters observed at this time. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles outbreak; This case was reported by a physician via sales rep and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported that a female patient developed outbreak of shingles on the arm after first dose of Shingrix.   No further details were available. The reporter consented to follow up.
Sex: F
Vaccine: UNK
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Miscarriage; Vaccine exposure during pregnancy; This is a spontaneous case, initially received from other non-health professional via company [reference number: SEQ19-05598] on 25-Oct-2019, concerning an adult, pregnant female patient.   The patient's medical history and concomitant medications were not reported.   The patient's last menstrual period (LMP) date, estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were not reported. The patient's obstetrical history was not reported.   On an unknown date in 2009, the patient was administered unspecified flu vaccine [influenza vaccine; dose, route of administration, anatomical location, batch number and expiration date: not reported] (explicitly coded as 'Vaccine exposure during pregnancy') for an influenza prophylaxis.   On an unknown date in 2009, one week after vaccination, the patient experienced miscarriage.   The case was assessed as serious.  The reporter stated that she does not feel the vaccine was related to the miscarriage.  This case is linked to case 201905503 (same reporter and same patient).  Company Comment: The patient experienced abortion spontaneous one week after vaccination with the suspect product unspecified flu vaccine. Reportedly, vaccination occurred during pregnancy at unknown gestational age. Chronology is plausible. More information is needed regarding medical history, diagnostic findings and concomitant medications to exclude potential confounders. Considering all the above mentioned, causal role of the suspect product is assessed as related.; Reporter's Comments: The reporter stated that she does not feel the vaccine was related to the miscarriage.; Sender's Comments: The patient experienced abortion spontaneous one week after vaccination with the suspect product unspecified flu vaccine. Reportedly, vaccination occurred during pregnancy at unknown gestational age. Chronology is plausible. More information is needed regarding medical history, diagnostic findings and concomitant medications to exclude potential confounders. Considering all the above mentioned, causal role of the suspect product is assessed as related.
Age: 32.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Hyperhidrosis, Presyncope
Clinical narrative: Patient became light headed and diaphoretic, and vasovagal Vitalsigns monitored, given orange juice. Patient stable within 15-20 minutes
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site swelling, Pyrexia
Clinical narrative: PATIENT HAD FEVER AND CHILLS FOR 2 DAYS AFTER INJECTION. FEVER AND SWELLING IN LEFT ARM ABOVE ELBOW WHERE INJECTION SITE
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pruritus
Clinical narrative: Red itchy blisters appeared on arms, chest, and legs
Age: 1.42
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Localized redness and swelling to vaccine site
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Skin reaction, Skin warm
Clinical narrative: patient came in this morning (monday) with a red band across her lower bicep that is warm and swollen. started yesterday (day after shot). recommended tylenol and ice
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain, Pain in extremity, Sleep disorder
Clinical narrative: The pharmacist who was giving the shot insisted several times I had to pull my sleeve up higher because she had to give it ?very high? on my arm.  As she was injecting the vaccine it hurt very much, more than I have every experienced with a flu shot.  My arm continued to hurt after the initial pain of the injection subsided.  The band aid that she applied was at the very top of my arm, on my shoulder.  As the days went by my arm continued to hurt, and the pain seemed to increase.  It especially hurts to dress and undress, at night laying in any position, though I cannot lay on my left side as I used to.  It hurts less when I don?t use it much, such as doing desk work.   I intend to see my family practitioner and have an appointment with her.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Insomnia, Pain, Pain in extremity
Clinical narrative: Sharp pain when moving right arm, also difficulty sleeping on right side, applied ice to affected area.
Age: 39.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pain in extremity
Clinical narrative: large red area on arm   very painful
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Decreased appetite, Pyrexia
Clinical narrative: Fever of 103 F, anorexia for three days after vaccination.
Age: 26.0
Sex: U
Vaccine: UNK
Symptoms: Hypersensitivity
Clinical narrative: Allergies 1 year later
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Dizziness, Mobility decreased
Clinical narrative: Woke in early morning and so dizzy I couldn't get out of bed. Temperature of 101. Called family doctor who said to take aspirin and see if that helped. Temp did go down some. Took 3 days to get temp back to normal and no longer dizzy or light headed.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Patient first noticed redness and itching at injection site at 24hrs post-injection. States that over the following 24hrs, the erythema grew larger and itching persisted. Tender to touch; mild induration. Site approximately 6cm in diameter.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Erythema, Headache
Clinical narrative: Patient Complained of headaches starting day after, went away after 24 hours.  Complained of arm redness measuring 2 x 5 cm, went away three days later.  Also had persistent, non-productive cough that is still going on.  Has gotten better, taking Alka-Seltzer and cough drops.  No fever.
Age: 12.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Headache, Vision blurred
Clinical narrative: 6 days ago she came in for her Hep A and Flu shot. After that she had blurred vision and a headache.  L eye.  Went to dance right after that and at dance blurry vision then headache.  HA pushing, forehead, behind eyes. Lasted several hours.  Took ibuprofen and went to bed.  Still had HA in am.  Some days small HA, sometimes worse.  Ibuprofen prn since then.  (tylenol last night) Taking it 2-3 times a day since then.  Since then the blurred vision is gone but the headache has been there everyday since.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Rash
Clinical narrative: Patient came in the store complaining of a red arm and rash that seems to have gotten worse since she got the shot.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site warmth, Scar pain
Clinical narrative: Patient came in the store complaining of a red arm and rash that seems to have gotten worse since she got the shot.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Headache, Injection site pain, Pain
Clinical narrative: Headache came two days after injection and lasted for 18 hours; soreness at injection site came six hours after injection and is ongoing at time of this writing; low-grade fever and chills came on six hours after injection and lasted nine hours, then returned for two hours next day; loss of appetite day after the injection and lasted two days; overall body soreness came six hours after injection and lasted two days; sinus pressure came day after injection and lasted all day.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Paranasal sinus discomfort, Pyrexia
Clinical narrative: Headache came two days after injection and lasted for 18 hours; soreness at injection site came six hours after injection and is ongoing at time of this writing; low-grade fever and chills came on six hours after injection and lasted nine hours, then returned for two hours next day; loss of appetite day after the injection and lasted two days; overall body soreness came six hours after injection and lasted two days; sinus pressure came day after injection and lasted all day.
Age: 57.0
Sex: M
Vaccine: UNK
Symptoms: Headache, Hyperhidrosis, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Fever, sweats,soreness and redness at the injection site.  headache. Broke out in a full body sweat to where the sheets were soaked.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Loss of consciousness, Tremor
Clinical narrative: Patient passed out about a minute after vaccines. He shook some and then came to. Snack was given and monitored for 15 minutes.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Hypersomnia
Clinical narrative: Chills began about 9 hours after vaccine. No fever noted. Slept a long time. Very weak the next day. Recovered by Sunday Nov. 3rd, two days later.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: This vaccination was given at Pharmacy
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Syncope following vaccination. Patient discharged home with no LOC, visual changes, or nausea.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Patient observed a palm sized hive approximately 5 days following vaccination (10/31).  Hive grew to size of hand with fingers spread by 11/2.  Patient began taking Benadryl per urgent care visit ~ 11/2 and had just seen PCP today (11/4) and was prescribed a 12 days Prednisone course.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Decreased appetite, Fatigue, Malaise, Pyrexia
Clinical narrative: On 10/19/19, approximately 7 hours after receiving an annual flu shot, my son had a fever of 103.0. He was given 400mg of ibuprofen at 7pm. Two hours later his temperature was 103.8, at which time he took another 200mg of ibuprofen. He did not have an appetite and slept through the night. At 7am the next morning (10/20/19) his temperature was 102.4. He was exhausted and did not feel well all day. At 9pm his temperature was 100.8. He did not have any other symptoms prior to the fever or after. He missed school one day of school on 10/21/19, but returned the following day.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site infection, Injection site rash, Skin warm
Clinical narrative: patient called me and said her arm was red, warm, and she had a rash the size of a person's palm around the injection site. I instructed her to go to her dr because it sounded like the signs of an infection. she went to her dr & got a prescription for cephalexin
Age: 43.0
Sex: F
Vaccine: FLUR4, PPV, TDAP
Symptoms: Injection site pain, Injection site urticaria, Rash macular
Clinical narrative: Patient reported symptoms of pain in Right arm beginning 10/31/19 which is normal.  On 11/01/19 she reported hives, blotchy skin on Right bicep.  She self-treated with hydrocortisone.  She claimed it was painful, blotchy on right arm.  She searched symptoms.  Symptoms self-resolved 11/3/2019.
Age: 70.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Itchy bumpy red rash across chest and abdomen of patient. Treated with cortizone for about 1 week.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Unilateral Supraclavicular lymph node swelling, tenderness
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received an additional dose of Shingrix approximately 14 months after completion of the  2 dose series in 2018.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; a 25 year old patient was administered the 1st dose ofGARDASIL 9 on an unspecified date in l/2019 and is currently in the pharmacy to receive the 2nd dose ofGARDASIL 9 on 10/8/2019; This spontaneous report was received from a pharmacist and refers to a 25-year-old patient of an unknown gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On an unknown date in January 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) injection for prophylaxis (exact dose, route of administration, lot number and expiration date were not reported).  On 08-OCT-2019, 10 months after the first dose, the patient received second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection for prophylaxis, lot number: R001262, expiration date: 10-NOV-2020 (exact dose and route of administration was not provided). No adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patient received dose of PNEUMOVAX 23 that was improperly stored; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in 2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # S012246, expiry date 10-FEB-2021) (exact dose, frequency and route of administration were not reported) for prophylaxis.  On 30-SEP-2019, the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) experienced a storage error. The storage temperature was 68 Fahrenheit degrees during the time frame of 8 hours. Previous temperature excursion was 57 Fahrenheit degrees for 2 hours. A digital data logger was involved.  No adverse effects were reported. The outcome of the event was unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Cerebellar stroke
Clinical narrative: presented to his medical provider and was diagnosed with Cerebellar Stroke Despite receiving treatment; Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), (lot #, anatomical location, expiration date and route of administration were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  Shortly on an unspecified date, after receiving the zoster vaccine live (ZOSTAVAX), the pt suffered a stroke. The pt  presented to his medical provider and was diagnosed with Cerebellar Stroke Despite receiving treatment; It was reported that the pt continued to suffer the affects of his stroke. The reporter considered the cerebellar stroke to be related to Zoster Vaccine Live(ZOSTAVAX). Upon internal review, the cerebellar stroke was considered as a medically significant event.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; one patient was administered improperly stored PROQUAD; This spontaneous report was received from a administrator, concerning to a 1-year-old patient of an unknown gender. Information about the patient's concurrent conditions, pertinent medical history and previous drug reactions or allergies was not provided. The concomitant medications included sterile diluent.  On 14-OCT-2019, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) for prophylaxis (strength, formulation, dose number, route of administration and anatomical location of vaccination were not provided; lot number has been verified to be S003861; expiration date 08-AUG-2020) (product storage error). It was reconstituted with a properly stored sterile diluent.  It was reported that on a unknown date, the vaccine was exposed to a temperate excursion from 6 Fahrenheit degrees (F) to 14 F for 420 hours and from 15 F to 46 F, where the highest temperature was above 34 F, for 106 hours. The previous temperature excursion reported was from 6 F to 14 F for 200 hours and from 15 F to 46 F, where the highest temperature was above 34.268 F, for 18 hours. The call was placed because of a Digital Data logger report.  No adverse effects were reported.; Sender's Comments:  US-009507513-1908USA005541: US-009507513-1911USA000511: US-009507513-1911USA000728: US-009507513-1911USA000791: US-009507513-1911USA000804:
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Angioedema, Lip swelling, Swelling face
Clinical narrative: angioedema; swelling of lips and chin; Swelling of chin; This case was reported by a physician via call center representative and described the occurrence of angioedema in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 24th October 2019, 3 days after receiving Shingrix, the patient experienced angioedema (serious criteria GSK medically significant), lip swelling and facial swelling. On an unknown date, the outcome of the angioedema, lip swelling and facial swelling were unknown.   It was unknown if the reporter considered the angioedema, lip swelling and facial swelling to be related to Shingrix.  Additional details were provided as follows: The reporter who was a physician and reporting a case for himself. The patient received a dose of Shingrix on the left deltoid. The patient experienced swelling of lips, chin and angioedema. The reporter asked if there was data available regarding how long after the 2nd Shingrix shot did angioedema occur. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Breath sounds abnormal, Chills, Dysphonia, Ear discomfort, Fatigue
Clinical narrative: hurting in my arms back and shoulder, sore body; coldness, feeling cold; feels sweaty; voice is jittery; feel horrible; soughing; dark green mucus; feels fatigued; sick everyday ever since getting the vaccine; shivering; her ears and eyes are stopped up and full; Flu; temperature of 100.3 degree F; fever of 130 degrees F; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 68 years old female patient who experienced hurting in my arms back and shoulder, sore body (pain), coldness, feeling cold (feeling cold), feels sweaty (hyperhidrosis), voice is jittery (dysphonia), feel horrible (feeling abnormal), soughing (breath sounds abnormal), dark green mucus (sputum discoloured), feels fatigued (fatigue), sick everyday ever since getting the vaccine (malaise), shivering (chills), her ears and eyes are stopped up and full (unevaluable event), flu (influenza like illness), temperature of 100.3 degree f (body temperature increased) and fever of 130 degrees f (pyrexia), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past vaccination(s) included FLUZONE HD. The patient's past medical history, medical treatment(s) and family history were not provided.   On 18-Sep-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the left arm.  On an unknown date, the patient experienced a non-serious hurting in my arms back and shoulder, sore body (pain), coldness, feeling cold (feeling cold), feels sweaty (hyperhidrosis), voice is jittery (dysphonia), feel horrible (feeling abnormal), soughing (breath sounds abnormal), dark green mucus (sputum discoloured), feels fatigued (fatigue), sick everyday ever since getting the vaccine (malaise), shivering (chills), her ears and eyes are stopped up and full (unevaluable event), flu (influenza like illness), temperature of 100.3 degree f (body temperature increased) and fever of 130 degrees f (pyrexia) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was fever of 130 degrees f, temperature of 100.3 degree f, flu, her ears and eyes are stopped up and full, shivering, sick everyday ever since getting the vaccine, feels fatigued, dark green mucus, soughing, feel horrible, voice is jittery, feels sweaty, coldness, feeling cold and hurting in my arms back and shoulder, sore body.   It was not reported if the patient received a corrective treatment.  The patient outcome was not reported for the events.  Information on the batch number was requested.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Feeling cold, Hyperhidrosis, Influenza, Malaise
Clinical narrative: hurting in my arms back and shoulder, sore body; coldness, feeling cold; feels sweaty; voice is jittery; feel horrible; soughing; dark green mucus; feels fatigued; sick everyday ever since getting the vaccine; shivering; her ears and eyes are stopped up and full; Flu; temperature of 100.3 degree F; fever of 130 degrees F; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 68 years old female patient who experienced hurting in my arms back and shoulder, sore body (pain), coldness, feeling cold (feeling cold), feels sweaty (hyperhidrosis), voice is jittery (dysphonia), feel horrible (feeling abnormal), soughing (breath sounds abnormal), dark green mucus (sputum discoloured), feels fatigued (fatigue), sick everyday ever since getting the vaccine (malaise), shivering (chills), her ears and eyes are stopped up and full (unevaluable event), flu (influenza like illness), temperature of 100.3 degree f (body temperature increased) and fever of 130 degrees f (pyrexia), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past vaccination(s) included FLUZONE HD. The patient's past medical history, medical treatment(s) and family history were not provided.   On 18-Sep-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the left arm.  On an unknown date, the patient experienced a non-serious hurting in my arms back and shoulder, sore body (pain), coldness, feeling cold (feeling cold), feels sweaty (hyperhidrosis), voice is jittery (dysphonia), feel horrible (feeling abnormal), soughing (breath sounds abnormal), dark green mucus (sputum discoloured), feels fatigued (fatigue), sick everyday ever since getting the vaccine (malaise), shivering (chills), her ears and eyes are stopped up and full (unevaluable event), flu (influenza like illness), temperature of 100.3 degree f (body temperature increased) and fever of 130 degrees f (pyrexia) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was fever of 130 degrees f, temperature of 100.3 degree f, flu, her ears and eyes are stopped up and full, shivering, sick everyday ever since getting the vaccine, feels fatigued, dark green mucus, soughing, feel horrible, voice is jittery, feels sweaty, coldness, feeling cold and hurting in my arms back and shoulder, sore body.   It was not reported if the patient received a corrective treatment.  The patient outcome was not reported for the events.  Information on the batch number was requested.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular discomfort, Pain, Pyrexia, Sputum discoloured
Clinical narrative: hurting in my arms back and shoulder, sore body; coldness, feeling cold; feels sweaty; voice is jittery; feel horrible; soughing; dark green mucus; feels fatigued; sick everyday ever since getting the vaccine; shivering; her ears and eyes are stopped up and full; Flu; temperature of 100.3 degree F; fever of 130 degrees F; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 68 years old female patient who experienced hurting in my arms back and shoulder, sore body (pain), coldness, feeling cold (feeling cold), feels sweaty (hyperhidrosis), voice is jittery (dysphonia), feel horrible (feeling abnormal), soughing (breath sounds abnormal), dark green mucus (sputum discoloured), feels fatigued (fatigue), sick everyday ever since getting the vaccine (malaise), shivering (chills), her ears and eyes are stopped up and full (unevaluable event), flu (influenza like illness), temperature of 100.3 degree f (body temperature increased) and fever of 130 degrees f (pyrexia), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past vaccination(s) included FLUZONE HD. The patient's past medical history, medical treatment(s) and family history were not provided.   On 18-Sep-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the left arm.  On an unknown date, the patient experienced a non-serious hurting in my arms back and shoulder, sore body (pain), coldness, feeling cold (feeling cold), feels sweaty (hyperhidrosis), voice is jittery (dysphonia), feel horrible (feeling abnormal), soughing (breath sounds abnormal), dark green mucus (sputum discoloured), feels fatigued (fatigue), sick everyday ever since getting the vaccine (malaise), shivering (chills), her ears and eyes are stopped up and full (unevaluable event), flu (influenza like illness), temperature of 100.3 degree f (body temperature increased) and fever of 130 degrees f (pyrexia) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was fever of 130 degrees f, temperature of 100.3 degree f, flu, her ears and eyes are stopped up and full, shivering, sick everyday ever since getting the vaccine, feels fatigued, dark green mucus, soughing, feel horrible, voice is jittery, feels sweaty, coldness, feeling cold and hurting in my arms back and shoulder, sore body.   It was not reported if the patient received a corrective treatment.  The patient outcome was not reported for the events.  Information on the batch number was requested.