chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: MEN, MENB
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site lump in a 16-year-old female patient who received BEXSERO. Concomitant products included Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine. On 16th December 2015, the patient received the 1st dose of BEXSERO (intramuscular). On an unknown date, an unknown time after receiving BEXSERO, the patient experienced injection site lump and injection site warmth. On an unknown date, the outcome of the injection site lump and injection site warmth were unknown. It was unknown if the reporter considered the injection site lump and injection site warmth to be related to BEXSERO. Additional details were received as follows: The patient received the 1st dose in the series of BEXSERO. She also received a meningococcal vaccine on the same day (she believed it might have been brand name MENVEO, but was unsure). The 2 vaccines were administered in different arms. The patient developed a golf-ball sized lump at the site of the BEXSERO vaccine. The lump was red, warm to the touch, and sore for 1 month. The muscle soreness was severe enough to prevent the patient from driving. The patient attempted applying heat and ice, but the pain did not resolve. The patient also took over-the-counter pain medications to relieve the pain. When the patient presented to the clinic for the second BEXSERO injection, the lump had decreased in size, but was still present at the site of the previous injection. The patient's mother requested that the second BEXSERO injection be administered slightly lower on the muscle and the patient did not have an adverse reaction to the second BEXSERO injection.
Age: 23.0
Sex: M
Vaccine: RAB
Symptoms: Antibody test negative
Clinical narrative: Case number PHEH2015US008514 is an initial spontaneous report from a nurse received on 30 APR 2015 and with a follow-up information received from the Quality Assurance Department (reference number: 370206) on 12 MAY 2015, with the follow-up information received from Quality Assurance Department (reference number: 370206) on 03 JUN 2015. This report refers to a 25-year-old male patient. Medical history and concomitant medications were not reported. He was vaccinated with RABAVERT (batch number 524011C) first dose on 16 JAN 2014, second dose on 23 JAN 2014 and third dose on 06 FEB 2014. On 09 MAR 2015 the patient had his titre checked and they were low (0.4). No further information was reported. Based on the investigation performed, the QA department stated that, RABAVERT (batch number: 524011C) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 370206) on 12 MAY 2015: Updated QA reference number only. Follow-up information received from the Quality Assurance Department (reference number: 370206) on 03 JUN 2015: Updated RABAVERT batch review report.
Age: 12.0
Sex: M
Vaccine: HPV9, MMRV
Symptoms: Lymphadenopathy, Rash
Clinical narrative: Pt developed a rash the day of the vaccine on mouth/ears/lips/face. Mom said it was still present on 3/18/16 when I examined but could not appreciate recommended BENADRYL PRN. Pt also developed lymph node enlargement on (R) posterior neck 3/17/16. He is to follow up in 1 wk to reassess. Rash resolved on my exam, lymph node reevaluation pending.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Erythematous, warm, raised induration 3x4 inches at right anterolateral thigh.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC13
Symptoms: Decreased appetite, Dehydration, Laboratory test normal, Vomiting
Clinical narrative: Loss of appetite. Unable to keep anything down. Dehydration.
Age: 0.88
Sex: F
Vaccine: RAB
Symptoms: Pyrexia
Clinical narrative: Case number PH#H2015US011126, is an initial spontaneous report from a physician received on 04 JUN 2015., This report refers to a 10 months old female patient. Medical history and concomitant medications were not reported. Her vaccination history included administration of first dose of RABAVERT (batch number: 559011A, expiry date: 28 APR 2018) on 26 MAY 2015 and experienced loose stool (see case: PHEH2015US010822). She was vaccinated with second dose of RABAVERT (batch number: 546011A, expiry date: 30 MAY 2018) on 03 JUN 2015. On the same day, six hours after vaccination, the patient experienced fever of 100.4 degrees F. At 02:50 PM, fever was 103.7 degrees F (maximum temperature reading noted as per physician). On the same day, the patient was treated with Tylenol. On 04 JUN 2015, the patient's temperature was trending down; 102.5 degrees F at 05:30 AM and 100.2 degrees F at 10 AM. On the same day, the patient was treated Tylenol and Motrin. Final outcome of the event was unknown. Seriousness and causality of the event was not reported.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Asthenia, Dizziness, Pyrexia
Clinical narrative: Case number PHEH2015US013180 is an initial spontaneous report from a healthcare professional received on 07 JUL 2015. This report refers to a 24-year-old female patient. Medical history and concomitant medications were not provided. She was vaccinated with RABAVERT (batch number unknown) first dose on 01 JUL 2015. On 05 JUL 2015 she started feeling feverish, dizzy and weak. On 07 JUL 2015 her temperature was 102.7. She did not go to doctor or received any medical attention. Her second dose was going to be withheld because of fever. The reporter was not sure if the vaccine caused these events. The outcome of the events was reported as "unresolved". The events were reported as non-serios. Causality was unknown. The case was lost to follow up.
Sex: M
Vaccine: RAB
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: Case number PHEH2015US019724, is an initial spontaneous report received from a consumer (patients mother) on 25 SEP 2015. This report refers to a 4 year old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with RABAVERT (batch number: unknown) on an unknown date. Post vaccination on 28 JUL 2015, the patient experienced pain and discomfort at the injection site. Outcome of the event was recovered on 19 AUG 2015. Seriousness and causality assessment was not reported.
Age: 48.0
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of drug administration, Panic attack, Therapeutic response unexpected
Clinical narrative: Case number PHEH2015US001511 is an initial spontaneous report received from a consumer on 17 JAN 2015 with a follow up report from a consumer received on 29 JUL 2015, and with follow-up information from physician received on 21 SEP 2015. This report refers to a 47-year-old female patient. Her current conditions included severe trigeminal neuralgia which was diagnosed many years ago which was terrible pain. Her concomitant medications included Lyrica, gabapentin, Neurontin and others. She was vaccinated with a post exposure prophylaxis series of RABABERT (batch number: not reported) from FEB 2014 till 16 JAN 2015 after  being bitten by bat. Right away, after receiving the first injection she noticed a reduction in her trigeminal neuralgia. The pain from the neuralgia had been at a 10 for years, and she was on gabapentin or Neurontin to control it. She stopped her medication  when receiving the vaccine because of a fear of any interaction and there was an immediate reduction in pain after receiving RABAVERT. To this day, the pain remains at a 1-2 and she believes the RABAVERT vaccine has changed her life. She was amazed at what a difference this has made in her life. After the bat bit her she had panic attacks and had to undergo phycological counseling, but she said she would do it again. for the  benefit it gave her with her trigeminal neuralgia. The panic attacks were due entirely to the trauma of the attack and the rabies scare. The outcome of the events was reported as unkown. The seriousness of the events was not reported. The causality of unexpected effect was reported as suspected and causality of panic attacks was reported as not suspected. Follow up report from a consumer received on 29 JUL 2015: Updated patient's comment, event (panic attacks) and causality. Follow-up from a physician received on 21 SEP 2015: New event inappropriate schedule of vaccine administered), concurrent conditions and other clinically relevant information updated in the narrative.
Sex: M
Vaccine: RAB
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: Case number PHEH2015US019722 is an initial spontaneous report received from a consumer (patient's mother) on 25 SEP 2015. This report refers to a 6 years old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with RABAVERT (batch number: not reported) on an unknown date. Post vaccination, on 28 JUL 2015 the patient experienced pain and discomfort at the site of injection. The events recovered on 19 AUG 2015. The seriousness and causality of the events was not reported. The reporter declined to provide further information and hence the case was considered as lost to follow up.
Age: 70.0
Sex: M
Vaccine: RAB
Symptoms: Somnolence
Clinical narrative: Case number PHEH2015US021783 is an initial spontaneous report received from a consumer on 19 OCT 2015. This report refers to a 70 year old male patient. Past medical history and concomitant medications were not reported. There was a bat in patient's house and hence the doctor recommended vaccination for protection in the event the patient was bitten. His vaccination history included administration of first dose of RABAVERT (batch number: 556011A) on 12 JUN 2015 for post exposure following which he was very sleep (see related case number: PHEH201US021782). He was vaccinated with second dose of RABAVERT (batch number: 556011A) on 15 JUN 2015. After vaccination he felt very sleepy. The events outcome, seriousness and causality were not reported. He further received third dose of RABAVERT (batch number: 559011A) on 19 JUN 2015, following which he was sleepy (see related case number: PHEH2015US021784). He further received fourth dose of RABAVERT (batch number: 559011A) on 26 JUN 2015 following which he experienced sleepiness and arthritis flare up (see related case number: PHEH2015US021396). No further information was provided.
Age: 70.0
Sex: M
Vaccine: RAB
Symptoms: Somnolence
Clinical narrative: Case number PHEH2015US021784 is an initial spontaneous report received from a consumer on 19 Oct 2015. This report refers to a 70 year old male patient. Past medical history and concomitant medications were not reported. There was a bat in patient's house and hence the doctor recommended vaccination for protection in the event the patient was bitten. His vaccination history included administration of two doses of RABARVERT (batch number: 556011A) on 12 Jun 2015 and on 15 Jun 2015 for post respectively). He was vaccinated with the third dose of RABAVERT (batch number: 559011A) on 19 Jun 2015. After vaccination he felt very sleepy. The events outcome, seriousness and causality were not reported. He further received fourth dose of RABAVERT (batch number: 559011A) on 26 Jun 2015 following which he experienced sleepiness and arthritis flare up (see related case number: PHEH2015US021396). No further information was provided.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a other health professional and described the occurrence of pain in a 17-year-old female patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced pain in thigh. On an unknown date, the outcome of the pain in thigh was recovered/resolved. It was unknown if the reporter considered the pain in thigh to be related to BEXSERO. Additional details provided were as follows: The pain in thigh lasted for 8 days.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of drug administration, Irritability, Tension
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling tense in a 11-week-old female patient who received PEDIARIX. Co-suspect products included PEDIARIX. On 16th February 2016, the patient received the 1st dose of PEDIARIX. On 8th March 2016, the patient received the 2nd dose of PEDIARIX. On 16th February 2016, less than a day after receiving PEDIARIX and not applicable after receiving PEDIARIX, the patient experienced feeling tense and irritability. On 8th March 2016, the patient experienced drug dose administration interval too short, in March 2016, the patient experienced feeling tense and irritability. On 17th February 2016, the outcome of the feeling tense and irritability were recovered/resolved. On an unknown date, the outcome of the drug dose administration interval too short, feeling tense and irritability were unknown. The reporter considered the feeling tense and irritability to be related to PEDIARIX. Additional details provided were as follows: This case was reported by the patient's mother. This case was previously reported to a doctor. On 8th March 2016, the patient inadvertently received the 2nd dose of PEDIARIX vaccine 3 weeks after receiving the 1st dose. This led to the shortening of vaccination schedule. The patient's mother reported that, less than a month after vaccination with the 2nd dose the patient appeared to be fine, but was usual fussy and easily startled. The patient also experienced the similar events less than a day after receiving the 2st dose of the vaccine as well. She noted no fever for either administration. The patient's mother did not have any other details but states her daughter did receive other vaccines on those days as well.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding unspecified number of patients. Patient demographics were not reported. Information on their concurrent conditions, pertinent medical history and drug allergies were not reported. On an unknown date in March 2016 (starting on or after 09-MAR-2016) the patients were vaccinated with improperly stored VARIVAX (Merck) lot # L026405, expiry date 15-JUL-2017, lot # L027288, expiry date 21-JUL-2017, lot # L034367, expiry date 08-SEP-2017, lot/batch # L037565, expiry date 29-SEP-2017 (dose, frequency, route and anatomical location were not reported) (incorrect product storage). Concomitant medication were not reported. No adverse effects were reported. There were no Product Quality Concern (PQC) involved. Temperature at which the administered product was stored was 9.3 Fahrenheit, there were no previous temperature excursions performed. This is one of several reports received from same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray abnormal, Pneumonia
Clinical narrative: This spontaneous report was received from a currently 68 year old female patient reporting on herself. The patient did not have concurrent conditions, medical history, drug reactions or allergies. On an unspecified date in 2012 at the age of 65 years, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route, dose number, anatomical place of vaccination, lot # and expiration date were not reported). The patient was not taking any concomitant medication. On unspecified dates since vaccination with PNEUMOVAX 23 the patient reported to had developed 4 episodes of pneumonia. The patient reported that for the last episode of pneumonia she sought for medical attention and this one was confirmed by an X-ray on 01-MAR-2016. The patient started treatment with unspecified steroids and antibiotic. At the time of the report, the outcome of pneumonia was reported as recovering. The reporter did not provide a causality assessment between PNEUMOVAX 23 and the pneumonia. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown demographics. The patient's pertinent medical history and drug reactions/allergies were not provided. On an unspecified dates, in 2016, reported as "starting on or after 15-FEB-2016", the patients were vaccinated with an unspecified number of improperly stored doses of ROTATEQ (lot # L027719 and expiration date 28-APR-2017) oral. The temperature excursion details were reported as "Temperature: 49.9F, time fram; 8 hours, 40 minutes; there was no previous temperature excursion and it was not because the data logger". There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint involved. Additional information has been requested.
Age: 31.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse concerning a 31 years old patient of unknown gender. The patient's medical history and concurrent condition were not reported. On 04-MAR-2016, the patient was vaccinated with an expired dose of MMR II lot # J008533 and expiration date 12-JUL-2015 (dose and route of administration were not reported). Concomitant or co-suspect therapies were not provided. The reporter was not aware of any adverse effects. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. Information on concurrent conditions, pertinent medical history and drug allergies of the patient were not reported. On 11-MAR-2016, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025765, expiry date 08-JUN-2016 (dose, frequency, route and anatomical location were not reported) (incorrect product storage). Concomitant medication were not reported. No adverse effects were reported. There were no Product Quality Concern (PQC) involved. Temperature at which the administered product was stored was 9.3 Fahrenheit, there were no previous temperature excursions performed. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. Patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with improperly stored doses of (Merck) VARIVAX (dose, unit and route not reported, Lot# K015993 and Exp. date 23-SEP-2016). The vaccines were exposed to 6.65 F for 14 hours 15 minutes. There was previous temperature excursion reported, vaccines had been exposed to 17 F for 1 hour and 6.05 F for 14 hours. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. Information on their concurrent conditions, pertinent medical history and drug allergies were not reported. On 16-MAR-2016, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L027288, expiry date 21-JUL-2017)(dose, frequency, route and anatomical location were not reported) (incorrect product storage). Concomitant medications were not reported. No adverse effects were reported. There were no Product Quality Concern (PQC) involved. Temperature at which the administered product was stored was 9.3 Fahrenheit, there were no previous temperature excursions performed. This is one of several reports received from same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site bruising, Injection site pruritus, Injection site reaction, Nausea
Clinical narrative: Information has been received from a 60 year old female patient with abnormal blood pressure and reactions/allergies to sulfa, LEVAQUIN and CT dye. On 10-MAR-2016, the patient was vaccinated with ZOSTAVAX in the left arm (1 time injection; dose, route, lot # and expiration date were not reported). The patient was also on unspecified concomitant medications "for blood pressure". On the same day, the patient experienced a red rash, "about the size of a fifty cent piece" at the insertion site, and "it was bruised in the middle". She also stated having "headaches, nausea, itchiness at the site, and heart palpitations", after getting the vaccine. The patient did not seek medical attention. Outcome of the event was not reported. Causality assessment was not reported. Additional information is not expected as the physician is not allowed to be contacted.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations, Rash erythematous
Clinical narrative: Information has been received from a 60 year old female patient with abnormal blood pressure and reactions/allergies to sulfa, LEVAQUIN and CT dye. On 10-MAR-2016, the patient was vaccinated with ZOSTAVAX in the left arm (1 time injection; dose, route, lot # and expiration date were not reported). The patient was also on unspecified concomitant medications "for blood pressure". On the same day, the patient experienced a red rash, "about the size of a fifty cent piece" at the insertion site, and "it was bruised in the middle". She also stated having "headaches, nausea, itchiness at the site, and heart palpitations", after getting the vaccine. The patient did not seek medical attention. Outcome of the event was not reported. Causality assessment was not reported. Additional information is not expected as the physician is not allowed to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown date and gender. Information on their concurrent conditions, pertinent medical history and drug allergies were not reported. On 15-MAR-2016, the patient was vaccinated with improperly stored (Merck) VARIVAX lot # L026405, expiry date 15-JUL-2017 (dose, frequency, route and anatomical location were not reported) (incorrect product storage). Concomitant medication were not reported. No adverse effects were reported. There were no Product Quality Concern (PQC) involved. Temperature at which the administered product  was stored was 9.3 Fahrenheit, there were no previous temperature excursions performed. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a healthcare worker (Medical Assistant) concerning multiple unspecified patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On unknown dates the patients were vaccinated with doses of improperly stored VAQTA (lot # L023936 with expire date 15-MAR-2017) (dosage and route not reported). The improper conditions of storage was reported as 9 degree centigrade for 2 hours. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PPV, RV5, DTAPIPVHIB, FLU3, HEP, PPV, RV5
Symptoms: Wrong drug administered
Clinical narrative: Patient was given PNEUMOVAX instead of PREVNAR 13.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Crying, Faeces discoloured, Gastrointestinal disorder, Injection site erythema, Injection site pain
Clinical narrative: Severe swelling and redness around injection site, fever, skin very hot to touch around injection site, crying when touched, also green stools for 3 days following vaccination.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Injection site swelling, Injection site warmth, Pyrexia, Stereotypy
Clinical narrative: Severe swelling and redness around injection site, fever, skin very hot to touch around injection site, crying when touched, also green stools for 3 days following vaccination.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Injection site induration, Injection site pruritus, Injection site warmth, Peripheral swelling
Clinical narrative: Mild swelling on evening of 3/22/2016 and slight red arm. Morning of 3/23/2016 more swelling and red puffiness, arm where injection hard, very hot to touch and a little itchy. By 7p on 3/23/2016 arm was swollen and rash like looking measuring 4 in long and 3 inch wide, very warm. No fever, temp was 99.0 by ear on one side and 98.9 on other ear.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Rash, Swelling
Clinical narrative: Mild swelling on evening of 3/22/2016 and slight red arm. Morning of 3/23/2016 more swelling and red puffiness, arm where injection hard, very hot to touch and a little itchy. By 7p on 3/23/2016 arm was swollen and rash like looking measuring 4 in long and 3 inch wide, very warm. No fever, temp was 99.0 by ear on one side and 98.9 on other ear.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site pain
Clinical narrative: Complained of right deltoid pain and right sided headache.
Age: 30.0
Sex: F
Vaccine: RAB
Symptoms: Blister, Exposure to toxic agent, Rash erythematous
Clinical narrative: Significant correction performed. Suspect product coding was changed from IPV (VERO)-product code 059 to RABIES (HDC) VACCINE- product code 046. Initial unsolicited report received from a healthcare professional on 25 June 2014. A 30-year-old female patient had received an intramuscular first dose of IMOVAX RABIES (lot number J1676-1) in the left deltoid on 18 June 14 and had also received an intramuscular dose of RABAVERT (manufacturer: Novartis, lot number and dose in series was not reported) in the deltoid on 21 June 2014. "At the time of vaccination the cat bite to the patient on left calf." leads to understanding that the patient was bitten by a cat during the vaccination. The patient had Indomethacin allergy due to which the platelet count was decreased, Verapamil allergy, migraines and left kidney was removed due to hydronephrosis. It was reported that the patient was exposed to poison ivy two weeks earlier. Patient has been using Neosporin ointment on cat bite and red patches. On 22 June 2014, the patient developed a red blistery, patchy, circular rash, one patch on right forearm, one patch on left forearm, one patch on right lower leg and also had one blister in her mouth. On 23 June 2014 the patient had received a dose of HyperRab (Novartis) in left calf. On 25 June 2014, the patient had received an intramuscular dose of Imovax vaccine (batch number: J1676-1) in the left deltoid. The patient corrective treatments and laboratory investigations were not reported. The patient required ER/doctor visit. At the time of this report, the outcome was unknown. Documents held by sender: none. Follow up information was received from a physician on 13 February 2015: No new information was received. Addendum on 05-MAY-2015: Upon second medical examination of case at time of internal review a significant correction was performed to change the suspect product coding from IPV (VERO)-product code 059 to RABIES (HDC) VACCINE- product code 046.
Age: 52.0
Sex: F
Vaccine: RAB
Symptoms: Mass, Pain in extremity
Clinical narrative: Upon second medical examination of the case during internal review, a significant correction was performed on 18 January 2016 to correct the suspect product from IMOVAX (IPV (VERO)) to IMOVAX RABIES (RABIES (HDC) VACCINE). Initial unsolicited report received from a consumer on 10 July 2015. A 52-years-old female patient, whose concomitant medication was not reported, had received a first dose of IPV (VERO) (Imovax) (batch number: J0404, expiration date, dose, dose number and route of administration were not reported) in left deltoid and also received a first dose of PASTEURIZED HUMAN RABIES IMMUNOGLOBULIN (Imogam) (batch number, expiration date, dose, dose number and route of administration were not reported) in "Mult"on 9 July 2015. The patient's medical history reported as, penicillin, sulfa allergy, fluoroquinolone, latex allergy and MGUS (Monoclonal gammopathy of unknown significance) and Myeloma. On 9 July 2015, same day post-vaccination, the patient experienced a lump just below the site of injection and arm soreness. The patient did not have pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at time of vaccination. Patient did not receive other vaccination within four weeks. The patient required ER/doctor visit. Laboratory investigation was none reported. The patient applied ice as a corrective treatment. At the time of this report, the patient was recovered from lump just below the site of injection but not recovered from arm soreness. List of documents held by sender: none. Addendum on 18 January 2016: Upon second medical examination of the case during internal review, a significant correction was performed on 18 January 2016 to correct the suspect product from IMOVAX (IPV (VERO)) to IMOVAX RABIES (RABIES (HDC) VACCINE).
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: Pt's Mother states that the day after office visit (03/18/16), child was slightly fussy, with some low grade fever, and sight of injection to left leg was red, raised.  On the afternoon of 03/19/16 Mother became concerned, the sight of injection to the left leg became severely red, and was raised and hot to touch. Mother then took child to the emergency room for evaluation. The afternoon of 03/19/2016.  According to pt's Mother they diagnosed child with a skin infection, and cellulitis.  Child was seen in the office on 03/22/2016 for follow up.  At that time the physician diagnosed with reaction to immunization.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Pyrexia, Skin infection, Vaccination complication
Clinical narrative: Pt's Mother states that the day after office visit (03/18/16), child was slightly fussy, with some low grade fever, and sight of injection to left leg was red, raised.  On the afternoon of 03/19/16 Mother became concerned, the sight of injection to the left leg became severely red, and was raised and hot to touch. Mother then took child to the emergency room for evaluation. The afternoon of 03/19/2016.  According to pt's Mother they diagnosed child with a skin infection, and cellulitis.  Child was seen in the office on 03/22/2016 for follow up.  At that time the physician diagnosed with reaction to immunization.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a multiple unspecified patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medications. On an unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L037561 and expiry date 29-SEP-2017) (dosing details unspecified). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Details of temperature excursion: Temperature: Ranging from -14.9c to -9.8c for 30 to 31 minute increments from 01-MAR-2016 through 15-MAR-2016. Previous temperature excursion: No. Data logger in use: No, possible malfunctioning thermometer. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 65 year old male patient. Pertinent Medical History: unspecified chronic pain issue. Drug reactions/Allergies: None. On 07-MAR-2016 the patient was vaccinated with the right arm with ZOSTAVAX lot # L035285/expiry: 15-DEC-2016, dose: 0.65ml, once, subcutaneous for prevention of shingles. Concomitant therapies included gabapentin, acetaminophen, PERCOCEET, ibuprofen (+) acetaminophen (manufacturer unknown) and lisinopril (manufacturer unknown). On 08-MAR-2016 the patient developed an area of redness, swelling, and soreness in a 3-inch diameter around the injection site. Patient's wife reported to pharmacist on 11-MAR-2016 that the redness was spreading down the patient's arm, and that "little white spots" have also developed around the injection site. Patient sought medical attention and visited pharmacist. No treatment given for the events. No additional information provided. The outcome of all the events was reported as not resolved. Causality assessment was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Dehydration, Immediate post-injection reaction, Impaired work ability, Influenza like illness, Meningitis
Clinical narrative: Information has been received via company employee from a friend of company employee referring to a female patient of unknown age. In late December 2015 the patient was vaccinated with a dose of ZOSTAVAX (route, lot# and dose were unknown). Immediately after vaccination the patient developed flu like symptoms. After several months of illness, the patient was diagnosed with meningitis type A in her optic nerves which an unspecified physician referred to as a "rare side effect of the vaccine." The patient saw a neurological ophthalmologist. It was not known if she was admitted to the hospital. She was recovering but was still having vision problems. The experience caused her to leave work for a semester (disability). On an unspecified date, the patient was hospitalized at an unspecified location for dehydration. The outcome of dehydration was reported as recovering/resolving. The causality was not reported. Upon internal review, meningitis was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: Information has been received via company employee from a friend of company employee referring to a female patient of unknown age. In late December 2015 the patient was vaccinated with a dose of ZOSTAVAX (route, lot# and dose were unknown). Immediately after vaccination the patient developed flu like symptoms. After several months of illness, the patient was diagnosed with meningitis type A in her optic nerves which an unspecified physician referred to as a "rare side effect of the vaccine." The patient saw a neurological ophthalmologist. It was not known if she was admitted to the hospital. She was recovering but was still having vision problems. The experience caused her to leave work for a semester (disability). On an unspecified date, the patient was hospitalized at an unspecified location for dehydration. The outcome of dehydration was reported as recovering/resolving. The causality was not reported. Upon internal review, meningitis was considered to be medically significant. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Information has been received from a 75 year old male physician reporting on himself with no pertinent medical history. The subject had iodine allergy. On 31-JAN-2007, the patient received a dose of an unspecified pneumococcal vaccine from an unspecified manufacturer with no adverse effects. On 14-AUG-2013, the patient received a dose of PNEUMOVAX 23 (dose, unit and route not reported, Lot # H017759 and Exp. 04-JUL-2014) with no adverse effects. Then he received another dose of PNEUMOVAX 23 (dose not reported, intramuscular, Lot # K016294 and Exp. 28-APR-2016) on 12-MAR-2015. All doses received in the right arm. Concomitant therapies included LIPITOR, aspirin (manufacturer unknown) and BYSTOLIC. On 13-MAR-2015, the patient developed redness, swelling, pain at the injection site and had a decreased ability to raise his right shoulder for several days. The patient diagnosed himself and applied most heat as treatment. No lab diagnostic studies were performed. The patient was fully recovered from all the events (except Extra dose administered) 5-7 days after the injection in March 2016. The causal relationship between the events (except Extra dose administered) and PNEUMOVAX 23 was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # L010143 and expiry date 24-SEP-2016) (dosing details unspecified). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Details of temperature excursion: Temperature: Ranging from -14.9C to -9.8C for 30 to 31 minute increments from 01-MAR-2016 through 15-MAR-2016. Previous temperature excursion: No. Data logger in use: No, possible malfunctioning thermometer. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 21-MAR-2016 the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (1350U, lot # L036831 with the expiration date 24-SEP-2017, dose and route were unknown). The patient's concomitant medication was not reported. No adverse effects reported. This is one of two reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, Herpes zoster
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a patient of unknown age and gender. The patient was immunosuppressed (cause was unknown). On an unknown date the patient was vaccinated with a shot of ZOSTAVAX (lot# and expiration date were unknown) subcutaneously. After vaccination, the patient developed shingles and was subsequently hospitalized. The patient was hospitalized for three weeks at an unspecified facility. The event of shingles was improved on therapy. It was also reported that the patient received the vaccine from an unknown doctor, who was aware of the patient's immunosuppressed status (medication error). Additional information is not expected as there was no consent for follow up.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician via field employee refers to multiple unspecified patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, multiple unspecified patients were vaccinated with improperly stored RECOMBIVAX HB injection 10 y (unspecified) lot # L027733 (expiry date: 13-SEP-2017), L025738 (expiry date: 14-AUG-2017), L016427 (expiry date 13-APR-2017) (dosage not reported). This vaccine was lot # L027733 was stored at temperature 31.3F, time frame was 211.45 hours and no previous temperature excursion was reported. This vaccine with lot t# L025738 was stored at temperature 31.1F, time frame was 419 hours and no previous temperature excursions was reported. This vaccine with lot # L016427 was stored at temperature 31.1F, time frame was 552 hours and no previous temperature excursion was reported. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. The patient's relevant medical history, concomitant medications, and past drug history were unknown. On 19-MAR-2016 the patient was vaccinated with 1 vial of ZOSTAVAX, lot # L021609, expiration date: 10-SEP-2016 (dose and route were not reported). The vaccine administered had undergone an excursion; the vial had been refrigerated at 6 degrees Celsius for about 48 hours prior to reconstitution and administration. It is unknown if there was any relevant lab work. The event was considered to be medically significant by the reporter as it required intervention to prevent permanent impairment/damage. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Rash
Clinical narrative: Itching over 3 days, rash and pain of shingles after that. Still current with shingles at this time.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a pharmacist refers to multiple patients of unknown age and gender. Concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored (temperature excursion: 34.3F, time frame: 10 hours) doses of VAQTA with lot/batch # L014265, expiry date 28-APR-2017 (dose, dose number, vaccination site and route of administration not provided). Concomitant therapies were not reported. The previous temperature excursion was reported as 48.4F for 7 hours. Product quality complaint (PQC) was not involved. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a male patient in his 60's (exact age was not reported). The patient's pertinent medical history, drug reaction or allergies and concomitant medications were unspecified. On an unknown date (also reported as within the last year or two), the patient was vaccinated with one shot of ZOSTAVAX (lot #, expiration, date and dose were not reported), subcutaneously. On an unknown date after administration of ZOSTAVAX, the patient experienced vaccination failure. He developed a bad case of shingles. The patient sought medical attention, saw his physician and was administered unspecified antivirals and possibly gabapentin for shingles. The patient recovered from the events on an unknown date. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Axillary mass
Clinical narrative: Information has been received from a pharmacist referring to a 60 year old female patient with hypertension, who was a pharmacy employee. On 19-MAR-2016 the patient was vaccinated with PNEUMOVAX 23 (intramuscularly in left arm, lot# reported as M000386 with expiration date of 17-AUG-2-17 for vaccination. Concomitant therapies included lisinopril (manufacturer unknown) and hydrochlorothiazide (manufacturer unknown). On 21-MAR-2016, the patient developed a large, tender limp, "like a boil", in her left axilla. The patient self-treated with hot compresses to the area. The patient sought medical attention via coming to pharmacy. The outcome of the event was reported as not recovered/not resolved. Additional information is not expected as the reporter did not want to contacted.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a pharmacist refers to multiple patients of unknown age and gender. Concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored (temperature excursion: 34.3F, time frame: 10 hours) doses of RECOMBIVAX HB with lot/batch # K023310, expiry date 15-APR-2017 and lot/batch # L026037, expiry date 17-JAN-2018 (dose, dose number, vaccination site and route of administration not provided). Concomitant therapies were not reported. The previous temperature excursion was reported  as 48.4F for 7 hours. Product quality complaint (PQC) was not involved. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to 3 patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L034367 with the expiration date 08-SEP-2017, dose and route were unknown). The patients' concomitant medication was not reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a pharmacist refers to multiple patients of unknown age and gender. Concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored (temperature excursion: 34.3F, time frame: 10 hours) doses of PNEUMOVAX 23 with lot/batch# L18503, expiry date 16-MAR-2017 (dose, dose number, vaccination site and route of administration not provided). Concomitant therapies were not reported. The previous temperature excursion was reported as 48.4F for 7 hours. Product quality complaint (PQC) was not involved. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via field employee refers to a multiple unspecified patients of an unknown date age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, multiple unspecified patients were vaccinated with improperly stored VAQTA injection 25/0.5 lot# L023936 (expiry date: 15-MAR-2017) and lot # K018181 (expiry date: 04-JUN-2017) (dosage not reported). The VAQTA with lot # L023936 was stored at temperature 31.3F, time frame was 211.45 hours and no previous temperature excursion was reported. The VAQTA with lot # K018181 was stored at temperature 31.1F, time frame was 419 hours and no previous temperature excursion was reported. No adverse effect reported. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.