chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # K025002 with exp. 20-JUL-2017 and lot # L009649 with exp. 29-NOV-2017, (route and dose were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse referring to unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on unspecified dates, the patients were administered improperly stored GARDASIL injection (lot # K009482 with expiration date 06-MAR-2017; dose, frequency and route were not provided). No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. It was reported that on 11-AUG-2015, the patient was inadvertently administered less than full dose of ZOSTAVAX (lot number K016322, expiration date 24-DEC-2015) (dose and route not reported). No adverse experiences were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse referring to unspecified patients of unknown age and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated on unspecified dates, the patients were administered improperly stored PNEUMOVAX 23 injection (lot # K008410 with expiration date 26-FEB-2016; dose, frequency and route were not provided). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Anxiety, Breath holding, Contusion, Crying, Fall
Clinical narrative: Patient had a syncopal event after receiving vaccines (approx 2-3 mm after MA left room). She was crying, anxious after administration. Mom reports she appeared to hold her breath then passed out briefly, fell to the floor. She regained consciousness quickly and mom placed her on exam table before staff arrived. She was assessed, found to have a small laceration inside upper lip and mild bruising of (R) forehead. No major injuries noted. Pt was anxious but alert and interactive. Monitored x approx 20 minutes, allowed to leave when she could stand  and walk w/out symptoms. Reviewed signs and symptoms to watch for with mom and they expressed understanding.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Lip injury, Loss of consciousness, Syncope
Clinical narrative: Patient had a syncopal event after receiving vaccines (approx 2-3 mm after MA left room). She was crying, anxious after administration. Mom reports she appeared to hold her breath then passed out briefly, fell to the floor. She regained consciousness quickly and mom placed her on exam table before staff arrived. She was assessed, found to have a small laceration inside upper lip and mild bruising of (R) forehead. No major injuries noted. Pt was anxious but alert and interactive. Monitored x approx 20 minutes, allowed to leave when she could stand  and walk w/out symptoms. Reviewed signs and symptoms to watch for with mom and they expressed understanding.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L016959, expiration date 12-MAR-2018 (strength, dose and route of administration were not provided). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse referring to unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on unspecified dates, the patients were administered improperly stored PEDVAXHIB injection (lot # L006545 with expiration date 16-NOV-2017; dose, frequency and route were not provided). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II, lot # reported as L011528, expiration date 03-APR-2017 (strength, dose, route of administration and albumin status were not provided). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 1.02
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information on patients' concurrent conditions, medical history or drug allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) injection (Lot number L003775 and expiry date 04-FEB-2017) (dosing regimen and route were unknown). No information on patients' concomitant medications was provided. No adverse effects were reported. Lot number L003775 has been verified to be a valid lot number for VARIVAX (Merck). Follow-up information has been received on 03-AUG-2015. All telephone attempts to obtain follow up information had been unsuccessful. Follow-up information has been received on 05-AUG-2015. The Certified Medical Assistant reported that she would have to research the request made for patient identifiers, lot number, expiration date and dates of vaccination. The company tax number was reviewed with the reporter, if information becomes available. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015. The patient was 12 month old. The patient was vaccinated with improperly stored dose of VARIVAX (Merck) on 28-SEP-2015. This is one of the several reports received from the same reporter. Additional information has been requested. Patient, event, product and narrative information was updated.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tingling feet/hands ina 48-year-old female patient who received FLUARIX QUADRIVALENT (batch number 7HR72, expiry date 30th June 2016). Concomitant products included magnesium, vitamin C, Curcumin and fish oil. On 22nd October 2015, the patient received FLUARIX QUADRIVALENT .5 ml. On 22nd October 2015, several hours after receiving FLUARIX QUADRIVALENT, the patient experienced tingling feet/hands and numbness of extremities. On 26th October 2015, the patient experienced tingling lips and numb lips. The patient was treated with ZYRTEC. On an unknown date, the outcome of the tingling feet/hands and numbness of extremities were not recovered/not resolved and the outcome of the tingling lips and numb lips were unknown. The reporter considered the tingling feet/hands, numbness of extremities, tingling lips and numb lips to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: This case was previously reported to manufacturer. The patient stated that she had never taken any medication. On 22nd October 2015, between 1 pm to 2 pm, the patient received a dose of FLUARIX QUADRIVALENT. On 22nd October 2015, early evening, the patient started to experience bilateral transient tingling and numbness in her hands and feet. Over the weekend (24th October 2015 to 25th October 2015), minimum 2 days after vaccination, the patient experienced tingling that went up to calves. On 26th October 2015 (Monday), in morning, 4 days after the vaccination, the patient woke up with transient tingling and numbness in her lips, tongue and the tip of nose, which was very noticeable. The reporter stated that, she contacted to nurse because she could be having a stroke but she did not think that was a stroke. At the time of reporting, the patient did not diagnosed with stroke. The patient was told to ZYRTEC and to contact her health care professional the next day. The patient visited the doctor and was informed that the events were due to FLUARIX QUADRIVALENT. On 30th October 2015, the events were got worsened. The patient tried to contact her physician but the physician was not available. The reporter stated that, FLUARIX vaccine was mandatory for her to keep her job.
Age: 1.23
Sex: F
Vaccine: DTAPIPV, FLUX, MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a 15-month-old female patient who received KINRIX (batch number T325H, expiry date 17th FEBRUARY 2017). Concomitant products included influenza vaccine, measles, mumps rubella and VARIVAX. On 29th OCTOBER 2015, the patient received the 1st dose of KINRIX (intramuscular) .5 ml. On 30th OCTOBER 2014, 1 days after receiving KINRIX, the patient experienced fever. On an unknown date, the patient experienced inappropriate age at vaccine administration. The patient was treated with Ibuprofen. On an unknown date, the outcome of the fever and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the fever to be related to KINRIX. Additional details provided were as follows: The case was previously reported to a doctor. Prior receiving the vaccine, the patient's body temperature was 37.6 degree C. On 29th OCTOBER 2015, the patient received the 1st dose of KINRIX. After further investigation, the nurse notified that, the patient in advertently received the vaccine at an age of 15 months. This led up to an inappropriate age of vaccination. On the same day, the patient also concomitantly received other non-GSK vaccines, which included MMR, Flu and VARIVAX vaccines. On 30th OCTOBER 2015, 1 day after vaccination, the parent of child called the office and reported that the patent's body temperature was 99 to 100 degree F (37.2 to 37.8 degree F). The doctor told the patient's father to give the patient Ibuprofen. The reported lot number (T385H) for KINRIX vaccine did not exist and was updated to T325H according to sales database.
Age: 85.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea
Clinical narrative: Case number PHEH2015US022241 is an initial report received from a consumer via patient oriented program on 25 Oct 2015. This report refers to an 85 year old female patient. Her current condition included blood pressure, unspecified heart condition and hospitalization due to congestive heart failure last week. Her concomitant medications were amlodipine, NORVASC, JANUVIA, metolazone, LOPRESSOR, fenofibrate, Baby aspirin and potassium used for the treatment of blood pressure and unspecified heart condition. She was treated with LASIX (other manufacturer) for congestive heart failure at an unknown dose from an unspecified date when she was hospitalized. She also received seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date (same time as of LASIX). On an unspecified date she experienced difficulty in breathing when she was in the hospital. Action taken with LASIX was not reported. The events outcome was not reported. The events were reported as serious. The causality of the event was not reported. The reporter stated that she might be taking Novartis medications, but was not certain. No further information was provided.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Muscle spasms
Clinical narrative: Arm swelling and redness at injection site, neck muscle spasms.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Erythema, Tenderness
Clinical narrative: Right arm with large area 7 cm x 12 cm redness and tender to touch.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased
Clinical narrative: Injected (R) arm -> developed inability to move arm/very decreased ROM -> seen ive our clinic -> placed on MEDROl -> to follow up.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Left upper arm cellulitis as evidence by redness, warmth, tenderness at injection site. Treated with KEFLEX 500 mg 4x/day x 7 days and also IV ROCEPHIN 2 gm x 1 dose.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age. The nurse reported that an unspecified number of patient's were administered improperly stored ROTATEQ. The lots involved are: # L004466, exp *02-AUG-2016), # L008996, exp (01-DEC-2016) and # L013190, exp (16-NOV-2016). The outcome of incorrect product storage is unknown. No symptoms reported. No further information provided. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Local reaction, Vaccination site pain, Vaccination site warmth
Clinical narrative: Local reaction, redness, heat, pain, at 24 hours in area of vaccination. Spoke with his PCP, gave PO BENADRYL, cool compress.
Age: 41.0
Sex: M
Vaccine: FLUX
Symptoms: Dry mouth, Dyspnoea, Ocular hyperaemia, Pharyngeal oedema, Tremor
Clinical narrative: Red eyes, shortness of breath, dry mouth, swollen throat, shaking hands, blurred vision.
Age: 41.0
Sex: M
Vaccine: FLUX
Symptoms: Vision blurred
Clinical narrative: Red eyes, shortness of breath, dry mouth, swollen throat, shaking hands, blurred vision.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Influenza like illness, Insomnia, Pain
Clinical narrative: Terrible headache, insomnia, chills, aches, pains all over body, flu-like symptoms, went on for five days.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site reaction, Rash erythematous
Clinical narrative: PINK RASH SURROUNDING INJECTION SITE, AND A LIGHTER PINK SKIN COLOR EXTENDING SEVERAL INCHES BEYOND THAT.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13, TDAP
Symptoms: Chills, Injection site erythema, Injection site swelling, Pruritus, Pyrexia
Clinical narrative: Pt stated she had fevers/chills and redness/swelling around the injection site as well as localized itching on right arm.
Age: 55.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Sepsis, Skin disorder
Clinical narrative: Patients mother states that she has big circle on arm and underneath. Dr said it was blood poisoning.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Chills, Headache, Impaired work ability
Clinical narrative: Fever, nausea/vomiting, chills, headache, muscle/joint pain, weakness beginning AM of 11/5/15; Advil, Tylenol, and Benadryl taken; rest and hydration; had to call out of work that night; did not begin feeling better until Saturday 11/7/15.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever, nausea/vomiting, chills, headache, muscle/joint pain, weakness beginning AM of 11/5/15; Advil, Tylenol, and Benadryl taken; rest and hydration; had to call out of work that night; did not begin feeling better until Saturday 11/7/15.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site warmth, Pain, Skin warm, Swelling
Clinical narrative: PAIN, SWELLING, SITE WARM TO TOUCH TO LFA.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site became red, hot, swollen, painful, and itched a little.  It is smaller today by pt report.  Today it measured 13x11 mm of induration and redness.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth
Clinical narrative: Injection site became red, hot, swollen, painful, and itched a little.  It is smaller today by pt report.  Today it measured 13x11 mm of induration and redness.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Fatigue, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Started with numbness around the mouth, chin, and cheeks area. Within 1 hour I started to have tingling, pins and needles in my fingers and toes. I felt overall very tired and weak. Within 12 hours I had extreme pain with stiffness in the lower back area, including the muscles along my spine. The next day I returned to the clinic and they sent me directly to ER. I was evaluated by a neurologist and prescribed pain medicine. Today, 5 days post vaccination he numbness and tingling sensations are 70% gone, but my back pain and stiffness is only 10% lower.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Paraesthesia
Clinical narrative: Started with numbness around the mouth, chin, and cheeks area. Within 1 hour I started to have tingling, pins and needles in my fingers and toes. I felt overall very tired and weak. Within 12 hours I had extreme pain with stiffness in the lower back area, including the muscles along my spine. The next day I returned to the clinic and they sent me directly to ER. I was evaluated by a neurologist and prescribed pain medicine. Today, 5 days post vaccination he numbness and tingling sensations are 70% gone, but my back pain and stiffness is only 10% lower.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Eye pain, Eyelid function disorder, Eyelid oedema, Headache, Hypoaesthesia
Clinical narrative: On 11/3/15 pt received flu vaccine and soon after developed headache and achy feeling all over her body. Later in the day she developed nausea and eventually right facial numbness. At school on 11/4 she noticed that she had a red splotchy rash on the right side of her face and neck that resolved after several hours. She also developed swelling around her right eye and the pain that felt like pressure behind her right eye worsened. She noticed that some colors began looking different in her right eye and later that day developed some sensitivity to light and a feeling that the back of her tongue and right side of throat was numb. That night they were seen in an Urgent care and started on a course of steroids. She woke on the morning of day of admission with worsening light sensitivity, nausea and pressure behind her right eye. She also began having trouble opening her right eye. No fevers throughout this time and no paresthesias or weakness in any extremities. In the hospital, the patient is currently receiving a 5 day course of IV methylprednisolone and testing. Patient received seasonal influenza vaccination in 2014 and developed similar facial and ophthalmic symptoms.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia oral, Nausea, Ocular discomfort, Pain, Pharyngeal hypoaesthesia
Clinical narrative: On 11/3/15 pt received flu vaccine and soon after developed headache and achy feeling all over her body. Later in the day she developed nausea and eventually right facial numbness. At school on 11/4 she noticed that she had a red splotchy rash on the right side of her face and neck that resolved after several hours. She also developed swelling around her right eye and the pain that felt like pressure behind her right eye worsened. She noticed that some colors began looking different in her right eye and later that day developed some sensitivity to light and a feeling that the back of her tongue and right side of throat was numb. That night they were seen in an Urgent care and started on a course of steroids. She woke on the morning of day of admission with worsening light sensitivity, nausea and pressure behind her right eye. She also began having trouble opening her right eye. No fevers throughout this time and no paresthesias or weakness in any extremities. In the hospital, the patient is currently receiving a 5 day course of IV methylprednisolone and testing. Patient received seasonal influenza vaccination in 2014 and developed similar facial and ophthalmic symptoms.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Photophobia, Rash erythematous, Rash macular
Clinical narrative: On 11/3/15 pt received flu vaccine and soon after developed headache and achy feeling all over her body. Later in the day she developed nausea and eventually right facial numbness. At school on 11/4 she noticed that she had a red splotchy rash on the right side of her face and neck that resolved after several hours. She also developed swelling around her right eye and the pain that felt like pressure behind her right eye worsened. She noticed that some colors began looking different in her right eye and later that day developed some sensitivity to light and a feeling that the back of her tongue and right side of throat was numb. That night they were seen in an Urgent care and started on a course of steroids. She woke on the morning of day of admission with worsening light sensitivity, nausea and pressure behind her right eye. She also began having trouble opening her right eye. No fevers throughout this time and no paresthesias or weakness in any extremities. In the hospital, the patient is currently receiving a 5 day course of IV methylprednisolone and testing. Patient received seasonal influenza vaccination in 2014 and developed similar facial and ophthalmic symptoms.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Feeling hot, Full blood count normal, Hemihypertrophy, Mobility decreased
Clinical narrative: According to the parents the arm started swelling 2 hours after it was given. They gave Benadryl and Tylenol. The following day they starting placing cold compresses. On Sunday morning the child woke to find his entire right arm swollen to the wrist, the swelling extended over the right side of the chest to the sternum, it extended down the right flank to his waist and extending to the right buttocks. They presented to the ER at 8:30 AM. There he had this extensive swelling which was pink, hot and the skin was tense. He complained of little pain, never had any problem breathing. Restricted movement of his arm because of swelling of the arm. Finger were pink always FROM. He looked he had right sided hemihypertrophy. Upon arrival he was given epinephrine SC 0.5mg, IV hydrocortisone 50mg and PO Benadryl 12.5mg. His vitals signs were always stable and within normal limits. Patient was sent home on Tylenol, Benadryl and prednilasone. Parents were also instructed to give warm compresses alternating with cold compresses. Patient call in AM about 24 hours later and parents reported that the swelling had gone markedly.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Peripheral swelling, Skin tightness, Swelling
Clinical narrative: According to the parents the arm started swelling 2 hours after it was given. They gave Benadryl and Tylenol. The following day they starting placing cold compresses. On Sunday morning the child woke to find his entire right arm swollen to the wrist, the swelling extended over the right side of the chest to the sternum, it extended down the right flank to his waist and extending to the right buttocks. They presented to the ER at 8:30 AM. There he had this extensive swelling which was pink, hot and the skin was tense. He complained of little pain, never had any problem breathing. Restricted movement of his arm because of swelling of the arm. Finger were pink always FROM. He looked he had right sided hemihypertrophy. Upon arrival he was given epinephrine SC 0.5mg, IV hydrocortisone 50mg and PO Benadryl 12.5mg. His vitals signs were always stable and within normal limits. Patient was sent home on Tylenol, Benadryl and prednilasone. Parents were also instructed to give warm compresses alternating with cold compresses. Patient call in AM about 24 hours later and parents reported that the swelling had gone markedly.
Age: 55.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia
Clinical narrative: Patient received the rabies PEP series on 10/5/15, 10/8/15, 10/12/15, and 10/19/15. Patient reported significant joint pain in knees and wrists for 2 weeks after completetion of the series.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Rash macular, Type IV hypersensitivity reaction
Clinical narrative: The gradual onset macular erythematous rash which appears to be a type 4 hypersensitivity reaction which continues to worsen.
Sex: U
Vaccine: FLUN4
Symptoms: Lymphadenopathy, Peritonsillar abscess, Pyrexia
Clinical narrative: Student present approx 5 hours after vaccine administration with high temp 102 degrees and swollen lymph. Later diagnosed with tonsil abscess. Likely not RA.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Headache, Malaise, Pain
Clinical narrative: 3:30 Headache, dizziness, 5:00 chills, 5:30 body aches, 6:30 overall malaise, 9:00 PM. I took Tylenol around 1:00 PM because I was feeling headache and body aches. Took Tylenol again at 6:00 PM and every 6 hours after that through 11/8/2015.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pruritus generalised
Clinical narrative: Itching all over skin and scalp. No rash. Large red area around injection site.
Age: 23.0
Sex: M
Vaccine: YF, YF
Symptoms: Mouth swelling, Pruritus, Urticaria
Clinical narrative: Received phone call at about 1:45 pm. Client stated that he was at the ER because of swelling in the mouth and hives likely from Yellow Fever vaccine. He had received IV fluids and Benadryl as at 3pm; when he stated that swelling had subsided but itching still present.
Age: 23.0
Sex: M
Vaccine: YF, YF
Symptoms: Dyspnoea, Pruritus, Swollen tongue, Urticaria
Clinical narrative: Received phone call at about 1:45 pm. Client stated that he was at the ER because of swelling in the mouth and hives likely from Yellow Fever vaccine. He had received IV fluids and Benadryl as at 3pm; when he stated that swelling had subsided but itching still present.
Age: 23.0
Sex: M
Vaccine: YF, YF
Symptoms: Mouth swelling, Pruritus, Urticaria
Clinical narrative: Shortness of breath, swollen tongue, hives, itching.
Age: 23.0
Sex: M
Vaccine: YF, YF
Symptoms: Dyspnoea, Pruritus, Swollen tongue, Urticaria
Clinical narrative: Shortness of breath, swollen tongue, hives, itching.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Neuropathy peripheral
Clinical narrative: Numbness in hands, shoulders and neck. PCP diagnosed it as Brachial Plexus Neuropathy.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient almost immediately broke out in itchy hives on face.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Drug administered at inappropriate site, Pain in extremity, Skin tightness
Clinical narrative: Sore arm felt shot was given too high on arm pain lasting re check 11/9/15 arm still sore and pain in elbow and arm feels tight no redness swelling or drainage.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Headache, Injection site urticaria, Vaccination site pain
Clinical narrative: Left arm soreness; significant aching, raised welt at site of vaccination to half way down the upper arm; headache and fatigue.
Age: 86.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling
Clinical narrative: Arm started swelling..applied ice pack. Took BENADRYL and TYLENOL but did not notice sx alleviation.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Pharyngeal oedema
Clinical narrative: Flu shot given 11-3-15, called 11/7/15 and said he was sore and his throat was sore and swollen. Took BENADRYL.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site pruritus, Mobility decreased
Clinical narrative: Patient came into Health Department reporting redness, itching, and bruising to right arm that started the evening after receiving PREVNAR 13 on 10-30-15. She stated she was unable to raise her arm above her head the evening of 10-30-15 but has since had no trouble with range of motion. She had a bruise approximately 2 cm in diameter at injection site with redness and hardness extending to the elbow. She stated it was itching. No warmth or drainage noted. She reported this on 11-3-15. Since client has stated the redness has gone down and is doing better.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, HIBV, MMR, PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: Fever x2d. Rash x 5d beginning 3 days after vaccines.
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Blood culture negative, Full blood count normal, Mental status changes, Metabolic function test normal
Clinical narrative: Baby was admitted to hospital for altered mental status < 24 hours after receiving Hep A vaccine in clinic. All tests were normal at hospital.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Breast cellulitis, Cellulitis
Clinical narrative: Patient developed cellulitis in (L) arm and breast after receiving injection on 11/8/15.
Age: 1.72
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: Fever.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Inflammation, Insomnia, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Left arm pain/swelling, inflamm, itching at elbow, difficulty sleeping arm noticeably swollen and warm to touch.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Skin warm
Clinical narrative: Left arm pain/swelling, inflamm, itching at elbow, difficulty sleeping arm noticeably swollen and warm to touch.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient's husband called pharmacy and described redness, pain, and swelling that was spreading down the arm. I was not able to confirm visually, but I recommended they follow up with a physician visit since the reaction was of much concern.
Age: 1.29
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Abasia, Diarrhoea, Muscular weakness, Neuroblastoma, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Extreme diarrhea, fever, turned into leg weakness then eventually not walking. Treated with Tylenol. On Sept 21 2015 was diagnosed with Neuroblastoma medium risk.
Age: 1.29
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Extreme diarrhea, fever, turned into leg weakness then eventually not walking. Treated with Tylenol. On Sept 21 2015 was diagnosed with Neuroblastoma medium risk.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Feeling cold
Clinical narrative: Severe chills and shivering.  Lasted about 6 hours.  Wore ski hat, gloves and winter coat indoors to control.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Burning sensation, Dizziness, Dysphonia, Nasopharyngitis
Clinical narrative: I was given the flu shot in two doses, one half on 10/5 and the other half on 10/9.  The first shot I had a sore arm and burning which I reported to the nurse when I came back for the second dose.  When I had the second dose, I began to experience burning under my nose and a woozy feeling at about the 15 minute mark after the shot was administered.  My blood pressure elevated and I felt like my heart was going to come out of my chest. I was in the doctors office when this happened as the PA had me stay after the shot.  The PA and nurse monitored my symptoms and when my blood pressured lowered I was able to leave the office.  After the adverse event at the office, I began to experience pain and burning in both arms and across my upper torso.  Those symptoms are still bothering me as of today.  The PA had me take Benadryl initially and then I changed to Allegra after e-mailing the doctor and getting his permission.  I am still on 2 Allegra a day.  I take one rapid release Tylenol in the morning and at night on the days when the burning and pain in my arms and torso is more bothersome.  On those days, I also have a raspy voice.  I also got cold symptoms a few days after the second injection.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Palpitations
Clinical narrative: I was given the flu shot in two doses, one half on 10/5 and the other half on 10/9.  The first shot I had a sore arm and burning which I reported to the nurse when I came back for the second dose.  When I had the second dose, I began to experience burning under my nose and a woozy feeling at about the 15 minute mark after the shot was administered.  My blood pressure elevated and I felt like my heart was going to come out of my chest. I was in the doctors office when this happened as the PA had me stay after the shot.  The PA and nurse monitored my symptoms and when my blood pressured lowered I was able to leave the office.  After the adverse event at the office, I began to experience pain and burning in both arms and across my upper torso.  Those symptoms are still bothering me as of today.  The PA had me take Benadryl initially and then I changed to Allegra after e-mailing the doctor and getting his permission.  I am still on 2 Allegra a day.  I take one rapid release Tylenol in the morning and at night on the days when the burning and pain in my arms and torso is more bothersome.  On those days, I also have a raspy voice.  I also got cold symptoms a few days after the second injection.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Throat irritation
Clinical narrative: Patient stated her "throat felt itchy" approximately 1 minute after injection, asked the patient if she would take an antihistamine, she agreed and took 2 Diphenhydramine 25mg tablets by mouth. Over 15 minutes later the patient insisted she was fine that she "would know if it was going to get worse".  Patient did not have any rash or swelling at injection site, nor did she have any rash or swelling any other location.  Called patient over 3 hours later at home her husband stated she was napping but that she was great.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Nerve injury, Vaccination complication
Clinical narrative: Nerve damage and reaction to vaccine was immediate upon injection.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Patient came to pharmacy on 11/9/2015 with a red circle still present around the injection site. Not warm to the touch.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Swelling and pain of the upper arm in which injection was received.  Had headache and fever. Symptoms lasted 5 days.
Age: 27.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dizziness, Hypertension, Paraesthesia, Pyrexia
Clinical narrative: Patient's/Employee's statement:  "Around 4:00 PM I began experiencing a tingling sensation in my left arm, a slight fever and I also became light headed.  The ED noted that I had hypertension as well."
Age: 27.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dizziness, Hypertension, Nasopharyngitis, Paraesthesia, Pyrexia
Clinical narrative: Patient's/Employee's statement:  "Around 4:00 PM I began experiencing a tingling sensation in my left arm, a slight fever and I also became light headed.  The ED noted that I had hypertension as well."
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Musculoskeletal stiffness, Neck pain
Clinical narrative: Pain and stiffness on right side of neck, back of head as of Monday 11/9/2015 - pain and stiffness still there.
Age: 54.0
Sex: F
Vaccine: FLUC3
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Next day after receiving vaccine pain noted in shoulder area and was unable to lift arm. Used massage and yoga with some improvement but pain returned approximately 1 hour later.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chills, Ear pain, Eye pain, Fatigue, Headache
Clinical narrative: Postherpetic neuralgia of right 2nd trigeminal nerves. Symptoms unilateral sharp headache, eye pain, jaw pain, feeling of earache and mouth sores without concomitant clinical signs, neuropathy upper lip. Also had fatigue and chills. Symptoms persist over 2 months later but are less severe. Previously had herpes zoster, shingles, at age 52, 8 years prior. It also was on the right 2nd trigeminal nerve. Treated with Valacyclovir tid x 10 days. Medication lessened symptoms but did not clear them permanently.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Neuropathy peripheral, Pain in jaw, Stomatitis, Trigeminal neuralgia
Clinical narrative: Postherpetic neuralgia of right 2nd trigeminal nerves. Symptoms unilateral sharp headache, eye pain, jaw pain, feeling of earache and mouth sores without concomitant clinical signs, neuropathy upper lip. Also had fatigue and chills. Symptoms persist over 2 months later but are less severe. Previously had herpes zoster, shingles, at age 52, 8 years prior. It also was on the right 2nd trigeminal nerve. Treated with Valacyclovir tid x 10 days. Medication lessened symptoms but did not clear them permanently.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Arthritis, Axillary pain, Hypoaesthesia, Injection site pain, Joint range of motion decreased
Clinical narrative: 10/24/2015 excruciating pain left arm at injection site, high deltoid region. Also pain in shoulder blade and extending to armpit. Tenderness and sorness Left arm tingling and numbness extending into hand and fingers. Tingling and numbness subside after a minute or so. Cannot put any pressure on left hand, arm. Pain would not subside. Went to urgent care 10/24/2015 8:00 PM. Was seen by PA, told it was pinched nerve, given one injection of prednisone and one of Toprol. Told to take Aleve as needed, given Rx of 4mg Prednisone 2x daily for 5 days. Injections eased nerve pain SLIGHTLY, range of motion somewhat better. 10/31/2015 Bad pain still there but felt more in elbow than shoulder blade. Pain severe now still with numbness and tingling in left arm and extending into hand and fingers. Ice helping somewhat to dull the pain, Aleve not helping at all. Made appointment with primary care physician. Couldnt get in until Nov. 9. Nov. 9, went to see primary care physician. Explained symptoms. Rx 300 mg capsule Neurontin 1 at bedtime for nerve pain, and Diclofenac 75 mg 2xday for pain. I have never taken this much medicine in one months time for any reason. I am so discouraged. I am hoping that this pain will eventually go away!!!!!
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Nerve compression, Pain, Paraesthesia, Spinal X-ray abnormal
Clinical narrative: 10/24/2015 excruciating pain left arm at injection site, high deltoid region. Also pain in shoulder blade and extending to armpit. Tenderness and sorness Left arm tingling and numbness extending into hand and fingers. Tingling and numbness subside after a minute or so. Cannot put any pressure on left hand, arm. Pain would not subside. Went to urgent care 10/24/2015 8:00 PM. Was seen by PA, told it was pinched nerve, given one injection of prednisone and one of Toprol. Told to take Aleve as needed, given Rx of 4mg Prednisone 2x daily for 5 days. Injections eased nerve pain SLIGHTLY, range of motion somewhat better. 10/31/2015 Bad pain still there but felt more in elbow than shoulder blade. Pain severe now still with numbness and tingling in left arm and extending into hand and fingers. Ice helping somewhat to dull the pain, Aleve not helping at all. Made appointment with primary care physician. Couldnt get in until Nov. 9. Nov. 9, went to see primary care physician. Explained symptoms. Rx 300 mg capsule Neurontin 1 at bedtime for nerve pain, and Diclofenac 75 mg 2xday for pain. I have never taken this much medicine in one months time for any reason. I am so discouraged. I am hoping that this pain will eventually go away!!!!!
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Tenderness
Clinical narrative: 10/24/2015 excruciating pain left arm at injection site, high deltoid region. Also pain in shoulder blade and extending to armpit. Tenderness and sorness Left arm tingling and numbness extending into hand and fingers. Tingling and numbness subside after a minute or so. Cannot put any pressure on left hand, arm. Pain would not subside. Went to urgent care 10/24/2015 8:00 PM. Was seen by PA, told it was pinched nerve, given one injection of prednisone and one of Toprol. Told to take Aleve as needed, given Rx of 4mg Prednisone 2x daily for 5 days. Injections eased nerve pain SLIGHTLY, range of motion somewhat better. 10/31/2015 Bad pain still there but felt more in elbow than shoulder blade. Pain severe now still with numbness and tingling in left arm and extending into hand and fingers. Ice helping somewhat to dull the pain, Aleve not helping at all. Made appointment with primary care physician. Couldnt get in until Nov. 9. Nov. 9, went to see primary care physician. Explained symptoms. Rx 300 mg capsule Neurontin 1 at bedtime for nerve pain, and Diclofenac 75 mg 2xday for pain. I have never taken this much medicine in one months time for any reason. I am so discouraged. I am hoping that this pain will eventually go away!!!!!
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Pruritus, Skin warm, Swelling, Tenderness
Clinical narrative: Itchiness, tenderness, swelling, Hot to touch.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Muscle spasms, Vaccination site pain
Clinical narrative: On his arm in area of vaccination he said he felt burning pain, muscle spasms and weakness intermittent (about 20 times daily). Physician was consulted by myself and PT made visit to office (phone consult physician said may be temporary nerve irritation). Symptoms stopped 2 months later.
Age: 71.0
Sex: M
Vaccine: TD
Symptoms: Pain in extremity
Clinical narrative: Soreness in left arm; it has continued for three weeks with it getting worse in middle of the night.
Age: 64.0
Sex: F
Vaccine: FLUC3
Symptoms: Dysgeusia, Feeling abnormal, Hypoaesthesia, Injection site pain, Paraesthesia oral
Clinical narrative: Feeling 'funny," metallic taste, pain with injection site, irritated throat, sinus congestion, opposite-arm numbness, lip tingling - 2 doses of 25 mg oral diphenhydarmine liquid 10 minutes apart.
Age: 64.0
Sex: F
Vaccine: FLUC3
Symptoms: Sinus congestion, Throat irritation
Clinical narrative: Feeling 'funny," metallic taste, pain with injection site, irritated throat, sinus congestion, opposite-arm numbness, lip tingling - 2 doses of 25 mg oral diphenhydarmine liquid 10 minutes apart.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Pain in extremity, Somnolence
Clinical narrative: Patient got extremely tired and can't seem to be up for more than 3 hours at a time. Also had severe leg pain (even with medication, pain scale at 8 (usually 2 on pain scale with pain med) 5 days later when patient reported these symptoms has occurred, patient said she was doing better but still very tired and leg pain has gone down.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Speech disorder
Clinical narrative: Speech abilities regressed, did not regain previous level of ability for approximately 3 months after influenza vaccine.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Hypertension
Clinical narrative: This spontaneous report was received from 54 year old female patient via Kiosk, reporting on herself and enrolled in market research. The patient's concurrent conditions included high blood pressure, hypertension and diabetes. On 04-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiration date were not provided). Concomitant medications were not provided. On an unknown date, the patient experienced high blood pressure and had a prolonged hospitalization. At the time of the report, the patient was recovering from high blood pressure. The adverse event of high blood pressure was considered to be not related to ZOSTAVAX by the reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information was received from a consumer on 30-OCT-2015 via Sanofi Pasteur (MSD) and refers to an unspecified number (reports as hundreds) of children patients of unknown ages and genders. This report was found in the comments part of a petition about HPV vaccine. On an unspecified date, the patients were vaccinated with GARDASIL (lot number, expiration date, dose and route of administratoin were not reported). There was no concomitant medication reported. The reporter stated that "its hard to imagine that GARDASIL an other vaccines for the HPV virus were stll on the market knowing the hundreds of our children that had died (1511USA002460) and those that had harmful adverse reactions (not specified) and were living with new medical conditions after receiving the vaccine (not specified)". This is one of several reports from the same reporter. Additional information u
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Left upper arm 5cm x 10 cm of erythema, and warmth, non tender to palpation cool compress and ibuprofen or TYLENOL.
Age: 51.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Fever, chills, injection site hot to touch. Injection site swollen to "size of a grapefruit" in right arm (ZOSTAVAX site) beginning day after shot. Administered.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Drug administered at inappropriate site, Erythema, Gait disturbance, Swelling
Clinical narrative: KINRIX and varicella given in left leg. KINRIX given in a site past the vastus lateralis closer to the buttocks. As a result, the buttocks swelled up, and became very red. Child had difficult walking. Acetaminophen helped. Reaciton solved within a few days. Father took pictures. Father brought this to clinics attention last week.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: 11/5/16 pt returned to pharmacy and reported a bruise as a result of the flu shot. Bruise was 2 inhces in diameter.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Next AM fever, swollen arm, red, warm gradually became worse, getting better 11/3/15 and almost gone.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Hypertonic bladder, Injection site erythema, Injection site pruritus
Clinical narrative: None stated.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Patient received PREVNAR 13 on 10/29/15 and had sore arm next day then was fine. On 11/7/15 symptoms returned, but worse, complaining of sore arm down to elbow. Hurts to lift arm.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Faecal incontinence, Lumbar puncture, Monoplegia, Myelitis transverse, Nuclear magnetic resonance imaging
Clinical narrative: Acute onset transverse myelitis with lower extremity paralysis and loss of bowel/bladder control 4 days after high dose flu vaccine FLUZONE High Dose.