chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Urticaria
Clinical narrative: Patient Developed Hives on body in random places around 4:00pm post vaccination. Patient given Benadryl PO 3.75ml with some stabilization. No fever or other issues noted, temperament good, eating and drinking as normal.  Hives seemed to increase 24 hours post vaccination. Health Dept. RN consulted via phone. Instructed patient mom to contact urgent care or pediatrician given worsening hives.  Follow-up call morning of 7/26. Mom reports pediatrician was called and recommended 3.75ml Benadryl PO every 4-6 hours for 48 hours. Patient given Benadryl dose of 3.57ml last night and greatly improved. Mom reports no more hives since last night. 7/25/2019.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Influenza like illness, Myalgia
Clinical narrative: Headache, nausea, chills, muscle ache, joint ache - very much like flu
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Headache, nausea, chills, muscle ache, joint ache - very much like flu
Age: 49.0
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Pain, Pyrexia, Vomiting
Clinical narrative: Patient received vaccine around 7:15 pm and reports feeling pain around 9:00 pm. Describes pain as all over, at the site of injection, and reports a fever of 102. Says it feels like he received a bullet to the arm. Reports throwing up in the night and still in pain as of 8:30 am the next morning.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased
Clinical narrative: Pulse rate of 115, normally 70
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Tremor
Clinical narrative: Patient reported severe shaking, muscle aches, and a fever (unknown what temperature) the day after receiving vaccine.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Body temperature increased, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Pt noted some dizziness after receiving vaccines on 7/24/19 (this occurred while in office, but subsided prior to leaving the office). After arriving home, noted generalized aching, fatigue, and chills. With a dose of Ibuprofen, this improved. Woke up in the morning of 7/25/19 and was sweating and temp was 100 oral. Right arm (injection site for Men B) was sore with movement, but denies any further local symptoms. She had a headache on 7/24/19, but not beyond that date.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Hyperhidrosis, Pain, Pain in extremity
Clinical narrative: Pt noted some dizziness after receiving vaccines on 7/24/19 (this occurred while in office, but subsided prior to leaving the office). After arriving home, noted generalized aching, fatigue, and chills. With a dose of Ibuprofen, this improved. Woke up in the morning of 7/25/19 and was sweating and temp was 100 oral. Right arm (injection site for Men B) was sore with movement, but denies any further local symptoms. She had a headache on 7/24/19, but not beyond that date.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Eye irritation, Injection site pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Aching/throbbing in left arm radiating from injection site to neck and wrist.  Sore throat, post nasal drip, stiff neck, burning eyes.  This is occurring within the first 24 hours.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pain, Pain in extremity, Upper-airway cough syndrome
Clinical narrative: Aching/throbbing in left arm radiating from injection site to neck and wrist.  Sore throat, post nasal drip, stiff neck, burning eyes.  This is occurring within the first 24 hours.
Age: 1.0
Sex: M
Vaccine: UNK
Symptoms: Groin pain, Herpes zoster, Pain in extremity, Polymerase chain reaction positive, Rash
Clinical narrative: Patient diagnosed with shingles on 07/19/19. Presented to Physician's Group on 07/17/19 with leg pain at left groin/thigh region x 24hrs prior to provider visit. Parents noticed a blister-like rash on the anterior ankle which spread upward. Patient complained of leg pain at site of rash on shin.  Parents deny fever, headache, changes in behavior, joint swelling or pain, and nausea/vomiting/diarrhea. Patient presented to ED and was admitted with leg pain.
Age: 1.0
Sex: M
Vaccine: UNK
Symptoms: Rash vesicular, Varicella virus test positive
Clinical narrative: Patient diagnosed with shingles on 07/19/19. Presented to Physician's Group on 07/17/19 with leg pain at left groin/thigh region x 24hrs prior to provider visit. Parents noticed a blister-like rash on the anterior ankle which spread upward. Patient complained of leg pain at site of rash on shin.  Parents deny fever, headache, changes in behavior, joint swelling or pain, and nausea/vomiting/diarrhea. Patient presented to ED and was admitted with leg pain.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Started w/ 102.3 temp the evening of vaccine admin. Other symptoms/SEs included nausea, headache, and dizziness. Not as well the next morning but fever broke and symptoms seemed to subside within next 24hrs.
Sex: M
Vaccine: MMR
Symptoms: Ear infection, Ear tube insertion, Pyrexia, Tonsillectomy, Tonsillitis
Clinical narrative: developed a 105 fever and was taken to an unspecified hospital; repetitive tonsilitis; ear infections; This spontaneous report was received from a consumer referring to his son at an unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in 2007 (reported as 12 years ago), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type, dose, site, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date within a week of the vaccination, the patient developed a 105 (unit not provided) fever and was taken to an unspecified hospital by ambulance and admitted what was not clarified further by the reporter. Additionally, on unknown dates, the patient experienced repetitive tonsillitis and ear infections, treated with a tonsilectomy and ear tubes, respectively (dates of the procedures were not reported). The outcome of the events and the relatedness between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.; Sender's Comments:  US-009507513-1907USA013750: US-009507513-1907USA013751: US-009507513-1907USA013749:
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: herpes zoster ophthalmicus; This initial spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently 73 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced herpes zoster ophthalmicus. On an unspecified date, the patient was treated by a healthcare provider for herpes zoster ophthalmicus. The outcome of the event herpes zoster ophthalmicus was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event herpes zoster ophthalmicus was determined to be medically significant.  Additional information has been requested.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 77-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions or concomitant medications.   On or around 31-OCT-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event was not reported.   The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Neck Pain; Left Arm Pain; This case was reported by a nurse via sales rep and described the occurrence of neck pain in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 95LX9, expiry date 22nd February 2021) for prophylaxis.   On 17th July 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced neck pain and pain in arm. On an unknown date, the outcome of the neck pain and pain in arm were recovered/resolved.   It was unknown if the reporter considered the neck pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient experienced neck and arm pain that lasted for approximately 2 months.  The patient was not sure which limb was involved with the 1st dose. The reporter did not provide any additional details. For tolerance after 2nd dose of Shingrix, refer case US2019129916.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Hyperglycaemia, Injection site erythema
Clinical narrative: Injection site swelling; Injection site redness/redness around 3 inches; Headache; fatigue; Muscle ache; hyperglycemia; upset stomach; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included type i diabetes mellitus.   On 25th April 2019, the patient received the 1st dose of Shingrix. On 25th April 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling and injection site erythema. On 28th April 2019, the patient experienced hyperglycemia. On an unknown date, the patient experienced headache, fatigue, muscle pain and upset stomach. On 29th April 2019, the outcome of the injection site swelling and injection site erythema were recovered/resolved. On an unknown date, the outcome of the headache, fatigue, muscle pain, hyperglycemia and upset stomach were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, headache, fatigue, muscle pain, hyperglycemia and upset stomach to be related to Shingrix.  Additional details were provided as follows: The reporting nurse was the concerned patient. The patient received 1st dose of Shingrix on left deltoid. The lot number for Shingrix was not reported. It was reported that the adverse events after receiving 1st dose were at level 3 and the adverse events after receiving 2nd dose of Shingrix was around a level 5 to 6. The patient experienced swelling at the injection site of the left arm, redness around 3 inches in diameter, that resolved in 4 days headache, upset stomach, fatigue, muscle ache (thigh region of both the legs) that lasted for 36 hours and hyperglycemia lasted for about 2.5 days. The reporter consented to follow up. The outcome reported for adverse events injection site redness and swelling' in the structured field of source document was recovered/resolved with sequel' while in database it was reported as recovered/resolved'. For tolerance of 2nd dose of Shingrix, refer case US2019129931.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia
Clinical narrative: Injection site swelling; Injection site redness/redness around 3 inches; Headache; fatigue; Muscle ache; hyperglycemia; upset stomach; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included type i diabetes mellitus.   On 25th April 2019, the patient received the 1st dose of Shingrix. On 25th April 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling and injection site erythema. On 28th April 2019, the patient experienced hyperglycemia. On an unknown date, the patient experienced headache, fatigue, muscle pain and upset stomach. On 29th April 2019, the outcome of the injection site swelling and injection site erythema were recovered/resolved. On an unknown date, the outcome of the headache, fatigue, muscle pain, hyperglycemia and upset stomach were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, headache, fatigue, muscle pain, hyperglycemia and upset stomach to be related to Shingrix.  Additional details were provided as follows: The reporting nurse was the concerned patient. The patient received 1st dose of Shingrix on left deltoid. The lot number for Shingrix was not reported. It was reported that the adverse events after receiving 1st dose were at level 3 and the adverse events after receiving 2nd dose of Shingrix was around a level 5 to 6. The patient experienced swelling at the injection site of the left arm, redness around 3 inches in diameter, that resolved in 4 days headache, upset stomach, fatigue, muscle ache (thigh region of both the legs) that lasted for 36 hours and hyperglycemia lasted for about 2.5 days. The reporter consented to follow up. The outcome reported for adverse events injection site redness and swelling' in the structured field of source document was recovered/resolved with sequel' while in database it was reported as recovered/resolved'. For tolerance of 2nd dose of Shingrix, refer case US2019129931.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Reactogenicity event
Clinical narrative: large erythematous area at the injection site/redness at injection site; reactogenicity; This case was reported by a physician via sales rep and described the occurrence of injection site erythema in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site erythema and reactogenicity event. On an unknown date, the outcome of the injection site erythema and reactogenicity event were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and reactogenicity event to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid about 2 months ago and stated he experienced reactogenicity with a large, red, erythematous area at the injection site. It did not inhibit his daily activities, but lasted about a week. The patient stated that his experience would not prevent him from getting the 2nd dose to provide him with protection from shingles. He requested not to be followed up with as he expressed his experience was within what he may had expected.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles/ shingles outbreak; This case was reported by a physician via sales rep and described the occurrence of shingles in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix .5 ml. On an unknown date, 2 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   The reporter considered the shingles to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient experience shingles, 2 days after receiving vaccine at pharmacy. The reporter reported that, the patient experienced outbreak on the same side of body as the injection. The reporter did not think that, the oubreak to be related to shingrix. The physician did not agree to be followed up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Product supply issue, Pruritus
Clinical narrative: pruritus; This case was reported by a other health professional via call center representative and described the occurrence of pruritus in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix (1st dose received on 27th March 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. It was reported that patient was greater than 6 month since the 1st dose of Shingrix. This case was linked with case US2019097136 reported by the same reporter.   Follow up information was received from the other healthcare professional on 16th July 2019: The patient's demographic details were updated. On 27th March 2018, the patient received the 1st dose of Shingrix. On 27th March 2018, less than a day after vaccination, the patient experienced pruritus and declined 2nd dose. The reporter considered the pruritus to be unrelated to Shingrix. The VAERS details were updated.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Product administered to patient of inappropriate age
Clinical narrative: Shingles; inappropriate age at vaccine administration; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 48-year-old female patient who received Herpes zoster (Shingrix) (batch number 497D9, expiry date 11th September 2021) for prophylaxis.   On 4th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 4th June 2019, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On 7th July 2019, the patient experienced shingles. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the inappropriate age at vaccine administration 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 reported by the Pharmacy Intern on the line. 33 days after receiving Shingrix in the left arm, the patient experienced a shingles outbreak and started acyclovir with an unknown dose on an unknown date. The reporter consented to follow up. The outcome reported for the event in the structured field is "resolved with sequelae" instead of "recovered/ resolved" (outcome uploaded).
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Laboratory test normal, Neck pain, Pain in extremity, Sciatica
Clinical narrative: Neck Pain; Arm Pain; numbness in the fingertips/ left leg; sciatica pain; This case was reported by a nurse via sales rep and described the occurrence of neck pain in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 27J4P, expiry date 12th April 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 17th July 2018. Please refer the case US2019AMR131401).   On 26th October 2018, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced neck pain, pain in arm, numbness in leg and sciatica. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the neck pain, pain in arm, numbness in leg and sciatica were unknown.   It was unknown if the reporter considered the neck pain, pain in arm, numbness in leg and sciatica to be related to Shingrix.  Additional details were provided as follows: The patient experienced neck and pain in the left arm and also experienced numbness in the fingertips of the left hand and numbness in the left leg. On 14th February 2019, the patient went in to see her doctor and the doctor ordered lab work. Lab work came back normal. On 16th July 2019, the Patient went back to see the doctor and complained of sciatica pain.  Emergency room visit required. The reporter did not provide any additional details.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: Neck Pain; Arm Pain; numbness in the fingertips/ left leg; sciatica pain; This case was reported by a nurse via sales rep and described the occurrence of neck pain in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 27J4P, expiry date 12th April 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 17th July 2018. Please refer the case US2019AMR131401).   On 26th October 2018, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced neck pain, pain in arm, numbness in leg and sciatica. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the neck pain, pain in arm, numbness in leg and sciatica were unknown.   It was unknown if the reporter considered the neck pain, pain in arm, numbness in leg and sciatica to be related to Shingrix.  Additional details were provided as follows: The patient experienced neck and pain in the left arm and also experienced numbness in the fingertips of the left hand and numbness in the left leg. On 14th February 2019, the patient went in to see her doctor and the doctor ordered lab work. Lab work came back normal. On 16th July 2019, the Patient went back to see the doctor and complained of sciatica pain.  Emergency room visit required. The reporter did not provide any additional details.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Gastrointestinal disorder, Headache, Hyperglycaemia, Injection site erythema
Clinical narrative: Hyperglycemia; Injection site swelling; Injection site redness; Tenderness of the injection site; GI symptoms; Fatigue; Headache; Muscle ache; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site swelling (1st dose received on 25th April 2019 (refer case US2019AMR131452).). Concurrent medical conditions included type i diabetes mellitus.   On 12th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 12th July 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling and injection site erythema. In July 2019, the patient experienced injection site tenderness, gastrointestinal symptom nos, fatigue, headache and muscle pain. On 15th July 2019, the patient experienced hyperglycemia. On 17th July 2019, the outcome of the injection site erythema and injection site tenderness were recovered/resolved. On an unknown date, the outcome of the injection site swelling and hyperglycemia were not recovered/not resolved and the outcome of the gastrointestinal symptom nos, fatigue, headache and muscle pain were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site tenderness, gastrointestinal symptom nos, fatigue, headache, muscle pain and hyperglycemia to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix on right deltoid. The lot number for Shingrix was not reported. The patient experienced multiple adverse events from both the doses of Shingrix. It was reported that the adverse events after receiving 1st dose were at level 3 and the adverse events after receiving 2nd dose of Shingrix was around a level 5 to 6. The patient experienced redness and swelling of the injection site of the right arm. Also, GI (gastrointestinal) symptoms, fatigue, headache, generalized muscle ache (whole body). The redness and tenderness of the injection site almost resolved at the time of reporting.  The patient noted hyperglycemia from 15th July 2019 and still ongoing, requiring her to triple her dose of her short-acting insulin. The reporter consented to follow up. In form structural field outcome for event swelling reported as RECOVERING/RESOLVING, but as per narrative section only redness and tenderness were reported as resolved. So outcome captured as per narrative.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Hyperglycemia; Injection site swelling; Injection site redness; Tenderness of the injection site; GI symptoms; Fatigue; Headache; Muscle ache; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site swelling (1st dose received on 25th April 2019 (refer case US2019AMR131452).). Concurrent medical conditions included type i diabetes mellitus.   On 12th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 12th July 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling and injection site erythema. In July 2019, the patient experienced injection site tenderness, gastrointestinal symptom nos, fatigue, headache and muscle pain. On 15th July 2019, the patient experienced hyperglycemia. On 17th July 2019, the outcome of the injection site erythema and injection site tenderness were recovered/resolved. On an unknown date, the outcome of the injection site swelling and hyperglycemia were not recovered/not resolved and the outcome of the gastrointestinal symptom nos, fatigue, headache and muscle pain were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site tenderness, gastrointestinal symptom nos, fatigue, headache, muscle pain and hyperglycemia to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix on right deltoid. The lot number for Shingrix was not reported. The patient experienced multiple adverse events from both the doses of Shingrix. It was reported that the adverse events after receiving 1st dose were at level 3 and the adverse events after receiving 2nd dose of Shingrix was around a level 5 to 6. The patient experienced redness and swelling of the injection site of the right arm. Also, GI (gastrointestinal) symptoms, fatigue, headache, generalized muscle ache (whole body). The redness and tenderness of the injection site almost resolved at the time of reporting.  The patient noted hyperglycemia from 15th July 2019 and still ongoing, requiring her to triple her dose of her short-acting insulin. The reporter consented to follow up. In form structural field outcome for event swelling reported as RECOVERING/RESOLVING, but as per narrative section only redness and tenderness were reported as resolved. So outcome captured as per narrative.
Sex: F
Vaccine: FLU4
Symptoms: Nonspecific reaction
Clinical narrative: Severe Reaction; This case was reported by a pharmacist via call center representative and described the occurrence of nonspecific reaction in a 69-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced nonspecific reaction. On an unknown date, the outcome of the nonspecific reaction was unknown.   It was unknown if the reporter considered the nonspecific reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist on the line with the patient that had a history of a severe reaction to a flu shot and they think it was due to egg proteins. The reporter gave consent to follow up No other detailes were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Blister rash; This case was reported by a pharmacist via call center representative and described the occurrence of blistery rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced blistery rash. On an unknown date, the outcome of the blistery rash was unknown.   It was unknown if the reporter considered the blistery rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The health care professional stated that the patient had a rash that was blister like on face and several other areas where it occurred in clusters. The health care professional thought it was possibly within a week of the Shingrix vaccination. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Pyrexia
Clinical narrative: Dry Cough; Fever; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 53RF3, expiry date 17th October 2021) for prophylaxis.   On 16th July 2019, the patient received Shingrix (intramuscular) .5 ml. On 16th July 2019, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the patient experienced dry cough. On an unknown date, the outcome of the fever was not recovered/not resolved and the outcome of the dry cough was unknown.   It was unknown if the reporter considered the fever and dry cough to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left deltoid. The pharmacist on the line reporting that the patient developed a fever the evening of the dose and it was persisting.  The patient said their fever was around 100 degrees Fahrenheit. The patient provided no information on the dry cough, just mentioned to contact that they had one.  The reporter did not know whether this was the 1st or 2nd dose did not capture during the call. The reporter consented to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site paraesthesia
Clinical narrative: sensation from the neck down to elbow on left side; This case was reported by a pharmacist via call center representative and described the occurrence of tingling sensation in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number 7PS9E, expiry date 10th September 2021) for prophylaxis.   On 22nd May 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced tingling sensation. On an unknown date, the outcome of the tingling sensation was not recovered/not resolved.   It was unknown if the reporter considered the tingling sensation to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported on behalf of patient describes tingling sensation from the neck down to elbow on left side only which was the same side of vaccination of shingrix vaccine.  Tingling sensation began at an unknown date and time but occurred after receiving 2nd dose.  Tingling sensation reported as occurring 1-2 times a day, every day, for approximately 5 minutes that has not resolved. The pharmacist unsure of date and time when tingling sensation first occurred following 2nd dose.
Sex: M
Vaccine: FLUX
Symptoms: Bursitis, Injected limb mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: bursitis; tendonitis; pain in arm; pain in shoulder; trouble reising left arm; This case was reported by a consumer via call center representative and described the occurrence of bursitis in a male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine (intramuscular). On an unknown date, several years after receiving Flu vaccine, the patient experienced bursitis, tendonitis, pain in arm, shoulder pain and injected limb mobility decreased. On an unknown date, the outcome of the bursitis, tendonitis and pain in arm were recovering/resolving and the outcome of the shoulder pain and injected limb mobility decreased were unknown.   It was unknown if the reporter considered the bursitis, tendonitis, pain in arm, shoulder pain and injected limb mobility decreased to be related to Flu vaccine.  Additional details were received as follows: The age vaccination was not reported. The patient did not know what brand flu vaccine was used. The patient refused to provide his address. The patient received a flu vaccine a few years ago from the time of reporting and experienced pain in his arm. The pain continued so the patient had an MRI that showed the shot had gone into the bursal sac, causing bursitis and tendonitis. Till the time of reporting the patient has a pain in shoulder and has trouble raising his left arm.      Lab Comments: On an unknown date MRI has been done
Sex: M
Vaccine: FLUX
Symptoms: Tendonitis
Clinical narrative: bursitis; tendonitis; pain in arm; pain in shoulder; trouble reising left arm; This case was reported by a consumer via call center representative and described the occurrence of bursitis in a male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine (intramuscular). On an unknown date, several years after receiving Flu vaccine, the patient experienced bursitis, tendonitis, pain in arm, shoulder pain and injected limb mobility decreased. On an unknown date, the outcome of the bursitis, tendonitis and pain in arm were recovering/resolving and the outcome of the shoulder pain and injected limb mobility decreased were unknown.   It was unknown if the reporter considered the bursitis, tendonitis, pain in arm, shoulder pain and injected limb mobility decreased to be related to Flu vaccine.  Additional details were received as follows: The age vaccination was not reported. The patient did not know what brand flu vaccine was used. The patient refused to provide his address. The patient received a flu vaccine a few years ago from the time of reporting and experienced pain in his arm. The pain continued so the patient had an MRI that showed the shot had gone into the bursal sac, causing bursitis and tendonitis. Till the time of reporting the patient has a pain in shoulder and has trouble raising his left arm.      Lab Comments: On an unknown date MRI has been done
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus, Rash erythematous
Clinical narrative: ITCHY; RED; SWOLLEN; This case was reported by a pharmacist via call center representative and described the occurrence of itchy upper limbs in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 7A7H4, expiry date unknown) for prophylaxis.   On 7th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced itchy upper limbs, red rash and swelling arm. On an unknown date, the outcome of the itchy upper limbs, red rash and swelling arm were unknown.   It was unknown if the reporter considered the itchy upper limbs, red rash and swelling arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and afterwards he reported that his left arm was itchy and there was a swollen, red spot covering the top portion of his arm. The reporter would like to know if there were any concerns receiving the 2nd dose and any concerns with anaphylaxis The reporter did not consent to follow-up.
Age: 4.0
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Wrong patient received product, Wrong product administered
Clinical narrative: This patient presented with her family and brother whom both needed four immunizations.  We added on the brother to our schedule but when it was time to give patient her vaccines we recognized that she was given her brothers (2 of them - PCV and Hib instead of the DTaP and IPV).
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Muscle rigidity, Periarthritis
Clinical narrative: Patient states that after receiving the vaccine that it caused her to get a frozen shoulder on the left, where she was having a hard time moving her arm. She came in and saw my partner on a late evening visit. He started her on steroids, which helped some. We are getting an ultrasound on her in that area, and if needed, might try a longer tapering course of steroids. There were no other symptoms. No redness, swelling, warmth, or fevers - just the "locked up shoulder." She is still having trouble with the movement of her arm that I am aware of.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Diarrhoea, Discomfort, Fatigue
Clinical narrative: on 7/25, when I woke up at 3 am, my arm at the injection site was swollen and warm. As the day went on the swelling got worse. The swelling was about 4 inches in diameter.. I felt like I had the flu and it hurt to raise my arm above my shoulder. Today, 7/26, the swelling is worse, About 6 inches in diameter. The site is very hot. It itches and is uncomfortable to raise my arm above my head. I feel very sick. Have diarrhea, Stomach cramps, feel run down like i have a bad flu. My neck and hip joints ache. (I don't usually have any pain). I feel fuzzy in my head and my throat hurts. I contacted the medical office yesterday and will again today. ,
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: on 7/25, when I woke up at 3 am, my arm at the injection site was swollen and warm. As the day went on the swelling got worse. The swelling was about 4 inches in diameter.. I felt like I had the flu and it hurt to raise my arm above my shoulder. Today, 7/26, the swelling is worse, About 6 inches in diameter. The site is very hot. It itches and is uncomfortable to raise my arm above my head. I feel very sick. Have diarrhea, Stomach cramps, feel run down like i have a bad flu. My neck and hip joints ache. (I don't usually have any pain). I feel fuzzy in my head and my throat hurts. I contacted the medical office yesterday and will again today. ,
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Neck pain, Oropharyngeal pain, Pain
Clinical narrative: on 7/25, when I woke up at 3 am, my arm at the injection site was swollen and warm. As the day went on the swelling got worse. The swelling was about 4 inches in diameter.. I felt like I had the flu and it hurt to raise my arm above my shoulder. Today, 7/26, the swelling is worse, About 6 inches in diameter. The site is very hot. It itches and is uncomfortable to raise my arm above my head. I feel very sick. Have diarrhea, Stomach cramps, feel run down like i have a bad flu. My neck and hip joints ache. (I don't usually have any pain). I feel fuzzy in my head and my throat hurts. I contacted the medical office yesterday and will again today. ,
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Impaired work ability, Nausea
Clinical narrative: Fever 100, aches, chills, headache, nausea, exhaustion, sore arm. Today is 48 hours since receiving injection. Ibuprofen helps, but could not go to work.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever 100, aches, chills, headache, nausea, exhaustion, sore arm. Today is 48 hours since receiving injection. Ibuprofen helps, but could not go to work.
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Husband called on  Friday 7/26/19 and stated his wife's arm was very red swollen and painful. Advised them to ice and take ibuprofen and benadryl.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site inflammation, Injection site rash, Limb discomfort
Clinical narrative: The patients left arm bicep area became inflamed red and itching with a red rash around 5:15am this morning... it has slowly since began to subside with no other pain or itching occurring at time of visit to pharmacy 11:55a.  At presentation patients arm was still red and slightly swollen but no longer uncomfortable.  The patient experienced NO respiratory side effects.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: The patients left arm bicep area became inflamed red and itching with a red rash around 5:15am this morning... it has slowly since began to subside with no other pain or itching occurring at time of visit to pharmacy 11:55a.  At presentation patients arm was still red and slightly swollen but no longer uncomfortable.  The patient experienced NO respiratory side effects.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Chills pain muscle and joint pain headache mild nausea tiredness
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: Chills pain muscle and joint pain headache mild nausea tiredness
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No Adverse effects were reported; the patient was inadvertently administered 2 doses ofVAQTA; the patient was inadvertently administered 2 doses ofVAQTA; This spontaneous report was received from a nurse and refers to a 2-year-old patient of unknown gender. There was no information regarding patient's pertinent medical history, drug reactions, allergies and concomitant therapies provided. On 12-JUL-2019, the patient was inadvertently administered with two doses of hepatitis a vaccine, inactivated (VAQTA) injection, intramuscularly (lot # S002460 has been verified to be a valid lot number, expiration date 15-MAY-2020 ). First dose was administered in the patient's left tight and the second dose of hepatitis a vaccine, inactivated (VAQTA) was administered in the patient's right tight. The reporter confirmed it was not product confusion. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 92-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date in 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 65-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date in 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 04-OCT-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date in 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 77-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 10-OCT-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 64-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 29-SEP-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).