chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Ligament pain, Neuralgia, Pain in extremity, Tendon pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included nerve pain (experience 15 years ago in his right arm that was caused by neck issues.) and neck discomfort (neck issue). Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose, refer case US2018196933). On 9th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 9th August 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 23rd August 2018, the patient experienced ligament pain and tendon pain. On an unknown date, the patient experienced nerve pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm was resolved with sequelae and the outcome of the ligament pain, tendon pain and nerve pain were recovering/resolving. The reporter considered the pain in arm, ligament pain and tendon pain to be related to SHINGRIX. The reporter considered the nerve pain to be unrelated to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right deltoid and experienced arm pain. Fourteen days after receiving SHINGRIX, the patient experienced additional ligament or tendon pain the radiates from where the vaccine was administered in the shoulder to the elbow. Less than a year after receiving SHINGRIX, the patient had nerve pain in his left arm and he did not feel that it was related to the SHINGRIX vaccination.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included nerve pain (experience 15 years ago in his right arm that was caused by neck issues.) and neck discomfort (neck issue). Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose, refer case US2018196933). On 9th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 9th August 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 23rd August 2018, the patient experienced ligament pain and tendon pain. On an unknown date, the patient experienced nerve pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm was resolved with sequelae and the outcome of the ligament pain, tendon pain and nerve pain were recovering/resolving. The reporter considered the pain in arm, ligament pain and tendon pain to be related to SHINGRIX. The reporter considered the nerve pain to be unrelated to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right deltoid and experienced arm pain. Fourteen days after receiving SHINGRIX, the patient experienced additional ligament or tendon pain the radiates from where the vaccine was administered in the shoulder to the elbow. Less than a year after receiving SHINGRIX, the patient had nerve pain in his left arm and he did not feel that it was related to the SHINGRIX vaccination.
Age: 63.0
Sex: M
Vaccine: VARZOS, PPV, VARZOS
Symptoms: Arthralgia, Chest pain, Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included Pneumonia Vaccine for prophylaxis. The patient's past medical history included Bell's palsy (years before the date of reporting). Concomitant products included REMICADE. On 15th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received Pneumonia Vaccine (intramuscular). On 15th October 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. In October 2018, the patient experienced wrist pain, radiating pain and mobility decreased. The patient was treated with VICKS VAPORUB. On an unknown date, the outcome of the pain in arm and mobility decreased were recovered/resolved and the outcome of the wrist pain and radiating pain were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, wrist pain, radiating pain and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and Pneumonia vaccine on the left arm. The patient experienced soreness at injection site the day of vaccination and four days later he experienced a wave of soreness from chest to shoulder to hips to his legs and the patient could hardly move. This lasted for 3 days and he recovered. Less than a month after receiving SHINGRIX, the patient joint pain in his wrist and while moving thumbs. This occurred on both hands but it was more dominant on his left hand. On 29th October 2018, the site of injection and his arm was very painful. The patient applied VICKS VAPORUB everywhere to help it provided some relief but it was very painful. The patient gave consent to follow up and gave permission to contact his healthcare provider (HCP). The patient was referred to his HCP. It was unknown if the reporter considered the pain in arm, wrist pain, radiating pain and mobility decreased to be related to Pneumonia vaccine. No further details were provided.
Age: 63.0
Sex: M
Vaccine: VARZOS, PPV, VARZOS
Symptoms: Toothache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included Pneumonia Vaccine for prophylaxis. The patient's past medical history included Bell's palsy (years before the date of reporting). Concomitant products included REMICADE. On 15th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received Pneumonia Vaccine (intramuscular). On 15th October 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. In October 2018, the patient experienced wrist pain, radiating pain and mobility decreased. The patient was treated with VICKS VAPORUB. On an unknown date, the outcome of the pain in arm and mobility decreased were recovered/resolved and the outcome of the wrist pain and radiating pain were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, wrist pain, radiating pain and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and Pneumonia vaccine on the left arm. The patient experienced soreness at injection site the day of vaccination and four days later he experienced a wave of soreness from chest to shoulder to hips to his legs and the patient could hardly move. This lasted for 3 days and he recovered. Less than a month after receiving SHINGRIX, the patient joint pain in his wrist and while moving thumbs. This occurred on both hands but it was more dominant on his left hand. On 29th October 2018, the site of injection and his arm was very painful. The patient applied VICKS VAPORUB everywhere to help it provided some relief but it was very painful. The patient gave consent to follow up and gave permission to contact his healthcare provider (HCP). The patient was referred to his HCP. It was unknown if the reporter considered the pain in arm, wrist pain, radiating pain and mobility decreased to be related to Pneumonia vaccine. No further details were provided.
Age: 63.0
Sex: M
Vaccine: VARZOS, PPV, VARZOS
Symptoms: Arthralgia, Chest pain, Injection site pain, Mobility decreased, Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included Pneumonia Vaccine for prophylaxis. The patient's past medical history included Bell's palsy (years before the date of reporting). Concomitant products included REMICADE. On 15th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received Pneumonia Vaccine (intramuscular). On 15th October 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. In October 2018, the patient experienced wrist pain, radiating pain and mobility decreased. The patient was treated with VICKS VAPORUB. On an unknown date, the outcome of the pain in arm and mobility decreased were recovered/resolved and the outcome of the wrist pain and radiating pain were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, wrist pain, radiating pain and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and Pneumonia vaccine on the left arm. The patient experienced soreness at injection site the day of vaccination and four days later he experienced a wave of soreness from chest to shoulder to hips to his legs and the patient could hardly move. This lasted for 3 days and he recovered. Less than a month after receiving SHINGRIX, the patient joint pain in his wrist and while moving thumbs. This occurred on both hands but it was more dominant on his left hand. On 29th October 2018, the site of injection and his arm was very painful. The patient applied VICKS VAPORUB everywhere to help it provided some relief but it was very painful. The patient gave consent to follow up and gave permission to contact his healthcare provider (HCP). The patient was referred to his HCP. It was unknown if the reporter considered the pain in arm, wrist pain, radiating pain and mobility decreased to be related to Pneumonia vaccine. No further details were provided.
Age: 63.0
Sex: M
Vaccine: VARZOS, PPV, VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included Pneumonia Vaccine for prophylaxis. The patient's past medical history included Bell's palsy (years before the date of reporting). Concomitant products included REMICADE. On 15th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received Pneumonia Vaccine (intramuscular). On 15th October 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. In October 2018, the patient experienced wrist pain, radiating pain and mobility decreased. The patient was treated with VICKS VAPORUB. On an unknown date, the outcome of the pain in arm and mobility decreased were recovered/resolved and the outcome of the wrist pain and radiating pain were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, wrist pain, radiating pain and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and Pneumonia vaccine on the left arm. The patient experienced soreness at injection site the day of vaccination and four days later he experienced a wave of soreness from chest to shoulder to hips to his legs and the patient could hardly move. This lasted for 3 days and he recovered. Less than a month after receiving SHINGRIX, the patient joint pain in his wrist and while moving thumbs. This occurred on both hands but it was more dominant on his left hand. On 29th October 2018, the site of injection and his arm was very painful. The patient applied VICKS VAPORUB everywhere to help it provided some relief but it was very painful. The patient gave consent to follow up and gave permission to contact his healthcare provider (HCP). The patient was referred to his HCP. It was unknown if the reporter considered the pain in arm, wrist pain, radiating pain and mobility decreased to be related to Pneumonia vaccine. No further details were provided.
Age: 71.0
Sex: F
Vaccine: IPV, IPV
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 09-Nov-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 71 years old female patient who received 0.5 mL dose of vaccine IPOL lot N1G411M, expiry date: 28-Jul-2019 via intradermal route in the right arm on 09-NOV-2018 instead of TUBERSOL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to Wrong vaccine administered. It was reported that female patient received IPOL instead of TUBERSOL for PPD skin test. No known reported symptoms. 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. Documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: IPV, IPV
Symptoms: Incorrect route of product administration, Wrong product administered
Clinical narrative: Initial information received on 09-Nov-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 71 years old female patient who received 0.5 mL dose of vaccine IPOL lot N1G411M, expiry date: 28-Jul-2019 via intradermal route in the right arm on 09-NOV-2018 instead of TUBERSOL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to Wrong vaccine administered. It was reported that female patient received IPOL instead of TUBERSOL for PPD skin test. No known reported symptoms. 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. Documents held by sender: none.
Age: 59.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Patient  called and stated "I have an axillary lymph node the size of her hand" and states it tender, and she has been putting heat on it. She states it is getting progressively larger. Advised patient to follow with her PCP, and to call her rheumatology Dr. Patient stated she had a positive ANA, and was being worked up for Rheumatoid vs Psoriatic arthritis. She states she is going to be started on methotrexate and her Dr. wanted her to get a flu shot.
Age: 59.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Antinuclear antibody positive, Lymph node pain, Lymphadenopathy
Clinical narrative: Patient  called and stated "I have an axillary lymph node the size of her hand" and states it tender, and she has been putting heat on it. She states it is getting progressively larger. Advised patient to follow with her PCP, and to call her rheumatology Dr. Patient stated she had a positive ANA, and was being worked up for Rheumatoid vs Psoriatic arthritis. She states she is going to be started on methotrexate and her Dr. wanted her to get a flu shot.
Age: 33.0
Sex: F
Vaccine: HEPAB
Symptoms: Diarrhoea, Malaise, Nausea, Pyrexia, Vomiting
Clinical narrative: General malaise and fever began two hours after vaccination. Diarrhea began three hours after vaccination. Nausea and vomiting began five hours after vaccination.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Pain, Pain in extremity
Clinical narrative: Starting within 3 hours of initial injection, sharp, burning pain started in left deltoid, and progressively radiated downward into the left elbow, radius, and thumb. Effects have resisted anti inflammatory medication and Epsom salt soaks. Symptoms have lasted 9 days.
Age: 73.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches, headache.
Age: 0.75
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Crying, Decreased appetite, Dizziness, Fatigue, Insomnia
Clinical narrative: Vomiting, Fever over 104 for three days, Rash in whole body, Lack of appetite, Tired, Dizzy, lack of sleep, crying.
Age: 0.75
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pyrexia, Rash generalised, Vomiting
Clinical narrative: Vomiting, Fever over 104 for three days, Rash in whole body, Lack of appetite, Tired, Dizzy, lack of sleep, crying.
Age: 0.92
Sex: M
Vaccine: MMR
Symptoms: Crying, Dizziness, Fatigue, Pyrexia, Vomiting
Clinical narrative: Fever over 105 for three days, nonstop crying for a day and night, tired, dizzy, vomiting.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Dizziness, Headache, Nausea, Pain
Clinical narrative: C/o feeling dizzy, had a terrible HA, body aches and extreme nausea. More intense than previously experienced.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Local reaction, Pruritus, Rash, Urticaria
Clinical narrative: FLUARIX Quadrivalent given IM right deltoid at 1500 / 14 November 2018. Approximately 1700; developed hives on right thigh with localized pain in spreading rash area, very itchy and body chills.   15 November 2018 - no pain or chills and rash is not spreading, but continues to itch. 16 November 2016 - no pain or chills, rash is not spreading and itching is less.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site rash, Nodule
Clinical narrative: Rash around injection site, knot in arm that moved towards elbow and red ring around elbow.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Chills, Fatigue, Headache
Clinical narrative: Very bad headache lasting 12 hours; chills; fatigue requiring complete bedrest for 24 hours.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy were not provided. On 18-OCT-2018, the patient was administered with a dose of expired M-M-R II (expiration date 26-SEP-2018, lot # M039914, therapy type recombinant Human albumin (rHA)) (strength, dose, frequency and route were not reported) and sterile diluent for prophylaxis. No adverse event reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 17-OCT-2018 or 22-OCT-2018 the patient was vaccinated with improperly stored VARIVAX (lot # N029628 and expiration date 23-NOV-2019, route, strength, dose and frequency were not reported) for prophylaxis. Medical assistant also reported the sterile diluent (lot # M041989 and expiration date 03-JUL-2019) used to reconstitute VARIVAX did not undergo a temperature excursion. No adverse effects were reported. The temperature excursion was 6 Fahrenheit to 14 Fahrenheit (12 Fahrenheit) for 1 hour and 59 minutes. The previous excursion was 6 Fahrenheit to 14 Fahrenheit for 47 hours and 57 minutes and 15 Fahrenheit to 46 Fahrenheit for 39 hours and 57 minutes. The call was because of a data logger. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1810USA012249: US-009507513-1810USA012248.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an medical assistant and referred to a unknown age female patient. The patient's medical history, other relevant condition and concomitant medications were not reported. On 25-OCT-2018, the patient was vaccinated with an expired dose of VAQTA intramuscular, lot number: N020689, expiration date: 22-OCT-2018 for prophylaxis (dosage schedule and anatomical location were not provided). No adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent condition, medical history, drug reactions or allergies was unknown. Concomitant medication therapies included sterile diluent. On 29-OCT-2018, the patient received 2 doses of PROQUAD rHA (recombinant Human albumin) (lot # R015738 with expiration date auto-populated as 12-FEB-2019; strength and dose detail were not provided) subcutaneously for prophylaxis (overdose). No adverse effect was reported.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: Information has been received from a 71 years old male patient. Concomitant therapies included CRESTOR and drug reactions included penicillin. The patient had no medical history. On 11-OCT-2018, the patient was vaccinated with the 1st dose of PNEUMOVAX 23 (lot # R018735, expiration date 06-APR-2020, indication reported as recommended vaccine) on left shoulder and the patient presumed in the muscle. On 13-OCT-2018, the patient developed a bump about an inch in diameter on his arm which was painful and his whole left shoulder area was sore. The patient sought the medical attention via office visit and unspecified treatment was given for the events. No lab diagnostics/studies were performed. The outcome of the events was not recovered. Causality assessment was not provided by the reporter.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Skin warm
Clinical narrative: Information has been received from an office manager via a company representative referring to a 73 year old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown by reporter. On 31-OCT-2018, the patient received an injection of PNEUMOVAX 23 (intramuscular, 1 x 0.5 mL dose; strength, batch/lot # and expiration date were not reported) for prophylaxis (reported as prevention of pneumonia). On the same date, the patient experienced cellulitis on her right arm and her arm was warm to the touch from below the deltoid to below the elbow. At the time of report, the patient had recovered from the events. The treatment was given for the events. The patient had sought medical attention. Information about lab diagnostics/studies was unknown by reporter.The causality was not reported. Upon internal review, the event of cellulitis of arm was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 14-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 01-NOV-2014, the patient's healthcare provider at a medical center administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 29-APR-2017, the patient was treated by the patient's healthcare providers at a hospital emergency department for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a nurse referring to a 5-year old patient (gender not reported). The patient's medical history, concurrent conditions and concomitant medications were not reported. On 18-OCT-2018, the 5-year old patient was administered with GARDASIL 9 (Lot: N035032; expiry date: 24-SEP-2020). No adverse effects reported.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Eczema
Clinical narrative: My son developed signs of Eczema exactly 10 days after getting these vaccinations. I went to the doctor later on thinking it was a rash and they dismissed me saying that was all it was. As the days passed it got worse and worse. Now it is so bad I have to cake him up in AVEENO eczema lotion every day. We went back to the doctor again, same one, and they finally said "yeah, that does look like eczema".
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: "3 CM BY 3 CM AREA OF HOT, ERTHYMATOUS EDEMATOUS SKIN AT THE INJECTION SITE" "TENDER TO THE TOUCH".
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus
Clinical narrative: Client stated that he was experiencing some redness and itchiness on 11/13/2018 at FLU injection site on LUA. Client denies receiving any other vaccine or injury to arm post vaccination and prior to. Client stated that the area is "dime size"  flat and with some redness and itchiness. Denies any numbness, tingling, pain and has full ROM of hand and arm. Denies any fever or illness. Client stated that he had the FLU vaccine before in previous years with no reaction but had not received the high dose. This nurse advised client to have area evaluated by his PCP or walk in facility asap. Client stated that he was going to Clinic on 11/15/2018. I spoke with the client on 11/15/2018 and he was going to have it evaluated after our phone conversation.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Ataxia, Back pain, Disturbance in attention, Fatigue
Clinical narrative: Patient reports: shock-like sensation in fingers of left hand (only the first evening and following day) dull ache along spine, especially affecting neck and lower back (began the second day and continues in the present). Extreme fatigue, body aching (began the second day and continues in the present). Numbness on the bottom of the left foot (began the second day and continues in the present). Problem with gait-ataxia (began the second day and continues in the present). Dull headache, impeding ability to focus (began the second day and continues in the present). Weakness/feeling of heaviness in limbs. Intermittent feelings of overall weakness (began the second day and continues in the present). Patient's medications include (in addition to the above): Low-dose Naltrexone (see available literature on novel treatment for pain); supplement: Alpha Lipoic Acid. At this point, one cannot fully respond to the question under "Result or Outcome of the Adverse Event" concerning the transience or performance of the patient's symptoms. After twelve days, the patient's symptoms have not resolved or improved.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Hypoaesthesia, Limb discomfort, Neck pain, Pain
Clinical narrative: Patient reports: shock-like sensation in fingers of left hand (only the first evening and following day) dull ache along spine, especially affecting neck and lower back (began the second day and continues in the present). Extreme fatigue, body aching (began the second day and continues in the present). Numbness on the bottom of the left foot (began the second day and continues in the present). Problem with gait-ataxia (began the second day and continues in the present). Dull headache, impeding ability to focus (began the second day and continues in the present). Weakness/feeling of heaviness in limbs. Intermittent feelings of overall weakness (began the second day and continues in the present). Patient's medications include (in addition to the above): Low-dose Naltrexone (see available literature on novel treatment for pain); supplement: Alpha Lipoic Acid. At this point, one cannot fully respond to the question under "Result or Outcome of the Adverse Event" concerning the transience or performance of the patient's symptoms. After twelve days, the patient's symptoms have not resolved or improved.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia, Spinal pain
Clinical narrative: Patient reports: shock-like sensation in fingers of left hand (only the first evening and following day) dull ache along spine, especially affecting neck and lower back (began the second day and continues in the present). Extreme fatigue, body aching (began the second day and continues in the present). Numbness on the bottom of the left foot (began the second day and continues in the present). Problem with gait-ataxia (began the second day and continues in the present). Dull headache, impeding ability to focus (began the second day and continues in the present). Weakness/feeling of heaviness in limbs. Intermittent feelings of overall weakness (began the second day and continues in the present). Patient's medications include (in addition to the above): Low-dose Naltrexone (see available literature on novel treatment for pain); supplement: Alpha Lipoic Acid. At this point, one cannot fully respond to the question under "Result or Outcome of the Adverse Event" concerning the transience or performance of the patient's symptoms. After twelve days, the patient's symptoms have not resolved or improved.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Electrocardiogram ST segment elevation
Clinical narrative: Diarrhea. Chills. Arm pain  arm red 2" circle are place of shot. Stomach pain. General ill feeling. Weakness light headed. Tired.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Malaise, Pain in extremity
Clinical narrative: Diarrhea. Chills. Arm pain  arm red 2" circle are place of shot. Stomach pain. General ill feeling. Weakness light headed. Tired.
Age: 39.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT RECEIVED FLUBLOK DUE TO EGG ALLERGY. WITHIN 20 MINUTES OF RECEIVING VACCINE, INJECTION SITE BEGAN ITHCING. WITHIN 2 HOURS OF RECEIVING VACCINE, INJECTION SITE BECAME RED AND SWOLLEN. ON 11-15-18 AT APPROXIMATELY 9:00AM, INJECTION SITE RED, SWOLLEN  AND HOT TO TOUCH. ON 11-16-18 AT 9:00AM, PATIENT SEEN BY HEALTHCARE PROVIDER.  PER CNP, AREA ERYTHEMATIS-13cmX7cm, NO SWELLING NOTED. NOT HOT TO TOUCH. NO SIGNS OR SYMPTOMS OF INFECTION.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Loss of personal independence in daily activities, Pain
Clinical narrative: Moderate pain when moving arm. Difficulty getting dressed due to pain on movement of arm. No swelling, redness, or warmth at injection site. No fever. No pain when injection site touched. Injection administered 2 1/2 inches below shoulder into deltoid muscle.
Age: 67.0
Sex: M
Vaccine: FLUC4
Symptoms: Influenza like illness, Laboratory test normal
Clinical narrative: Was sick with flu type symptoms foe 10 days.
Age: 48.0
Sex: F
Vaccine: PNC13
Symptoms: Insomnia, Mobility decreased
Clinical narrative: I cannot move my arm. I was up most of the night and I still have very limited arm movement. It is even very difficult to complete this form.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Dizziness, nausea, sweating
Age: 67.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Injection site nodule
Clinical narrative: Patient describes "knot" at injection site weeks after injection.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Angioedema, Ear swelling, Mouth swelling, Swelling of eyelid, Vomiting
Clinical narrative: Dr notified by mother, I called mom "child was riding back home with dad when eye lids started swelling, then mouth, then ear lobes. Went to ER got Epipen shot and kept overnight for observation" - angioedema with vomiting treated with steroids and epinephrine.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 26.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Headache, Hypoaesthesia, Influenza, Nasopharyngitis, Pruritus generalised
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 26 year old Adult female patient. Patient had no pertinent medical history, drug allergies or reactions and concomitant medication. On 30-OCT-2018, the patient was vaccinated with VARIVAX lot # R011806, expiration date: 23-APR-2020, in the left arm for prophylaxis. Other suspect therapies included BOOSTRIX and sterile diluent. On 30-OCT-2018, the patient experienced itching all over, cold and flu symptoms, fever, headache and numbness in her left arm (pyrexia, hypoaesthesia, nasopharyngitis, influenza like illness and pruritus generalized). On 02-NOV-2018. Patient sought medical attention from pharmacist and reported that the patient was still experiencing headache, pruritus generalised, pyrexia, hypoaesthesia, nasopharyngitis and influenza like illness and instructed her to take unspecified doses of TYLENOL and BENADRYL as needed to heal events. No laboratory diagnostics were performed. The outcome of the event was as not resolved. The causality assessment between itching all over, cold and flu symptoms, fever, headache and numbness in her left arm and VARIVAX was not provided.
Age: 26.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 26 year old Adult female patient. Patient had no pertinent medical history, drug allergies or reactions and concomitant medication. On 30-OCT-2018, the patient was vaccinated with VARIVAX lot # R011806, expiration date: 23-APR-2020, in the left arm for prophylaxis. Other suspect therapies included BOOSTRIX and sterile diluent. On 30-OCT-2018, the patient experienced itching all over, cold and flu symptoms, fever, headache and numbness in her left arm (pyrexia, hypoaesthesia, nasopharyngitis, influenza like illness and pruritus generalized). On 02-NOV-2018. Patient sought medical attention from pharmacist and reported that the patient was still experiencing headache, pruritus generalised, pyrexia, hypoaesthesia, nasopharyngitis and influenza like illness and instructed her to take unspecified doses of TYLENOL and BENADRYL as needed to heal events. No laboratory diagnostics were performed. The outcome of the event was as not resolved. The causality assessment between itching all over, cold and flu symptoms, fever, headache and numbness in her left arm and VARIVAX was not provided.
Age: 62.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Back pain, Blood test normal, Nuclear magnetic resonance imaging normal, Pain in extremity, Walking aid user
Clinical narrative: This is a spontaneous report from a contactable consumer. A 62-year-old male patient received PREVNAR 13 via an unspecified route of administration on the right arm at single dose for immunization and FLUARIX, intramuscular at 0.5 ml, single for flu shot, both from 23Oct2018. Medical history included Herniated disc since 2015, Open heart surgery and Heart attack in 2004, cardiac stent in 2015. There were no concomitant medications. Her husband received a PREVNAR 13 injection on 23Oct2018. He also received a flu shot at the same time in different arms and started to get pain in his lower back that radiated down the legs. She described the pain like burning or hurting. It did not get any better over time. On 29Oct2018 they had to call an ambulance and he was transported to the hospital. He had a MRI that did not find anything wrong. He does have a herniated disc which occurred prior to receiving the PREVNAR 13. They gave him a steroid injection and sent him home. He saw a neuro surgeon on 02Nov2018. They did not find anything wrong. As of today he is still not any better. He was worse than he's ever been. He was using a couple of canes to walk. Caller adds that her husband was very upset and is in pain. Caller adds that her husband had blood work and X-rays that didn't show anything. Stated her husband was supposed to see a pain management doctor. Her husband has tried muscle relaxers. They didn't do anything for him. Caller adds it seemed so strange. When he got the injection, the needle was so long and it seemed to take forever and her husband hurt so bad afterwards like the needle went to the bone. She states her husband has never experienced anything like this before. She was not sure how long the needle was supposed to be but states it was long. The doctor said their hands were tied too. Operating will not relieve this and the doctor does not know want to do. He will be set up with pain management for epidural injections. The outcome of the events pain in the lower back and down the legs and walking with canes was not recovered while unknown for the other events.
Age: 62.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: X-ray normal
Clinical narrative: This is a spontaneous report from a contactable consumer. A 62-year-old male patient received PREVNAR 13 via an unspecified route of administration on the right arm at single dose for immunization and FLUARIX, intramuscular at 0.5 ml, single for flu shot, both from 23Oct2018. Medical history included Herniated disc since 2015, Open heart surgery and Heart attack in 2004, cardiac stent in 2015. There were no concomitant medications. Her husband received a PREVNAR 13 injection on 23Oct2018. He also received a flu shot at the same time in different arms and started to get pain in his lower back that radiated down the legs. She described the pain like burning or hurting. It did not get any better over time. On 29Oct2018 they had to call an ambulance and he was transported to the hospital. He had a MRI that did not find anything wrong. He does have a herniated disc which occurred prior to receiving the PREVNAR 13. They gave him a steroid injection and sent him home. He saw a neuro surgeon on 02Nov2018. They did not find anything wrong. As of today he is still not any better. He was worse than he's ever been. He was using a couple of canes to walk. Caller adds that her husband was very upset and is in pain. Caller adds that her husband had blood work and X-rays that didn't show anything. Stated her husband was supposed to see a pain management doctor. Her husband has tried muscle relaxers. They didn't do anything for him. Caller adds it seemed so strange. When he got the injection, the needle was so long and it seemed to take forever and her husband hurt so bad afterwards like the needle went to the bone. She states her husband has never experienced anything like this before. She was not sure how long the needle was supposed to be but states it was long. The doctor said their hands were tied too. Operating will not relieve this and the doctor does not know want to do. He will be set up with pain management for epidural injections. The outcome of the events pain in the lower back and down the legs and walking with canes was not recovered while unknown for the other events.
Sex: F
Vaccine: PNC13
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: Upon receipt of follow-up information on 06Nov2018, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A 8-decade-old (in her 70s) female patient received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that it was both swollen at injection and inflamed on an unspecified date for a couple of days with no restriction of movement. The outcome of the events was unknown. Information on batch number has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Patient has rash and swelling at injection site rash is warm to touch, and itchy. Rash is about the size of palm. Patient's PCP diagnosed the rash as cellulitis and pt is treated with 7 days at KEFLEX.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Electrocardiogram normal, Pain in extremity, Vaccination complication
Clinical narrative: Arm was sore 3-4 days. 2-3 after vaccine felt weak 7-10 days. Pt went to ER and was told it was a reaction to shot.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: She had redness and inflammation on her shoulder that had received the injection.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Hepatic enzyme increased, Influenza like illness, Laboratory test normal
Clinical narrative: Flu like symptoms, ER for Treatment at MC, elevated liver enzymes, 1 week later repeat labs and they had doubled. Admitted inpatient where levels continued to rise before beginning to decline after 2 days. Follow up testing included multiple GI tests and all were negative. Provider instructed, no cause identified and will default to influenza vaccine being cause.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Headache, Pain
Clinical narrative: On 11/15/2018 at 3:30PM reported recurring "headache since that afternoon" (afternoon of vaccination, 11/13/2018); perhaps recurring due to relief by, then wearing off of, OTC analgesics. Also reported joint pain/ ache when turning over in bed, which started "that night, I guess." Requested that these symptoms be documented.
Age: 9.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity, Pallor, Pyrexia
Clinical narrative: Per family phone call within 24 hours of vaccination patient developed fever, sore arm with a red raised area around the injection site. No respiratory/airway issues discussed. 48 hours later she had fevers and was pale with continue red raised area around the injection site.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pain during administration. Over the next week post-vaccination the pain continued to increase into shoulder. The following week, the patient experienced a great deal of pain in right shoulder and arm making it difficult to do certain tasks. She has been seen by urgent care who prescribed prednisolone. She followed up with her PCP and now has a future appointment with orthopedics for continued pain.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Pallor, Syncope, Vomiting
Clinical narrative: Syncope, Pallor, and Vomiting. Applied cold compress, laid with feet elevated. Due to concern with persistent vomiting and possible concussion, transferred patient to ER.
Age: 41.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Vaccine given expired 09/11/2018.
Age: 63.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Discomfort, Injection site erythema, Injection site induration, Injection site swelling, Muscular weakness
Clinical narrative: Patient stated that the area where she received the SHINGRIX vaccine (left deltoid) was hard, red, and swollen. The swelling and redness was about the size of her palm. She said that her arm felt weak.  Symptoms were all localized to injection site. Patient treated discomfort with Tylenol and ice pack.  Provider suggested using OTC antihistamine (IE Allegra, Zyrtec, Benadryl) as well.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Nervous system disorder, Thirst, Tremor
Clinical narrative: 6:30 PM onset I felt slight trembling through whole body. By 7:30 PM started uncontrollable trembling, felt very thirsty. Felt chilled throughout body. Drank about a gallon and a half of water within 20 minutes and went to bed about 10:30 PM. I felt very concerned that I was not in control of my nervous system.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Rash
Clinical narrative: Rash under both eyes down side of face and forehead - could be allergic Rxn. Fever 12-36 hrs post injection. Arm pain stopped Tues 10/20. Rash started Wed 10/31/2018 - considered normal.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine administered on 11/7/2018 in (L) deltoid. Pt came back on 11/9/18 and injection site was red, swollen to the size of half dollar and emanating heat. Pt referred to MD to seek medical att. Pt given BACTRIM DS 1 BID x7 days #14 as prophylaxis for cellulitis.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: Severe swelling in his left arm, beginning in upper arm, descending to his whole arm. Seen in ER, diagnosed with cellulitis, placed on clindamycin for 10 days.
Age: 86.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Same day as shot, area got red, swollen painful, itchy, Dx'd cellulitis in Hospital ER.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient got his flu shot on 10/1/18. Patient's wife came to Pharmacy to pick up prescriptions and informed us that patient still had pain in the arm and they were thinking of possible muscle injury. Tried to reach patient couple times but he had not returned our calls. I am reporting this on the basis of what wife told me.
Age: 81.0
Sex: M
Vaccine: FLUA3
Symptoms: Muscle spasms
Clinical narrative: Patient received injection on 10/17/18 - The next day developed severe cramps in neck and shoulders that lasted for 5 days. Required MD office visit.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Middle insomnia, Pain in extremity
Clinical narrative: Patient had sore arm and was awakened at night. Took 3 Aspirin and went back to sleep. No problems with arm the next day.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: PNEUMOVAX 23 was administered at 3 pm, later that evening her arm from shoulder to elbow was warm, swollen, itchy and red. She reported to me the following day. The reaction was limited to injection site arm.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Local reaction, Pruritus
Clinical narrative: Small amount of redness at injection site noticed last night (>24hr from injection). Patient scratched at it last night. Redness area became larger this morning (>36hrs from vaccine) and there was some swelling superficial to injection site. No pain/discomfort. No fevers. No breathing issues or wheezing, no hives, no facial swelling, no anaphylaxis. Patient.