chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Case number PHEH2015US027094, is an initial spontaneous report received from a consumer on 23 Dec 2015. This report refers to a 45 years old female patient. Family history included as father (72 years old) had high cholesterol, renal cancer, prostate cancer and hypertension. Patient mother (65 years old) had cancer. The patient underwent appendectomy (1989). Patient husband underwent vasectomy in 1999. The patient historical condition included last period occurred on 01 Jul 2013, 12 menarche. Patient was smoker (less than 1 pack per day). Concomitant medications was not reported. The patient was vaccinated with FLUVIRIN (manufacturer unknown and batch number: not reported) at a dose of 1 DF (reported as 0.5 mg) intramuscularly on 09 Oct 2015. On 10 Oct 2015, the patient experienced numbness and pain to left side of face, neck and arm. On the next day, the patient experienced numbness and pain to left leg. Approximately 2 weeks after vaccination, the patient experienced numbness and pain to all extremities including joint pain. Blood tests, magnetic resonance imaging (MRI) of brain and C spine were unremarkable. Electromyography (EMG) showed increased weakness. It was reported that due to these suspected symptoms the physician diagnosed the patient with Atypical Guillain Barre Syndrome. On an unknown date, the patient experienced paraesthesias in extremities. The patient lumbar puncture had been examined and had weakness and painful paraesthesias of both legs, chronic inflammatory demyelinating polyneuropathy (CIDP). The patient had immunoglobulins total over 03 days with transient improvement of symptoms. It was stated that, present symptomatology primarily in legs and shoulder regions and she started LYRICA at high dose. The patient was treated with gabapentin (manufacturer unknown) for numbness with no relief, painful paraesthesias and intravenous immunoglobulins (IVIG) on 21 Dec 2015, tramadol HCL (manufacturer unknown), nortriptyline HCL (manufacturer unknown) and FETZIMA. The outcome of chronic inflammatory demyelinating polyneuropathy and painful paraesthesias of both legs was not reported and rest of events was reported as condition deteriorating. Seriousness of the events was not reported. The causality of chronic inflammatory demyelinating polyneuropathy and painful paraesthesias of both legs was not reported and rest of events was reported as suspected. Seriousness of the event Guillain Barre syndrome was upgraded based on the Novartis important medical events list. Seriousness of chronic inflammatory demyelinating polyradiculoneuropathy was upgraded to medically significant based on the NVS IME list. Seriousness of paraesthesia was upgraded to medically significant based on the information available in the source document. Follow up report received from a physician on 02 Feb 2016: Added family history, medical history, events (painful paraesthesias of both legs and chronic inflammatory demyelinating polyneuropathy) and treatment medications (LYRICA, tramadol HCL, nortriptyline HCL and FETZIMA).
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort, Cough, Dizziness, Dysphonia, Dyspnoea
Clinical narrative: Case number PHHY2015US172753, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 604071) website on 29 Dec 2015. This report refers to a 30 years old female patient. Past medical history and concomitant medication were not reported. The patient received seasonal influenza vaccine (other manufacturer, batch number: 07557) on 21 Oct 2015. On the same day after vaccination at 14:00 she felt tightness in her chest. She tried to rest and woke up at 14:30 with worsening symptoms. Her throat was scratchy, very hoarse voice, felt like had to try really hard to talk. Breathing was difficult, felt like had something in throat, but did not felt airway was compromised. She was unable to talk it was just difficult and sounded hoarse. She also experienced cough and felt very dizzy. She took BENADRYL at a dose 25 mg. The event did not improve, but did not get worse. The patient decided to go to the physician and got some steroids. She got an intramuscular injection of dexamethasone (manufacture unknown) and methylprednisone (manufacture unknown). Her voice was less hoarse and easier to breathe within 3 hours. The final outcome of the events was reported as complete recovery on an unknown date. The seriousness was reported as non serious and causality was not reported. The seriousness assessment of chest discomfort was upgraded based on information available in source document. Following an internal review done on 01 Feb 2016: It was confirmed that, previously reported batch number (07557) was not a valid Novartis influenza vaccine batch number. Hence, this case will be deactivated.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Sensation of foreign body, Throat irritation
Clinical narrative: Case number PHHY2015US172753, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 604071) website on 29 Dec 2015. This report refers to a 30 years old female patient. Past medical history and concomitant medication were not reported. The patient received seasonal influenza vaccine (other manufacturer, batch number: 07557) on 21 Oct 2015. On the same day after vaccination at 14:00 she felt tightness in her chest. She tried to rest and woke up at 14:30 with worsening symptoms. Her throat was scratchy, very hoarse voice, felt like had to try really hard to talk. Breathing was difficult, felt like had something in throat, but did not felt airway was compromised. She was unable to talk it was just difficult and sounded hoarse. She also experienced cough and felt very dizzy. She took BENADRYL at a dose 25 mg. The event did not improve, but did not get worse. The patient decided to go to the physician and got some steroids. She got an intramuscular injection of dexamethasone (manufacture unknown) and methylprednisone (manufacture unknown). Her voice was less hoarse and easier to breathe within 3 hours. The final outcome of the events was reported as complete recovery on an unknown date. The seriousness was reported as non serious and causality was not reported. The seriousness assessment of chest discomfort was upgraded based on information available in source document. Following an internal review done on 01 Feb 2016: It was confirmed that, previously reported batch number (07557) was not a valid Novartis influenza vaccine batch number. Hence, this case will be deactivated.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Balance disorder, Blindness transient, Clonus, Headache, Hyperreflexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 year old female patient. The patient had none medical history, none drug reactions nor allergies and none concomitants medications. None of lab diagnostic studies were performed. On 16-04-2015, the patient received the first dose of GARDASIL (Lot number: L001442 and expiration date: 22-JUN-2015) and on 15-JUN-2015, the second dose of GARDASIL (Lot number: L001442 and expiration date: 04-NOV-2016). On 19-NOV-2015, the patient received GARDASIL 9 (Lot number: L028083 and expiration date: 23-SEP-2017) intramuscular as the third dose in the series. On 19-NOV-2015 (five to ten minutes after receiving GARDASIL 9), the patient developed a headache, blurry vision and became nauseous. The patient sought medical attention as she was in the office at the time of the adverse event. The patient was given Ondansetron (manufacturer unspecified) and Ibuprofen (manufacturer unspecified) as a treatment. On 20-NOV-2015, the patient was still feeling groggy and was seen by the physician on the same day. The physician completed a neurological exam and determined the patient was very tremulous in the legs and arms, she had clonus of the ankles, both hands were weak with the left hand being a little weaker than the right hand, the patient's knees were hyperreflexive, and the patient had optical neuritis. The outcome of headache, blurry vision, nausea, optic neuritis, hyperreflexia, muscular weakness, clonus and tremor was unknown. The relatedness between the events and GARDASIL, GARDASIL 9 was not reported. Follow up information has been received on 02-FEB-2016, from the reporting registered nurse, who informed that the 12 year old female patient reported before, had no known allergies, nor any birth defect. Concurrent conditions included: Asthma (controlled with no recent exacerbation), seborrhea capitis and atopic dermatitis. The patient was vaccinated with GARDASIL 9 on 19-NO-2015 at 15:53, in her left deltoid. According to the reporter, the patient was on therapy with the following concomitant medications: SINGULAIR 5 mg tablet, PROAIR per needed, ZYRTEC and triamcinolone, topical, on a tid frequency. The reporting nurse stated that, following vaccination with GARDASIL 9 the patient experienced, clonus of legs, unsteady, and a temporary vision loss, for which the patient went to a ophthalmologist visit. The outcome of all the patient's adverse events was reported as recovered on an unspecified date in November 2015 (reported as within 24-48 hours). Upon internal review the event of Blindness transient was considered medically significant. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Muscular weakness, Nausea, Neurological examination abnormal, Optic neuritis, Somnolence
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 year old female patient. The patient had none medical history, none drug reactions nor allergies and none concomitants medications. None of lab diagnostic studies were performed. On 16-04-2015, the patient received the first dose of GARDASIL (Lot number: L001442 and expiration date: 22-JUN-2015) and on 15-JUN-2015, the second dose of GARDASIL (Lot number: L001442 and expiration date: 04-NOV-2016). On 19-NOV-2015, the patient received GARDASIL 9 (Lot number: L028083 and expiration date: 23-SEP-2017) intramuscular as the third dose in the series. On 19-NOV-2015 (five to ten minutes after receiving GARDASIL 9), the patient developed a headache, blurry vision and became nauseous. The patient sought medical attention as she was in the office at the time of the adverse event. The patient was given Ondansetron (manufacturer unspecified) and Ibuprofen (manufacturer unspecified) as a treatment. On 20-NOV-2015, the patient was still feeling groggy and was seen by the physician on the same day. The physician completed a neurological exam and determined the patient was very tremulous in the legs and arms, she had clonus of the ankles, both hands were weak with the left hand being a little weaker than the right hand, the patient's knees were hyperreflexive, and the patient had optical neuritis. The outcome of headache, blurry vision, nausea, optic neuritis, hyperreflexia, muscular weakness, clonus and tremor was unknown. The relatedness between the events and GARDASIL, GARDASIL 9 was not reported. Follow up information has been received on 02-FEB-2016, from the reporting registered nurse, who informed that the 12 year old female patient reported before, had no known allergies, nor any birth defect. Concurrent conditions included: Asthma (controlled with no recent exacerbation), seborrhea capitis and atopic dermatitis. The patient was vaccinated with GARDASIL 9 on 19-NO-2015 at 15:53, in her left deltoid. According to the reporter, the patient was on therapy with the following concomitant medications: SINGULAIR 5 mg tablet, PROAIR per needed, ZYRTEC and triamcinolone, topical, on a tid frequency. The reporting nurse stated that, following vaccination with GARDASIL 9 the patient experienced, clonus of legs, unsteady, and a temporary vision loss, for which the patient went to a ophthalmologist visit. The outcome of all the patient's adverse events was reported as recovered on an unspecified date in November 2015 (reported as within 24-48 hours). Upon internal review the event of Blindness transient was considered medically significant. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Tremor, Vision blurred
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 year old female patient. The patient had none medical history, none drug reactions nor allergies and none concomitants medications. None of lab diagnostic studies were performed. On 16-04-2015, the patient received the first dose of GARDASIL (Lot number: L001442 and expiration date: 22-JUN-2015) and on 15-JUN-2015, the second dose of GARDASIL (Lot number: L001442 and expiration date: 04-NOV-2016). On 19-NOV-2015, the patient received GARDASIL 9 (Lot number: L028083 and expiration date: 23-SEP-2017) intramuscular as the third dose in the series. On 19-NOV-2015 (five to ten minutes after receiving GARDASIL 9), the patient developed a headache, blurry vision and became nauseous. The patient sought medical attention as she was in the office at the time of the adverse event. The patient was given Ondansetron (manufacturer unspecified) and Ibuprofen (manufacturer unspecified) as a treatment. On 20-NOV-2015, the patient was still feeling groggy and was seen by the physician on the same day. The physician completed a neurological exam and determined the patient was very tremulous in the legs and arms, she had clonus of the ankles, both hands were weak with the left hand being a little weaker than the right hand, the patient's knees were hyperreflexive, and the patient had optical neuritis. The outcome of headache, blurry vision, nausea, optic neuritis, hyperreflexia, muscular weakness, clonus and tremor was unknown. The relatedness between the events and GARDASIL, GARDASIL 9 was not reported. Follow up information has been received on 02-FEB-2016, from the reporting registered nurse, who informed that the 12 year old female patient reported before, had no known allergies, nor any birth defect. Concurrent conditions included: Asthma (controlled with no recent exacerbation), seborrhea capitis and atopic dermatitis. The patient was vaccinated with GARDASIL 9 on 19-NO-2015 at 15:53, in her left deltoid. According to the reporter, the patient was on therapy with the following concomitant medications: SINGULAIR 5 mg tablet, PROAIR per needed, ZYRTEC and triamcinolone, topical, on a tid frequency. The reporting nurse stated that, following vaccination with GARDASIL 9 the patient experienced, clonus of legs, unsteady, and a temporary vision loss, for which the patient went to a ophthalmologist visit. The outcome of all the patient's adverse events was reported as recovered on an unspecified date in November 2015 (reported as within 24-48 hours). Upon internal review the event of Blindness transient was considered medically significant. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 22 January 2016. This case involves a 41 year old female patient who was vaccinated with a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (ADACEL), (batch number: U5292AA and expiry date and dose number were not reported) via intramuscular route in left deltoid on 1 January 2016. It was reported that patient had no other vaccinations within 4 weeks of vaccinations and illness at time of vaccination was none and patient had allergy to MAXALT. Concomitant medications were not reported. On 2 January 2016, one day post vaccination; the patient could not move her arm. It was reported that patient had doctor visit. Lab data and corrective treatments were not reported. At the time of this report, the outcome of the event was unknown. List of documents held by sender: none.
Age: 41.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Mobility decreased
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 22 January 2016. This case involves a 41 year old female patient who was vaccinated with a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (ADACEL), (batch number: U5292AA and expiry date and dose number were not reported) via intramuscular route in left deltoid on 1 January 2016. It was reported that patient had no other vaccinations within 4 weeks of vaccinations and illness at time of vaccination was none and patient had allergy to MAXALT. Concomitant medications were not reported. On 2 January 2016, one day post vaccination; the patient could not move her arm. It was reported that patient had doctor visit. Lab data and corrective treatments were not reported. At the time of this report, the outcome of the event was unknown. List of documents held by sender: none.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: 08:15 AM - FEVER OF 100.3 GIVEN TYLENOL. 05:00 PM - FEVER OF 102.9 GIVEN TYLENOL. 09:00 PM - FEVER OF 102.3 GIVEN MOTRIN. 02:30 AM - FEVER OF 102.2 GIVEN TYLENOL.
Age: 52.0
Sex: F
Vaccine: FLU3, MMR
Symptoms: Arthralgia, Chills, Pyrexia, Tremor
Clinical narrative: Chills, shaking, fever of 101F, joints aching. Pushing fluids and resting. Will call doctor if fever stays high until noon.
Age: 1.28
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV
Symptoms: Wrong drug administered
Clinical narrative: DTAP was ordered and Pediarix was given.
Sex: U
Vaccine: MMRV
Symptoms: Seizure
Clinical narrative: This spontaneous case report was received from a registered nurse who heard from an unspecified nurse regarding a patient of unknown age and gender. No concurrent conditions and medical history was reported. On an unknown date (reported as years ago), the patient was vaccinated with PROQUAD injection (dosing regimen, frequency, strength and route unknown). Concomitant medications of the patient were unknown. On an unknown date, unspecified time after being vaccinated with PROQUAD, the patient experienced seizure and had to be air-lifted to the hospital. The outcome of the seizure was unknown. The causality assessment was unknown. No product quality complaint was reported. Upon internal review, the event seizure was considered to be medically significant. The reporter considered the event to be immediately life threatening. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Back pain, Computerised tomogram normal, Feeling abnormal, Injection site pain, Laboratory test normal
Clinical narrative: 01/21/2016 The day following vaccination the patient stated that she just didn't feel herself. 01/22/2016 Two days following vaccination the patient reported she woke up at 4:00 AM with major pain the back, the right shoulder, right arm and with pain also shooting down the right arm that was sharp and nagging. The pain was so bad her husband took her to the ER between 5-6 am that morning thinking that she was having a heart attack. All tests that morning came back negative. She has tried massage therapy which seemed to help some. But as of 2/4/2016, with a little improvement she is not back to her normal self yet. She is scheduled to see pain management physician next week.
Age: 47.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Pain, Pain in extremity
Clinical narrative: 01/21/2016 The day following vaccination the patient stated that she just didn't feel herself. 01/22/2016 Two days following vaccination the patient reported she woke up at 4:00 AM with major pain the back, the right shoulder, right arm and with pain also shooting down the right arm that was sharp and nagging. The pain was so bad her husband took her to the ER between 5-6 am that morning thinking that she was having a heart attack. All tests that morning came back negative. She has tried massage therapy which seemed to help some. But as of 2/4/2016, with a little improvement she is not back to her normal self yet. She is scheduled to see pain management physician next week.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Blood glucose increased, Blood urea increased, Immediate post-injection reaction, Injection site pain, Musculoskeletal stiffness
Clinical narrative: At 3:50 pm 2-1-16 patient called Dr. office to report left arm painful and stiff, body shaking, blood sugar 175. Took TYLENOL. Patient was instructed to relax, apply a warm towel to the area and move the arm. If tingling, numbness or condition worsens go to the emergency room. Patient arrived at emergency room 2-1-2016 at 19:32 with complaint of fever and left arm pain. Patient said initial Pneumovax 23 injection site had immediate pain "like a shock" down the patient left arm. Fever onset this afternoon. Fever continues tonight as well as pain. Temp 101.7 oral, pulse 106 radial, resp 20, bp 161/74 right arm sitting, O2sat 94. IV started 1955 NS 0.9% at 50ml/hr. Vancomycin started 2105. Lab results: 2-1-16 WBC 16.93 BUN 24, Neutrophil % 88.9, Neutrophil count 15.04.  2-2-16 labs: WBC 18.59, BUN 23, Neutrophil % 85, Neutrophil count 15.81.  2-3-16 labs: WBC 11.71, BUN 21, neutrophil % 79.6, neutrophil count 9.32. Patient receive physical therapy while in hospital.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Neutrophil count increased, Neutrophil percentage increased, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: At 3:50 pm 2-1-16 patient called Dr. office to report left arm painful and stiff, body shaking, blood sugar 175. Took TYLENOL. Patient was instructed to relax, apply a warm towel to the area and move the arm. If tingling, numbness or condition worsens go to the emergency room. Patient arrived at emergency room 2-1-2016 at 19:32 with complaint of fever and left arm pain. Patient said initial Pneumovax 23 injection site had immediate pain "like a shock" down the patient left arm. Fever onset this afternoon. Fever continues tonight as well as pain. Temp 101.7 oral, pulse 106 radial, resp 20, bp 161/74 right arm sitting, O2sat 94. IV started 1955 NS 0.9% at 50ml/hr. Vancomycin started 2105. Lab results: 2-1-16 WBC 16.93 BUN 24, Neutrophil % 88.9, Neutrophil count 15.04.  2-2-16 labs: WBC 18.59, BUN 23, Neutrophil % 85, Neutrophil count 15.81.  2-3-16 labs: WBC 11.71, BUN 21, neutrophil % 79.6, neutrophil count 9.32. Patient receive physical therapy while in hospital.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Tremor, White blood cell count increased
Clinical narrative: At 3:50 pm 2-1-16 patient called Dr. office to report left arm painful and stiff, body shaking, blood sugar 175. Took TYLENOL. Patient was instructed to relax, apply a warm towel to the area and move the arm. If tingling, numbness or condition worsens go to the emergency room. Patient arrived at emergency room 2-1-2016 at 19:32 with complaint of fever and left arm pain. Patient said initial Pneumovax 23 injection site had immediate pain "like a shock" down the patient left arm. Fever onset this afternoon. Fever continues tonight as well as pain. Temp 101.7 oral, pulse 106 radial, resp 20, bp 161/74 right arm sitting, O2sat 94. IV started 1955 NS 0.9% at 50ml/hr. Vancomycin started 2105. Lab results: 2-1-16 WBC 16.93 BUN 24, Neutrophil % 88.9, Neutrophil count 15.04.  2-2-16 labs: WBC 18.59, BUN 23, Neutrophil % 85, Neutrophil count 15.81.  2-3-16 labs: WBC 11.71, BUN 21, neutrophil % 79.6, neutrophil count 9.32. Patient receive physical therapy while in hospital.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Left thigh diffusely swollen.  Patient able to bear weight without difficulty.  Adequate perfusion, no focal area of fluctuance.
Age: 36.0
Sex: F
Vaccine: ANTH, JEV1, MMR, TYP
Symptoms: Burning sensation, Haemorrhage
Clinical narrative: PT'S ARM WAS BLEEDING, HAD TO APPLY PRESSURE TO STOP .  PT C/O BURNING SENSATION RADIATING DOW TO WRIST.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Lymphadenopathy, Pain, Rash
Clinical narrative: Aching body, chills, rash that lasted 48 hours near armpits and swollen lymph nodes.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site infection, Peripheral swelling, Rash
Clinical narrative: Not sure when the reaction began for the patient. Put in today's date. Patient states arm began to swell and rash began to spread down arm. She went to doctor 2/5/16 who told her the site was infected. I told patient we would fill out adverse event report for the reaction.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Diarrhoea, Nausea, Pregnancy test, Vomiting
Clinical narrative: N/V/D
Sex: M
Vaccine: RVX
Symptoms: Diarrhoea, Gastroenteritis, Pyrexia
Clinical narrative: This spontaneous report, which refers to a male patient of unknown age, was received from a company representative via the patient's mother. At the time of the report, the patient was 6 years old. No medical history, drug reactions/allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with rotavirus vaccine (manufacturer unknown), administered orally by default (lot number, expiration date, dose and frequency were not reported). No concomitant therapies were reported. On an unknown date, the patient was taken to an unspecified hospital since he experienced severe diarrhea and a fever of 103 degrees (unspecified units). The reporter also indicated that her son had experienced gastroenteritis every two or three weeks since the vaccination (date unspecified) but no action was taken when the patient had visited a gastroenterologist. Additionally, it was mentioned that the vaccination with rotavirus vaccine (manufacturer unknown), was not discontinued. The outcomes of severe diarrhea, gastroenteritis and fever of 103 degrees were reported as not recovered. No causal relationship was provided between the events and vaccination with the rotavirus vaccine (manufacturer unknown). There was no quality complaint reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Arthralgia, Dyspnoea, Fatigue, Headache
Clinical narrative: Initial unsolicited report received from a nurse via (other company Pfizer manufacturer number 2015443993) on 21 December 2015. This case involves a (61-year-old) female patient who was vaccinated with a dose of INFLUENZA VACCINE (FLU VACCINE) (batch number, expiry date, route of administration were not reported) in arm and also received a dose of PNEUMOCOCCAL POLYSACCHARIDE VACCINE (PREVNAR 13) (manufacturer Pfizer, batch number, expiry date, route of administration were not reported) in deltoid on 04 December 2015. Patient has medical history of rheumatoid arthritis. Patient had no vaccine given 4 weeks prior. On 04 December 2015, few hours "the same evening after getting the vaccine" following the vaccination patient experienced shortness of breath and feeling that she cannot get a lot of air. On December 2015, "after two or three days later" patient experienced headache, fatigue and increased joint pain. Patient did not required emergency room or doctors visit. Laboratory investigation and corrective treatment were not reported. The outcome of event was not recovered. Causality was reported as related "yes" for events shortness of breath and unknown for Headache, Fatigue and Increased joint pain. List of documents held by sender: none. Follow-up information received from a physician on 12 January 2016. Patient had received intramuscular dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (Fluzone) (batch number- UI431AB, expiry date- 06-Jan-2016) in left deltoid and an intramuscular dose of prevenar 13 (batch number- L99271, expiry date- 03-Mar-2017) in right deltoid on 4 December 2015 at 11:55 and 11:56 AM. Patient had no illness at the time of vaccination. Patient had a history of allergy to sulfa (January 2001), allergy to atorvastatin (October 2014), mild renal insufficiency (December 2001), reactive airway disease (October 2008), respiratory problems, wheezing, decreased memory and work. Patient was vaccinated at private physician's office/hospital. On 05 December 2015, one day after vaccination, patient experienced increased joint pain, headache and fatigue. The patient did not require any specific tests and treatments. Patient stated that she was recovering from the events but the symptoms were not totally gone and she said that her lungs were clear.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Feeling cold, Hypoaesthesia, Injected limb mobility decreased, Injection site pain
Clinical narrative: I had extreme muscle pain from the injection site shooting down to my forearm into my hand. The pain went up my should around to my back and into my neck.  My arm was so painful that I could not move it and the next day the pain continues.  At around 6:30 pm I got very cold and piled on several blankets that did not warm me or help the shivering.  I had nausea for about 30 minutes starting at 7:30 pm. Two fingers became numb and normal feeling has not returned the following day. I have had many vaccines and never had pain like this.  The side effects of this vaccine are far worse than any I have experienced.  Even the anthrax vaccine was less painful.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Nausea, Pain in extremity
Clinical narrative: I had extreme muscle pain from the injection site shooting down to my forearm into my hand. The pain went up my should around to my back and into my neck.  My arm was so painful that I could not move it and the next day the pain continues.  At around 6:30 pm I got very cold and piled on several blankets that did not warm me or help the shivering.  I had nausea for about 30 minutes starting at 7:30 pm. Two fingers became numb and normal feeling has not returned the following day. I have had many vaccines and never had pain like this.  The side effects of this vaccine are far worse than any I have experienced.  Even the anthrax vaccine was less painful.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Hepatic enzyme increased, Pain, Pruritus generalised, Pyrexia
Clinical narrative: Patient described onset of fever, body aches approx. 12 hours after vaccination.  Symptoms were not resolving after a week so she came for a f/u visit and bloodwork was done.  Bloodwork showed elevated liver enzymes, further bloodwork showed increasingly high liver enzymes and patient was complaining of generalized itching.
Age: 18.0
Sex: M
Vaccine: FLU3, HEPA, HPV9, MNQ, VARCEL
Symptoms: Incorrect route of drug administration
Clinical narrative: Gave HPV9 vaccine subcutaneously instead of IM.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity, X-ray
Clinical narrative: Severe pain in arm and shoulder could not lift arm. Went to dr gave me prednisone tool x-ray. Dec.30-15 went to orthopedic dr gave shot in shoulder and sent me to therapy.
Age: 57.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injected limb mobility decreased
Clinical narrative: Pt reports limited range of motion in arm starting approximately 2 weeks following vaccine administration, physical therapy ordered by physician - left arm.
Age: 0.54
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Crying, Electrocardiogram abnormal, Electroencephalogram normal, Hypotonia, Laboratory test normal
Clinical narrative: After patient was placed to bed and cried out with an unusual cry/scream. Mother rushed to get her and picked her up. At that time patient became limp and unresponsive. Mother gave mouth to mouth breathing, which made patient cry. Then she became unresponsive again, which made the mother provide more mouth to mouth breathing. Again, patient started crying but also became unresponsive for a third time. In the meantime the father called 911. Upon arrival patient still seemed lethargic so she was taken to Emergency Room.
Age: 0.54
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Lethargy, Resuscitation, Screaming, Unresponsive to stimuli
Clinical narrative: After patient was placed to bed and cried out with an unusual cry/scream. Mother rushed to get her and picked her up. At that time patient became limp and unresponsive. Mother gave mouth to mouth breathing, which made patient cry. Then she became unresponsive again, which made the mother provide more mouth to mouth breathing. Again, patient started crying but also became unresponsive for a third time. In the meantime the father called 911. Upon arrival patient still seemed lethargic so she was taken to Emergency Room.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Disturbance in attention, Limb discomfort, Somnolence
Clinical narrative: Patient states having trouble concentrating, arms and legs are heavy, drowsy.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Vaccination complication
Clinical narrative: Pt arrived this morning upon opening the center; pt reports having a "bad reaction to the pneumococcal vaccine" she received here 2 days ago. Pt immediately taken in to a triage room to assess. R-deltoid noted as being very red and hot. Pt c/o of the R-deltoid having localized "itching, but no pain". Dr. came in to assess. Pt was walked in to schedule and s/s were tx'd accordingly.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Acne, Pain of skin, Pruritus
Clinical narrative: Received Pneumonia vax on 1/26. Around 1/30 - 1/31 soreness and sensitivity started on scalp on top left side of head. Touching it feels like type of acne. Itchiness began a couple of days ago and reminded him of chickenpox when younger. Affected area has several acne-like bumps not just one. Reporting it as a possible side effect to vaccine. As of yet has not noticed any other changes/symptoms.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: Fever, pain, redness, swelling, fatigue, and muscle pain.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: Fever, pain, redness, swelling, fatigue, and muscle pain.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Redness around site, hot and hard.  Redness expanding down and partially around arm with vague borders-approx 16cm long 11cm wide with swelling.  Warm to touch.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Herpes zoster
Clinical narrative: HERPES ZOSTER IN 2 DOSE VARICELLA VACCINE RECIPIENT (UNILATERAL RASH IN ONE DERMATOME, NO PAIN, LASTED LESS THAN 4 WEEKS, NO ANTIVIRAL TREATMENT).
Age: 1.05
Sex: F
Vaccine: MMR
Symptoms: Eyelid oedema
Clinical narrative: Family noted right upper eyelid swelling on waking the day after this vaccine. Family also notes this has happened after every vaccination, but resolves by the end of the day.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: RASH IN LINEAR PATTERN ON RIGHT SIDE, NO PAIN, UNILATERAL IN 1 DERMATOME.
Age: 47.0
Sex: M
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: MMR vaccine was given at an inappropriate interval from TB and TDaP. Did not wait 3 months after TB to give MMR.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMRV
Symptoms: Adenotonsillectomy, Pharyngitis streptococcal, Sleep apnoea syndrome
Clinical narrative: Sleep apnea and strep throat.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Rash generalised
Clinical narrative: Severe rash started from the area near the vaccinated site then spread all over the body. The child is still suffering from severe and daily life interesting rash all over the body from head to toe as of today (2/5/2015).
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Pruritus, Rash
Clinical narrative: Rash and itch.
Age: 51.0
Sex: F
Vaccine: DTOX
Symptoms: Arthralgia, Asthenia, Chest pain, Decreased appetite, Diarrhoea
Clinical narrative: Disorientated, sweating more than ever in my life, explosive diarrhea, weakness, little movement in my arm I received the shot in. Pain under my left breast would come and go till day after the shot. Today 02/05/2016 a lot of pressure in my head, sleepy, no appetite and weak, pain in rt. heel and ankle muscle.
Age: 51.0
Sex: F
Vaccine: DTOX
Symptoms: Disorientation, Head discomfort, Hyperhidrosis, Injected limb mobility decreased, Myalgia
Clinical narrative: Disorientated, sweating more than ever in my life, explosive diarrhea, weakness, little movement in my arm I received the shot in. Pain under my left breast would come and go till day after the shot. Today 02/05/2016 a lot of pressure in my head, sleepy, no appetite and weak, pain in rt. heel and ankle muscle.
Age: 51.0
Sex: F
Vaccine: DTOX
Symptoms: Pain in extremity, Somnolence
Clinical narrative: Disorientated, sweating more than ever in my life, explosive diarrhea, weakness, little movement in my arm I received the shot in. Pain under my left breast would come and go till day after the shot. Today 02/05/2016 a lot of pressure in my head, sleepy, no appetite and weak, pain in rt. heel and ankle muscle.
Age: 0.9
Sex: F
Vaccine: DTAPIPVHIB, FLUX, HEP, PNC13
Symptoms: Drug administered at inappropriate site, Febrile convulsion
Clinical narrative: Case number PHHY2015US157419, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 596564) website on 24 Nov 2015. This report refers to a 9 months old female patient. Past medical history and concomitant medications were not reported. Vaccination history included administration of first dose of Hepatitis B vaccine (manufacturer unknown) and PREVNAR 13. The patient had no allergies or relevant family history. She was vaccinated with seasonal influenza vaccine (other manufacturer and batch number: UT41199), PENTACEL (batch number: C381899), Hepatitis b vaccine (manufacturer unknown and batch number: 15172) and PREVNAR 13 (batch number: 916599) all received intramuscularly on 16 Nov 2011. On the same day after the vaccination, the patient experienced febrile seizure (several) for which she was taken to the emergency room for evaluation. Treatment of event included TYLENOL. The patient was evaluated on 17 Nov 2011 by the physician at a follow up visit with no treatment. Outcome of the events reported as recovered without sequelae. Event was reported as non serious and causality was not reported. Seriousness of the event febrile convulsion was upgraded based on the available information in the source document. Following an internal review done 29 Jan 2016, it was confirmed that, previously reported batch number (UT41199) belongs to other manufacturer (invalid Novartis vaccine batch number). Hence, this case will be deactivated.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Itching at administration site within minutes, large area of redness surrounding site in hours. Treated with BENADRYL. Saw urgent care MD, no further treatment necessary.
Age: 24.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Throat tightness
Clinical narrative: 1136 Pt c/o tightness in throat. EPIPEN 0.3mg to (R) thigh. 50 mg BENADRYL. Pt denies any other s/s. 1240 Pt discharged to home with husband.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: Immediately hurt when administered in the left arm. Continues to have dull ache in this location. Reported today 2/5/16.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness approximately the size of a golf ball with swelling and warmth at the injection site. Onset within several hours. Pt. saw MD, diagnosed with cellulitis, treatment started with Amoxicillin.
Age: 24.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: 105.5 temporal fev after immunizations lasted approx. 30-35 mins and down to 100 after giving TYELNOL and using cool compresses.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Eye irritation, Eye swelling
Clinical narrative: Patient's left eye got swollen and irritated, especially the area under the eye got really swollen. The swelling got improved by Friday.
Age: 64.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: (L) deltoid swelling and soreness s/p flu vaccine. Soreness still persists today.
Age: 64.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: (L) deltoid swelling and soreness s/p flu vaccine. Soreness still persists today.
Age: 67.0
Sex: M
Vaccine: FLUC3
Symptoms: Rash
Clinical narrative: Skin rash. Hydroxyzine 25 mg QID, Fluocinonide BID, Pramoxine Prn.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Case number PHHY2015US029717, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 551120) website on 05 Mar 2015. This report refers to a female patient of an unknown age. Medical history and concomitant medications were not reported. On an unknown date, she was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported). On an unknown date, following the vaccination, she felt so sick that she cannot take flu vaccines as it made her very ill. The outcome, seriousness and causality of the event were not reported.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an adolescent patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 22-Sep-2015, the patient was vaccinated with second dose of improperly stored VAQTA, lot # L018499; expiry: 25-FEB-2017 (dose, route and frequency unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored oral, ROTATEQ (lot # L000569, expiration date 13-JUL-2016) (dose and route were not reported). Previous temperature excursion was reported as 1.5C for 28 minutes. Time frame was reported as 1 hour and 14 minute under temperature: +0.9C. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an adolescent patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 21-Sep-2015, the patient was vaccinated with second dose of improperly stored VAQTA, lot # L018499; expiry: 25-FEB-2017 (dose, route and frequency unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of (Merck) VARIVAX (doses, routes of administration, injection sites, lot numbers and expiration dates were not reported). Administered doses of (Merck) VARIVAX underwent temperature excursion at 7 Fahrenheit degrees. At the time of reporting, the time frame of temperature excursion and information about the previous temperature excursions were unknown. No adverse effects were reported. 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: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (doses, routes of administration, injection sites, lot numbers and expiration dates were not reported). Administered doses of PROQUAD (Merck) underwent temperature excursion at 7 Fahrenheit degrees. At the time of reporting, the time frame of temperature excursion and information about the previous temperature excursions were unknown. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 30 years old female patient. No information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was provided. On an unknown dates, the patient was vaccinated with unspecified number of doses of M-M-R II injection (dose, route, lot# and expiration date were not reported). On an unknown date, the patient underwent antibody test (titers) and she had low titers for rubella. The patient's rubella titer was "0.9 and it needs to be 0.99 to be positive". On 03-FEB-2016, the patient who was 30 years old received a dose of PROQUAD (Merck) injection, lot# L033692, expiration date 28-FEB-2017 (dose and route of vaccination were not reported). No adverse effects associated with this vaccination were reported. The outcome of low titers for rubella and the causality between low titers for rubella and doses of M-M-R II were not provided. Causality between low titers for rubella and PROQUAD (Merck) was assessed as not related as the vaccine was administered after low titers for rubella onset. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 30 years old female patient. No information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was provided. On an unknown dates, the patient was vaccinated with unspecified number of doses of M-M-R II injection (dose, route, lot# and expiration date were not reported). On an unknown date, the patient underwent antibody test (titers) and she had low titers for rubella. The patient's rubella titer was "0.9 and it needs to be 0.99 to be positive". On 03-FEB-2016, the patient who was 30 years old received a dose of PROQUAD (Merck) injection, lot# L033692, expiration date 28-FEB-2017 (dose and route of vaccination were not reported). No adverse effects associated with this vaccination were reported. The outcome of low titers for rubella and the causality between low titers for rubella and doses of M-M-R II were not provided. Causality between low titers for rubella and PROQUAD (Merck) was assessed as not related as the vaccine was administered after low titers for rubella onset. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 22-SEP-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L004754, expiry date- 10-NOV-2016) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.