chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.32
Sex: F
Vaccine: 6VAX-F
Symptoms: Autopsy, Brain oedema, CSF test normal, Cerebral haemorrhage, Culture negative
Clinical narrative: Redness/inflamation at site, fever, vomiting, diarrhea, for 2 days, admitted to the hospital then within 12 hours decreased tone, decreased mental status, seizure, necrotizing encephalopathy, death.
Age: 0.32
Sex: F
Vaccine: 6VAX-F
Symptoms: Death, Diarrhoea, Encephalopathy, Full blood count normal, Hepatic necrosis
Clinical narrative: Redness/inflamation at site, fever, vomiting, diarrhea, for 2 days, admitted to the hospital then within 12 hours decreased tone, decreased mental status, seizure, necrotizing encephalopathy, death.
Age: 0.32
Sex: F
Vaccine: 6VAX-F
Symptoms: Hypotonia, Injection site erythema, Injection site inflammation, Laboratory test normal, Mental status changes
Clinical narrative: Redness/inflamation at site, fever, vomiting, diarrhea, for 2 days, admitted to the hospital then within 12 hours decreased tone, decreased mental status, seizure, necrotizing encephalopathy, death.
Age: 0.32
Sex: F
Vaccine: 6VAX-F
Symptoms: Pyrexia, Seizure, Vomiting
Clinical narrative: Redness/inflamation at site, fever, vomiting, diarrhea, for 2 days, admitted to the hospital then within 12 hours decreased tone, decreased mental status, seizure, necrotizing encephalopathy, death.
Age: 34.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 34 year old male patient. It was reported that the patient had no medical history and concurrent conditions. On 07-FEB-2016 the patient was vaccinated with ZOSTAVAX, 0.65 ml, (lot number L035506, expiry date 16-DEC-2016) (frequency reported as once) subcutaneously. Concomitant therapies included meloxicam (manufacturer unknown) and tramadol hydrochloride (manufacturer unknown). On 07-FEB-2016, (also reported as that same night and next day) the patient experienced itchiness at the injection site. On an unknown date approximately in February 2016 (also reported as over the next couple of days) the patient developed redness and swelling around the injection site and 6 inches either way on the upper arm that was warm to touch and a little tender to touch. On 10-FEB-2016 the patient visited the pharmacy to report the event. There was no lab diagnostics studies performed. On 11-FEB-2016 the patient was seen at an unspecified urgent care facility and was prescribed KEFLEX as treatment. The action taken with the therapy with ZOSTAVAX was unknown. It was reported that the pharmacist had spoken to the patient on 13-FEB-2016 and the patient was feeling much better hence the outcome of injection site pruritus, injection site warmth, injection site pain, injection site oedema and injection site erythema was considered as recovering. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality complaint reported. Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 34 year old male patient. It was reported that the patient had no medical history and concurrent conditions. On 07-FEB-2016 the patient was vaccinated with ZOSTAVAX, 0.65 ml, (lot number L035506, expiry date 16-DEC-2016) (frequency reported as once) subcutaneously. Concomitant therapies included meloxicam (manufacturer unknown) and tramadol hydrochloride (manufacturer unknown). On 07-FEB-2016, (also reported as that same night and next day) the patient experienced itchiness at the injection site. On an unknown date approximately in February 2016 (also reported as over the next couple of days) the patient developed redness and swelling around the injection site and 6 inches either way on the upper arm that was warm to touch and a little tender to touch. On 10-FEB-2016 the patient visited the pharmacy to report the event. There was no lab diagnostics studies performed. On 11-FEB-2016 the patient was seen at an unspecified urgent care facility and was prescribed KEFLEX as treatment. The action taken with the therapy with ZOSTAVAX was unknown. It was reported that the pharmacist had spoken to the patient on 13-FEB-2016 and the patient was feeling much better hence the outcome of injection site pruritus, injection site warmth, injection site pain, injection site oedema and injection site erythema was considered as recovering. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality complaint reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV, DTAPIPV, MMRV
Symptoms: Pruritus, Urticaria
Clinical narrative: This spontaneous report was received from a nurse regarding a 4 year old female patient. Concurrent condition and medical history was none. The patient had no allergies. On 12-FEB-2016, the patient was vaccinated with PROQUAD (Merck) (lot # L019998, expiry date- 12-FEB-2016) 0.5 ml, subcutaneously. Other suspect therapies included KINRIX (lot and expiry date not specified) intramuscular route, 0.5 ml on the left arm, vaccinated on 12-FEB-2016. There were no concomitant medication. On 12-FEB-2016 while the patient was still in office, the patient experienced erythema, which began at the ears and extended to trunk, arms and legs. It was also reported that the patient experienced hives, mainly on the arms and legs, pruritus and swelling at the injection site for PROQUAD (Merck). Patient had sought medical attention by being in office and was treated with diphenhydramine 0.25 ml (50mg/ml) and had improved significantly. There were no lab diagnostics studies performed. The outcome of the events was reported as recovering/resolving. There was no Product Quality Complaint (PQC) involved. The reporting nurse did not provide the causal relationship of the events with PROQUAD (Merck) and KINRIX. Upon internal review, the events were considered to be medically significant as they are treated with diphenhydramine 0.25 ml (50mg/ml). Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV, DTAPIPV, MMRV
Symptoms: Erythema, Injection site pruritus, Injection site swelling, Urticaria
Clinical narrative: This spontaneous report was received from a nurse regarding a 4 year old female patient. Concurrent condition and medical history was none. The patient had no allergies. On 12-FEB-2016, the patient was vaccinated with PROQUAD (Merck) (lot # L019998, expiry date- 12-FEB-2016) 0.5 ml, subcutaneously. Other suspect therapies included KINRIX (lot and expiry date not specified) intramuscular route, 0.5 ml on the left arm, vaccinated on 12-FEB-2016. There were no concomitant medication. On 12-FEB-2016 while the patient was still in office, the patient experienced erythema, which began at the ears and extended to trunk, arms and legs. It was also reported that the patient experienced hives, mainly on the arms and legs, pruritus and swelling at the injection site for PROQUAD (Merck). Patient had sought medical attention by being in office and was treated with diphenhydramine 0.25 ml (50mg/ml) and had improved significantly. There were no lab diagnostics studies performed. The outcome of the events was reported as recovering/resolving. There was no Product Quality Complaint (PQC) involved. The reporting nurse did not provide the causal relationship of the events with PROQUAD (Merck) and KINRIX. Upon internal review, the events were considered to be medically significant as they are treated with diphenhydramine 0.25 ml (50mg/ml). Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Middle insomnia, Nasopharyngitis, Pyrexia
Clinical narrative: Fever 100.8, cold symptoms and worsening cough. Cough severe enough to wake from sleep. Intensifying cough episodes.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort, Musculoskeletal stiffness, Pain, Pain in extremity, X-ray
Clinical narrative: Arm was incredibly painful the same night. It felt stiff and it hurt to move it. This continued for a few days. Thought my bicep was going to explode.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Drug administered at inappropriate site, Immediate post-injection reaction, Injection site discomfort, Injection site pain
Clinical narrative: 8/21/15- Influenza injection given in rt. shoulder, I knew immediately that it was given too high (I am a nurse). Injection stung as given, shoulder became very sore, stiff and movements (especially crossing midline) became very painful over the course of next few days, interfering with sleep and ADL. Took Aleve, kept thinking it would improve.  When it did not, I emailed Dr. to notify her and ask for direction. She referred me to orthopedic MD with shoulder specialty. Appointment was 9/21/15. Exam and Xray done. Xray was not significant. Exam significant for rotator cuff type injury, cortisone injection given and PT prescribed. Significant relief after cortisone injection. Went to PT x 5 sessions. Felt better, some continued discomfort with movements over midline, but able to sleep and do most activities with little/no discomfort. 12/10/2015 - Return of shoulder discomfort symptoms. Notified Dr. and orthopedic. Saw orthopedic. Symptoms present as noted above. PT prescribed x 3 with recommendation to return if not significant improvement after 3 PT. Return to orthopedic 2/2/16 after no significant improvement from PT. Recommendation for MRI with contrast. 2/8/2016 MRI with contrast done, right shoulder. 2/12/2016 Received call from orthopedic. Orthopedic reported that MRI showed "some significant tears in rotator cuff". Orthopedic recommended referral to shoulder surgeon. This appointment has not been scheduled as of yet. Awaiting phone call from this office.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal stiffness, Nuclear magnetic resonance imaging abnormal, Pain, Rotator cuff syndrome, Scan with contrast
Clinical narrative: 8/21/15- Influenza injection given in rt. shoulder, I knew immediately that it was given too high (I am a nurse). Injection stung as given, shoulder became very sore, stiff and movements (especially crossing midline) became very painful over the course of next few days, interfering with sleep and ADL. Took Aleve, kept thinking it would improve.  When it did not, I emailed Dr. to notify her and ask for direction. She referred me to orthopedic MD with shoulder specialty. Appointment was 9/21/15. Exam and Xray done. Xray was not significant. Exam significant for rotator cuff type injury, cortisone injection given and PT prescribed. Significant relief after cortisone injection. Went to PT x 5 sessions. Felt better, some continued discomfort with movements over midline, but able to sleep and do most activities with little/no discomfort. 12/10/2015 - Return of shoulder discomfort symptoms. Notified Dr. and orthopedic. Saw orthopedic. Symptoms present as noted above. PT prescribed x 3 with recommendation to return if not significant improvement after 3 PT. Return to orthopedic 2/2/16 after no significant improvement from PT. Recommendation for MRI with contrast. 2/8/2016 MRI with contrast done, right shoulder. 2/12/2016 Received call from orthopedic. Orthopedic reported that MRI showed "some significant tears in rotator cuff". Orthopedic recommended referral to shoulder surgeon. This appointment has not been scheduled as of yet. Awaiting phone call from this office.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Sleep disorder, X-ray limb abnormal
Clinical narrative: 8/21/15- Influenza injection given in rt. shoulder, I knew immediately that it was given too high (I am a nurse). Injection stung as given, shoulder became very sore, stiff and movements (especially crossing midline) became very painful over the course of next few days, interfering with sleep and ADL. Took Aleve, kept thinking it would improve.  When it did not, I emailed Dr. to notify her and ask for direction. She referred me to orthopedic MD with shoulder specialty. Appointment was 9/21/15. Exam and Xray done. Xray was not significant. Exam significant for rotator cuff type injury, cortisone injection given and PT prescribed. Significant relief after cortisone injection. Went to PT x 5 sessions. Felt better, some continued discomfort with movements over midline, but able to sleep and do most activities with little/no discomfort. 12/10/2015 - Return of shoulder discomfort symptoms. Notified Dr. and orthopedic. Saw orthopedic. Symptoms present as noted above. PT prescribed x 3 with recommendation to return if not significant improvement after 3 PT. Return to orthopedic 2/2/16 after no significant improvement from PT. Recommendation for MRI with contrast. 2/8/2016 MRI with contrast done, right shoulder. 2/12/2016 Received call from orthopedic. Orthopedic reported that MRI showed "some significant tears in rotator cuff". Orthopedic recommended referral to shoulder surgeon. This appointment has not been scheduled as of yet. Awaiting phone call from this office.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Pruritus, Urticaria
Clinical narrative: Hives on Face, neck, elbows, hands, ears. Swollen eyes. Extremely itchy Pruritis.
Age: 15.0
Sex: M
Vaccine: FLU3, HPV9
Symptoms: Aggression, Headache, Vision blurred
Clinical narrative: Blurry vision, headache, combative.
Age: 53.0
Sex: F
Vaccine: DPP
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Swelled, hard 2 inch diameter fever at injection site, pain at injection site, muscle ache whole arm, unable to lift arm without pain.
Age: 1.2
Sex: M
Vaccine: FLU3, HEP, HEPA, PNC13
Symptoms: Activated partial thromboplastin time, Full blood count, Metabolic function test, Petechiae, Prothrombin time
Clinical narrative: Pinpoint, petechiae on both upper extremities - few on legs and feet.
Age: 46.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Impaired work ability, Influenza virus test positive, Malaise, Vaccination failure
Clinical narrative: Initial unsolicited report received from a nurse on 06 February 2016. This case involves a 47-year-old female patient who was vaccinated with a dose of INFLUENZA VACCINE (Flu shot) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On 02 February 2016, following the vaccination, the patient felt sick. On an unknown date, the patient was tested in health center with positive flu. It was a vaccination failure. It was reported that, the patient had restriction as "not work until 08 January 2016". The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. Upon medical review, the case was considered as serious due to important medical event: tested with positive flu and vaccination failure. List of documents held by sender: none. As with any vaccine, Influenza vaccine may not protect 100% of susceptible individuals. Additional information on the vaccination details, time to onset, tests performed to confirm Influenza infection, the strain identified, as well as the patient's immune status at the time of vaccination would be helpful to further assess this case. Based on the available information, a role of the vaccine cannot be assessed.
Age: 46.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Influenza, Influenza virus test positive, Malaise, Vaccination failure
Clinical narrative: Initial unsolicited report received from a nurse on 06 February 2016. This case involves a 47-year-old female patient who was vaccinated with a dose of INFLUENZA VACCINE (Flu shot) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On 02 February 2016, following the vaccination, the patient felt sick. On an unknown date, the patient was tested in health center with positive flu. It was a vaccination failure. It was reported that, the patient had restriction as "not work until 08 January 2016". The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. Upon medical review, the case was considered as serious due to important medical event: tested with positive flu and vaccination failure. List of documents held by sender: none. As with any vaccine, Influenza vaccine may not protect 100% of susceptible individuals. Additional information on the vaccination details, time to onset, tests performed to confirm Influenza infection, the strain identified, as well as the patient's immune status at the time of vaccination would be helpful to further assess this case. Based on the available information, a role of the vaccine cannot be assessed.
Age: 1.26
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Abnormal behaviour, Blood magnesium normal, Electrocardiogram normal, Electroencephalogram normal, Full blood count normal
Clinical narrative: 2/9/16 PM: fever to max of 100.7. 2/11/16 AM: 2 min. unresponsive episode staring during therapy and "not herself" x 20 min. Seen in office: Temp 98.6 normal exam. 2/11/16 4 PM: 2nd episode of unresponsiveness - admitted thru ER - nl EEG.
Age: 1.26
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Metabolic function test normal, Pyrexia, Staring, Unresponsive to stimuli
Clinical narrative: 2/9/16 PM: fever to max of 100.7. 2/11/16 AM: 2 min. unresponsive episode staring during therapy and "not herself" x 20 min. Seen in office: Temp 98.6 normal exam. 2/11/16 4 PM: 2nd episode of unresponsiveness - admitted thru ER - nl EEG.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Redness, warm, swelling, pain to upper arm of injection site. Area was reported by patient to cover 3/4 length of upper arm. Patient developed malaise for 1.5 days.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Erythema/pain over most of right forearm.
Age: 30.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Influenza like illness
Clinical narrative: Initial unsolicited report received from a non-health care professional on 19 January 2016. This case involves a male patient (age unknown) who was vaccinated with a dose of INFLUENZA VACCINE (FLU VACCINE) (manufacturer: unknown, batch number, expiry date, route and site of administration were not reported) on an unspecified date (reported that he received the vaccine "this year"). Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced flu A. It was reported that the patient saw the doctor. Laboratory investigation and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none. Addendum on 15 February 2016: Upon second medical examination of the case during internal review, a significant correction was performed on 15 February 2016 to change the event coding of flu A from influenza A virus infection to flu-like illness and change the seriousness to No and Workflow Case priority to Class 4.
Sex: M
Vaccine: DTAP
Symptoms: Allergy to vaccine, Candida infection, Feeling abnormal, Respiration abnormal
Clinical narrative: Initial unsolicited report received from a consumer via partner company (Pfizer) (manufacturer report number- 2016056934) on 09 February 2016. This case involves 4-year-old male patient who was vaccinated with a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (Dtap) (batch number, route and site of administration not reported) eight year ago on an unspecified date. The patient's medical history includes allergy to nuts and asthma and concomitant medications were not reported. On an unspecified date (eight years ago), following the vaccination, the patient had experienced allergy to vaccine, thrush and was not good. The patient's breathing was bad. Laboratory data and corrective treatment were not reported. The outcome of events was not reported. Upon internal review the case was considered as serious because of important medical event terrible allergy, bad breathing, and thrush. List of documents held by sender: none. This is a poorly documented case. Further information on time to onset, vaccination details, medical history, allergy testings to identify the culprit allergen, etc. will be required to complete the assessment. Based on the information available, a role of the vaccine cannot be assessed.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Left arm cellulitis 2/5/16 treated by MD with doxycycline 100mg BID.
Sex: F
Vaccine: FLUN4
Symptoms: Pneumonia
Clinical narrative: A report has been received from a Health professional via medical representative concerning a female patient. It was reported that the patient might be having reactive airway before taking FLUMIST. On an unknown date, the patient (Healthcare professional) started taking FLUMIST (intranasal) every year (0.2 mL, every hour, Nasal). The patient had Pneumonia three days after taking FLUMIST between October to December 2015 on an unknown date. FLUMIST quadrivalent was continued. The outcome of the event of pneumonia was unknown. The company physician assessed the event of pneumonia to be serious due to important medical event.
Sex: M
Vaccine: PNC13
Symptoms: Blood pressure increased, Syncope
Clinical narrative: This is a spontaneous report from a contactable pharmacist reported through a Pfizer sales representative. A male patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on 09Feb2016. The patient medical history and concomitant medications were not reported. On an unspecified date in Feb 2016, the patient experienced fainted, collapse, elevated blood pressure. The outcome of the events was unknown.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Mobility decreased
Clinical narrative: Could not move arm. Radiating chest pain. Went to urgent care, 1 week course of symptoms had to get medication (tizanidine and NORCO).
Age: 0.2
Sex: F
Vaccine: DTP
Symptoms: Cerebrospinal fluid drainage, Encephalitis, Ephelides, Hypersensitivity, Meningitis
Clinical narrative: Upon second medical examination of the case during internal review, a significant correction was performed on 5 February 2016 to correct the product code of DPT from 'DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE' to 'DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED)'. Upon second medical examination of the case during internal review, a significant correction was performed on 2 February 2016 to correct the product code of DPT from 'DIPHTHERIA/TETANUS/WHOLE CELL PERTUSSIS ADSORBED VACCINE' to 'DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE'. SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received from a consumer on 29 September 2014 via a social media page. That report is from social media and contact information in based upon the location of our trading partner. A female consumer reported that in 1975, at two months of age, she received DTP (DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED)) (manufacturer and lot number not reported) and an unspecified amount of time later experienced spinal meningitis and encephalitis ("I had just gotten my DPT shot"). According to the reporter, family history included a third cousin who experienced a similar "allergic reaction", and the reporter attributed the events to a "recessive gene". Symptoms included a fever of 106 degrees, and per the reporter "they took the fluid off my brain with a needle, and I still have the white freckle from the scar on my scalp". Outcome was not reported. Documents held by sender: None. Addendum on 2 February 2016: Upon second medical examination of the case during internal review, a significant correction was performed to correct the product code of DPT from 'DIPHTHERIA/TETANUS/WHOLE CELL PERTUSSIS ADSORBED VACCINE' to 'DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE'. Addendum on 5 February 2016: Upon second medical examination of the case during internal review, a significant correction was performed on 5 February 2016 to correct the product code of DPT from 'DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE' to 'DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED)'. Sender's Comments: This is a poorly documented, consumer-reported case of meningitis in a 2-month-old following DTP vaccination. Infants are at higher risk for meningitis, as are patients with certain underlying diseases. In addition, the event occurred in 1975 prior to the availability of a vaccine for Hib, a common cause of meningitis in infants. Additional information regarding the patient's past medical history, laboratory and pathology findings, and vaccination details would be helpful in fully assessing the case.
Age: 0.2
Sex: F
Vaccine: DTP
Symptoms: Paracentesis, Pyrexia, Scar
Clinical narrative: Upon second medical examination of the case during internal review, a significant correction was performed on 5 February 2016 to correct the product code of DPT from 'DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE' to 'DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED)'. Upon second medical examination of the case during internal review, a significant correction was performed on 2 February 2016 to correct the product code of DPT from 'DIPHTHERIA/TETANUS/WHOLE CELL PERTUSSIS ADSORBED VACCINE' to 'DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE'. SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received from a consumer on 29 September 2014 via a social media page. That report is from social media and contact information in based upon the location of our trading partner. A female consumer reported that in 1975, at two months of age, she received DTP (DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED)) (manufacturer and lot number not reported) and an unspecified amount of time later experienced spinal meningitis and encephalitis ("I had just gotten my DPT shot"). According to the reporter, family history included a third cousin who experienced a similar "allergic reaction", and the reporter attributed the events to a "recessive gene". Symptoms included a fever of 106 degrees, and per the reporter "they took the fluid off my brain with a needle, and I still have the white freckle from the scar on my scalp". Outcome was not reported. Documents held by sender: None. Addendum on 2 February 2016: Upon second medical examination of the case during internal review, a significant correction was performed to correct the product code of DPT from 'DIPHTHERIA/TETANUS/WHOLE CELL PERTUSSIS ADSORBED VACCINE' to 'DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE'. Addendum on 5 February 2016: Upon second medical examination of the case during internal review, a significant correction was performed on 5 February 2016 to correct the product code of DPT from 'DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE' to 'DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED)'. Sender's Comments: This is a poorly documented, consumer-reported case of meningitis in a 2-month-old following DTP vaccination. Infants are at higher risk for meningitis, as are patients with certain underlying diseases. In addition, the event occurred in 1975 prior to the availability of a vaccine for Hib, a common cause of meningitis in infants. Additional information regarding the patient's past medical history, laboratory and pathology findings, and vaccination details would be helpful in fully assessing the case.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray normal, Cough, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt reports having severe cold like symptoms that started immediately after his influenza vaccine that he received last week. Had fever, cough and body aches which lasted several days. He also c/o having severe soreness in the left arm and is now unable to move the shoulder due to pain. Denies having rash or anaphylactic symptoms. He has since improved but still is having productive cough and left shoulder impairment. Musculoskeletal - abnormal exam of left shoulder; unable to fully examine due to Pain. TTP focal at origin of the biceps tendon. TENDINITIS OF LEFT BICEPS TENDON. Note: Unclear if this was related to the vaccine or not. He looks like he may have a frozen shoulder vs biceps tendonitis. He declines any nsaids or PT. Agreeable to icing only.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Nasopharyngitis, Pain, Pain in extremity, Productive cough, Pyrexia
Clinical narrative: Pt reports having severe cold like symptoms that started immediately after his influenza vaccine that he received last week. Had fever, cough and body aches which lasted several days. He also c/o having severe soreness in the left arm and is now unable to move the shoulder due to pain. Denies having rash or anaphylactic symptoms. He has since improved but still is having productive cough and left shoulder impairment. Musculoskeletal - abnormal exam of left shoulder; unable to fully examine due to Pain. TTP focal at origin of the biceps tendon. TENDINITIS OF LEFT BICEPS TENDON. Note: Unclear if this was related to the vaccine or not. He looks like he may have a frozen shoulder vs biceps tendonitis. He declines any nsaids or PT. Agreeable to icing only.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Tendonitis
Clinical narrative: Pt reports having severe cold like symptoms that started immediately after his influenza vaccine that he received last week. Had fever, cough and body aches which lasted several days. He also c/o having severe soreness in the left arm and is now unable to move the shoulder due to pain. Denies having rash or anaphylactic symptoms. He has since improved but still is having productive cough and left shoulder impairment. Musculoskeletal - abnormal exam of left shoulder; unable to fully examine due to Pain. TTP focal at origin of the biceps tendon. TENDINITIS OF LEFT BICEPS TENDON. Note: Unclear if this was related to the vaccine or not. He looks like he may have a frozen shoulder vs biceps tendonitis. He declines any nsaids or PT. Agreeable to icing only.
Age: 26.0
Sex: M
Vaccine: HEPAB
Symptoms: Burning sensation, Diarrhoea, Lip swelling, Local swelling, Nausea
Clinical narrative: Experienced burning sensation R arm. 5:00 AM 2/9/16 wife woke him up; Lips swollen & white; right side of neck swollen. Went to urgent care.  Dr. prescribed steroids. Night of 2/9/16 had nausea, vomiting, diarrhea.  Symptoms improved by 2/14 16. Has appointment with "specialist" on 2/22/16.
Age: 26.0
Sex: M
Vaccine: HEPAB
Symptoms: Pallor, Vomiting
Clinical narrative: Experienced burning sensation R arm. 5:00 AM 2/9/16 wife woke him up; Lips swollen & white; right side of neck swollen. Went to urgent care.  Dr. prescribed steroids. Night of 2/9/16 had nausea, vomiting, diarrhea.  Symptoms improved by 2/14 16. Has appointment with "specialist" on 2/22/16.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Injection site erythema, Myalgia, Pain in extremity, Pollakiuria
Clinical narrative: Pain down Rt leg explained as a deep muscle pain, started approx 4 PM 2-2-16,  Pain down Left side of torso started approx 9 PM 2-2-16, Burning and Frequent urination started in the AM on 2-3-16, Reddened area at sight of injection 2-3-16.  Client reports that the frequent urination and pain in the left torso ended by 2-6-16, but the pain in the Rt leg continued until 2-16-16.  Client reports that the redness at the sight of injection is still present but is very faint.  Client reports that she took Advil as needed for the discomfort.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Aphasia, Biopsy brain normal, Blood test, Brain neoplasm, Computerised tomogram
Clinical narrative: Started getting numbness in right hand and face. Was having trouble with finding words, didn't go to the doctor until a few months later and they did brain scans and blood tests. Said there was inflammation in her brain after several tests and ruling out many different things. Inflammation progressively became worse in her brain, she had 2 brain biopsies in 2015 that came back inconclusive. Facility could not diagnose her. Inflammation still worsening by the end of 2015. Hardly able to walk anymore, can't use her right hand at all anymore, can't speak well at all either. By December 2015 was diagnosed with a brain tumor and died on 01/16/2016.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Death, Gait disturbance, Hypoaesthesia, Musculoskeletal disorder, Noninfective encephalitis
Clinical narrative: Started getting numbness in right hand and face. Was having trouble with finding words, didn't go to the doctor until a few months later and they did brain scans and blood tests. Said there was inflammation in her brain after several tests and ruling out many different things. Inflammation progressively became worse in her brain, she had 2 brain biopsies in 2015 that came back inconclusive. Facility could not diagnose her. Inflammation still worsening by the end of 2015. Hardly able to walk anymore, can't use her right hand at all anymore, can't speak well at all either. By December 2015 was diagnosed with a brain tumor and died on 01/16/2016.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging, Scan brain, Speech disorder
Clinical narrative: Started getting numbness in right hand and face. Was having trouble with finding words, didn't go to the doctor until a few months later and they did brain scans and blood tests. Said there was inflammation in her brain after several tests and ruling out many different things. Inflammation progressively became worse in her brain, she had 2 brain biopsies in 2015 that came back inconclusive. Facility could not diagnose her. Inflammation still worsening by the end of 2015. Hardly able to walk anymore, can't use her right hand at all anymore, can't speak well at all either. By December 2015 was diagnosed with a brain tumor and died on 01/16/2016.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Pt is complaining of itching in area of back.
Age: 36.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: 36yo male presents to clinic with right upper arm pain, swelling and redness which developed 24hrs after he was given an anthrax booster. Pt has received prior with no reaction. 6cmx10cm indurated area which is firm and nonfluctuant with no drainage or discharge. Erythema with edema and warmth. No significant streaking. Area marked. Differential dx: Injection site reaction versus cellulitis. Likely an injection site reaction but will cover pt for cellulitis given holiday. Septra DS for 10 days with warm compresses and Tylenol for pain. Pt instructed to return tomorrow at 0730 if area of erythema has increased. Gave ER precautions. Pt's questions answered and expressed understanding.
Age: 36.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: 36yo male presents to clinic with right upper arm pain, swelling and redness which developed 24hrs after he was given an anthrax booster. Pt has received prior with no reaction. 6cmx10cm indurated area which is firm and nonfluctuant with no drainage or discharge. Erythema with edema and warmth. No significant streaking. Area marked. Differential dx: Injection site reaction versus cellulitis. Likely an injection site reaction but will cover pt for cellulitis given holiday. Septra DS for 10 days with warm compresses and Tylenol for pain. Pt instructed to return tomorrow at 0730 if area of erythema has increased. Gave ER precautions. Pt's questions answered and expressed understanding.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Impaired work ability, Injection site swelling, Injection site vesicles, Myalgia
Clinical narrative: Patient reported rash on neck that lasted 2 weeks after the vaccination. Injection site was initially very swollen with blisters at the site of injection. Patient had joint and muscle pain that lasted through November and caused her to missed 2-3 days of work each week between August and November. Patient reported being diagnosed with fibromyalgia. Physician told patient other patients with history of fibromyalgia had reported the same response to the vaccine. Patient's most severe response appeared to be bed sore type ulcers on and surrounding both knees and after several office visits tested positive for the chicken pox. Ulcers lasted 2+ weeks, unclear for exactly how long from patient's description. Patient states she had chicken pox as a child. Patient did not report this to the pharmacy until February 12, 2016 when symptoms had resolved.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin ulcer, Varicella virus test positive
Clinical narrative: Patient reported rash on neck that lasted 2 weeks after the vaccination. Injection site was initially very swollen with blisters at the site of injection. Patient had joint and muscle pain that lasted through November and caused her to missed 2-3 days of work each week between August and November. Patient reported being diagnosed with fibromyalgia. Physician told patient other patients with history of fibromyalgia had reported the same response to the vaccine. Patient's most severe response appeared to be bed sore type ulcers on and surrounding both knees and after several office visits tested positive for the chicken pox. Ulcers lasted 2+ weeks, unclear for exactly how long from patient's description. Patient states she had chicken pox as a child. Patient did not report this to the pharmacy until February 12, 2016 when symptoms had resolved.
Age: 30.0
Sex: F
Vaccine: HEPAB, MMR, VARCEL
Symptoms: Dizziness, Dyspnoea, Erythema, Skin warm, Tachycardia
Clinical narrative: Dizziness, tachycardia, dyspnea, redness, warmth on right arm. Checked vital signs after patient returned on 2/17/16 Temp. 97.1 BP 97/68 Pulse 73
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Decreased appetite, Fatigue, Injection site bruising, Injection site erythema
Clinical narrative: Onset time of adverse event is unknown. Pain at injection site accompanied by chills and fatigue. Patient reports on 2/12/2016 injection site had hard bruised (purple color) area and this was accompanied with loss of appetite in addition to previously cited symptoms. Today, 2/17/2016, patient presented to clinic with increased redness and swelling at injection site that extended from shoulder to elbow.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Onset time of adverse event is unknown. Pain at injection site accompanied by chills and fatigue. Patient reports on 2/12/2016 injection site had hard bruised (purple color) area and this was accompanied with loss of appetite in addition to previously cited symptoms. Today, 2/17/2016, patient presented to clinic with increased redness and swelling at injection site that extended from shoulder to elbow.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Full blood count normal, Influenza virus test negative, Pyrexia, Streptococcus test negative
Clinical narrative: Fever 103.3F.
Age: 19.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Employee Presented to Employee Health Dept. with c/o of itchy, red area at post-vaccination site measuring 50x60 mm in greatest dimensions. The area is red and warm and appears to have been administered correctly in the subcutaneous tissue.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling, hot to touch.
Age: 24.0
Sex: M
Vaccine: HPV4
Symptoms: Blood test, Cardiac stress test, Electrocardiogram, Electrocardiogram ambulatory, Heart rate increased
Clinical narrative: Hospitalized for High Pulse and low blood pressure. 6 months of testing. Diagnosed 04/13/2015 with POTS.
Age: 24.0
Sex: M
Vaccine: HPV4
Symptoms: Hypotension, Postural orthostatic tachycardia syndrome, Tilt table test, Ultrasound scan
Clinical narrative: Hospitalized for High Pulse and low blood pressure. 6 months of testing. Diagnosed 04/13/2015 with POTS.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: Bilateral thigh pain, aching, myalgias.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, IPV, PNC13
Symptoms: Erythema, Urticaria
Clinical narrative: Mother reports that child awoke that morning with "hives all over", describes as red and raised and large, as in some areas measure approximately 2 inches by 1 inch to the belly, diaper area, on the back and head and in the hair. No fever and maybe a little fussy. Went to an urgent care and was told likely not the vaccines causing the rash 2 days after, but could not be fore sure. Child was given a large dose of Benadryl and prescribed Prednisone and monitor for three days.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: I received a pneumococcal polysaccharide booster in my left arm on Monday afternoon.  On Tuesday afternoon while changing a shirt I observed that a large area around the injection site was red and swollen.  My upper arm felt tight, as if being squeezed.  By the time I saw a Doctor Wed. morning the swelling and redness had spread further toward the underside of my arm.  It did not itch, but was tender to the touch.  It did not respond to Benadryl (I had taken two doses 6 hours apart on Tuesday night.). There was no treatment prescribed other than ibuprofen, which I declined to take.  Over the next few days the reddened areas turned yellow, then faded completely by week's end.  Five years previously (in Dec., 2014 I had had a metal plate removed from that arm because it was infected with strep.  The plate was surgically inserted to repair a broken humerus in 2006.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Skin tightness
Clinical narrative: I received a pneumococcal polysaccharide booster in my left arm on Monday afternoon.  On Tuesday afternoon while changing a shirt I observed that a large area around the injection site was red and swollen.  My upper arm felt tight, as if being squeezed.  By the time I saw a Doctor Wed. morning the swelling and redness had spread further toward the underside of my arm.  It did not itch, but was tender to the touch.  It did not respond to Benadryl (I had taken two doses 6 hours apart on Tuesday night.). There was no treatment prescribed other than ibuprofen, which I declined to take.  Over the next few days the reddened areas turned yellow, then faded completely by week's end.  Five years previously (in Dec., 2014 I had had a metal plate removed from that arm because it was infected with strep.  The plate was surgically inserted to repair a broken humerus in 2006.
Age: 37.0
Sex: M
Vaccine: MMR, TD, TDAP, VARCEL
Symptoms: Rash, Swelling face
Clinical narrative: Rash all on face and upper body back and swollen face.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Computerised tomogram, Confusional state, Dizziness, Dysarthria, Gait disturbance
Clinical narrative: Dizziness, nausea, numbness of the arms, weakness of the arms and legs, numbness in the face, severe gait, headache, slurred speech, confusion.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Headache, Hypoaesthesia, Muscular weakness, Nausea, Nuclear magnetic resonance imaging
Clinical narrative: Dizziness, nausea, numbness of the arms, weakness of the arms and legs, numbness in the face, severe gait, headache, slurred speech, confusion.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEPA, PNC13
Symptoms: Injection site erythema, White blood cell count increased
Clinical narrative: Reddened thigh (R).
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: Persistent left shoulder pain after flu shot 9/21/15. The pain has never stopped. I have difficulty moving my left arm. I have received treatment from 3 MDs, including medications, sling, injection, PT and weight restrictions etc.
Age: 72.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Musculoskeletal pain, Myalgia, X-ray
Clinical narrative: I have extreme pain in upper left arm some time after Flu shot given at pharmacy. I can't remember the onset but I have a text on Oct 17 telling my sister about the pain in my upper arm where I got the Flu shot. She found other people suffered from same symptoms on internet. Doctor had x rays of neck done. Two doctors said it was from nerves coming from my neck. One prescribed physical therapy. I'm still having pain in the muscles and shoulder.
Age: 72.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: I have extreme pain in upper left arm some time after Flu shot given at pharmacy. I can't remember the onset but I have a text on Oct 17 telling my sister about the pain in my upper arm where I got the Flu shot. She found other people suffered from same symptoms on internet. Doctor had x rays of neck done. Two doctors said it was from nerves coming from my neck. One prescribed physical therapy. I'm still having pain in the muscles and shoulder.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: Redness on left arm.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Describe pain and discomfort (L) arm - Nov. 13, 2015 when raising on sleeping on it. Called MD and was told to ice.
Age: 20.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Disorientation, Tremor
Clinical narrative: Body shaking, no loss of consciousness, disorientation.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Shot received 9/26/2015. Patient says arm has hurt ever since, almost 5 months has trouble sleeping at night because of pain.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in unspecified number of patients who received FLUARIX Quadrivalent. On an unknown date, the patients received FLUARIX Quadrivalent at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX Quadrivalent, the patients experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to FLUARIX Quadrivalent. Additional details were provided as follows: A director of the pharmacy reported to GlaxoSmithKline's sales representative via email. The reporter heard from staff that there were unspecified number of patients, who experienced sore arms after flu vaccination this past flu season. It was reported that nearly 100 percent of the sore arms were from GlaxoSmithKline vaccine. The reporter noted that she was reporting the case to the sales representative just so that he knew. No other information or specifics were communicated.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 16-FEB-2016, the patient was inadvertently administered an expired dose of ZOSTAVAX lot # K020801, exp. 31-JAN-2016 (dose, route and site of administration were not reported). There was no adverse effects reported. Additional information has been requested.