chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Allergy test, Blood pressure increased, Chills, Migraine, Myalgia
Clinical narrative: This is a spontaneous report from a contactable nurse through a Pfizer sales representative. A 17-year-old male patient (reporter's son) received, on an unspecified date (at the same time) at 08:10 am, in the opposite arm, TRUMENBA, lot number J29203, expiry date Jun2016 on the left deltoid at 0.5 ml single and the second dose of MENACTRA, lot number JU5180AA on the right deltoid, both intramuscularly. Relevant medical history included allergy to hickory, pecan, cats, dust, mites in 2012. All allergies were mild confirmed by lab testing and the patient takes ZYRTEC at 10 mg daily. The patient previously received the first dose of MENACTRA. Concomitant medications were unknown. The patient experienced migraine headache, vomiting and muscle pain on 16May2016 at 09:30 and chills and blood pressure increased on unknown date. No admission to the hospital, treatment of physician visit was required for the events. The patient recovered from migraine headache, vomiting and muscle pain on 17May2016. The outcome of the events chills and blood pressure increased was unknown. The nurse confirmed that the patient provided to him/her information regarding the reported adverse events with the use of the vaccines. The nurse considered the Pfizer product had a causal effect to the adverse events. Follow up (13Jun2016): New information reported from a contactable nurse includes: time of vaccination, lot number, expiry date dose and anatomical location of vaccination with TRUMENBA, medical history, past vaccine history, onset date of migraine headache, vomiting and muscle pain, no admission to the hospital, treatment or physician visit was required for the events, outcome, causality assessment, nurse confirmed that the patient provided to him/her information regarding the reported adverse events with the use of the vaccines. Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: MEN, MENB
Symptoms: Blister, Rash erythematous, Rash pruritic
Clinical narrative: This is a spontaneous report from a Pfizer-Sponsored Program IBCC (Inbound Call Center for HCPs). A contactable consumer reported for her son. This male patient of an unspecified age received meningococcal group b rlp2086, via an unspecified route of administration on 25APR2016 at single dose. Concomitant medication included VYVANSE and CYMBALTA. The patient medical history was not reported. The patient experienced blisters and broke out in little red itchy dots and both on an unspecified date. The outcome of the event blister was reported as not recovered while the outcome of the other two events was unknown. The vaccine was given by hospital. No follow-up attempts are needed. No further information expected. Pfizer is Marketing Authorization Holder of meningococcal group b rlp2086 in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of meningococcal group b rlp2086 has submitted the same report to the regulatory authorities.
Age: 22.0
Sex: U
Vaccine: MENB, MENB
Symptoms: Chills, Fatigue, Muscular weakness, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer. A 22-years-old female patient received TRUMENBA, NDC number: 00005-0100-10. Expiry Date: JULY 2015), Intramuscular on 04JUN2016 at 0.5 ml, single. The patient medical history was not reported. The patient did not take other medicines. The patient experienced fever, chills, muscle weakness and fatigue all on 05JUN2016 with outcome of recovered; pain on 04JUN2016 with outcome of not recovered; very hot to touch, rash on an unspecified date with outcome of not recovered; redness at site of injection, a lot of soreness, pain at injection site both on an unspecified date with outcome of unknown. The patient stated that she received this vaccine about 48 hours before and she had some fever about 101 degrees, chills, muscle weakness and fatigue and lot of pain at the injection site on the arm and it is very hot to touch and she have a big rash about 4 inches long on the arm. The patient mentioned that she did not get the prescription for it. She did not take any treatment for the adverse effects. Follow-up (31JUL2016): Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: U
Vaccine: MENB, MENB
Symptoms: Rash, Skin warm
Clinical narrative: This is a spontaneous report from a contactable consumer. A 22-years-old female patient received TRUMENBA, NDC number: 00005-0100-10. Expiry Date: JULY 2015), Intramuscular on 04JUN2016 at 0.5 ml, single. The patient medical history was not reported. The patient did not take other medicines. The patient experienced fever, chills, muscle weakness and fatigue all on 05JUN2016 with outcome of recovered; pain on 04JUN2016 with outcome of not recovered; very hot to touch, rash on an unspecified date with outcome of not recovered; redness at site of injection, a lot of soreness, pain at injection site both on an unspecified date with outcome of unknown. The patient stated that she received this vaccine about 48 hours before and she had some fever about 101 degrees, chills, muscle weakness and fatigue and lot of pain at the injection site on the arm and it is very hot to touch and she have a big rash about 4 inches long on the arm. The patient mentioned that she did not get the prescription for it. She did not take any treatment for the adverse effects. Follow-up (31JUL2016): Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: U
Vaccine: MENB, MENB
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable consumer. A 22-years-old female patient received TRUMENBA, NDC number: 00005-0100-10. Expiry Date: JULY 2015), Intramuscular on 04JUN2016 at 0.5 ml, single. The patient medical history was not reported. The patient did not take other medicines. The patient experienced fever, chills, muscle weakness and fatigue all on 05JUN2016 with outcome of recovered; pain on 04JUN2016 with outcome of not recovered; very hot to touch, rash on an unspecified date with outcome of not recovered; redness at site of injection, a lot of soreness, pain at injection site both on an unspecified date with outcome of unknown. The patient stated that she received this vaccine about 48 hours before and she had some fever about 101 degrees, chills, muscle weakness and fatigue and lot of pain at the injection site on the arm and it is very hot to touch and she have a big rash about 4 inches long on the arm. The patient mentioned that she did not get the prescription for it. She did not take any treatment for the adverse effects. Follow-up (31JUL2016): Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: U
Vaccine: MENB, MENB
Symptoms: Muscular weakness, Pain, Pyrexia, Rash, Skin warm
Clinical narrative: This is a spontaneous report from a contactable consumer. A 22-years-old female patient received TRUMENBA, NDC number: 00005-0100-10. Expiry Date: JULY 2015), Intramuscular on 04JUN2016 at 0.5 ml, single. The patient medical history was not reported. The patient did not take other medicines. The patient experienced fever, chills, muscle weakness and fatigue all on 05JUN2016 with outcome of recovered; pain on 04JUN2016 with outcome of not recovered; very hot to touch, rash on an unspecified date with outcome of not recovered; redness at site of injection, a lot of soreness, pain at injection site both on an unspecified date with outcome of unknown. The patient stated that she received this vaccine about 48 hours before and she had some fever about 101 degrees, chills, muscle weakness and fatigue and lot of pain at the injection site on the arm and it is very hot to touch and she have a big rash about 4 inches long on the arm. The patient mentioned that she did not get the prescription for it. She did not take any treatment for the adverse effects. Follow-up (31JUL2016): Follow-up attempts are completed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Asthenia, Blood creatine phosphokinase normal, Headache, Hypoaesthesia, Musculoskeletal chest pain
Clinical narrative: This is a spontaneous report from a contact pediatrician via a company sales representative. A 19-year-old female patient of an unspecified ethnicity received the first dose of TRUMENBA lot M95612, on 20Jun2016, at 0.5 ml single, in arm (Deltoid). The patient medical history was not reported. Concomitant medication included JUNEL FE for oral contraception from 2015, 1 pill daily. The patient experienced fever, redness, swelling and pain in her ribs (myalgia) and weakness, all on an unspecified date in Jun2016. On 21Jun2016 she went to the emergency room because of the events where she received TRAMADOL for pain in her ribs. Patient started to get better and then was released. She was not admitted to the hospital. Outcome of the events was recovered. The reporter considered that meningococcal group b had a causal effect to the adverse event. Follow up (29Jul2016 and 29Jul2016): New information from the same contactable physician included: product details, new event weakness, outcome, concomitant medication and reporter's assessment.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Myalgia, Neck pain, Painful respiration, Paraesthesia, Pyrexia
Clinical narrative: This is a spontaneous report from a contact pediatrician via a company sales representative. A 19-year-old female patient of an unspecified ethnicity received the first dose of TRUMENBA lot M95612, on 20Jun2016, at 0.5 ml single, in arm (Deltoid). The patient medical history was not reported. Concomitant medication included JUNEL FE for oral contraception from 2015, 1 pill daily. The patient experienced fever, redness, swelling and pain in her ribs (myalgia) and weakness, all on an unspecified date in Jun2016. On 21Jun2016 she went to the emergency room because of the events where she received TRAMADOL for pain in her ribs. Patient started to get better and then was released. She was not admitted to the hospital. Outcome of the events was recovered. The reporter considered that meningococcal group b had a causal effect to the adverse event. Follow up (29Jul2016 and 29Jul2016): New information from the same contactable physician included: product details, new event weakness, outcome, concomitant medication and reporter's assessment.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: White blood cell count normal
Clinical narrative: This is a spontaneous report from a contact pediatrician via a company sales representative. A 19-year-old female patient of an unspecified ethnicity received the first dose of TRUMENBA lot M95612, on 20Jun2016, at 0.5 ml single, in arm (Deltoid). The patient medical history was not reported. Concomitant medication included JUNEL FE for oral contraception from 2015, 1 pill daily. The patient experienced fever, redness, swelling and pain in her ribs (myalgia) and weakness, all on an unspecified date in Jun2016. On 21Jun2016 she went to the emergency room because of the events where she received TRAMADOL for pain in her ribs. Patient started to get better and then was released. She was not admitted to the hospital. Outcome of the events was recovered. The reporter considered that meningococcal group b had a causal effect to the adverse event. Follow up (29Jul2016 and 29Jul2016): New information from the same contactable physician included: product details, new event weakness, outcome, concomitant medication and reporter's assessment.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Asthenia, Blood culture, CSF culture, Chest X-ray, Erythema
Clinical narrative: This is a spontaneous report from a contact pediatrician via a company sales representative. A 19-year-old female patient of an unspecified ethnicity received the first dose of TRUMENBA lot M95612, on 20Jun2016, at 0.5 ml single, in arm (Deltoid). The patient medical history was not reported. Concomitant medication included JUNEL FE for oral contraception from 2015, 1 pill daily. The patient experienced fever, redness, swelling and pain in her ribs (myalgia) and weakness, all on an unspecified date in Jun2016. On 21Jun2016 she went to the emergency room because of the events where she received TRAMADOL for pain in her ribs. Patient started to get better and then was released. She was not admitted to the hospital. Outcome of the events was recovered. The reporter considered that meningococcal group b had a causal effect to the adverse event. Follow up (29Jul2016 and 29Jul2016): New information from the same contactable physician included: product details, new event weakness, outcome, concomitant medication and reporter's assessment.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Musculoskeletal chest pain, Myalgia, Pyrexia, Swelling
Clinical narrative: This is a spontaneous report from a contact pediatrician via a company sales representative. A 19-year-old female patient of an unspecified ethnicity received the first dose of TRUMENBA lot M95612, on 20Jun2016, at 0.5 ml single, in arm (Deltoid). The patient medical history was not reported. Concomitant medication included JUNEL FE for oral contraception from 2015, 1 pill daily. The patient experienced fever, redness, swelling and pain in her ribs (myalgia) and weakness, all on an unspecified date in Jun2016. On 21Jun2016 she went to the emergency room because of the events where she received TRAMADOL for pain in her ribs. Patient started to get better and then was released. She was not admitted to the hospital. Outcome of the events was recovered. The reporter considered that meningococcal group b had a causal effect to the adverse event. Follow up (29Jul2016 and 29Jul2016): New information from the same contactable physician included: product details, new event weakness, outcome, concomitant medication and reporter's assessment.
Age: 17.0
Sex: F
Vaccine: MENB, TYP, MENB, TYP
Symptoms: Back pain, Fatigue, Feeling abnormal, Hypoaesthesia, Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable nurse. A 17-year-old female patient received TRUMENBA (Lot # M687669, Expiry Date 30 APR2017), intramuscular in deltoid muscle in left arm on 26JUN2016 at 10:57 AM at 0.5 ml, single and fifth dose of TYPHIM VI (Sanofi Pasteur) (Lot # L1072. NDC # 49281-790-38, Expiry Date 17FEB2017), intramuscular in deltoid muscle in right arm on 26JUN2016 at 10:57 AM at 0.5 ml, single. Medical history was not reported. There were no concomitant medications. Previously the patient took 4 doses of typhoid vaccine, all intramuscular in right arm, on unspecified dates. The patient experienced discomfort in her arm and leg, numbness and tingling in arms and legs and feeling of uneasiness 3-4 hours after taking injection on 26JUN2016. The patient was very very tired on same day. The patient was complaining the same symptoms and she also had lower back pain, general fatigue and malaise on 28JUN2016. She was referred to neurologist the next day. The nurse mentioned that the patient came to visit doctor office for the events but events did not require hospitalization. Patient's mouth status was ill for at least one week after receiving injection, she was unable to attend injections due to her illness. The events recovered 1 week later. The nurse assessed there is a reasonable possibility that the event is related to meningococcal group b rlp2086; it was unknown if event is related to typhoid vaccine.  Follow-up (14JUL2016): New information received from a contactable nurse includes vaccination details, suspect trade name updated event outcome, vaccination history, events updated.  Follow-up (05AUG2016): This is a follow-up spontaneous report from a contactable Nurse. This Nurse reported in response to the HCP letter sent to the Physician that included: New information included: Did the patient provide information to you regarding the reported adverse event(s) with the use of the product? Yes. If yes above, do you consider the Pfizer product had a causal effect to the adverse event? Unknown. Are you willing to be contacted again by Pfizer on the reported adverse event(s)? Yes. Anatomical location of the administration of the vaccine: LD. Dechallenge/Rechallendge? Did reaction9s) recur on re-administration: No. Were specific tests and/or treatment required? Yes. Have you reported this adverse event previously: Physician, Manufacturer. May we contact you to request additional information if needed? Yes. Follow-up attempts completed. No further information expected.
Age: 17.0
Sex: F
Vaccine: MENB, TYP, MENB, TYP
Symptoms: Back pain, Fatigue, Feeling abnormal, Hypoaesthesia, Limb discomfort
Clinical narrative: This is a spontaneous report from a contactable nurse. A 17-year-old female patient received TRUMENBA (Lot # M687669, Expiry Date 30 APR2017), intramuscular in deltoid muscle in left arm on 26JUN2016 at 10:57 AM at 0.5 ml, single and fifth dose of TYPHIM VI (Sanofi Pasteur) (Lot # L1072. NDC # 49281-790-38, Expiry Date 17FEB2017), intramuscular in deltoid muscle in right arm on 26JUN2016 at 10:57 AM at 0.5 ml, single. Medical history was not reported. There were no concomitant medications. Previously the patient took 4 doses of typhoid vaccine, all intramuscular in right arm, on unspecified dates. The patient experienced discomfort in her arm and leg, numbness and tingling in arms and legs and feeling of uneasiness 3-4 hours after taking injection on 26JUN2016. The patient was very very tired on same day. The patient was complaining the same symptoms and she also had lower back pain, general fatigue and malaise on 28JUN2016. She was referred to neurologist the next day. The nurse mentioned that the patient came to visit doctor office for the events but events did not require hospitalization. Patient's mouth status was ill for at least one week after receiving injection, she was unable to attend injections due to her illness. The events recovered 1 week later. The nurse assessed there is a reasonable possibility that the event is related to meningococcal group b rlp2086; it was unknown if event is related to typhoid vaccine.  Follow-up (14JUL2016): New information received from a contactable nurse includes vaccination details, suspect trade name updated event outcome, vaccination history, events updated.  Follow-up (05AUG2016): This is a follow-up spontaneous report from a contactable Nurse. This Nurse reported in response to the HCP letter sent to the Physician that included: New information included: Did the patient provide information to you regarding the reported adverse event(s) with the use of the product? Yes. If yes above, do you consider the Pfizer product had a causal effect to the adverse event? Unknown. Are you willing to be contacted again by Pfizer on the reported adverse event(s)? Yes. Anatomical location of the administration of the vaccine: LD. Dechallenge/Rechallendge? Did reaction9s) recur on re-administration: No. Were specific tests and/or treatment required? Yes. Have you reported this adverse event previously: Physician, Manufacturer. May we contact you to request additional information if needed? Yes. Follow-up attempts completed. No further information expected.
Age: 17.0
Sex: F
Vaccine: MENB, TYP, MENB, TYP
Symptoms: Malaise, Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable nurse. A 17-year-old female patient received TRUMENBA (Lot # M687669, Expiry Date 30 APR2017), intramuscular in deltoid muscle in left arm on 26JUN2016 at 10:57 AM at 0.5 ml, single and fifth dose of TYPHIM VI (Sanofi Pasteur) (Lot # L1072. NDC # 49281-790-38, Expiry Date 17FEB2017), intramuscular in deltoid muscle in right arm on 26JUN2016 at 10:57 AM at 0.5 ml, single. Medical history was not reported. There were no concomitant medications. Previously the patient took 4 doses of typhoid vaccine, all intramuscular in right arm, on unspecified dates. The patient experienced discomfort in her arm and leg, numbness and tingling in arms and legs and feeling of uneasiness 3-4 hours after taking injection on 26JUN2016. The patient was very very tired on same day. The patient was complaining the same symptoms and she also had lower back pain, general fatigue and malaise on 28JUN2016. She was referred to neurologist the next day. The nurse mentioned that the patient came to visit doctor office for the events but events did not require hospitalization. Patient's mouth status was ill for at least one week after receiving injection, she was unable to attend injections due to her illness. The events recovered 1 week later. The nurse assessed there is a reasonable possibility that the event is related to meningococcal group b rlp2086; it was unknown if event is related to typhoid vaccine.  Follow-up (14JUL2016): New information received from a contactable nurse includes vaccination details, suspect trade name updated event outcome, vaccination history, events updated.  Follow-up (05AUG2016): This is a follow-up spontaneous report from a contactable Nurse. This Nurse reported in response to the HCP letter sent to the Physician that included: New information included: Did the patient provide information to you regarding the reported adverse event(s) with the use of the product? Yes. If yes above, do you consider the Pfizer product had a causal effect to the adverse event? Unknown. Are you willing to be contacted again by Pfizer on the reported adverse event(s)? Yes. Anatomical location of the administration of the vaccine: LD. Dechallenge/Rechallendge? Did reaction9s) recur on re-administration: No. Were specific tests and/or treatment required? Yes. Have you reported this adverse event previously: Physician, Manufacturer. May we contact you to request additional information if needed? Yes. Follow-up attempts completed. No further information expected.
Age: 17.0
Sex: F
Vaccine: FLU3, MENB, MNQ, FLU3, MENB, MNQ, MNQ
Symptoms: Erythema, Headache, Injection site erythema, Pain in extremity, Pruritus
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 17-year-old female patient of an unspecified ethnicity received TRUMENBA (Lot/Batch # M74089) intramuscular in right deltoid at 0.5 ml single on 12May2016 at 2:34 PM and MENACTRA at single dose on 12May2016. Medical history included biliary atresia (BA) and sinusitis. Vaccines given on same date along with suspect vaccines included second dose of MENVEO (Lot # M15035) intramuscular in left deltoid and FLUARIX (Lot # 9F39E) intramuscular in left deltoid. The patient experienced pain, redness, inflammation, petechiae (little spots in the skin) and swelling, all on 13May2016 with outcome of unknown. The events required an emergency room or physician visit. The patient provided information to the nurse regarding the reported adverse events with the use of the TRUMENBA. The nurse considered that TRUMENBA had a causal effect to the adverse events. Follow-up (05Jul2016): New information reported from a contactable nurse includes: medical history; TRUMENBA details, concomitant vaccines, events details and onset date, physician acknowledgement of the occurrence of the events and causality assessment. Follow-up attempts completed. No further information expected.
Age: 17.0
Sex: F
Vaccine: FLU3, MENB, MNQ, FLU3, MENB, MNQ, MNQ
Symptoms: Pyrexia, Rash
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 17-year-old female patient of an unspecified ethnicity received TRUMENBA (Lot/Batch # M74089) intramuscular in right deltoid at 0.5 ml single on 12May2016 at 2:34 PM and MENACTRA at single dose on 12May2016. Medical history included biliary atresia (BA) and sinusitis. Vaccines given on same date along with suspect vaccines included second dose of MENVEO (Lot # M15035) intramuscular in left deltoid and FLUARIX (Lot # 9F39E) intramuscular in left deltoid. The patient experienced pain, redness, inflammation, petechiae (little spots in the skin) and swelling, all on 13May2016 with outcome of unknown. The events required an emergency room or physician visit. The patient provided information to the nurse regarding the reported adverse events with the use of the TRUMENBA. The nurse considered that TRUMENBA had a causal effect to the adverse events. Follow-up (05Jul2016): New information reported from a contactable nurse includes: medical history; TRUMENBA details, concomitant vaccines, events details and onset date, physician acknowledgement of the occurrence of the events and causality assessment. Follow-up attempts completed. No further information expected.
Age: 17.0
Sex: F
Vaccine: FLU3, MENB, MNQ, FLU3, MENB, MNQ, MNQ
Symptoms: Erythema, Inflammation, Pain, Petechiae, Swelling
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 17-year-old female patient of an unspecified ethnicity received TRUMENBA (Lot/Batch # M74089) intramuscular in right deltoid at 0.5 ml single on 12May2016 at 2:34 PM and MENACTRA at single dose on 12May2016. Medical history included biliary atresia (BA) and sinusitis. Vaccines given on same date along with suspect vaccines included second dose of MENVEO (Lot # M15035) intramuscular in left deltoid and FLUARIX (Lot # 9F39E) intramuscular in left deltoid. The patient experienced pain, redness, inflammation, petechiae (little spots in the skin) and swelling, all on 13May2016 with outcome of unknown. The events required an emergency room or physician visit. The patient provided information to the nurse regarding the reported adverse events with the use of the TRUMENBA. The nurse considered that TRUMENBA had a causal effect to the adverse events. Follow-up (05Jul2016): New information reported from a contactable nurse includes: medical history; TRUMENBA details, concomitant vaccines, events details and onset date, physician acknowledgement of the occurrence of the events and causality assessment. Follow-up attempts completed. No further information expected.
Age: 1.33
Sex: M
Vaccine: HEPA, MMRV, VARCEL, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Information was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not reported. On 11-AUG-2016, the patient inadvertently received a dose of PROQUAD (lot# M015695, expiration date 26-SEP-2017, recombinant human albumin (rHA)) (dose and route unknown) and a dose of VARIVAX (lot# L045953, expiration date 17-NOV-2017) (dose and route unknown ) (accidental overdose). No adverse effect was reported. Additional information has been requested.
Age: 1.33
Sex: M
Vaccine: HEPA, MMRV, VARCEL, MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event
Clinical narrative: Information was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not reported. On 11-AUG-2016, the patient inadvertently received a dose of PROQUAD (lot# M015695, expiration date 26-SEP-2017, recombinant human albumin (rHA)) (dose and route unknown) and a dose of VARIVAX (lot# L045953, expiration date 17-NOV-2017) (dose and route unknown ) (accidental overdose). No adverse effect was reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: This spontaneous report was received from an officer administrator refers to  female patient of unknown age. On 08-AUG-2016, the patient was vaccinated with PNEUMOVAX 23, intramuscular. On 10-AUG-2016, the patient called to report her left arm was swollen and she had fever after receiving vaccine. No treatment was given. The outcome of the events were unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: This spontaneous report was received from an officer administrator refers to  female patient of unknown age. On 08-AUG-2016, the patient was vaccinated with PNEUMOVAX 23, intramuscular. On 10-AUG-2016, the patient called to report her left arm was swollen and she had fever after receiving vaccine. No treatment was given. The outcome of the events were unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Gait disturbance, Herpes zoster, Pain, Walking aid user
Clinical narrative: Information has been received from a 74 year old male patient referring to himself. The patient's concurrent condition included high cholesterol. Concomitant therapy included medication for cholesterol. On 28-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route were unknown). In October 2013 (reported as four months later), he developed sores and pimples on his head, under his arms, buttocks and back of thigh. The shingles symptoms continued for 3 years because his doctor did not diagnose him with shingles. The patient was prescribed an antibiotic and cream but over the next three years the sores became blisters and oozed liquid. The sores also developed on his testicles and groin area, making it difficult to hold his penis to urinate. He had difficulty sitting down because of pain and began to have difficulty walking and needed a cane for support to keep from falling. His leg turned red and purple and he went to the Emergency Room on 05-JUN-2016 where he was diagnosed as having shingles and received treatment. The patient was treated with valacyclovir, gabapentin 100 mg then increased to 300 mg, and ibuprofen 600 mg. He began to feel he was recovering in July 2016 and presently. It was also reported that the recovery date was "1 week July 2016 about month later". The patient reported that his doctor and pharmacist were not aware that ZOSTAVAX was a live vaccine and that he could develop shingles. Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Acne, Blister, Erythema, Herpes zoster, Pain
Clinical narrative: Information has been received from a 74 year old male patient referring to himself. The patient's concurrent condition included high cholesterol. Concomitant therapy included medication for cholesterol. On 28-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route were unknown). In October 2013 (reported as four months later), he developed sores and pimples on his head, under his arms, buttocks and back of thigh. The shingles symptoms continued for 3 years because his doctor did not diagnose him with shingles. The patient was prescribed an antibiotic and cream but over the next three years the sores became blisters and oozed liquid. The sores also developed on his testicles and groin area, making it difficult to hold his penis to urinate. He had difficulty sitting down because of pain and began to have difficulty walking and needed a cane for support to keep from falling. His leg turned red and purple and he went to the Emergency Room on 05-JUN-2016 where he was diagnosed as having shingles and received treatment. The patient was treated with valacyclovir, gabapentin 100 mg then increased to 300 mg, and ibuprofen 600 mg. He began to feel he was recovering in July 2016 and presently. It was also reported that the recovery date was "1 week July 2016 about month later". The patient reported that his doctor and pharmacist were not aware that ZOSTAVAX was a live vaccine and that he could develop shingles. Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Skin discolouration, Skin ulcer, Walking aid user, Wound secretion
Clinical narrative: Information has been received from a 74 year old male patient referring to himself. The patient's concurrent condition included high cholesterol. Concomitant therapy included medication for cholesterol. On 28-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route were unknown). In October 2013 (reported as four months later), he developed sores and pimples on his head, under his arms, buttocks and back of thigh. The shingles symptoms continued for 3 years because his doctor did not diagnose him with shingles. The patient was prescribed an antibiotic and cream but over the next three years the sores became blisters and oozed liquid. The sores also developed on his testicles and groin area, making it difficult to hold his penis to urinate. He had difficulty sitting down because of pain and began to have difficulty walking and needed a cane for support to keep from falling. His leg turned red and purple and he went to the Emergency Room on 05-JUN-2016 where he was diagnosed as having shingles and received treatment. The patient was treated with valacyclovir, gabapentin 100 mg then increased to 300 mg, and ibuprofen 600 mg. He began to feel he was recovering in July 2016 and presently. It was also reported that the recovery date was "1 week July 2016 about month later". The patient reported that his doctor and pharmacist were not aware that ZOSTAVAX was a live vaccine and that he could develop shingles. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 5 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the first dose of M-M-R II (dose, lot#, expiration date and route of administration were not reported). On 17-AUG-2016, the patient received his second dose M-M-R II subcutaneously, in his right lateral arm, lot# reported as M004305 with expiration date: January (dose was not reported). The medical assistant reported that within two hours, the patient's mother called and stated that the patient developed swollen lymph nodes on the left side of his neck and behind his ear, without fever. The patient was seen in the office again and it was noted by the physician that the lymph nodes were swollen. On 18-AUG-2016, the lymph nodes were "much bigger". The patient's mother consistently administered MOTRIN to the patient. The outcome of the event was reported as not recovered. The relatedness between the event and M-M-R II was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV9, MENB, HPV4, MENB
Symptoms: Dyspnoea, Movement disorder, Pain, Swelling, Throat tightness
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of anaphylactic reaction in a patient who received BEXSERO (batch number 153701, expiry date unknown). On an unknown date, the patient received BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced anaphylactic reaction (serious criteria GSK medically significant) and extensive swelling of vaccinated limb. On an unknown date, the outcome of the anaphylactic reaction and extensive swelling of vaccinated limb were unknown. It was unknown if the reporter considered the anaphylactic reaction and extensive swelling of vaccinated limb to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The arm where the patient got BEXSERO swelled up like a grapefruit. After the events, the physician placed a note on the refrigerator instructing her staff to not offer BEXSERO until further notice. The sales rep did not have any additional details. The healthcare professional did not indicate that she wanted to file a product complaint. This case was linked to case US2016116223, reported by the same reporter.
Sex: U
Vaccine: HPV9, MENB, HPV4, MENB
Symptoms: Anaphylactic reaction, Extensive swelling of vaccinated limb, Injection site swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of anaphylactic reaction in a patient who received BEXSERO (batch number 153701, expiry date unknown). On an unknown date, the patient received BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced anaphylactic reaction (serious criteria GSK medically significant) and extensive swelling of vaccinated limb. On an unknown date, the outcome of the anaphylactic reaction and extensive swelling of vaccinated limb were unknown. It was unknown if the reporter considered the anaphylactic reaction and extensive swelling of vaccinated limb to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The arm where the patient got BEXSERO swelled up like a grapefruit. After the events, the physician placed a note on the refrigerator instructing her staff to not offer BEXSERO until further notice. The sales rep did not have any additional details. The healthcare professional did not indicate that she wanted to file a product complaint. This case was linked to case US2016116223, reported by the same reporter.
Sex: M
Vaccine: MMR
Symptoms: Neoplasm malignant, Stem cell transplant
Clinical narrative: Information has been received from a registered nurse referring to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions or drug reactions/allergies were unknown by reporter. On an unknown date, the patient was vaccinated with M-M-R II (dose 1, lot number and route not provided). Following that administration, the patient received a "stem cell transplant" in 2014 (reported as "two years ago") due to the development of an unspecified type of cancer. The primary reporter also stated that the unknown patient was administered a second dose of M-M-R II (lot number and route not provided) on 20-JUL-2016. The outcome of event was unknown. Upon internal review,  the event stem cell transplant  due to the development of an unspecified type of cancer was considered to be medically significant. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Facial paralysis
Clinical narrative: Information has been received from a nurse practitioner via a company representative referring to a 16 year old female patient. Concomitant therapy included MENACTRA. On an unknown date the patient was vaccinated with GARDASIL 9 dose 2, intramuscularly (dose unknown). 24 hours after the vaccination, the patient developed bells palsy. The patient called to the office to seek medical attention. It was unknown if treatment was given for the event. At the report time, the patient was recovering from the event. Upon internal review, bells palsy was considered as medically significant. Additional information has been requested.
Sex: F
Vaccine: RAB
Symptoms: Exposure during pregnancy, Syncope
Clinical narrative: Initial unsolicited pregnancy report received from the literature on 10-AUG-2016. This case was linked to 2006-03101, 2016SA148766, 2016SA148776, 2007-00117, U2002-00204, 2016SA148885, 2016SA148897 AND 2016SA148892. (Same literature). The following is verbatim from the article: Abstract: Background: In 1980, human diploid cell vaccine (HDCV, Imovax Rabies, Sanofi Pasteur), was licensed for use. Objective: To assess adverse events (AEs) after HDCV reported to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. Methods: We searched VAERS for reports after HDCV among persons vaccinated from January 1, 1990-July 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barre syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category to each report using Med-DRA system organ classes. Empirical Bayesian (EB) data mining was used to identify disproportional AE reporting after HDCV. Results: VAERS received 1,611 reports after HDCV; 93 (5.8%) were serious. Among all reports, the three most common AEs included pyrexia (18.2%), headache (17.9%), and nausea (16.5%). Among serious reports, four deaths appeared to be unrelated to vaccination. Conclusions: This 25-year review of VAERS did not identify new or unexpected AEs after HDCV. The vast majority of AEs were non-serious. Injection site reactions, hypersensitivity reactions, and non-specific constitutional symptoms were most frequently reported, similar to findings in pre-licensure studies. This case involves a female patient (unknown age) who was vaccinated with a dose of RABIES (HDC) VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date while she was pregnant. The patients last menstrual period date and pregnancy trimester was not reported. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination during her pregnancy, the patient experienced syncope. It was a case of Vaccine exposure during pregnancy. Lab data and corrective treatment were not reported. The outcome of the event was not reported. Documents held by sender: none.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Impaired driving ability, Muscular weakness, Nausea
Clinical narrative: Initial unsolicited report received from a nurse via other company representative (Pfizer) on 17 August 2016. Manufacturer Report Number: 2016384510 This case involves a 18-year-old female patient who was vaccinated with a dose of MENACTRA and with an injection of dose of TRUMENBA (batch number: M68769) expiry date, dose, dose in series, route and site of administration were not reported) intramuscularly on 25 July 2016 around 09:30 AM. The patient's medical history and Concomitant medications were not reported. On 25 July 2016, around 13:30 hours, same day 04 hours following the vaccination, the patient's legs felt like jelly, she was nauseated and was unable to drive. The patient's laboratory data and corrective treatment was not reported. The outcome of event was unknown. List of documents held by sender: none.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Initial unsolicited report received from a non-healthcare professional via other company (Pfizer) on 17-AUG-2016. Manufacturer Report Number: 2016380155. This case involves a male patient (unknown age) who was vaccinated with a dose of INFLUENZA VACCINE (batch number, dose, dose in series, route and site of administration was not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient developed flu. Lab data and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Diarrhoea, Vomiting
Clinical narrative: Initial unsolicited report received from a consumer on 19-AUG-2016. This case involves a 27-year-old female patient who was vaccinated with a dose of INFLUENZA USP TRIVAL A-B INTRADERMAL ADULT SUBVIRION VACCINE (FLUZONE TIV) (batch number, expiry date, dose, site of administration were not reported), intramuscularly on 14-Oct-2013. Patient's Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as mast cell disease. Patient's concomitant medications were not reported. On 14-Oct-2013, 12 hours following the vaccination, the patient had a temperature of 101.8 degree F, vomiting and diarrhea. It was reported that the patient required ER visit. Lab data was reported as none and corrective treatment were not reported. On an unspecified date, the patient recovered from the event. List of documents held by sender: none.
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report was received from a physician via company representative, who saw an article by another physician. This report refers to 44 female patients of unknown age, whose concurrent conditions, medical history and concomitant medications were not known. On an unknown date, the patients were vaccinated with GARDASIL (details not known). As per the article the 44 patients died as a result of receiving GARDASIL and hence causality of death was considered to be related to the vaccine. The reporter considered the event serious (death). Upon internal review, death was considered to be medically significant. Additional information is not expected as the physician does not want to be contacted.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Activities of daily living impaired, Grip strength decreased, Hypoaesthesia, Influenza like illness, Injection site pain
Clinical narrative: Injection site (left arm) extremely sore, made arm feel numb, could not grip or pick-up anything with left arm. Next day felt achy all over, like I had the flu, stay in bed most of the next day (missed work). Arm felt numb for about 3 days.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Pain
Clinical narrative: Injection site (left arm) extremely sore, made arm feel numb, could not grip or pick-up anything with left arm. Next day felt achy all over, like I had the flu, stay in bed most of the next day (missed work). Arm felt numb for about 3 days.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Pruritus
Clinical narrative: A.M had a few red areas, when coming after playing in afternoon had round red eraser size areas that itched mainly on back and stomach with a few on face and arms.
Age: 41.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Abdominal pain upper, Arthralgia, Diarrhoea, Joint swelling, Pain in extremity
Clinical narrative: MMR and Varicella vaccines given 07/11/2016. Shorts given seperatly. Fever experienced the next day it lasted 2 days. Hand, wrist pain started 24 hours after shots. Diarrhea started 2 days after shots. Stomach pain lasted for 1 week. Swelling of hands and wrists along with pain to hands/wrists lasted 2-3 weeks.
Age: 41.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: MMR and Varicella vaccines given 07/11/2016. Shorts given seperatly. Fever experienced the next day it lasted 2 days. Hand, wrist pain started 24 hours after shots. Diarrhea started 2 days after shots. Stomach pain lasted for 1 week. Swelling of hands and wrists along with pain to hands/wrists lasted 2-3 weeks.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Redness and rash at injection site right deltoid area; unknown which vaccine administered in right arm.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Contusion, Peripheral swelling
Clinical narrative: An area 10mm by 11mm became red and swollen. unable to move arm from shoulder to elbow with really bad pain. Even when not moving moving arm extreme pain. Ibuprofen didn't help.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Erythema, Local swelling, Mobility decreased, Pain, Pain in extremity
Clinical narrative: An area 10mm by 11mm became red and swollen. unable to move arm from shoulder to elbow with really bad pain. Even when not moving moving arm extreme pain. Ibuprofen didn't help.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Inflammation, Injection site reaction
Clinical narrative: Injection site reaction. Medications received during ER visit. Diphenhydramine injectable and ketorolac injectable.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient called the following day said her arm was red, and swollen.
Age: 77.0
Sex: F
Vaccine: FLU3, PNC13, FLUX
Symptoms: Musculoskeletal pain
Clinical narrative: Pt complain of shoulder pain since night of vaccine.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling/redness and heat distal to the injection site, from biceps to below the elbow. The injection site looks normal.
Age: 33.0
Sex: M
Vaccine: DPP
Symptoms: Abdominal pain upper, Confusional state, Dizziness, Muscle spasms, Pruritus
Clinical narrative: Swelling, muscle spasms, fever, itching, stomach pains, confusion, dizziness.
Age: 33.0
Sex: M
Vaccine: DPP
Symptoms: Pyrexia, Swelling
Clinical narrative: Swelling, muscle spasms, fever, itching, stomach pains, confusion, dizziness.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HIBV, PNC13
Symptoms: Vomiting projectile
Clinical narrative: Projectile vomiting.