chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Paraesthesia, Rash, Tremor
Clinical narrative: This spontaneous report as received from a consumer refers to a 69 year old male patient concerning himself with no pertinent medical history/concurrent conditions. On 13-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot number, route and expiration date were not reported). No concomitant medication reported. On 13-OCT-2014, the patient experienced headache, body aches and injection site discomfort. On 15-OCT-2014, about two days after receiving the injection, the patient experienced real bad chills, muscle cramps, body aches and shaked in a ball position for 30 seconds. On an unknown date in 2014, the patient developed a rash under his arm and a bladder infection. The patient also reported that he is now experiencing pain in the balls of his feet and when he "nods his head he gets a vibration of tingling feeling in the base of his neck that runs down to the base of his spine sometimes, and other times it runs down to his left leg and to his foot". The patient reported that after visiting the doctor for the adverse effects, his doctor told him that the shingles anti-virus is not in his system. The patient reported that the vaccine had failed. The outcome of headache, bladder infection, rash under arm, muscle cramps, shaking in a ball position for 30 seconds, chills real bad, body aches and injection site discomfort was reported as "eventually went away", recovered. The outcome of pain in the balls of his feet and when he "nods his head he gets a vibration of tingling feeling in the base of his neck that runs down to the base of his spine sometimes, and other times it runs down to his left leg and to his foot" was reported as not recovered. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Rash, Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old female patient with psoriasis. Medical history was not reported. On 02-DEC-2014 the patient was vaccinated with ZOSTAVAX injection, subcutaneous in the left arm, lot # K003597, expiration date: 12-MAR-2014, dosage was not reported. Concomitant therapy was unknown. On 19-DEC-2014 the patient developed a blistery rash that was painful and burned, located on the left side hip-joint area. It was unknown if there was any relevant laboratory data. The patient reported that was not a psoriasis outbreak. The outcome of the event was not recovered at the time of this report. Additional information has been requested.
Age: 1.59
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 19 months old female patient. Medical history and current conditions were not reported. On 18-NOV-2013, the patient was vaccinated with a dose of VARIVAX (Merck) lot # reported as J006106, expiration date: 17-MAY-2015 (route and dose were not reported) that was improperly stored on 04-SEP-2012, 06-NOV-2012, 21-MAR-2013 and 07-AUG-2014. The cumulative excursions were supported. Concomitant medication was not reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested. Event, Analysis was updated.
Age: 1.85
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 22 month old male patient. Medical history and current conditions were not reported. On 07-AUG-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # reported as J006106, expiration date: 17-MAY-2015 (route and dose were not reported) that was improperly stored on 04-SEP-2012, 06-NOV-2012, 21-MAR-2013 and 07-AUG-2014. The cumulative excursions were supported. Concomitant medications was not reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 11 years old male patient. Medical history and current conditions were not reported. On 18-AUG-2014, the patient was vaccinated with a dose of VARIVAX (Merck), lot # reported as J006106, expiration date: 17-MAY-2015 (route and dose were not reported) that was improperly stored on 04-SEP-2012, 06-NOV-2012. 21-MAR-2013 and 07-AUG-2014. The cumulative excursions were supported. Concomitant medication was not reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site pain
Clinical narrative: Case number PHHY2014US093565 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Event Reporting System (VAERS reference number: 511046) website on 24 Jul 2014. This case refers to a 42 year old female patient. Her past medical history and concomitant medications were not reported. On 16 Oct 2013, the patient was vaccinated with FLUCELVAX, (batch number: 006011A). On the same day, after the vaccination, the injection site remained extremely sore. The outcome of the event was unknown. The event was assessed as non serious by the Health Authority and the causality of the event was not reported.
Age: 37.0
Sex: M
Vaccine: FLUC3
Symptoms: Asthenia, Musculoskeletal pain, Vaccination site pain
Clinical narrative: Case number PHHY2014US093624 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 516614) website on 24 Jul 2014. This report refers to a 37-year-old male patient. His medical history and concomitant medications were not reported. His current condition included ragweed allergy. On 16 Nov 2013, he was vaccinated with FLUCELVAX, (batch number: 005031A) intramuscularly in the left arm. Following the vaccination, on 17 Nov 2013, he had pain at the site of vaccination (pain localized) which progressed to shoulder pain and to weakness in the left shoulder over a period of several weeks. He was referred to a primary care physician and also Sports or Orthopedic Specialist to consider advanced imaging, labs and possibly Electromyogram and Nerve Conduction Studies (NCS/EMG). The final outcome was reported as condition unchanged. The events were reported as non-serious. The causality of the events was not reported.
Age: 47.0
Sex: M
Vaccine: FLUC3, TDAP
Symptoms: Cough, Oropharyngeal pain, Swollen tongue, Tongue blistering
Clinical narrative: Case number PHHY2014US093783, is an initial spontaneous report from Vaccine adverse event reporting website (VAERS id: 516726) received on 24 Jul 2014. This report refers to a 47 year old male patient. His medical history and concomitant medication was not reported. He had no known drug allergy. He was vaccinated with FLUCELVAX (batch number: 010031A) intramuscular into left arm on 04 Dec 2013. On the same day he also received BOOSTRIX (batch number: 3T549) intramuscular into right arm. On the same day he developed swollen tongue with blisters, sore throat and cough. He took BENADRYL and symptoms resolved. The final outcome of the events was recovered. Causality assessment was not reported. The events were reported as non-serious; however the case was internally upgraded as medically significant by the agency.
Age: 65.0
Sex: M
Vaccine: FLUC3
Symptoms: Asthenia, Chills, Hyperhidrosis, Pyrexia
Clinical narrative: Case number PHHY2014US094302 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Event Reporting System (VAERS reference number: 516765) website on 24 Jul 2014. This case refers to an 65 year old male patient. His past medical history was not reported and had previously taken codeine for an unspecified indication. His concomitant medications were not reported. On 06 Dec 2013, the patient was vaccinated with FLUCELVAX, (batch number: 006011A) intramuscularly into his left arm. On 08 Dec 2013, the patient had chills, perspiration, general weakness and probable fever. The outcome of the events was complete recovery. The event was assessed as non serious by the Health Authority and the causality of the event was not reported.
Age: 37.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Case number PHHY2014US094040 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 516874) web site on 24 Jul 2014. This report refers to a 37 year old female patient. Her medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX (batch number: 010031A) into the left arm on 21 Nov 2013. On 22 Nov 2013, she developed a knot in her arm at injection site. The injection site was also red and little swollen. She did not seek medical attention. Final outcome was reported as complete recovery. The events were reported as non-serious. Causality was not reported.
Age: 51.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered at inappropriate site, Mobility decreased, Pain, Paraesthesia
Clinical narrative: Case number PHHY2014US093660 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 517619) website on 24 Jul 2014. This report refers to a 51-year-female patient. Past medical history and concomitant medications were not provided. She received FLUCELVAX, (batch number: 1346SP) intramuscularly into left arm on 07 Dec 2013. On 08 Dec 2013, one day after vaccination, she experienced inability to raise arm, tingling to fingers and constant pain. It was reported that the injection was given very high in joint area. She had taken ibuprofen and iced and exercised. The pain and inability to raise arm was almost continued for three weeks after injection. These events were reported as non-serious. Final outcome of the events was reported as condition unchanged as of 24 Dec 2013. Causality of the events was not reported.
Age: 7.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Rash
Clinical narrative: Case number PHHY2014US070781, is an initial spontaneous report from a consumer (patient mother) via Vaccine adverse event reporting website (VAERS id: 526069) received on 09 Jun 2014. This report refers to a 7 year old male patient. His medical history and concomitant medication was not reported. He was vaccinated with FLUCELVAX (batch number: 006031A) intramuscular into left arm on 30 Dec 2013. On 31 Dec 2013, patient had a rash reaction to the shot on chest and face and needed treatment (unspecified medication). He visited to the emergency room. Causality of the events was not reported. Outcome of the events was recovered. The event was reported as non-serious. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 09 Jun 2014: Added event "inappropriate age at vaccine administration" and second indication as "Adult product administered to child".
Age: 7.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Drug administered to patient of inappropriate age, Rash
Clinical narrative: Case number PHHY2014US070781, is an initial spontaneous report from a consumer (patient mother) via Vaccine adverse event reporting website (VAERS id: 526069) received on 09 Jun 2014. This report refers to a 7 year old male patient. His medical history and concomitant medication was not reported. He was vaccinated with FLUCELVAX (batch number: 006031A) intramuscular into left arm on 30 Dec 2013. On 31 Dec 2013, patient had a rash reaction to the shot on chest and face and needed treatment (unspecified medication). He visited to the emergency room. Causality of the events was not reported. Outcome of the events was recovered. The event was reported as non-serious. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 09 Jun 2014: Added event "inappropriate age at vaccine administration" and second indication as "Adult product administered to child".
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Myalgia, Nausea, Pain
Clinical narrative: Case number PHHY2014US066386 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 527577) web site on 28 May 2014. This report refers to a 50 year old male patient. He had no known drug allergy. His current condition included upper respiratory illness. He was vaccinated with FLUCELVAX, (batch number: 08011A) into left arm on 02 Apr 2014, approximately at 17:00 hours. On 03 Apr 2014, he woke up at 01:00 am with severe body aches and nausea which lasted till 04:00 am (approximately 03 hours). He also experienced mild persistent muscle pain. The final outcome of the events was unknown. The events were reported as non-serious. Causality was not reported.
Age: 31.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Pain, Pain in extremity, Tenderness
Clinical narrative: Case number PHHY2014US071273, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 529285) website on 09 Jun 2014. This report refers to a 31-year-old male patient. Historical conditions were not reported. Concomitant medication included clomipramine, fluvoxamine and clonazepam. He was vaccinated with FLUCELVAX, (batch number: 010011A) intramuscularly into the left arm on 11 Jan 2014. On the same day after vaccination, he experienced sore arm lasting one plus month. The arm was sore with movement and arm was sore on touch. The outcome of the event was unknown. The event was reported as non-serious. Causality was not reported.
Age: 58.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Feeling cold, Full blood count normal, Malaise, Nerve conduction studies normal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Case number PHHy2014US081793 is an initial spontaneous report from vaccine adverse event reporting system web site (VAERS reference number: 530531) on 01 Jul 2014. This case refers to a 58 year old female patient. Her past medical history included hypothyroidism which was existent for many years prior to this report. On 01 Nov 2013, she was vaccinated with FLUCELVAX, (batch number: 004011A) intramuscularly into her left arm. On 04 Nov 2013, after the vaccination, she felt like she was coming down with something each time she got on a plane to work, each of the three days per week that she flew as she was a flight attendant. At the end of each day at work, she would lie down in her bed for the entire night until the very last minute that she had to get up for work. She would take SUDAFED, MUCINEX, ZYRTEC and TYLENOL just to get up under it. This went on for the whole month of Nov 2013. Then the feeling that she would come down with something turned into horrible (Flu or cold) which was really bad by the end of the trip on 30 Nov 2013. When she got home, it had gotten progressively worse and her scalp was tingling on the left side. It took her nearly two full weeks to get back to work on 18 Dec 2013. On 20 Jan 2014, she woke up in the morning, at home, and her entire left side was tingling, from her scalp down to her toes. This went on steadily for three to four days, then it was on and off for another week, until it subsided somewhat and became more sporadic. The tingling on her left side was moving over to her right side eventually by the last week of Mar 2014. She still had sensations of a chill on and off in the right arm and shoulder. She visited a neurologist and underwent a magnetic resonance imaging scan of her brain, a nerve conduction study and a complete blood workup. The possibilities of stroke or neurological disease were ruled out. She still had the symptoms. On an unspecified date, she visited the emergency room. The outcome of felt like she was coming down with something was condition deteriorated and the outcome of tingling sensation and chills was condition unchanged. The seriousness and causality of the events were not reported.
Age: 58.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Paraesthesia
Clinical narrative: Case number PHHy2014US081793 is an initial spontaneous report from vaccine adverse event reporting system web site (VAERS reference number: 530531) on 01 Jul 2014. This case refers to a 58 year old female patient. Her past medical history included hypothyroidism which was existent for many years prior to this report. On 01 Nov 2013, she was vaccinated with FLUCELVAX, (batch number: 004011A) intramuscularly into her left arm. On 04 Nov 2013, after the vaccination, she felt like she was coming down with something each time she got on a plane to work, each of the three days per week that she flew as she was a flight attendant. At the end of each day at work, she would lie down in her bed for the entire night until the very last minute that she had to get up for work. She would take SUDAFED, MUCINEX, ZYRTEC and TYLENOL just to get up under it. This went on for the whole month of Nov 2013. Then the feeling that she would come down with something turned into horrible (Flu or cold) which was really bad by the end of the trip on 30 Nov 2013. When she got home, it had gotten progressively worse and her scalp was tingling on the left side. It took her nearly two full weeks to get back to work on 18 Dec 2013. On 20 Jan 2014, she woke up in the morning, at home, and her entire left side was tingling, from her scalp down to her toes. This went on steadily for three to four days, then it was on and off for another week, until it subsided somewhat and became more sporadic. The tingling on her left side was moving over to her right side eventually by the last week of Mar 2014. She still had sensations of a chill on and off in the right arm and shoulder. She visited a neurologist and underwent a magnetic resonance imaging scan of her brain, a nerve conduction study and a complete blood workup. The possibilities of stroke or neurological disease were ruled out. She still had the symptoms. On an unspecified date, she visited the emergency room. The outcome of felt like she was coming down with something was condition deteriorated and the outcome of tingling sensation and chills was condition unchanged. The seriousness and causality of the events were not reported.
Age: 58.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Blood test, Chills, Feeling abnormal, Influenza, Nasopharyngitis
Clinical narrative: Case number PHHy2014US081793 is an initial spontaneous report from vaccine adverse event reporting system web site (VAERS reference number: 530531) on 01 Jul 2014. This case refers to a 58 year old female patient. Her past medical history included hypothyroidism which was existent for many years prior to this report. On 01 Nov 2013, she was vaccinated with FLUCELVAX, (batch number: 004011A) intramuscularly into her left arm. On 04 Nov 2013, after the vaccination, she felt like she was coming down with something each time she got on a plane to work, each of the three days per week that she flew as she was a flight attendant. At the end of each day at work, she would lie down in her bed for the entire night until the very last minute that she had to get up for work. She would take SUDAFED, MUCINEX, ZYRTEC and TYLENOL just to get up under it. This went on for the whole month of Nov 2013. Then the feeling that she would come down with something turned into horrible (Flu or cold) which was really bad by the end of the trip on 30 Nov 2013. When she got home, it had gotten progressively worse and her scalp was tingling on the left side. It took her nearly two full weeks to get back to work on 18 Dec 2013. On 20 Jan 2014, she woke up in the morning, at home, and her entire left side was tingling, from her scalp down to her toes. This went on steadily for three to four days, then it was on and off for another week, until it subsided somewhat and became more sporadic. The tingling on her left side was moving over to her right side eventually by the last week of Mar 2014. She still had sensations of a chill on and off in the right arm and shoulder. She visited a neurologist and underwent a magnetic resonance imaging scan of her brain, a nerve conduction study and a complete blood workup. The possibilities of stroke or neurological disease were ruled out. She still had the symptoms. On an unspecified date, she visited the emergency room. The outcome of felt like she was coming down with something was condition deteriorated and the outcome of tingling sensation and chills was condition unchanged. The seriousness and causality of the events were not reported.
Age: 58.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Nerve conduction studies, Nuclear magnetic resonance imaging brain normal, Paraesthesia
Clinical narrative: Case number PHHy2014US081793 is an initial spontaneous report from vaccine adverse event reporting system web site (VAERS reference number: 530531) on 01 Jul 2014. This case refers to a 58 year old female patient. Her past medical history included hypothyroidism which was existent for many years prior to this report. On 01 Nov 2013, she was vaccinated with FLUCELVAX, (batch number: 004011A) intramuscularly into her left arm. On 04 Nov 2013, after the vaccination, she felt like she was coming down with something each time she got on a plane to work, each of the three days per week that she flew as she was a flight attendant. At the end of each day at work, she would lie down in her bed for the entire night until the very last minute that she had to get up for work. She would take SUDAFED, MUCINEX, ZYRTEC and TYLENOL just to get up under it. This went on for the whole month of Nov 2013. Then the feeling that she would come down with something turned into horrible (Flu or cold) which was really bad by the end of the trip on 30 Nov 2013. When she got home, it had gotten progressively worse and her scalp was tingling on the left side. It took her nearly two full weeks to get back to work on 18 Dec 2013. On 20 Jan 2014, she woke up in the morning, at home, and her entire left side was tingling, from her scalp down to her toes. This went on steadily for three to four days, then it was on and off for another week, until it subsided somewhat and became more sporadic. The tingling on her left side was moving over to her right side eventually by the last week of Mar 2014. She still had sensations of a chill on and off in the right arm and shoulder. She visited a neurologist and underwent a magnetic resonance imaging scan of her brain, a nerve conduction study and a complete blood workup. The possibilities of stroke or neurological disease were ruled out. She still had the symptoms. On an unspecified date, she visited the emergency room. The outcome of felt like she was coming down with something was condition deteriorated and the outcome of tingling sensation and chills was condition unchanged. The seriousness and causality of the events were not reported.
Age: 15.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Rash
Clinical narrative: Case number PHHY2014US100488, is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 532725) website on 08 Aug 2014. This case refers to a 15-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated FLUCELVAX, (batch number: 010021A) intramuscularly into right arm on 03 Jan 2014. On an unknown date, after an unspecified period of vaccination, he experienced rash. The event was reported as non-serious. Outcome of the event was reported as condition unchanged. Causality of the event was not reported. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 08 Aug 2014: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 15.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Drug administered to patient of inappropriate age, Rash
Clinical narrative: Case number PHHY2014US100488, is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 532725) website on 08 Aug 2014. This case refers to a 15-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated FLUCELVAX, (batch number: 010021A) intramuscularly into right arm on 03 Jan 2014. On an unknown date, after an unspecified period of vaccination, he experienced rash. The event was reported as non-serious. Outcome of the event was reported as condition unchanged. Causality of the event was not reported. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 08 Aug 2014: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 19.0
Sex: F
Vaccine: ADEN_4_7, FLUC3, HEP, MNQ, TDAP, ADEN_4_7, FLUC3, HEPA, MNQ, TDAP
Symptoms: Pruritus
Clinical narrative: Case number PHHY2014US100349, is an initial spontaneous report received from the consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 533505) website on 08 Aug 2014. This report refers to a 19-year-old female patient. She was vaccinated with FLUCELVAX, (batch number: 007011A) intramuscularly in the right arm on 10 Jun 2014 at 11:15 AM. On the same date at 11:15 AM, she also received oral adenovirus vaccine (other manufacturer, batch number: 34600161) orally, ENGERIX B, (batch number: 5J5HT, other manufacturer) in the left arm intramuscularly, MENACTRA, (other manufacturer, batch number: U4686AB) in the left arm intramuscularly and BOOSTRIX (other manufacturer, batch number: N3BE2) in the right arm intramuscularly. On the same date at approximately at 11:45 AM, she developed itching in the right arm, neck and right face. She was given BENADRYL 25 mg intramuscular injection at 12:00 PM. The patient reproted improvement in symptoms after 10 minutes and was released at 12:45 PM with resolved symptoms. The events reproted as non-serious. The causality of the events was not reported.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Insomnia, Pain in extremity, Rotator cuff syndrome
Clinical narrative: This medically confirmed spontaneous report (initial receipt 31-Oct-2014) concerns a 53-year-old female patient. The patient had medical history of citrus, tomato, strawberries and chocolate allergies and was also allergic to cephalexin. Her concomitant medications included venlafaxine, loratadine and acetylsalicylic acid. On 08-Oct-2014 at 13:00, the patient received intramuscular AFLURIA (batch number: T56805) in the right arm. On 08-Oct-2014, six hours after vaccination, the patient developed intense pain in the arm that the vaccine was injected into. The pain progressively worsened to a point, she felt like her rotator cuff tore. Patient also had difficulty in moving arm due to pain. She was unable to apply deodorant. On 28-Oct-2014, at a PT appointment showed a possible impingement syndrome and her shoulder was taped. The pain kept her up at night and rated 4 on 1 to 10 scale. The patient took ibuprofen with minimal relief. The outcome was reported as not yet recovered. Reporter's comments: The reporter assessed the events as non-serious and the causality as probable to AFLURIA. Follow-up (15-Dec-2014): Case upgraded to serious, VAERS number, concomitant medications, medical history, new AEs, site of administration, treatment and clinical course.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Insomnia, Pain in extremity
Clinical narrative: This medically confirmed spontaneous report (initial receipt 31-Oct-2014) concerns a 53-year-old female patient. The patient had medical history of citrus, tomato, strawberries and chocolate allergies and was also allergic to cephalexin. Her concomitant medications included venlafaxine, loratadine and acetylsalicylic acid. On 08-Oct-2014 at 13:00, the patient received intramuscular AFLURIA (batch number: T56805) in the right arm. On 08-Oct-2014, six hours after vaccination, the patient developed intense pain in the arm that the vaccine was injected into. The pain progressively worsened to a point, she felt like her rotator cuff tore. Patient also had difficulty in moving arm due to pain. She was unable to apply deodorant. On 28-Oct-2014, at a PT appointment showed a possible impingement syndrome and her shoulder was taped. The pain kept her up at night and rated 4 on 1 to 10 scale. The patient took ibuprofen with minimal relief. The outcome was reported as not yet recovered. Reporter's comments: The reporter assessed the events as non-serious and the causality as probable to AFLURIA. Follow-up (15-Dec-2014): Case upgraded to serious, VAERS number, concomitant medications, medical history, new AEs, site of administration, treatment and clinical course.
Age: 24.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Convulsion, Immediate post-injection reaction, Loss of consciousness, Pallor, Posture abnormal
Clinical narrative: Patient was administered Twinrix vaccination in left arm. Then Typhim vaccination was administered in right arm. Immediately following administration, patient stated "Im having a reaction" in which his face turned very pale and his head tilted back. One pharmacist went to call 911 while myself, the intern pharmacist, stayed with the patient to monitor. Patient appeared to have a seizure for about 10 to 15 seconds then regained consciousness. Patient stated he wanted to lay down and EMT arrived to check vitals. Patient requested not to go to hospital and waiting about 10 minutes before going home.
Age: 34.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Arthralgia, Dyspnoea, Hypertension, Mood altered, Palpitations
Clinical narrative: Joint Pain, Sleep Apnea, HBP, Palpitations, Difficult breathing, mood change.
Age: 34.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Sleep apnoea syndrome
Clinical narrative: Joint Pain, Sleep Apnea, HBP, Palpitations, Difficult breathing, mood change.
Age: 15.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Colitis ulcerative, Colostomy, Computerised tomogram, Erythema, Immune system disorder
Clinical narrative: 3 ER visits/CAT scan/ colostomy/ MRI/ Flagyl med/ steroids/ 6 nights in hospital/ extreme bleeding from rectum/ immune system attacking it's self/ morphine giving for pain.
Age: 15.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Nuclear magnetic resonance imaging, Pain, Rectal haemorrhage, Swelling
Clinical narrative: 3 ER visits/CAT scan/ colostomy/ MRI/ Flagyl med/ steroids/ 6 nights in hospital/ extreme bleeding from rectum/ immune system attacking it's self/ morphine giving for pain.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: Swelling directly under/above injection site, slight bleeding.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Increased swelling & redness left upper arm that spread encompessing the entire posterior upper arm & extending to the left elbow.  Treatment included Benadryl, Medrol Dose Pak, Amoxicillin 500 mg q8h for 7 days, ice packs.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Like any tetanus shot, my shoulder was sore shortly after the vaccine was administered.  However, within about 12-24 hours I began to notice the pain intensify beyond that of a typical tetanus shot.  The pain continued to intensify for the next several weeks, leaving me in constant pain and almost completely immobile.  I went to my family care practice one week after the injection to see what was wrong, but the injury was not showing the typical adverse reactions to the tetanus (redness, swelling, etc.), so I was prescribed pain medication for the week and sent home.  To this day, I still have chronic pain and limited mobility in my shoulder.
Age: 57.0
Sex: F
Vaccine: FLUC3
Symptoms: Cardiac function test normal, Chest X-ray normal, Coagulation test normal, Computerised tomogram normal, Guillain-Barre syndrome
Clinical narrative: Numbness/tingling in hands and feet which progressed to elbows and knees. Two to three days post vaccination developed upper respiratory illness.  ER visit 12/3/14 with diagnosis of parathesia upper and lower extremities.  Follow-up visit on 12/5/14 with PCP, diagnosis of Guillain Barre related to influenza vaccine. Scheduled neurologic visit this date for further evaluation.
Age: 57.0
Sex: F
Vaccine: FLUC3
Symptoms: Haematology test normal, Hypoaesthesia, Laboratory test normal, Paraesthesia, Upper respiratory tract infection
Clinical narrative: Numbness/tingling in hands and feet which progressed to elbows and knees. Two to three days post vaccination developed upper respiratory illness.  ER visit 12/3/14 with diagnosis of parathesia upper and lower extremities.  Follow-up visit on 12/5/14 with PCP, diagnosis of Guillain Barre related to influenza vaccine. Scheduled neurologic visit this date for further evaluation.
Age: 57.0
Sex: F
Vaccine: FLUC3
Symptoms: Urine analysis normal
Clinical narrative: Numbness/tingling in hands and feet which progressed to elbows and knees. Two to three days post vaccination developed upper respiratory illness.  ER visit 12/3/14 with diagnosis of parathesia upper and lower extremities.  Follow-up visit on 12/5/14 with PCP, diagnosis of Guillain Barre related to influenza vaccine. Scheduled neurologic visit this date for further evaluation.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist technician refers to a multiple anonymous patients of unknown age. On an unknown date the patients were vaccinated with VAQTA (dose and route of administration were not provided). On an unknown date the patients have been administered VAQTA post supported excursion. No adverse effects noted by any patients. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a clinical medical assistant refers to an unknown number of patients of unknown age and gender. Since on 05-DEC-2014, the patients were vaccinated with M-M-R II (dose, frequency and lot number unknown), subcutaneously, and VARIVAX (Merck) (dose, frequency and lot number unknown), subcutaneously. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practice nurse refers to 4 unspecified patients of unknown age and gender. The patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (doses, lot numbers and expiration dates were not reported) between 12-MAY-2014 and 30-OCT-2014 (exact dates were not reported). No adverse effects were reported. Additional information is not expected as there is no consent to contact the health professional.
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a male patient of unknown age. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with two PNEUMOVAX 23. Other suspect therapies included PREVENAR 13. On an unknown date, the patient experienced localized arm swelling with that PNEUMOVAX. Pharmacist reported that patient who had the reaction to PNEUMOVAX 23 was getting PREVNAR 13 instead. Pharmacist reported that he believe it was his personal experience, the patient had got PNEUNMOVAX 23 for the second time and had this reaction and wanted to know if he can get the PREVNAR 13. Patient did not have the PREVENAR 13 before but he only wanted to it get now as he was looking for the alternative of the PNEUMOVAX 23. There was no product complaint to report. The Pharmacist called in to know if the patient can get any data about the previous patients who had previous interaction with PNEUMOVAX 23 and the PREVNAR 13. Patients who have reaction with PNEUMOVAX 23 now wanted to take the PREVNAR 13. The outcome of localized arm swelling was unknown. The reporter considered localized arm swelling to be related to PNEUMOVAX 23. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Burning sensation, Erythema, Pain, Peripheral swelling, Pruritus
Clinical narrative: Swelling of upper extremity, itching, pain, burning, redness.
Age: 57.0
Sex: F
Vaccine: FLUR3
Symptoms: Adverse reaction
Clinical narrative: Unknown. Pt went to PCP for evaluation and treatment on 12/15/14. Patient has life-threatening egg and non egg allergies. I have prescribed prednisone, which is absolutely necessary for this reaction. It is my medical opinion that a patient with this problem should never take a flu injection whether egg base or not. If you have any questions or concerns, please contact me. Under my care for 12/15/14 to 12/16/14 and should return to work 12/17/14.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Blood test, Computerised tomogram, Dysarthria, Dysgeusia, Eyelid function disorder
Clinical narrative: Metallic taste in mouth on the way home from pharmacy.  Next day eye running tingling in mouth. Next day tingling in mouth worse. Next day hospital speech slurred, mouth drooped eye not closing.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Eyelid ptosis, Lacrimation increased, Paraesthesia oral
Clinical narrative: Metallic taste in mouth on the way home from pharmacy.  Next day eye running tingling in mouth. Next day tingling in mouth worse. Next day hospital speech slurred, mouth drooped eye not closing.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Crying, Dysstasia, Mobility decreased, Pain, Pyrexia
Clinical narrative: Woke up unable to move neck, turn side to side or sit or stand. Crying in pain whenever he was put in any upright position. Low-grade fever.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Skin warm, Tenderness
Clinical narrative: Redness, hot to touch; tender and cellulitis.
Age: 29.0
Sex: M
Vaccine: DTP
Symptoms: Chest discomfort, Dyspnoea, Flushing, Respiratory depression, Throat tightness
Clinical narrative: Symptom lasted approx 10 minutes. Pt does not have a hx to reaction to previous vaccines. Tightness chest and throst-difficulty breathing. Resp Depression and shortness of breath, face flushing, chest tightness.
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Incorrect route of drug administration
Clinical narrative: This is a spontaneous report from a non-contactable other hcp. A female patient of an unspecified age and ethnicity started to receive PREVNAR, via an unspecified route of administration from an unspecified date to an unspecified date at single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced cellulitis (medically significant) on an unspecified date with outcome of unknown, may have given the vaccine subcutaneous (incorrect route of drug administration) (non-serious) on an unspecified date with outcome of unknown. The action taken in response to the event(s) for PREVNAR was not applicable.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Incorrect route of drug administration
Clinical narrative: This is a spontaneous report from a contactable nurse and vaccine coordinator. A 56-year-old female patient received PREVNAR 13 (Lot # P007262 Exp. Date 25Nov2015), subcutaneous at 0.5 ml, single on 09Dec2014. Medical history included breast cancer from Dec2011, chronic obstructive pulmonary disease from Oct2003 and ongoing, Crohn's disease from Feb2008 and ongoing. Concomitant medication included albuterol neb 0.083% as needed, Albuterol inhaler 108 8.5ml 1-2 puffs every 2 hours as needed, anastrozole 1mg 1 tab daily, Calcium + Vit D twice a day 500-400mg, FLOVENT 12g 2 puffs 2 times a day. The patient received the PREVNAR 13 vaccine on 09Dec2014 subcutaneously instead of intramuscularly in the right arm and was diagnosed with cellulitis of the right arm on 12Dec2014. The patient was not hospitalized and was treated with an unspecified antibiotic. The outcome of the events was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Nodule, Pyrexia, Skin exfoliation
Clinical narrative: This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. An 84-year-old female patient received PREVNAR 13 single dose via an unspecified route of administration on 21Nov2014. Relevant medical history was not reported and concomitant medications were none. The patient experienced a knot which progressed to redness, cellulitis, and skin peeling on 24Nov2014 with outcome of unknown and a lot of fever on an unspecified date with outcome of unknown. The Pfizer sales representative mentioned that "all reported adverse events were due to PREVNAR-13 as the patient had all reported events after receiving shot and she was not taking any other medication."
Age: 31.0
Sex: M
Vaccine: DTP
Symptoms: Anaphylactic reaction, Limb discomfort, Throat tightness
Clinical narrative: Shortly after (3-5 minutes) vaccine was given pt began to feel tightness in his throat and right arm. According to staff present symptoms lasted approximately 5 minutes total. Anaphylaxis.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Flushing, Syncope
Clinical narrative: 11/11/14 Patient has had flu shots on other occasions, always get faint. Administered flu shot and patient became flush, but said okay and then he fainted, head forward on table. Immediately asked someone to call 911. We moved him up chair to try to lay him flat on the floor. He came to and I monitored his vitals; pulse. Tried to use blood pressure cuff, but would not work error #1, error #2. Patient finally patient felt better and I advised any unusual or anaphylactic symptoms to call 911 immediately, or go to see MD to verify okay. Security officers came down to take story. 911 never arrived, apparently was canceled, not sure why.
Sex: F
Vaccine: FLUC3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US014947 is an initial spontaneous report from the pharmacist (consumer) received on 24 Jul 2014. This report refers to a female patient of an unknown age. The patient was vaccinated with FLUCELAX (batch number: not reported) on 22 Jul 2014, intramuscularly. It was reported that the vaccine taken by the patient went above the recommended temperature, before it was administered. It was reported that FLUCELVAX was shipped on 20 Jul 2014. The vaccines were warm to the touch upon arrival at the facility on 21 Jul 2014 and the ice pack was slushy. No adverse event reported following this medication error (incorrect storage of drug).
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 3 unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with PNEUMOVAX 23 inj (strength dose and frequency not reported) (lot# and expiration date not provided) (route). On an unknown date the patients developed injection site swelling and soreness after receiving PNEUMOVAX 23. The outcome of injection site swelling and soreness after receiving PNEUMOVAX 23 was unknown. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 0.37
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Eye swelling, Rash
Clinical narrative: Rash ? hives and left eye swollen per ER notes!
Age: 29.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest X-ray, Culture negative, Full blood count normal, Granulocyte count, Influenza A virus test negative
Clinical narrative: Complaint/Assessment: Seen yesterday for leukocytosis - instructed to return today for repeat cbc. HPI/ROS: feels some better today but still running fever to 130 over night -- seen yesterday for fever (per pt home temp up to 102 -- body aches -- wbc 20,000 with L shift -- cxr neg -- ID called no tx recommended.. but to return. This am for re-evaluation and repeat labs.. pt got PNEUMOVAX in L deltoid on Monday and flu shot in R deltoid same day -- L deltoid is slight swollen -- warm to touch,, TTp .. pt denies sick exposures -- no cough - sore throat or dysuria -- no abd pain - no n/v or diarrhea -- no traveling. Redness and warmth at injection site; flu sx
Age: 29.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site oedema, Injection site swelling, Injection site warmth
Clinical narrative: Complaint/Assessment: Seen yesterday for leukocytosis - instructed to return today for repeat cbc. HPI/ROS: feels some better today but still running fever to 130 over night -- seen yesterday for fever (per pt home temp up to 102 -- body aches -- wbc 20,000 with L shift -- cxr neg -- ID called no tx recommended.. but to return. This am for re-evaluation and repeat labs.. pt got PNEUMOVAX in L deltoid on Monday and flu shot in R deltoid same day -- L deltoid is slight swollen -- warm to touch,, TTp .. pt denies sick exposures -- no cough - sore throat or dysuria -- no abd pain - no n/v or diarrhea -- no traveling. Redness and warmth at injection site; flu sx
Age: 29.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Laboratory test normal, Leukocytosis, Pain, Polymerase chain reaction, Pregnancy test urine negative
Clinical narrative: Complaint/Assessment: Seen yesterday for leukocytosis - instructed to return today for repeat cbc. HPI/ROS: feels some better today but still running fever to 130 over night -- seen yesterday for fever (per pt home temp up to 102 -- body aches -- wbc 20,000 with L shift -- cxr neg -- ID called no tx recommended.. but to return. This am for re-evaluation and repeat labs.. pt got PNEUMOVAX in L deltoid on Monday and flu shot in R deltoid same day -- L deltoid is slight swollen -- warm to touch,, TTp .. pt denies sick exposures -- no cough - sore throat or dysuria -- no abd pain - no n/v or diarrhea -- no traveling. Redness and warmth at injection site; flu sx
Age: 29.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Tympanic membrane disorder
Clinical narrative: Complaint/Assessment: Seen yesterday for leukocytosis - instructed to return today for repeat cbc. HPI/ROS: feels some better today but still running fever to 130 over night -- seen yesterday for fever (per pt home temp up to 102 -- body aches -- wbc 20,000 with L shift -- cxr neg -- ID called no tx recommended.. but to return. This am for re-evaluation and repeat labs.. pt got PNEUMOVAX in L deltoid on Monday and flu shot in R deltoid same day -- L deltoid is slight swollen -- warm to touch,, TTp .. pt denies sick exposures -- no cough - sore throat or dysuria -- no abd pain - no n/v or diarrhea -- no traveling. Redness and warmth at injection site; flu sx
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Extra dose administered, Pyrexia, Tenderness, Vomiting
Clinical narrative: Revaccinated from 8/31/14 compromised vaccine. 12/29/14 Fever, vomiting, generalized body pain to touch.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Injection site erythema, Injection site pain, Injection site swelling, Vomiting
Clinical narrative: Swelling, redness and soreness at injection site. Vomited about 9:30am.  Diarrhea onset at 5:00 pm.  Diarrhea contined off and on until Morning of Dec 28.  Vomited again at 1:00 pm on Dec 27.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Alanine aminotransferase increased, Antinuclear antibody negative, Aspartate aminotransferase increased, Ataxia, Blood alkaline phosphatase increased
Clinical narrative: Patient with increased numbness and with progressive numbness in hands. Progressive ataxia and unable to walk without assistance. Patient also reporting an URI.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: CSF glucose normal, CSF lymphocyte count increased, CSF protein increased, CSF white blood cell count increased, Gait disturbance
Clinical narrative: Patient with increased numbness and with progressive numbness in hands. Progressive ataxia and unable to walk without assistance. Patient also reporting an URI.