chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: M
Vaccine: DTAPIPV, HEPA, VARCEL
Symptoms: Cough, Insomnia, Irritability, Rhinorrhoea, Thirst
Clinical narrative: This case was reported by a healthcare professional via sales representative and described the occurrence of wrong vaccine administered in a 18-month-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included HAVRIX; GlaxoSmithKline; unknown; unknown given on 27 April 2012; varicella virus vaccine (non-gsk); Merck; unknown; unknown given on 27 April 2012. There were no concurrent medications. On 27 April 2012 at 14:00 the subject received 4th dose of KINRIX (.5 ml, unknown, right thigh) and experienced wrong vaccine administered. The subject was given KINRIX vaccine at 18 months of age instead of DTap and separate IPV. At the time of the report no adverse events were reported. Follow-up information was received on 09 May 2012 via consumer (subject's mother). The subject's medical history included ear tube. The mother reported that the subject developed cranky behavior and couldn't sleep at night about three to four days ago (05 May 2012) and then two days ago (07 May 2012) developed runny nose, drainage (nasal drainage (runny nose)), cough and thirst (like he cannot get enough to drink) so she took him to the physician office yesterday. The subject was prescribed BENADRYL and saline nose spray. At this time the mother was made aware at that the subject received KINRIX instead of a DTaP and Polio vaccine on 27 April 2012. The physician's office stated the subject "hasn't received those vaccines before so they were administered. It is unclear and the mother was not aware of what vaccines the subject had received in the past, but he has received some and she was under the assumption he was up-to date". She stated the subject received one vaccine in one leg and two shots in the other leg on 27 April 2012, but unsure as to which shots went where. At the time of reporting the outcome of the nasal drainage (runny nose), cough, fever and warm were unresolved; cranky behavior, unable to sleep, and thirst were unspecified.
Age: 1.5
Sex: M
Vaccine: DTAPIPV, HEPA, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional via sales representative and described the occurrence of wrong vaccine administered in a 18-month-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included HAVRIX; GlaxoSmithKline; unknown; unknown given on 27 April 2012; varicella virus vaccine (non-gsk); Merck; unknown; unknown given on 27 April 2012. There were no concurrent medications. On 27 April 2012 at 14:00 the subject received 4th dose of KINRIX (.5 ml, unknown, right thigh) and experienced wrong vaccine administered. The subject was given KINRIX vaccine at 18 months of age instead of DTap and separate IPV. At the time of the report no adverse events were reported. Follow-up information was received on 09 May 2012 via consumer (subject's mother). The subject's medical history included ear tube. The mother reported that the subject developed cranky behavior and couldn't sleep at night about three to four days ago (05 May 2012) and then two days ago (07 May 2012) developed runny nose, drainage (nasal drainage (runny nose)), cough and thirst (like he cannot get enough to drink) so she took him to the physician office yesterday. The subject was prescribed BENADRYL and saline nose spray. At this time the mother was made aware at that the subject received KINRIX instead of a DTaP and Polio vaccine on 27 April 2012. The physician's office stated the subject "hasn't received those vaccines before so they were administered. It is unclear and the mother was not aware of what vaccines the subject had received in the past, but he has received some and she was under the assumption he was up-to date". She stated the subject received one vaccine in one leg and two shots in the other leg on 27 April 2012, but unsure as to which shots went where. At the time of reporting the outcome of the nasal drainage (runny nose), cough, fever and warm were unresolved; cranky behavior, unable to sleep, and thirst were unspecified.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of injection site reaction (skin) in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX. One to two days after vaccination with KINRIX, the subject developed a red wheel-like skin reaction at the injection site (skin). The physician who examined the site also note that it felt warm. There was no medical intervention and the subject was sent home and told to keep an eye on it. At the time of reporting the outcome of the events was unspecified. It was reported that a total of three subject experienced similar reactions following administration with KINRIX. It was reported that one subject may have been male, and another taking an antibiotic, but it was not known which patient's specifically. The subject that was taking the unknown antibiotic also received an unknown vaccine, other than KINRIX, on the same date. The dates of vaccination and events were not known. Linked cased include: A0978765A and A0978766A.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX. One to two days after vaccination with KINRIX, the subject developed a red wheel-like skin reaction at the injection site (skin). The physician who examined the site also note that it felt warm. There was no medical intervention and the subject was sent home and told to keep an eye on it. At the time of reporting the outcome of the events was unspecified. It was reported that a total of three subjects experienced similar reactions following administration with KINRIX. It was reported that one subject may have been male, and another taking antibiotic. but it was not known which patient's specifically. The subject that was taking the unknown antibiotic also received an unknown vaccine, other than KINRIX, on the same date. The date of vaccination and events were not known. Linked cases include: A0978760A and A0978766A.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of injection site reaction (skin) in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX. One to two days after vaccination with KINRIX, the subject developed a red wheel-like skin reaction at the injection site. The physician who examined the site also note that it felt warm. There was no medical intervention and the subject was sent home and told to keep an eye on it. At the time of reporting the outcome of the events was unspecified. It was reported that a total a three subjects experienced similar reactions following administration with KINRIX. It was reported that one subject may have been male, and another taking an antibiotic, but it was not known which patient's specifically. The subject that was taking the unknown antibiotic also received an unknown vaccine, other than KINRIX, on the same date. The dates of vaccination and events were not known. Linked cases include: A097B760A and A0978765A.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site reaction, Local reaction
Clinical narrative: This case was reported by a healthcare professional (nurse) and a consumer (mother of another subject at the nurse's office) and described the occurrence of injection site reaction in a child subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of KINRIX (details unknown). At an unspecified time after vaccination with KINRIX, the subject experienced injection site reaction. The mother of another subject at the nurse's office reported that her daughter (see case A0987998A) and other children had the "same reaction". The nurse in the physician's office informed that they have different information from what was provided by the consumer reporter. The nurse stated that she conferred with the physician. According to the nurse, there were a total of 3 children (including the subject whose mother had called) with local reactions, but not confirmed to be systemic and the other two were different lot numbers. The nurse did not have the lot numbers of the two subjects or their information. This is case two of the two subjects. See case A0989130A for the first subject and A0987998A for the daughter of the consumer reporter. At the time of reporting the outcome of the event was unspecified.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Pyrexia, Rash
Clinical narrative: This case was reported by a healthcare professional via a GSK sales representative and described the occurrence of rash in a 12-month-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). On 15 December 2011 at 13:30 the subject received a dose of KINRIX (details unknown) and experienced inappropriate age at vaccine administration. The subject was younger than the indicated age for KINRIX. On 29 December 2011, 14 days after vaccination with KINRIX, the subject experienced rash and fever. On 30 December 2011, the subject was taken to the emergency room because she had developed a rash and had a temperature of 101.3. On 3 January 2012, she had an office visit with her physician and had a rash on her face and a temperature of 98.3. At the time of reporting the events were improved.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, Fatigue, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 67 year old male patient. Patient current conditions included gastroesophageal reflux disease (GERD), anxiety, insomnia, high blood pressure and high cholesterol. On 25-SEP-2012, the patient was vaccinated with an expired dose of PNEUMOVAX23 intramuscularly (lot number: 669579/0595AA, expiry date: 30-AUG-2012). Thirty minutes later (on 25-SEP-2012), he received another dose of PNEUMOVAX23 intramuscularly. Lot number and expiry date was provided as H010515 and 13-FEB-2014 respectively. Concomitant medications included omeprazole, diazepam, zolpidem tartrate, CRESTOR and lisinopril. On 25-SEP-2012 (that night), the patient became tired, felt feverish and experienced a red, swollen area at the injection site. The patient came back to the pharmacy. He took TYLENOL as a treatment. The outcome of felt feverish, red, swollen area at the injection site and tired was reported as not resolved at the time of reporting. The relatedness for tired, red, swollen area at the injection site and felt feverish was unknown for PNEUMOVAX23. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Injection site warmth, Nodule, Oedema peripheral, Pain in extremity
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to 3 patients of unknown age and gender. On an unknown date, patients were vaccinated with, .5 ml PNEUMOVAX 23, IM, with 25 gauge needle, 1 inch (site of administration not reported, lot # reported as H012650, exp 27-FEB-2014). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, patients experienced swelling, "knot" in the arm, pain that runs down the arm that starts at injection site and site was warm to the touch. No treatment was commenced. Pain subsided in 2-3 days. The events went away in 3 days. Patients sought unspecified medical attention. There were no lab diagnostic studies performed. It was reported that PNEUMOVAX 23 was not reintroduced. The relatedness for swelling, "knot" in the arm, pain that runs down the arm that starts at injection site and site was warm to the touch is unknown for PNEUMOVAX 23. This is one of several reports from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 years old female patient with no pertinent medical history. The patient's drug reactions/allergies included: trimethoprim, sulfamethoxazole, simvastatin, lovastatin, penicillin and codeine. The patient was vaccinated with ZOSTAVAX in upper left arm in 2011 "about a year ago". Lot# and administration route were unspecified. Concomitant medication included: doxepin. In 2011 on the day that ZOSTAVAX was administered, the patient experienced pain at the injection site and it persisted for an unspecified amount of time. In 2012 at the reporting time, the patient had a dime size lump on her upper left arm at the injection site. The outcome of patient was reported as not recovered/not resolved. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site haemorrhage
Clinical narrative: This spontaneous report as received from an office manager refers to a female patient of unknown age, called to report a patient was given 0.65ml ZOSTAVAX (Lot number unspecified) intramuscularly instead of subcutaneously "about 2 weeks ago" in approximately 01-OCT-2012. The patient may have bled at the injection site on the same day of injection. The patient had no pertinent medical history or drug reactions/allergies. No lab diagnostics study was performed. No treatment was given. The outcome was unknown. The patient was in office when the adverse event happened and sought medical attention. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Influenza like illness, Injected limb mobility decreased, Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report was received from a physician refers to a 21 year old female patient. The patient did not have any drug allergies or reactions. On 19-SEP-2012, the patient was vaccinated with a dose of 0.5 ml PNEUMOVAX 23, intramuscularly lot number reported as 0225AE, expiration date 03-JUN-2013. Concomitant medications included: Birth control (hormonal contraceptives (unspecified). On an unknown date in SEP-2012, the patient experienced "swollen, red bumps several inches around the injection site, limited mobility, and flu-like symptoms of fever, fatigue and feeling achy" after she was administered the PNEUMOVAX 23. On 20-SEP-2012, the patient contacted the physician's office and was directed to apply ice packs to the injection site and prescribed Ibuprofen as a treatment. The outcome of the events were reported as recovering at the time of this report. The patient sought medical attention (notified office). This is one of several reports from the same source (MARRS#1210USA00130), please do not forget to add the MARRS# of the third patient. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a physician refers to a 21 year old female patient. The patient did not have any drug allergies or reactions. On 19-SEP-2012, the patient was vaccinated with a dose of 0.5 ml PNEUMOVAX 23, intramuscularly lot number reported as 0225AE, expiration date 03-JUN-2013. Concomitant medications included: Birth control (hormonal contraceptives (unspecified). On an unknown date in SEP-2012, the patient experienced "swollen, red bumps several inches around the injection site, limited mobility, and flu-like symptoms of fever, fatigue and feeling achy" after she was administered the PNEUMOVAX 23. On 20-SEP-2012, the patient contacted the physician's office and was directed to apply ice packs to the injection site and prescribed Ibuprofen as a treatment. The outcome of the events were reported as recovering at the time of this report. The patient sought medical attention (notified office). This is one of several reports from the same source (MARRS#1210USA00130), please do not forget to add the MARRS# of the third patient. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a female patient of unknown age. On 10-OCT-2012, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (dose, lot number not reported). No other co-suspects were reported. No concomitant medications were reported. On 11-OCT-2012, the patient developed a swollen, hot, hard lump at the injection site, after receiving ZOSTAVAX, 2 days after onset of therapy. No treatment information was reported. The outcome of a swollen, hot, hard lump at the injection site was reported as not recovered/not resolved. The patient sought unspecified medical attention. The relatedness for a swollen, hot, hard lump at the injection site was not reported for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, patients were vaccinated with hepatitis B vaccine (manufacturer unknown) (dose, route, site of administration and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, patients experienced injection site reaction: swelling, a raised knot and site was warm to the touch. No treatment was commenced. The events went away in 3 days. Patients sought unspecified medical attention. There was no lab diagnostic studies performed. The relatedness for injection site swelling, site was warm to the touch and raised knot is unknown for hepatitis B vaccine (manufacturer unknown). This is one of several reports from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site warmth, Nodule, Oedema peripheral, Pain in extremity
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 56 years old male patient. On an unknown date, the patient was vaccinated with, .5 ml PNEUMOVAX 23, IM, with 25 gauge needle, 1 inch (site of administration not reported, lot # reported as H012650, exp 27-FEB-2014). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient experienced swelling, "knot" in the arm, pain that runs down the arm that starts at injection site and site was warm to the touch. No treatment was commenced. Pain subsided in 2-3 days. The events went away in 3 days. The patient sought unspecified medical attention. There was no lab diagnostic studies performed. It was reported that PNEUMOVAX 23 was not reintroduced. The relatedness for swelling, "knot" in the arm, pain that runs down the arm that starts at injection site and site was warm to the touch is unknown for PNEUMOVAX 23. This is one of several reports from the same source. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 years old female patient with hypertension, depression who was allergic to cephalosporins and penicillins. The patient was vaccinated subcutaneously with ZOSTAVAX (lot number H012521, expiration date 09-OCT-2013) on 20-OCT-2012. No other co-suspects were reported. Concomitant medications included butalbital, aspirin, caffeine, HCTZ, VIIBRYD, amlodipine, benazepril, TOPROL and hydroxyzine. Sometime before 22-OCT-2012 the patient developed a warm, red, hard area on the back of the arm. This is the arm where the ZOSTAVAX was given. The patient came into the pharmacy for medical attention. No treatment or laboratory diagnostics studies were given. The outcome of the events was given was reported as recovering/resolving. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site warmth, Nodule, Oedema peripheral, Pain in extremity
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 65 years old male patient. On an unknown date, the patient was vaccinated with, .5 ml PNEUMOVAX23, IM, with 25 gauge needle, 1 inch (site of administration not reported, lot # reported as H012650, exp 27-FEB-2014). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient experienced swelling, "knot" in the arm, pain that runs down the arm that starts at injection site and site was warm to the touch. No treatment was commenced. Pain subsided in 2-3 days. The events went away in 3 days. The patient sought unspecified medical attention. There was no lab diagnostic studies performed. It was reported that PNEUMOVAX23 was not reintroduced. The relatedness for swelling, "knot" in the arm, pain that runs down the arm that starts at injection site and site was warm to the touch is unknown for PNEUMOVAX23. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender, an office staff person. On an unknown date, the patient was vaccinated with, .5 ml PNEUMOVAX 23, IM (site of administration and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. ON an unknown date, the patient experienced injection site swelling, a raised knot and the site was warm to the touch. No treatment was commenced. The events went away in 3 days. The patient sought unspecified medical attention. It was reported that PNEUMOVAX 23 was not reintroduced. No lab diagnostic studies were performed. The relatedness for injection site swelling, site was warm to the touch and raised knot is unknown for PNEUMOVAX 23. This is one of several reports from the same source. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site warmth, Nodule, Oedema peripheral, Pain in extremity
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 75 years old female patient. On an unknown date, the patient was vaccinated with, .5 ml PNEUMOVAX 23, IM, with 25 gauge needle, 1 inch (site of administration not reported, lot # reported as H012650, exp 27-FEB-2014). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient experienced swelling, "knot" in the arm, pain that runs down the arm that starts at injection site and site was warm to the touch. No treatment was commenced. Pain subsided in 2-3 days. The events went away in 3 days. The patient sought unspecified medical attention. There was no lab diagnostic studies performed. It was reported that PNEUMOVAX 23 was not reintroduced. The relatedness for swelling, "knot" in the arm, pain that runs down the arm that starts at injection site and site was warm to the touch is unknown for PNEUMOVAX 23. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose of MMR II (lot# unknown). No other co-suspects were reported. No concomitant medications were reported. The reporter stated that on an unknown date the patient failed to seroconvert the rubella portion after received a dose of MMR II. It was unknown that if the patient had sought medical attention. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported), last week in October 2012. No other co-suspects were reported. No concomitant medications were reported. Medical assistant mentioned the patient was given ZOSTAVAX by an unspecified staff member who stored reconstituted ZOSTAVAX improperly. The staff member reconstituted ZOSTAVAX, drew it up into a syringe then stored it in the freezer overnight. The next morning the staff member took out the ZOSTAVAX, thawed it by hand, and then administered to the patient. The patient was not experiencing any known symptoms. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity
Clinical narrative: Information has been received from a 60 year old female patient with drug reactions/allergies to "PERCOCET" and a history of tendon injury in approximately 1997 ("about 15 years ago"), who on 08-MAY-2012 was vaccinated with ZOSTAVAX (Merck) (dose and lot number not reported). Concomitant therapy included metoprolol, amlodipine, vitamin B12 and low dose aspirin. On approximately 11-MAY-2012 ("3-4 days after receiving ZOSTAVAX (Merck)") the patient had joint pain felt similar to the tendon injury she had several years ago. It was in the same spot in her right thumb and wrist going up to her forearm. The pain lasted for about 2-3 days, and the switched to her left hand. Treatment was given for an AE: 600mg MOTRIN, and ice. At the time of the report the outcome of the pain switched to left hand of the patient was not recovered. The patient did not seek medical attention. No laboratory diagnostic studies were performed. Follow up information was received from the physician concerning a 60 year old female patient with no illness at the time of vaccination and no previous adverse events following prior vaccination. On 08-MAY-2012, at 12 PM, the patient was vaccinated with a 1st dose of ZOSTAVAX subcutaneously in the left arm by a nurse (name unspecified). Lot number was reported as 671142/1268AA. The patient was vaccinated at a private doctor's office/hospital. Address of the facility where the patient was vaccinated was updated. On 09-MAY-2012 at 8 AM, the patient experienced right arm pain/numb (3 days) and left arm pain (3 days) (previously reported as 13-MAY-2012). One week later, on approximately 16-MAY-2012, the patient recovered. The patient did not seek medical attention. Causality was unknown for all the events. Additional information is not expected.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash erythematous, Rash pruritic
Clinical narrative: Information has been received from a 71 year old male consumer reporting on himself, with no pertinent medical history, who in October 2009 (3 years ago), was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). No concomitant medications were reported. It was reported that, on approximately 04-AUG-2012 ("2 months ago"), the patient developed shingles with pain after receiving ZOSTAVAX. The red bumps and blisters appeared on the navel area to the left side of his back. The patient tried hydrocodone and tramadol for pain but developed itchy rash after taking them. The physician switched them (the patient saw a doctor) to TYLENOL and NEURONTIN. VALTREX treatment also reported. No laboratory tests were reported. At the time of the report, the patient's outcome was recovering. Causality was not reported. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a medical assistant refers to a male patient of approximately 5 years old. The patient was vaccinated with dose 1 VARIVAX (merck) on 20-OCT-2008. The second dose of VARIVAX (merck) was administered on 23-JUL-2012. Lot number for the second dose was reported as H012132 (lot in validation), exp 25-JUN-2014. No other co-suspects were reported. As concomitant medication, 'inhalers' were reported. On an unknown date the patient experienced rash that looks like chickenpox. The patient had not been seen by a physician yet at the time of reporting and the medical assistant requested 'VZVIP packet' for analysis. No treatment was given for the event. The outcome of rash that looks like chickenpox is unknown. The relatedness for rash that looks like chickenpox is unknown for VARIVAX (Merck). Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a consumer refers to herself, a 68 years old female psychologist. The patient was vaccinated with ZOSTAVAX (dose, route and Lot# not reported) on 08-OCT-2012. No other co-suspects were reported. Concomitant medications included LEVOXYL, estradiol and NASACORT. On 08-OCT-2012 the patient experienced itchiness at injection site, slight swelling at injection site, warmth at injection site and redness at injection site. No treatment information was reported. The outcome of itchiness at injection site, slight swelling at injection site, warmth at injection site and redness at injection site was reported as not recovered/not resolved. The relatedness for itchiness at injection site, slight swelling at injection site, warmth at injection site and redness at injection site was not reported for ZOSTAVAX. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Haemorrhage, Immediate post-injection reaction, Incorrect route of drug administration, Muscle disorder, Pain
Clinical narrative: This spontaneous report a 64 year old female consumer refers to herself who was allergic to Sulfa and erythromycin with no pertinent medical history. The patient was vaccinated intramuscularly with ZOSTAVAX (lot number not reported) in fall 2011. No other co-suspects were reported. Concomitant medications included "LABOXOL" and lisinopril. The pharmacy near her home gave her the ZOSTAVAX intramuscularly (or IM) instead of subcutaneous. Her arm started bleeding right away and the pain began right away and it did something to her arm muscles. The patient had sought unspecified medical attention. No treatment or any laboratory diagnostics study was given. The outcome of bleeding, it did something to her arm muscles and pain was reported as recovered/resolved in September 2012. Additional information has been requested.
Age: 0.08
Sex: M
Vaccine: 6VAX-F, HPV4
Symptoms: Acute myeloid leukaemia, Blood test abnormal, Chemotherapy, Death, Rash
Clinical narrative: Information has been received from an agency, via a Case Line Listing through CSL as part of a business agreement concerning a 55 day old male who on 11-MAY-2009 was vaccinated with a 0.5mL/IM dose of HPV vaccine. Concomitant vaccination on the same day included a 0.5 mL, IM dose of INFANRIX HEXA. On 11-MAY-2009 the patient experienced a medication error (not severe). At the time of the report, the patient's status was unknown. The original reporting source was not provided. Additional information is not expected. Update (21-Oct-2012): Information received from regulatory authority concerning duplicate cases. Information from case 0909USA01594: Information has been received from the parents of a patient via CSL as part of a business agreement concerning a 6 weeks old male patient who on an unspecified date was accidentally vaccinated with a dose of HPV vaccine instead of a different infant vaccine. At the time of the report, the baby seemed fine and the parents stated that the patient had not had any health issues since the vaccine had been administered. The parents were counseled by their doctor. There was no medical treatment. The reporter felt that the suspect vaccine was the highly probable cause of the adverse event. Follow-up information was reported in a newspaper article and the internet that the 6 weeks old male patient who in May 2009 was accidentally vaccinated with a dose of HPV vaccine instead of one to prevent meningitis. In approximately March 2011, at two years of age, the patient was diagnosed with acute myeloid leukaemia after his parents took him to the doctor when they noticed a rash on his neck and blood test results came back abnormal. On 17-MAR-2011 the patient began 10 hours of aggressive chemotherapy a day for the M7 strand of acute myeloid leukaemia in hospital. The patient was doing "remarkably well", despite being cooped up in hospital ward for 23 hours a day. The doctors cannot tell whether the HPV vaccine he was injected caused the cancer. The parents were concerned about a possible link between HPV vaccine vaccination mistake and leukaemia. Additional information was received which indicated that the patient died. The date of death and cause of death were not provided. Additional information has been requested. The original reporting source was provided by a consumer. The VAERS ID # is 421071. It has been determined that case # 0909USA01594 is a duplicate of case # 0908USA05072. Therefore, case # 0909USA01594 is being deleted from our files and the cases consolidated into case 0908USA05072.
Age: 0.08
Sex: M
Vaccine: 6VAX-F, HPV4
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from an agency, via a Case Line Listing through CSL as part of a business agreement concerning a 55 day old male who on 11-MAY-2009 was vaccinated with a 0.5mL/IM dose of HPV vaccine. Concomitant vaccination on the same day included a 0.5 mL, IM dose of INFANRIX HEXA. On 11-MAY-2009 the patient experienced a medication error (not severe). At the time of the report, the patient's status was unknown. The original reporting source was not provided. Additional information is not expected. Update (21-Oct-2012): Information received from regulatory authority concerning duplicate cases. Information from case 0909USA01594: Information has been received from the parents of a patient via CSL as part of a business agreement concerning a 6 weeks old male patient who on an unspecified date was accidentally vaccinated with a dose of HPV vaccine instead of a different infant vaccine. At the time of the report, the baby seemed fine and the parents stated that the patient had not had any health issues since the vaccine had been administered. The parents were counseled by their doctor. There was no medical treatment. The reporter felt that the suspect vaccine was the highly probable cause of the adverse event. Follow-up information was reported in a newspaper article and the internet that the 6 weeks old male patient who in May 2009 was accidentally vaccinated with a dose of HPV vaccine instead of one to prevent meningitis. In approximately March 2011, at two years of age, the patient was diagnosed with acute myeloid leukaemia after his parents took him to the doctor when they noticed a rash on his neck and blood test results came back abnormal. On 17-MAR-2011 the patient began 10 hours of aggressive chemotherapy a day for the M7 strand of acute myeloid leukaemia in hospital. The patient was doing "remarkably well", despite being cooped up in hospital ward for 23 hours a day. The doctors cannot tell whether the HPV vaccine he was injected caused the cancer. The parents were concerned about a possible link between HPV vaccine vaccination mistake and leukaemia. Additional information was received which indicated that the patient died. The date of death and cause of death were not provided. Additional information has been requested. The original reporting source was provided by a consumer. The VAERS ID # is 421071. It has been determined that case # 0909USA01594 is a duplicate of case # 0908USA05072. Therefore, case # 0909USA01594 is being deleted from our files and the cases consolidated into case 0908USA05072.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Muscle fatigue, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 years old female patient. The patient's pertinent medical history included smoking. On 24-SEP-2012 the patient was vaccinated intramuscularly with PNEUMOVAX 23, 0.5 ml once in the arm. No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient developed muscle pain in the arm where she had received a dose of PNEUMOVAX 23. The patient could not event lift the arm. No treatment was given. The patient sought medical attention by calling the pharmacist. No relevant lab tests were performed. The outcome of the event was reported as not recovered. A reporter causality for the event was not provided for PNEUMOVAX 23. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site reaction, Myalgia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 years old female patient. The patient's pertinent medical history included smoking. On 24-SEP-2012 the patient was vaccinated intramuscularly with PNEUMOVAX 23, 0.5 ml once in the arm. No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient developed muscle pain in the arm where she had received a dose of PNEUMOVAX 23. The patient could not event lift the arm. No treatment was given. The patient sought medical attention by calling the pharmacist. No relevant lab tests were performed. The outcome of the event was reported as not recovered. A reporter causality for the event was not provided for PNEUMOVAX 23. Additional information is not expected.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 06-SEP-2012, the patient was vaccinated with ZOSTAVAX 0.65 millimeter (ml) subcutaneously on the left upper arm. Lot number was reported as 0423AE (lot validation has been requested) and the expiration date was 02-APR-2013. No concomitant medications were reported. On 08-SEP-2012, the patient noticed the injection site of the left arm was hard, red, swollen and itchy. The patient was now (on approximately 11-SEP-2012) experiencing fever, chills, severe muscle aches and respiratory symptoms with secretions. The patient sought medical attention by calling the pharmacy. The patient was recommended to follow-up with her physician. No treatment information was reported. The outcome of all the events was reported as not recovered/not resolved. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Cough, Influenza like illness, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 06-SEP-2012, the patient was vaccinated with ZOSTAVAX 0.65 millimeter (ml) subcutaneously on the left upper arm. Lot number was reported as 0423AE (lot validation has been requested) and the expiration date was 02-APR-2013. No concomitant medications were reported. On 08-SEP-2012, the patient noticed the injection site of the left arm was hard, red, swollen and itchy. The patient was now (on approximately 11-SEP-2012) experiencing fever, chills, severe muscle aches and respiratory symptoms with secretions. The patient sought medical attention by calling the pharmacy. The patient was recommended to follow-up with her physician. No treatment information was reported. The outcome of all the events was reported as not recovered/not resolved. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Myalgia, Respiratory disorder
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 06-SEP-2012, the patient was vaccinated with ZOSTAVAX 0.65 millimeter (ml) subcutaneously on the left upper arm. Lot number was reported as 0423AE (lot validation has been requested) and the expiration date was 02-APR-2013. No concomitant medications were reported. On 08-SEP-2012, the patient noticed the injection site of the left arm was hard, red, swollen and itchy. The patient was now (on approximately 11-SEP-2012) experiencing fever, chills, severe muscle aches and respiratory symptoms with secretions. The patient sought medical attention by calling the pharmacy. The patient was recommended to follow-up with her physician. No treatment information was reported. The outcome of all the events was reported as not recovered/not resolved. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Increased upper airway secretion, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 06-SEP-2012, the patient was vaccinated with ZOSTAVAX 0.65 millimeter (ml) subcutaneously on the left upper arm. Lot number was reported as 0423AE (lot validation has been requested) and the expiration date was 02-APR-2013. No concomitant medications were reported. On 08-SEP-2012, the patient noticed the injection site of the left arm was hard, red, swollen and itchy. The patient was now (on approximately 11-SEP-2012) experiencing fever, chills, severe muscle aches and respiratory symptoms with secretions. The patient sought medical attention by calling the pharmacy. The patient was recommended to follow-up with her physician. No treatment information was reported. The outcome of all the events was reported as not recovered/not resolved. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site swelling, Myalgia, Pyrexia, Respiratory disorder
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 06-SEP-2012, the patient was vaccinated with ZOSTAVAX 0.65 millimeter (ml) subcutaneously on the left upper arm. Lot number was reported as 0423AE (lot validation has been requested) and the expiration date was 02-APR-2013. No concomitant medications were reported. On 08-SEP-2012, the patient noticed the injection site of the left arm was hard, red, swollen and itchy. The patient was now (on approximately 11-SEP-2012) experiencing fever, chills, severe muscle aches and respiratory symptoms with secretions. The patient sought medical attention by calling the pharmacy. The patient was recommended to follow-up with her physician. No treatment information was reported. The outcome of all the events was reported as not recovered/not resolved. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Blood creatinine normal, Blood electrolytes normal, Blood urea normal, Body temperature increased, Convulsion
Clinical narrative: A report has been received from a Health Professional concerning a patient. The patient's medical history were not reported. Patient was receiving nasal FLUMIST started on 28-Sep-2012. Caller is an RN reporting an adverse event experienced by her daughter. Her daughter received FLUMIST on 28-SEP-12. On 03-OCT-12, she developed a low grade fever of 100.6 F and a cough that went away by 05OCT12. On Sunday afternoon around 2:30 PM (07-OCT-12), she experienced a grand mal seizure and 911 was called and she was taken to the hospital by ambulance. She was later released. On 09-OCT-12,  she experienced another small seizure that lasted 5 seconds at 7:30am. On 11-OCT-12 the cough returned. Action taken with suspect drug was unknown. The patient recovered from the event of seizures, fever and cough on an unspecified date. The company physician assessed the serious criteria for the event of seizures as important medical event and fever and cough considered as Non-serious.
Age: 2.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Cough, Electroencephalogram normal, Haematocrit normal, Haemoglobin normal, Throat irritation
Clinical narrative: A report has been received from a Health Professional concerning a patient. The patient's medical history were not reported. Patient was receiving nasal FLUMIST started on 28-Sep-2012. Caller is an RN reporting an adverse event experienced by her daughter. Her daughter received FLUMIST on 28-SEP-12. On 03-OCT-12, she developed a low grade fever of 100.6 F and a cough that went away by 05OCT12. On Sunday afternoon around 2:30 PM (07-OCT-12), she experienced a grand mal seizure and 911 was called and she was taken to the hospital by ambulance. She was later released. On 09-OCT-12,  she experienced another small seizure that lasted 5 seconds at 7:30am. On 11-OCT-12 the cough returned. Action taken with suspect drug was unknown. The patient recovered from the event of seizures, fever and cough on an unspecified date. The company physician assessed the serious criteria for the event of seizures as important medical event and fever and cough considered as Non-serious.
Age: 2.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Unresponsive to stimuli
Clinical narrative: A report has been received from a Health Professional concerning a patient. The patient's medical history were not reported. Patient was receiving nasal FLUMIST started on 28-Sep-2012. Caller is an RN reporting an adverse event experienced by her daughter. Her daughter received FLUMIST on 28-SEP-12. On 03-OCT-12, she developed a low grade fever of 100.6 F and a cough that went away by 05OCT12. On Sunday afternoon around 2:30 PM (07-OCT-12), she experienced a grand mal seizure and 911 was called and she was taken to the hospital by ambulance. She was later released. On 09-OCT-12,  she experienced another small seizure that lasted 5 seconds at 7:30am. On 11-OCT-12 the cough returned. Action taken with suspect drug was unknown. The patient recovered from the event of seizures, fever and cough on an unspecified date. The company physician assessed the serious criteria for the event of seizures as important medical event and fever and cough considered as Non-serious.
Age: 2.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Convulsion, Cough, Grand mal convulsion, Pyrexia
Clinical narrative: A report has been received from a Health Professional concerning a patient. The patient's medical history were not reported. Patient was receiving nasal FLUMIST started on 28-Sep-2012. Caller is an RN reporting an adverse event experienced by her daughter. Her daughter received FLUMIST on 28-SEP-12. On 03-OCT-12, she developed a low grade fever of 100.6 F and a cough that went away by 05OCT12. On Sunday afternoon around 2:30 PM (07-OCT-12), she experienced a grand mal seizure and 911 was called and she was taken to the hospital by ambulance. She was later released. On 09-OCT-12,  she experienced another small seizure that lasted 5 seconds at 7:30am. On 11-OCT-12 the cough returned. Action taken with suspect drug was unknown. The patient recovered from the event of seizures, fever and cough on an unspecified date. The company physician assessed the serious criteria for the event of seizures as important medical event and fever and cough considered as Non-serious.