chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Feeling hot, Hypoaesthesia, Injection site joint pain, Injection site mass
Clinical narrative: This spontaneous report as received from a 63 year old female patient regarding herself. The patient's medical history included dizzy and upset stomach while on some unspecified pain killers (details unspecified). On 06-DEC-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). Concomitant therapies included NITRO-BID. On 06-DEC-2013 in the evening of the vaccine, her arm felt heavy and warm. She also experienced arm pain since the day of the injection. It originated at the injection site but now went through her elbow and down into her fingers. Sometimes her fingers went numb. The pain was getting worse each day. She also stated that ever since getting the vaccine she feels lightheaded every now and then. On 07-DEC-2013 the patient experienced small lump at the injection site. The patient saw the physician however he could not give her any treatment. The outcome of her arm felt heavy and warm, feeling lightheaded every now and then, fingers go numb, pain in elbow and down into fingers, arm pain and small lump at the injection site was reported as not recovered. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality issue reported. Additional information has been received from a physician regarding an approximately 63 year old female patient. Patient's medical history includes codeine (unspecified reaction), ADVIL and ALEVE (which caused stomach upset) and hypothyroid. The physician reported that on 06-DEC-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J006827, expiry: 14-SEP-2014), 0.65 ml, subcutaneously. Concomitant medication include levothyroxine. On 07-DEC-2013, the patient experienced a red, swollen, tender lump at left arm injection site and vesicles on her forehead and back. On an unknown date in approximately December 2013, the patient began to experience pain in her left arm. On an unknown date in January 2014 the patient stated that her left arm hurts all the time and she can't lift heavy objects with her left arm. The patient received the treatment for the events with moist heat and TYLENOL. The patient sought medical attention by visiting physician's office. No laboratory tests were performed. The patient recovered from the event red, swollen, tender lump at left arm injection site and vesicles on her forehead and back after a couple of weeks approximately on 21-DEC-2013. The outcome of the events, her left arm hurts all the time and she can't lift heavy objects with her left arm were not recovered. No further information was provided. The reporter considered the events her left arm hurts all the time and she can't lift heavy objects with her left arm as disability. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Pain in extremity, Sensation of heaviness
Clinical narrative: This spontaneous report as received from a 63 year old female patient regarding herself. The patient's medical history included dizzy and upset stomach while on some unspecified pain killers (details unspecified). On 06-DEC-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). Concomitant therapies included NITRO-BID. On 06-DEC-2013 in the evening of the vaccine, her arm felt heavy and warm. She also experienced arm pain since the day of the injection. It originated at the injection site but now went through her elbow and down into her fingers. Sometimes her fingers went numb. The pain was getting worse each day. She also stated that ever since getting the vaccine she feels lightheaded every now and then. On 07-DEC-2013 the patient experienced small lump at the injection site. The patient saw the physician however he could not give her any treatment. The outcome of her arm felt heavy and warm, feeling lightheaded every now and then, fingers go numb, pain in elbow and down into fingers, arm pain and small lump at the injection site was reported as not recovered. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality issue reported. Additional information has been received from a physician regarding an approximately 63 year old female patient. Patient's medical history includes codeine (unspecified reaction), ADVIL and ALEVE (which caused stomach upset) and hypothyroid. The physician reported that on 06-DEC-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J006827, expiry: 14-SEP-2014), 0.65 ml, subcutaneously. Concomitant medication include levothyroxine. On 07-DEC-2013, the patient experienced a red, swollen, tender lump at left arm injection site and vesicles on her forehead and back. On an unknown date in approximately December 2013, the patient began to experience pain in her left arm. On an unknown date in January 2014 the patient stated that her left arm hurts all the time and she can't lift heavy objects with her left arm. The patient received the treatment for the events with moist heat and TYLENOL. The patient sought medical attention by visiting physician's office. No laboratory tests were performed. The patient recovered from the event red, swollen, tender lump at left arm injection site and vesicles on her forehead and back after a couple of weeks approximately on 21-DEC-2013. The outcome of the events, her left arm hurts all the time and she can't lift heavy objects with her left arm were not recovered. No further information was provided. The reporter considered the events her left arm hurts all the time and she can't lift heavy objects with her left arm as disability. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Dizziness, Hypoaesthesia, Injected limb mobility decreased, Injection site erythema
Clinical narrative: This spontaneous report as received from a 63 year old female patient regarding herself. The patient's medical history included dizzy and upset stomach while on some unspecified pain killers (details unspecified). On 06-DEC-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). Concomitant therapies included NITRO-BID. On 06-DEC-2013 in the evening of the vaccine, her arm felt heavy and warm. She also experienced arm pain since the day of the injection. It originated at the injection site but now went through her elbow and down into her fingers. Sometimes her fingers went numb. The pain was getting worse each day. She also stated that ever since getting the vaccine she feels lightheaded every now and then. On 07-DEC-2013 the patient experienced small lump at the injection site. The patient saw the physician however he could not give her any treatment. The outcome of her arm felt heavy and warm, feeling lightheaded every now and then, fingers go numb, pain in elbow and down into fingers, arm pain and small lump at the injection site was reported as not recovered. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality issue reported. Additional information has been received from a physician regarding an approximately 63 year old female patient. Patient's medical history includes codeine (unspecified reaction), ADVIL and ALEVE (which caused stomach upset) and hypothyroid. The physician reported that on 06-DEC-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J006827, expiry: 14-SEP-2014), 0.65 ml, subcutaneously. Concomitant medication include levothyroxine. On 07-DEC-2013, the patient experienced a red, swollen, tender lump at left arm injection site and vesicles on her forehead and back. On an unknown date in approximately December 2013, the patient began to experience pain in her left arm. On an unknown date in January 2014 the patient stated that her left arm hurts all the time and she can't lift heavy objects with her left arm. The patient received the treatment for the events with moist heat and TYLENOL. The patient sought medical attention by visiting physician's office. No laboratory tests were performed. The patient recovered from the event red, swollen, tender lump at left arm injection site and vesicles on her forehead and back after a couple of weeks approximately on 21-DEC-2013. The outcome of the events, her left arm hurts all the time and she can't lift heavy objects with her left arm were not recovered. No further information was provided. The reporter considered the events her left arm hurts all the time and she can't lift heavy objects with her left arm as disability. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site joint pain, Injection site mass, Injection site pain, Injection site swelling, Muscular weakness
Clinical narrative: This spontaneous report as received from a 63 year old female patient regarding herself. The patient's medical history included dizzy and upset stomach while on some unspecified pain killers (details unspecified). On 06-DEC-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). Concomitant therapies included NITRO-BID. On 06-DEC-2013 in the evening of the vaccine, her arm felt heavy and warm. She also experienced arm pain since the day of the injection. It originated at the injection site but now went through her elbow and down into her fingers. Sometimes her fingers went numb. The pain was getting worse each day. She also stated that ever since getting the vaccine she feels lightheaded every now and then. On 07-DEC-2013 the patient experienced small lump at the injection site. The patient saw the physician however he could not give her any treatment. The outcome of her arm felt heavy and warm, feeling lightheaded every now and then, fingers go numb, pain in elbow and down into fingers, arm pain and small lump at the injection site was reported as not recovered. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality issue reported. Additional information has been received from a physician regarding an approximately 63 year old female patient. Patient's medical history includes codeine (unspecified reaction), ADVIL and ALEVE (which caused stomach upset) and hypothyroid. The physician reported that on 06-DEC-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J006827, expiry: 14-SEP-2014), 0.65 ml, subcutaneously. Concomitant medication include levothyroxine. On 07-DEC-2013, the patient experienced a red, swollen, tender lump at left arm injection site and vesicles on her forehead and back. On an unknown date in approximately December 2013, the patient began to experience pain in her left arm. On an unknown date in January 2014 the patient stated that her left arm hurts all the time and she can't lift heavy objects with her left arm. The patient received the treatment for the events with moist heat and TYLENOL. The patient sought medical attention by visiting physician's office. No laboratory tests were performed. The patient recovered from the event red, swollen, tender lump at left arm injection site and vesicles on her forehead and back after a couple of weeks approximately on 21-DEC-2013. The outcome of the events, her left arm hurts all the time and she can't lift heavy objects with her left arm were not recovered. No further information was provided. The reporter considered the events her left arm hurts all the time and she can't lift heavy objects with her left arm as disability. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Sensation of heaviness, Skin warm
Clinical narrative: This spontaneous report as received from a 63 year old female patient regarding herself. The patient's medical history included dizzy and upset stomach while on some unspecified pain killers (details unspecified). On 06-DEC-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). Concomitant therapies included NITRO-BID. On 06-DEC-2013 in the evening of the vaccine, her arm felt heavy and warm. She also experienced arm pain since the day of the injection. It originated at the injection site but now went through her elbow and down into her fingers. Sometimes her fingers went numb. The pain was getting worse each day. She also stated that ever since getting the vaccine she feels lightheaded every now and then. On 07-DEC-2013 the patient experienced small lump at the injection site. The patient saw the physician however he could not give her any treatment. The outcome of her arm felt heavy and warm, feeling lightheaded every now and then, fingers go numb, pain in elbow and down into fingers, arm pain and small lump at the injection site was reported as not recovered. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality issue reported. Additional information has been received from a physician regarding an approximately 63 year old female patient. Patient's medical history includes codeine (unspecified reaction), ADVIL and ALEVE (which caused stomach upset) and hypothyroid. The physician reported that on 06-DEC-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J006827, expiry: 14-SEP-2014), 0.65 ml, subcutaneously. Concomitant medication include levothyroxine. On 07-DEC-2013, the patient experienced a red, swollen, tender lump at left arm injection site and vesicles on her forehead and back. On an unknown date in approximately December 2013, the patient began to experience pain in her left arm. On an unknown date in January 2014 the patient stated that her left arm hurts all the time and she can't lift heavy objects with her left arm. The patient received the treatment for the events with moist heat and TYLENOL. The patient sought medical attention by visiting physician's office. No laboratory tests were performed. The patient recovered from the event red, swollen, tender lump at left arm injection site and vesicles on her forehead and back after a couple of weeks approximately on 21-DEC-2013. The outcome of the events, her left arm hurts all the time and she can't lift heavy objects with her left arm were not recovered. No further information was provided. The reporter considered the events her left arm hurts all the time and she can't lift heavy objects with her left arm as disability. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood test, Lumbar puncture, Malaise, Nuclear magnetic resonance imaging
Clinical narrative: 11/27/13: URI symptoms with lymphadenopathy. 12/3/13: headache; worsening EBV-associated symptom. 12/5/13: myalgia. 12/7/13: generalized pain and weakness; diag with Bell's Palsy. 12/7/13: hospitalized at Med Center for Guillain-Barre Syndrome.
Age: 17.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Borrelia test negative, Epstein-Barr virus antibody positive, Epstein-Barr virus infection, Guillain-Barre syndrome
Clinical narrative: 11/27/13: URI symptoms with lymphadenopathy. 12/3/13: headache; worsening EBV-associated symptom. 12/5/13: myalgia. 12/7/13: generalized pain and weakness; diag with Bell's Palsy. 12/7/13: hospitalized at Med Center for Guillain-Barre Syndrome.
Age: 17.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Headache, Lymphadenopathy, Myalgia, Pain, Platelet count decreased
Clinical narrative: 11/27/13: URI symptoms with lymphadenopathy. 12/3/13: headache; worsening EBV-associated symptom. 12/5/13: myalgia. 12/7/13: generalized pain and weakness; diag with Bell's Palsy. 12/7/13: hospitalized at Med Center for Guillain-Barre Syndrome.
Age: 17.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Thrombocytopenia, Upper respiratory tract infection, VIIth nerve paralysis
Clinical narrative: 11/27/13: URI symptoms with lymphadenopathy. 12/3/13: headache; worsening EBV-associated symptom. 12/5/13: myalgia. 12/7/13: generalized pain and weakness; diag with Bell's Palsy. 12/7/13: hospitalized at Med Center for Guillain-Barre Syndrome.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot, Flushing, Injection site erythema, Injection site induration
Clinical narrative: Warmth throughout body, flushed feeling, dizziness and felt like fainting. Injection site swollen, hard to touch and red. Heart palpatations for only the day of injection.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Palpitations
Clinical narrative: Warmth throughout body, flushed feeling, dizziness and felt like fainting. Injection site swollen, hard to touch and red. Heart palpatations for only the day of injection.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 11-APR-2012, the patient was administered with a dose of VARIVAX (Lot # 1218AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 05-OCT-2011, the patient was administered with a dose of VARIVAX (Lot # 1703Z, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 14-OCT-2011, the patient was administered with a dose of VARIVAX (Lot # 0471AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Age: 1.5
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event, Product packaging issue
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 18 month old patient. On 20-JAN-2014 the patient was vaccinated with expired MMR II dose 2. The reporter reported of alleged mix where 3 expired MMR II vials with lot 1508AA and expiration date: 09/23/2013, were found in a sealed multi-vial carton of 10 vials for MMR II with lot 0648AE expiration date: 03/27/2014 but no adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 19-OCT-2011, the patient was administered with a dose of VARIVAX (Lot # 17032, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 61 year old female patient. No information regarding the patient's medical history was provided. On 17-JUN-2013 the patient was vaccinated with RECOMBIVAX HB dose 1. On 15-JUL-2013 the patient received dose 2 with valid lot # J001527 (expiry date 07-SEP-2013) and on 23-DEC-2013 the patient received doe 3 with valid lot # J006027 (expiry date 16-DEC-2015). Routes of administration were not reported. Concomitant therapies included TOPROL, losartan (manufacturer unknown), metformin, metoprolol, SYMBICORT and HYZAAR. On 20-JAN-2014 the patient came to the office and had a hepatitis B surface antibody test which was negative. The result was "less than 5". No treatment was given. No outcome was reported. No causality assessment was provided. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 58 year old female patient. On 20-JAN-2014, the patient was vaccinated with ZOSTAVAX lot number J011218, subcutaneous for vaccination. On 21-JAN-2014, the patient developed redness and pain at the injection site. The area of redness extended from the site of injection past the elbow. The patient came to the pharmacy and was advised to take the unspecified over the counter pain medication and apply ice to the area of reaction. No lab diagnostics were performed. The outcome of developed redness and pain at the injection site was reported as recovering. Additional information has been requested.
Age: 0.9
Sex: F
Vaccine: FLUX
Symptoms: Autoimmune disorder, Neutropenia, Neutrophil count decreased, Pyrexia
Clinical narrative: This consumer report from the internet (initial receipt 15-Jan-2014) concerns a 10 month old female patient. On an unspecified date, (approximately six to seven years ago) the patient received the flu shot (manufacturer and batch number not reported) first dose of a series of two. On an unspecified date, roughly one or two weeks after receiving the flu shot, the patient developed a high fever and the doctors concluded she had neutropenia. Her neutrophil levels were so low that she was hospitalised for a couple of days. It took five months for her count to return to a normal level. She has not had an episode since. The doctor's thought it was autoimmune. Outcome was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 20-OCT-2011, the patient was administered with a dose of VARIVAX (Lot # 1703Z, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient. On 21-JAN-2014, the patient was vaccinated with ZOSTAVAX lot number J011218, subcutaneous for vaccination. On 22-JAN-2014, the patient developed a small raised area of redness at the injection site. The patient came to the pharmacy and was advised to apply ice to the area of reaction. No lab diagnostics were performed. The outcome of developed a small raised area of redness at the injection site was reported as recovering/resolving. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This spontaneous report as received from a nurse refers to her healthcare colleague, a female patient of unknown age. Initially the case was reported by a pharmacy representative. No information regarding the patient's medical history was provided. On 05-SEP-2012 the patient was vaccinated with RECOMBIVAX HB dose 1. She received the second dose on 02-OCT-2012 and the third dose on 04-MAR-2013. Route was not reported. No concomitant medication was reported. On an unknown date after completion of the three dose series, the patient had a negative titer test for Hepatitis B, also reported as the patient failed to seroconvert. No other adverse events were reported. No outcome was reported. No causality assessment was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 27-OCT-2011, the patient was administered with a dose of VARIVAX (merck) (Lot # 1730Z, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a field employee refers to an unspecified number of patients of unknown age and gender. No information regarding medical history was provided. On an unknown date the patient were vaccinated with GARDASIL. No concomitant medication was reported. The patients have been receiving the vaccine outside of the recommended vaccination schedule. No adverse effects were reported. No outcome ws reported. Additional information is not expected.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist, via field representative, refers to a 54 year old male patient. The pharmacist reported that "immediately" after an unspecified patient was administered ZOSTAVAX (lot#, dose unknown) on an unknown date, the injection site swelled "bigger than he had ever seen, it was the size of a golf ball". The pharmacist reported to the field representative that "everything had cleared up now and the patient was ok". Causality between the event and ZOSTAVAX was not assessed by pharmacist. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 21-OCT-2011, the patient was administered with a dose of VARIVAX (merck) (Lot # 0471AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Myalgia, Rash
Clinical narrative: This spontaneous report as received from a patient's wife refers to a 75 year old male patient with high blood pressure and no drug reactions or allergies. On 04-SEP-2012 the patient was vaccinated with ZOSTAVAX injection (route, strength, lot number and expiration date not provided). In October 2013 (reported as late October 2013) the patient developed shingles after getting ZOSTAVAX. He developed the rash on his left shoulder and then it advanced to his chest and back on the left side. At the time of report he still had tenderness in the muscles in that area (onset date of tenderness in the muscles was not reported). The patient saw the physician. For the treatment he was given an unspecified pain medication. No lab diagnostics studies were performed. The outcome of the patient's adverse events was reported as not recovered/not resolved. The relatedness between vaccination with ZOSTAVAX and the patient's adverse events was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unknown number of patients of unknown demographics. On an unknown date the patients were vaccinated with RECOMBIVAX HB. The nurse reported that she had had an unknown number of patients who had presented with negative Hepatitis B antibody titers after receiving a complete hepatitis B vaccine series. Sometimes the negative titers were about 2 months after completion of the vaccine series, and sometimes the negative titers were many years after completion of the vaccine series. The nurse practitioner also stated that in some cases, a patient may have initially had a positive hepatitis B titer and then have a negative titer many years later. The nurse practitioner did not know which brand of hepatitis B vaccine was used in these cases. The outcome of the event was unknown. This case is linked to 1401USA013354 by same reporter. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 09-JAN-2012, the patient was administered with a dose of VARIVAX (merck) (Lot # G009639, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 23-FEB-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 670799/0975AA, expiry date 17-JUN-2013) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 23-JAN-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0975AA, expiry date 17-JUN-2013) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unknown number of patients of unknown demographics. On an unknown date the patients were vaccinated with RECOMBIVAX HB. The nurse reported that she had had an unknown number of patients who had presented with negative Hepatitis B antibody titers after receiving a complete hepatitis B vaccine series. Sometimes the negative titers were about 2 months after completion of the vaccine series, and sometimes the negative titers were many years after completion of the vaccine series. The nurse practitioner also stated that in some cases, a patient may have initially had a positive hepatitis B titer and then have a negative titer many years later. The nurse practitioner did not know which brand of hepatitis B vaccine was used in these cases. The outcome of event was unknown. This case is linked to 1401USA013232 by same reporter. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 21-MAY-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0975AA expiry date 17-JUN-2013) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Breast cancer female, Cancer in remission, Chemotherapy, Laboratory test, Mastectomy
Clinical narrative: This spontaneous report as received from a pharmacist refers herself, a 61 or 62 year old female patient. The patient's current conditions included high blood pressure. The patient's medical history included cancer of the left breast (diagnosed 16 years prior to the adverse event) requiring a lumpectomy. On an unspecified date in 2011, the patient completed her three doses regimen for RECOMBIVAX HB. No dosage information or lot number was reported. Concomitant therapies included verapamil. It was reported that in February 2012, the patient was diagnosed with cancer of the left breast (considered as medically significant upon internal review). The patient sought medical attention and received chemotherapy treatment and a mastectomy for which she was hospitalized overnight. It was added that lab diagnostics studies were performed but this was not further specified. It was reported that the patient was still considered to be in remission. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 20 patients of unknown age and gender. On an unspecified dates from 23-DEC-2013 until 17-JAN-2014 the patients were vaccinated intramuscular with LIQUID PEDVAXHIB with reported lot number J011121 (exp. date 04-JUN-2016), intramuscular. On 18-DEC-2013, a shipment of PEDVAX was shipped to the nurse's office. However, the LIQUID PEDVAXHIB remained in transit in the sealed shipper until 23-DEC-2013. When it arrived at the nurse's office the LIQUID PEDVAXHIB was placed into refrigeration. The refrigerator had no temperature excursions. On unspecified dates from 23-DEC-2013 until 17-JAN-2014, 20 patients received these LIQUID PEDVAXHIB doses (incorrect storage of vaccine). No known adverse effects. Additional information has been requested.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Diet refusal, Irritability
Clinical narrative: Got shots this AM, cried all day, will not drink. PC w/mother; since 45 minutes after the vaccines, the infant has been crying. Mother did give infant acetaminophen (correct dose for infant's wt per mother). The infant slept for about 20 minutes was crying inconsolably again. She has refused her formula until took about an ounce a little while ago. Will calm down for couple minutes if bounced on mother's knee and back rubbed. Injection sites and areas surrounding sites look usual per mother. Plan: recommended the mother to take infant to ER. Follow up call made. Mom states she did not go to ER. That patient was much better, she had a lg bm. Mom stated that she had given patient a full jar of bananas the night before and believes this was the cause of babies fussiness. Injection sites clear. No redness/swelling. Reported to DPH.
Age: 44.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram, Electrocardiogram, Encephalitis post immunisation, Troponin I
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 21 January 2014. A 44 year-old male subject whose past medical history included chest pain, chest pressure, abnormal ECG, and blood clots was found to have encephalitis following immunization procedures on 29 November 2013 after the subject had received on 19 November 2013 an injection of ACAM2000 (lot number, route and site of administration not reported) and the following vaccines on 18 November 2013: TYPHIM VI (lot number, route and site of administration not reported), Influenza seasonal injectable vaccine (manufacturer, lot number, route and site of administration not reported) and Anthrax 3 (manufacturer, lot number, route and site of administration not reported). Troponin I, ECG and echocardiogram results were not available. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 20.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, TYP
Symptoms: Cardiac failure congestive, Echocardiogram, Electrocardiogram, Troponin I
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 21 January 2014. An 20 year-old male subject with no significant past medical history was found to have congestive heart failure, unspecified 20 days after the subject had received the following vaccines on 05 September 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), Influenza seasonal injectable vaccine (manufacturer, lot number, route and site of administration not reported), Typhoid oral vaccine (manufacturer, lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). Results of Troponin I, ECG and echocardiogram were not available. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 33.0
Sex: M
Vaccine: SMALL
Symptoms: Carditis, Echocardiogram normal, Electrocardiogram
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 21 January 2014. An 33 year-old male subject whose past medical history included high blood pressure, elevated cholesterol and shortness of breath was found to have "other, carditis" 18 days after receiving on 30 August 2013 an injection of ACAM2000 (lot number, route and site of administration not reported). The subject had a normal echocardiogram on 01 October 2013. ECG results were not available. Troponin I, Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Induration, Musculoskeletal pain, Nodule, Pain, Pain in extremity
Clinical narrative: Pt had a hard knot and she doubled over in pain. Whole arm and shoulder hurt with an egg size knot.
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Contraindication to vaccination, Headache, Vomiting, Weight decreased
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with allergic to erythromycin. On 20-JAN-2014 the patient was vaccinated with a dose of ZOSTAVAX, (lot #, expiration date, indication not reported, 0.65 ml, subcutaneously). On 20-JAN-2014, patient began vomiting every 20 minutes for two days, losing 4 pounds and necessitating a visit to her local emergency room. The reporter had no information regarding treatment provided at emergency room. The patient had had continuing headaches in January 2014 and had missed work. The patient's physician told her that should not have been administered the ZOSTAVAX as she had noted allergy to erythromycin. The outcome of the events was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to a female patient of unknown age who on 29-SEP-2012 and on 29-MAR-2013 was vaccinated with the first and the second dose of GARDASIL (doses and lot numbers not reported) respectively. On 27-JAN-2014, the patient would like to receive the third dose. No adverse symptoms were reported. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Cough, Diarrhoea, Nausea, Pain, Productive cough
Clinical narrative: Patient received Hep B #3 on 1/22/14; about 24 hours later she developed fever and body aches. Did not measure temp. Fever persisted for 4 days; developed chest congestion with cough - day 3 which continues and is productive. She has been afebrile x 2 days. She also reports nausea, vomiting and diarrhea x 1 day - on day 3 post immunization. She still has cough - no fever, and feels better.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Respiratory tract congestion, Vomiting
Clinical narrative: Patient received Hep B #3 on 1/22/14; about 24 hours later she developed fever and body aches. Did not measure temp. Fever persisted for 4 days; developed chest congestion with cough - day 3 which continues and is productive. She has been afebrile x 2 days. She also reports nausea, vomiting and diarrhea x 1 day - on day 3 post immunization. She still has cough - no fever, and feels better.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Local swelling, Neck pain
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. Patient was not pregnant. Patient medical history, drug allergy and reactions were unspecified. On an unknown date, the patient was vaccinated with ZOSTAVAX single dose vaccine (therapy route: vaccine, lot # unspecified, expiry date unspecified) for shingles. Concomitant medication was unspecified. On an unknown date, patient developed significant swelling and pain, which extended from the injection-site, to the neck area. The symptoms lasted for several weeks and patient sought medical attention prompted a visit to the Emergency Room. No product quality complaint. Patient was recovering from the reported event significant swelling and pain, which extended from the injection-site, to the neck area. Action taken with ZOSTAVAX was assessed as not applicable. Causality of the reported event was unknown (not provided). Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: FLU3, MMR, TD
Symptoms: Injection site pain
Clinical narrative: The patient called the medical provider 9 months after the date of vaccination to report persistent pain at the Td injection site. The patient did not specify at what point the pain started (i.e. at time of vaccination or after several months). Patient was asked to present to office for an evaluation, but he has not returned. All attempts to obtain additional information have been unsuccessful.
Age: 6.0
Sex: M
Vaccine: TD
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Td was administered to a 6-year-old male patient after being bitten by a dog.
Age: 57.0
Sex: M
Vaccine: TD
Symptoms: Blood test, Rash generalised, Rash pruritic, Rash pustular, Skin hyperpigmentation
Clinical narrative: Four days after the date of vaccination, the patient developed a mild itchy rash with pustules that evolved to violet spotty patches, approximately 2 cm in diameter. The patient's current condition is hyperpigmented spotty lesion. The rash occurred all over the patient's body. Patient was seen by the health care provider on 01/06/13. Patient has not received any treatment for the adverse reactions. The patient's physician will order that the patient stop taking Hydrochlorothiazide and will re-evaluate his condition. Patient recovered by 01/14/13.
Age: 57.0
Sex: M
Vaccine: TD
Symptoms: Skin lesion
Clinical narrative: Four days after the date of vaccination, the patient developed a mild itchy rash with pustules that evolved to violet spotty patches, approximately 2 cm in diameter. The patient's current condition is hyperpigmented spotty lesion. The rash occurred all over the patient's body. Patient was seen by the health care provider on 01/06/13. Patient has not received any treatment for the adverse reactions. The patient's physician will order that the patient stop taking Hydrochlorothiazide and will re-evaluate his condition. Patient recovered by 01/14/13.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Lip swelling, Local swelling, Pharyngeal oedema, Pruritus, Swollen tongue
Clinical narrative: Hives and swelling in hands, feet, tongue, lips and throat.  Two emergency room visits on day after with Epipen and steroids.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Throat tightness, Urticaria
Clinical narrative: Hives and swelling in hands, feet, tongue, lips and throat.  Two emergency room visits on day after with Epipen and steroids.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Laboratory test, Mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: The normal arm being sore began later that evening, Tuesday October 1, 2013. The pain continued to get worse and I was unable to have the full use of my arm from that point till now. I was at the doctor for a routine checkup and asked her about my arm ant the pain and lack of full use and she began to run tests. At this time, there have been no exact diagnosis. The pain is beginning to travel from the injection site to my elbow. I am scheduled this Saturday, February 1st for a MRI for further testing. I am very careful what I try to do with this arm because of the pain and weakness. I am left handed and the injection was in my left arm. At this point, I am continuing treatment to find out the damage done and will continue to follow up with VAERS as to the findings.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Pain, Pain in extremity
Clinical narrative: Sharp shooting pain that radiated down my left arm immediately after injection.  Have had pain in left arm and left shoulder since the injection that is getting worse.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Convulsion, Pyrexia
Clinical narrative: Fever as high as 105 with seizures, gave ibuprofen and took to hospital.
Age: 42.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Autoimmune thyroiditis, Blood test, Fatigue, Fibromyalgia
Clinical narrative: Flu like symptoms, headache, all over joint, muscle pain, tingling, heaviness of lower extremities. Diagnosed with Fibromyalgia, Chronic Fatigue, Irritable Bowel Syndrome, Hashimoto's Thyroid Disease, all after receiving two anthrax shots 1st one on 1/10/2003 lot FAV 070 and 2nd one 1/24/2003 Fav 063.
Age: 42.0
Sex: F
Vaccine: ANTH
Symptoms: Headache, Influenza like illness, Irritable bowel syndrome, Myalgia, Paraesthesia
Clinical narrative: Flu like symptoms, headache, all over joint, muscle pain, tingling, heaviness of lower extremities. Diagnosed with Fibromyalgia, Chronic Fatigue, Irritable Bowel Syndrome, Hashimoto's Thyroid Disease, all after receiving two anthrax shots 1st one on 1/10/2003 lot FAV 070 and 2nd one 1/24/2003 Fav 063.
Age: 42.0
Sex: F
Vaccine: ANTH
Symptoms: Sensation of heaviness
Clinical narrative: Flu like symptoms, headache, all over joint, muscle pain, tingling, heaviness of lower extremities. Diagnosed with Fibromyalgia, Chronic Fatigue, Irritable Bowel Syndrome, Hashimoto's Thyroid Disease, all after receiving two anthrax shots 1st one on 1/10/2003 lot FAV 070 and 2nd one 1/24/2003 Fav 063.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: Patient came in for HIV & STD testing.  She was administered an HPV immunization and later found out that she is pregnant.