chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Dyspnoea, Headache
Clinical narrative: Pt called clinic on 2-12-19 after having flu vaccine on 2-8-19 stated "started having sx of H/A, dizziness and SOB the next AM". Instructed to see Dr. Also stated "have heart valve issue". Will call pt back after sees Dr. this AM. No answer when called back x 2.
Age: 77.0
Sex: U
Vaccine: VARZOS
Symptoms: Induration, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pt vaccinated at 3:09 PM on 2/12/19; No S/Sxs until she woke up 2/13/19 at about 9:00 AM. She described her right arm as being sore, hot, swollen and hard. These symptoms were not at the deltoid muscle, but rather lower on the upper arm below the deltoid muscle and above the elbow. Pt showed me her arm on 2/14/19 at 5:00 PM; S/Sxs stated above were still present. Pt stated that it was not as bad as first thing in the AM 2/13/19; PCP prescribed AUGMENTIN 875 one q12h x 7d for these symptoms. Med picked up 2/14/19.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Rt upper arm red and swollen. Received immunization on 2-18-19. No fever or vomiting. No C/O pain. Ice pack applied as needed. Info provided per Mom.
Age: 1.42
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 8cm X 6cm - red, swollen (slightly), warm to touch patch on (R) thigh.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Diplopia, Gait inability, Guillain-Barre syndrome, Lumbar puncture abnormal, Muscular weakness
Clinical narrative: Night of shot got body ache and tense feelings. Couldn't walk. Went to ER next day. Diagnosed with Guillain Barre virus. Hospitalized for 1 month. Double vision. Muscle weakness.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Tension
Clinical narrative: Night of shot got body ache and tense feelings. Couldn't walk. Went to ER next day. Diagnosed with Guillain Barre virus. Hospitalized for 1 month. Double vision. Muscle weakness.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Hand-foot-and-mouth disease, Rash
Clinical narrative: Rash developing 2 days after vaccines. Starting on soles spreading to legs, buttocks and arms. No fevers, cough or congestion. Rash consistent with hand, foot and mouth.
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Nausea, Vomiting
Clinical narrative: Chills, nausea, fatigue. Patient did vomit. Occurred when patient awoke the morning after received the injection.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus, Skin discolouration, Urticaria
Clinical narrative: Patient stated his arm started to itch the evening of the vaccines and he developed welts all over his upper and lower arm. His arm turned purple but he feels it may have been from scratching the itch. He came to the pharmacy the day after and was advised to take BENADRYL.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Blood creatine phosphokinase, Chills, Cough, Culture urine, Diarrhoea
Clinical narrative: Lightheaded, loose stools, fever 101.5/chills, cough-productive clear phlegm, sinuses started getting congested, decreased urinary stream/burning/headache, nausea/emesis x1.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Full blood count, Headache, Influenza A virus test negative, Nausea
Clinical narrative: Lightheaded, loose stools, fever 101.5/chills, cough-productive clear phlegm, sinuses started getting congested, decreased urinary stream/burning/headache, nausea/emesis x1.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Productive cough, Pyrexia, Sinus congestion, Urine analysis abnormal, Urine flow decreased
Clinical narrative: Lightheaded, loose stools, fever 101.5/chills, cough-productive clear phlegm, sinuses started getting congested, decreased urinary stream/burning/headache, nausea/emesis x1.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Lightheaded, loose stools, fever 101.5/chills, cough-productive clear phlegm, sinuses started getting congested, decreased urinary stream/burning/headache, nausea/emesis x1.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 11-FEB-2019, the patient was vaccinated with GARDASIL 9 (strength and dose were not reported) lot # R017251, expiration date 04-MAY-2021, intramusculary for prophylaxis. Later, it was discovered that the patient was 12 weeks and 6 days pregnant as of 13-FEB-2019. The patient's last menstrual period (LMP) was 15-NOV-2018 and estimated delivery date (EDD) was 22-AUG-2019. The pregnancy outcome was pending. No adverse effect were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Cataract nuclear, Conjunctivitis allergic, Dry eye, Herpes ophthalmic, Ophthalmic herpes zoster
Clinical narrative: Information has been received on 22-FEB-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around 21-MAR-2017, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster.) One week after receiving the ZOSTAVAX, the patient suffered Zoster Ocular Disease, Nuclear Sclerosis OU, Acute allergic conjunctivitis OU, Punctuate Keratitis OS, Herpes Zoster Keratouveitis OS and Dry Eye Syndrome. As a direct and proximate result of ZOSTAVAX the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has suffered and incurred damages, including medical expenses, loss of accumulations and other economic and non-economic damages. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including but not limited to the patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Zoster Ocular Disease, Nuclear Sclerosis OU, Acute allergic conjunctivitis OU, Punctuate Keratitis OS, Herpes Zoster Keratouveitis OS and Dry Eye Syndrome were considered to be disabling. Upon internal review, Zoster Ocular Disease, Punctuate Keratitis OS, and Herpes Zoster Keratouveitis OS were considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Punctate keratitis
Clinical narrative: Information has been received on 22-FEB-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around 21-MAR-2017, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster.) One week after receiving the ZOSTAVAX, the patient suffered Zoster Ocular Disease, Nuclear Sclerosis OU, Acute allergic conjunctivitis OU, Punctuate Keratitis OS, Herpes Zoster Keratouveitis OS and Dry Eye Syndrome. As a direct and proximate result of ZOSTAVAX the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has suffered and incurred damages, including medical expenses, loss of accumulations and other economic and non-economic damages. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including but not limited to the patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Zoster Ocular Disease, Nuclear Sclerosis OU, Acute allergic conjunctivitis OU, Punctuate Keratitis OS, Herpes Zoster Keratouveitis OS and Dry Eye Syndrome were considered to be disabling. Upon internal review, Zoster Ocular Disease, Punctuate Keratitis OS, and Herpes Zoster Keratouveitis OS were considered to be medically significant. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 4-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 21-FEB-2019, the 4-month-old patient was vaccinated with 1 dose of PNEUMOVAX 23 (dose, and route of administration were not provided; lot # R021045, expiration date: 14-APR-2020). No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 01-JAN-2009, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a health care provider for the following injury resulting from his use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to himself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 73-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain and product supply issue. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were received as follows: The patient stated that she experienced achiness the next day after she received the 1st dose. The patient had not been able to get the 2nd dose within 6 months because of the lack of availability of the vaccine. The achiness lasted for 1 to 2 days before resolving. The reporter gave consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a nurse practitioner via Pfizer refers to an 88 year old female patient. The patient's medical history and concurrent condition were not reported. The patient's concomitant medication included methotrexate. On an unknown date in 2016 (reported as two years prior from Pfizer's aware date), the patient was vaccinated with ZOSTAVAX for prophylaxis (lot, expiry date, dose and frequency were not reported). On an unknown date, the patient experienced herpes zoster. Outcome and causality assessment were not provided by the reporter.
Age: 5.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Local reaction to immunization, redness at injection site, right thigh with 8x10cm erythema, faded on periphery, slightly warm, indurated, left 5x6 cm erythema.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Shingles returned same area, very painful, left rear thigh upper, below the cheek.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Bone pain, Feeling cold, Hypersomnia, Injection site nodule
Clinical narrative: Patient complained of aching bones, fever, can't get warm, off balance, slept for 2 days - resolved after 4 days. Shot location - knotted up and pain - continues.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Patient complained of aching bones, fever, can't get warm, off balance, slept for 2 days - resolved after 4 days. Shot location - knotted up and pain - continues.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pain
Clinical narrative: Enlarged area at injection site on (R) deltoid. Warm to touch. C/O extended days of pain.
Age: 4.0
Sex: F
Vaccine: FLU4, MMRV
Symptoms: Erythema, Pruritus
Clinical narrative: Pt mother stated that her leg was red and was itching a lot. Parent requested to bring child in for evaluation but declined.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Received 1st SHINGRIX 8/9/18 and 2nd dose on 11/14/18. Developed shingles around 10/27/18 - very painful. Cleared up with VALTREX and Prednisone but returned on 12/6/19. Had shingles outbreak after both immunizations.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Tiredness, nausea that subsided after eating, feeling woozy rest of day. Had terrible chills in evening, headache during the night. Lasted about 24 hours.
Age: 0.75
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Cough, Exposure to communicable disease, Febrile convulsion, Irritability, Pyrexia
Clinical narrative: Received last set of shots last Thurs (Here) Friday 10:30AM his mom called said he was shaking. Took him to Medical ER. Diagnosed w/Febrile seizure. I took him home w/Ibuprofen/TYLENOL and kept fever controlled. Still has fever-cough/runny nose and irritability.
Age: 0.75
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Rhinorrhoea, Tremor
Clinical narrative: Received last set of shots last Thurs (Here) Friday 10:30AM his mom called said he was shaking. Took him to Medical ER. Diagnosed w/Febrile seizure. I took him home w/Ibuprofen/TYLENOL and kept fever controlled. Still has fever-cough/runny nose and irritability.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Crying, Dizziness, Fear
Clinical narrative: Patient was scared and crying during immunizations. After felt dizziness and laid down on exam table for 3-5 minutes. BP 111/69 laying down, sitting 117/61, standing 100/75. Patient stated felt better and had patient sit in waiting room for 10 minutes before leaving. Patient seemed might have been scared and not experiencing dizziness.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Blood pressure abnormal, Crying, Dizziness, Fear
Clinical narrative: Patient was scared and crying during immunizations. After felt dizziness and laid down on exam table for 3-5 minutes. BP 111/69 laying down, sitting 117/61, standing 100/75. Patient stated felt better and had patient sit in waiting room for 10 minutes before leaving. Patient seemed might have been scared and not experiencing dizziness.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous report was received from a nurse, referring to an adult patient of unknown age and gender. There was no information about the patient's medical history, concomitant medication, concurrent conditions and drug reactions/allergies. On an unspecified date, the patient was inadvertently administered a dose of PROQUAD, lot number R008207 and expiration date 16-SEP-2019 (strength and route not provided), instead of the intended dose of M-M-R II lot number N023150 and expiration date 24-AUG-2019, (strength and route not provided). Additionally, the patient received a dose of VARIVAX lot number R009411 and expiration date 29-MAR-2020 (strength and route not provided). Both, PROQUAD and of VARIVAX were reconstituted with sterile diluent (MERCK) lot number M041688 and expiration date 12-JUN-2019. It was reported that the error occurred because the provider that administered the vaccines did not realize the clinic had PROQUAD in stock, therefore she mistakenly thought the dose of PROQUAD was actually a dose of M-M-R II. No adverse effect reported.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Paraesthesia, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. In or around 19-OCT-2017, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot number were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles. Approximately one day after receiving the ZOSTAVAX vaccine, the patient suffered sharp, stabbing, tingling pain on the right side of her head. The very next day, the patient developed a rash on her scalp and was diagnosed with herpes zoster. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX vaccine, the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the use of the ZOSTAVAX vaccine, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. As a direct and proximate consequence, patient sustained serious personal injuries and related losses including, but not limited to, the following: patient required and will continue to require healthcare and services; patient incurred and will continue to incur medical and related expenses, and patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The event herpes zoster was considered disabling. Additional information has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Hypersensitivity
Clinical narrative: This is a spontaneous report from a contactable physician from a Pfizer-sponsored program. A 68-year-old male patient of an unspecified ethnicity received clindamycin HCL (manufacturer unknown), PREVNAR 13 at single dose for immunization, Bupivacaine HCL (manufacturer unknown), azithromycin (manufacturer unknown), ciprofloxacin (manufacturer unknown), chlorthalidone, trimethoprim, torsemide, moxifloxacin HCL, enoxaparin, metolazone and sulfamethoxazole all via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient experienced allergy on an unspecified date with outcome of unknown. Pfizer is a marketing authorization holder of Clindamycin HCL, Bupivacaine HCL, Azithromycin, Ciprofloxacin in the reporter's country. This may be a duplicate report if another marketing authorization holder of Clindamycin HCL, Bupivacaine HCL, Azithromycin, Ciprofloxacin has submitted the same report to the regulatory authorities. Follow-up attempts are completed. No further information is expected. Follow-up (18Feb2019): additional information received from the same contactable Physician includes new suspect drugs added.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Petechiae
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable healthcare professional reported that a 78-year-old female patient received PREVNAR 13, (lot number and expiration date unknown), via an unspecified route of administration on 07Feb2019 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The reporter asked if there were any reports linking pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and petechiae as the patient developed petechiae on 11Feb2019 after receiving the vaccine on 07Feb2019 at a pharmacy. She was treated in the ER and was not admitted. The outcome of the event was unknown. Information on the lot/batch number has been requested.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Chills, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non HCP (the patient). A 71-years-old male patient received PREVNAR 13, intramuscular on 01Feb2019 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced chills on 03Feb2019 with outcome of recovered, fever on 03Feb2019 with outcome of recovered, no energy on 03Feb2019 with outcome of not recovered. All the reported events were considered non serious. The patient is having horrible adverse reactions and it has been 8 days. The patient stated that Pfizer puts out a product that almost kills people. He clarified that two days after receiving the product he experienced chills, fever, and was with no energy. The chills started around 11 PM Sunday night. The fever also started on Sunday. Both the fever and chill took about 3 or 4 days to recover completely. He is still feeling like he has no energy. The information on the batch number has been requested.
Age: 81.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Arthralgia, Blood test normal, Electrocardiogram, Gait disturbance, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non HCP (the patient). A 81-years-old male patient received the second dose of PREVNAR 13, intramuscular in the left deltoid on 23Jan2019 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient previously received dose one of PREVNAR 13 for immunisation on 05Nov2015. The patient experienced polymyalgia rheumatica on 24Jan2019 with outcome of not recovered. Caller stated that joint pain and muscle pain started on 24Jan2019; he had a hard time walking; when he got out of bed, his left leg was so sore he could hardly walk. The patient stated he is in his 4th week, and it is the same; it hasn't gotten better or worse but has moved. His main problem now is his shoulders and arms. The prognosis is muscle aches and pain; it is still in his leg but mainly now in his shoulders and arms. The patient is receiving prednisone and ibuprofen. The patient underwent lab tests and procedures which included blood test and electrocardiogram on unknown date. The information on the batch number has been requested.
Age: 81.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Pain in extremity, Polymyalgia rheumatica
Clinical narrative: This is a spontaneous report from a contactable consumer or other non HCP (the patient). A 81-years-old male patient received the second dose of PREVNAR 13, intramuscular in the left deltoid on 23Jan2019 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient previously received dose one of PREVNAR 13 for immunisation on 05Nov2015. The patient experienced polymyalgia rheumatica on 24Jan2019 with outcome of not recovered. Caller stated that joint pain and muscle pain started on 24Jan2019; he had a hard time walking; when he got out of bed, his left leg was so sore he could hardly walk. The patient stated he is in his 4th week, and it is the same; it hasn't gotten better or worse but has moved. His main problem now is his shoulders and arms. The prognosis is muscle aches and pain; it is still in his leg but mainly now in his shoulders and arms. The patient is receiving prednisone and ibuprofen. The patient underwent lab tests and procedures which included blood test and electrocardiogram on unknown date. The information on the batch number has been requested.
Age: 81.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Blood test, Echocardiogram, Impaired work ability, Pain in extremity, Polymyalgia rheumatica
Clinical narrative: This is a spontaneous report from a contactable consumer or other non HCP (the patient). A 81-years-old male patient received the second dose of PREVNAR 13, intramuscular in the left deltoid on 23Jan2019 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient previously received dose one of PREVNAR 13 for immunisation on 05Nov2015. The patient experienced polymyalgia rheumatica on 24Jan2019 with outcome of not recovered. Caller stated that joint pain and muscle pain started on 24Jan2019; he had a hard time walking; when he got out of bed, his left leg was so sore he could hardly walk. The patient stated he is in his 4th week, and it is the same; it hasn't gotten better or worse but has moved. His main problem now is his shoulders and arms. The prognosis is muscle aches and pain; it is still in his leg but mainly now in his shoulders and arms. The patient is receiving prednisone and ibuprofen. The patient underwent lab tests and procedures which included blood test and electrocardiogram on unknown date. The information on the batch number has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: This is a spontaneous report from a contactable physician (mother in law). A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (unspecified trade name), via an unspecified route of administration in the arm, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced redness on her arm after the injection (vaccination site erythema) on an unspecified date. The event lasted a few days, then it completely self-resolved. Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a Pfizer Sponsored Program, from a contactable consumer (the patient). A 69-year-old female patient received PREVENAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient reported that after the vaccine shot  "my arm was killing me for a few days afterward" on an unspecified date with outcome of unknown. No follow-up attempts are possible. No further information is expected. Information about batch number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Death, Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored Program. A contactable consumer reported that a female patient (Consumer's Mother) of unknown age received a single dose of PREVNAR 13 for immunization on an unknown date. Medical history and concomitant medications were not reported. The patient had this vaccine but died of pneumonia anyway on an unknown date. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: Pneumonia.
Sex: M
Vaccine: PNC13
Symptoms: Apparent death
Clinical narrative: This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported for a male patient (his or her grandson) almost died from a PREVNAR shot. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Initial information received on 20-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional via other company (Pfizer). This case involves a consumer of unknown age where temperature was out range going to 1.7 MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect storage. It was unknown whether vaccine was used or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUR4
Symptoms: Dyspnoea, Immediate post-injection reaction
Clinical narrative: Initial information received on 21-Feb-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves female patient who experienced shortness of breath, while she received vaccine FLUBLOK QIV. The patient had known egg allergy. The patient's past medical history, past medical treatment(s), vaccination(s) and family history were not provided. In Sep-2018, the patient received a dose of suspect FLUBLOCK QIV lot number not reported via unknown route in unknown administration site. In Sep-2018, the patient developed a non-serious shortness of breath, (dyspnoea) immediately after the administration of FLUBLOCK QIV. Details: Reporter stated that the practice feels the patient may be allergic to some other ingredient in the FLUBLOCK vaccine, since it contains no egg component. Reporter stated that to the best of her knowledge the patient had previously avoided getting a flu shot because of her allergy to eggs. Other relevant tests not reported. Final diagnosis was shortness of breath. It was not reported if the patient received a corrective treatment. The patient recovered from shortness of breath. List of documents held by sender: none.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 22-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 6 months old male patient who received 0.5 ml vaccine PENTACEL (lot number: C5590AA), in which the powder component (ACT-HIB) component was reconstituted with a MMR diluent, sterile water in left vastus lateralis. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE for Immunisation; PREVNAR 13 for Immunisation; and ROTAVIRUS VACCINE for Immunisation. It was a case of actual medication error due to Inappropriate reconstitution technique. It was unknown whether adverse reaction was experienced. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Initial information received on 22-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves male patient of an unknown age who was vaccinated with a first dose of vaccine ACT-HIB (lot: U6000BA, which was expired on 18-Feb-2019) in the left deltoid on 20-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to expired product administered. It was reported that nurse did not realize that the ACTHIB lypholized powder and the liquid diluent had different expiration dates - the diluent expired on 18-Feb-2019 and it was given on the 20-Feb-2019. Lypholized Powder vial: Lot: UI863AA, expiry date: 17-OCT-2019, Diluent vial: Lot: U6000BA expiry date: 18FEB2019 and Package: Lot: UI863AAA , expiry date: 18FEB2019. The patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 9.0
Sex: M
Vaccine: DTAPIPV, HEP, HEPA, MMRV
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 22-Feb-2019 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves a nine-years-old male patient who received a 0.5ml dose of vaccines DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] batch C5532AB, expiration date: 09-Oct-2020 via intramuscular route in the left deltoid on 18-Feb-2019. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccinations included was HEPATITIS A VACCINE, PROQUAD and HEPATITIS B VACCINE. It was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. A 9 year old male patient received QUADRACEL instead of TDaP and polio. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: Initial information received on 21-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves female patient who experienced flu like symptoms and severe sore arm, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious flu like symptoms and severe sore arm for several days (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. (Other relevant tests included no lab data.) Final diagnosis was severe sore arm and flu like symptoms. It was not reported if the patient received a corrective treatment. The event outcome was reported as Unknown all the event. List of documents held by sender: none.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 22-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 40 years old female patient who received a dose of ADACEL (prefilled syringe) that was shipped greater than 2 days. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was there. On 22-Feb-2019, the patient received a second 0.5 ml single dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6141AB (expiry date: 15-Dec-2020) via intramuscular route in the left deltoid. It was a case of actual medication error due to incorrect product storage. It was reported that no adverse event was noted. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 22-Feb-2019 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a patient of unknown age who was vaccinated with a dose of vaccine FLUZONE QUADRIVALENT prior 2 days of sixth months birthday, lot number, Expiration date, dose, route and site of administration not reported. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to inappropriate age at vaccine administration. It was unknown whether the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 22-Feb-2019 regarding an unsolicited valid non-serious case received from Other health care professional (Medical assistant). This case involves a 4 years old female patient who received vaccine FLUZONE QUADRIVALENT. The patients past medical history, concomitant medication and family history were not provided. On 21-Feb-2019, the patient received a 0.25ml dose of prefilled syringe of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number, expiry date not reported via intramuscular route in unknown administration site. It was an actual medication error due to Vaccine underdose. It was reported that 4 years Child received an injection for 0.25 instead of the 0.5ml of vaccine FLUZONE QUADRIVALENT. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Decreased appetite, Fatigue, Influenza like illness, Injection site erythema
Clinical narrative: Approximately 12 hours after receiving the vaccine, I was awakened with a soreness in my upper left arm where I had been vaccinated. At that time I also began experiencing flu-like symptoms (primarily aching and fatigue) and by the next morning I was experiencing severe flu-like symptoms, causing me to primarily sleep through that day and experiencing no appetite. This continued through the next day (causing me to miss a day of work). While I am feeling much better, I am still experiencing from time to time some slight flu-like symptoms including fatigue. Within a couple of days of the vaccine, my upper left arm also swelled up quite a bit and was hard to the touch as well as very red.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site swelling, Somnolence, Vaccination site pain
Clinical narrative: Approximately 12 hours after receiving the vaccine, I was awakened with a soreness in my upper left arm where I had been vaccinated. At that time I also began experiencing flu-like symptoms (primarily aching and fatigue) and by the next morning I was experiencing severe flu-like symptoms, causing me to primarily sleep through that day and experiencing no appetite. This continued through the next day (causing me to miss a day of work). While I am feeling much better, I am still experiencing from time to time some slight flu-like symptoms including fatigue. Within a couple of days of the vaccine, my upper left arm also swelled up quite a bit and was hard to the touch as well as very red.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Injected limb mobility decreased, Injection site swelling, Pain in extremity
Clinical narrative: I received the shot and my arm started hurting within the hour. The next day I awoke my left arm was swollen at the injection site; it was bulging. The nurse said this could happen. I waited and thought the pain would go away. Eight days later the swelling had gone down but my arm was still in pain. It has been almost a year and my left arm still has pain. It hurts to lift my arms in certain directions. I've complained to my PC multiple times over the last year. Nothing has been done to assist me. I'm now pregnant and am unable to receive an x-ray, although I believe this should have been done when I went in on 7/27 complaining of the pain in my left arm. I also went in on 1/16 and all they did was a blood test. My arm is in pain and I never had an issue with my arm before the Tdap vaccine.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Diarrhea x 16 days.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia, Pyrexia
Clinical narrative: He had tingling and numbness in his face, right side that would then transiently be all over his body. He had a fever of 104 a couple hours after receiving vaccine.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at the site of injection.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Erythematous rash over the left anterior upper arm. Blanches. No significant urticarial. not tender.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Crying, Decreased appetite, Diarrhoea, Discomfort, Eye movement disorder
Clinical narrative: Eyes rolling into back of head, lethargy, not reacting to sights or sounds, discomfort, fever, inconsolable crying, loss of appetite, diarrhea, slight vomiting.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Lethargy, Pyrexia, Unresponsive to stimuli, Vomiting
Clinical narrative: Eyes rolling into back of head, lethargy, not reacting to sights or sounds, discomfort, fever, inconsolable crying, loss of appetite, diarrhea, slight vomiting.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Injection site pain, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Nausea and fatigue morning after injection, resolved by midday. Local arm swelling, pain, warmth at injection site.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient given PNEUMOVAX 23 early. No adverse reaction reported.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site hypoaesthesia, Injection site inflammation, Injection site pain, Injection site paraesthesia
Clinical narrative: PAIN, REDNESS, INFLAMMATION RADIATING 3-6 INCHES AROUND INJECTION SITE WITH NUMBNESS, TINGLING, SMALL WHELPS, APPEARING AFTER FIRST DAY ON 2/26 I SOLD PT OTC LIDOCAINE CREAM IN THE EARLY AFTERNOON AND WHEN I SPOKE WITH HER AT 8PM SHE SAID MOST OF THE PAIN AND TINGLING WAS RESOLVED. PT IS TRAVELING IN A FEW DAYS AND JUST WANTS TO MAKE SURE SHE SHOULDN'T HAVE ANY PROBLEMS WHILE SHE IS OUT OF THE COUNTRY.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: PAIN, REDNESS, INFLAMMATION RADIATING 3-6 INCHES AROUND INJECTION SITE WITH NUMBNESS, TINGLING, SMALL WHELPS, APPEARING AFTER FIRST DAY ON 2/26 I SOLD PT OTC LIDOCAINE CREAM IN THE EARLY AFTERNOON AND WHEN I SPOKE WITH HER AT 8PM SHE SAID MOST OF THE PAIN AND TINGLING WAS RESOLVED. PT IS TRAVELING IN A FEW DAYS AND JUST WANTS TO MAKE SURE SHE SHOULDN'T HAVE ANY PROBLEMS WHILE SHE IS OUT OF THE COUNTRY.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Severe pain to left deltoid, decreased ROM to ipsilateral shoulder, no swelling, erythema or rash to injection site.
Age: 29.0
Sex: F
Vaccine: FLU4, HEPA, MMR, TD
Symptoms: Exposure during pregnancy
Clinical narrative: Client came to the clinic for vaccines on 2/4/2019. Assessment was done as routine and we asked twice if she was pregnant, asked by both nurses at the clinic. Client said she was not. Then client called on 2/26/2029 to say that she found out she was six weeks pregnant.
Age: 53.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Myalgia
Clinical narrative: Patient reported muscle pain and soreness for 3 weeks after vaccine was given. It is  now resolved and patient does not have pain.