chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tremor aggravated in a adult male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included tremor. 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 tremor aggravated. On an unknown date, the outcome of the tremor aggravated was recovered/resolved. It was unknown if the reporter considered the tremor aggravated to be related to SHINGRIX. Additional information received as follows: The reporter was an advocate for the Agency, a nonprofit that supports people with central tremor condition. The age at vaccination was not reported. The patient had a history of central tremor and reported that the condition worsened after he received the shot. The tremor eventually subsided. The reporter had no additional information to provide. The reporter was going to tell the patient to call GlaxoSmithKline response center for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received 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 shingles. On an unknown date, the outcome of the shingles was unknown.  It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional reported that, the patient experienced Shingles after having the SHINGRIX. The healthcare professional declined to provide any additional information including product and patient identifiers.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of mobility decreased in a 80-year-old male patient who received SHINGRIX (batch number 32PE4, expiry date 23rd January 2021) for prophylaxis. On 2nd July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced mobility decreased and pain in arm. On an unknown date, the outcome of the mobility decreased and pain in arm were recovered/resolved. It was unknown if the reporter considered the mobility decreased and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient could not lift his arm for 2 weeks after receiving SHINGRIX. He did not have any redness or swelling, just soreness where he could not lift his arm. The patient was fine at the reporting time. The reported batch number belongs to the adjuvant of SHINGRIX.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Lethargy, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 64-year-old male patient who received  for prophylaxis. In March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, 3 hrs after receiving SHINGRIX, the patient experienced chills, lethargy and pain. On an unknown date, the outcome of the chills, lethargy and pain were recovered/resolved. It was unknown if the reporter considered the chills, lethargy and pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm approximately 6 months before the date of reporting. Few hours after receiving SHINGRIX, the patient experienced chills, achiness, and lethargy. The symptoms continued for a day or two and then cleared. For tolerance to next dose, refer case US2018GSK180430.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 74-year-old female patient who received SHINGRIX (batch number MY2B2, expiry date 28th February 2021) for prophylaxis. On 19th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 21st September 2018, 2 days after receiving SHINGRIX, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. The patient developed a rash on her neck which was diagnosed with shingles at primary care on 24th September 2018. The health care professional stated she did not know what treatment or interventions were prescribed to the patient.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Anger, Crying, Decreased immune responsiveness, Depression, Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of depression in a adult female patient who received SHINGRIX for prophylaxis. On 21st September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 mg. In September 2018, less than a week after receiving SHINGRIX, the patient experienced depression, crying, decreased immune responsiveness and tiredness. On an unknown date, the outcome of the depression, crying, decreased immune responsiveness and tiredness were not recovered/not resolved. It was unknown if the reporter considered the depression, crying, decreased immune responsiveness and tiredness to be related to SHINGRIX. Additional details were provided as follows: The caller reported side affects from her 1st vaccine of SHINGRIX on 21st september 2018 (Friday), She reported she had depression, was crying constantly, tired, and her immune system was decreased. She reported she would not get the 2nd vaccine of SHINGRIX. No PQC, unable to obtain the physician's name and phone number secondary to call flow. The patient was angry because of side affects, would not get 2nd vaccine.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of depression in a adult female patient who received SHINGRIX for prophylaxis. On 21st September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 mg. In September 2018, less than a week after receiving SHINGRIX, the patient experienced depression, crying, decreased immune responsiveness and tiredness. On an unknown date, the outcome of the depression, crying, decreased immune responsiveness and tiredness were not recovered/not resolved. It was unknown if the reporter considered the depression, crying, decreased immune responsiveness and tiredness to be related to SHINGRIX. Additional details were provided as follows: The caller reported side affects from her 1st vaccine of SHINGRIX on 21st september 2018 (Friday), She reported she had depression, was crying constantly, tired, and her immune system was decreased. She reported she would not get the 2nd vaccine of SHINGRIX. No PQC, unable to obtain the physician's name and phone number secondary to call flow. The patient was angry because of side affects, would not get 2nd vaccine.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 60-year-old male patient who received SHINGRIX (batch number J4D5J, expiry date 8th February 2021) for prophylaxis. On 5th September 2018 18:00, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, less than a month after receiving SHINGRIX, the patient experienced headache, diarrhea, general body pain and fever. In September 2018, the outcome of the headache, diarrhea, general body pain and fever were recovered/resolved. It was unknown if the reporter considered the headache, diarrhea, general body pain and fever to be related to SHINGRIX. Additional details were provided as follows: The patient reported to the pharmacist that his symptoms lasted 7 to 10 days.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a elderly male patient who received SHINGRIX for prophylaxis. In September 2018, the patient received SHINGRIX. In September 2018, less than a week 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 recovering/resolving. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional was calling from her car and was not at the pharmacy to provide the patient's demographics, but she believed the male patient was around 67 years old. The patient was vaccinated with SHINGRIX about 8 days before the reporting date. The patient was reporting redness and swelling at the injection site that was still persisting at the time of reporting. The health care professional said that the patient stated the redness and swelling were mild and had began to improve.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 54-year-old female patient who received SHINGRIX (batch number B334Y, expiry date 17th October 2020) for prophylaxis. On 16th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th September 2018, 102 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: he patient was diagnosed with shingles on 26th September 2018 (reporting date). The health care professional stated that the patient was prescribed Valtrex to treat shingles.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of rash in a 55-year-old female patient who received SHINGRIX for prophylaxis. On 27th August 2018, the patient received the 1st dose of SHINGRIX. On 9th September 2018, 13 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.  It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The reporter was in the GlaxoSmithKline Health Clinic.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Mobility decreased, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 59-year-old female patient who received SHINGRIX (batch number KB99G, expiry date 22nd February 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose, no adverse events). On 11th September 2018, the patient received the 2nd dose of SHINGRIX(intramuscular) 50 ug. On 11th September 2018, less than a day after receiving SHINGRIX, the patient experienced fever, general body pain, stiff neck and chills. On an unknown date, the outcome of the fever, general body pain, stiff neck and chills were recovered/resolved. It was unknown if the reporter considered the fever, general body pain, stiff neck and chills to be related to SHINGRIX. Additional details were reported as follows: The patient experienced fever, chills, body aches and stiff neck after receiving a dose of SHINGRIX. The symptoms lasted 3 to 4 days, during which time she could not get out of bed. The patient did not have these symptoms after the 1st dose. The 1st dose was not administered at the present pharmacy where 2nd dose was administered.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles in a adult patient who received 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 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 reported as follows: The age at vaccination was not reported. The age group was not reported but was captured adult as per vaccine indication. The patient had a mild shingles outbreak before dose two of the SHINGRIX series. This request was coming in through queue. The physician did not specifically mention that the patient did receive the first dose of the SHINGRIX series, but was asking when the second dose could be given after a mild case of shingles. The patient might have the first dose of the series. The physician did not report any patient or vaccine details.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a adult patient who received 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 rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were reported as follows: The pharmacist called on behalf of the patient who was a physician. The age at vaccination was not reported. The age group was not reported but was captured adult as per vaccine indication. The reporting pharmacist did not provide any further details about the patient. The pharmacist stated that the patient would be able to provide further details upon contact. No further information was provided by the reporting pharmacist.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: General physical health deterioration
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of general physical health deterioration in a adult male patient who received FLUARIX QUADRIVALENT (batch number ZG3S5, expiry date 6th June 2017) for prophylaxis. In November 2016, the patient received FLUARIX QUADRIVALENT. On an unknown date, unknown after receiving FLUARIX QUADRIVALENT, the patient experienced general physical health deterioration. On an unknown date, the outcome of the general physical health deterioration was unknown. It was unknown if the reporter considered the general physical health deterioration to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The reported batch number ZG355 was corrected to ZG3S5 as per sales data review. The healthcare professional reported that, the patient received the FLUARIX QIV. After receiving the vaccine, the patient health deteriorated. The patient believed that it was from mercury in the medication. The letter was send to healthcare professional stating that, the FLUARIX does not contain thimerosal/mercury. No additional information was provided.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 75-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX vaccine (received years before the reporting date). In August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, 14 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: This case was previously reported to doctor. The patient received the vaccine on the right arm. He developed shingles 2 weeks after receiving SHINGRIX. The patient had denied permission to contact their physician.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult patient who received 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 pain in arm. On an unknown date, the outcome of the pain in arm was not reported. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable for this report. Several unspecified patients had reported a sore arm after a SHINGRIX injection. The patient had denied permission to contact their physician. The reporter said this in passing, but needed to get to MI for a stability question.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old male patient who received SHINGRIX for prophylaxis. On 25th September 2018, the patient received the 1st dose of SHINGRIX (inhaled). On 25th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on Left deltoid. The patient received SHINGRIX and experienced soreness in his left arm. The patient had denied permission to contact their physician. This case was linked with case US2018176527, reported by same reporter.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Myalgia, Poor quality sleep
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 24th September 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than a day after receiving SHINGRIX, the patient experienced poor quality sleep. On 25th September 2018, the patient experienced joint pain, muscle pain and tiredness. On an unknown date, the outcome of the joint pain, poor quality sleep, muscle pain and tiredness were unknown. It was unknown if the reporter considered the joint pain, poor quality sleep, muscle pain and tiredness to be related to SHINGRIX. Additional details were provided as follows: This case was reported via a live click to chat. The patient had terrible night sleep, awoke with muscle aches, joint pains and general tired feeling. The call center representative transferred the call to product specialist who works closely with this product and who was the pharmacist. The patient said that the side effects reported by the pharmacist were pretty common, they seemed to be fading with exercise and general movement, but he awoke with a SHINGRIX hangover. The patient was going to see his doctor on Wednesday and his wife had immediate access to her doctor as well, they just wanted to touch base to see if this was a normal reaction, which it appeared to be. This case was linked with the case US2018GSK174207, reported for his wife.
Sex: F
Vaccine: FLU4
Symptoms: Extensive swelling of vaccinated limb, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a female patient who received FLUARIX QUADRIVALENT 2018-2019 season) (batch number LB7NS, expiry date unknown) for prophylaxis. Previously administered products included influenza shot (received every year with no problem). In September 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season. In September 2018, less than a month after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced extensive swelling of vaccinated limb and injection site pain. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site pain were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site pain to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced swelling and pain from injection site almost down to her elbow. The patient was aware of the reactions but wondered why. The patient had a lot of sensitivities to different things and the patient would like to know how the Flu shot was made, straight up, all the details, how it was grown, in what type of matter and exactly what is added to it, every step and every product added to it or that it touches.
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Heart rate increased
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of chest pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, several hours after receiving SHINGRIX, the patient experienced chest pain and heartbeats increased. On an unknown date, the outcome of the chest pain and heartbeats increased were unknown. It was unknown if the reporter considered the chest pain and heartbeats increased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced chest pain and fast heart beats hours following administration. The reporter was agree to follow up from GlaxoSmithKline.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Lethargy, Pain, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 64-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of chills (fever and lethargy after receiving 1st dose in March 2018, refer case US2018175513). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced chills, lethargy and pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the chills, lethargy and pain were not recovered/not resolved. It was unknown if the reporter considered the chills, lethargy and pain to be related to SHINGRIX. Additional details were provided as follows: Approximately 3 to 4 weeks before the reporting date at around 1:00 pm, the patient received the 2nd dose. The patient again experienced the same symptoms as experienced after 1st dose.
Sex: U
Vaccine: DTAP
Symptoms: Product storage error
Clinical narrative: Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a physician. This case is linked to case 2018SA272032 and 2018SA271924 (same reporter). This case involves patients (unknown demographics) who received DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine (lot number, expiry date, dose, dose in series, route and site of administration was not reported). It was a case of actual medication error due to incorrect product storage. It was unknown if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 12.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Body temperature increased, Chills, Pain
Clinical narrative: Mom called 10/5/18 to state patient had 102 temp, with body aches and chills on 9/29/18 last until 9/30/18 (lasted 24 hrs) then was fine.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Neurological examination, Sensory loss, Skin warm
Clinical narrative: Patient was given TRUMENBA 9/28 and had small area of redness on arm. Possibly started to have some numbness that night. The next day she had increase in size of redness and it became quite warm. Also patient had loss of sensation to front and back of arm and hand below area of where shot was given (in a glove-like distribution). Patient was seen in office on 9/29 and had intact neurologic exam apart from endorsing a loss of sensation on exam. She was placed on KEFLEX for possible early cellulitis and was observed. Returned to care on 10/2 with persistent loss of sensation but improvement in erythema. A neurology referral was made.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Exposure during pregnancy
Clinical narrative: Initial pregnancy report received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 36 years old female patient who was exposed to expired vaccine FLUZONE QUADRIVALENT while she was pregnant. Pregnant currently. occurred at unknown gestation period, the date of last menstrual period was not reported, the estimated due date is 10-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines received on that day. On 26-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT5934NA (expiry date: 30-Jun-2018) via intramuscular route. It was a case of actual medication error due to expired vaccine used. It was also a case of Vaccine exposure during pregnancy. It was unknown whether patient experienced any adverse event. Pregnancy outcome is unknown. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling.Doctor said it was injection site reaction.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Mother reported swelling, pain ,redness, heat and occasional itching, that started at time of injection and continued after arriving home. Symptoms got worse the next day, with swelling and pain increased.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient called the pharmacy a few hours after receiving the vaccine and said her arm was red, warm, swollen, and she was having chills. I asked if she had a fever, if the pain was radiating down her arm or towards her chest; she answered no to both. No difficulty breathing. I told the patient to call back if things did not improve. Next morning, 10/4/18 I called the patient to check on her and she said she was doing better. She no longer had chills but her arm was still swollen, red, and warm. She was taking ALEVE and applying an ice pack to the site. Her son is a doctor so he looked at her arm on 10/4/18 that afternoon. Patient called and said her son also agreed that this was caused from the shot. I reinforced that anytime we administer a vaccine the arm could be sore, red, and swollen around the injection sire. She said she understood and she would monitor it. Today, 10/5/18 patient reported to her PCP because her arm was still red, swollen, and sore. They called in Cephalexin 500mg BID X 5 days. When the patient came into the pharmacy she asked to talk with me and she said that the doctor informed her that she received a Pneumo 23 back in 2014 and that she should not have received this vaccine. Our records indicated at the time that the patient had only received a PREVNAR 13. The patient showed me her arm and the redness and swelling was all the way down to her elbow but on the inside of her arm. It was not red at the injection site. Patient said she is going to go back to her PCP on Monday and that she would let me know after her appointment how she is doing.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Red swollen arm extending from shoulder to elbow.
Age: 0.33
Sex: M
Vaccine: UNK
Symptoms: Erythema multiforme
Clinical narrative: Patient was diagnosed with erythema multiforme. I was instructed to give him BENADRYL and watch for further complications.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, C-reactive protein increased, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: Was well at time of vaccination on 29 Sep. The following day he woke up with a runny nose and feeling a little weak. During the PM he developed chest discomfort, like an elephant sitting on chest, rated 8/10. No radiation, no n/v/diaphoresis. Reported SOB and pain increased when he was on his back. He went to the ED later that PM and was admitted. He denied problems with previous immunizations and never had pain like this before. He stated he was told he had pericarditis. Symptoms: CHEST PAIN, UNSPECIFIED (R079), OTH SPEC DISORD, NOSE & NAS SINES (J3489), WEAKNESS (R531).
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Myocardial necrosis marker normal, Pericarditis, Rhinorrhoea, Sinus disorder
Clinical narrative: Was well at time of vaccination on 29 Sep. The following day he woke up with a runny nose and feeling a little weak. During the PM he developed chest discomfort, like an elephant sitting on chest, rated 8/10. No radiation, no n/v/diaphoresis. Reported SOB and pain increased when he was on his back. He went to the ED later that PM and was admitted. He denied problems with previous immunizations and never had pain like this before. He stated he was told he had pericarditis. Symptoms: CHEST PAIN, UNSPECIFIED (R079), OTH SPEC DISORD, NOSE & NAS SINES (J3489), WEAKNESS (R531).
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Pyrexia, Urticaria
Clinical narrative: The evening of the vaccine my daughter had 103 fever, given TYLENOL and MOTRIN, woke with hives the next morning.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site reaction, Rash erythematous
Clinical narrative: Red rash around site of injection and tiredness.
Age: 80.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Product administered at inappropriate site
Clinical narrative: Patient came into the pharmacy on 10/3/18 to inform us she was treated with a medrol dose pack for shoulder pain after receiving her pneumonia vaccine too high in her arm. Patients states she had pain and had to seek treatment on 9/25/18. We called the doctor who treated her to inquire, his nurse  relayed to us that doctor said he could not say if the pain was from the vaccination, they could only say her shoulder was red, painful, and swollen. The patient states the medrol helped relieve much of the discomfort.
Age: 22.0
Sex: M
Vaccine: FLU4
Symptoms: Chest pain, Dyspnoea, Endotracheal intubation, Haemoptysis, Medical induction of coma
Clinical narrative: Started to experience shortness of breath and chest pain on 4Oct15. Was induced into a coma on 8Oct18 due to coughing up blood tinged fluid and having fluid build up around my heart. Was intubated for 4 days and kept in observation for several days after that.
Age: 22.0
Sex: M
Vaccine: FLU4
Symptoms: Pericardial effusion
Clinical narrative: Started to experience shortness of breath and chest pain on 4Oct15. Was induced into a coma on 8Oct18 due to coughing up blood tinged fluid and having fluid build up around my heart. Was intubated for 4 days and kept in observation for several days after that.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Induration, Pain, Tenderness
Clinical narrative: Pain, hardness, tender to touch  in left arm a few inches below site of shot in deltoid 1 day after. 3 days after patient experienced shift of redness, pain, area of tenderness to inside of bicep.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pharyngeal oedema, Swelling face
Clinical narrative: SWELLING IN THROAT THE NIGHT FOLLOWING VACCINATION AND AND SWELLING IN FACE THE FOLLOWING DAY.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Head discomfort
Clinical narrative: Patient received second dose of SHINGRIX and saw MD complaining of feeling off balance with some pressure in his forehead. Symptoms were improving when patient was seen on 08/30/2018.  MD believed symptoms were related to SHINGRIX vaccine.
Age: 24.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Exposure during pregnancy, Insomnia, Mobility decreased, Pain in extremity, Vomiting
Clinical narrative: I am due 12/23/18. In the arm I received the tdap vaccine I had severe soreness. I could barely move my arm and could not sleep because of the pain. Also shortly after getting home I was violently throwing up.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Patient began noticing a large, warm, red area appear on her right upper arm on Wednesday October 3rd near where she received her PNEUMOVAX vaccine. The area spread and became larger over the course of the next 2 days. The patient became concerned and went to the local ER where she was diagnosed with cellulitis of the upper right arm. The patient was started on a course of antibiotics on Friday October 5th.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain
Clinical narrative: Severe body aches, nausea, headaches for 4 days.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Loss of personal independence in daily activities, Pyrexia, Rash generalised, Rash pruritic
Clinical narrative: This was my booster shot. 24 hours after injection, the injection was dark pink in a 2-3 inch circumference. I began to have a rash all over my body. About 4 hours after that started, I felt feverish and had a 99.5 temperature. I felt run down and very tired. I called in to work the next morning and stayed home. That night the rash began to itch. I have been itching for nearly 24 hours now.  I do not know the brand of flu vaccine  that was given to me a few weeks ago.  I was not given any vaccinations with the shingles vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Noticed redness and swelling on day 4 (had bandaid on before so didn't notice). Itching on day 4 redness about 2 inches. Day 7 developed blotchy rash at injection site. Day 8 rash spread to about 3 inches, hot to the touch, very itchy, white where injection was and red around.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Rash macular
Clinical narrative: Noticed redness and swelling on day 4 (had bandaid on before so didn't notice). Itching on day 4 redness about 2 inches. Day 7 developed blotchy rash at injection site. Day 8 rash spread to about 3 inches, hot to the touch, very itchy, white where injection was and red around.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Constipation, Swelling
Clinical narrative: Patient reported kidney swelling, and inability to have a bowel movement to her physician.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Blood potassium decreased, Dizziness, Electrocardiogram normal, Full blood count normal, Heart rate increased
Clinical narrative: Within 1-2 hours of the shot I began having palpitations and felt as if my heart was racing. I had several dizzy spells and new syncopal episodes throughout the early part of the day. At around 9:30-10:00pm the dizziness worsened with extremity numbness and a lack of feeling in my extremities sort nausea. I went in to my bathroom and sat on the floor. I did not vomit, I did not lose consciousness but my body went in to a state of constant contraction with me being unable to release or move any extremities. I had  high heart rate and respiratory rate. This went on for 15-20 minutes while EMS arrived. My vitals were stable besides heart rate and respiratory rate. I was transported to a local hospital. In route I was given BENADRYL this slightly improved the contractions. At the hospital I was given ATIVAN which also helped release the contractions.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Laboratory test, Nausea, Palpitations, Respiratory rate increased
Clinical narrative: Within 1-2 hours of the shot I began having palpitations and felt as if my heart was racing. I had several dizzy spells and new syncopal episodes throughout the early part of the day. At around 9:30-10:00pm the dizziness worsened with extremity numbness and a lack of feeling in my extremities sort nausea. I went in to my bathroom and sat on the floor. I did not vomit, I did not lose consciousness but my body went in to a state of constant contraction with me being unable to release or move any extremities. I had  high heart rate and respiratory rate. This went on for 15-20 minutes while EMS arrived. My vitals were stable besides heart rate and respiratory rate. I was transported to a local hospital. In route I was given BENADRYL this slightly improved the contractions. At the hospital I was given ATIVAN which also helped release the contractions.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Within 1-2 hours of the shot I began having palpitations and felt as if my heart was racing. I had several dizzy spells and new syncopal episodes throughout the early part of the day. At around 9:30-10:00pm the dizziness worsened with extremity numbness and a lack of feeling in my extremities sort nausea. I went in to my bathroom and sat on the floor. I did not vomit, I did not lose consciousness but my body went in to a state of constant contraction with me being unable to release or move any extremities. I had  high heart rate and respiratory rate. This went on for 15-20 minutes while EMS arrived. My vitals were stable besides heart rate and respiratory rate. I was transported to a local hospital. In route I was given BENADRYL this slightly improved the contractions. At the hospital I was given ATIVAN which also helped release the contractions.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: 10/3/2018 3:00 AM WEAKNESS COULD NOT GET OUT OF BED WITHOUT HELP, SORENESS  AT INJECTION SITE, NO RASH, CHILLS, SHIVERING, FATIGUE BY 4:00 PM SHE SAID SHE WAS FINE.
Age: 62.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: PATIENT STATES HE EXPERIENCED FEVER, SORENESS IN ARMS, CHILLS, AND ACHES ALL OVER BODY.
Age: 67.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Diarrhoea, Fatigue, Hyperhidrosis, Rash papular
Clinical narrative: She reported that she developed chills and fatigue about 4 hours after vaccine. Followed by several episodes of diarrhea that continued to the following day. No documented fever but she had chills and sweats. Also reported itching of neck and torso with redness and fine popular rash on neck and chest (not seen in office the day patient was seen by me on 10/5/18). The patient was afebrile and had normal stools on 10/5/18 and was feeling better.
Age: 67.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash pruritic
Clinical narrative: She reported that she developed chills and fatigue about 4 hours after vaccine. Followed by several episodes of diarrhea that continued to the following day. No documented fever but she had chills and sweats. Also reported itching of neck and torso with redness and fine popular rash on neck and chest (not seen in office the day patient was seen by me on 10/5/18). The patient was afebrile and had normal stools on 10/5/18 and was feeling better.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red patch inferior to injection site at left arm that is warm to touch. Decline any other symptoms of fever, chills, feeling ill/weak, no shortness of breath, eating fine.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Computerised tomogram abdomen normal, Computerised tomogram head normal, Decreased appetite
Clinical narrative: About 5 pm, went out to dinner, having chills, couldnt eat much, feeling cold, thirsty, dizziness came on @ 7pm, aching all over, temperature was 101 degrees F, hurt all night, severe headache and neck pain, then next day, radiating pain to abdomen/extremities that evening, thinks she had a seizure on Saturday, fell down and injured face, on Sunday morning, extreme pain still and fever 102, went to ER at some point in the afternoon, ran tests, stayed in hospital, fever broke on Wed morning and discharged on Wed, Oct 3rd in the evening on 7 or so different medications, MD determined it was from the SHINGRIX vaccine.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Face injury, Fall, Feeling cold, Headache
Clinical narrative: About 5 pm, went out to dinner, having chills, couldnt eat much, feeling cold, thirsty, dizziness came on @ 7pm, aching all over, temperature was 101 degrees F, hurt all night, severe headache and neck pain, then next day, radiating pain to abdomen/extremities that evening, thinks she had a seizure on Saturday, fell down and injured face, on Sunday morning, extreme pain still and fever 102, went to ER at some point in the afternoon, ran tests, stayed in hospital, fever broke on Wed morning and discharged on Wed, Oct 3rd in the evening on 7 or so different medications, MD determined it was from the SHINGRIX vaccine.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, Neck pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: About 5 pm, went out to dinner, having chills, couldnt eat much, feeling cold, thirsty, dizziness came on @ 7pm, aching all over, temperature was 101 degrees F, hurt all night, severe headache and neck pain, then next day, radiating pain to abdomen/extremities that evening, thinks she had a seizure on Saturday, fell down and injured face, on Sunday morning, extreme pain still and fever 102, went to ER at some point in the afternoon, ran tests, stayed in hospital, fever broke on Wed morning and discharged on Wed, Oct 3rd in the evening on 7 or so different medications, MD determined it was from the SHINGRIX vaccine.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Thirst
Clinical narrative: About 5 pm, went out to dinner, having chills, couldnt eat much, feeling cold, thirsty, dizziness came on @ 7pm, aching all over, temperature was 101 degrees F, hurt all night, severe headache and neck pain, then next day, radiating pain to abdomen/extremities that evening, thinks she had a seizure on Saturday, fell down and injured face, on Sunday morning, extreme pain still and fever 102, went to ER at some point in the afternoon, ran tests, stayed in hospital, fever broke on Wed morning and discharged on Wed, Oct 3rd in the evening on 7 or so different medications, MD determined it was from the SHINGRIX vaccine.
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: Red patch inferior to injection site at left arm. Site is warm to the touch. Declines any fever, SOB, chills. Treated for cellulitis - AUGMENTIN.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Fainted approx. 5 min after receiving vaccination, was revived immediately and felt back to normal about 5 min after incident.
Age: 1.58
Sex: F
Vaccine: DTAPIPV, FLU4, HEPA
Symptoms: Erythema, Injection site induration, Injection site nodule, Peripheral swelling, Skin warm
Clinical narrative: Her right thigh was bright red, hot-to-touch, very swollen with a large, hard knot under the injection site within 15 hours. It has now been 48 hours, the redness, swelling, and fever has spread further out. I have tried cold compresses, topical BENADRYL, and TYLENOL. I have contacted the Dr's office 2 times with concerns and provided a picture. They have told me it is a normal reaction and should clear up in 5-7 days. I have talked to other medical professionals and after seeing her leg, they do not think it is normal.
Age: 52.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Full blood count, Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Patient stated that on 10/2/18 at 1900 he came down with a fever of 103 and then by 2200 his temp came down to 101 and by 00 his temp was below 100. On 10/3 he noticed swelling at the site of injection on his left arm where the PPSV23 and flu vaccines were given and area was hot to the touch and on 10/4 his arm became painful. 10/5 he called into the medical office and reported his symptoms and stated that he had been taking Ibuprofen and Tylenol and that the swelling had gone down but that it was still red and he could feel a lump. An appointment was made for him to be seen. (at time of this report appointment had not yet taken place).
Age: 52.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Monocyte count increased, Neutrophil count increased, Pyrexia, White blood cell count increased
Clinical narrative: Patient stated that on 10/2/18 at 1900 he came down with a fever of 103 and then by 2200 his temp came down to 101 and by 00 his temp was below 100. On 10/3 he noticed swelling at the site of injection on his left arm where the PPSV23 and flu vaccines were given and area was hot to the touch and on 10/4 his arm became painful. 10/5 he called into the medical office and reported his symptoms and stated that he had been taking Ibuprofen and Tylenol and that the swelling had gone down but that it was still red and he could feel a lump. An appointment was made for him to be seen. (at time of this report appointment had not yet taken place).
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site induration, Neuralgia, Pain, Pain in extremity
Clinical narrative: Patient reported significant pain, including nerve pain shooting down her arm and into her hand.  She also noticed a hardened area at the site of the vaccine and a band of redness around her arm.  No treatment was given, but the symptoms initiated within a couple of hours after vaccine administration and lasted for about 4 days.
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Peripheral swelling, Skin warm
Clinical narrative: Employee received flu vaccine at a workplace influenza vaccine administration clinic. She later noted a warm arm and swelling. She reports feeling tired. She treated with ice packs and oral diphenhydramine. Improvement noted in 2 days.