chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Fatigue, Hypersensitivity, Injection site pain, Malaise, Rash
Clinical narrative: Rash on hip and forearm; allergic reaction to the vaccine; Pain at injection site; Fatigue; Feeling sick; This case was reported by a nurse via call center representative and described the occurrence of allergic reaction in a 36-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 53BF4, expiry date 14th August 2021) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number N754X, expiry date 11th November 2021) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Boostrix (intramuscular) and the 3rd dose of Engerix B (intramuscular). On 12th September 2019, 3 days after receiving Boostrix and Engerix B, the patient experienced allergic reaction, injection site pain, fatigue and feeling unwell. On 23rd September 2019, the patient experienced localized rash. On an unknown date, the outcome of the allergic reaction, injection site pain, fatigue, feeling unwell and localized rash were unknown.   It was unknown if the reporter considered the allergic reaction, injection site pain, fatigue, feeling unwell and localized rash to be related to Boostrix and Engerix B.  Additional details were provided as follows: The patient received both Boostrix and Engerix B in her left deltoid. On 12th September 2019, the patient reported to his employer that, he was experiencing fatigue, pain at injection site and feeling sick.  On 23rd September 2019, the patient again reported to his employer that, he had a rash on hip and forearm and he was wondering if he was having an allergic reaction to the vaccines.  The reporter consented to follow up. The reporter stated that, further details were not known to her and she could only relay what the patient's employer reported to her.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia, Product storage error
Clinical narrative: Product Storage Error; Flu Like Symptoms; Muscle ache on entire body; This case was reported by a consumer via call center representative and described the occurrence of flu like symptoms in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 28th March 2019, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the patient experienced flu like symptoms and generalized muscle aches. On an unknown date, the outcome of the flu like symptoms and generalized muscle aches were recovered/resolved and the outcome of the incorrect storage of drug was unknown.   It was unknown if the reporter considered the flu like symptoms and generalized muscle aches to be related to Shingrix.  Additional case details were provided as follows: The patient was administered a frozen dose of Shingrix vaccine in her left arm, which led to incorrect storage of vaccine. She experienced flu like symptoms and muscle ache on entire body for about 3 days.  The patient had reported this event to her physician. The patient did not consent to follow-up. No further details were provided.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness at injection site; swelling at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number TB2PK, expiry date 5th October 2021) for prophylaxis.   On 17th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th September 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The day after receiving the vaccine, the patient developed redness and swelling at the injection site. The reporter did not provide any additional information. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Condition aggravated
Clinical narrative: A-Fib exacerbation; This case was reported by a other health professional via call center representative and described the occurrence of atrial fibrillation aggravated in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included atrial fibrillation.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced atrial fibrillation aggravated (serious criteria GSK medically significant). On an unknown date, the outcome of the atrial fibrillation aggravated was recovered/resolved.   It was unknown if the reporter considered the atrial fibrillation aggravated to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however the patient could be 72 or 71 years old at time of vaccination. The pharmacy intern stated that the patient with history of rate-controlled A-Fib. The patient received the first dose of Shingrix and then experienced an exacerbation of the A-Fib. The patient had to be rate-controlled for two weeks, and then the episode resolved. The reporter was consented to follow up. No further details available to pharmacy intern at the time of this call.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Confusional state, Encephalitis, Laboratory test normal, Lumbar puncture normal
Clinical narrative: Hospitalized for possible encephalitis; Problems with thyroid; Prolonged confusion; Weakness; Unresponsive for several hours; Loss of urinary control; Syncopal episode; This case was reported by a physician via call center representative and described the occurrence of encephalitis in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA12BA, expiry date 28th February 2021) for prophylaxis.   Previously administered products included Bexsero (received 1st dose on 31st July 2019).   On 3rd September 2019, the patient received the 2nd dose of Bexsero. On 3rd September 2019, 6 hrs after receiving Bexsero, the patient experienced syncopal attack (serious criteria GSK medically significant). In September 2019, the patient experienced encephalitis (serious criteria hospitalization and GSK medically significant), thyroid disorder (serious criteria hospitalization), confusion (serious criteria hospitalization) and weakness (serious criteria hospitalization). On an unknown date, the patient experienced unresponsive to stimuli (serious criteria GSK medically significant) and urinary incontinence. The patient was treated with thyroid medication {nos} (Thyroid Medication). On an unknown date, the outcome of the encephalitis, thyroid disorder, confusion, weakness and urinary incontinence were unknown and the outcome of the syncopal attack and unresponsive to stimuli were recovered/resolved.   It was unknown if the reporter considered the encephalitis, thyroid disorder, confusion, weakness, syncopal attack, unresponsive to stimuli and urinary incontinence to be related to Bexsero.  Additional details were provided as follows: On 3rd September 2019, the physician reported that on day patient had second Bexsero vaccination, the patient was running in a cross country event and experienced a syncopal episode. The event occurred about 6 to 8 hours after patient had received vaccination. The patient was unresponsive for several hours with loss of urinary control. In September 2019, less than 3 weeks after receiving Bexsero the patient experienced possible encephalitis, problems with her thyroid, prolonged confusion and weakness. In September 2019, the patient was hospitalized for 2 weeks with possible encephalitis, problems with her thyroid, prolonged confusion and weakness. The patient's thyroid issue was confusing and did not respond to treatment with thyroid medication. A lumbar puncture and other lab tests were all negative. The patient did not receive a specific diagnosis for event. The reporter was consented to follow up.      Lab Comments: On unknown date, Other lab test were negative.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Syncope, Thyroid disorder, Unresponsive to stimuli, Urinary incontinence
Clinical narrative: Hospitalized for possible encephalitis; Problems with thyroid; Prolonged confusion; Weakness; Unresponsive for several hours; Loss of urinary control; Syncopal episode; This case was reported by a physician via call center representative and described the occurrence of encephalitis in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA12BA, expiry date 28th February 2021) for prophylaxis.   Previously administered products included Bexsero (received 1st dose on 31st July 2019).   On 3rd September 2019, the patient received the 2nd dose of Bexsero. On 3rd September 2019, 6 hrs after receiving Bexsero, the patient experienced syncopal attack (serious criteria GSK medically significant). In September 2019, the patient experienced encephalitis (serious criteria hospitalization and GSK medically significant), thyroid disorder (serious criteria hospitalization), confusion (serious criteria hospitalization) and weakness (serious criteria hospitalization). On an unknown date, the patient experienced unresponsive to stimuli (serious criteria GSK medically significant) and urinary incontinence. The patient was treated with thyroid medication {nos} (Thyroid Medication). On an unknown date, the outcome of the encephalitis, thyroid disorder, confusion, weakness and urinary incontinence were unknown and the outcome of the syncopal attack and unresponsive to stimuli were recovered/resolved.   It was unknown if the reporter considered the encephalitis, thyroid disorder, confusion, weakness, syncopal attack, unresponsive to stimuli and urinary incontinence to be related to Bexsero.  Additional details were provided as follows: On 3rd September 2019, the physician reported that on day patient had second Bexsero vaccination, the patient was running in a cross country event and experienced a syncopal episode. The event occurred about 6 to 8 hours after patient had received vaccination. The patient was unresponsive for several hours with loss of urinary control. In September 2019, less than 3 weeks after receiving Bexsero the patient experienced possible encephalitis, problems with her thyroid, prolonged confusion and weakness. In September 2019, the patient was hospitalized for 2 weeks with possible encephalitis, problems with her thyroid, prolonged confusion and weakness. The patient's thyroid issue was confusing and did not respond to treatment with thyroid medication. A lumbar puncture and other lab tests were all negative. The patient did not receive a specific diagnosis for event. The reporter was consented to follow up.      Lab Comments: On unknown date, Other lab test were negative.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Influenza like illness, Myalgia, Nausea
Clinical narrative: flu like symptoms; FEVER; WEAKNESS; HEADACHE; NAUSEA; MUSCLE PAIN; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 3HX44, expiry date 15th November 2021) for prophylaxis.   On 23rd September 2019 04:00, the patient received the 2nd dose of Shingrix .5 ml. On 23rd September 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, fever, weakness, headache, nausea and muscle pain. On an unknown date, the outcome of the influenza-like symptoms, fever, weakness, headache, nausea and muscle pain were recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms, fever, weakness, headache, nausea and muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix at 4:00 pm and few hours later she began to experience flu like symptoms including, fever, weakness, headache, nausea and muscle pain. The symptoms are resolving but not entirely resolved. There is discrepancy between the outcome reported in the structured field of system recovering while in source document it is reported as fatal.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: flu like symptoms; FEVER; WEAKNESS; HEADACHE; NAUSEA; MUSCLE PAIN; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 3HX44, expiry date 15th November 2021) for prophylaxis.   On 23rd September 2019 04:00, the patient received the 2nd dose of Shingrix .5 ml. On 23rd September 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, fever, weakness, headache, nausea and muscle pain. On an unknown date, the outcome of the influenza-like symptoms, fever, weakness, headache, nausea and muscle pain were recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms, fever, weakness, headache, nausea and muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix at 4:00 pm and few hours later she began to experience flu like symptoms including, fever, weakness, headache, nausea and muscle pain. The symptoms are resolving but not entirely resolved. There is discrepancy between the outcome reported in the structured field of system recovering while in source document it is reported as fatal.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site reaction, Rash vesicular
Clinical narrative: cellulitis/ cellulitis from the injection site down to the antecubital fossa; looks like chickenpox; This case was reported by a physician via call center representative and described the occurrence of cellulitis of arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis. Concomitant products included methotrexate.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced cellulitis of arm (serious criteria GSK medically significant) and varicella-like rash. On an unknown date, the outcome of the cellulitis of arm and varicella-like rash were unknown.   It was unknown if the reporter considered the cellulitis of arm and varicella-like rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported that a patient with rheumatoid arthritis developed what looks like chickenpox and cellulitis (according to their primary care physician) from the injection site down to the antecubital fossa. The patient was also on methotrexate. The date of administration was also not available. The six month mark since the first dose will be in two days. Th e lot number was not available. The reporter was did not consent to follow-up.
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: PCV13 in 2015 and had pneumonia in 2017; PCV13 in 2015 and had pneumonia in 2017; This is a spontaneous report from a Pfizer sponsored program. A 95-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date in 2015 at single dose for immunization. Medical history included had pleurasie in lungs when she was young and is susceptible for pneumonia; blood disorders. Concomitant medication included atorvastatin calcium (LIPITOR); BP medications and pills for blood disorders. The patient previously took PPSV23 in 2013. It was reported that the patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein)  in 2015 and had pneumonia in 2017. It was reported that the patient took another flu shot (not specified). It was also reported that the patient is still very active. Outcome of the events was unknown.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.  Further information like confirmative pathological/serotype results are needed for full medical assessment.
Sex: U
Vaccine: PNC13
Symptoms: Dyspnoea
Clinical narrative: it seems like ever since I have been kind of short-winded and I have emphysema anyways but I am usually not this short-winded; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization. Medical history included ongoing emphysema and short-winded. The patient's concomitant medications were not reported. The patient had a shot of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and ever since that the patient has been kind of short winded. The patient has emphysema but reported not usually that short-winded. The outcome of the event was unknown.   Information on the batch number has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Flank pain, Influenza like illness, Injection site pain
Clinical narrative: PATIENT STATES  SHE HAS HAD PAIN ON HER LEFT SIDE. SHE STATES THE PAIN HAS MOVED UP AND DOWN HER ARM AND INTO HER SHOULDER. SHE HAS FELT WEAK AND EXHAUSTED SINCE 9/28/19. SHE DESCRIBES IT AS FEELING FLU-LIKE WITH ACHES AND FATIGUE.  SHE STATES SHE IS FEELING SLIGHTLY BETTER BUT HAS FATIGUE THAT WORSENS IN THE AFTERNOON. SHE ALSO HAD A COLD SORE DEVELOP FOR THE FIRST TIME IN HER LIFE. I SUGGESTED SHE SPEAK TO HER PHYSICIAN SINCE IT SOUNDS LIKE SHE IS HAVING NERVE PAIN AND HER IMMUNE SYSTEM IS HYPER-RESPONDING TO THE VACCINE.  SHE STATED SHE HAD A YEAR LONG REACTION TO A HEPATITIS B VACCINE, BUT DID NOT REPORT THAT TO US AT THE TIME OF HER SHINGRIX VACCINATION.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes, Pain, Pain in extremity, Vaccination complication
Clinical narrative: PATIENT STATES  SHE HAS HAD PAIN ON HER LEFT SIDE. SHE STATES THE PAIN HAS MOVED UP AND DOWN HER ARM AND INTO HER SHOULDER. SHE HAS FELT WEAK AND EXHAUSTED SINCE 9/28/19. SHE DESCRIBES IT AS FEELING FLU-LIKE WITH ACHES AND FATIGUE.  SHE STATES SHE IS FEELING SLIGHTLY BETTER BUT HAS FATIGUE THAT WORSENS IN THE AFTERNOON. SHE ALSO HAD A COLD SORE DEVELOP FOR THE FIRST TIME IN HER LIFE. I SUGGESTED SHE SPEAK TO HER PHYSICIAN SINCE IT SOUNDS LIKE SHE IS HAVING NERVE PAIN AND HER IMMUNE SYSTEM IS HYPER-RESPONDING TO THE VACCINE.  SHE STATED SHE HAD A YEAR LONG REACTION TO A HEPATITIS B VACCINE, BUT DID NOT REPORT THAT TO US AT THE TIME OF HER SHINGRIX VACCINATION.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Dizziness, body pain and soreness, swelling and redness and heat in the area immunized, fatigue, one episode of night sweat
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Night sweats, Pain
Clinical narrative: Dizziness, body pain and soreness, swelling and redness and heat in the area immunized, fatigue, one episode of night sweat
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Myalgia, Pyrexia, Rash, Swelling
Clinical narrative: Fever 101.3 Muscle aches 3? diameter redness and swelling about 2 inches below the injection site with several bumps contained in swelling area
Age: 33.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Pt fainted about 2 minutes after receiving the vaccine. He was safely lowered to the floor, administered an epipen, and he regained consciousness withing 2 minutes.
Age: 15.0
Sex: M
Vaccine: TD
Symptoms: Seizure
Clinical narrative: Patient came to the clinic today, with his father, to get a Td.  His father wanted him to get a Td because he poked himself with a tack. Patient was administered the Td vaccination in the left deltoid muscle, he reported he was feeling fine after vaccine and was talkative. Father and son then left clinic room. Approximately 10-15 minutes later the father came to desk and reported that his son just had a seizure.  RN was at the desk when father reported incident and went into the Immunization room and told RN, emergency supplies and oxygen canister were gathered by both RNs and returned to waiting room.  By that time father had brought son (patient) back into the waiting room from parking lot and patient was sitting in a chair.  RN asked how he was feeling and he stated ?fine? there was no visible signs of injury.  RN suggested he lay down in the clinic room and he verbalized okay and that he also could walk there on his own.  Patient was steady when he walked to the clinic and lay down on the exam table, RN elevated his legs.  A third RN was in the clinic room with oxygen canister and gave him 8L oxygen via mask.  Throughout patient was alert and talking to RNs.  BP was 102/62, pulse 60.  Father explained to RNs that they walked to the car and as son was getting into the car he had a ?seizure.?  911 was called and arrived within approximately 10 minutes, patient talked with EMS crewmember for approximately 10 minutes and then walked to gurney and got on.  Patient then was transported to the hospital for further evaluation.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Inflammation, Injection site erythema, Pain
Clinical narrative: Patient complained of Redness at the injection site and pain that went from her armpits down her sides.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Throat tightness
Clinical narrative: No history of adverse reaction to flu vaccine; receives a flu shot every year; received vaccine as required by workplace through occupational health dept, approximately 30 mins later began feeling as if "throat was closing" and thought maybe it was "all in her head"; sought treatment from emergency department at approximately 1345
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: pt reports swelling rash in area of injection became painful and required visit to PCP office and treatment with antibiotic
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: PATIENT EXPERIENCED A RED RASH AROUND ARMPIT AREA THAT SPANNED ABOUT 2 INCHES, THAT BEGAN 4 DAYS AFTER VACCINATION.  DOES NOT REPORT ITCHING OR PAIN, JUST REDNESS.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Balance disorder, Gait disturbance, Irritability
Clinical narrative: Fussiness, Stumbling and Unsteadiness within an hour of receiving the vaccine
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Lymph node pain, Myalgia, Nausea, Pain in extremity
Clinical narrative: Muscle aches (body), arm sore to the touch, armpit nodes painful, low grade fever, chills, slightly nauseous.,
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Muscle aches (body), arm sore to the touch, armpit nodes painful, low grade fever, chills, slightly nauseous.,
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Chills, Tremor
Clinical narrative: The patient stated he experienced severe shaking and chills that worsened over time starting at around 8-9pm the night of 9/24 after receiving the Fluzone High Dose Vaccine. It progressed and eventually he was experiencing chest tightness and went to the emergency room for medical treatment around 10pm. He was admitted for 1 day there and released after that.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Patient said intern gave him shot to high and his shoulder still aches.
Age: 36.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Inflammation, Pain, Shoulder injury related to vaccine administration
Clinical narrative: Patient went to primary care doctor and was diagnosed with a shoulder injury due to vaccine given too high. She was given a Medrol dose pack for inflammation and pain.
Age: 36.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient went to primary care doctor and was diagnosed with a shoulder injury due to vaccine given too high. She was given a Medrol dose pack for inflammation and pain.
Age: 36.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Inflammation, Pain, Shoulder injury related to vaccine administration
Clinical narrative: severe shoulder pain , arm pain and loss of range of motion of shoulder within few hours of vaccine.
Age: 36.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: severe shoulder pain , arm pain and loss of range of motion of shoulder within few hours of vaccine.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Ear pain, Feeling hot, Headache, Hypersensitivity, Influenza like illness
Clinical narrative: Daughter woke up at 4am, morning after vaccination of MMR. Woke up with hot, earache and headache. Could not go back to sleep for 2 hours. Lethargic all day, flu like body symptoms, fever on and off and super sensitive.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Lethargy, Middle insomnia, Pyrexia
Clinical narrative: Daughter woke up at 4am, morning after vaccination of MMR. Woke up with hot, earache and headache. Could not go back to sleep for 2 hours. Lethargic all day, flu like body symptoms, fever on and off and super sensitive.
Age: 36.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site rash
Clinical narrative: Patient developed a painful, red, warm, hard, and sharply circumscribed patch below the injection site (not at the injection site) next day after the vaccination. She was seen by her dermatologist 3 days after (9/19/19) - it was felt it is cellulitis vs injection site rxn vs reactive skin eruption. She was treated empirically for cellulitis with  cephalexin 500 mg PO tid x 10 days. The red area started to get better within hours after the 1st dose of antibiotics, and resolved on 9/23/19.
Age: 36.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth
Clinical narrative: Patient developed a painful, red, warm, hard, and sharply circumscribed patch below the injection site (not at the injection site) next day after the vaccination. She was seen by her dermatologist 3 days after (9/19/19) - it was felt it is cellulitis vs injection site rxn vs reactive skin eruption. She was treated empirically for cellulitis with  cephalexin 500 mg PO tid x 10 days. The red area started to get better within hours after the 1st dose of antibiotics, and resolved on 9/23/19.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Electroencephalogram, Febrile convulsion
Clinical narrative: Complex Febrile Seizure on 9/30- 10/1 . Two in 6 hours.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Dyspnoea, Headache, Immediate post-injection reaction, Migraine
Clinical narrative: Patient reported adverse reaction from immunization (9/29/19) to the pharmacy on 10/1/19. She detailed having hives, labored breathing (chest tightness), congestion, drainage on 9/30/19. She also reported having a migraine/headache immediate after the administration of the immunization. Patient has been nursing her symptoms and monitoring  her progress.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Respiratory tract congestion, Rhinorrhoea, Urticaria
Clinical narrative: Patient reported adverse reaction from immunization (9/29/19) to the pharmacy on 10/1/19. She detailed having hives, labored breathing (chest tightness), congestion, drainage on 9/30/19. She also reported having a migraine/headache immediate after the administration of the immunization. Patient has been nursing her symptoms and monitoring  her progress.
Age: 70.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Feeling abnormal, Injection site erythema, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Began feeling bad within a couple of hours after immunizations.  Was given two, both in left arm.  One was for the seasonal influenza and the other was for the #2 Pneumonia immunization.  Began to feel feverish, achy, and left arm began to be sore and by following evening, Oct 1, the area below immunization site was very red and hot and swelled up.  Had felt sick and feverish all night  the first night after the shots and also the second night.  On second day after shot, the top part of arm underneath injection site is still very swelled up, red and hot.  Tried a cold compress the second morning on it and it seemed to reduce the redness and swelling to some extent.  We took photos of the arm if that would be helpful.  He is still waiting it out to see if it clears up and he gets to feeling better.  Have sought no medical intervention.
Age: 70.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Began feeling bad within a couple of hours after immunizations.  Was given two, both in left arm.  One was for the seasonal influenza and the other was for the #2 Pneumonia immunization.  Began to feel feverish, achy, and left arm began to be sore and by following evening, Oct 1, the area below immunization site was very red and hot and swelled up.  Had felt sick and feverish all night  the first night after the shots and also the second night.  On second day after shot, the top part of arm underneath injection site is still very swelled up, red and hot.  Tried a cold compress the second morning on it and it seemed to reduce the redness and swelling to some extent.  We took photos of the arm if that would be helpful.  He is still waiting it out to see if it clears up and he gets to feeling better.  Have sought no medical intervention.
Age: 33.0
Sex: M
Vaccine: TDAP, TYP
Symptoms: Dizziness
Clinical narrative: Experienced an episode of feeling very dizzy and light headed that started within 15 mins after having both shots and lasted for about an hour.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dyspnoea, Flushing, Nausea, Palpitations
Clinical narrative: Palpitations, dizziness, shortness of breath ( wheezing), flushing, nausea Palpitations started when left arm raised, followed by flushing, shortness of breath and nausea.  Dizziness and flushing lasted over one hour
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Wheezing
Clinical narrative: Palpitations, dizziness, shortness of breath ( wheezing), flushing, nausea Palpitations started when left arm raised, followed by flushing, shortness of breath and nausea.  Dizziness and flushing lasted over one hour
Sex: M
Vaccine: HPV9
Symptoms: Blood test, Headache, Pain, Paraesthesia
Clinical narrative: Tingling sensation; Stinging in the left hand; Stinging in some parts of the leg; Patient developed slight headache; This spontaneous report was received from a consumer referring to a 33-year-old male patient. The patient's concurrent conditions included vomiting, Human Immunodeficiency Virus (HIV) infection and blood pressure measurement. The patient's medical history included papilloma viral infection. Concomitant therapies included antiviral (unspecified)(ANTIVIRAL (UNSPECIFIED)), escitalopram oxalate(LEXAPRO), diacerein(ART), ASSRI and beta blocker. On 26-SEP-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) about 2 inches from the to of shoulder (strength, formulation, dose/frequency, lot# and expiry date were unknown) for prophylaxis. On 26-SEP-2019, after receiving the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) the patient experienced headache, tingling sensation (paraesthesia), stinging in the left hand (pain in extremity) and some parts of leg (pain in extremity). Patient had routine blood work. Patient did not seek any medical attention. The outcome of events paraesthesia, headache and pain in extremity was reported as not recovered. The causality of the events was not reported with respect to suspect therapy hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site discolouration, Injection site swelling, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: arm soreness; swelling at injection site; white dot at injection site; can't lift arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced pain in arm, injection site swelling, injection site hypopigmentation and injected limb mobility decreased. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, injection site swelling, injection site hypopigmentation and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, injection site swelling, injection site hypopigmentation and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient demographic details were not reported. 5 weeks ago from the date of reporting, the patient received 2nd dose of Shingrix. The patient experienced soreness in arm, on which the inajection has been received, since from the day of vaccination. At the time of reporting, the events were unresolved, and the patient stated that she can not lift her arm above shoulder. The patient did not consent to follow up. This case was 1 of 3 linked cases.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This case was reported by a consumer via call center representative and described the occurrence of stroke in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingix (1st dose received on 20th April 2019).   On 20th July 2019, the patient received the 2nd dose of Shingrix. On 23rd August 2019, 34 days after receiving Shingrix, the patient experienced stroke (serious criteria GSK medically significant). On an unknown date, the outcome of the stroke was unknown.   It was unknown if the reporter considered the stroke to be related to Shingrix.  Additional information was reported as follows: The patient wanted to know, could a 3rd dose of Shingrix would safe on blood thinner.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: Shingles / mild outbreak; Small area about the size of a dime with one tiny blister the size of a straight pin head; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had chronic outbreaks for over 20 years).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shingles and blister. On an unknown date, the outcome of the shingles and blister were unknown.   It was unknown if the reporter considered the shingles and blister to be related to Shingrix.  Additional information was reported as follows: The age at vaccination was not reported. Two months before the time of reporting, the patient received a dose of Shingrix. The patient was pretty confident this was a mild outbreak, there was just one small area about the size of a dime with one tiny blister the size of a straight pin head. The patient wanted to know, had broke out with Shingles between a Shingrix Vaccination. The patient was not comfortable to giving out the information online. The GSK pharmacist provided the information that, during clinical trials, evaluation of the efficacy of Shingrix started 1 month after the 2nd dose. Therefore, the efficacy of the vaccine was unknown if the second dose was not received. Also, the GSK clinical trials (ZOE50 and ZOE70) excluded patients who had a history of previous herpes zoster (shingles). The patient guessed that, the patient would contact the physician.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: arm soreness; Injection site swelling; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and injection site swelling. On an unknown date, the outcome of the pain in arm and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the pain in arm and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received dose of Shingrix in the left arm a while ago. After vaccination, the patient experienced soreness in arm, for only a few days. The patient did not consent to follow up. For tolerance to 2nd dose of Shingrix, refer case US2019AMR123504. This case has been linked with the case US2019122954, reported by the same reporter.
Sex: U
Vaccine: FLUX
Symptoms: Hepatitis
Clinical narrative: Hepatitis; This case was reported in a literature article and described the occurrence of hepatitis in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Concurrent medical conditions included non-small cell lung cancer.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced hepatitis (serious criteria GSK medically significant). On an unknown date, the outcome of the hepatitis was unknown.   The reporter considered the hepatitis to be related to Flu vaccine.  This case was reported in a literature article and described the occurrence of hepatitis in a patient of unspecified age and gender who was vaccinated with unspecified influenza vaccine (manufacturer unknown) for prophylaxis.  The patient was a part of single-center retrospective analysis that was conducted for patients with advanced non-small cell lung cancer (NSCLC) who received prolonged cell death 1 (PD-1) or prolonged cell death ligand 1 (PD-L1) inhibitor monotherapy between March 2015 and December 2018 to interrogate if influenza vaccination in patients with NSCLC receiving immune checkpoint inhibitors (ICPI) therapy had an increased incidence of immune-related adverse events (irAEs) compared to non-vaccinated patients. Comparisons of adverse event incidence between flu vaccinated and control patients were tested using chi-square statistics. The patient had history of non-small cell lung carcinoma (NSCLC). No information on patient's family history was provided.   On an unspecified date, between March 2015 and December 2018, the patient received unspecified influenza vaccine (administration route and site unspecified, dosages unknown, batch number not provided). [In this study, influenza immunization records from both institutional and state-wide registries were obtained from 2014 -2019. 19 received quadrivalent influenza vaccine, 13 received trivalent influenza vaccine and 1 was undetermined]. The age at vaccination was not reported. The patient also received prolonged cell death 1 (PD-1) or prolonged cell death ligand 1 (PD-L1) inhibitor monotherapy (ICPI). [In this study, 33 were vaccinated during ICPI therapy].   On an unspecified date, an unknown period after vaccination, the patient had hepatitis. It was considered as irAE.  [In this study, 22 vaccinated patients had an irAE versus 53 patients who were not vaccinated during ICPI therapy. 8 vaccinated patients had an irAE leading to discontinuation of therapy].  Treatment was unknown.  The outcome of the event was not reported.  The authors commented and concluded "Our study suggests that irAEs are not significantly increased with vaccination for influenza during ICPI therapy. However, there is a slight trend toward increased incidence of irAE warranting ICPI discontinuation for which further investigation is needed. Limitations of this study include a small sample size and inability to grade irAE retrospectively."
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Ear infection, Varicella post vaccine
Clinical narrative: Dx with Varicella (Chicken Pox) 10/1/2019. Atarax 10mg/5ml TID prescribed for symptoms.  Pt also treated for ear infection today with Amoxicillin.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: Feeling feverish, achy, headache, nausea, injection site pain.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Multiple hives noted to the upper limbs with itching. Hives subsided and through the weekend and redness faded
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Neck pain, Pain in extremity, Skin warm
Clinical narrative: Patient's reports warmth all around neck, and pain in arm where she was vaccinated lasting from 9/19/2019 until present (10/1/2019). Patient's arm pain extends to neck and can not fully lift arm.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Asthenia, Chills, Dizziness, Feeling hot, Headache
Clinical narrative: 10 hours after injection I became shivery  and couldn't get warm.  My body started shaking uncontrollably from head to toe. It was very intense. Muscles spasms with cramps. I felt very dizzy and nauseous with headache and pains in arms and legs. I had feverish hot sweats and chills which continued all night with intermittent fitful sleep. Next day I felt better but very weak with aches and pains.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Hyperhidrosis, Muscle spasms, Nausea, Pain, Pain in extremity
Clinical narrative: 10 hours after injection I became shivery  and couldn't get warm.  My body started shaking uncontrollably from head to toe. It was very intense. Muscles spasms with cramps. I felt very dizzy and nauseous with headache and pains in arms and legs. I had feverish hot sweats and chills which continued all night with intermittent fitful sleep. Next day I felt better but very weak with aches and pains.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Pyrexia, Sleep disorder, Tremor
Clinical narrative: 10 hours after injection I became shivery  and couldn't get warm.  My body started shaking uncontrollably from head to toe. It was very intense. Muscles spasms with cramps. I felt very dizzy and nauseous with headache and pains in arms and legs. I had feverish hot sweats and chills which continued all night with intermittent fitful sleep. Next day I felt better but very weak with aches and pains.
Age: 54.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Eye swelling, Paraesthesia, Pyrexia, Rash
Clinical narrative: Swollen eye, rash on neck, fever and tingling in her nose
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Nausea
Clinical narrative: Nausea Muscle aches, especially legs Tired
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Cough, Pyrexia, Rash, Varicella post vaccine
Clinical narrative: Fever  Cough  Rash/chicken pox
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity, Vaccination complication
Clinical narrative: pt states he had severe pain in the left arm. he was evaluated by his doctor and they believe he had a reaction to the vaccine. his arm was very painful and unable to move.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Eating disorder, Feeling abnormal, Headache, Herpes zoster, Hyperaesthesia teeth
Clinical narrative: within 2 hours of shot, my right arm hurt (possibly left- Not sure) and then immediately within an hour I started to feel like my head was shooting small bursts of pain. It felt similar to really bad flu. I asked nurse if I should have any questions and she said "your arm will hurt". I knew the arm pain was due to shot, I did not know where the other symptoms came from or why. From that day forward, my teeth became extremely sensitive to touch and eating food became a painful event. I did not call the doctor, because I had no idea this was related. On June 29th I went to urgent care as my tongue swelled up so bad I couldn't open my mouth except to swallow small amounts of food and water. The urgent care said to go to ER as this could be life threatening. ER said it was an infection of the salivary gland involving the lymph nodes. I was given a prescription for Keflex(?) and told to follow up with the doctor. I spent the next 10 days sick and in pain. I finally returned to work on July 8th. On August 10th I returned to Urgent Care and said I felt horrible. Everything from my neck up hurt and it kept moving around. The doctor said he had never seen this before and didn't know what to do. He gave me a prednisone shot and sent me home.   I finally made an appointment with my primary for August 30th. She referred me to an infectious disease specialist and to a neurologist. I am still waiting until November 27th to see the neurologist. I saw Dr on Tuesday, September 10th. I explained the symptoms again and what I had been through. He diagnosed me with Trigeminal Neuralgia Zoster. He also gave me a prescription for Valtrex. I took if for two weeks and my face swelled up under both lower right and left chins. He referred me to a pain management specialist and told me to stop taking the Valtrex.   I cannot seem to get into see anybody without waiting months and in the mean time I am in tremendous, actually horrific pain and I cannot take pain meds.  My body rejects them. I understand that Trigeminal Neuralgia has no cure. I got this because of the shingles shot, and absolutely no one listened to me when I mentioned when my personal hell started. But apparently, it is true... some people have extremely adverse reations to vaccines, and I am one of them. I feel as it I am on my own and basically with no help or resources. How dare they put out a product with no warning or testing.