chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Underdose
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 11-FEB-2019, the patient was vaccinated with PROQUAD in the arm lot number reported as R014355, with expiration date on 21-MAY-2021 (dosage scheduleand route were not reported), indicated for prophylaxis, reconstituted with sterile diluent. During the vaccine administration, the patient moved the arm causing the needle to come out of the arm before the complete dose was administered. Lot number R014355 was an invalid lot number for PROQUAD.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A currently 74-year-old female patient received the PREVENAR 13, via an unspecified route of administration in the arm on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced slight arm pain/pain in my arm, redness, and swollen arm. The patient reported that she "usually did not get any vaccines but I did get one a few years ago and the same side effect were slight arm pain and redness". The clinical outcome of the events was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: PAIN AND MUSCLE SORENESS IN THE ARM FOR 2 DAYS AFTER THE VACCINE. THE PATIENT HAS NO PAIN OR DISCOMFORT NOW AND DID NOT GO TO THE DOCTOR.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Periarthritis
Clinical narrative: Patient got a flu shot on 9/4/2017 and could not move her arm the next day. The pain didn't go away after a month so she went to see her doctor. Her doctor said she has frozen shoulder. She had to to physical therapy for 6 months.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, Urticaria, Vaccination complication
Clinical narrative: 2/26/2019 ADVERSE RXN CONSULTATION:  pt called pharmacy to state that he's experiencing a bad reaction to the SHINGRIX shot he got earlier today. Patient stated that even during the 10 minutes after the shot while he was waiting in the wait room, he said that he felt a little "tingling" but thought it would go away. Pt called at 4:30pm to state that he now has a quarter size "bubble" or welt on the back side of his hand, above his wrist. Pain is now constant and has been getting worse, at a 4-5 out of 1-10 scale. Pt confirmed allergy to doxycycline and NO food allergies. NO vaccine rxn like this before. Transferred to the front clinic to take it from here. 2/26/19 4:38pm phone note: (per NP) Spoke with patient re: arm soreness where he got SHINGRIX vaccine today. Noticed a quarter size welt on the hand of that arm. No respiratory compromise or swelling or numbness. Advised to take OTC antihistamine and some ibuprofen to help manage sxs. ED precautions discussed and advised him to call back tomorrow if symptoms do not improve. 2/27/2019 at 1:37pm: (per NP) Follow up on symptoms s/p adverse reaction to SHINGRIX. Awaiting call back.
Age: 57.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Back pain, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Soreness in left arm. Started at injection site, and spread to my entire upper left arm. Could raise arm above shoulder level. Pain in my neck and back.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Nasal congestion, Pain, Swelling
Clinical narrative: 1) Body aches, whole body experienced beginning morning of day after vaccination. Some relief with ibuprofen. Persisted approx. 12-14 hours and resolved. 2) "Severe" nasal congestion/swelling experienced beginning morning of day after vaccination. Persisted into overnight hours and resolved before next morning.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Arrhythmia, Chest discomfort, Headache, Insomnia, Muscle spasms
Clinical narrative: Shot at 4:30. painful. Could not sleep and at 0212 episode of tachycardia/arrythmia; tremors for 6 days, headache, painful leg cramps, knees to toes; 2/19 arrhythmia/tachycardia, chest pressure. took nitro. I was in the Clinic and had a myriad of innoculations with no side effects. I get a flu shot every year with no side effects. My arm from shoulder to fingertips ached for 3-4 days. I do not want to take the second shot. Would the efficacy of the first shot be diminished by NOT getting the second one?
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Tachycardia, Tremor
Clinical narrative: Shot at 4:30. painful. Could not sleep and at 0212 episode of tachycardia/arrythmia; tremors for 6 days, headache, painful leg cramps, knees to toes; 2/19 arrhythmia/tachycardia, chest pressure. took nitro. I was in the Clinic and had a myriad of innoculations with no side effects. I get a flu shot every year with no side effects. My arm from shoulder to fingertips ached for 3-4 days. I do not want to take the second shot. Would the efficacy of the first shot be diminished by NOT getting the second one?
Age: 65.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Blood glucose decreased, Dizziness, Nausea
Clinical narrative: Dizziness, Nausea during day after vaccine administration, patient also had insulin administration techniques altered/corrected day previously, lower than average blood sugars could also explain these symptoms.
Age: 11.0
Sex: M
Vaccine: MENB, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 11 year old was meant to get routine 11 yo MENACTRA but MA did not know that TRUMENBA was a different immunization (thought they were both the same meningitis vaccine) so gave TRUMENBA in error. We are newly carrying the TRUMENBA for 16 yo's if needed and she was unaware. The patient had no ill effects other than getting an incorrect injection and now needing to get the MENACTRA.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Hyperhidrosis, Myalgia, Nausea, Pyrexia
Clinical narrative: Approx. 1 hr after injection, pt. developed nausea, headache, fever/ sweating, muscle aches. This lasted all day Tuesday 2/26/2019, and started subsiding Wednesday morning 2/27/2019.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Patient developed raised, itchy almost weeping rash on the inside elbow of the arm opposite the injection site. Still very itchy, no other symptoms.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Myalgia, Pain, Pyrexia
Clinical narrative: Patient states that within 9 hours of 2nd dose of SHINGRIX she had a fever, muscle aches, general body aches, and headache that lasted 36 hours. After that time, she felt fine and had no further symptoms, states that she is feeling well at this time. This only occurred with the 2nd vaccine, with first SHINGRIX she just had muscle soreness at injection site.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Patient developed raised, itch, almost weeping rash on the inside elbow of the arm opposite the injection site. Still very itchy, no other symptoms.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Pt states that after reading the VIS more extently when she got home she started to experience the side effects as listed on the paper as fatigue/soreness/fever. Instructed pt that she should take TYLENOL for the pain and that we would follow up with her pcp and also give them that information.
Age: 50.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Chills, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Patient experienced fever, chills, vomiting and watery diarrhea throughout the night. Patient continued to experience diarrhea through next day.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Grip strength decreased, Injected limb mobility decreased, Injection site hypoaesthesia, Injection site pain, Pain in extremity
Clinical narrative: Numbness and pain left upper arm, pain radiates to left lower arm. Unable to lift arm over head, unable to open jars. No redness or swelling. Treatment includes Ibuprofen for 1 week. If no improvement, will obtain an ultrasound or MRI.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Muscular weakness
Clinical narrative: For item 17 - Dose on form says 0.5 ml. Directly after injection and through the evening/night and all of the following day, injection site was very sore with a very mildly raised and hardened feel and lightly tinted red color about 2" in diameter. 2/23/2019 - Cluster seizures: 7:45 am - 5 second facial seizure. 7:46 am - 87.5 mg of Lamotrigine and 180 mg of Oxcarbazepine administered. 7:50 am - 15 second facial seizure. 7:51 am - 30 second facial seizure. 8:20 am - 20 second facial seizure. 8:29 am - 3 minute facial seizure (some weakness in legs/arms). 9:11 am - 5 second facial seizure. 9:28 am - absence seizure of unknown length - no outward signs of seizure but he urinated while sitting on the couch. 10:30 am - 0.25 Clonazepam administered. No further seizures.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Petit mal epilepsy, Seizure, Seizure cluster, Urinary incontinence
Clinical narrative: For item 17 - Dose on form says 0.5 ml. Directly after injection and through the evening/night and all of the following day, injection site was very sore with a very mildly raised and hardened feel and lightly tinted red color about 2" in diameter. 2/23/2019 - Cluster seizures: 7:45 am - 5 second facial seizure. 7:46 am - 87.5 mg of Lamotrigine and 180 mg of Oxcarbazepine administered. 7:50 am - 15 second facial seizure. 7:51 am - 30 second facial seizure. 8:20 am - 20 second facial seizure. 8:29 am - 3 minute facial seizure (some weakness in legs/arms). 9:11 am - 5 second facial seizure. 9:28 am - absence seizure of unknown length - no outward signs of seizure but he urinated while sitting on the couch. 10:30 am - 0.25 Clonazepam administered. No further seizures.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Swollen painful right armpit.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Cold sweat, Dizziness, Flushing, Malaise, Nausea
Clinical narrative: 44 year old female into clinic on 02/25/2019 for TDaP vaccine. Client's daughter will be having baby. Client was a little apprehensive about injection, because does not like injections, and she had started antibiotics for tooth infection before having teeth pulled. Client concerned that she might have a reaction because of antibiotics. PHN explained that per our guidelines and VIS statement that should not have a problem. Client asked if wanted injection or wanted to wait, but agreed to have injection. She had watched daughter get injection and said that just watching this made her feel funny. TDaP given in Left Deltoid at 4:10 PM, client stated that she felt sick, and lightheaded. PHN assisted client to lie down on exam table. Lowered head and tool BP 140/88 at 4:15PM, client skin cool and clammy and flushed neck and face. BP 150/90 at 4:30PM continued to have nausea if tried to elevate head, BP 143/88 at 4:45 given juice, flushing of face and neck began to diminish. Offered to call EMS but client does not have insurance. BP140/88 at 5:00PM, BP 136/84 at 5:15PM, and gradually elevated head. BP126/74 at 5:30PM and client was able to stand and walked out of clinic with family. PHN called 02/26/2018 to check on client, talked with aunt and said client was still feeling a little weak, still questioned if TDaP should have been given with antibiotics.
Age: 62.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient received vaccine, next day arm was in pain, slowly over time Lt arm stuck to body, is not able to move freely, can lift only a little.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left upper mid forearm-Left lower mid forearm, erythema, swelling and pain. Tx: Doxycycline 100 mg BIDx7days.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site pain, Injection site vesicles
Clinical narrative: Pt had raised red area with small bumps as well and heat to area.
Age: 21.0
Sex: F
Vaccine: HEP, HEPA, HPV9, VARCEL, HEP, HEPA, HPV9, VARCEL
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out and hit floor.
Age: 21.0
Sex: F
Vaccine: HEP, HEPA, HPV9, VARCEL, HEP, HEPA, HPV9, VARCEL
Symptoms: Fall, Loss of consciousness
Clinical narrative: Patient passed out and hit floor.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site pain, Nausea, Pain
Clinical narrative: 2/23 Pain and redness at injection site. Body aches, nausea, fever 101 degrees x 2 d. Starting 2/25 feeling better, swelling and itching decreased and redness decreasing. Recommended Cephalexin - pt did not start recommended BENADRYL 50mg q 6 hr.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Pyrexia, Swelling
Clinical narrative: 2/23 Pain and redness at injection site. Body aches, nausea, fever 101 degrees x 2 d. Starting 2/25 feeling better, swelling and itching decreased and redness decreasing. Recommended Cephalexin - pt did not start recommended BENADRYL 50mg q 6 hr.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Bone cyst, Burning sensation, Computerised tomogram, Fatigue
Clinical narrative: Immediate, intense shooting pain down arm during injection followed by burning, numbness, throbbing, and tingling in left arm from shoulder to fingertips. Sharp severe pain upon movement or pressure on left shoulder joint. Sensations continued in left arm before spreading to feet, both hands, then everywhere. Had numerous infections, fatigue, headaches, visual migraines, visual changes, that were not experienced before vaccination. Over two years later still currently experiencing milder but constant neuropathy in extremities, numbness at times  in left hand, and left shoulder never fully returned to how it felt before the vaccination.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Fluid retention, Headache, Hypoaesthesia, Immediate post-injection reaction, Infection
Clinical narrative: Immediate, intense shooting pain down arm during injection followed by burning, numbness, throbbing, and tingling in left arm from shoulder to fingertips. Sharp severe pain upon movement or pressure on left shoulder joint. Sensations continued in left arm before spreading to feet, both hands, then everywhere. Had numerous infections, fatigue, headaches, visual migraines, visual changes, that were not experienced before vaccination. Over two years later still currently experiencing milder but constant neuropathy in extremities, numbness at times  in left hand, and left shoulder never fully returned to how it felt before the vaccination.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia, Migraine with aura, Nerve conduction studies abnormal
Clinical narrative: Immediate, intense shooting pain down arm during injection followed by burning, numbness, throbbing, and tingling in left arm from shoulder to fingertips. Sharp severe pain upon movement or pressure on left shoulder joint. Sensations continued in left arm before spreading to feet, both hands, then everywhere. Had numerous infections, fatigue, headaches, visual migraines, visual changes, that were not experienced before vaccination. Over two years later still currently experiencing milder but constant neuropathy in extremities, numbness at times  in left hand, and left shoulder never fully returned to how it felt before the vaccination.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Neuropathy peripheral, Nuclear magnetic resonance imaging abnormal, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Immediate, intense shooting pain down arm during injection followed by burning, numbness, throbbing, and tingling in left arm from shoulder to fingertips. Sharp severe pain upon movement or pressure on left shoulder joint. Sensations continued in left arm before spreading to feet, both hands, then everywhere. Had numerous infections, fatigue, headaches, visual migraines, visual changes, that were not experienced before vaccination. Over two years later still currently experiencing milder but constant neuropathy in extremities, numbness at times  in left hand, and left shoulder never fully returned to how it felt before the vaccination.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Visual impairment, X-ray
Clinical narrative: Immediate, intense shooting pain down arm during injection followed by burning, numbness, throbbing, and tingling in left arm from shoulder to fingertips. Sharp severe pain upon movement or pressure on left shoulder joint. Sensations continued in left arm before spreading to feet, both hands, then everywhere. Had numerous infections, fatigue, headaches, visual migraines, visual changes, that were not experienced before vaccination. Over two years later still currently experiencing milder but constant neuropathy in extremities, numbness at times  in left hand, and left shoulder never fully returned to how it felt before the vaccination.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Loss of consciousness
Clinical narrative: Patient had and adverse rxn 4 hours after the immuinzation of SHINGRIX. She spiked a fever of 101F and had severe flu like sx (severe muslce aches and pain, vertigo, imbalance posture, sweats, etc). Was admitted to the hospital for 1 day per patient.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Balance disorder, Hyperhidrosis, Influenza like illness, Myalgia, Pain
Clinical narrative: Patient had and adverse rxn 4 hours after the immuinzation of SHINGRIX. She spiked a fever of 101F and had severe flu like sx (severe muslce aches and pain, vertigo, imbalance posture, sweats, etc). Was admitted to the hospital for 1 day per patient.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Vertigo
Clinical narrative: Patient had and adverse rxn 4 hours after the immuinzation of SHINGRIX. She spiked a fever of 101F and had severe flu like sx (severe muslce aches and pain, vertigo, imbalance posture, sweats, etc). Was admitted to the hospital for 1 day per patient.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Muscle rigidity, Sensory integrative dysfunction
Clinical narrative: Sensory/stimming (holding an item in each hand and meltdowns if let go), rigidity.
Age: 7.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Headache, Influenza virus test negative, Malaise, Pain
Clinical narrative: Recieved the flu shot (unsure of which one) and within 5 or 6 hours wasn't feeling well. Had a headache, body ached, stomach hurt. By the next morning she had a fever around 101 and started to vomit later in day. Fearing she had been exposed to the flu based on a friend being diagnosed with it and having the same symptoms, she was taken to the doctor. They ruled out flu and strep. Said it may be norovirus. We are now into day 4 and she still has a fluctuating fever. Treating with advil and tylenol. Fever has been as high as 103.5. Vomiting lasted about 24 hours but she still has abdominal pain that comes and goes. No respiratory symptoms. Historically, if one person catches an illness, someone else in the family has caught it. We have a 2yo and 4yo that put everything in their mouths so germs are freely shared. So far no one has caught anything. We aren't positive but are questioning if this could be a reaction to the flu shot.
Age: 7.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Streptococcus test negative, Vomiting
Clinical narrative: Recieved the flu shot (unsure of which one) and within 5 or 6 hours wasn't feeling well. Had a headache, body ached, stomach hurt. By the next morning she had a fever around 101 and started to vomit later in day. Fearing she had been exposed to the flu based on a friend being diagnosed with it and having the same symptoms, she was taken to the doctor. They ruled out flu and strep. Said it may be norovirus. We are now into day 4 and she still has a fluctuating fever. Treating with advil and tylenol. Fever has been as high as 103.5. Vomiting lasted about 24 hours but she still has abdominal pain that comes and goes. No respiratory symptoms. Historically, if one person catches an illness, someone else in the family has caught it. We have a 2yo and 4yo that put everything in their mouths so germs are freely shared. So far no one has caught anything. We aren't positive but are questioning if this could be a reaction to the flu shot.
Age: 65.0
Sex: M
Vaccine: FLUA3, PNC13
Symptoms: Discomfort, Immediate post-injection reaction, Joint range of motion decreased, Pain
Clinical narrative: Felt as if not injected in the same part of the arm as previous injections. Immediate discomfort more than what is typical of a vaccination injection that progressed over next approximately two days to severe pain in and decreased range of motion of right shoulder that has persisted.
Sex: M
Vaccine: VARCEL
Symptoms: Accidental exposure to product, No adverse event, Occupational exposure to product, Product packaging issue
Clinical narrative: Information has been received from a office manager referring to an unknown age male patient(who is medical assistant as well). Information about concomitant medications, pertinent medical history and drug reactions/allergies was not reported. On 28-JAN-2019, the patient was vaccinated with VARIVAX(route: Topically, lot #: R018933, Expiration Date: 02-JUL-2020, dose, frequency were not reported) for prophylaxis. The reconstituted VARIVAX sprayed out of vial when being withdrawn and sprayed onto "scrub top" clothing of the patient (product packaging issue, accidental exposure to product and occupational exposure to product). No patient missed a dose of VARIVAX. No adverse effects were reported. The outcome of product packaging issue was unknown. Information about treatment given for the event, lab diagnostics/studies and medical attention was not provided. The causality assessment was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies. On 18-JAN-2019, the patient was vaccinated with an improperly stored VARIVAX lot # R010466, expiration date 10-APR-2020, for prophylaxis (route of administration and anatomical location were not reported). The vaccine was diluted with properly stored MERCK STERILE DILUENT. No adverse effects were reported. On an unspecified date, the dose of VARIVAX underwent a temperature excursion of - 14 Celsius degrees (°C) to -10°C for a time frame of 2 hours and 55 minutes. There were no previous temperature excursions. The call was because of a digital data logger.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 04-FEB-2019 the patient was administered with improperly stored ROTATEQ (product storage error). The current temperature excursion: 9 "C" for 63 hours. There was no previous temperature. No adverse effects were reported. Data logger was involved. (strength, dose, lot # and expiration date were not reported) orally for prophylaxis.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain, Paraesthesia, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 58 year old female patient. The patient's medical history included chronic pain. The patient's concomitant medications were reported as a bunch of medications. No information was provided regarding the patient's drug reactions/allergies. On 14-AUG-2018, the patient was vaccinated with the first dose of zoster ZOSTAVAX for shingles prevention (prophylaxis) (dose, route of administration, lot number and expiration date were not reported). The patient did not have any reactions. On 16-FEB-2019, the patient was vaccinated with the ZOSTAVAX for shingles prevention (prophylaxis) (dose, route of administration, lot number and expiration date were not reported). On 17-FEB-2019, the patient developed soreness (pain), tingling (paraesthesia), numbness (hypoaesthesia), and swelling of the forearm (peripheral swelling). The outcome of pain, peripheral swelling, hypoaesthesia and paraesthesia was reported as not recovered. The causal relationship between all the aforementioned events and therapy with ZOSTAVAX was not reported.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning an approximately 64 year old female patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2015, at approximately 62 years of age, the patient was administered the ZOSTAVAX (lot number, dosage and route of administration not provided) by a pharmacist at a pharmacy. On an unknown date in 2017, the patient was treated by a physician for the following injury resulting from his ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claims damages as a result of: injury to himself and economic losses. Additional information has been requested.
Age: 1.17
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 14 months old male patient. Information on pertinent medical history and concomitant medications were not reported. On 13-NOV-2018, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB, lot# R013570 with expiry date of 18-MAR-2021 for prophylaxis. No adverse effects were reported. Temperature: (-1.1 C) (Below 0.0 C). Time frame was 8 hours 10 minutes. There was no previous temperature excursion. The call was because of data logger. No product quality complaint (PQC) was present. This case is related to MARRS# 1811USA006589 and 1902USA011295 (Same reporter link).
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 4 months old female patient. Information on pertinent medical history and concomitant medications were not reported. On 13-NOV-2018, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB, lot# R013570 with expiry date of 18-MAR-2021 for prophylaxis. No adverse effects were reported. Temperature: (-1.1 C) (Below 0.0 C). Time frame was 8 hours 10 minutes. There was no previous temperature excursion. The call was because of data logger. No product quality complaint (PQC) was present.  This case was related to MARSS# 1902USA011294 and 1811USA006589 (Same reporter link).
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 25-FEB-2019 the patient was vaccinated with expired dose of RECOMBIVAX HB (lot # M037248, expiry date: 21-FEB-2019) (dose, frequency, lot #, expiry date and route were not reported) for prophylaxis. It was reported that, the RECOMBIVAX HB did not have any temperature excursions prior to administration. No adverse effects were reported. No product quality complaint was involved.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Headache, Immobile, Loss of personal independence in daily activities, Pain
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of pain in a 61-year-old female patient who received SHINGRIX (batch number L7SY9, expiry date 4th July 2021) for prophylaxis. The patient's past medical history included paralysis (left side). Previously administered products included SHINGRIX (On 15th November 2018, 1st dose received in left deltoid, batch number 424A7 and expiry date 18th April 2021). Concurrent medical conditions included multiple sclerosis. On 19th February 2019, the patient received the 2nd dose of SHINGRIX. In February 2019, less than a day after receiving SHINGRIX, the patient experienced pain (serious criteria hospitalization), back pain (serious criteria hospitalization), immobile (serious criteria GSK medically significant), headache and performance status decreased. On an unknown date, the outcome of the pain, back pain, immobile, headache and performance status decreased were unknown. It was unknown if the reporter considered the pain, back pain, immobile, headache and performance status decreased to be related to SHINGRIX. Additional details were provided as follows: The patient had multiple scerlosis and was in a motorized chair. The patient received SHINGRIX in left deltoid. There were no reaction from 1st dose. In night on the day of vaccination, the patient called the offices after hours and spoke to one of their providers. The patient complained of mild headache, and back pain increasing to 9 out of 10, no other symptoms besides severe pain, causing her not to be able to function. The patient was advised if got worse to call 911, mentioning everything hurts. On 19th February 2019, that night patient experienced so much pain she could not move, patient called 911 and went to the emergency room. The patient was admitted to hospital and was still there on day of reporting. The reporter agreed to follow up from GlaxoSmithKline.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Performance status decreased
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of pain in a 61-year-old female patient who received SHINGRIX (batch number L7SY9, expiry date 4th July 2021) for prophylaxis. The patient's past medical history included paralysis (left side). Previously administered products included SHINGRIX (On 15th November 2018, 1st dose received in left deltoid, batch number 424A7 and expiry date 18th April 2021). Concurrent medical conditions included multiple sclerosis. On 19th February 2019, the patient received the 2nd dose of SHINGRIX. In February 2019, less than a day after receiving SHINGRIX, the patient experienced pain (serious criteria hospitalization), back pain (serious criteria hospitalization), immobile (serious criteria GSK medically significant), headache and performance status decreased. On an unknown date, the outcome of the pain, back pain, immobile, headache and performance status decreased were unknown. It was unknown if the reporter considered the pain, back pain, immobile, headache and performance status decreased to be related to SHINGRIX. Additional details were provided as follows: The patient had multiple scerlosis and was in a motorized chair. The patient received SHINGRIX in left deltoid. There were no reaction from 1st dose. In night on the day of vaccination, the patient called the offices after hours and spoke to one of their providers. The patient complained of mild headache, and back pain increasing to 9 out of 10, no other symptoms besides severe pain, causing her not to be able to function. The patient was advised if got worse to call 911, mentioning everything hurts. On 19th February 2019, that night patient experienced so much pain she could not move, patient called 911 and went to the emergency room. The patient was admitted to hospital and was still there on day of reporting. The reporter agreed to follow up from GlaxoSmithKline.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Mobility decreased, Nuclear magnetic resonance imaging
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of pain in a 61-year-old female patient who received SHINGRIX (batch number L7SY9, expiry date 4th July 2021) for prophylaxis. The patient's past medical history included paralysis (left side). Previously administered products included SHINGRIX (On 15th November 2018, 1st dose received in left deltoid, batch number 424A7 and expiry date 18th April 2021). Concurrent medical conditions included multiple sclerosis. On 19th February 2019, the patient received the 2nd dose of SHINGRIX. In February 2019, less than a day after receiving SHINGRIX, the patient experienced pain (serious criteria hospitalization), back pain (serious criteria hospitalization), immobile (serious criteria GSK medically significant), headache and performance status decreased. On an unknown date, the outcome of the pain, back pain, immobile, headache and performance status decreased were unknown. It was unknown if the reporter considered the pain, back pain, immobile, headache and performance status decreased to be related to SHINGRIX. Additional details were provided as follows: The patient had multiple scerlosis and was in a motorized chair. The patient received SHINGRIX in left deltoid. There were no reaction from 1st dose. In night on the day of vaccination, the patient called the offices after hours and spoke to one of their providers. The patient complained of mild headache, and back pain increasing to 9 out of 10, no other symptoms besides severe pain, causing her not to be able to function. The patient was advised if got worse to call 911, mentioning everything hurts. On 19th February 2019, that night patient experienced so much pain she could not move, patient called 911 and went to the emergency room. The patient was admitted to hospital and was still there on day of reporting. The reporter agreed to follow up from GlaxoSmithKline.
Sex: U
Vaccine: TDAP
Symptoms: Anaemia, Arthralgia, Back pain, Bone pain, Guillain-Barre syndrome
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of cancer in a patient who received BOOSTRIX for prophylaxis. On an unknown date, the patient received BOOSTRIX. On an unknown date, 2 years after receiving BOOSTRIX, the patient experienced cancer (serious criteria GSK medically significant), guillain barre syndrome (serious criteria GSK medically significant), leukemia (serious criteria GSK medically significant), anemia, joint pain, bone pain, back pain and performance status decreased. On an unknown date, the outcome of the cancer, guillain barre syndrome, leukemia, anemia, joint pain, bone pain, back pain and performance status decreased were unknown. It was unknown if the reporter considered the cancer, guillain barre syndrome, leukemia, anemia, joint pain, bone pain, back pain and performance status decreased to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. Two years after receiving BOOSTRIX, the patient experienced leukemia symptoms. 11.5 years passed, could not function properly. The patient was going to hematologist in further week to confirm the diagnosis. The patient wanted to know how can he or she sue GlaxoSmithKline for the vaccine causing guillain barre syndrome, anemia, bone, back, joint pains and cancer.
Sex: U
Vaccine: TDAP
Symptoms: Leukaemia, Neoplasm malignant, Performance status decreased
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of cancer in a patient who received BOOSTRIX for prophylaxis. On an unknown date, the patient received BOOSTRIX. On an unknown date, 2 years after receiving BOOSTRIX, the patient experienced cancer (serious criteria GSK medically significant), guillain barre syndrome (serious criteria GSK medically significant), leukemia (serious criteria GSK medically significant), anemia, joint pain, bone pain, back pain and performance status decreased. On an unknown date, the outcome of the cancer, guillain barre syndrome, leukemia, anemia, joint pain, bone pain, back pain and performance status decreased were unknown. It was unknown if the reporter considered the cancer, guillain barre syndrome, leukemia, anemia, joint pain, bone pain, back pain and performance status decreased to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. Two years after receiving BOOSTRIX, the patient experienced leukemia symptoms. 11.5 years passed, could not function properly. The patient was going to hematologist in further week to confirm the diagnosis. The patient wanted to know how can he or she sue GlaxoSmithKline for the vaccine causing guillain barre syndrome, anemia, bone, back, joint pains and cancer.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 60-year-old male patient who received SHINGRIX for prophylaxis. On 11th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 12th February 2019, 1 days after receiving SHINGRIX, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were provided as follows: The patient developed a rash that was later diagnosed as shingles outbreak. The reporter gave consent to follow up.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Angioedema
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of angioedema in a 72-year-old male patient who received SHINGRIX for prophylaxis.  Concomitant products included cetirizine hydrochloride (Zyrtec) and magic mouthwash (nos) (Magic Mouthwash). On 15th February 2019, the patient received SHINGRIX. On 16th February 2019, 1 days after receiving SHINGRIX, the patient experienced angioedema (serious criteria GSK medically significant). On an unknown date, the outcome of the angioedema was not recovered/not resolved.  It was unknown if the reporter considered the angioedema to be related to SHINGRIX. Additional details were provided as follows: The batch number and expiration date was not provided as the vaccine was administered at an outside facility. The angioedema was unresolved with some slight improvement with treatment; the reporter also noted the patient might need corticosteroids if symptoms do not further improve.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypertension, Nausea, Tachycardia, Tremor
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of headache in a 60-year-old female patient who received SHINGRIX (batch number 5544H, expiry date 15th May 2021) for prophylaxis. On 21st February 2019, the patient received SHINGRIX. On 21st February 2019, less than a day after receiving SHINGRIX, the patient experienced headache, nausea, tachycardia, hypertension and tremor. The patient was treated with BENADRYL (NOS) and SOLUMEDROL. On an unknown date, the outcome of the headache, nausea, tachycardia, hypertension and tremor were unknown. It was unknown if the reporter considered the headache, nausea, tachycardia, hypertension and tremor to be related to SHINGRIX. Additional details were reported as follows: The registered nurse reported that they gave a patient SHINGRIX, in the morning and the patient went back in complaining of a severe headache, nausea, tachycardia, hypertension and tremors. The patient had no rash and no closing of the throat. The patient received BENADRYL and SOLUMEDROL. The full safety report was not completed at this time.
Sex: U
Vaccine: DT
Symptoms: Allergy to vaccine, Angioedema, Inflammation, Pain in extremity, Peripheral swelling
Clinical narrative: Initial information received on 22-Feb-2019 regarding an unsolicited valid serious case received from a health professional via other company, Pfizer (Manufacturer Report Number: 2018528839). This case involves a patient of an unknown demographics who developed angioedema, allergy to vaccine, arm became swollen/severe pain, while he/she received vaccine DIPHTHERIA AND TETANUS TOXOIDS. The patient's past medical history included Drug hypersensitivity to Penicillins. The patient's past medical treatment included penicillin with Hives and Swelling/ Angioedema. The patient's past vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious angioedema, following the administration of DIPHTHERIA AND TETANUS TOXOIDS. This event was assessed as medically significant (IME). On an unknown date, the patient developed a non-serious allergy to vaccine and arm became swollen/severe pain (inflammation), following the administration of DIPHTHERIA AND TETANUS TOXOIDS. No lab test was reported. Final diagnosis was arm became swollen/severe pain, allergy to vaccine and angioedema. Corrective treatment was unknown. The outcome of the events was not reported. List of documents held by sender: none.; Sender's Comments: A patient of unknown demographics presented with angioedema, allergy to vaccine, peripheral swelling and severe pain after vaccination with DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer. Time to onset is unknown. Moreover, further information including patient's relevant medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Heart rate increased, Hypersomnia
Clinical narrative: The day after vaccine (2/26/2019) I had severe pain and redness at the injection site, fever, chills, headache, elevated heart rate (100) and fatigue that sent me to bed. By the evening my arm was so sore and I could barely move it. On 2/27/2019 the redness at injection site was 6" x 3". I thought I had shingles. Still experiencing fever, chills, headache, elevated heart rate and fatigue. Slept 12 hours. Today, 2/28/2019, the redness is still there but lessening in color. Have slight headache and fatigue. I looked up the side effects of the vaccine and the only treatment I took was ibuprofen and bed rest. I did not report this to my physician or Pharmacy after I realized I could report it online. I'm not sure I want to take the 2nd dose of the series.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: The day after vaccine (2/26/2019) I had severe pain and redness at the injection site, fever, chills, headache, elevated heart rate (100) and fatigue that sent me to bed. By the evening my arm was so sore and I could barely move it. On 2/27/2019 the redness at injection site was 6" x 3". I thought I had shingles. Still experiencing fever, chills, headache, elevated heart rate and fatigue. Slept 12 hours. Today, 2/28/2019, the redness is still there but lessening in color. Have slight headache and fatigue. I looked up the side effects of the vaccine and the only treatment I took was ibuprofen and bed rest. I did not report this to my physician or Pharmacy after I realized I could report it online. I'm not sure I want to take the 2nd dose of the series.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Fatigue, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Swelling in top right arm and shoulder. Exteme pain in that area, Extreme hardened around the injection site, about four-five inches wide. Hight fever, chills, while blood count high. Tired and lethargic.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Lethargy, Pyrexia, White blood cell count increased
Clinical narrative: Swelling in top right arm and shoulder. Exteme pain in that area, Extreme hardened around the injection site, about four-five inches wide. Hight fever, chills, while blood count high. Tired and lethargic.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the office manager referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication. On 06-FEB-2019 the patient was inadvertently administered M-M-R II (rHA) lot number R025335 and expiration date of 06-APR-2020 and lot number R001659 with expiration date of 17-JAN-2020 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). No adverse effects were reported. The vaccine was exposed to a temperature excursion of 60°F for 60 minutes while the sterile water diluent did not undergo a temperature excursion. There was no previous temperature excursion. A "data logger" was involved.; Sender's Comments: US-009507513-1902USA011926: US-009507513-1902USA011925: US-009507513-1902USA011924: US-009507513-1902USA011927: US-009507513-1902USA011923:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were not provided. On unknown date, the patient was administered a dose of improperly stored VAQTA (strength, dose, route, lot# and expiration date were unknown) for prophylaxis (product storage error).  Temperature was reported as below 36 degrees Fahrenheit (35 degrees Fahrenheit). Time frame was reported as 14 hours. There was previous temperature excursion involved. Total time and lowest temperature below 36 degrees Fahrenheit (35 degrees Fahrenheit) for 14 hours. Total time and highest temperature above 47 degrees Fahrenheit (47 degrees Fahrenheit) for 12 hours. The call was because of a data logger. No adverse reaction reported.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning an approximately 62 year old male patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In March 2017, at approximately 62 years of age, the patient was administered the ZOSTAVAX (lot number, dosage and route of administration not provided) by a healthcare provider. On an unknown date in 2017, the patient was treated by a physician for the following injury resulting from his ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claims damages as a result of: injury to himself and economic losses. Additional information has been requested.