chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash, Spinal operation
Clinical narrative: This spontaneous report was received from a nurse via a company representative refers to a 62 year old male patient (the reporter's husband). No relevant medical history of the patient was reported. On an unknown date approximately in 2009, reported as 5 years ago, the patient was vaccinated with ZOSTAVAX vial, 1 injection (route of administration, lot number and expiry date were not reported). There were no concomitant medications reported. On an unknown date approximately in 2012, reported as 2 years ago, the patient had a mild case of shingles. And on an unknown date approximately in October 2014, reported as about a month ago, the patient underwent a spine surgery (medically significant). The patient was treated with NEURONTIN for the spine surgery. Approximately on 11-NOV-2014, reported as 2 weeks ago, the patient had a recurrence of shingles. The patient had a rash on the right side of his trunk with blistering. The patient was treated with VALTREX and the rash went away in about 4 days. It was unknown if the patient had any prior history of shingles before being administered with ZOSTAVAX. It was reported that the patient had sought medical attention for the outbreak shingles. There was no product quality complaint involved. The outcome of spine surgery was unknown. The outcome of the first episode of shingles was recovered on an unknown date and the second episode of shingles was recovered on an unknown date approximately in November 2014. The causality of the events spine surgery and the two episodes of shingles were unknown. Upon internal review the event spine surgery was considered to be medically significant. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: Received FLUARIX Quadrivalent. Stated her throat felt a little "itchy" after. Stated she took 2 BENADRYL gel caps and symptoms resolved in 3-5 min.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cough, Dyspnoea, Headache, Injection site bruising, Injection site nodule
Clinical narrative: Lemon size bruising and knot at the injection site of left arm. Breathing difficulties, cough, headache. Z-PAK and albuterol treatment.
Age: 68.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received from a pharmacist via RMPDC refers to a 68 year old male patient. The patient's medical history included occasional colds. The patient's relevant past drug history was unknown. On 05-NOV-2013 the patient was vaccinated with the first dose of ZOSTAVAX (lot#, dose, route not reported). On 31-OCT-2014 the patient was vaccinated with the second dose of ZOSTAVAX (route not reported, lot # J012657, expiration date 10-JAN-2015, dose 0.65 ml). Concomitant therapies included testosterone (manufacturer unknown) and influenza virus vaccine inactivated (unspecified) which was given on 31-OCT-2014. It was reported that the patient's wife phoned the pharmacy later and said she did not know what the patient was doing because he got one ZOSTAVAX last year. The patient's relevant tests or laboratory data was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 27-OCT-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K006681, expired date 21-OCT-2015), (dose and route unspecified). On an unspecified date in 2014, the patient only experienced slight pain at the injection site, which quickly resolved, without treatment. This is one of several reports received from same source. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient noticed redness and some itching localized to right arm where a shingles vaccine had been given on 11-28-14 at approx 13:11 SQ. Patient seeking medical attention today 11-30-14 at 18:00. PA treatment recommendations of NSAIDS, ice and antihistamines.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Myalgia
Clinical narrative: This spontaneous report as received from a 75 year old male patient with bladder cancer, erythrocytosis, PERCOCET and penicillin allergy, lung cancer and prostate cancer refers to himself. On 19-Oct-2014 the patient was vaccinated with PNEUMOVAX 23 with injection route (dose, dose# and lot# unknown). Concomitant therapies included BENICAR, KEPPRA, SYNTHROID, allopurinol and simvastatin (manufacturer unknown). On 19-OCT-2014, the patient experienced muscle pain and shoulder joint pain after received PNEUMOVAX 23. The patient did not seek medical attention. There was no treatment given to the events. No labs performed. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a male patient of unknown age. On 06NOV2014 the patient was vaccinated with ZOSTAVAX (lot # K007987, expiration date 03SEP2015) 0.65 ml once, subcutaneous. The pharmacist reported that the patient received a dose of ZOSTAVAX that was stored at 10F for 144 hours. No adverse effects were reported. The outcome of the event was unknown. Additional information is expected.
Age: 52.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site rash, Varicella post vaccine
Clinical narrative: Pt received varicella vaccine to (R) upper arm on 11/29/14. She reports that on 11/29/14 she developed pain to site of injection and a painful rash on 11/30/14. Pt seen in clinic on 11/30/14 and dx with varicella rash at site of injection. VALTREX rx to alleviate symptom.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a male consumer of unknown  age referring to himself. Medical history and drug reactions or allergies was not provided. No medical history and drug reactions or allergies reported. On an unknown date the patient was vaccinated with ZOSTAVAX, (dose, lot# and expiration date was not reported). Concomitant therapy was not reported. On an unknown date the patient reported that he got shingles after receiving the ZOSTAVAX. The outcome of the patient reported he got shingles after receiving the ZOSTAVAX was unknown. Additional information is not expected since no contact details were provided.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 year old male patient with no Drug Reactions/Allergies. On 27-OCT-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K006681, expired date 21-OCT-2015), (dose unspecified), intramuscular. On 27-OCT-2014, the patient began to experience "some pain" in the injection arm "a few hours" after the administration. Pharmacist reported that the pain progressively got worse over the next several days and the patient did not sleep for 4 days because of the pain, therefore the patient went to see his unspecified physician on an unspecified date. Pharmacist reported that the physician prescribed FLECTOR patches and MOTRIN for treatment of the pain but the pain had still persisted. Pharmacist reported that the patient was still experiencing severe pain, but it had gotten "a little better". No Lab Diagnostics Studies Performed. The events outcome was recovering. This is one of several reports received from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Caesarean section, Convulsion, Eclampsia, Exposure during pregnancy, Neonatal disorder
Clinical narrative: Information has been received from an 18 years old female patient reporting herself, for VARIVAX (Merck), a Pregnancy Registry product. The patient's concurrent condition included West Nile virus from August 2013 and none of drug reactions/allergies. On 16-AUG-2013 the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route, injection site and lot# not provided) as the requirement for college. Concomitant therapies included PROZAC and unspecified other medication. Yesterday (21-AUG-2013) she found she was 5 weeks pregnant which calculated that the patient's LMP (last menstrual period) was on 17-JUL-2013 and EDD (Expected Delivery of Date) was on 23-APR-2014. The patient had called physician assistant and no treatment was given. No lab diagnostics performed. No adverse event or other symptoms were reported. The outcome of adverse events was unknown. Phone calls were placed on the physician assistant (PA) on 11-NOV-2014, 18-NOV-2014 and 24-NOV-2014, but the PA was unavailable at that time. All telephone attempts to obtain follow up information has been unsuccessful. The follow up with significant information was received on 26-NOV-2014. On 26-NOV-2014 a phone call was received from Registered Nurse at Health Clinic. The Registered Nurse stated that the patient, had her first dose of VARIVAX (Merck) on 02-JUN-2000 for negative varicella antibodies, and the second dose of VARIVAX (Merck) was given on 16-AUG-2013 "as a booster shot." The patient had a last menstrual period of 16-JUL-2013. The patient was not seen at the clinic for her obstetrical care, but did deliver with this clinic. On 30-MAR-2014, 37 weeks gestational age, the patient had a cesarean section due to eclampsia (onset date unknown); she was experiencing seizures. The female baby was 6 pounds, 3.5 ounces and born with no congenital anomalies. The mother and baby were both transferred to another facility; (unknown) the baby was in Neonatal Intensive Care Unit (NICU) for an unknown amount of time and for unknown reasons. "The patient and baby were both doing well now." Relatedness between use of the VARIVAX (Merck) and the adverse events was unknown. No further information is available at this time. Additional information is not expected.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, RV5, DTAPHEPBIP, RV5
Symptoms: Blepharospasm, Convulsion, Crying, Eye movement disorder, Musculoskeletal stiffness
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of eye fluttering in a 4-month-old female patient who received PEDIARIX (batch number LK94M, expiry date 5th September 2016). Concomitant products included ROTATEQ. On 2nd October 2014 09:30, the patient received the 2nd dose of PEDIARIX .5 ml. On 3rd October 2014 03:00, 1 days after receiving PEDIARIX, the patient experienced eye fluttering, screaming, fever, injection site swelling and muscle stiffness. On an unknown date, the outcome of the eye fluttering, screaming, fever, injection site swelling and muscle stiffness were recovered/resolved. The reporter considered the eye fluttering, screaming, fever, injection site swelling and muscle stiffness to be probably related to PEDIARIX. Additional information received on 07 October 2014: There was no concomitant medication, no relevant medical history and no adverse event following previous vaccinations. Nurse calling to report adverse event as reported to her by the patient's mother. On 03 October 2014, between 3:00 and 6:45 am, the mother reports 3-5 sec episodes of muscle stiffness and eye fluttering, along with fever of 102F, screaming, fussiness and swollen injection site. They associate this to the pertussis component of PEDIARIX and plan on not using PEDIARIX for future immunizations. Doctor's Office (phone consult only) was required as medical attention.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, RV5, DTAPHEPBIP, RV5
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of eye fluttering in a 4-month-old female patient who received PEDIARIX (batch number LK94M, expiry date 5th September 2016). Concomitant products included ROTATEQ. On 2nd October 2014 09:30, the patient received the 2nd dose of PEDIARIX .5 ml. On 3rd October 2014 03:00, 1 days after receiving PEDIARIX, the patient experienced eye fluttering, screaming, fever, injection site swelling and muscle stiffness. On an unknown date, the outcome of the eye fluttering, screaming, fever, injection site swelling and muscle stiffness were recovered/resolved. The reporter considered the eye fluttering, screaming, fever, injection site swelling and muscle stiffness to be probably related to PEDIARIX. Additional information received on 07 October 2014: There was no concomitant medication, no relevant medical history and no adverse event following previous vaccinations. Nurse calling to report adverse event as reported to her by the patient's mother. On 03 October 2014, between 3:00 and 6:45 am, the mother reports 3-5 sec episodes of muscle stiffness and eye fluttering, along with fever of 102F, screaming, fussiness and swollen injection site. They associate this to the pertussis component of PEDIARIX and plan on not using PEDIARIX for future immunizations. Doctor's Office (phone consult only) was required as medical attention.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, RV5, DTAPHEPBIP, RV5
Symptoms: Excessive eye blinking, Injection site swelling, Irritability, Musculoskeletal stiffness, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of eye fluttering in a 4-month-old female patient who received PEDIARIX (batch number LK94M, expiry date 5th September 2016). Concomitant products included ROTATEQ. On 2nd October 2014 09:30, the patient received the 2nd dose of PEDIARIX .5 ml. On 3rd October 2014 03:00, 1 days after receiving PEDIARIX, the patient experienced eye fluttering, screaming, fever, injection site swelling and muscle stiffness. On an unknown date, the outcome of the eye fluttering, screaming, fever, injection site swelling and muscle stiffness were recovered/resolved. The reporter considered the eye fluttering, screaming, fever, injection site swelling and muscle stiffness to be probably related to PEDIARIX. Additional information received on 07 October 2014: There was no concomitant medication, no relevant medical history and no adverse event following previous vaccinations. Nurse calling to report adverse event as reported to her by the patient's mother. On 03 October 2014, between 3:00 and 6:45 am, the mother reports 3-5 sec episodes of muscle stiffness and eye fluttering, along with fever of 102F, screaming, fussiness and swollen injection site. They associate this to the pertussis component of PEDIARIX and plan on not using PEDIARIX for future immunizations. Doctor's Office (phone consult only) was required as medical attention.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, RV5, DTAPHEPBIP, RV5
Symptoms: Screaming
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of eye fluttering in a 4-month-old female patient who received PEDIARIX (batch number LK94M, expiry date 5th September 2016). Concomitant products included ROTATEQ. On 2nd October 2014 09:30, the patient received the 2nd dose of PEDIARIX .5 ml. On 3rd October 2014 03:00, 1 days after receiving PEDIARIX, the patient experienced eye fluttering, screaming, fever, injection site swelling and muscle stiffness. On an unknown date, the outcome of the eye fluttering, screaming, fever, injection site swelling and muscle stiffness were recovered/resolved. The reporter considered the eye fluttering, screaming, fever, injection site swelling and muscle stiffness to be probably related to PEDIARIX. Additional information received on 07 October 2014: There was no concomitant medication, no relevant medical history and no adverse event following previous vaccinations. Nurse calling to report adverse event as reported to her by the patient's mother. On 03 October 2014, between 3:00 and 6:45 am, the mother reports 3-5 sec episodes of muscle stiffness and eye fluttering, along with fever of 102F, screaming, fussiness and swollen injection site. They associate this to the pertussis component of PEDIARIX and plan on not using PEDIARIX for future immunizations. Doctor's Office (phone consult only) was required as medical attention.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient. No concurrent conditions or medical history were provided. On 19-NOV-2014, the patient was vaccinated with a dose of ZOSTAVAX injection administered subcutaneously in the deltoid region at dose 0.65 ml (lot # K010646 with expiry date: 30-OCT-2015). No concomitant medications were reported. The patient notified the pharmacy on 21-NOV-2014 by telephone that her injection site, where she received ZOSTAVAX, was reddened and the patient also developed "some pain and itching" (since November 2014, exact date unknown). The pharmacist did not know if the patient notified her healthcare provider, and she did not think that the patient had taken any treatment for her adverse experience. Pharmacist believed that the patient was improving. The relatedness between the events and ZOSTAVAX was not reported. The pharmacist is requesting a lot check for ZOSTAVAX lot # K010646 (exp. 30-OCT-2015) because this patient and another patient experienced injection site adverse experiences after receiving this lot. The other patient's AE is reported in MARRS# 1411USA012048. This is one of several reports from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Pain, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient. No concurrent conditions or medical history were provided. On 19-NOV-2014, the patient was vaccinated with a dose of ZOSTAVAX injection administered subcutaneously in the deltoid region at dose 0.65 ml (lot # K010646 with expiry date: 30-OCT-2015). No concomitant medications were reported. The patient notified the pharmacy on 21-NOV-2014 by telephone that her injection site, where she received ZOSTAVAX, was reddened and the patient also developed "some pain and itching" (since November 2014, exact date unknown). The pharmacist did not know if the patient notified her healthcare provider, and she did not think that the patient had taken any treatment for her adverse experience. Pharmacist believed that the patient was improving. The relatedness between the events and ZOSTAVAX was not reported. The pharmacist is requesting a lot check for ZOSTAVAX lot # K010646 (exp. 30-OCT-2015) because this patient and another patient experienced injection site adverse experiences after receiving this lot. The other patient's AE is reported in MARRS# 1411USA012048. This is one of several reports from the same source. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: FLUC3, PPV, FLUC3, PPV, FLUC3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient experienced pain, swelling and redness at injection site approximately 24 hours after the injection. Symptoms/signs worsened initially, but resolved 2-3 days later.
Age: 20.0
Sex: F
Vaccine: FLUC3, PPV, FLUC3, PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Leukocytosis, Pyrexia
Clinical narrative: This spontaneous report as received from a healthcare student refers to an approximately 20 year old female patient. The patient's medical history included asthma, overdose of BENADRYL and current conditions included allergic to unspecified sulfa drugs, fever, tachycardia and leukocytosis. On 09-NOV-2014, the patient was vaccinated with PNEUMOVAX 23 lot # K008409, expiration date: 04-MAR-2016, 0.5 milliliter, intramuscular in the right arm. Concomitant therapies included unspecified psychiatric medications and FLUCELVAX on 09-NOV-2014 in the left arm. On 10-NOV-2014, the patient experienced pain, swelling and redness at injection site (hospitalization) that worsened, pre-existing low grade fever (hospitalization), leukocytosis (hospitalization) and tachycardia (hospitalization). Patient was hospitalised for an overdose of BENADRYL at the time patient received PNEUMOVAX 23. Patient sought medical attention as patient was hospitalised at the time of adverse events. The reporter reported that redness was quarter-sized, initially and increased outside the marked site. The patient was treated with MOTRIN, LEVAQUIN, IV fluids and TYLENOL. The outcome of the events was unknown. The relatedness of the events to the therapy with PNEUMOVAX 23 was not reported. The reporter requested for a lot number check and the results to be sent to the pharmacy department. Product quality complaint was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: FLUC3, PPV, FLUC3, PPV, PPV
Symptoms: Tachycardia
Clinical narrative: This spontaneous report as received from a healthcare student refers to an approximately 20 year old female patient. The patient's medical history included asthma, overdose of BENADRYL and current conditions included allergic to unspecified sulfa drugs, fever, tachycardia and leukocytosis. On 09-NOV-2014, the patient was vaccinated with PNEUMOVAX 23 lot # K008409, expiration date: 04-MAR-2016, 0.5 milliliter, intramuscular in the right arm. Concomitant therapies included unspecified psychiatric medications and FLUCELVAX on 09-NOV-2014 in the left arm. On 10-NOV-2014, the patient experienced pain, swelling and redness at injection site (hospitalization) that worsened, pre-existing low grade fever (hospitalization), leukocytosis (hospitalization) and tachycardia (hospitalization). Patient was hospitalised for an overdose of BENADRYL at the time patient received PNEUMOVAX 23. Patient sought medical attention as patient was hospitalised at the time of adverse events. The reporter reported that redness was quarter-sized, initially and increased outside the marked site. The patient was treated with MOTRIN, LEVAQUIN, IV fluids and TYLENOL. The outcome of the events was unknown. The relatedness of the events to the therapy with PNEUMOVAX 23 was not reported. The reporter requested for a lot number check and the results to be sent to the pharmacy department. Product quality complaint was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: FLUC3, PPV, FLUC3, PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a healthcare student refers to an approximately 20 year old female patient. The patient's medical history included asthma, overdose of BENADRYL and current conditions included allergic to unspecified sulfa drugs, fever, tachycardia and leukocytosis. On 09-NOV-2014, the patient was vaccinated with PNEUMOVAX 23 lot # K008409, expiration date: 04-MAR-2016, 0.5 milliliter, intramuscular in the right arm. Concomitant therapies included unspecified psychiatric medications and FLUCELVAX on 09-NOV-2014 in the left arm. On 10-NOV-2014, the patient experienced pain, swelling and redness at injection site (hospitalization) that worsened, pre-existing low grade fever (hospitalization), leukocytosis (hospitalization) and tachycardia (hospitalization). Patient was hospitalised for an overdose of BENADRYL at the time patient received PNEUMOVAX 23. Patient sought medical attention as patient was hospitalised at the time of adverse events. The reporter reported that redness was quarter-sized, initially and increased outside the marked site. The patient was treated with MOTRIN, LEVAQUIN, IV fluids and TYLENOL. The outcome of the events was unknown. The relatedness of the events to the therapy with PNEUMOVAX 23 was not reported. The reporter requested for a lot number check and the results to be sent to the pharmacy department. Product quality complaint was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: FLUC3, PPV, FLUC3, PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Leukocytosis, Pyrexia
Clinical narrative: Patient developed low-grade fever with pain, swelling, and redness at injection site that worsened. Patient's tachycardia and leukocytosis also worsened. Symptoms/signs resolved 2-3 days after initial presentation.
Age: 20.0
Sex: F
Vaccine: FLUC3, PPV, FLUC3, PPV, PPV
Symptoms: Tachycardia
Clinical narrative: Patient developed low-grade fever with pain, swelling, and redness at injection site that worsened. Patient's tachycardia and leukocytosis also worsened. Symptoms/signs resolved 2-3 days after initial presentation.
Age: 20.0
Sex: F
Vaccine: FLUC3, PPV, FLUC3, PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient developed low-grade fever with pain, swelling, and redness at injection site that worsened. Patient's tachycardia and leukocytosis also worsened. Symptoms/signs resolved 2-3 days after initial presentation.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, HIBV, RV5
Symptoms: Pyrexia
Clinical narrative: This case was reported by a other health professional and described the occurrence of fever in a 6-month-old female patient who received PEDIARIX (batch number 7J77Y, expiry date 4th July 2016). Co-suspect products included PEDVAXHIB (batch number K002935, expiry date 11th December 2016), PREVENAR 13 (batch number H65735, expiry date 1st July 2015) and ROTATEQ (batch number J015063, expiry date 25th October 2015). On 11th November 2014, the patient received the 2nd dose of PEDIARIX .5 ml, the 2nd dose of PEDVAXHIB, the 2nd dose of PREVENAR 13 and the 2nd dose of ROTATEQ. On 12th November 2014, 1 days after receiving PEDIARIX, the patient experienced fever (serious criteria clinically significant/intervention required). The patient was treated with TYLENOL. On 13th November 2014, the outcome of the fever was recovered/resolved. The reporter considered the fever to be probably related to PEDIARIX. Additional information: There was no concomitant medication and the patient had no medical history. Fever occurred 21 hours after vaccination and resolved on the morning of 13 November 2014.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Diarrhoea, Injection site pain, Insomnia, Malaise
Clinical narrative: I took the vaccine at Pharmacy on November 20, 2014. Within a couple of hours I began to ache, particularly in my lower back and down my legs. I developed a rash on one side of my body, stuffiness in my sinuses, felt generally very unwell and had a hard time sleeping and getting up and out of the bed the next morning. The following day I had diarrhea and felt generally unwell. I took one Aleve the second day and no longer has leg and back pain. The attendant gave the shot in what appeared to be my shoulder socket. It was quite painful. I believe that my body worked so hard to overcome the vaccination that it might have been at risk for other viruses. I have had some sort of a reaction with every flu shot taken since the vaccinations have not been live. In the old days, our doctor would give half the live dose then the other half in two weeks. No one became ill. Can the current vaccines also be given in two dosages? It seems the dosage is the same whether you are 100 pounds or 250. Having taken allergy shots for years with no reactions, I find these flu vaccines wrought with problems.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Rash, Sinus congestion
Clinical narrative: I took the vaccine at Pharmacy on November 20, 2014. Within a couple of hours I began to ache, particularly in my lower back and down my legs. I developed a rash on one side of my body, stuffiness in my sinuses, felt generally very unwell and had a hard time sleeping and getting up and out of the bed the next morning. The following day I had diarrhea and felt generally unwell. I took one Aleve the second day and no longer has leg and back pain. The attendant gave the shot in what appeared to be my shoulder socket. It was quite painful. I believe that my body worked so hard to overcome the vaccination that it might have been at risk for other viruses. I have had some sort of a reaction with every flu shot taken since the vaccinations have not been live. In the old days, our doctor would give half the live dose then the other half in two weeks. No one became ill. Can the current vaccines also be given in two dosages? It seems the dosage is the same whether you are 100 pounds or 250. Having taken allergy shots for years with no reactions, I find these flu vaccines wrought with problems.
Age: 4.0
Sex: F
Vaccine: FLUN4, HEPA
Symptoms: Asthenia, Eye movement disorder, Unresponsive to stimuli
Clinical narrative: Patient became unresponsive and her eye rolled.  She became very weak.
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site streaking
Clinical narrative: PATIENT HAD MILD PAIN, SWELLING AND REDNESS AT INJECTION SITE(ON LEFT ARM), RED STREAKS THAT WENT INTO ARMPIT ON LEFT ARM WAS DIAGNOSISED WITH CELLULITIS AT ER AND TREATED WITH VANCOMYCIN IV & DOXYCYCLINE 100MG BID X10 DAYS.
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site swelling
Clinical narrative: PATIENT HAD MILD PAIN, SWELLING AND REDNESS AT INJECTION SITE(ON LEFT ARM), RED STREAKS THAT WENT INTO ARMPIT ON LEFT ARM WAS DIAGNOSISED WITH CELLULITIS AT ER AND TREATED WITH VANCOMYCIN IV & DOXYCYCLINE 100MG BID X10 DAYS.
Age: 12.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Rash, Rash vesicular
Clinical narrative: Rash over legs and trunk.  Extended to face area as day went on.  Treated with Benadryl and topical creams.  Father is an MD--describes as vesicular rash.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Palpitations
Clinical narrative: Participant initially denied being pregnant. Heart was racing when she came back to the clinic.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during breast feeding, Vaccination error
Clinical narrative: No date or time onset for adverse reaction. Patient was a nursing mother. Vaccination error.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during breast feeding, Vaccination error
Clinical narrative: No date or time onset for adverse reaction. Patient was a nursing mother. Vaccination error.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Vaccination error
Clinical narrative: No date or time onset for adverse reaction. Patient was pregnant. Vaccination error.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Vaccination error
Clinical narrative: No date or time onset for adverse reaction. Patient was a pregnant. Vaccination error.
Age: 42.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction, Exposure during pregnancy, Vaccination error
Clinical narrative: No date or time onset for adverse reaction. Patient was a pregnant. Vaccination error.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Vaccination error
Clinical narrative: No date or time onset for adverse reaction. Patient was a pregnant. Vaccination error.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Vaccination error
Clinical narrative: No date or time onset for adverse reaction. Patient was a pregnant. Vaccination error.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Pain
Clinical narrative: Shoulder pain and stiffness.  Unable to move shoulde, or sleep on shoulder without pain.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: No date or time onset for adverse reaction. Under-dose or possible second dose was given. Vaccination error.
Age: 38.0
Sex: F
Vaccine: FLUR3
Symptoms: Anaphylactic reaction, Confusional state, Dyspnoea, Headache, Hypersensitivity
Clinical narrative: Approximately 10:45 to 11:00 AM, beginning to feel tightness in throat and headache.  Symptoms progressed to throat closing and shortness of breath, confusion by 12:00PM. Primary Care physician contacted via phone at 12:00PM and instructed patient to take Benadryl 50mg PO.  Benadryl 50mg liquid PO was taken PO at 12:15PM (after being purchased) and continued Q6H around-the-clock until 11/30/2014. Patient also went to facility at 12:20 after Benadryl taken to discuss allergic/anaphylactic reaction with nurses who administered vaccine.
Age: 38.0
Sex: F
Vaccine: FLUR3
Symptoms: Throat tightness
Clinical narrative: Approximately 10:45 to 11:00 AM, beginning to feel tightness in throat and headache.  Symptoms progressed to throat closing and shortness of breath, confusion by 12:00PM. Primary Care physician contacted via phone at 12:00PM and instructed patient to take Benadryl 50mg PO.  Benadryl 50mg liquid PO was taken PO at 12:15PM (after being purchased) and continued Q6H around-the-clock until 11/30/2014. Patient also went to facility at 12:20 after Benadryl taken to discuss allergic/anaphylactic reaction with nurses who administered vaccine.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Burning sensation, Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: Woke up with ankles and wrists hurting and over a month later still aching and muscles burn.  Legs and arms feel weird.  I'm tired and cold all the time and don't have an appetite.  I lost 10-20 lbs in that time period.  It hurst to pick things up.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling cold, Weight bearing difficulty, Weight decreased
Clinical narrative: Woke up with ankles and wrists hurting and over a month later still aching and muscles burn.  Legs and arms feel weird.  I'm tired and cold all the time and don't have an appetite.  I lost 10-20 lbs in that time period.  It hurst to pick things up.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: No date or time onset for adverse reaction. Under-dose or possible second dose was given. Vaccination error.
Age: 58.0
Sex: M
Vaccine: FLUC3, FLU4
Symptoms: Ageusia
Clinical narrative: Loss of taste.
Age: 58.0
Sex: M
Vaccine: FLUC3, FLU4
Symptoms: Anosmia, Computerised tomogram, Dysgeusia, Malaise, Nuclear magnetic resonance imaging
Clinical narrative: Loss of taste.
Age: 58.0
Sex: M
Vaccine: FLUC3, FLU4
Symptoms: Weight decreased
Clinical narrative: Loss of taste.
Sex: F
Vaccine: VARCEL
Symptoms: Adverse event, Caesarean section, Foetal exposure during pregnancy, Intensive care
Clinical narrative: Information has been received from a Registered Nurse for VARIVAX (Merck), a Pregnancy Registry product, regarding female baby. The Registered Nurse stated that the mother received had her first dose of VARIVAX (Merck) on 02-JUN-2000 for negative varicella antibodies, and the second dose of VARIVAX (Merck) was given on 16-AUG-2013 "as a booster shot." The mother had a last menstrual period of 16-JUL-2013. EDD (Estimated Delivery Date) was assessed as 22-APR-2014. The mother was not seen at the clinic for her obstetrical care, but did deliver with this clinic. On 30-MAR-2014, 37 weeks gestational age, the mother had a caesarean section due to eclampsia (onset date unknown); she was experiencing seizures. The female baby was 6 pounds, 3.5 ounces and born with no congenital anomalies on an unknown date in 2014. The mother and baby were both transferred to another facility; (unknown). The baby was in Neonatal Intensive Care Unit (NICU) for an unknown amount of time and for unknown reasons. It was reported that "the patient and baby were both doing well now." Relatedness between use of the VARIVAX (Merck) and the adverse events was unknown. No further information is available at this time. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: Steady progression of left arm cellulitis after vaccine administration. Gave prescription for penicillin but did not require treatment.
Age: 38.0
Sex: F
Vaccine: FLUN4
Symptoms: Influenza, Influenza like illness
Clinical narrative: HUSBAND STATED WIFE WAS "SEVERELY" ILL WITH THE FLU (AND FLU LIKE SYMPTOMS) FOR 4 DAYS. PATIENT AND 4 OTHER MEMBERS OF THE HOUSE HOLD REC. FLU MIST AND WERE ILL AS WELL.  NONE OF THE PATIENTS WENT TO THE DOCTOR OR WERE DIAGNOSED OR TREATED WITH MEDICATION FOR THE FLU.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Aphthous stomatitis, Arthralgia, Erythema, Genital ulceration, Pain in extremity
Clinical narrative: Red hot sore arm, severe combined with radiating pain in arm then to joints - systemic.  Developed aphthous ulcers oral and genital with fever.  Elevated temp and aches 5 days later.  Has had vaccines in the past with no known reactions.  Saw MD - no cellulitis dx.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Skin warm
Clinical narrative: Red hot sore arm, severe combined with radiating pain in arm then to joints - systemic.  Developed aphthous ulcers oral and genital with fever.  Elevated temp and aches 5 days later.  Has had vaccines in the past with no known reactions.  Saw MD - no cellulitis dx.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Patient was given Pneumovax (PPSV23) instead of Prevnar 13.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site rash, Injection site reaction
Clinical narrative: Injection site reaction (rash, swelling, red blotches, itchy), headache, and fever. Still one month later has occassional itchy red blotches on waist on side of vaccine and other arm.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pruritus, Pyrexia, Rash macular
Clinical narrative: Injection site reaction (rash, swelling, red blotches, itchy), headache, and fever. Still one month later has occassional itchy red blotches on waist on side of vaccine and other arm.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abscess, Blood test, Cellulitis, Injection site reaction, Mobility decreased
Clinical narrative: By next morning-could not hardly move arm started with blotches in area of injection. Then fever. Second day doctor visit with shot of antibiotic and blood wk. That night Emergency room swelling spreading. Admitted for IV-antibiotics-two days.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Rash macular, Swelling
Clinical narrative: By next morning-could not hardly move arm started with blotches in area of injection. Then fever. Second day doctor visit with shot of antibiotic and blood wk. That night Emergency room swelling spreading. Admitted for IV-antibiotics-two days.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Systemic inflammatory response syndrome
Clinical narrative: Initial unsolicited report received on 20 November 2014 from a consumer who is the patient. A 51 year old female patient, date of birth not reported, was vaccinated on an unspecified date in 2012 with INFLUENZA, batch number, route and site of administration were not reported. The patient's medical history and concomitant medications were not reported. The patient experienced an unspecified severe inflammatory response on an unreported date in 2012. Laboratory tests were not reported. The patient required 7 weeks of physician therapy and states that a VAERS was filed in 2012. The patient outcome is recovered on an unreported date. Documents held by sender: None.
Sex: U
Vaccine: FLUX
Symptoms: Pharyngeal oedema
Clinical narrative: Initial unsolicited report was received on 20 November 2014 from a pharmacy student. A patient (name unknown to the reporter) had received on an unspecified date an Influenza vaccine (manufacturer, lot number, route and site of administration not reporter) and an unspecified amount of time after vaccination experienced throat swelling. No further information was provided at the time of the report. Outcome was unknown. Documents held by sender: None.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abscess drainage, Erythema, Groin abscess, Laparoscopy, Local swelling
Clinical narrative: Given 2 month immunizations on 10/6/2014. Developed sudden onset of groin swelling, redness on 10/23/14. Hospitalized 10-23-24/14 - diagnostic laparoscopy with I&D of Rt groin abscess.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Staphylococcus test positive, White blood cell count increased
Clinical narrative: Given 2 month immunizations on 10/6/2014. Developed sudden onset of groin swelling, redness on 10/23/14. Hospitalized 10-23-24/14 - diagnostic laparoscopy with I&D of Rt groin abscess.
Age: 61.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Myalgia, Nausea, Pyrexia
Clinical narrative: Severe redness, swollen arm, 101 fever, muscle aches throughout body. Nausea.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Burning sensation, Hypoaesthesia, Paraesthesia, Poor quality sleep
Clinical narrative: This case was reported by a consumer and described the occurrence of palms felt numb in a 43-year-old female patient who received FLUARIX. Previously administered products included FLUZONE with an associated reaction of pain and FLUZONE with an associated reaction of nausea. Concurrent medical conditions included sulfonamide allergy (No other drug allergies). Concomitant products included ZYRTEC, ibuprofen and ALEVE. On 7th October 2014 10:30, the patient received FLUARIX .5 ml. On 7th October 2014, less than a day after receiving FLUARIX, the patient experienced palms felt numb, arm burned, joints ached, nerve tingling and sleep unwell. On an unknown date, the outcome of the palms felt numb, joints ached and nerve tingling were not recovered/not resolved and the outcome of the arm burned was recovering/resolving and the outcome of the sleep unwell was unknown. It was unknown if the reporter considered the palms felt numb, arm burned, joints ached, nerve tingling and sleep unwell to be related to FLUARIX. Additional information received on 08 October 2014: The patient took 1 ALEVE 30 minutes before receiving the FLUARIX vaccination at 10:30 AM. The injection itself did not hurt, but a few minutes later she felt a vibration that progressed to her elbow that felt like jammed nerves and tingling. By 2 PM the sensation subsided, but her palms felt numb. She could not sleep well last night and around 2 AM she was feeling achier than she normally gets after her previous FLUZONE vaccinations. This morning the tingling feeling is back. Doctor's office was required as medical attention.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer and described the occurrence of sore arm in a patient who received Influenza vaccine. The patient's past medical history included blood sugar increased (she lost 55 pounds to get her blood sugar down to normal 4 years ago). Concurrent medical conditions included seasonal allergy, osteoarthritis, blood pressure high and gastroesophageal reflux disease. On an unknown date, the patient received influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced sore arm and got the flu. Rechallenge with Influenza vaccine as positive. On an unknown date, the outcome of the sore arm and got the flu were unknown. It was unknown if the reporter considered the sore arm and got the flu to be related to Influenza vaccine. See case US2014GSK002983 for reaction after next vaccinations.
Sex: F
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 2-year-old female patient who received FLUARIX QUADRIVALENT (batch number 5J9E9, expiry date 20th May 2015). In 2014, the patient received FLUARIX QUADRIVALENT. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration to be related to FLUARIX QUADRIVALENT.
Sex: F
Vaccine: FLUX
Symptoms: Autoimmune disorder
Clinical narrative: Initial spontaneous case received from a consumer, who is also the patient, on 20 November 2014. A female patient received an INFLUENZA VACCINE (manufacturer, lot number, and administration details not reported) on an unspecified date "26 years ago", and subsequently developed an autoimmune disease. No additional details were reported, and the patient did not provide contact information for follow-up. Outcome was unknown. Documents held by sender: None.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation
Clinical narrative: This case was reported by a other health professional and described the occurrence of arm burning sensation in a 53-year-old female patient who received FLUARIX. On 2nd October 2014, the patient received FLUARIX. On 20th October 2014, 18 days after receiving FLUARIX, the patient experienced arm burning sensation. On 20th October 2014, the outcome of the arm burning sensation was recovered/resolved. It was unknown if the reporter considered the arm burning sensation to be related to FLUARIX. Additional information received on 08 October 2014: The patient experienced a burning sensation in her arm that lasted 30 to 45 min and went away. There was no additional detail regarding this report.
Sex: U
Vaccine: MEN
Symptoms: Meningococcal infection
Clinical narrative: Initial case retrieved from the scientific literature on 18 November 2014. It pertains to issues discussed at a Food and Drug Administration drug and biologic advisory committee meeting. Within the context of evaluating the risk evaluation and mitigation strategy (REMS) for SOLIRIS (Alexion Pharmaceuticals, Inc) it was reported that 16 patients had been vaccinated with Meningococcal vaccine (manufacturers, lot numbers, and dates of administration not reported) and subsequently developed meningococcal infection as of April 2014. All patients had also been administered SOLIRIS for treatment of either paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, or atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. Additional information, including treatment, relevant test results, and outcome, were not reported. Documents held by sender: None.
Age: 1.5
Sex: F
Vaccine: DTAP, FLU3, HIBV, MMR, PNC13
Symptoms: Convulsion, Pyrexia
Clinical narrative: Elevation, fever with seizure activity approx 7 hrs. after administration.
Age: 0.37
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a 4 months old patient of unknown gender who on 22-OCT-2014 was vaccinated with ROTATEQ (lot # J014868 expiration date 13-OCT-2015), oral (dose not reported). The vaccine was reported to have temperature excursions from 10-SEP-2014 to 12-SEP-2014. No adverse reports. This is one of several reports from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Neoplasm malignant
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 68 year old male patient. In approximately November 2009 (reported as 5 years ago), the patient was vaccinated with PNEUMOVAX 23 (strength, dose and lot # was not reported). The reporter stated that a patient who received a dose of PNEUMOVAX 23, 5 years ago, was scheduled to begin chemotherapy for unspecified cancer (onset date not reported). At the time of the report, the patient's outcome was unknown. Upon internal review unspecified cancer was considered as an other important medical event. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Patient has a painful lump that is sore and red where the immunization was administered intramuscularly.