chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis, Erythema, Hypotonia, Injected limb mobility decreased, Loss of personal independence in daily activities
Clinical narrative: tenderness in shoulder; Arthritis; redness in arm; severe excruciating pain/soreness in arm; arm limp; unable to dress herself; could not raise arm; This case was reported by a consumer via call center representative and described the occurrence of arthritis in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th June 2019, the patient received the 2nd dose of Shingrix. On 25th June 2019, less than a day after receiving Shingrix, the patient experienced arthritis, erythema of extremities, pain in arm, flaccidity, activities of daily living impaired and injected limb mobility decreased. On an unknown date, the patient experienced shoulder pain. The patient was treated with steroids nos (Steroid Pack (Nos)) and paracetamol (Tylenol). On 30th June 2019, the outcome of the erythema of extremities was recovered/resolved. On 1st July 2019, the outcome of the activities of daily living impaired was recovered/resolved. On 2nd July 2019, the outcome of the flaccidity was recovered/resolved. On an unknown date, the outcome of the arthritis and injected limb mobility decreased were unknown and the outcome of the pain in arm was recovered/resolved and the outcome of the shoulder pain was not recovered/not resolved.   It was unknown if the reporter considered the arthritis, erythema of extremities, pain in arm, flaccidity, activities of daily living impaired, injected limb mobility decreased and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced a tiny bit of redness, after receiving 1st dose in March 2019. The patient received a dose of Shingrix in the left arm. After vaccination with 2nd dose of Shingrix, the patient had severe excruciating pain, her arm went limp, could not raise it. The pharmacist advised ibuprofen or Tylenol to the patient, but the patient used Tylenol, and still had a lot of pain. On 26th June 2019, the patient went to doctor, and doctor gave her a steroid dosepak (name unknown). By Sunday, the patient was able to use her arm again. On 1st July 2019, the patient reported that, she still had soreness in the arm. The redness was gone and soreness was mostly gone. On 1st July 2019, The patient had x ray of shoulder with mild arthritis. The patient reported that, she did not have any problem with any shot. The patient reported that tenderness in shoulder gone partway down her arm. The reporter consented to follow up. For the tollerence of 1st dose refer case US2019AMR124429.      Lab Comments: The patient had mild arthritis on x ray test.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity, Tenderness, X-ray limb abnormal
Clinical narrative: tenderness in shoulder; Arthritis; redness in arm; severe excruciating pain/soreness in arm; arm limp; unable to dress herself; could not raise arm; This case was reported by a consumer via call center representative and described the occurrence of arthritis in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th June 2019, the patient received the 2nd dose of Shingrix. On 25th June 2019, less than a day after receiving Shingrix, the patient experienced arthritis, erythema of extremities, pain in arm, flaccidity, activities of daily living impaired and injected limb mobility decreased. On an unknown date, the patient experienced shoulder pain. The patient was treated with steroids nos (Steroid Pack (Nos)) and paracetamol (Tylenol). On 30th June 2019, the outcome of the erythema of extremities was recovered/resolved. On 1st July 2019, the outcome of the activities of daily living impaired was recovered/resolved. On 2nd July 2019, the outcome of the flaccidity was recovered/resolved. On an unknown date, the outcome of the arthritis and injected limb mobility decreased were unknown and the outcome of the pain in arm was recovered/resolved and the outcome of the shoulder pain was not recovered/not resolved.   It was unknown if the reporter considered the arthritis, erythema of extremities, pain in arm, flaccidity, activities of daily living impaired, injected limb mobility decreased and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced a tiny bit of redness, after receiving 1st dose in March 2019. The patient received a dose of Shingrix in the left arm. After vaccination with 2nd dose of Shingrix, the patient had severe excruciating pain, her arm went limp, could not raise it. The pharmacist advised ibuprofen or Tylenol to the patient, but the patient used Tylenol, and still had a lot of pain. On 26th June 2019, the patient went to doctor, and doctor gave her a steroid dosepak (name unknown). By Sunday, the patient was able to use her arm again. On 1st July 2019, the patient reported that, she still had soreness in the arm. The redness was gone and soreness was mostly gone. On 1st July 2019, The patient had x ray of shoulder with mild arthritis. The patient reported that, she did not have any problem with any shot. The patient reported that tenderness in shoulder gone partway down her arm. The reporter consented to follow up. For the tollerence of 1st dose refer case US2019AMR124429.      Lab Comments: The patient had mild arthritis on x ray test.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Malaise, Myalgia, Rash
Clinical narrative: feeling poorly; diffuse rash on trunk, arms and legs; flu-like symptoms; myalgia; This case was reported by a physician via sales rep and described the occurrence of rash in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included gluten sensitivity.   On 28th June 2019, the patient received the 1st dose of Shingrix. On 29th June 2019, 1 days after receiving Shingrix, the patient experienced rash, influenza-like symptoms and myalgia. In July 2019, the patient experienced feeling unwell. The patient was treated with antihistamine and steroids nos (Steroids). On an unknown date, the outcome of the rash was not recovered/not resolved and the outcome of the influenza-like symptoms, myalgia and feeling unwell were unknown.   The reporter considered the rash, influenza-like symptoms, myalgia and feeling unwell to be related to Shingrix.  Additional details were provided as follows: On Friday 28th June 2019 at around 12 pm, the patient received vaccine. The patient did not received any other concomitant mediaction. By the Saturday, the patint developed diffused rash on trunk, legs and arms. On following Monday, the patient was seen by doctor and was feeling poorly and still had the rash. Patient was treated with antihistamines and offered steroids but turned the steroids down. Patient did not call back after taking antihistamines. The reporter agreed to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: faint; This case was reported by a physician via sales rep and described the occurrence of faint in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo at an unknown dose. On an unknown date, unknown after receiving Menveo, the patient experienced faint (serious criteria GSK medically significant). On an unknown date, the outcome of the faint was unknown.   It was unknown if the reporter considered the faint to be related to Menveo.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patients fainted after receiving Menveo. The reporter stated that they encourage the patients to wait for 15 minutes after vaccination but the patients did not always wait. This case was linked to case US2019AMR122570, reported by same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Lymphoma, Malaise
Clinical narrative: lymphoma; Ill; This case was reported by a consumer via call center representative and described the occurrence of lymphoma in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced lymphoma (serious criteria GSK medically significant) and unwell. On an unknown date, the outcome of the lymphoma and unwell were unknown.   It was unknown if the reporter considered the lymphoma and unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in spring 2018. The patient became ill with lymphoma and could not get the 2nd dose of Shingrix within 6 months.  The patient asked if the patient could could start all over again and get two new doses of Shingrix or only the one which the patient had not received till the time of reporting. At the time of reporting the patient was in remission and was doing well.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymph node pain
Clinical narrative: left axillary lymph node tenderness; This case was reported by a physician via call center representative and described the occurrence of lymph node tenderness in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 28th June 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 1st July 2019, 3 days after receiving Shingrix, the patient experienced lymph node tenderness. On an unknown date, the outcome of the lymph node tenderness was not recovered/not resolved.   It was unknown if the reporter considered the lymph node tenderness to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient who himself was the Physician. The patient experienced tenderness in axillary lymph node after receiving 2nd dose of Shingrix. No other information was available.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: pain; redness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 28th June 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were unknown.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The 1st dose was administered on 2nd May 2019, concomitantly. The caller reported that the patient received Shingrix and had been experiencing pain and redness at the injection site.  Did not consent to follow up. Related to Patient. The reporters declined to provide any additional information. This is 1 of the 2 cases reported by the same reporter.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: a tiny bit of redness; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced erythema. On an unknown date, the outcome of the erythema was unknown.   It was unknown if the reporter considered the erythema to be related to Shingrix.  Additional details were provided as follows: After vaccination with Shingrix, the patient experienced a tiny bit of redness. The reporter consented for follow up. For the tollerence of 2nd dose refer case US2019119431.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Felt really sick; This case was reported by a pharmacist via call center representative and described the occurrence of feeling unwell in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number ER5ZB, expiry date 20th June 2019) for prophylaxis.   On 26th March 2018, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell. Shingrix was discontinued. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient refused to receive the 2nd dose of Shingrix because it made her feel really sick after receiving the 1st dose of Shingrix.  No additional details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site dryness, Injection site pruritus, Injection site rash
Clinical narrative: injection site rash; Injection site itchy; injection site drynes; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site rash, injection site itching and injection site dryness. On an unknown date, the outcome of the injection site rash was recovered/resolved and the outcome of the injection site itching and injection site dryness were not recovered/not resolved.   It was unknown if the reporter considered the injection site rash, injection site itching and injection site dryness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The health care professional called to report that 2 months before the reporting date, the patient received Shingrix and around the injection site the patient experienced a rash. The rash has since resolved, but the area was still dry and itchy 2 months later.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 5G7A7, expiry date 18th May 2021) for prophylaxis.   On 1st April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In June 2019, less than a year after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The pharmacist on the line reported that the patient experienced shingles. The vaccine was given in the upper arm, which arm was unknown. Another pharmacist at the site was the one who spoke with the patient.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema 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, unknown after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced red at injection site. The reporter refused to provide any information for this case as no details available. The reporter did not consent to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Injection site swelling, Pain
Clinical narrative: Almost immediate soreness and some swelling in right arm muscle where injection occurred.  The next morning, extreme fatigue and low grade fever, chills, and aches.  By evening, 102 degree fever.  Next morning, no fever but still extreme fatigue.  Took Advil/Tylenol since injection to help relieve symptoms.  Arm still sore but not as bad.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Almost immediate soreness and some swelling in right arm muscle where injection occurred.  The next morning, extreme fatigue and low grade fever, chills, and aches.  By evening, 102 degree fever.  Next morning, no fever but still extreme fatigue.  Took Advil/Tylenol since injection to help relieve symptoms.  Arm still sore but not as bad.
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain upper, Cold sweat, Vomiting
Clinical narrative: EMPLOYEE GIVEN HEP B VACCINE 07/11/2019. EMPLOYEE CALLED CENTER SPOKE WITH MEDICAL SPECIALIST AND STATED THAT AT 7:45AM THAT HE WAS HAVING STOMACH CRAMPS, AND COLD SWEATS. INFORMED MEDICAL SPECIALIST HE VOMITED ONE TIME. EMPLOYEE DENIES ANY OTHER SYMPTOMS. INFORMED IF SYMPTOMS WORSED TO SEEK MEDICICAL ATTENTION. AND TO INFORM CENTER OF ANY CHANGES. EMPLOYEE VERBAILIZED UNDERSTANDING. DENIES ANY QUESTIONS AT THIS TIME. 071219
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patinet complained of pain in left arm that has not resolved since vaccination.
Age: 75.0
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Pyrexia
Clinical narrative: nausea; Fever; ill; This case was reported by a consumer and described the occurrence of nausea in a 75-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nausea, fever and unwell. On an unknown date, the outcome of the nausea, fever and unwell were unknown.   It was unknown if the reporter considered the nausea, fever and unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had nausea and little fever. The patient had no problem with 1st dose.  There is a discrepancy in the event ill in narrative given as lil that may be a typo error. As insufficent information we have so capture the event ill conservatively.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Fatigue, Myalgia, Pain
Clinical narrative: myalgia; arthralgia; arthritis; lot of pain in administered arm and limbs from her waist to knees; Fatigue; event lot of pain/ pain in limbs from her waist to knees; This case was reported by a other health professional via call center representative and described the occurrence of myalgia in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st May 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced myalgia, arthralgia, arthritis, pain in arm, fatigue and generalized aching. On an unknown date, the outcome of the myalgia, arthralgia, arthritis, pain in arm, fatigue and generalized aching were unknown.   It was unknown if the reporter considered the myalgia, arthralgia, arthritis, pain in arm, fatigue and generalized aching to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient experienced myalgia and arthralgia and she was feeling like she has arthritis, has a lot of pain in the administered arm, and then also in her limbs from her waist to knees. The reporter stated that, the patient was also fatigued. The reporter was wondering if the events could possibly be related to the vaccine or it was more likely something else.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: myalgia; arthralgia; arthritis; lot of pain in administered arm and limbs from her waist to knees; Fatigue; event lot of pain/ pain in limbs from her waist to knees; This case was reported by a other health professional via call center representative and described the occurrence of myalgia in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st May 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced myalgia, arthralgia, arthritis, pain in arm, fatigue and generalized aching. On an unknown date, the outcome of the myalgia, arthralgia, arthritis, pain in arm, fatigue and generalized aching were unknown.   It was unknown if the reporter considered the myalgia, arthralgia, arthritis, pain in arm, fatigue and generalized aching to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient experienced myalgia and arthralgia and she was feeling like she has arthritis, has a lot of pain in the administered arm, and then also in her limbs from her waist to knees. The reporter stated that, the patient was also fatigued. The reporter was wondering if the events could possibly be related to the vaccine or it was more likely something else.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Local reaction
Clinical narrative: rash below injection site; This case was reported by a physician via sales rep and described the occurrence of injection site rash in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received her first Shingrix dose and did not have any reaction).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site rash. The patient was treated with antihistamine and medication unknown (Topical (Nos)). On an unknown date, the outcome of the injection site rash was unknown.   The reporter considered the injection site rash to be related to Shingrix.  Additiopnal details were provided as follows: The age at vaccination was not reported. The patient had 1st dose of Shingrix, and did not have any reaction. After vaccinated with 2nd dose, the patient had local reaction, rash, below the injection site. The patient did not receive any other vaccines at the time. The patient was treated with antihistamines and topical medications. The physician did attribute the rash to the Shingrix vaccine. The physician agreed to be followed up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number 4X733, expiry date 8th March 2021) for prophylaxis.   On 28th March 2019, the patient received the 1st dose of Shingrix .5 ml. In April 2019, 7 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left arm. Approximately one week following the vaccination, the patient developed a mild case of shingles.
Age: 97.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 97-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's daughter. In March or April, the patient received a dose of shingrix in the left arm and experienced arm pain. The arm pain resolved after a few days. This was 3 of 3 cases reported by same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia
Clinical narrative: fatigue; fever; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2018, the patient received the 1st dose of Shingrix. In November 2018, several hours after receiving Shingrix, the patient experienced fatigue and fever. On an unknown date, the outcome of the fatigue and fever were recovered/resolved.   It was unknown if the reporter considered the fatigue and fever to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient received the 1st dose in November 2018 in the mid afternoon in left arm. On next morning about 2 hours after getting up she experienced fatigue that put her back in bed.  The patient also had a 101 degree fever.  The symptoms resolved by the next day. The reporter did not consent to follow up. This case has been linked with case US2019120314, reported by the same reporter.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: client reports redness, raised, and warm to touch at site of varicella vaccine
Age: 1.08
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMRV
Symptoms: Pyrexia, Rash, Viral infection
Clinical narrative: On 7/11/2019 patient presented with mild rash and fever of 101.7. Fever was considered viral On 7/12/2019 patient presented with worsening rash spreading and low grade fever of 99.0
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Headache, Local reaction, Nausea, Pain
Clinical narrative: Local reaction:  redness, swelling, pain  Headache, nausea
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Swelling
Clinical narrative: Local reaction:  redness, swelling, pain  Headache, nausea
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Dizziness, Headache, Influenza like illness, Pain
Clinical narrative: Light headed, Achy, Flu Like Symtoms, Blood Pressure dropped to 98/54  and Ears Pounding the day after vaccination.   The second day after vaccination, she had a red rash from her neck down to under her arms and along her rib cage.  She notified her physician and they did not treat her or see her.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Light headed, Achy, Flu Like Symtoms, Blood Pressure dropped to 98/54  and Ears Pounding the day after vaccination.   The second day after vaccination, she had a red rash from her neck down to under her arms and along her rib cage.  She notified her physician and they did not treat her or see her.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Blood test, Echocardiogram, Electroencephalogram, Infantile spasms, Laboratory test
Clinical narrative: Starting having staring spells on 06/14/19, er visit on 06/15/19, er visit on 06/16/19 and admitted to hospital on 06/16/19.  06/16/19 diagnosed with Focal seizures Multiple seizures a day anywhere from 10-20 07/10/19 admitted to hospital again and diagnosed with infantile spasms
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging, Partial seizures, Seizure, Staring
Clinical narrative: Starting having staring spells on 06/14/19, er visit on 06/15/19, er visit on 06/16/19 and admitted to hospital on 06/16/19.  06/16/19 diagnosed with Focal seizures Multiple seizures a day anywhere from 10-20 07/10/19 admitted to hospital again and diagnosed with infantile spasms
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Fatigue, Nausea, Palpitations
Clinical narrative: Felt nausea and fatigue the next am starting at 7 when he woke, had continued through day till he reported at 12:30 pm that he felt heart pounding in chest for about 10 seconds, and wanted blood pressure to be checked- 145/89- pulse 92. Stated he felt better, symptoms resolved 2 hours later after he ate and drank 2 bottles of water.
Age: 3.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site swelling, Swelling face
Clinical narrative: Mother states child's right arm was swollen 3 times it's normal size and swollen up in the Right side of child's jaw.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Ill-defined disorder, Injection site haemorrhage, Injection site rash, Vaccination complication
Clinical narrative: Customer received a viaccine on 7-8 and it bled a lot. So it was bandaged up and customer went home. The next day right below where the vaccine was injected, customer developed a rash and it kept getting worse. Customer went to her DR and said she had developed an illness caused by the Vaccine.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Gastrointestinal pain, Headache, Myalgia
Clinical narrative: Generalized moderately severe myalgia, gastrointestinal cramps, dizziness, mild headache.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Throat tightness
Clinical narrative: When patient got home on 7/3/19 site was sore, redness, and warm to touch.  Contine to get bigger and 7/5/19 was the worst day. On 7/6/19 throat felt tight. Pt. seen in office on 7/8/19 and site was red, warm to touch. Measuring 9 cm across arm and  8 cm down the arm
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Burning sensation, Muscle spasms
Clinical narrative: Patient has been having pain and muscle spasms down her and back for 1month. It burns and is painful
Sex: F
Vaccine: MMR
Symptoms: Measles post vaccine
Clinical narrative: measles; This spontaneous report was received from a nurse via a company representative and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously (strength, exact dose, lot# and expiry date were not reported) for measles, mumps and rubella virus.  On an unknown date, the patient developed measles.  The outcome of measles was reported as not recovered. The causality assessment was not reported.  Upon internal review, the event of measles was considered to be medically significant.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 86-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 2011, the patient was prescribed and vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient was treated by a healthcare provider for the following injuries resulting from the use of zoster vaccine live (ZOSTAVAX): shingles. The outcome of shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 75-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 23-OCT-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) by a pharmacist at the pharmacy for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient was treated by a healthcare provider for the following injuries resulting from the use of zoster vaccine live (ZOSTAVAX): herpes zoster. The outcome of herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 52.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 59-year-old patient of an unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 11-APR-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) by a physician for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient was treated by the physician for the following injuries resulting from their use of zoster vaccine live (ZOSTAVAX): herpes zoster. The outcome of herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: incident; Information was received from a lawyer regarding a female patient, age and history not provided.  The lawyer reported that the patient experienced a incident on 01-EB-2016 related to zoster vaccine live (ZOSTAVAX). Dates of immunization was not provided and details surrounding the incident were not provided.  Outcome of the incident was not provided.   Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Peripheral swelling, Rash erythematous, Skin warm
Clinical narrative: -Right arm with swollen with a round warm red rash measuring 6m x 5.5.  -Left arm with same reaction but smaller measuring 5x 4.5cm
Age: 6.0
Sex: F
Vaccine: DTAP, HEP, HEPA, MMRV
Symptoms: Expired product administered
Clinical narrative: Infanrix given 5 days past expiration date
Age: 14.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray, Full blood count, Headache, Injection site erythema, Injection site pain
Clinical narrative: Patient became febrile approx. 2-3 hours post injection, malaise, headache and left deltoid pain.  T max 102. Patient admitted to Hospital on 7/12/19 with fever, high wbc count, redness to injection site.
Age: 14.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Musculoskeletal pain, Pyrexia, White blood cell count increased
Clinical narrative: Patient became febrile approx. 2-3 hours post injection, malaise, headache and left deltoid pain.  T max 102. Patient admitted to Hospital on 7/12/19 with fever, high wbc count, redness to injection site.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Anxiety, Discomfort, Injection site pain, Pain, Tearfulness
Clinical narrative: The following information is directly transferred from the office visit note 7/12/19- Provider:, PA HPI HPI Details: Patient is a 16-year-old female presenting today for concern about her right shoulder hurting.  Last Wednesday 7/3/19 she got her meningitis shot in the right arm and another in the left.  She admits to having shot anxiety and was tensed when she got injection.  The day after she had more pain.  Ibuprofen helped and applied ice.  It stopped hurting Monday 7/8/19.  No sports until she had gymnastics yesterday with floor routine and tearful because it hurt so much.  Ibuprofen and ice again helped.  Today is better but feels tight.  No swelling or redness at injection site.  She can't specifically locate the exact location that injection was  at.  She has not had any symptoms consistent with allergic reaction.  Mother is concerned because she is still having discomfort and has had a bad experience with another child that she thought could have possibly been related to immunizations.  Plan Plan: At this time hard to determine if pain is still in relation to the injection or not.  She had a pain free period after immunization only for it to start hurting again once doing gymnastics.  May simply need some more time to recover and after discussion on continuing conservative approach or more aggressive treatment with PT or even sports medicine referral they opted to continue with ice and ibuprofen prn.  She will not participate in cheer or gymnastics again until Sunday and recommended that she not do bars.  Could be unusual shoulder injury related to vaccine administration with concern about immune response causing inflammation in the bursa or joint or given into the bursa or joint itself especially if she did flinch or move related to her fear of infections.  They will call clinic on Monday for update to see how she is doing and proceed from there.  They stated understanding and agreement.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Tension
Clinical narrative: The following information is directly transferred from the office visit note 7/12/19- Provider:, PA HPI HPI Details: Patient is a 16-year-old female presenting today for concern about her right shoulder hurting.  Last Wednesday 7/3/19 she got her meningitis shot in the right arm and another in the left.  She admits to having shot anxiety and was tensed when she got injection.  The day after she had more pain.  Ibuprofen helped and applied ice.  It stopped hurting Monday 7/8/19.  No sports until she had gymnastics yesterday with floor routine and tearful because it hurt so much.  Ibuprofen and ice again helped.  Today is better but feels tight.  No swelling or redness at injection site.  She can't specifically locate the exact location that injection was  at.  She has not had any symptoms consistent with allergic reaction.  Mother is concerned because she is still having discomfort and has had a bad experience with another child that she thought could have possibly been related to immunizations.  Plan Plan: At this time hard to determine if pain is still in relation to the injection or not.  She had a pain free period after immunization only for it to start hurting again once doing gymnastics.  May simply need some more time to recover and after discussion on continuing conservative approach or more aggressive treatment with PT or even sports medicine referral they opted to continue with ice and ibuprofen prn.  She will not participate in cheer or gymnastics again until Sunday and recommended that she not do bars.  Could be unusual shoulder injury related to vaccine administration with concern about immune response causing inflammation in the bursa or joint or given into the bursa or joint itself especially if she did flinch or move related to her fear of infections.  They will call clinic on Monday for update to see how she is doing and proceed from there.  They stated understanding and agreement.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Abnormal sensation in eye, Eye pain, Eye swelling, Injection site pain, Injection site swelling
Clinical narrative: Swelling, warmth and tender at injection site and also right eye.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: Swelling, warmth and tender at injection site and also right eye.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Broke 0ut Gradually over a few days  on various parts of body with Hives_raised (bumpy).  I did not scratch. The hives are still  there. I am taking an allergy pill daily and applying 3times a day a cream  generic fo Kenalog.
Age: 4.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient was already current on her Hep A vaccines.  In error, patient was given Havrix (Hep A) vaccine, instead of the Kinrix (DTaP) vaccine.
Age: 1.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Erythema multiforme, Malaise, Pruritus, Pyrexia
Clinical narrative: Erythema Multiform -like rash with high fever, severe itching and malaise. Symptoms present after 48-72hrs of vaccines. Only treated with oral Tylenol and Benadryl and Hydrocortisone cream.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Product preparation issue
Clinical narrative: The Pentacel vaccine that was administered was only partially administered; the HIB portion of it was not mixed with the DTAP-IPV portion of it. Sanofi-Pasteur was called; Sanofi-Pasteur advised giving an ActHib vaccine additionally. They advised that the DTAP-IPV portion of vaccine is valid and counts as a valid DTAP and IPV vaccine.
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Adenovirus test, Borrelia test negative, Chlamydia test negative, Decreased appetite, Fatigue
Clinical narrative: Patient presented with itchy rash all over her whole body that started the night prior. Mildly pruritic.  Appetite low and some fatigue.  no fever.  No cough, coryza, or conjunctivitis.   She had one lesion in right oral mucosa suspicious for a koplick spot.
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Human metapneumovirus test, Human rhinovirus test, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative
Clinical narrative: Patient presented with itchy rash all over her whole body that started the night prior. Mildly pruritic.  Appetite low and some fatigue.  no fever.  No cough, coryza, or conjunctivitis.   She had one lesion in right oral mucosa suspicious for a koplick spot.
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Measles, Measles antibody negative, Mycoplasma test negative, Polymerase chain reaction, Rash
Clinical narrative: Patient presented with itchy rash all over her whole body that started the night prior. Mildly pruritic.  Appetite low and some fatigue.  no fever.  No cough, coryza, or conjunctivitis.   She had one lesion in right oral mucosa suspicious for a koplick spot.
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Rash generalised, Rash pruritic, Respiratory syncytial virus test negative, Skin lesion, Viral test negative
Clinical narrative: Patient presented with itchy rash all over her whole body that started the night prior. Mildly pruritic.  Appetite low and some fatigue.  no fever.  No cough, coryza, or conjunctivitis.   She had one lesion in right oral mucosa suspicious for a koplick spot.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Crying, Induration, Irritability
Clinical narrative: The child had about 6 hours of nonstop crying, fussiness and irritability. By day two she had recovered but still with induration. No cellulitis.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Influenza like illness, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient presented to the pharmacy on 6/27/19 for his second and final dose of his shingles vaccine. Prior to administration of the second dose, the pharmacist questioned how the patient did with the first dose of Shingrix on 3/9/19. The patient mentioned that his arm had swelled down past his elbow and became very red, itchy, and warm to the touch. He stated the symptoms only lasted about 3-5 days and that he medicated with Tylenol during this time which seemed to help. As the patient was being prepped with an alcohol swab on his deltoid muscle, he mentioned that he had not received his first dose in that part of his arm, rather the pharmacist had given it to him in the back, lower part of his arm, indicative of a subcutaneous injection. After contacting our supervisor, it was determined that the first dose, although administered incorrectly, was still effective. After further discussion of the reaction, the patient decided he still wanted to continue with his second dose. A follow up phone call was made 7/12/19 for second dose. Patient did better with this dose in terms of injection site reaction, mild muscle pain for 3-5 days. He experienced more flu-like symptoms with the second dose and medicated with Tylenol. Patient is doing well at this time.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Myalgia, Peripheral swelling
Clinical narrative: Patient presented to the pharmacy on 6/27/19 for his second and final dose of his shingles vaccine. Prior to administration of the second dose, the pharmacist questioned how the patient did with the first dose of Shingrix on 3/9/19. The patient mentioned that his arm had swelled down past his elbow and became very red, itchy, and warm to the touch. He stated the symptoms only lasted about 3-5 days and that he medicated with Tylenol during this time which seemed to help. As the patient was being prepped with an alcohol swab on his deltoid muscle, he mentioned that he had not received his first dose in that part of his arm, rather the pharmacist had given it to him in the back, lower part of his arm, indicative of a subcutaneous injection. After contacting our supervisor, it was determined that the first dose, although administered incorrectly, was still effective. After further discussion of the reaction, the patient decided he still wanted to continue with his second dose. A follow up phone call was made 7/12/19 for second dose. Patient did better with this dose in terms of injection site reaction, mild muscle pain for 3-5 days. He experienced more flu-like symptoms with the second dose and medicated with Tylenol. Patient is doing well at this time.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Human chorionic gonadotropin negative, Hypertension, Oropharyngeal discomfort, Rash pruritic, Tachycardia
Clinical narrative: About one hour following vaccination,  employee had throat discomfort/itching, pruritic rash.  Was admitted to ED who noted tachycardia, hypertensive but not hypoxic.  Benadryl, pepcid and solumedrol given.  Wheezing developed.  IM epinephrine given after which symptoms rapidly resolved.  Patient monitored for 4 hours and released with 3 day course of steroids and anti-histamines.  Recommended follow up with allergist.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Throat irritation, Wheezing
Clinical narrative: About one hour following vaccination,  employee had throat discomfort/itching, pruritic rash.  Was admitted to ED who noted tachycardia, hypertensive but not hypoxic.  Benadryl, pepcid and solumedrol given.  Wheezing developed.  IM epinephrine given after which symptoms rapidly resolved.  Patient monitored for 4 hours and released with 3 day course of steroids and anti-histamines.  Recommended follow up with allergist.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Fatigue, Hyperhidrosis, Laboratory test, Myalgia
Clinical narrative: Fever of 102.5 within 2-3 hours of getting vaccine, severe muscle pain, diaphoresis, chills, fatigue.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: Fever of 102.5 within 2-3 hours of getting vaccine, severe muscle pain, diaphoresis, chills, fatigue.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Injection site pain, Middle insomnia
Clinical narrative: Fever, body tremors with teeth chattering, dizziness, fatigue. The dizziness and fatigue lasted 4 days. The body tremors woke me up at 5AM 6/15 after the vaccination at 2pm 6/14. The injection of the vaccine itself was very painful. And I barely had any of these symptoms after the first dose except some symptoms of malaise. But the tremors and fever that woke me up at 5 a.m. after I received my 2nd injection the previous day at 2 p.m. were severe. My teeth were chattering and my whole body was shaking. I could barely hold my cup of tea to my mouth. I went back to bed with 2 blankets to recover. It took me 5 - 6 days to recover. Then I caught a cold afterwards which I believe was a consequence of my immune system being compromised. I am fully recovered now after 2 weeks. In spite of all this, I still would rather get the vaccine vs. getting the disease. Please make people aware that these symptoms are possible.