chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Electromyogram normal, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Pain, Paraesthesia
Clinical narrative: This spontaneous report was received from an 60-year-old female patient regarding herself. On 31-MAY-2012 the patient was vaccinated with ZOSTAVAX single dose vial (lot# not reported) subcutaneously. No relevant medical history reported. No concomitant medications were reported. On 03-JUN-2012 the patient developed persistent burning, tingling pain in bilateral upper and lower extremities. The patient has had a work-up approximately on an unknown date in 2012 including a Magnetic Resonance Imaging (MRI) of head as well as upper and lower back, by an unspecified neurologist and all results have been normal. Electromyogram was normal. The patient was scheduled for evaluation at the neurology department in the future. Treatment was not given for the events. Medical attention was sought for the events, the patient had an office visit. No further information provided. The reported events were not resolved at the time of this report. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history included shingles. A few months ago, the patient was vaccinated with ZOSTAVAX (lot # not reported) dosing details unspecified. No concomitant medications were reported. The reporter stated that a patient was administered ZOSTAVAX by him at an unspecified time a few months ago and experienced a 2 inch patch of redness at injection site but no other adverse effects. Outcome of the reported event was unknown. No further information provided. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus
Clinical narrative: This spontaneous report was received from a pharmacy intern refers to an approximately 70-year-old female patient. On 14-MAY-2012 the patient was vaccinated with ZOSTAVAX lot # (672605/1658AA), expiration date 21-JAN-2013 subcutaneously 0.65 milliliters (ml). No concomitant medications were reported. The patient came into the pharmacy because of itchy, painful bumps on the scalp on an unknown date in September 2012 (last week). The patient called the pharmacy on 17-SEP-2012 to report she was diagnosed with shingles. The reported event did not resolve at the time of this report. The patient sought medical attention for the event. She visited the pharmacy and the physician office. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site extravasation, No adverse event
Clinical narrative: This spontaneous report was received from a physician and nurse via a company representative refers to a male patient of unknown age. Approximately on an unknown date in September 2012 (reported as last week) the patient was vaccinated with a dose of ZOSTAVAX (lot# not reported) dose and route not reported. No concomitant medications were reported. Physician and nurse mentioned to the representative that a male patient received ZOSTAVAX last week and when patient went home and took off the band aid that was at the injection site, liquid came out of the injection site. There was concern the patient did not get the proper dose of ZOSTAVAX. The patient was not experiencing any known symptoms. The outcome of the event was unknown. No further information is available. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Hyperhidrosis
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 69-year-old female patient. Concurrent conditions included asthma, anxiety, depression and allergy to codeine. Historical drug included codeine. The patient was vaccinated with ZOSTAVAX (lot # H011048, expiration date 05-SEP-2013) subcutaneously, on 18-SEP-2012. Concomitant medications included ADVAIR, AMITIZA, paroxetine and phentermine. On 20-SEP-2012 the patient developed chills, sweats and dizziness. The patient recovered on 22-SEP-2012. No treatment was given for the events. No lab studies were performed. Patient sought medical attention by calling the pharmacist. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a patient of unknown age and gender, who on 18-SEP-2012 and on 16-OCT-2012 was vaccinated with the first and second dose of PNEUMOVAX 23, intramuscularly (doses, and lot #s not reported). No adverse effects reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site mass, Injection site pain
Clinical narrative: This spontaneous report as received from a 68-year-old female patient regarding herself with no drug reactions or allergies and no pertinent medical history. The patient was vaccinated with dose 2, 0.5 milliliter PNEUMOVAX 23 (lot# not reported) either subcutaneously or intramuscularly on 03-OCT-2012. Concomitant medications included unspecified thyroid and blood pressure medications (meds). On 04-OCT-2012 the patient noticed that the injection site was sore, very tender and contained a bump. She claimed to have gotten a PNEUMOVAX 23 shot 6-7 years ago, and worried maybe it was some kind of overdose. There were no laboratory diagnostic tests performed. Treatment was not given for the adverse events. Patient did not seek medical attention but called FDA. The reported events did not resolve at the time of this report. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 years old male patient. The patient was vaccinated with ZOSTAVAX (lot# reported as H012577, exp 28-SEP-2013) on unknown date. No concomitant medications were reported. The patient came down with shingles 11 days after receiving ZOSTAVAX. The patient visited office for medical attention. No treatment information was reported. The outcome of shingles was not reported. Additional information has been requested.
Age: 1.3
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 15-month-old patient of unknown gender. The patient was vaccinated with, 0.65 milliliter ZOSTAVAX (lot# not reported) on 25-SEP-2012. No concomitant medications were reported. Reporter mentioned that the patient received ZOSTAVAX instead of VARIVAX (Merck). The patient was not experiencing any known symptoms. No further information is available. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site vesicles
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a current 73 years old patient. The patient was vaccinated with ZOSTAVAX (lot number not provided) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. The patient developed a huge water blister the size of a lemon, at the injection site. The outcome of adverse event was unknown. It was unspecified if the patient had sought medical attention. Additional information has been requested. This is one of several reports received from the same source.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a current 73 years old patient. The patient was vaccinated with ZOSTAVAX (lot number not provided) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. The patient developed a huge water blister the size of a lemon, at the injection site. The outcome of adverse event was unknown. It was unspecified if the patient had sought medical attention. Additional information has been requested. This is one of several reports received from the same source.
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to an elderly male patient of unknown age. The patient was vaccinated with PNEUMOVAX23 (lot # reported H009826, expiration date 11-FEB-2014) intramuscularly in the arm on 24-SEP-2012. Concomitant vaccine included FLUZONE in the opposite arm on 24-SEP-2012. Sometime between 24-SEP-2012 and 26-SEP-2012 the patient developed redness and swelling at the site of PNEUMOVAX23 injection. He went to see an unspecified physician who diagnosed him with cellulitis at the site of PNEUMOVAX23 injection. The physician prescribed KEFLEX to the patient. He was recovering. A lot check was requested. The patient sought medical attention for the event by going to a physician. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Axillary pain, Fatigue, Malaise, Pyrexia, Swelling
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 05-OCT-2012 the patient was vaccinated with PNEUMOVAX23 (lot # H013847, expiration date unknown) dose and route not reported. No concomitant medications were reported. The physician reported that the patient experienced adverse effects of malaise, fatigue, swelling, fever and under-arm pain. The date of birth was not available for this patient nor was the specific information about the patient. The patient did not recover from the reported events at the time of this report. Treatment was not given for the events. The patient sought medical attention by notifying the physician. The physician was enquiring if there had been an increase in reports of adverse effects from this lot of PNEUMOVAX23 and was it possible that this lot of PNEUMOVAX23 was contaminated. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 5-5year-old female patient. The patient was vaccinated with, 0.5 milliliter (ml) PNEUMOVAX 23 (lot # 1947AA, expiration date 20-OCT-2013) unspecified dose intramuscularly on 02-OCT-2012. Concomitant medications included OXYCODONE, METHADONE HYDROCHLORIDE and ESTRADIOL. No pertinent medical history, drug reactions/allergies were reported. The pharmacist reported that a patient developed pain, redness and warmth at the injection site after receiving a dose of PNEUMOVAX 23 on 02-OCT-2012. Treatment was given for the events, TYLENOL and ice treatment were given. The patient sought medical attention by calling the pharmacist. The events did not resolved at the time of this report. Additional information is not expected.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Confusional state, Diarrhoea, Fatigue, Increased upper airway secretion
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a 73 year old male patient with cholesterol, diabetes, depression and anxiety. On 05-OCT-2012, the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot number reported as 0363AE expiration was 16-MAR-2013), subcutaneously on the right arm. Concomitant medications included cholesterol medication, diabetes medication, MAO inhibitor medication. The patient had no drug reactions or allergies. On 06-OCT-2012, the patient experienced phlegm production, diarrhea, mental cloudiness and was being tired after receiving ZOSTAVAX. There was no treatment rendered for the events. There were no labs or diagnostic tests performed. The outcome of the events was reported as unknown at the time of this report. The patient sought medical attention (pharmacy visit). Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a health worker refers to a current 5 years old male patient with no pertinent medical history and no drug reactions/allergies. The patient was subcutaneously vaccinated with a dose of 0.5 ml VARIVAX (merck) (lot number not provided) on 13-APR-2010. Concomitant therapies included PREVNAR 13 and ACTHIB. On an unknown date the patient developed chicken pox at an unspecified time after receiving VARIVAX (merck). It was unspecified if the patient had sought medical attention. No treatment was given for the adverse event. The outcome of the chicken pox was unknown. Additional information is not expected.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to an elderly female patient of unknown age. The patient was vaccinated with PNEUMOVAX23 (lot # reported H009826, expiration date 11-FEB-2014) intramuscularly in the arm on 24-SEP-2012. Other suspect therapies included FLUZONE (manufacturer unspecified) on the opposite arm on 24-SEP-2012. No concomitant medications were reported. Sometime between 24-SEP-2012 and 26-SEP-2012 the patient developed redness and swelling at the site of PNEUMOVAX23 injection. She went to see an unspecified physician who diagnosed her with cellulitis at the site of PNEUMOVAX23 injection. The physician prescribed KEFLEX to the patient. She was recovering. A lot check was requested. The patient sought medical attention for the event by going to a physician. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: This spontaneous report was received from a registered pharmacist refers about 4 patients of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX (lot # not reported) dose and route not reported. No concomitant medications were reported. Pharmacist reported that she had about 4 patients, over the course of 4 years that she's been vaccinating, who called and complained of having red welt right around injection site after receiving ZOSTAVAX. The outcome of the reported event was unknown. Pharmacist did not have any additional information. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from medical assistant refers to a patient of unknown age and gender. The patient was vaccinated with dose 1, 0.5 milliliter (ml) PNEUMOVAX 23 (lot # not reported) intramuscularly (IM) on 04-JAN-2012. No concomitant medications were reported. The medical assistant reported that patient was inadvertently administered a dose of (dose 2) of PNEUMOVAX 23 (lot # not reported) dose and route not reported, on 04-OCT-2012. No adverse effects reported. No further information provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Axillary pain, Fatigue, Malaise, Pyrexia, Swelling
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 05-OCT-2012 the patient was vaccinated with PNEUMOVAX 23 (lot # H013847, expiration date unknown) dose and route not reported. No concomitant medications were reported. The physician reported that the patient experienced adverse effects of malaise, fatigue, swelling, fever and a under arm pain. The date of birth was not available at the time of this report. Treatment was not given for the events. The patient sought medical attention by notifying the physician. There were no laboratory tests performed. The physician was inquiring if there had been an increase in reports of adverse effects from this lot of PNEUMOVAX 23 and was it possible that this lot of PNEUMOVAX 23 was contaminated. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Antibody test negative, Incorrect dose administered, Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown demographics. On unknown date, the patient was vaccinated with ZOSTAVAX (dosing details, route and lot number were not reported). No concomitant medications were reported. The pharmacist had a prescription for the second dose of ZOSTAVAX for a patient who previously on an unspecified date in September 2012 (reported as recently) had a prescription for ZOSTAVAX and the patient had enquired if a booster dose was recommended. The pharmacist had not spoken to the patient or the physician but was suspecting that the patient might have received improperly stored ZOSTAVAX or titer result was low or negative as the reason for second prescription. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 years old patient. The pharmacist reported that an expired PNEUMOVAX 23 (Lot # 665708/0651Z, Exp date:15-JUN-2011, dose, route unspecified) given to the patient of 31-OCT-2012. No adverse effect reported. No treatment information was reported. The outcome was unknown. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site reaction, Rash vesicular
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to 3 years old male patient. Pertinent medical history, drug reactions and allergies were reported as none. On 26-SEP-2012, the patient was vaccinated with lot # (1216AA) VARIVAX (Merck) subcutaneously (dosing details was not reported). Expiry date was 26-JUL-2013. Concomitant medications were reported as none. On 07-OCT-2012, the patient experienced chickenpox like rash at the injection site after receiving VARIVAX (Merck). The patient's father had called the nurse practitioner and had sought medical attention for the same. No treatment information was reported. No laboratories diagnostic tests were performed. The outcome of chickenpox like rash at the injection site was reported as recovering/resolving. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Axillary pain, Fatigue, Malaise, Pyrexia, Swelling
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 05-OCT-2012 the patient was vaccinated with PNEUMOVAX 23 (lot # H013847, expiration date unknown) dose and route not reported. No concomitant medications were reported. The physician reported that the patient experienced adverse effects of malaise, fatigue, swelling, fever and under arm pain. The date of birth was not available for this patient nor was the specific information about the patient. The patient did not recover from the reported events at the time of this report. Treatment was not given for the events. The patient sought medical attention by notifying the physician. The physician was enquiring if there had been an increase in reports of adverse effects for this lot of PNEUMOVAX 23 and was it possible that this lot of PNEUMOVAX 23 was contaminated. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 80 years male patient. On an unspecified date in 2005, the patient was vaccinated with ZOSTAVAX (dosing details, route and lot number were not reported). No concomitant medications were reported. In March 2012, the patient experienced shingles after receiving ZOSTAVAX at another facility. The patient had visited a physician for the same and had sought medical attention. The patient was treated with antiviral medication (unspecified). On an unspecified date, the event shingles was recovered/resolved. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Axillary pain, Fatigue, Malaise, Pyrexia, Swelling
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 05-OCT-2012 the patient was vaccinated with PNEUMOVAX 23 (lot # H013847, expiration date unknown) dose and route not reported. No concomitant medications were reported. The physician reported that the patient experienced adverse effects of malaise, fatigue, swelling, fever and under-arm pain. The date of birth was not available for this patient nor was the specific information about the patient. The patient did not recover from the reported events at the time of this report. Treatment was not given for the events. The patient sought medical attention by notifying the physician. The physician was enquiring if there had been an increase in reports of adverse effects from this lot of PNEUMOVAX 23 and was it possible that this lot of PNEUMOVAX 23 was contaminated. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 years old female patient with no known pertinent medical history and no known drug allergies. On 23-OCT-2012, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (lot # reported as H011427, exp date 12-SEP-2013). No other co-suspects were reported. There was no concomitant medication. On 24-OCT-2012 the patient developed itch, redness, warmth, and pain at the site of injection. The patient went to see the pharmacist to seek medical attention. No treatment was given for the events. No lab diagnostics studies were performed. At the time of the report, the outcome of the events was reported as not recovered. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: The primary reporter is a medical assistant who administers vaccines. This medical assistant noted that patient was inadvertently administered an expired dose of VARIVAX (1233Z; 09/24/2012) on 10/08/2012. The medical assistant noted this is the first and only dose of VARIVAX the patient has received. No adverse effect reported. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age. The patients were vaccinated with PNEUMOVAX 23 (dose and route were unknown, Lot # reported as H013581, expiration date 03-MAR-2014). The reporter requested a Lot # check. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patients experienced redness around injection site, rash around injection site and fever. The patients sought medical attention by an office visit. No treatment information was reported. The reporter did not have detailed individual patient information but she said 6 patients experienced redness and rash around injection site and ac couple of patients experienced fever as well (MARRS Case # 1211USA001593, same reporter link) and one patient experienced "red streak" around injection site (MARRS Case # 1211USA001593, same reporter link). The outcome of rash around injection site and redness around injection site is unknown. The related ness for redness around injection site and rash around injection site was not reported for PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated SC with a dose of ZOSTAVAX (Lot number and dose not reported) on 29-OCT-2012 which expired on 25-OCT-2012. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with expired dose of M-M-R II on 01-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported. The outcome of expired vaccine used is unknown. Expired vaccine used is not related to M-M-R II. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacy intern refers to a 79 years old female patient with hypertension, diabetes, depression and allergy to penicillin. The patient was vaccinated subcutaneously with 0.65 ml dose of ZOSTAVAX on 19-OCT-2012 (lot# reported as H012523; expiration date 09-OCT-2013). No other co-suspects were reported. Concomitant medications included GLUCOPHAGE, meclizine, glimepiride, lisinopril, amlodipine, sertraline hydrochloride and escitalopram. The same day, on 19-OCT-2012 the patient began to experience redness and swelling at the injection site. On 23-OCT-2012 the patient reported to the pharmacy that at this time she had bumps which appear to be a rash at the site of injection. No other adverse effects had been observed or reported. The patient sought unspecified medical attention. No treatment was given to the patient. The outcome of the events was reported as not recovered/not resolved. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a current 59 years old female patient with a history of itchiness and a rash caused by vancomycin IV. The patient may have gotten M-M-R II (dose, route and lot # not reported) years ago. No other co-suspects were reported. No concomitant medications were reported. It was reported that now the patient was equivocal to rubella. The patient did not have her vaccine record but it was possible the patient may have gotten M-M-R II previously. It was unknown if the patient sought medical attention. No treatment information was reported. The relatedness for equivocal to rubella was unknown for M-M-R II. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Hypoaesthesia, Lymphadenopathy
Clinical narrative: Patient developed left cheek, left neck, left arm & left hand (thumb & 5th digit) numbness & tingling day after receiving influenza vaccine.
Age: 42.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient developed left cheek, left neck, left arm & left hand (thumb & 5th digit) numbness & tingling day after receiving influenza vaccine.
Age: 41.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a pharmacist (Pharm D) refers to a 41 years old female patient. The patient's medical history included drug reactions/allergies to Penicillin (unspecified) and "Sulfa" drugs. On 04-OCT-2012 the patient was vaccinated with PNEUMOVAX 23, lot number H010661, expiry date 02-02-2014, intramuscularly in the right deltoid (dose and dose number not provided). No other co-suspects or concomitant medication was reported. On 05-OCT-2012 (reported: 'a little over 24 hours later') the patient developed cellulitis at the injection site. On 06-OCT-2012 the patient went to the emergency room, but was not admitted. The patient received treatment for the event with doxycycline. A lot check was requested by the reporter. The outcome of cellulitis at the injection site was reported as recovering/resolving. A reporter causality for cellulitis at the injection site was not provided for PNEUMOVAX 23. A lot check was requested by the reporter. The reporter informed about two adverse events with PNEUMOVAX 23; linked case report: 1210USA005751. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report as received from a pharmacist (Pharm D) refers to a 41 years old female patient. The patient's medical history included drug reactions/allergies to Penicillin (unspecified) and "Sulfa" drugs. On 04-OCT-2012 the patient was vaccinated with PNEUMOVAX 23, lot number H010661, expiry date 02-02-2014, intramuscularly in the right deltoid (dose and dose number not provided). No other co-suspects or concomitant medication was reported. On 05-OCT-2012 (reported: 'a little over 24 hours later') the patient developed cellulitis at the injection site. On 06-OCT-2012 the patient went to the emergency room, but was not admitted. The patient received treatment for the event with doxycycline. A lot check was requested by the reporter. The outcome of cellulitis at the injection site was reported as recovering/resolving. A reporter causality for cellulitis at the injection site was not provided for PNEUMOVAX 23. A lot check was requested by the reporter. The reporter informed about two adverse events with PNEUMOVAX 23; linked case report: 1210USA005751. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Fungal skin infection, Pruritus, Rash
Clinical narrative: This spontaneous report as received from a practitioner nurse refers to a 61 years old female patient. On an unknown date, the patient was vaccinated with ZOSTAVAX SQ, (dose not reported). The product batch number was H011050. On 23-OCT-2012, the patient experienced itchy red spot on her left arm after the injection. The patient also later developed a rash on her back. It was reported that the patient did not receive any treatment for the adverse events and it was unspecified if the patient sought medical attention. The outcome of itchy red spot on her arm after the injection and rash in her back was unknown. The relatedness for itchy red spot on her left arm after the injection and rash was unknown for ZOSTAVAX. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: This spontaneous report as received from a practitioner nurse refers to a 61 years old female patient. On an unknown date, the patient was vaccinated with ZOSTAVAX SQ, (dose not reported). The product batch number was H011050. On 23-OCT-2012, the patient experienced itchy red spot on her left arm after the injection. The patient also later developed a rash on her back. It was reported that the patient did not receive any treatment for the adverse events and it was unspecified if the patient sought medical attention. The outcome of itchy red spot on her arm after the injection and rash in her back was unknown. The relatedness for itchy red spot on her left arm after the injection and rash was unknown for ZOSTAVAX. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Chills, Pyrexia
Clinical narrative: Patient was administered vaccine and less than 24 hours later developed high temperature, became toxic, developed a rapidly enlarging area of cellulitis in right arm which required IV antibiotics.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Pyrexia, Toxicity to various agents
Clinical narrative: Patient was administered vaccine and less than 24 hours later developed high temperature, became toxic, developed a rapidly enlarging area of cellulitis in right arm which required IV antibiotics.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain
Clinical narrative: Shoulder was sore, which was not a big deal.  It went away, but then came back and has been more sore and achy the last two days than it was originally.  I've had flu shots before and never had it get sore again later and stay sore.
Age: 40.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Dizziness, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red swelling of left upper arm, sore, tender. Its been 5 days. Tingling/sharp pain of the arm right arm. Tiredness and light dizzy spells.
Age: 40.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Red swelling of left upper arm, sore, tender. Its been 5 days. Tingling/sharp pain of the arm right arm. Tiredness and light dizzy spells.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Eye haemorrhage, Eye irritation, Eye pruritus, Eye swelling, Nausea
Clinical narrative: Case number PHEH2012US021518 is an initial spontaneous report received from a pharmacist on 23 Oct 2012. This report refers to a 66-years-old female patient. She was vaccinated with FLUVIRIN (batch number: 1207201, expiry date: Jun 2013) intramuscularly on 19 Oct 2012. Her eye was itching 30 minutes after receiving FLUVIRIN. Her eye turned black and vision became blurry and her eyes were burning after vaccine was administered. She then rubbed her eye and then it got blurry again and was swollen. She then went to the eye doctor who said that there was a blood vessel popped in the eye. She was also feeling nauseous after a few days and still had blurred vision. The outcome of the event, blurred vision was reported as condition unchanged and that of other events were not reported.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Scleral discolouration, Vision blurred
Clinical narrative: Case number PHEH2012US021518 is an initial spontaneous report received from a pharmacist on 23 Oct 2012. This report refers to a 66-years-old female patient. She was vaccinated with FLUVIRIN (batch number: 1207201, expiry date: Jun 2013) intramuscularly on 19 Oct 2012. Her eye was itching 30 minutes after receiving FLUVIRIN. Her eye turned black and vision became blurry and her eyes were burning after vaccine was administered. She then rubbed her eye and then it got blurry again and was swollen. She then went to the eye doctor who said that there was a blood vessel popped in the eye. She was also feeling nauseous after a few days and still had blurred vision. The outcome of the event, blurred vision was reported as condition unchanged and that of other events were not reported.
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Sleep disorder
Clinical narrative: Case number PHEH2012US021503 is an initial spontaneous report received from a consumer on 23 Oct 2012. This report refers to a male patient. He was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on an unknown date in Sep 2012. He reported that he experienced bouts of shortness of breath shortly after receiving FLUVIRIN. It was reported that by the beginning of October, his shortness of breath was waking him up in the middle of the night and he went outside to catch his breath. He felt like he could not get enough air and it was like a bag was over his head. The shortness of breath occurred at night and while he was awake. The outcome of the event was not reported. No further information was available.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Upper right arm started to swell.  Eventually became as large as half a baseball and was extremely itchy, red and tender.  Lasted approximately 4 days before the swelling started to go down.  Still itchy and slightly pink at 8 days past. Used Benadryl (did not help much) and topical hydrocortisone as well as Tylenol and ice packs.  Nothing really helped much.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Oedema peripheral, Pain in extremity
Clinical narrative: The patient called on 11/05/12 and reported that she was given a flu shot on 9/24/12 and that her left arm from her elbow down to her hand had been painful and slightly swollen since that day. She stated the reason she had not reported before this date was that she thought the symptoms would improve with time. She stated she had an appointment with her private physician scheduled on 11/9/12.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Ocular hyperaemia, Rash, Tachycardia, Throat tightness
Clinical narrative: Tightening throat; itchy red eyes; rash; tachycardia.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Blood pressure decreased, Cardiac enzymes normal, Dizziness, Dyspnoea
Clinical narrative: Difficulty breathing (not wheezing, but unable to draw breath), extreme weakness, tingling, vomiting, dizzy, lower than normal blood pressure, fast heart rate, difficulty walking.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Electrocardiogram normal, Gait disturbance, Heart rate increased, Paraesthesia, Vomiting
Clinical narrative: Difficulty breathing (not wheezing, but unable to draw breath), extreme weakness, tingling, vomiting, dizzy, lower than normal blood pressure, fast heart rate, difficulty walking.
Age: 47.0
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Pyrexia
Clinical narrative: High fever that reached 103 for 2 days.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Biopsy, Injection site rash, Injection site vasculitis, Rash
Clinical narrative: Rash left arm with vasculitis mildly raised eruption about 1 cm superior to site of flu vaccination, no TTP.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Pruritus, Rash
Clinical narrative: Patient reports experiencing intense pruritis at injection site, around eyes, in ears within a few hours after receiving the vaccine. The next day a rash developed on her face along with pruritis over her entire body. Pt self-treated with diphenydramine for several days, while itching continued and rash came and went daily. Called PCP on 10/31/12 and was started on methylprednisolone taper. Pt reports that symptoms improved initially, but did not completely resolve by the end of the steroid taper. Is still experiencing minor itching.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Lacrimation increased, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Runny nose, watery eyes cough & congestion.
Age: 44.0
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Pyrexia
Clinical narrative: Fever 102 lasting until 10/29/2012.
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Cough, Grip strength decreased, Pain, Pain in extremity
Clinical narrative: WENT TO BED AND AT 9.30 PM LEGS STARTED HURTING TERRIBLE, REST OF BODY WAS ACHING, GOT UP TO US BATHROOM, AFTER THIS WENT TO GET A DRINK OUT OF THE FRIGE, WHEN WENT TO TAKE HOLD OF BOTTLE OF CRANBERRY WAS UNABLE TO HOLD DUE TO VIOLENT SHAKING, SOMEHOW MADE IT BACK TO BED AND BY WRAPPING UP GOOD FINALLY GOT RID OF CHILLS. BUT STILL ACHED ALL NIGHT LONG, AS OF TODAY, I STILL HAVE ACHES, RUNNING NOSE, STOPPED UP, COUGHING.
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Rhinorrhoea, Tremor
Clinical narrative: WENT TO BED AND AT 9.30 PM LEGS STARTED HURTING TERRIBLE, REST OF BODY WAS ACHING, GOT UP TO US BATHROOM, AFTER THIS WENT TO GET A DRINK OUT OF THE FRIGE, WHEN WENT TO TAKE HOLD OF BOTTLE OF CRANBERRY WAS UNABLE TO HOLD DUE TO VIOLENT SHAKING, SOMEHOW MADE IT BACK TO BED AND BY WRAPPING UP GOOD FINALLY GOT RID OF CHILLS. BUT STILL ACHED ALL NIGHT LONG, AS OF TODAY, I STILL HAVE ACHES, RUNNING NOSE, STOPPED UP, COUGHING.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray normal, Computerised tomogram head normal, Hyperhidrosis, Hypotension, Loss of consciousness
Clinical narrative: Pt. had syncopal episode while eating with friends, passed out, tremoring of extremities, legs & arms very weak, vomited, hypotensive, and diaphoretic. B/P 87/50 in ER.  CT scan of head was normal.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Syncope, Tremor, Ultrasound Doppler, Ultrasound Doppler normal
Clinical narrative: Pt. had syncopal episode while eating with friends, passed out, tremoring of extremities, legs & arms very weak, vomited, hypotensive, and diaphoretic. B/P 87/50 in ER.  CT scan of head was normal.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: Pt. had syncopal episode while eating with friends, passed out, tremoring of extremities, legs & arms very weak, vomited, hypotensive, and diaphoretic. B/P 87/50 in ER.  CT scan of head was normal.
Age: 20.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Alveolar osteitis, Anxiety, Injection site erythema, Injection site pain, Nightmare
Clinical narrative: Given immunizations for influenza and pneumonia vaccination due to prior history of asthma.  Following day developed redness at the right shoulder at the site of one injection and fevers to 102.  Has had persistent fevers for the last couple of days with 101-102 and tenderness at the site along with increasing redness.  Patient also has a history of dry sockets.  He had dental work done the previous week and was having pain so went in on Tuesday and saw his dentist.  Noted to have dry sockets but no evidence of infection.  He was not started on antibiotics.  He reports that he has also had had nightmares associated with anxiety coinciding with the illness.  He also started taking clonazepam and wondering if that could be associated.  Review of the medication shows that it has been associated with nightmares in the past. Bactrim Ds 800-160 Mg Tabs (Sulfamethoxazole-trimethoprim) .... Take one tab bid for skin infection.   Vicodin 5-500 Mg Tabs (Hydrocodone-acetaminophen) .... Take one tablet by mouth every four hours as needed for pain.
Age: 20.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Oral pain, Pyrexia
Clinical narrative: Given immunizations for influenza and pneumonia vaccination due to prior history of asthma.  Following day developed redness at the right shoulder at the site of one injection and fevers to 102.  Has had persistent fevers for the last couple of days with 101-102 and tenderness at the site along with increasing redness.  Patient also has a history of dry sockets.  He had dental work done the previous week and was having pain so went in on Tuesday and saw his dentist.  Noted to have dry sockets but no evidence of infection.  He was not started on antibiotics.  He reports that he has also had had nightmares associated with anxiety coinciding with the illness.  He also started taking clonazepam and wondering if that could be associated.  Review of the medication shows that it has been associated with nightmares in the past. Bactrim Ds 800-160 Mg Tabs (Sulfamethoxazole-trimethoprim) .... Take one tab bid for skin infection.   Vicodin 5-500 Mg Tabs (Hydrocodone-acetaminophen) .... Take one tablet by mouth every four hours as needed for pain.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Blood culture negative, Chest X-ray normal, Culture urine negative, Full blood count normal, Influenza virus test negative
Clinical narrative: Fever up to 105 rectally x 48-72 hours. Irritability.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Irritability, Metabolic function test normal, Pyrexia, Respiratory syncytial virus test negative, Streptococcus test negative
Clinical narrative: Fever up to 105 rectally x 48-72 hours. Irritability.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Urine analysis normal
Clinical narrative: Fever up to 105 rectally x 48-72 hours. Irritability.
Age: 74.0
Sex: F
Vaccine: FLUX
Symptoms: Acute disseminated encephalomyelitis, Demyelination, Myelitis transverse, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Transverse myelitis. Region of demyelination in right frontal lobe.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Blister, Cellulitis, Pyrexia, Staphylococcal infection, Staphylococcus test positive
Clinical narrative: Got PNEUMOVAX and less than 12 hours later developed cellulitis in right arm with fever. Admitted to hospital, IV vancomycin and KEFLEX.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Chills, Injection site swelling, Pyrexia
Clinical narrative: Got PNEUMOVAX and less than 12 hours later developed cellulitis in right arm with fever. Admitted to hospital, IV vancomycin and KEFLEX.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Bronchospasm, Laryngeal oedema, Lip swelling, Swelling face
Clinical narrative: Laryngeal edema, facial & lip swelling and bronchospasm.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Pyrexia
Clinical narrative: Chills, diarrhea, low fever.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Extreme full-body hives resulting in 2 ER visits over the course of 1.5 weeks. Never had any prior allergies to anything. Fully healthy individual. Hives are almost gone, however not completely and it's been almost 2 weeks.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Complaint of severe pain (6 out of 10) in Left arm where vaccination was given for 10 days following vaccine administration.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Tachycardia
Clinical narrative: Approx. 20-25 minutes following flu shot, she experienced nausea, dizziness and tachycardia.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Flushing, Pain
Clinical narrative: Body aches, fatigue, "flushed" feeling (no fevers).
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Deep aching pain in left shoulder since flu shot received.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Anti-NMDA antibody, Blood test, CSF test, Electroencephalogram
Clinical narrative: Initially started as abdominal pain, by 10/13/12 patient had fever of 104F. Went to Emergency Room on 10/15/12.  Admitted to hospital on 10/16/12 with high fever and neurological symptoms.  Diagnosed with postinfectious or parainfectious myoclonus and aseptic meningitis.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Lumbar puncture, Meningitis aseptic, Myoclonus, Neurological examination, Neurological symptom
Clinical narrative: Initially started as abdominal pain, by 10/13/12 patient had fever of 104F. Went to Emergency Room on 10/15/12.  Admitted to hospital on 10/16/12 with high fever and neurological symptoms.  Diagnosed with postinfectious or parainfectious myoclonus and aseptic meningitis.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Pyrexia, Viral test
Clinical narrative: Initially started as abdominal pain, by 10/13/12 patient had fever of 104F. Went to Emergency Room on 10/15/12.  Admitted to hospital on 10/16/12 with high fever and neurological symptoms.  Diagnosed with postinfectious or parainfectious myoclonus and aseptic meningitis.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Brain oedema, Computerised tomogram head abnormal, Inflammation, Influenza like illness, Injection site inflammation
Clinical narrative: Initial growing pain and slight inflammation from injection site to finger tips. Initial migraine started within 5 hours of shot and lasted 30 hours. Flu like symptoms for the next 7 days with migraine coming and going. Final migraine called for hospilization. CT scan done, no tumor found but slight brain swelling on right side of brain causing servere migraine. Put on morphine and left in hospital till the PM.  Sent home with pain killers and anti biotic for sinus infection suspected.  Sinus infection not related to migraine or brain swelling according to Doctor.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Migraine, Pain in extremity, Sinusitis
Clinical narrative: Initial growing pain and slight inflammation from injection site to finger tips. Initial migraine started within 5 hours of shot and lasted 30 hours. Flu like symptoms for the next 7 days with migraine coming and going. Final migraine called for hospilization. CT scan done, no tumor found but slight brain swelling on right side of brain causing servere migraine. Put on morphine and left in hospital till the PM.  Sent home with pain killers and anti biotic for sinus infection suspected.  Sinus infection not related to migraine or brain swelling according to Doctor.
Age: 0.24
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: ERRONEOUS VACCINATION ADMINISTERED.