chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Urticaria
Clinical narrative: hives/broke out in hives; trouble breathing; This case was reported by a physician via sales rep and described the occurrence of hives in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included typhoid.   On 1st May 2019, the patient received the 2nd dose of Shingrix. In May 2019, less than a month after receiving Shingrix, the patient experienced hives and difficulty breathing. On an unknown date, the outcome of the hives and difficulty breathing were unknown.   It was unknown if the reporter considered the hives and difficulty breathing to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix on 1st May 2019 at pharmacy,  The patient experienced broke out in hives and had trouble breathing.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Dyskinesia, Hypotonia, Pallor, Syncope
Clinical narrative: Patient became pale limp and  fainted had jerking episode recovered in observation for 30 min post vaccines
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: The patient has not reported any side effects; After the vaccine was administered on 10May2019, the pharmacist realized the patient was administered vaccine that expired 19Apr2019; This spontaneous report was received from a pharmacist, referring to a 20 year old female patient. The patient's medical history, concurrent conditions, concomitant therapies and drug or allergy reactions were not provided.   On 09-APR-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) intramuscularly (strength, lot number and expiration date were not reported), for prophylaxis.  After the vaccination, the product was placed back in the refrigerator.   On 10-MAY-2019, the patient was administered the second dose (strength, administration route and lot number were not reported). However, the pharmacist did not confirm the product expiration date and, after the patient was vaccinated, realized that the vaccine expired on 19-APR-2019. The patient had not reported any side effects related to receiving the expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Laboratory data was unknown.   As of 12-MAY-2019, it was unknown if the patient would be re-vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
Sex: F
Vaccine: HPV9
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Product preparation issue, Wrong technique in product usage process
Clinical narrative: The Pharmacist reported she received two dose of GARDASIL 9 that were not shaken or agitated, prior to administration.; It was a pre filled syringe and it was flicked; Circumstance or information capable of leading to medication error; No adverse effects; This spontaneous report was received from a pharmacist regarding herself of an unknown age. The patient's concurrent conditions, drug allergies, medical history and concomitant medications were not reported. Pharmacist reported that she received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) approximately 2 months ago in mid march 2019 and received second dose on 19-MAY-2019(0.5 ml/doses, route via intramuscular for prophylaxis. On an unknown date, she reported that she received 2 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) that were not shaken or agitated prior to administration(wrong technique in product usage process).  Pharmacist reported, after receiving the second dose, she confronted the unspecified pharmacist, who administered the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the unspecified pharmacist informed her that it was a pre filled syringe and it was 't flicked(product preparation issue, and circumstance or information capable of leading to medication error).No adverse effects were reported(no adverse event). No further information was provided. No PQC found.
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: inadvertently received PROQUAD, instead of M-M-R II; inadvertently received PROQUAD, instead of M-M-R II; An adult inadvertently received PROQUAD, instead of M-M-R II; No adverse effects were reported; This spontaneous report was received from a nurse refers to an adult patient of an unknown age and gender. The patient's concurrent conditions, drug allergies, medical history and concomitant medications were not reported. On 20-MAY-2019, the patient was inadvertently received with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) )(0.5 milliliter, lot # R022564 and expiry date 04-FEB-2020) route via subcutaneous for prophylaxis instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R-II (interchange of vaccine products, wrong product administered and product administered to patient of inappropriate age). Other suspect therapies included sterile diluent(lot N035969 and expiry date 18-APR-2020). No adverse effects reported(No adverse event).
Sex: F
Vaccine: MMR
Symptoms: Injection site mass
Clinical narrative: developed a lump at the injection site; This spontaneous report was received from a pharmacist regarding herself of an unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. She reported that she was diagnosed with low titers of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) as part of a work physical. On an unknown date, 4 weeks ago(approximately in April 2019), she was given a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) with lot number R030812 and expiry date 24-OCT-2020(also reported as 24-OCT-2019) route via subcutaneous for immunization to correct the low titers and she had since developed a lump at the injection site(vaccination site mass). No treatment was given for the lump. The outcome of vaccination site mass was reported as not recovered. Causality assessment was not provided. No PQC found.
Sex: M
Vaccine: MMR, UNK
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: reported that he had a red bump on his right arm; the red bump was approximately 2" in diameter and is warm to the touch; This spontaneous report was received from a pharmacist refers to a 57 year old male patient. The patient's drug allergies were none. Patient's medical history and concurrent conditions were unknown.  Concomitant therapies included lamotrigine, pravastatin, lurasidone hydrochloride(LATUDA), albuterol sulfate(PROAIR HFA), metformin, zoster rge vaccine (mammalian)(SHINGRIX), montelukast sodium(SINGULAIR), gemfibrozil, latanoprost, tiotropium bromide(SPIRIVA), fluticasone furoate, vilanterol trifenatate(BREO ELLIPTA), prazosin and gabapentin. On 20-APR-2019, the patient was received 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # R028002 and expiry date 01-OCT-2020, route via subcutaneous in the right arm for prophylaxis.  Other suspect therapies included sterile diluent(1 dose, Lot number S003325 and expiry date 03-NOV-2019).  On 13-MAY-2019, after the therapy the patient reported that he had a red bump on his right arm which was also the same arm that he was administered the vaccine. The pharmacist noted that the red bump was approximately 2 in diameter and was warm to the touch(vaccination site erythema and vaccination site warmth). The pharmacist reported that the patient would be going to his physician today to seek medical treatment for the red bump. The outcome of vaccination site erythema and vaccination site warmth was reported as not recovered. Causality assessment was not provided. No additional information was provided.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis contact, Herpes zoster, Mass, Pain, Rash pruritic
Clinical narrative: Shingles; Poison ivy; wrists (palm side up) broke out/ Rash/ Itchy rash; Hurts; Single lumps on my arms and near my nose and upper lip; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th April 2019, the patient received the 1st dose of Shingrix. On 14th April 2019, 3 days after receiving Shingrix, the patient experienced shingles, poison ivy rash, itchy rash and pain. In April 2019, the patient experienced mass. On an unknown date, the outcome of the shingles, poison ivy rash, itchy rash, pain and mass were not reported.   It was unknown if the reporter considered the shingles, poison ivy rash, itchy rash, pain and mass to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient. The reporter stated that she had a rash and did not know if it was shingles or poison ivy. The patient was out in some brush on Wednesday. The patient received the first Shingrix shot on Thursday. The patient's wrists (palm side up) broke out on Sunday, right wrist was worse than left. The rash was not really itchy as much as it was hurting. The patient was periodically noticing single lumps on arms and near nose and upper lip in less than a week after receiving vaccine. If needed, the permission to contact the patient's physician was granted.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: injection site pain; sore arm; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were unknown.   It was unknown if the reporter considered the injection site pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported that he has experienced pain at the injection site and sore arm with Bexsero.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Decreased appetite, Dizziness, Influenza like illness
Clinical narrative: Body Rash Itchiness; red rash; Flu-like Symptoms; Runny Nose; Dizziness; Lack of Appetite; Upset Stomach; Weakness; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th April 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced itchy rash, red rash, influenza-like symptoms, runny nose, dizziness, appetite absent, upset stomach and weakness. On an unknown date, the outcome of the itchy rash, red rash, influenza-like symptoms, runny nose, dizziness, appetite absent, upset stomach and weakness were not recovered/not resolved.   It was unknown if the reporter considered the itchy rash, red rash, influenza-like symptoms, runny nose, dizziness, appetite absent, upset stomach and weakness to be related to Shingrix.  Additional details were provided as follows: The patient reported a rash at the injection site that started with three small red bumps, as well as a red streak near the injection site. The patient also reported that 8 hours after the injection the rash, like small red bumps, spread from her bottom, to her back, up to her hairline. The rash at the injection site and on her body, was itchy. None of the patient's symptoms have resolved. The reporter gave consent to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site streaking, Rash erythematous, Rash pruritic, Rhinorrhoea
Clinical narrative: Body Rash Itchiness; red rash; Flu-like Symptoms; Runny Nose; Dizziness; Lack of Appetite; Upset Stomach; Weakness; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th April 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced itchy rash, red rash, influenza-like symptoms, runny nose, dizziness, appetite absent, upset stomach and weakness. On an unknown date, the outcome of the itchy rash, red rash, influenza-like symptoms, runny nose, dizziness, appetite absent, upset stomach and weakness were not recovered/not resolved.   It was unknown if the reporter considered the itchy rash, red rash, influenza-like symptoms, runny nose, dizziness, appetite absent, upset stomach and weakness to be related to Shingrix.  Additional details were provided as follows: The patient reported a rash at the injection site that started with three small red bumps, as well as a red streak near the injection site. The patient also reported that 8 hours after the injection the rash, like small red bumps, spread from her bottom, to her back, up to her hairline. The rash at the injection site and on her body, was itchy. None of the patient's symptoms have resolved. The reporter gave consent to follow up.
Age: 24.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Pain in extremity
Clinical narrative: patient had redness in his arm and some pain. Patient went to MD office and was diagnosed with Cellulitis
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haemorrhage, Injection site reaction, Injection site ulcer, Wound
Clinical narrative: Patient's caregiver presented a photo of what appeared to be an ulcer on the patient's upper arm . It was bandaged but the caregiver said it was at the injection site and was actively bleeding. Informed caregiver that I was not aware of this vaccine causing that reaction and referred her to her PCP or urgent care for treatment, whichever was quicker. Caregiver stated home health would be coming in the morning. Explained the risk and signs of infection; instructed caregiver to keep wound clean/covered and to seek medical attention if pain/redness/swelling occurred or worsened or if bleeding increased.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Pt received MMRV vaccine in his Lt thigh on the 14th of May 2019. MOP reported the Pt's Lt thigh had redness in the size of a quarter on the 16th of May, the area was warm to the touch with small red bums in the area. Pt reported itchiness. No fever or pain.. Pt was seen on the 16th by his PCM and was treated with Benadryl and Steroids.  Pt followed up with PCM on the 17th of May and the redness, itchiness, and warmth  decreased.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Bursitis, Injection site pain, Injection site reaction, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient was complaining about pain in the left arm/shoulder that was still present weeks after vaccine administration. Upon consulting with his physician, he was diagnosed with bursitis (damage to tendon from shot according to his orthopedic) due to vaccine being administered too high.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Tendon injury
Clinical narrative: Patient was complaining about pain in the left arm/shoulder that was still present weeks after vaccine administration. Upon consulting with his physician, he was diagnosed with bursitis (damage to tendon from shot according to his orthopedic) due to vaccine being administered too high.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash, Tenderness
Clinical narrative: Patient reported a rash across arm approximately the length of her hand - no red rash underneath the injeciton.  Patient received the shot on 05/19/2019 and the rash developed in the evening 05/21/2019.  Patient stated the area was sore or better described "tender" at the end of the rash furthest from the injection site.   Reported adverse event to GSK and the clinical staff stated that there had been several reports of extensive rashes )greater than 100 mm) and that these were not classified as "allergic reactions" and were not life-threatening.   Advised patient to watch the rash closely and call MD if rash continued to spread or pain worsened.  Advised patient to use OTC analgesics ad/or cold compresses to ease the pain.  Taking Benadryl 50 mg after work was not a necessiity but may be advised before bedtime for one dose only.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Patient reported a rash across arm approximately the length of her hand - no red rash underneath the injeciton.  Patient received the shot on 05/19/2019 and the rash developed in the evening 05/21/2019.  Patient stated the area was sore or better described "tender" at the end of the rash furthest from the injection site.   Reported adverse event to GSK and the clinical staff stated that there had been several reports of extensive rashes )greater than 100 mm) and that these were not classified as "allergic reactions" and were not life-threatening.   Advised patient to watch the rash closely and call MD if rash continued to spread or pain worsened.  Advised patient to use OTC analgesics ad/or cold compresses to ease the pain.  Taking Benadryl 50 mg after work was not a necessiity but may be advised before bedtime for one dose only.
Age: 0.33
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient is currently not having any symptoms. Patient was given the wrong vaccine.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Eschar, Injection site erythema, Injection site pain, Injection site reaction, Injection site vesicles
Clinical narrative: Blisters (one egg sized and one quarter sized) formed over injection area.  Patient's wife popped the blisters.  Patient had pain, eschar had formed over blisters that popped.  Periwound area was reddened.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister rupture, Injection site erythema, Injection site reaction, Injection site vesicles, Skin exfoliation
Clinical narrative: Blisters (one egg sized and one quarter sized) formed over injection area.  Patient's wife popped the blisters.  Patient had pain, eschar had formed over blisters that popped.  Periwound area was reddened.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Skin wound
Clinical narrative: Blisters (one egg sized and one quarter sized) formed over injection area.  Patient's wife popped the blisters.  Patient had pain, eschar had formed over blisters that popped.  Periwound area was reddened.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Ear infection, Electroencephalogram normal, Respiratory tract infection, Respiratory tract inflammation, Seizure
Clinical narrative: Onset of Seizures, Ear Infections & Respiratory Inflammation. EEG performed with no diagnosis or unknown reasons for seizures. Recurrent respiratory infections/inflammation. Antibiotics that would only clear problem momentarily.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Injection site erythema, Injection site pain
Clinical narrative: Pt says about 12 hours after she got the shot, she had nausea, shivers, body weakness, elavated temp (98.4 F) bad headache and yesterday the area was still swallen. The sore are is about 2-3 inches big and the redness around the area is about 5-7 inches big
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Nausea
Clinical narrative: Pt says about 12 hours after she got the shot, she had nausea, shivers, body weakness, elavated temp (98.4 F) bad headache and yesterday the area was still swallen. The sore are is about 2-3 inches big and the redness around the area is about 5-7 inches big
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles rash /breakout; This case was reported by a physician via sales rep and described the occurrence of shingles in a 68-year-old 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, 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 patient experienced shingles rash or breakout after being immunized.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration
Clinical narrative: 3x2cm round, red, indurated area with white halo to right upper outer thigh.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling for two days.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Swelling
Clinical narrative: REDNESS AND SWELLING
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy test, Erythema, Urticaria
Clinical narrative: I became covered in red hives especially on my neck, torso front and back as well as to a lesser degree on my arms and legs. I have had hive reactions before so I started a course of benadryl OTC I have at home . Next day I called my MD & couldn't be seen. Went to Urgent Care where MD there had me carry on with Benadryl and wrote RX for dose pack of Methylprednisolone tablets 4mg. I chose not to take the prednisone as by the time I got them too late to take all 6  1st dose so just took benedryl & got better in 5 days. I don't think I'll take the followup 2nd vaccine for shingles.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Medical Assistant (Reporter) reconstituted the Menveo immunization with Sterile Diluent instead of reconstituting the immunization with the proper solution provided with the immunization.  Nurse notified medical assistant after discovering the medication count was off when medical assistant documented the count for vaccine.  Management was made aware, CDC was notified for proper administration recommendations for re-vaccination, an internal event report was made, patient's mother was notified of the error, patient was scheduled to come in for a repeat vaccination as recommended
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary mass, Mammogram abnormal, Swelling, Ultrasound scan
Clinical narrative: Received 1st dose on 03May19. When I woke up to get ready for work on the early morning of the 7th, I noticed a large swelling and lump on the lower part of my left armpit. I was able to see my PCP later that day for a checkup which resulted on having an ultrasound and mammogram which 1st available date was on the 21st of May.  Between then and now the swelling has gone down but I do still see some slight swelling in the area
Age: 20.0
Sex: F
Vaccine: HEPA, HPV9, TDAP
Symptoms: Abdominal pain, Chills, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Patient reported on Tuesday (05/22/19) evening @ approx. 7:30 pm Sweating and chills beginning approximately 3 hours after vaccination (on 05/17/19) Nausea and vomiting since Saturday (05/18/19) Abdominal pain since Sunday (05/19/19) Per patient she has not eaten since vaccination
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Adverse event: swelling, erythema, pruritis and increased heat around the injection site which has become progressively worse over 3 days since injection Treatment: Tylenol, cold compresses, xyzal twice a day
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Nausea, Presyncope
Clinical narrative: Patient complained of lightheadedness, dizziness, almost fainted, nausea. Treatment: head between knees, took BP & pulse, fanning.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia oral
Clinical narrative: tongue tingling 50mg benadryl given IM Resolution of symptoms
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Hypoaesthesia oral, Swollen tongue
Clinical narrative: Patient had numbness in tongue, labored breathing, and tongue swelling
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Hyperaesthesia, Hypersomnia
Clinical narrative: My left arm became very sore/painful a few hours after the vaccination.  I was not able to raise my arm at the shoulder without experiencing severe pain .  At 4 days later I was able to raise it with mild pain.     My arm was very sensitive to touch, and resting a sheet on it was too painful to leave the sheet on it for 2 days. The arm pain began to fade after 2 days, but 6 days later it still hurts if I press on it.  I was extremely tired for 2 days and slept a lot.  I had a mild headache for 2 days.  I had body aches for 2 days, and I had the chills for 2 days.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: My left arm became very sore/painful a few hours after the vaccination.  I was not able to raise my arm at the shoulder without experiencing severe pain .  At 4 days later I was able to raise it with mild pain.     My arm was very sensitive to touch, and resting a sheet on it was too painful to leave the sheet on it for 2 days. The arm pain began to fade after 2 days, but 6 days later it still hurts if I press on it.  I was extremely tired for 2 days and slept a lot.  I had a mild headache for 2 days.  I had body aches for 2 days, and I had the chills for 2 days.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Tinnitus
Clinical narrative: Approximately 35 minutes post-immunization, patient reported that he began experiencing tinnitus in his left ear.  Shortly thereafter, he returned to the pharmacy (approximately, 40 minutes after he began experiencing the symptoms) and he was still experiencing the tinnitus in his left ear at that point in time.  He stated that this is not something he has had occur previously.  He stated that he was not experiencing any additional symptoms at that point in time.  I advised patient to seek medical attention if the problem worsened, progressed, or continued into the next day.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia, Pain in extremity, Tremor
Clinical narrative: Patient reports, shaking uncontrollably for a period of time in the evening. Also states, developing joint and muscle pain several days later not including the localized pain in the arm.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: 3? red spot directly under injection sight on left arm.  Warm to the touch
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Alanine aminotransferase, Anion gap, Aspartate aminotransferase, Blood chloride, Blood creatinine
Clinical narrative: 3 pm uncomfortable but still awakening to feed but seems to suckle for comfort but not making gulping sounds or emptying breasts felt warm to touch ax temp 99 7 pm 101.9 temp ax Nurse advised take to ED due to chapped lips, sunken fontanel decreased wet diapers IV bolus and TYLENOL given in ED, labs drawn.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blood culture, Blood lactic acid, Blood lactic acid increased, Blood potassium, Blood urea
Clinical narrative: 3 pm uncomfortable but still awakening to feed but seems to suckle for comfort but not making gulping sounds or emptying breasts felt warm to touch ax temp 99 7 pm 101.9 temp ax Nurse advised take to ED due to chapped lips, sunken fontanel decreased wet diapers IV bolus and TYLENOL given in ED, labs drawn.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Body temperature increased, Chapped lips, Chest X-ray normal, Decreased appetite, Dehydration
Clinical narrative: 3 pm uncomfortable but still awakening to feed but seems to suckle for comfort but not making gulping sounds or emptying breasts felt warm to touch ax temp 99 7 pm 101.9 temp ax Nurse advised take to ED due to chapped lips, sunken fontanel decreased wet diapers IV bolus and TYLENOL given in ED, labs drawn.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Discomfort, Fontanelle depressed, Full blood count, Haemoglobin, Influenza virus test negative
Clinical narrative: 3 pm uncomfortable but still awakening to feed but seems to suckle for comfort but not making gulping sounds or emptying breasts felt warm to touch ax temp 99 7 pm 101.9 temp ax Nurse advised take to ED due to chapped lips, sunken fontanel decreased wet diapers IV bolus and TYLENOL given in ED, labs drawn.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Mean cell volume, Metabolic acidosis, Metabolic function test, Procalcitonin, Skin warm
Clinical narrative: 3 pm uncomfortable but still awakening to feed but seems to suckle for comfort but not making gulping sounds or emptying breasts felt warm to touch ax temp 99 7 pm 101.9 temp ax Nurse advised take to ED due to chapped lips, sunken fontanel decreased wet diapers IV bolus and TYLENOL given in ED, labs drawn.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Streptococcus test negative, Urine analysis, Urine output decreased
Clinical narrative: 3 pm uncomfortable but still awakening to feed but seems to suckle for comfort but not making gulping sounds or emptying breasts felt warm to touch ax temp 99 7 pm 101.9 temp ax Nurse advised take to ED due to chapped lips, sunken fontanel decreased wet diapers IV bolus and TYLENOL given in ED, labs drawn.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pain in extremity
Clinical narrative: Pt complains of arm pain/loss of mobility. Daily activities are affected such as dressing.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Joint range of motion decreased, Limb discomfort, Loss of personal independence in daily activities, Sleep disorder
Clinical narrative: Pt complains of arm pain/loss of mobility. Daily activities are affected such as dressing.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: X-ray
Clinical narrative: Pt complains of arm pain/loss of mobility. Daily activities are affected such as dressing.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: pt. reported on 5/21 (shot given 5/16) a raised splotchy red area at injections site.  5-6 inches across, hot to touch, itchy, painful (5 out of 10).  suspected by me to be cellulitis from pt. description, but I am not a diagnostic provider
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Rash macular
Clinical narrative: pt. reported on 5/21 (shot given 5/16) a raised splotchy red area at injections site.  5-6 inches across, hot to touch, itchy, painful (5 out of 10).  suspected by me to be cellulitis from pt. description, but I am not a diagnostic provider
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: patient stated that her arm was sore monday morning, but by monday evening the area about 2 inches below the injection site was warm to the touch and started swelling.  She state she had a fever which started late that evening.  The area continued to be red and warm to touch. She called and spoke to the other pharmacist this morning and he suggested she have her doctor to look at the area since she had an already scheduled appt today with said physician.  Dr prescribed an antibiotic for the patient and stated he felt like it was cellulitis in the arm nut did not think it was due to the injection since it was lower than where the injection site was.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: patient stated that her arm was sore monday morning, but by monday evening the area about 2 inches below the injection site was warm to the touch and started swelling.  She state she had a fever which started late that evening.  The area continued to be red and warm to touch. She called and spoke to the other pharmacist this morning and he suggested she have her doctor to look at the area since she had an already scheduled appt today with said physician.  Dr prescribed an antibiotic for the patient and stated he felt like it was cellulitis in the arm nut did not think it was due to the injection since it was lower than where the injection site was.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, stiffness, itching in left shoulder. Is hot to the touch.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness
Clinical narrative: Swelling, redness, stiffness, itching in left shoulder. Is hot to the touch.
Age: 34.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Pruritus, Pyrexia, Scab
Clinical narrative: Had itchy vesicles on face and trunk, with clear fluid inside. Fever 99.4 F. Patient came health unit at the same day his symptom started and treated with valacyclovir 1g Tid for 5 days, ibuprofen 400mg Q6h and cetirizne and calamine lotion. patient has no more fever, no new vesicles and all vesicles had dried out and crust 6 days after the onset.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site induration, Peripheral swelling, Pruritus, Rash
Clinical narrative: Patient has vaccination 4/30/19 and came to the pharmacy 5/01/19 to show the on duty pharmacist the reaction.  Her arm was red, swollen, and itchy.  The site wa hard and the size of a half dollar.   She contacted the pharmacy again on 5/4/19 saying  the rash was going down and there was no impingement.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Rash
Clinical narrative: Pt reported to the pharmacy day after getting shingrix. Pt had rashes on her arms and abdominal. Pt started getting the allergic reactions few hours after the immunization.  Pt had no signs of shortness of breath (or any medical emergency situations). Pt has been taking benadryl for alleviate any allergic reaction symptoms.  Pt knows to contact 911 if she experiences shortness of breath (or throat closing) or severity of rashes worsens.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site extravasation
Clinical narrative: while injecting  the vaccine into her left arm. it came shooting out of the arm. This was a small petite woman. she did not  complain of any discomfort. Re vaccinated on the right arm without incidents. monitored pt for 20 mins. counseled her to monitor for any issues outside of pain  on the injection site.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Mobility decreased, Musculoskeletal pain
Clinical narrative: Patient described her adverse event as causing her shoulder to have a limited range of motion.  She explained how her shoulder has continued to be sore and that lifting and moving her arm (especially when it involves the shoulder) is difficult.  She did say that just here lately it has slowly started to improve.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Swelling
Clinical narrative: localized swelling extending to 13 cm. x 12 cm. --treated  initially with local ice, 1% hydrocortisone , and oral diphenhydramine--prescribed next day clindamycin for possible cellulitis
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Chills, Fatigue, Mobility decreased, Musculoskeletal pain
Clinical narrative: Extreme pain in bicep, shoulder, and armpit of injected arm.  (Could not raise arm above shoulder level)., Temperature 99.9, fever, chills, fatigue.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Extreme pain in bicep, shoulder, and armpit of injected arm.  (Could not raise arm above shoulder level)., Temperature 99.9, fever, chills, fatigue.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Severe shoulder pain and limited range of motion
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Face injury, Syncope
Clinical narrative: The patient states that the morning after receiving her second dose of the Shingrix vaccination, she had fainted. This resulted in hitting a hard surface near her eye which caused bruising near the orbital area.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood test normal, Cytogenetic analysis normal, Electroencephalogram abnormal, Lumbar puncture normal, Metabolic function test normal
Clinical narrative: About 10 days after the vaccines he began having seizures. At the time we didn't know the staring spells were actually absence seizures. We noticed a few spells over the next few days but on November 9th they became very obvious and regular. By that evening he was having clusters of 4-5 seizures every hour. He was admitted to the hospital on the 10th where he was ultimately diagnosed with seizures after an EEG.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Nuclear magnetic resonance imaging normal, Petit mal epilepsy, Seizure, Staring
Clinical narrative: About 10 days after the vaccines he began having seizures. At the time we didn't know the staring spells were actually absence seizures. We noticed a few spells over the next few days but on November 9th they became very obvious and regular. By that evening he was having clusters of 4-5 seizures every hour. He was admitted to the hospital on the 10th where he was ultimately diagnosed with seizures after an EEG.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Fatigue, Seizure
Clinical narrative: Patient had a seizure  and was extremely exhausted
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: redness, erythema, hot, pruritus, swollen painful in a large area around the injection site for, was formally diagnosed as cellulitis. Was given cephalexin and redness, itching and heat was gone on 5/22. Slight pain still remains
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: redness, erythema, hot, pruritus, swollen painful in a large area around the injection site for, was formally diagnosed as cellulitis. Was given cephalexin and redness, itching and heat was gone on 5/22. Slight pain still remains
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site pain, Pain
Clinical narrative: Left front shoulder pain  and unable to move arm with out pain.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Left front shoulder pain  and unable to move arm with out pain.
Age: 27.0
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Upon request of Rabies shot I went out to ask what # shot was. He said this would be his 2nd for his dog bite. I checked & realized we don't give this shot per Pharmacy Policy. They need to see an MD anyways to get Igg! I denied 2nd shot! Drug Co. said pt. is going to be fine!
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Pyrexia, Rash maculo-papular
Clinical narrative: Large area (17x12cms) of maculopapular rash with Erythemous (L) arm - almost into the elbow with feeling feverish (0 temp recorded) Pt afebrile in clinic Treatment - Zyrtec, TAC Cream, Keflex 500mg q 6hrs Evaluated & treated today
Age: 22.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Immediate post-injection reaction, Loss of consciousness, Nausea, Syncope, Vomiting
Clinical narrative: Syncope experienced immediately following second shot (Havrix). Pt experienced loss of consciousness for approx. 30 seconds. Upon wakening patient experienced N/V for up to 10 minutes. All symptoms resolved with in 15 minutes. Blood pressure was 112/80.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Body temperature increased, Irritability, Pain in extremity, Screaming
Clinical narrative: MOM SAID THAT THE DAY OF SHOTS (4/22/19) AND THE NEXT DAY (4/23/19) WERE ROUGH FOR PATIENT. PATIENT HAD A TEMP OF 99.6, HIS LEGS WERE IN PAIN, AND HE WAS VERY IRRITABLE. PT WOKE UP ON 4/24/19 SCREAMING. AT TIME OF THE CALL (AROUND 11 AM ON 4/24/19) PT WAS CONTENT. MOM HAD BEEN GIVING TYLENOL. THIS OFFICE FOLLOWED UP WITH MOM THE NEXT DAY (4/25/19). PER MOM, ALL ADVERSE SYMPTOMS HAD RESOLVED
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: eruption improved 5/22/19
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: 5/1/19 (about a week) after 2nd shot, pt got blister rash between her breast & under left breast, very itchy. pt wash with soap & apply bactroban oint. - got little better.
Age: 0.75
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: IN FOR RE CHECK EAR AGAIN. AT APPROXIMATELY 9:30 AM 02/25/08 (CHART UP AT 930 AM) WAS SEEN BY DR  -- "WELL GIRL" . HBV #3 ORDERED AND GIVEN. MOTHER CALLED AT 4PM TO REPORT HIVES. HAD COMPLETED COURSE OF AUGMENTIN 2-24-08. LABELLERD ALLERGIC AUGMENTIN. HIVES CLEARED WITH BENADRYL.
Age: 14.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Dizziness, Vision blurred
Clinical narrative: AFTER VACCINES PT C/O FEELING DIZZY & BLURRY VISION
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Acute disseminated encephalomyelitis, Asthenia, Electroencephalogram abnormal, Fatigue, Headache
Clinical narrative: I have been ill since August 29, 2018. My current diagnosis from Dr. is - POST IMMUNIZATION ACUTE DISSEMINATED ENCEPHALITIS, MYELITIS, AND ENCEPHALOMYELITIS. The effects of this shot (such as weakness in legs, headaches, neck pain like a wire in my neck, and more) have been life-altering for me. I no longer have the robust good health and energy I had up to and on the day of the vaccine. I spend time every day resting with an ice pack on my head and neck. Ice seems to be the best medicine to help me deal with fatigue and pain.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Malaise, Muscular weakness, Neck pain
Clinical narrative: I have been ill since August 29, 2018. My current diagnosis from Dr. is - POST IMMUNIZATION ACUTE DISSEMINATED ENCEPHALITIS, MYELITIS, AND ENCEPHALOMYELITIS. The effects of this shot (such as weakness in legs, headaches, neck pain like a wire in my neck, and more) have been life-altering for me. I no longer have the robust good health and energy I had up to and on the day of the vaccine. I spend time every day resting with an ice pack on my head and neck. Ice seems to be the best medicine to help me deal with fatigue and pain.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: lethargy; feeling miserable; fever; body aches/painful; dizziness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd May 2019, the patient received Shingrix. On 4th May 2019, 1 days after receiving Shingrix, the patient experienced fever, general body pain and dizziness. On 5th May 2019, the patient experienced lethargy and feeling miserable. On an unknown date, the outcome of the fever, dizziness, lethargy and feeling miserable were unknown and the outcome of the general body pain was not recovered/not resolved.   It was unknown if the reporter considered the fever, general body pain, dizziness, lethargy and feeling miserable to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was 59 years old and in pretty good overall health otherwise. On 4th May 2019, the patient at woke up experienced fever of 100.6 degree F, painful body aches and dizziness.  On 5th May 2019, the patient's temperature was down to 99.6 degree F with continued body aches and lethargy. The patient asked, if this reaction was an allergic reaction and should the patient need to take 2nd dose. In addition, the patient asked, if  he or she could be better tomorrow. This side effects continue after tomorrow the patent was pretty miserable
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Feeling abnormal, Lethargy, Pain, Pyrexia
Clinical narrative: lethargy; feeling miserable; fever; body aches/painful; dizziness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd May 2019, the patient received Shingrix. On 4th May 2019, 1 days after receiving Shingrix, the patient experienced fever, general body pain and dizziness. On 5th May 2019, the patient experienced lethargy and feeling miserable. On an unknown date, the outcome of the fever, dizziness, lethargy and feeling miserable were unknown and the outcome of the general body pain was not recovered/not resolved.   It was unknown if the reporter considered the fever, general body pain, dizziness, lethargy and feeling miserable to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was 59 years old and in pretty good overall health otherwise. On 4th May 2019, the patient at woke up experienced fever of 100.6 degree F, painful body aches and dizziness.  On 5th May 2019, the patient's temperature was down to 99.6 degree F with continued body aches and lethargy. The patient asked, if this reaction was an allergic reaction and should the patient need to take 2nd dose. In addition, the patient asked, if  he or she could be better tomorrow. This side effects continue after tomorrow the patent was pretty miserable
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13
Symptoms: Apnoea, Cyanosis, Electrocardiogram, Electroencephalogram, Resuscitation
Clinical narrative: This is a spontaneous report from a contactable nurse. A 12-months-old female patient received, on 15May2019, the fourth dose of PREVNAR 13, (Lot. X62324, Expiration date: 30Nov2020) at 10:20 AM, intramuscularly, in the left thigh (left vastus lateralis), at single dose; hepatitis A vaccine (Lot. 9TL92, Expiration date: 27May2021, Manufacturer: GlaxoSmithKline) intramuscularly, in the right thigh (right vastus lateralis); PEDVAXHIB, (Lot. R027320, expiration date: 08Jul2021, Manufacturer: Merck) intramuscularly, in the left thigh (right vastus lateralis) and MMR, (Lot. R028004, Expiration date: 01Oct2020, Manufacturer: Merck) subcutaneously, in the right leg; all for immunization. Relevant medical history and concomitant medications were none. The patient previously received PREVNAR 13, first dose on 13Aug2018 (Lot. W11305, Expiration date: 30Apr2020), second dose on 24Sep2018 (Lot. W33491, Expiration date: 30Jun2020), and third dose on 26Nov2018 (Lot. X34315, Expiration date: 30Sep2020); all intramuscularly, in the left thigh, for immunization. On 15May2019, the patient experienced seizure and respiratory arrest. Patient had to have rescue breaths. It was reported that on an unspecified date, in May2019, the patient had a very high fever at the time of the seizure. The patient was hospitalized for seizure on 15May2019. The patient recovered from respiratory arrest on an unspecified date, in May2019, clinical outcome of seizure was recovering, while clinical outcome of fever was unknown. Sender's Comments: Based on the information currently available, a contributory role of PREVNAR 13 towards the occurrence of events high fever, seizure and respiratory arrest might not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.