chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Pyrexia, Skin warm
Clinical narrative: Patient went to bed feeling very cold, then woke up at around 4am feeling very warm, dizzy, and could not stand. Patient claims to have felt feverish at this time. Patient also said there was a very large bulge at the site of the injection. Next day, patient felt better, though not fully recovered, and arm was still warm to the touch. Patient returned to pharmacy on day 3, and upper arm was still pink, though he said he felt better today. Patient said symptoms are slowly abating, but said he has never had this severe of a reaction to a vaccine before.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Feeling of body temperature change, Pain in extremity
Clinical narrative: Started at 7pm on 9/19. Felt sore arm, during night. Pt felt hot and cold, weak.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Swelling of the (L) hand with redness that required hospitalization.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Lip pruritus, Lip swelling, Peripheral swelling, Pruritus
Clinical narrative: Pt returned 2 days after receiving high dose and PREVNAR w/itching and swelling of lips and hands.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt said the site of injection is red and warm to touch. She wanted us to report this because she never had some problem with prior immunizations.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Nausea, Vomiting
Clinical narrative: Patient called on 9/18/17, after receiving FLUZONE HD on 9/14/18, to report that after receiving the vaccination (not right after) she experienced nausea, vomiting, diarrhea, and chills. Patient went to see doctor and then called us on 9/18/17 to report this.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Pt called 9-19-states went to store and RPh told him to call us and report bruising at site of injection. He stated he noticed the next day a 2x3 inch bruised area where band aid from vaccinations. States rectangle black and blue. He does have a picture-states looks like it's getting better.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria, Injection site warmth
Clinical narrative: Red, painful, hot welt at injection site.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Pt. developed rash along the waist on one side of her body.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Pt got an extra seasonal flu shot in error. (Had one at PE 9/8/17 and then again on 9/15/17 while in office for sleep issues).
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Red, swollen arm.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Laboratory test, Peripheral swelling, Pruritus
Clinical narrative: Swelling of entire arm, redness, itching.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Erythema, Immediate post-injection reaction, Injected limb mobility decreased, Injection site erythema
Clinical narrative: Immediate - same day Sept 21: swelling, pain and redness which continued throughout the day Later same day Sept 21: : body aches started as well as fever and chills. Red raised welts, rash grew from the original injection site and spread from upper right arm to elbow. Difficulty sleeping, night sweats Next day: Sept 22: body aches continued, fever was 101.5 with Tylenol. Chills and rash continued. The upper arm was hot to touch and feel, with pain which prevented movement. Kept hydrated, ate fruit, alternated Tylenol and Aleeve for 4 days. Fever broke on Saturday morning (sept 23)  (48hurs) but the arm pain, redness and swelling didn't end until Sunday, Sept 24.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth, Insomnia
Clinical narrative: Immediate - same day Sept 21: swelling, pain and redness which continued throughout the day Later same day Sept 21: : body aches started as well as fever and chills. Red raised welts, rash grew from the original injection site and spread from upper right arm to elbow. Difficulty sleeping, night sweats Next day: Sept 22: body aches continued, fever was 101.5 with Tylenol. Chills and rash continued. The upper arm was hot to touch and feel, with pain which prevented movement. Kept hydrated, ate fruit, alternated Tylenol and Aleeve for 4 days. Fever broke on Saturday morning (sept 23)  (48hurs) but the arm pain, redness and swelling didn't end until Sunday, Sept 24.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Night sweats, Pain, Pyrexia, Rash, Swelling
Clinical narrative: Immediate - same day Sept 21: swelling, pain and redness which continued throughout the day Later same day Sept 21: : body aches started as well as fever and chills. Red raised welts, rash grew from the original injection site and spread from upper right arm to elbow. Difficulty sleeping, night sweats Next day: Sept 22: body aches continued, fever was 101.5 with Tylenol. Chills and rash continued. The upper arm was hot to touch and feel, with pain which prevented movement. Kept hydrated, ate fruit, alternated Tylenol and Aleeve for 4 days. Fever broke on Saturday morning (sept 23)  (48hurs) but the arm pain, redness and swelling didn't end until Sunday, Sept 24.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Urticaria
Clinical narrative: Immediate - same day Sept 21: swelling, pain and redness which continued throughout the day Later same day Sept 21: : body aches started as well as fever and chills. Red raised welts, rash grew from the original injection site and spread from upper right arm to elbow. Difficulty sleeping, night sweats Next day: Sept 22: body aches continued, fever was 101.5 with Tylenol. Chills and rash continued. The upper arm was hot to touch and feel, with pain which prevented movement. Kept hydrated, ate fruit, alternated Tylenol and Aleeve for 4 days. Fever broke on Saturday morning (sept 23)  (48hurs) but the arm pain, redness and swelling didn't end until Sunday, Sept 24.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Eyelid oedema, Lacrimation increased, Swelling face, Urticaria
Clinical narrative: Teary, watery and puffy eyes. Swollen cheeks. Hives on face. Treated with BENADRYL.
Age: 59.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Inflammation, Injection site inflammation, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Swelling, inflammation, muscle pain in arm radiating to upper shoulder and chest (Rt side) beginning several hours post immunization, persisting for 4 days then resolving. Patient works for physicians and with infectious disease doctor. Determined as non infectious local reaction with observations and reevaluation if needed. Reaction resolved w/o sequelae.
Age: 59.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Myalgia, Swelling
Clinical narrative: Swelling, inflammation, muscle pain in arm radiating to upper shoulder and chest (Rt side) beginning several hours post immunization, persisting for 4 days then resolving. Patient works for physicians and with infectious disease doctor. Determined as non infectious local reaction with observations and reevaluation if needed. Reaction resolved w/o sequelae.
Age: 1.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Blood glucose, Body temperature increased, Chest X-ray, Febrile convulsion, Hypotonia
Clinical narrative: Pt. spiked temp at home - Mom administered TYLENOL - pt. "went limp and was shaking" - proceeded to ER. Diagnosed w/Febrile seizure.
Age: 1.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Tremor, Urine analysis
Clinical narrative: Pt. spiked temp at home - Mom administered TYLENOL - pt. "went limp and was shaking" - proceeded to ER. Diagnosed w/Febrile seizure.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Migraine, Vomiting
Clinical narrative: Migraine and vomiting.
Age: 0.75
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Cyanosis, Pyrexia
Clinical narrative: Fever x 3 days. Cyanotic episode on day 3. ER visit. IVF.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient received PNEUMOVAX 23 and FLUZONE High Dose in the Left Deltoid Intramuscularly on 9/25/2017 at 11:13am. Patient called Pharmacy on 9/27/2017, to say her arm was swollen. Patient went to Urgent Care Facility on 9/27/2017 and was P.A. who prescribed a MEDROL Dose Pack and BACTRIM DS Tablets.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Erythema, Muscle swelling, Pain
Clinical narrative: Pt. got vaccine in AM Sept. 23. Show up in Pharmacy at 9 AM Sept. 24 with red, swollen bicep muscle. Pt. complains of pain on the arm pit through the breast area of the (R) arm. Tell pt. to take TYLENOL and ibuprofen and BENADRYL. Talked to pt. at 12 PM Sept. 24 - pt. felt better. Talked to pt. at 9 AM Sept. 25 - pt. said only a little bit of pain and swelling. Pt. felt much better.
Age: 16.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP
Symptoms: Asthenia, Dizziness, Feeling cold, Injected limb mobility decreased, Mobility decreased
Clinical narrative: Dizziness, weakness after vaccinated, c/o cold, and cold to touch, inability to raise arms or legs, oriented to place, time and location. BP at 3:40 130/82, approximately 10 min later BP 140/90. Sent patient via 911 rescue to hospital.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Electrocardiogram normal, Erythema, Injection site pain, Palpitations
Clinical narrative: Pt c/o palpitations, pain at injection site. Starting same evening vaccine given. Arm then became clot and swollen and red. Dx=Cellulitis. Seen 2 days post injection. Rx KEFLEX, warm compresses, EKG normal. Holter monitor ordered.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Pt c/o palpitations, pain at injection site. Starting same evening vaccine given. Arm then became clot and swollen and red. Dx=Cellulitis. Seen 2 days post injection. Rx KEFLEX, warm compresses, EKG normal. Holter monitor ordered.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth, Mobility decreased
Clinical narrative: Cellulitis - Evening at 9-25-17. Pt. stated arm hurt and difficult to move. Come into office 9-27-17 - red and sore below injection site, warm to touch.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Cellulitis - Evening at 9-25-17. Pt. stated arm hurt and difficult to move. Come into office 9-27-17 - red and sore below injection site, warm to touch.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Fatigue, Gait disturbance, Mobility decreased, Myalgia
Clinical narrative: Pain all over; extreme fatigue, muscle aches, and tingling in arms and legs. Patient is having difficulty walking and moving arms. No facial issues (breathing fine). Symptoms started 6 or 7 hours after the vaccine was administered. The patient's girlfriend, called the pharmacy about 5 PM to discuss. I called Dr. our over-seeing MD and she recommended to patient go to the emergency room for medical treatment immediately. I called the patient back and spoke to girlfriend relaying the MD advice. Pt did not want to seek medical attention. I strongly urged he go somewhere for treatment and explained the reaction could worsen and affect breathing and facial muscles. Pt wanted to
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Paraesthesia
Clinical narrative: Pain all over; extreme fatigue, muscle aches, and tingling in arms and legs. Patient is having difficulty walking and moving arms. No facial issues (breathing fine). Symptoms started 6 or 7 hours after the vaccine was administered. The patient's girlfriend, called the pharmacy about 5 PM to discuss. I called Dr. our over-seeing MD and she recommended to patient go to the emergency room for medical treatment immediately. I called the patient back and spoke to girlfriend relaying the MD advice. Pt did not want to seek medical attention. I strongly urged he go somewhere for treatment and explained the reaction could worsen and affect breathing and facial muscles. Pt wanted to
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Malaise
Clinical narrative: "Flu-like symptoms" - felt very ill.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient states she had a large red swollen spot at injection site w/ itching and headache.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event. Extra Dose DTAP given. DTAP given when not indicated. Client had received DTAP #5 on 5/25/17.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chills, Headache, Injection site pain
Clinical narrative: Severe arm pain at injection site relieved w/ice, chills, severe stomach pain, severe headache relieved by EXCEDRIN.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Erythema, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid became red, warm to touch, tight and swollen. These symptoms started 9/27/17. Patient states no pain from site but arm feels "tight". Parent told by PA that she could use warm compress to help and to return if worsened. No trouble swallowing or SOB. PA states there is no lymphadenopathy. Face/ears are red but pt says not related to reaction to Lt. arm.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Skin tightness
Clinical narrative: Left deltoid became red, warm to touch, tight and swollen. These symptoms started 9/27/17. Patient states no pain from site but arm feels "tight". Parent told by PA that she could use warm compress to help and to return if worsened. No trouble swallowing or SOB. PA states there is no lymphadenopathy. Face/ears are red but pt says not related to reaction to Lt. arm.
Age: 22.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Contusion, Erythema, Influenza like illness, Injection site hypersensitivity, Pain in extremity
Clinical narrative: Patient received FLUZONE Influenza and Pneumococcal-23 vaccines on 09/08/17. That evening patient started to experience arm started hurting and bruising and getting flu like symptoms. Saturday and Sunday right arm was swollen, hot, and bruised. 09/11/17 right arm hot, itchy, and really red but not feeling ill any longer. Arm still tender. Pt had had Influenza vaccine in the past but not a Pneumococcal-23 vaccine before. Pt was seen in the office on 09/12/17 and determined that right arm was red, swollen and feverish. DX: Allergic reaction to drug at injection site. Pt given BENADRYL and ZYRTEC to help with reaction.
Age: 22.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Peripheral swelling, Pruritus, Skin warm, Tenderness
Clinical narrative: Patient received FLUZONE Influenza and Pneumococcal-23 vaccines on 09/08/17. That evening patient started to experience arm started hurting and bruising and getting flu like symptoms. Saturday and Sunday right arm was swollen, hot, and bruised. 09/11/17 right arm hot, itchy, and really red but not feeling ill any longer. Arm still tender. Pt had had Influenza vaccine in the past but not a Pneumococcal-23 vaccine before. Pt was seen in the office on 09/12/17 and determined that right arm was red, swollen and feverish. DX: Allergic reaction to drug at injection site. Pt given BENADRYL and ZYRTEC to help with reaction.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Adverse reaction, Cellulitis
Clinical narrative: Reaction resulting in cellulitis.
Age: 32.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Chills, Injection site erythema, Injection site hypersensitivity, Injection site pain
Clinical narrative: Patient received FLUZONE influenza and Pneumococcal-23 vaccines on 09/08/17 at Doctor Office. Patient went to Urgent Care on 09/10/17 left upper arm redness, pain and swelling. Started on 09/08/17 receiving both influenza and PNEUMOVAX. Felt ill over the weekend feeling feverish and chilled. Has had influenza vaccine in past without any problems. Has not had PNEUMOVAX in the past. Pt was DX: with cellulitis and given Doxycycline at Urgent Care. Pt follow up at Doctor Office on 09/14/17 with Left arm some slight lymphedema. PDX: Allergic reaction to drug at injection site. Patient was advised to stop Doxycycline and given Ibuprofen and CLARITIN.
Age: 32.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site swelling, Lymphoedema, Malaise, Pyrexia
Clinical narrative: Patient received FLUZONE influenza and Pneumococcal-23 vaccines on 09/08/17 at Doctor Office. Patient went to Urgent Care on 09/10/17 left upper arm redness, pain and swelling. Started on 09/08/17 receiving both influenza and PNEUMOVAX. Felt ill over the weekend feeling feverish and chilled. Has had influenza vaccine in past without any problems. Has not had PNEUMOVAX in the past. Pt was DX: with cellulitis and given Doxycycline at Urgent Care. Pt follow up at Doctor Office on 09/14/17 with Left arm some slight lymphedema. PDX: Allergic reaction to drug at injection site. Patient was advised to stop Doxycycline and given Ibuprofen and CLARITIN.
Age: 80.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Injection site pain
Clinical narrative: Pt presented to pharmacy 1 day after vaccine administration, reporting severe pain in arm where 2 vaccines were administered. Pt had tried using ice and heat, as well as ibuprofen. Recommended to try TYLENOL and consult provider if no improvement in a few days.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: Pt presented 9/26/17 reported a slight swelling in vaccine arm. Hard to discern. Reported using ice after vaccinated. No redness or heat seen
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Balance disorder, Bladder disorder, Myelitis transverse
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of myelitis transverse in a 65-year-old female patient who received BOOSTRIX (batch number 542F3, expiry date unknown). On 1st August 2016, the patient received BOOSTRIX. On 3rd August 2016, 2 days after receiving BOOSTRIX, the patient experienced myelitis transverse (serious criteria hospitalization and GSK medically significant), bladder disorder (serious criteria hospitalization), balance disorder  (serious  criteria  hospitalization) and weakness (serious criteria hospitalization). On an unknown date, the outcome of the myelitis transverse, balance disorder and weakness were recovering/resolving and the outcome of the bladder disorder was not recovered/not  resolved. The reporter considered the myelitis transverse, bladder disorder, balance disorder and weakness to be almost certainly related to BOOSTRIX. Additional details were reported as follows: The patient received BOOSTRIX on right arm. The patient received supplement concomitantly. Several days after vaccination, the patient experienced unspecified bladder problems, balance issues, and weakness. The patient reported, she had gone to several physicians who had misdiagnosed her. The patient had spent time in the hospital on 4 occasions. In January 2017, the patient's neurologist diagnosed and began treating her for transverse myelitis. At the time of this reporting, the doctor shared that, the patient was 70 percent normal.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV, PPV
Symptoms: Cellulitis, Rash, Rash erythematous, Skin warm
Clinical narrative: This spontaneous report was received from a 66 year old female patient who was reporting on herself. The patient's pertinent medical history included anxiety and high blood pressure. She had no drug reactions or allergies. On 15-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 injection, in the arm, one dose (lot #, expiry date, route of administration and vaccination site were not specified) for prevention of pneumonia. Concomitant therapies included escitalopram oxalate (LEXAPRO) and bisoprolol. On 16-SEP-2017, the patient felt lethargic. On 17-SEP-2017, her arm turned red just below the injection site and felt warm. On an unknown date in September 2017, the patient contacted the pharmacist where she received the PNEUMOVAX 23 injection, but no treatment was provided due to the events. The outcome of the events was reported as not recovered/not resolved. The reporter did not provide the causality assessment between the events and PNEUMOVAX 23.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV, PPV
Symptoms: Erythema, Lethargy, Skin warm
Clinical narrative: This spontaneous report was received from a 66 year old female patient who was reporting on herself. The patient's pertinent medical history included anxiety and high blood pressure. She had no drug reactions or allergies. On 15-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 injection, in the arm, one dose (lot #, expiry date, route of administration and vaccination site were not specified) for prevention of pneumonia. Concomitant therapies included escitalopram oxalate (LEXAPRO) and bisoprolol. On 16-SEP-2017, the patient felt lethargic. On 17-SEP-2017, her arm turned red just below the injection site and felt warm. On an unknown date in September 2017, the patient contacted the pharmacist where she received the PNEUMOVAX 23 injection, but no treatment was provided due to the events. The outcome of the events was reported as not recovered/not resolved. The reporter did not provide the causality assessment between the events and PNEUMOVAX 23.
Age: 12.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 12-year-old male patient who received FLUARIX QUADRIVALENT. On 13th September 2017, the patient received FLUARIX QUADRIVALENT .5 ml. On 15th September 2017, 2 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain, injection site swelling and injection site erythema. On an unknown date, the patient experienced anaphylaxis (serious criteria GSK medically significant). In September 2017, the outcome of the injection site pain, injection site swelling and injection site erythema were recovered/resolved. On an unknown date, the outcome of the anaphylaxis was unknown. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and anaphylaxis to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The patient had 7 cm circle of redness around injection site. The reporter was worried about possible anaphylaxis and was having patient follow up with an allergist.
Age: 12.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Anaphylactic reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 12-year-old male patient who received FLUARIX QUADRIVALENT. On 13th September 2017, the patient received FLUARIX QUADRIVALENT .5 ml. On 15th September 2017, 2 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain, injection site swelling and injection site erythema. On an unknown date, the patient experienced anaphylaxis (serious criteria GSK medically significant). In September 2017, the outcome of the injection site pain, injection site swelling and injection site erythema were recovered/resolved. On an unknown date, the outcome of the anaphylaxis was unknown. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and anaphylaxis to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The patient had 7 cm circle of redness around injection site. The reporter was worried about possible anaphylaxis and was having patient follow up with an allergist.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, VARCEL, DTAPIPV, VARCEL
Symptoms: Cyanosis, Lip swelling, Pruritus, Swollen tongue, Urticaria
Clinical narrative: Anaphylaxis.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, VARCEL, DTAPIPV, VARCEL
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Allergy to chemicals, Blood test normal, Rash, Urticaria
Clinical narrative: Initial unsolicited report received from consumer on 18-Sep-2017. This case involves a 66-year-old male patient who was vaccinated with a dose of FLUZONE HD (frequency once, batch number: UI634AB, expiration date, dose was not reported) via intramuscular route in left deltoid on 29 Sep 2016. The patient's medical history revealed that patient had continued to have hives and itching for the past year. Concomitant medications was not reported. On an unspecified date, 30 minutes following the vaccination, the patient experienced had hives and itching over whole body. It was reported that, the patient are going to see an allergist this week. Lab data was not reported. The patient received corrective treatment with treated with Prednisone on 29 Sep 2016 and then again one month later. The patient was not recovered from events. List of documents held by sender: none.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Initial unsolicited report received from consumer on 18-Sep-2017. This case involves a 66-year-old male patient who was vaccinated with a dose of FLUZONE HD (frequency once, batch number: UI634AB, expiration date, dose was not reported) via intramuscular route in left deltoid on 29 Sep 2016. The patient's medical history revealed that patient had continued to have hives and itching for the past year. Concomitant medications was not reported. On an unspecified date, 30 minutes following the vaccination, the patient experienced had hives and itching over whole body. It was reported that, the patient are going to see an allergist this week. Lab data was not reported. The patient received corrective treatment with treated with Prednisone on 29 Sep 2016 and then again one month later. The patient was not recovered from events. List of documents held by sender: none.
Age: 0.42
Sex: M
Vaccine: IPV, PNC13
Symptoms: Cyanosis, Hypotonia, Somnolence, Unresponsive to stimuli
Clinical narrative: Within 10 minutes after immunization recipient became limp and unresponsive to efforts to wake him up. Speaking to him, moving his arms and legs, touching his face produced no reaction. His hands, arms and legs were completely limp with no muscle tone/resistance felt. His head was forward over his body and his body was curled forward (supported by the harness of the child seat). After rushing him back to the doctor's office he was woken up by one of the doctors through a firm massage in the right chest/shoulder area. His face appeared slightly blue. Examination showed normal breathing at the time. Doctor recommended to avoid future/ repeated Polio vaccination.
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: This spontaneous report was received from a female patient of unknown age reporting on herself. The patient did not have any pertinent medical history, concomitant medications and drug reactions or allergies. On 30-NOV-2016, the patient was vaccinated with GARDASIL 9 injection (route, anatomical location, lot# and expiration date were not reported). It was her first dose in planned three dose regiment. On 30-NOV-2016 (reported as immediately after getting the first injection of GARDASIL 9, the patient fainted (reported also as "they fainted"). The patient's physician told her to wait in the office for about half an hour and then let her to go home. The outcome of the event was reported as recovered (on 30-NOV-2016). The causality between the event and vaccination with GARDASIL 9 was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Product storage error
Clinical narrative: This spontaneous report was received from a female patient of unknown age who was referring to herself. There was no information regarding the patient's medical history, concomitant medications drug reactions or allergies provided. In early September 2005, the patient was vaccinated with ZOSTAVAX, intravenously for prophylaxis (dose, lot number and expiration date were not provided). The patient stated, that the vaccine was transported from a drug store to her doctor's office and may had thawed. The patient contacted her health care professional, however the clinician was uncertain how to proceed. The outcome of the event was unknown.
Age: 27.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from a 27 year old female patient referring to herself via Pfizer. The patient's medical history included knee surgery in 2005 and also that her period continued for 6 weeks, her current conditions included knee pain. The patient's concomitant therapies included naproxen. On 16-MAY-2017, the patient was inadvertently vaccinated at the physician's office with PROQUAD, 0.5 ml, intramuscularly in the right arm for prophylaxis, the patient was supposed to receive DEPO-PROVERA, which was her usual therapy started since the beginning of 2013, for contraception (strength, dose, frequency and route were not provided) and her 4 years old daughter, was supposed to receive the vaccine. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1709USA013588.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to an unspecified patient of unknown age and gender. The patient's medical history and drug reactions or allergies were not reported. The physician reported that on 15-SEP-2017 an unspecified patient may have received an improperly stored dose of VARIVAX lot number: N008077 (expiration date: 09-MAR-2019) for prophylaxis (strength, route, dose or units were not provided). There was digital data logger involved. The storage characteristics were the following: - Temperature: In the range 9°C to 25°C for 5 hours and 30 minutes. In the range -9°C to 8°C for 7 hours and 30 minutes - Previous temperature excursion: No. No adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse reporting on an unknown number of patients of unknown ages and genders. There was no information about the patients' concurrent conditions, medical history or concomitant medication. On unspecified dates in September 2017 (reported as "on or after  07-SEP-2017 "), the patients received improperly stored doses of PROQUAD for prophylaxis lot # M021427 expiry date 29-OCT-2017 or lot # N010867 expiry date 01-OCT-2018 (anatomical location, dose and route of administration were not reported), that were reconstituted with properly stored sterile diluent. It was reported that on an unspecified date, the vaccines were exposed to a temperature between - 9 Celsius degrees and 8 Celsius degrees for 11 hours. The vaccine underwent a previous temperature excursion between - 9 Celsius degrees and 8 Celsius degrees for 2 hours. The call was placed because of a Digital Data logger report. No adverse effects were reported. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1709USA012268.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 20-SEP-2017, the patient was vaccinated with a dose of ZOSTAVAX (strength and anatomical location were not provided) lot # N020852 with expiration date on 31-JUL-2018 for prophylaxis and with a sterile diluent (manufacturer unknown) (lot number and expiration date were not provided). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a health professional via company representative refers to a patient of unknown age and gender. On 20-JUN-2017, the patient was vaccinated with VARIVAX (lot # L042265). The patient did not receive any other dose after initial exposure date. On an unknown date in 2017, the patient experienced unspecified adverse event. The outcome and causality of the event were unknown. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1709USA013981.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. On unknown dates the patients were vaccinated with improperly stored VAQTA lot # L014068 and expiration date on 02-NOV-2017, lot # M036458 and expiration date on 02-MAR-2018 and lot # N014945, with expiration date on 31-AUG-2018, (dose and route of administration were not reported) for prophylaxis. The doses of VAQTA were exposed to a temperature excursion of 35 degrees Fahrenheit (°F) during a time frame of 1 hour and 15 minutes, which was detected by the data logger. There was no prior temperature excursion, no adverse events were reported and no product quality complaints were present. This is one of the several reports received from the same source. Sender's Comments: US-009507513-1709USA013506: US-009507513-1709USA013505.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 31-AUG-2017, the patient was vaccinated with improperly stored VARIVAX lot # M018436 and expiration date on 13-APR-2018, subcutaneously (dose was not reported) for prophylaxis; which was reconstituted with properly stored sterile diluent (MRK). The doses of VARIVAX were exposed to a temperature excursion of 15 degrees Fahrenheit (°F) to 46 °F (19°F) during a time frame of 10 minutes which was detected by the data logger. There was no prior temperature excursion, no adverse events were reported and no product quality complaints were present. This is one of the two reports received from the same source. Sender's Comments: US-009507513-1709USA013473.
Age: 9.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 11 year old patient. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided. On an unknown date in 2015, the patient was vaccinated with the first dose of GARDASIL 9 injection (lot#, expiration date, dose and route of administration were not reported). On an unknown date in August 2017, the patient was vaccinated with the second dose of GARDASIL 9 (lot#, expiration date, dose and route of administration were not reported). No adverse effects were reported. No product quality complaint was involved.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 15 years old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 12-JUL-2017, the patient was vaccinated with the first dose of GARDASIL 9 (lot # reported as M047660, expiration date 02-DEC-2018) (dose, route of administration and anatomical location were not reported) for prophylaxis. The administered doses of vaccine was exposed to a temperature excursion between 46.8 degrees Fahrenheit (F) which lasted for a 18 hours and 59 degrees Fahrenheit (F) which lasted for 65 hours on 13-JUN-2017. There was 59F previous temperature excursion for 4 hours. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA005381: US-009507513-1707USA010591: US-009507513-1709USA012722: US-009507513-1709USA012723: US-009507513-1709USA012724: US-009507513-1709USA012725: US-009507513-1709USA012726: US-009507513-1709USA012728: US-009507513-1709USA012729: US-009507513-1709USA012730: US-009507513-1709USA012731: US-009507513-1709USA012732. US-009507513-1709USA012733: US-009507513-1709USA010537: US-009507513-1709USA012774: US-009507513-1709USA012777: US-009507513-1709USA012776.
Sex: M
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: This spontaneous report was received per an e-mail from a consumer (a patient's parent) via a company representative and refers to a 11-year-old male patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient received a vaccine series of M-M-R II injection (albumin status: unknown; dose, route of administration, anatomical location, lot # and expiration date were not reported), for prophylaxis. On an unspecified date, the patient developed mumps. The outcome of mumps was unknown at the time of the report. The causality assessment was not reported. Additional information is not expected since the reporter details were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Arthralgia, Emotional distress, Fatigue, Herpes zoster
Clinical narrative: Information was received on 26-SEP-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age, who on 18-OCT-2016, received a dose of the ZOSTAVAX vaccine for it's intended purpose: the prevention of shingles. A few days later, the patient began to develop a rash on her shoulder, both ears, and scalp, characterized by blistering, pain and redness, as well as joint pain and fatigue. The patient was diagnosed with herpes zoster. The patient still suffers from this condition and medicine does not help. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations from, and seriousness of her condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of the use of ZOSTAVAX. Herpes zoster was considered disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injury, Physical disability, Quality of life decreased, Rash, Rash erythematous
Clinical narrative: Information was received on 26-SEP-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age, who on 18-OCT-2016, received a dose of the ZOSTAVAX vaccine for it's intended purpose: the prevention of shingles. A few days later, the patient began to develop a rash on her shoulder, both ears, and scalp, characterized by blistering, pain and redness, as well as joint pain and fatigue. The patient was diagnosed with herpes zoster. The patient still suffers from this condition and medicine does not help. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations from, and seriousness of her condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of the use of ZOSTAVAX. Herpes zoster was considered disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information was received on 26-SEP-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age, who on 18-OCT-2016, received a dose of the ZOSTAVAX vaccine for it's intended purpose: the prevention of shingles. A few days later, the patient began to develop a rash on her shoulder, both ears, and scalp, characterized by blistering, pain and redness, as well as joint pain and fatigue. The patient was diagnosed with herpes zoster. The patient still suffers from this condition and medicine does not help. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations from, and seriousness of her condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of the use of ZOSTAVAX. Herpes zoster was considered disabling. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB lot # N002913 and expiration date on 23-FEB-2019, lot # L016959 and expiration date on 12-MAR-2018 and lot # N002920 with expiration date on 30-SEP-2018, (dose and route of administration were not reported) for prophylaxis. The doses of RECOMBIVAX HB were exposed to a temperature excursion of 35 degrees Fahrenheit (°F) during a time frame of 1 hour and 15 minutes, which was detected by the data logger. There was no prior temperature excursion, no adverse events were reported and no product quality complaints were present. This is one of the several reports received from the same source. Sender's Comments: US-009507513-1709USA013506: US-009507513-1709USA011946.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. On unknown dates the patients were vaccinated with improperly stored GARDASIL 9 lot # M030380 and expiration date on 01-FEB-2019 and lot # M021407 with expiration date on 30-APR-2018 (dose and route of administration were not reported) for prophylaxis. The doses of GARDASIL 9 were exposed to a temperature excursion of 35 degrees Fahrenheit (°F) during a time frame of 1 hour and 15 minutes, which was detected by the data logger. There was no prior temperature excursion, no adverse events were reported and no product quality complaints were present. This is one of the several reports received from the same source. Sender's Comments: US-009507513-1709USA011946: US-009507513-1709USA013505.
Sex: U
Vaccine: VARCEL
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a health professional via company representative refers to a patient of unknown age and gender. On 16-AUG-2017, the patient was vaccinated with VARIVAX (lot # L042265). The patient did not receive any other dose after initial exposure date. On an unknown date in 2017, the patient experienced unspecified adverse event. The outcome and causality of the event were unknown. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1709USA011850.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Hypoaesthesia, Injection site erythema, Injection site swelling, Muscle tightness, Muscular weakness
Clinical narrative: Numbness to left arm, swelling and redness to site, muscle shakey, tight and weak.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Tremor
Clinical narrative: Numbness to left arm, swelling and redness to site, muscle shakey, tight and weak.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: PT REC'D VACCINE AT THE OFFICE. HER ARM SWELLED AND CONTINUED TO SWELL WITH INCREASE REDNESS AND SORENESS. SHE THEN STARTED WITH A TEMP AND WENT TO THE ER.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Patient was supposed to have received the vaccine for up to 36 mos. Patient did not turn 36 mos until 10/17.  No additional treatment or adverse event except for the wrong vaccine was given.
Age: 57.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: C-reactive protein, Full blood count, Injection site erythema, Injection site swelling, Metabolic function test
Clinical narrative: Patient complained of localized swelling and redness at the site and also fever that started the same night that he was given the vaccine. Patient was treated on 9/20/17 with Bactrim DS Tablet, 800-160 MG and IV with normal saline and Rocephin 1 gram IV pushed. Patient also instructed to do warm compresses at home. Patient was also seen on 9/21/17 and given Rocephin 1 gram and Vancomycin 1 gram through normal saline and 9/22/17 with IV normal saline and rocephin 1 gram.
Age: 57.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: Patient complained of localized swelling and redness at the site and also fever that started the same night that he was given the vaccine. Patient was treated on 9/20/17 with Bactrim DS Tablet, 800-160 MG and IV with normal saline and Rocephin 1 gram IV pushed. Patient also instructed to do warm compresses at home. Patient was also seen on 9/21/17 and given Rocephin 1 gram and Vancomycin 1 gram through normal saline and 9/22/17 with IV normal saline and rocephin 1 gram.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Axillary pain, Injection site pain, Neck pain, Urticaria
Clinical narrative: DAY AFTER VAX (9/26) ADMINISTRATION PT DEVELOPED SORENESS IN UNDERARM, INJECTION SITE AND NECK. ATTRIBUTED TO NORMAL SIDE EFFECTS AS DESCRIBED IN MANUFACTURER'S INFORMATION. 9/27 DEVELOPED WHEALS. URTICARIAL RASH ON BODY. NO OTHER KNOWN SUBSTANCE THAT WE COULD ATTRIBUTE THE RASH TO.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Ill-defined disorder
Clinical narrative: PATIENT WAS DIAGNOSED WITH THE DISEASE ON 9/25/2017.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Noticed minor itching at the site of injection the evening after receiving a flu shot. About 24 hours after receiving the vaccine, the itching turned into redness and swelling in the arm around the elbow (at a different area than the vaccine was given). The redness and swelling have gone down but have not completely gone away.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Heart rate decreased, Syncope, Tonic clonic movements
Clinical narrative: Patient syncope with tonic clonic activity. Patient was taken into a supine position & O2 administered via face mask at 5L/min, Vitals taken, Heart rate dropped to 52BPM. Heart rate then raised to a normal level & patient was given juice and crackers & observed for 25 min.