chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: M
Vaccine: HPV4
Symptoms: Blood test normal, Conjunctivitis, Iritis, Ocular hyperaemia, Pain
Clinical narrative: I was a 30 year old man then, I had recurring HPV outbreaks for a few years and my dermatologist suggested that I try the Gardasil Vaccine series because she said that she had patients see the outbreaks either reduce in frequency or stop all together after receiving the vaccine series.  So I got the first shot and a week later, I had severe eye redness, had sensitivity to light, and pain.  I went to the ophthalmologist, where they incorrectly diagnosed me with conjunctivitis.  The eye drops that they prescribed had an antibiotic and steroid mixture, so my eye symptoms improved.  When I got off of the eye drops, again my eye symptoms recurred and I saw a different ophthalmologist who diagnosed me with uveitis.  A course of steroid drops alleviated the symptoms again.  I did continue with the full three shot series of the vaccine because my dermatologist did not believe that it was the cause of my eye issues.  Plus, the first two shots happened before I was properly diagnosed with uveitis, so I was already two shots in and really wanted to get rid of the persistent HPV outbreaks.  The uveitis has recurred every 2-3 months since I received the first shot of Gardasil.  My eye has also presented cases of scleritis, treated with NSAIDs, most effectively Indomethacin.  I had no eye issues prior to the first dose of the vaccine and did not wear glasses or contacts.  I saw a rheumatologist to have blood tests performed to check for the typical autoimmune disorders that have symptoms such as iritis and scleritis.  All the blood tests came back negative.  I have seen five ophthalmologists, each diagnosing me with either iritis or scleritis.  My latest eye doctor has gotten it under control with a low dose of steroid drops and NSAIDs.  This has kept it mostly symptom free with a brief episode a few weeks ago that was quickly controlled with NSAIDs.
Age: 30.0
Sex: M
Vaccine: HPV4
Symptoms: Photophobia, Scleritis, Uveitis
Clinical narrative: I was a 30 year old man then, I had recurring HPV outbreaks for a few years and my dermatologist suggested that I try the Gardasil Vaccine series because she said that she had patients see the outbreaks either reduce in frequency or stop all together after receiving the vaccine series.  So I got the first shot and a week later, I had severe eye redness, had sensitivity to light, and pain.  I went to the ophthalmologist, where they incorrectly diagnosed me with conjunctivitis.  The eye drops that they prescribed had an antibiotic and steroid mixture, so my eye symptoms improved.  When I got off of the eye drops, again my eye symptoms recurred and I saw a different ophthalmologist who diagnosed me with uveitis.  A course of steroid drops alleviated the symptoms again.  I did continue with the full three shot series of the vaccine because my dermatologist did not believe that it was the cause of my eye issues.  Plus, the first two shots happened before I was properly diagnosed with uveitis, so I was already two shots in and really wanted to get rid of the persistent HPV outbreaks.  The uveitis has recurred every 2-3 months since I received the first shot of Gardasil.  My eye has also presented cases of scleritis, treated with NSAIDs, most effectively Indomethacin.  I had no eye issues prior to the first dose of the vaccine and did not wear glasses or contacts.  I saw a rheumatologist to have blood tests performed to check for the typical autoimmune disorders that have symptoms such as iritis and scleritis.  All the blood tests came back negative.  I have seen five ophthalmologists, each diagnosing me with either iritis or scleritis.  My latest eye doctor has gotten it under control with a low dose of steroid drops and NSAIDs.  This has kept it mostly symptom free with a brief episode a few weeks ago that was quickly controlled with NSAIDs.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Burning sensation, Cardiac disorder, Disturbance in attention, Lethargy, Memory impairment
Clinical narrative: Memory problems, concentration problems, brain burning, excruciating pain, lethargy. Heart problems or panic attacks.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Panic attack, Scan
Clinical narrative: Memory problems, concentration problems, brain burning, excruciating pain, lethargy. Heart problems or panic attacks.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: PATIENT PRESENTED TO THE PHARMACY ON 08/06/2016 WITH A RASH AT THE INJECTION SITE. PATIENT ADVISED TO FOLLOW UP WITH PHYSICIAN AND APPLY ICE, SHE HAD NO OTHER PROBLEMS.
Age: 12.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pruritus
Clinical narrative: Patient stated that severe itch ensued after both vaccines were administered and has not resolved in 5 days. Counseled mom and patient on antihistamine usage and to consult MD for further evaluation if that does not help.
Age: 43.0
Sex: M
Vaccine: TDAP, TYP
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Diffuse muscle aches and headache, chills.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm pain requiring pain med and physical therapy.
Age: 1.86
Sex: F
Vaccine: MMR, PPV
Symptoms: Decreased appetite, Fatigue, Irritability, Pyrexia
Clinical narrative: Fever 100'-102', fatigue, irritability, loss of appetite.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Skin infection
Clinical narrative: Pt came in 4 days post injection and stated she started with redness, inflammation and pain at injection site that traveled and progessed over the 4 days to under the arm and the entire top of the arm. Went to ER on the 4th day as it wasnt getting better with ibuprofen. ER Diagnosed pt with skin infection and gave antibotics.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Abdominal pain upper, Anxiety, Asthenia, Blood test, Dehydration
Clinical narrative: Developed mild pain and redness at the injection site and slight fever that became a moderate fever. Had paleness, stomach cramps, and significant vomiting. Anxiety and headache, weakness, dizziness, and lightheadedness, Dehydration. Went to the ER (night of 6 Aug 16).  Treated with IV solution with meds (Anti-nausea, Toradol, Tylenol).  Admitted: Midnight 7 Aug 16 0r 2300 Hrs 6 Aug 16, Released: 6 hours later.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Headache, Injection site erythema, Injection site pain, Pallor
Clinical narrative: Developed mild pain and redness at the injection site and slight fever that became a moderate fever. Had paleness, stomach cramps, and significant vomiting. Anxiety and headache, weakness, dizziness, and lightheadedness, Dehydration. Went to the ER (night of 6 Aug 16).  Treated with IV solution with meds (Anti-nausea, Toradol, Tylenol).  Admitted: Midnight 7 Aug 16 0r 2300 Hrs 6 Aug 16, Released: 6 hours later.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pyrexia, Urine analysis, Vomiting
Clinical narrative: Developed mild pain and redness at the injection site and slight fever that became a moderate fever. Had paleness, stomach cramps, and significant vomiting. Anxiety and headache, weakness, dizziness, and lightheadedness, Dehydration. Went to the ER (night of 6 Aug 16).  Treated with IV solution with meds (Anti-nausea, Toradol, Tylenol).  Admitted: Midnight 7 Aug 16 0r 2300 Hrs 6 Aug 16, Released: 6 hours later.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient, noted injection site reaction that did not respond to compresses, as discussed at time of immunization, site was itchy, red, and swollen, but patient very concerned, because of look of site and discomfort. She was told on 08/03/2016 to again use compresses and see if symptoms resolved. Voluntarily called patient as follow-up on 08/04/16 to get status of site and she stated it looked and felt better. However, later on the afternoon of 08/05/16 Patient contacted us and told us that her arm was again red and itchy, again at the site of injection. We called Merck, the manufacturer, and were told that injections site reactions may last up to 9 days, we relayed this information to patient and told her to use an antihistamine, benadryl AND to use cold compresses to the site for 15 minutes as needed. Called and spoke with patient on Saturday and Sunday, August 7 and 8th, 2016 and patient stated it looks and feels better. Explained to patient we would be calling her daily to check in with her progress and re-iterate the possible durations (9 days) of this injection site reaction.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient, noted injection site reaction that did not respond to compresses, as discussed at time of immunization, site was itchy, red, and swollen, but patient very concerned, because of look of site and discomfort. She was told on 08/03/2016 to again use compresses and see if symptoms resolved. Voluntarily called patient as follow-up on 08/04/16 to get status of site and she stated it looked and felt better. However, later on the afternoon of 08/05/16 Patient contacted us and told us that her arm was again red and itchy, again at the site of injection. We called Merck, the manufacturer, and were told that injections site reactions may last up to 9 days, we relayed this information to patient and told her to use an antihistamine, benadryl AND to use cold compresses to the site for 15 minutes as needed. Called and spoke with patient on Saturday and Sunday, August 7 and 8th, 2016 and patient stated it looks and feels better. Explained to patient we would be calling her daily to check in with her progress and re-iterate the possible durations (9 days) of this injection site reaction.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Seizure like phenomena, Tremor
Clinical narrative: Fever, shaking movements resembling a seizure.
Age: 20.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Haematemesis, Headache, Nausea, Pain in extremity, Vomiting
Clinical narrative: Sore left arm, Headach, Nausea, Vomiting....Patient said there was a little blood in the vomit. He only vomited once.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Respiratory disorder, Urticaria
Clinical narrative: Patient reports 2.5 X 1.5 inch welt over IMZ site - patient also states has had to use inhaler more frequently but is not having swelling of mouth, face, lips or difficulty breathing.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Appendicitis, Computerised tomogram abdomen abnormal, Surgery
Clinical narrative: Appendicitis- seen in ER & had surgery later in day.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions/allergies and medical history were not reported. On 01-JUL-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ orally, lot number was L037921 and expiration date of 31-MAY-2017(strength and dose were not reported). No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions/allergies and medical history were not reported. On 29-JUN-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ orally, lot number was L037921 and expiration date of 31-MAY-2017 (strength and dose were not reported). No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient' s concurrent conditions, drug reactions/allergies and medical history were not reported. On 07-JUL-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ orally, lot number was L037921 and expiration date of 31-MAY-2017 (strength and dose were not reported). No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions/allergies and medical history were not reported. On 06-JUL-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ orally, lot number was L037921 and expiration date of 31-MAY-2017(strength and dose were not reported). No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions/allergies and medical history were not reported. On 23-JUN-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ orally, lot number was L037921 and expiration date of 31-MAY-2017 (strength and dose were not reported). No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: This spontaneous report as received from a 63 year old female consumer refers to herself. The patient had no pertinent medical history and no drug allergies. Concomitant therapies included levothyroxine (manufacturer unknown) and acyclovir. On 28-JUL-2016,the patient was vaccinated with ZOSTAVAX (single vaccine injection, subcutaneously, lot # not reported), because her friends had advised her, as too many people were getting shingles. Two days later, on 30-JUL-2016, the patient began experiencing a rather large itchy rash at the injection site. The patient also stated that the rash was at times itchy. The patient did not seek medical attention. No treatment was given. No lab diagnostics studies were performed. The rash had not spread elsewhere at the time of this report. The outcome of the rash was reported as not recovered. Additional information is not expected because the patient refused to provide her physician's contact information.
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician via a company representative concerning a patient of unknown age and gender. Information regarding concurrent condition, medical history and concomitant therapy was not reported. On an unknown date, the patient was vaccinated with a dose of PNEUOMOVAX 23 (dose and route was not reported). On an unspecified date, the patient experienced swelling at the injection site after receiving the vaccine. The outcome of event was unknown. The relationship between event and vaccine was not reported. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist referring to an 81 year old male patient. The patient had no drug reaction or allergies. Concomitant medication included SYNTHROID, furosemide (manufacturer unknown), carvedilol, fluorouracil cream, simvastatin (manufacturer unknown), dutasteride, sotalol, hydralazine and isosorbide. On 20-JUL-2016 the patient was vaccinated with ZOSTAVAX (0.65 ml, once, subcutaneous in the left arm, lot # M010472, expiration date 01-JUN-2017). On an unknown date in July 2016 the patient developed shingles on his abdomen. The patient saw his physician on 27-JUL-2016 and was prescribed prednisone (manufacturer unknown) and VALTREX. No lab diagnostics studies were performed. The patient had not recovered from the event. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions/allergies and medical history were not reported. On 12-JUL-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ orally, lot number was L037921 and expiration date of 31-MAY-2017 (strength and dose were not reported). No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Musculoskeletal disorder, Pruritus, Skin warm, Swelling
Clinical narrative: Swelling, redness, itchy, lost some use of left arm and fingers (temporarily), fever in extremity - went to ER was told to take BENADRYL 50 mg.
Age: 57.0
Sex: U
Vaccine: FLU3, PPV, TDAP
Symptoms: Deep vein thrombosis
Clinical narrative: DVT of upper left arm.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Limb discomfort, Mobility decreased
Clinical narrative: Initial unsolicited report received from a pharmacist on 05 November 2015. This case involves a 74-year-old female patient who was vaccinated with a first dose of FLUZONE HD (batch number UI434AA, expiry date 4 April 2016, site of administration were not reported) intramuscularly in "left arm" on 19 September 2015 at 10:43 am. Illness at the time vaccination and pre-existing diagnosed allergies, birth defects, medical conditions was reported as none. Concomitant medications were not reported. On 19 September 2015 at 10:43 am, few seconds (reported as shortly following the vaccination) patient's arm was uncomfortable. On Monday 21 September 2015, two days following the vaccination pain was really increased. On an unspecified date, pain was localized to area around injection site and she was unable to lift arm or rotate without having discomfort. It was reported that patient still had pain and discomfort in the upper left arm and range of motion was limited. Laboratory investigation was not reported. Corrective treatment was Itami 140 mg patch. The outcome of event was not reported. List of documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site rash, Pruritus, Pyrexia
Clinical narrative: Initial unsolicited report received from a consumer on 29 October 2015. This case involves a 57-years-old female patient who was vaccinated with a dose of Fluzone QIV (batch number: UI445AA, expiry date: 30 June 2016, dose, dose in series were not reported) intramuscularly in left deltoid on 16 October 2015. Illness at time of vaccination was reported as no and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as AICD pacer implant in her chest Allergy to Vancomycin and Percocet. Concomitant medications were not reported. On 16 October 2015, 07 hours, following the vaccination, the patient had developed fever and itchy red dotted rash which started at injection site that spread over entire body. Relevant diagnostic tests/laboratory data reported as body temperature 100.8. The patient treated with Benedryl and Tylenol. On 18 October 2015, the patient was recovered from rash and on an unknown date, the patient was recovered from fever, localized itching, localized erythema and vaccination site reaction. List of documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Initial unsolicited report received from a consumer on 29 October 2015. This case involves a 57-years-old female patient who was vaccinated with a dose of Fluzone QIV (batch number: UI445AA, expiry date: 30 June 2016, dose, dose in series were not reported) intramuscularly in left deltoid on 16 October 2015. Illness at time of vaccination was reported as no and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as AICD pacer implant in her chest Allergy to Vancomycin and Percocet. Concomitant medications were not reported. On 16 October 2015, 07 hours, following the vaccination, the patient had developed fever and itchy red dotted rash which started at injection site that spread over entire body. Relevant diagnostic tests/laboratory data reported as body temperature 100.8. The patient treated with Benedryl and Tylenol. On 18 October 2015, the patient was recovered from rash and on an unknown date, the patient was recovered from fever, localized itching, localized erythema and vaccination site reaction. List of documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 15 December 2015. This case involves a 56-year-old female patient who was vaccinated with a dose of Fluzone QIV (batch number U5321BA, expiry date, dose, route and site of administration were not reported) "left" on 28 November 2015. Illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions and any other vaccinations within 4 weeks of vaccinations were reported as Denies. Concomitant medications were not reported. On 29 November 2015, one day following the vaccination, the patient had developed soreness to arm and limited range of motion. Soreness to arm and limited range of motion was persisted at the time of reporting. It was reported that, denies erythema or swelling. The patient's laboratory data and corrective treatment was reported. The outcome of event was reported as unknown. List of documents held by sender: none.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Initial unsolicited report received from a non- healthcare professional on 15 December 2015. This case involves a 65-year-old male patient who was vaccinated with a dose of Fluzone HD (batch number UI519AA, expiry date, dose, route and site of administration were not reported) "left" on 28 November 2015. Illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions and any other vaccinations within 4 weeks of vaccinations were reported as Denies. Concomitant medications were not reported. On 30 November 2015, two days following the vaccination, the patient had developed soreness of arm and limited range of motion. Soreness of arm and limited range of motion was persisted at the time of reporting. It was reported that, Denies erythema or swelling. The patient's laboratory data and corrective treatment was reported. The outcome of event was reported as unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: Initial unsolicited report received from a pharmacist on 23 December 2015. This case involves a female patient (age was not reported) who was vaccinated with a dose of FLUZONE HIGH DOSE (batch number U1502AA, Expiration date 30 June 2005, dose, dose in series, route and site of administration were not reported) on 7 December (unspecified year). Medical history and concomitant medications were not reported. On 8 December (unspecified year), one day following the vaccination, the patient experienced fever and severe congestion. Patient visited physician and emergency room. Lab data was not reported. The patient was discharge from emergency room with VENTOLIN and ZPAK. The patient was recovering from events. List of documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS, PNC13, VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a pharmacist via a field representative referring to a 71 year old female patient. The patient had no drug reactions/allergies or pertinent medical history. Concomitant therapies included Paroxetine and Lorazepam. On 19-JUL-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot # M001746 with expiration date 07-APR-2016, 065 ml once), subcutaneously. On an unknown date in July 2016, after the patient received ZOSTAVAX, she experienced "red, swollen area" at the injection site that "might be infected". The patient was seen by the pharmacist on 21-JUL-2016. There was no treatment given for the adverse event. No lab diagnostics studies were performed. The outcome of the event was reported as not recovered. Causality was not provided. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS, PNC13, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist via a field representative referring to a 71 year old female patient. The patient had no drug reactions/allergies or pertinent medical history. Concomitant therapies included Paroxetine and Lorazepam. On 19-JUL-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot # M001746 with expiration date 07-APR-2016, 065 ml once), subcutaneously. On an unknown date in July 2016, after the patient received ZOSTAVAX, she experienced "red, swollen area" at the injection site that "might be infected". The patient was seen by the pharmacist on 21-JUL-2016. There was no treatment given for the adverse event. No lab diagnostics studies were performed. The outcome of the event was reported as not recovered. Causality was not provided. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Axillary pain, Dizziness, Erythema, Immediate post-injection reaction
Clinical narrative: 5 mins after receiving immunization pt. complained of headache/rash/itching. Gave 4 tsp BENADRYL. Not sure if headache was related to not eating. Pt. recovered completely.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lymph node pain, Lymphadenopathy, Mobility decreased, Oedema peripheral, Pruritus
Clinical narrative: 5 mins after receiving immunization pt. complained of headache/rash/itching. Gave 4 tsp BENADRYL. Not sure if headache was related to not eating. Pt. recovered completely.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: 5 mins after receiving immunization pt. complained of headache/rash/itching. Gave 4 tsp BENADRYL. Not sure if headache was related to not eating. Pt. recovered completely.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Pruritus, Rash
Clinical narrative: 5 mins after receiving immunization pt. complained of headache/rash/itching. Gave 4 tsp BENADRYL. Not sure if headache was related to not eating. Pt. recovered completely.
Age: 66.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: REDNESS OF INJECTION SITE.
Age: 66.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Injection site erythema
Clinical narrative: REDNESS OF INJECTION SITE.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ, HPV4, MNQ
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Presents with redness (resolved) and swelling to the right upper arm 3 in x 2 1/4 in. firm area noted. Pt. has full ROM but reports it is sore to move arm. Pt and Mom report the area is looking better. Some itching noted.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ, HPV4, MNQ
Symptoms: Erythema, Induration, Pain, Pruritus, Swelling
Clinical narrative: Presents with redness (resolved) and swelling to the right upper arm 3 in x 2 1/4 in. firm area noted. Pt. has full ROM but reports it is sore to move arm. Pt and Mom report the area is looking better. Some itching noted.
Age: 0.22
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash across face and trunk.
Age: 6.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Large, hard, red, and hot to the touch at injection site. 3 inches in diameter.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Erythema, Induration, Skin mass, Skin warm
Clinical narrative: Large, hard, red lump, hot to the touch. 2 inches in diameter.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Pain, Vomiting
Clinical narrative: Initial unsolicited report received from a health care professional on 28 October 2015. This case involves a 73 years old female patient whose was vaccinated with a dose of FLUZONE HD (batch number UI457AA and expiry date was 22-APR-2016), dose and dose number were not reported via intramuscular route in left arm on 16 October 2015. Patient's medical history was reported as none and  concomitant medications were not reported. It was reported that, on 16 October 2015 (same day after vaccination) patient couldn't sleep, had aches, pains and vomiting. Lab data and corrective treatment were not reported. The outcome of the events sleep, aches, pains and vomiting were unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Adverse reaction
Clinical narrative: Initial unsolicited report received from a consumer on 27 October 2015. This case involves a female (age unknown) patient who was vaccinated with a dose of FLUZONE (batch number, expiry date, route and site of administration were not reported)on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced unique reaction. Laboratory investigation and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Dysphemia
Clinical narrative: Initial unsolicited report received from a non-health care professional on 30 October 2015. This case involves a 31 months old male patient whose was vaccinated with a dose of FLUZONE QIV (batch number U5338BA and expiry date was not reported), dose and dose number were not reported via intramuscular route in deltoid left on 10 October 2015. Patient's medical history and concomitant medications were not reported. It was reported that, on 11 October 2015, patient had begun stuttering within 24 hours after vaccination and continues till 30 October 2015. Lab data and corrective treatment were not reported. The outcome of the event stuttering was not recovered at the time of this report. Follow-up information received from a physician on 07 December 2015. No new information reported. List of documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache
Clinical narrative: Initial unsolicited report received from a nurse on 28 October 2015. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (manufacturer: unknown, batch number, expiry date, route and site of administration were not reported) on an unspecified date. Patient had major neurosurgery less than 5 years ago. Concomitant medications were not reported. On an unspecified date, few minutes (reported that the patient returned 15 minutes later) following the vaccination patient experienced headache and was lightheaded. Patient laboratory investigation and corrective treatment were not reported. The outcome of event was not reported. It was reported that, patient did not believe her episode was related to the vaccine, but rather her anxiety about getting the flu shot. Follow up information received from a nurse on 28 December 2015. The patient age was reported as 66 years. The patient had received a "0.5" dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (SANOFI QIV/ SANOFI MDV) (manufacturer: Sanofi Pasteur, batch number UI446AA) in the left arm on 08 October 2015. It was reported that patient had not had breakfast prior to injection. The events occurred on 08 October 2015. It was reported that the ambulance was called. The patient walked into ambulance by self and was taken to the hospital and was released (not admitted). It was reported that the patient was fine. On an unspecified date, the patient recovered from the above mentioned events. List of documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Initial unsolicited report received from Consumer on 29-Oct-2015. This case involves female patient (age was not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Flu Shot) (manufacturer: unknown, batch number, expiry date, route and site of administration were not reported) on an unspecified date several weeks ago. Medical history and concomitant medications were not reported. On an unspecified date, after vaccination, patient had had pain in my arm and the elbow till yesterday. Lab tests and corrective treatments were not reported. Patient was recovering from the event as it started to go away. Documents held by sender: none.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: Initial unsolicited report received from a pharmacist on 02 November 2015. This case involves a (age unknown) female patient who was vaccinated with a intramuscular [dose series not reported] dose of FLUZONE HD (batch number UI448AA, expiry date and site of administration were not reported) on 22 October 2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was unknown. Concomitant medications were not reported. On an unspecified date, following the vaccination patient complaining of vertigo. Laboratory investigation and corrective treatment were not reported. The outcome of event was not recovered. List of documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Inflammation, Peripheral swelling
Clinical narrative: Initial unsolicited report received from a consumer on 31 October 2015. This case involves a (66-year-old) female patient who was vaccinated with a [route and dose series not reported] dose of FLUZONE HD (batch number, expiry date and site of administration were not reported) on 27 October 2015. It was reported that, patient had FLUZONE HD last season and also had same reaction but by day 5 she was better. Concomitant medications were not reported. On 27 October 2015, same day "later that day" following the vaccination patient feeling weak and very tired and arm was "inflammed" and swollen. It was reported that, five days post vaccination, patient still feels very weak, not able to get up off couch but may be three times in a day, feeling extremely tired. Laboratory investigation and corrective treatment were not reported. The outcome of event was not recovered. List of documents held by sender: none. Follow up information received from a consumer on 07 December 2015. It was reported that, the patient was vaccinated with 0.5ml dose of FLUZONE HD (batch number-U1452AA, expiry date-25 April 2016) intramuscularly on left deltoid. It was reported that the patient was allergic to vaccine component thimerisol and had recieved pneumonia vaccine in the past.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Immediate post-injection reaction, Skin discolouration
Clinical narrative: Initial unsolicited report received from a consumer on 2 November 2015. This case involves a 64-Year-old female patient who was vaccinated with a dose of FLUZONE (route and site of administration, dose in series, batch number were not reported) on 29 October 2015. The patient had medical history of diabetes but declined to provide any further information and illness at the time of vaccination was not reported. The patient's concomitant medications were not reported. On 29 October 2015, immediately after vaccination, the patient's arm became red black and blue. Next day on 30 October 2015 the discolored area was larger. On 31 October 2015, the discolored area was extending towards elbow and the patient went to the clinic. The patient required ER/doctor visit. Other laboratory data was not reported. The patient's corrective treatment includes Keflex. The patient was not recovered from the event. List of documents held by sender: none.
Age: 90.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Bone pain, Gait disturbance, Myalgia, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer on 04 November 2015. This case involves a 90-years-old female patient who was vaccinated with an intramuscular dose of Fluzone HD (batch number, expiration date, dose, dose in series were not reported) and dose of PREVNAR 13 (batch number, expiration date, dose, dose in series, route were not reported) both in left arm on 29 October 2015. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were denied. Concomitant medications were not reported. On 31 October 2015, two days following the vaccination, the patient developed muscle aches, sore bones, unstable gait and left arm soreness. Lab data was not reported. The patient received corrective treatment with aspirin. It was reported that patient was not evaluated and treated by physician. patient was self-medicated with aspirin. Outcome of events was reported as unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness
Clinical narrative: Initial unsolicited report received from a pharmacist on 20-Oct-2015. This case involves two patients (age and gender not reported) who were vaccinated with FLUZONE (batch number: unknown, dose, dose in series, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, after vaccination, two patients developed very stiff arms. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Vomiting
Clinical narrative: Initial unsolicited report received from a physician on 5 November 2015. This case is linked with case number 2015SA179107, 2015SA179116 (same reporter, different patients). This case involve a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE HD (batch number, expiration date, dose, dose number and site of administration were not reported) intramuscularly on an unspecified day in 2015. The patient's medical history and concomitant medication were not reported. On an unspecified day in 2015, following the vaccination, the patients experienced symptoms of vomiting, diarrhea, and chills. On an unspecified date, the patient was hospitalized. Laboratory investigation and corrective treatment were not reported. On an unspecified date, the patient recovered from events. List of documents held by sender: none.; Sender's Comments: This is a case of vomiting, diarrhea and chills following INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE administration. All of the mentioned events are listed after the vaccine. However, patient demographics, time to event onset, investigational laboratory details, medical history would help assess the case better. Based on the information provided, the case cannot be completely assessed.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Maternal exposure before pregnancy, No adverse event
Clinical narrative: Initial solicited report received on 12 November 2015 from an investigator participating in the study. This case involves a 36-year-old female subject who had vaccine exposure before pregnancy. The date of LMP was reported as 17 August 2015. The estimated date of delivery was reported as 23 May 2016. The mother and father's health status was not reported. The father's age was not reported. The current pregnancy history was reported as not applicable. The subject's previous pregnancy information was not reported. The subject's maternal drug exposure was not reported. The subject received a first 0.5 ml intramuscular dose of FLUZONE QIV in the left deltoid on 09 January 2014 (batch number U5338AA). The information about treatment for infertility, family history of congenital abnormality was not reported. The subject had no relevant non serious adverse event. The information about pregnancy complications was not reported. Prenatal testing was not reported. Pregnancy was ongoing at the time of report. Relationship to investigational product according to Company: associated. Relationship to investigational product according to Investigator: not reported. List of documents held by sender: none.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Feeling jittery, Injection site pain, Pain in extremity
Clinical narrative: Initial unsolicited misuse report received from a nurse on 18-Nov-2015. This case involves 47-year-old female patient who was vaccinated with a second dose of FLUZONE Quadrivalent) (batch number- U5321FA and route was not reported) in right deltoid 22-Oct-2015 at 14:40 hours. Patient had no illness at the time of vaccination; patient did not receive any other vaccinations within 4 weeks prior to this vaccination. Patient had allergy to Epinephrine and Novacaine. Patient did not receive any concomitant medications. On 22-Oct-2015, 5 minutes after vaccination at 14:45 hours patient experienced jittery feeling, could not catch her breath and right deltoid pain. Also patient experienced left arm pain. Lab tests were not reported and patient ate "CAN04" (illegible) as treatment. On unspecified date, patient was recovered from the events feeling jittery, short of breath and pain at right deltoid region and was not recovered from the event left arm pain. Documents held by sender: none. Follow up information received from a physician on 01-Mar-2016. Corrective treatment was reported as candy (illegible in initial report). The outcome of the event left arm pain was reported as unknown.
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactoid reaction
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 23 November 2015. This case is linked with 2015SA194968 (same reporter). This case involves a male patient who was vaccinated with a dose of FLUZONE HD) (batch number, expiration date, dose, dose number, were not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On unspecified date, following the vaccination, the patient experienced anaphylactic symptoms. Laboratory investigations and corrective treatments were not reported. The outcome of the event was not reported. Upon internal review, the case was considered to be serious due to important medical events: anaphylactic reaction List of documents held by sender: none.; Sender's Comments: This is poorly documented medically not confirmed case. In which the consumer reported as anaphylactic reaction occurred after administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case. Based on the information the role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia oral
Clinical narrative: Initial unsolicited report received from a health care professional on 24 November 2015. This case involves a female patient (age: unknown) who was vaccinated with a [route not reported] first dose of FLUZONE ID (batch number, expiry date site and site of administration were not reported) on an unspecified date (2014-2015). Illness at time of vaccination was none and pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was no known allergy (NKA) and anxiety. Patient had no vaccinations within 4 weeks of vaccinations. On an unspecified date, few minutes following the vaccination patient had developed facial numbness and tingling especially around the lips. Patient had no laboratory investigation. Corrective treatment was not reported. It was reported that, the events were resolved on it's own after a few minutes of rest. List of documents held by sender: none.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer 11 December 2015. This case involves a female patient (age was not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Flu Vaccine) (manufacturer: unknown,batch number, dose, dose in series, route and site of administration was not reported) and with a dose of PREVNAR 13 (Manufactured by: Pfizer; batch number, dose, dose in series, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient's arm got sore for more than one day and a half. Laboratory data and corrective treatment was not reported. On an unknown date, the patient was recovered from the event. Follow-up information received from a consumer on 07 January 2016. No new information reported. List of documents held by sender: none.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: Patient noticed small "zit" like mark underneath injection site a few weeks after receiving vaccine. Patient popped it and noticed it got more swollen and inflamed. Patient came into clinic to have it looked at. Provider gave strict return precautions and strict self care to prevent spreading further.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a company representative refers to her daughter, a female patient of unknown age. The patient's medical history and concurrent conditions were not provided. On unknown dates in 2016, the patient received her first and second doses of GARDASIL (doses, route of administration, lot numbers and expiration dates were not reported). The reporter stated that the patient received the doses "more than 2 months apart". Then on 27-JUL-2016, the patient received a dose of GARDASIL 9 (dose, route of administration, lot number and expiration date were not reported), which was "more than 4 months" since the second dose of GARDASIL was administrated. No concomitant therapy was provided. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information is not expected as no permission has been granted to contact a physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. On unspecified dates in February 2016 (reported as between 15-FEB-2016 and 23-FEB-2016), the patients were vaccinated with doses of improperly stored doses of VARIVAX (dose, route, lot# and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. On unspecified dates in February 2016 (reported as between 15-FEB-2016 and 23-FEB-2016), the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (dose, route, lot # and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.