chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Drug ineffective
Clinical narrative: This spontaneous report was received from a female consumer of unknown age reporting on herself. The patient's medical history and concurrent conditions were not reported. Six months ago on an unspecified date in December 2016, the patient was administered an unspecified dose of ZOSTAVAX, subcutaneously, (concentration, dose lot number and expiration date were not reported) by an anonymous health care provider. Concomitant therapies were not reported. The patient was administered unspecified steroids for her back disorder on MAY-01-2017 and then reported that the unspecified steroids did not work and she thought that maybe it was because of the ZOSTAVAX. The patient has not consulted her physician. The patient stated that at the time of the report, she had not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacy personnel (administrator) referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the patient was vaccinated with an unspecified dose of ZOSTAVAX (concentration, dose, lot number and expiration date was not reported) for prevention of shingles and subsequently developed shingles, no further description of symptoms was provided. The outcome of shingles was unknown. The causal relationship between shingles and ZOSTAVAX was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Emotional distress, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 14-JUN-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated  with a dose of ZOSTAVAX (lot and expiration not reported) vaccine on or about 30-SEP-2011 at a medical center as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On  or about 02-MAY-2012 the patient was treated by a nurse practitioner at a medical center for a painful  vesicular outbreak that was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed  pregabalin (LYRICA) to help manage painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a wellness ambassador via company representative refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dosing details, route, vaccinate site, lot#, expiry date were not reported) for prophylaxis which was reconstituted with sterile diluent(MERCK STERILE DILUENT) (dosing details , lot#, expiry date were not reported). The vaccine was not administered by the reporter.  On an unknown, date the patient experienced a bad case of shingles (herpes zoster). The outcome of herpes zoster was unknown. The reporter did not provide the causality between the event and the suspect therapies. There were no product quality complaints (PQC) involved. Additional information is not expected as the reporter did not wish further contact.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program IBCC (Inbound Call Center for HCPs). A contactable pharmacist reported for 74-Year-old female patient of an unspecified race that received PREVNAR 13 for immunization at single dose via an unspecified route of administration on unknown date. Medical history included rheumatoid arthritis, concomitant medication included methotrexate. On unknown date the patient experienced redness and swelling at the site of injection. The outcome of the events was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Feeling abnormal, Weight decreased
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist through a Pfizer sales representative. A female patient of an unspecified age, ethnicity, and race received PREVENAR 13 on an unspecified date, at single dose, for immunization. The patient was underweight. She was on a lot of medication, particularly AIDS medication (all unspecified). On an unspecified date, after the vaccination, the patient experienced dizziness and she was feeling dazed. Clinical outcome of the events was unknown at time of this report.
Sex: U
Vaccine: MENB
Symptoms: Chills, Diarrhoea, Gastroenteritis viral, Influenza like illness, Influenza virus test negative
Clinical narrative: This is a spontaneous report from a contactable physician. This physician reported similar events for 3 patients. This is 3rd of 3 reports. A patient of unspecified age ethnicity and gender received TRUMENBA via an unspecified route of administration at single dose on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, 1 hr post administration, the patient experienced sudden onset of chills, vomiting, fever, pallor, diarrhea and also flu or flu like illness (rapid flu & strep negative) and viral gastroenteritis. The patient was not admitted to hospital. The reporter assessed there was a reasonable possibility that the event is related to suspect product. Sender's Comments: Linked Report(s): US-PFIZER INC-2017181830 same reporter/drug/event, different patient;US-PFIZER INC-2017181368 same reporter/drug/event, different patient.
Sex: U
Vaccine: MENB
Symptoms: Pallor, Pyrexia, Streptococcus test negative, Vomiting
Clinical narrative: This is a spontaneous report from a contactable physician. This physician reported similar events for 3 patients. This is 3rd of 3 reports. A patient of unspecified age ethnicity and gender received TRUMENBA via an unspecified route of administration at single dose on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, 1 hr post administration, the patient experienced sudden onset of chills, vomiting, fever, pallor, diarrhea and also flu or flu like illness (rapid flu & strep negative) and viral gastroenteritis. The patient was not admitted to hospital. The reporter assessed there was a reasonable possibility that the event is related to suspect product. Sender's Comments: Linked Report(s): US-PFIZER INC-2017181830 same reporter/drug/event, different patient;US-PFIZER INC-2017181368 same reporter/drug/event, different patient.
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Nausea, Ovarian cyst, Tachycardia
Clinical narrative: This is a spontaneous report from a contactable health care professional,  received via a Pfizer sales representative.   A 16-year-old female patient of an unspecified ethnicity received TRUMENBA (Lot# R45078, Expiration Date Sep2017), first dose, 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 experienced dizziness, nausea, ovarian cyst and tachycardia, all on an unspecified date. The outcome of all the events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Anxiety, Lacrimation increased, Pruritus, Rhinorrhoea, Urticaria
Clinical narrative: This employee advised she received FLUARIX on 12/31/2015 as part of hiring requirement as a mental health worker. She advised for years she had never received the flu vaccine as she had impetigo (?) as a child (age 5-6 years) and was told never to eat shellfish, nuts or eggs. She advised she doesn't eat eggs and did not like them any ways. She can eat items cooked with eggs such as breads, pastries, potato salad (picks out eggs if sees them). On 12/31/2015 she advised within 12 hours of the vaccine she began to experience a runny nose and watery eyes. Then she noticed "hives" to bilateral lower arms (forearms) and bilateral lower legs (shins) only. She denied hives to face, back, chest or abdomen. She described the hives as red raised single bumps that itched and she covered with calamine lotion x 4 days before they resolved. She was also anxious but was able to calm herself down prior to seeing HCP at clinic. (these records unavailable to this HCP at this time). She denied any recent travel, new foods, detergents, deodorants, clothing, nylons, lotions, hiking, razors, creams, or exposure to any items. She stated HCP attributed reaction to flu vaccine received day before.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARZOS
Symptoms: Rash, Rash papular, Rash vesicular, Varicella post vaccine, Viral test negative
Clinical narrative: On 1/5/2014 child was seen by HCP for 5 day history of vesicular rash to his back. HCP document papular vesicular lesions in 2 clusters to left upper back T2-3 region, and C6-7 region down left upper posterior arm. HCP identified Mom was currently pregnant and had had varicella at age 7-9 years and not while pregnant, and no known exposures to varicella. Father had history of HSV and takes ACV but no recent outbreaks. Mom advised child was ultimately treated with ACV 1/17/201 with viral culture of lesions was negative/no growth. Child final diagnosis on 1/30/2014 was most consistent with varicella zoster.
Age: 15.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None Reported.
Age: 15.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: None Reported.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Antinuclear antibody increased, Dyspnoea, Pain in extremity
Clinical narrative: Arm pains (wrists, fingers, elbows). SOB when sprinting across street or singing.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Hyperhidrosis, Mobility decreased, Pain in extremity, Pyrexia, Rash erythematous
Clinical narrative: Developed sore arm, with sl. fever, diaphoresis, and difficulty moving arm.  Now has a red rash about 2 inches below vaccine administration site, which gets more red with exercise.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Vaccination site reaction
Clinical narrative: Developed sore arm, with sl. fever, diaphoresis, and difficulty moving arm.  Now has a red rash about 2 inches below vaccine administration site, which gets more red with exercise.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haemorrhage, Injection site pain
Clinical narrative: This spontaneous report was received from a female consumer of unknown age referring herself. The patient's concurrent conditions, medical history or concomitant medications were not reported. On an unspecified date in late May or beginning June 2017 (reported as last week), the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously for shingles prophylaxis (dose, lot number and expiration date were not reported). Subsequently, the patient noted that the injection site bled more than expected (vaccination site haemorrhage) and stung (vaccination site stinging). Because of that, the patient thought the nurse might had administered the vaccine in her vein not subcutaneously. The patient stated that she did ask the nurse if she had administered the vaccine subcutaneously or if had been injected into the vein; however, she said that the nurse did not understand her. The patient did not seek medical attention, thus, she had not consulted her physician. Moreover, no treatment was given for the adverse events. At the time of reporting, the outcome of the events was unknown. The causal relationship between the events and the ZOSTAVAX was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Multiple allergies
Clinical narrative: This spontaneous report was received from a nurse via a company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, and concomitant medications were not reported. The patient had unspecified allergies. In May 2017 (reported as a week and half ago), the patient was vaccinated with LIQUID PEDVAXHIB for prophylaxis.  On an unknown date in 2017, the patient had a lot of allergies, besides the reporter did not confirm if the patient had an adverse event. The patient sought medical attention but, it was unknown if the patient had laboratory diagnostic tests or if he/she received any treatment. The outcome of multiple allergies was unknown. The causality between the event and LIQUID PEDVAXHIB was not reported. Additional information is not expected because no consent for follow up was provided.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 10-MAR-2011, the patient received the first dose of GARDASIL (dose, route, lot number and expiration date were not reported) for prophylaxis. On 10-APR-2017 and on 12-JUN-2017, the patient received the first and second dose respectively of GARDASIL 9 both vaccines had lot #M037770 with expiration date of 01-JUN-201 for prophylaxis (interchange of vaccine products). No adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Emotional distress, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information had been received on 14-JUN-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 28-NOV-2012 at a pharmacy (name of pharmacy was specified) as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster. On or about 22-JUN-2016, the male patient was treated by a physician at a medical clinic for a vesicular outbreak that was diagnosed as severe shingles.  On or about 02-AUG-2016 the patient was treated again for ongoing and worsening symptoms, which was diagnosed as post-herpetic neuralgia.  For management of his painful and chronic condition, the patient was prescribed Gabapentin, acetaminophen and hydrocodone (NORCO), oxycodone and acetaminophen (PERCOCET) and Hydrocodone-Acetaminophen to curb his discomfort. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Loss of consciousness
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 17-year-old male patient of an unspecified race received TRUMENBA and second dose of MENACTRA at 1DF single dose both as prophylaxis on 15Jun2017 at 0.5ml single dose via intramuscular route. Medical history and concomitant medications were unknown. On the same date the patient passed out within about 5 minutes. The patient went to ER as a precaution and it was unknown if the patient was admitted to the hospital. The outcome of the event was recovered.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Vaccination complication
Clinical narrative: 3 days post shot, patient's wife comes to pharmacy for unrelated business.Tell pharmacist the patient's are was red from shoulder to elbow, no other complaints. Has a little sorness at injection site. Patient's doctor told him he is having a mild reaction and might call in rx for steroids for him.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Juvenile myoclonic epilepsy, Seizure
Clinical narrative: Had first seizure in April 2007. Currently diagnosed with juvenile myoclonic epilepsy. Have had between 10-15 seizures from 2007-present. Currently on KEPPRA to control seizures.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Nausea, Pain, Pyrexia, Swelling
Clinical narrative: Swelling, severe pain, decreased range of motion, fever, nausea lasting approximately 50+ hours with swelling, moderate pain and swelling with decreased range of motion lasting through the time of this report. Treatment: tylenol and antiemetics.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash generalised, Rash papular
Clinical narrative: Pt came to office with red widespread papular rash, MD thought consistent with post MMR vaccine rash. No fever.
Age: 1.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Erythema, Pyrexia
Clinical narrative: 5cm by 9 cm redness 101.8 fever.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Patient came to pharmacy 6/19/17 stating she was diagnosed with a cellulitis due to the ZOSTAVAX immunization given on 6/16/17. I am unsure of the timing of the symptims.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Administration site pain, Administration site rash, Cellulitis
Clinical narrative: Soreness and pain at the site of administration that was eventually reported to the pharmacy on 6/19 as a burning rash on/around the site of administration on left arm. Diagnosed as cellulitis by the patient's PCP and prescribed KEFLEX 500 qid for 7 days.
Age: 12.0
Sex: M
Vaccine: HEPA, MEN, TDAP, VARCEL
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered. Vaccine expiration 05/06/2017 and vaccine administered on 06/19/2017.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient reported redness and soreness at sight of injection. She has been using topical Benadryl. She said it did get worse from Saturday to Sunday but no other significant problems.
Age: 33.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Musculoskeletal stiffness, Pyrexia, Swelling
Clinical narrative: Fever, redness, swelling stiffness in arm.
Age: 23.0
Sex: M
Vaccine: HEPA, TDAP, TYP, YF
Symptoms: Headache, Injection site pain, Musculoskeletal pain
Clinical narrative: 6/7/17 Vaccines administered. 6/12/17 Headache-worsens w/eye movement. 6/14/17 Slight improvement w/headache. Developed shoulder pain, both sides, worse on (R) side intermittently. 6/15/17 Follow-up in our office.
Age: 35.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Chest discomfort, Electrocardiogram, Throat tightness
Clinical narrative: Received Typhoid and Anthrax Immunization and after 30 minutes had chest and throat tightness. Given 0.3 EPIPEN. Given BENADRYL 75po. EMS arrived, IV started, 125 solcereadrol, EKG done, transported to university hospital. Final Disposition: Transported to ED and alert, oriented, and speaking.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pallor
Clinical narrative: Patient became pale in face followed by pallor of (R) arm and (R) leg. Symptoms lasted less than 5 mins. No treatment,
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Patient developed erythema, swelling a few hours after receiving ZOSTAVAX on right arm, subcutaneous site (back of arm). Erythema spread and pt. developed warmth to touch. Pt. was treated with BACTRIM 7-day course on 6/15/17 and then was seen 6/15, where BACTRIM was stopped and Tx with KEFLEX 500 mg due to spreading of rash.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: Reported redness, swelling and pain to (R) arm 2 hours after injection. Evaluated by PCP today 6/13/17 noted erythema, mild swelling and warmth (R) upper arm. Dx Cellulitis vs Allergic Rxn. RX KEFLEX, BENADRYL, Ibuprofen.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth, Pain in extremity, Peripheral swelling
Clinical narrative: Reported redness, swelling and pain to (R) arm 2 hours after injection. Evaluated by PCP today 6/13/17 noted erythema, mild swelling and warmth (R) upper arm. Dx Cellulitis vs Allergic Rxn. RX KEFLEX, BENADRYL, Ibuprofen.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Enterocolitis, Full blood count, Lethargy, Metabolic function test, Rhinorrhoea
Clinical narrative: Patient consumed sweet potatoes one day after vaccine - has had sweet potatoes from same batch several times w/o reaction. Within 2 hours, was vomiting and lethargic. Slept for several hours, limited intake of breast milk. Fully recovered in approximately 8 hours. Also experienced rhinorrhea. Dr. suspected food protein-induced enterocolitis syndrome.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Vomiting
Clinical narrative: Patient consumed sweet potatoes one day after vaccine - has had sweet potatoes from same batch several times w/o reaction. Within 2 hours, was vomiting and lethargic. Slept for several hours, limited intake of breast milk. Fully recovered in approximately 8 hours. Also experienced rhinorrhea. Dr. suspected food protein-induced enterocolitis syndrome.
Age: 0.42
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV1
Symptoms: Rash
Clinical narrative: When mom was called, she stated that Pt had a tiny rash on her cheeks but it went away the next day. No other symptoms.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Rash, Skin test positive, Urticaria, Vaccination complication
Clinical narrative: This employee was referred to the branch for detailed documentation of reported past influenza vaccine reactions. This request was made per agency that all healthcare personnel are required to be immunized against influenza annually as part of the annual mandatory influenza immunization policy.., agency recognizes some healthcare personnel do have adverse medical responses...and will strive to minimize adverse reactions by thoughtful consideration of sound documentation." Medical vaccine exemptions must be supplemented with the appropriate medical documentation and requests lacking will no be accepted.. healthcare personnel receiving a temporary or declined exemption will have opportunity to consult the agency. Past medical history reviewed and reliability of source of patient information was good. She advised history of hives, wheezing with shortness of breath, gurgling following receipt of past influenza vaccination. Agency note from 8/1/2011 documents flu exemption given due to positive skin testing to influenza vaccine by allergist. Pt states she tried twice and had reactions both times. She states she has similar reactions with eating raisins and ASA. She is requesting FLUBLOK when available. ON 12.28.2016 received FLUBLOK w/o reaction. Symptoms: Wheezing, rash&oth nonspec skin eruption.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Wheezing
Clinical narrative: This employee was referred to the branch for detailed documentation of reported past influenza vaccine reactions. This request was made per agency that all healthcare personnel are required to be immunized against influenza annually as part of the annual mandatory influenza immunization policy.., agency recognizes some healthcare personnel do have adverse medical responses...and will strive to minimize adverse reactions by thoughtful consideration of sound documentation." Medical vaccine exemptions must be supplemented with the appropriate medical documentation and requests lacking will no be accepted.. healthcare personnel receiving a temporary or declined exemption will have opportunity to consult the agency. Past medical history reviewed and reliability of source of patient information was good. She advised history of hives, wheezing with shortness of breath, gurgling following receipt of past influenza vaccination. Agency note from 8/1/2011 documents flu exemption given due to positive skin testing to influenza vaccine by allergist. Pt states she tried twice and had reactions both times. She states she has similar reactions with eating raisins and ASA. She is requesting FLUBLOK when available. ON 12.28.2016 received FLUBLOK w/o reaction. Symptoms: Wheezing, rash&oth nonspec skin eruption.
Age: 27.0
Sex: F
Vaccine: HEP, HIBV, MMR
Symptoms: Antibody test positive, Arthralgia, Cardiac stress test normal, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: Healthcare Branch was contacted via 24/7 Support line on 1/1/2017 questioning if recurrent body - muscular aches and pain with headaches were from her 12/1/2016 MMR, Hib, and first Hep B vaccinations. She had several concerns that these reactions could be early onset of MS or another autoimmune disorder. She stated 1 week after receipt of 12/1/2016 vaccinations she began to experience scattered muscular pain to various body parts (arms, legs, chest, back, abdomen) and she had a headache. She sought medical care with her HCP to R/O cardiac issues reporting a normal echo, stress test and EKG. Since Md's had no definitive diagnosis, she questions whether the vaccines caused her issues. A medical record review was completed with several scattered orthopedic issues to include lumbar sprain, right leg pain, and variety abdominal issues (GYN evaluations) since 2014. Labs documented 6/6/2016 MMR titer: positive for varicella, mumps, rubella but negative to rubeola, Hep B surface Ab was negative, and Hep A Ab was positive (reactive). As of 5/16/2017 she no further medical care for myalgia, headaches or diffuse muscular pain was identified in medical records. Her reaction was most likely commonly reported vaccine side effects (body aches, headaches, arthralgia, etc.) that may may not have exacerbated prior musculoskeletal issues (back and leg strains/pain).
Age: 27.0
Sex: F
Vaccine: HEP, HIBV, MMR
Symptoms: Gastrointestinal disorder, Headache, Hepatitis A antibody positive, Hepatitis B surface antibody negative, Ligament sprain
Clinical narrative: Healthcare Branch was contacted via 24/7 Support line on 1/1/2017 questioning if recurrent body - muscular aches and pain with headaches were from her 12/1/2016 MMR, Hib, and first Hep B vaccinations. She had several concerns that these reactions could be early onset of MS or another autoimmune disorder. She stated 1 week after receipt of 12/1/2016 vaccinations she began to experience scattered muscular pain to various body parts (arms, legs, chest, back, abdomen) and she had a headache. She sought medical care with her HCP to R/O cardiac issues reporting a normal echo, stress test and EKG. Since Md's had no definitive diagnosis, she questions whether the vaccines caused her issues. A medical record review was completed with several scattered orthopedic issues to include lumbar sprain, right leg pain, and variety abdominal issues (GYN evaluations) since 2014. Labs documented 6/6/2016 MMR titer: positive for varicella, mumps, rubella but negative to rubeola, Hep B surface Ab was negative, and Hep A Ab was positive (reactive). As of 5/16/2017 she no further medical care for myalgia, headaches or diffuse muscular pain was identified in medical records. Her reaction was most likely commonly reported vaccine side effects (body aches, headaches, arthralgia, etc.) that may may not have exacerbated prior musculoskeletal issues (back and leg strains/pain).
Age: 27.0
Sex: F
Vaccine: HEP, HIBV, MMR
Symptoms: Measles antibody negative, Mumps antibody test positive, Myalgia, Pain, Pain in extremity
Clinical narrative: Healthcare Branch was contacted via 24/7 Support line on 1/1/2017 questioning if recurrent body - muscular aches and pain with headaches were from her 12/1/2016 MMR, Hib, and first Hep B vaccinations. She had several concerns that these reactions could be early onset of MS or another autoimmune disorder. She stated 1 week after receipt of 12/1/2016 vaccinations she began to experience scattered muscular pain to various body parts (arms, legs, chest, back, abdomen) and she had a headache. She sought medical care with her HCP to R/O cardiac issues reporting a normal echo, stress test and EKG. Since Md's had no definitive diagnosis, she questions whether the vaccines caused her issues. A medical record review was completed with several scattered orthopedic issues to include lumbar sprain, right leg pain, and variety abdominal issues (GYN evaluations) since 2014. Labs documented 6/6/2016 MMR titer: positive for varicella, mumps, rubella but negative to rubeola, Hep B surface Ab was negative, and Hep A Ab was positive (reactive). As of 5/16/2017 she no further medical care for myalgia, headaches or diffuse muscular pain was identified in medical records. Her reaction was most likely commonly reported vaccine side effects (body aches, headaches, arthralgia, etc.) that may may not have exacerbated prior musculoskeletal issues (back and leg strains/pain).
Age: 27.0
Sex: F
Vaccine: HEP, HIBV, MMR
Symptoms: Rubella antibody positive
Clinical narrative: Healthcare Branch was contacted via 24/7 Support line on 1/1/2017 questioning if recurrent body - muscular aches and pain with headaches were from her 12/1/2016 MMR, Hib, and first Hep B vaccinations. She had several concerns that these reactions could be early onset of MS or another autoimmune disorder. She stated 1 week after receipt of 12/1/2016 vaccinations she began to experience scattered muscular pain to various body parts (arms, legs, chest, back, abdomen) and she had a headache. She sought medical care with her HCP to R/O cardiac issues reporting a normal echo, stress test and EKG. Since Md's had no definitive diagnosis, she questions whether the vaccines caused her issues. A medical record review was completed with several scattered orthopedic issues to include lumbar sprain, right leg pain, and variety abdominal issues (GYN evaluations) since 2014. Labs documented 6/6/2016 MMR titer: positive for varicella, mumps, rubella but negative to rubeola, Hep B surface Ab was negative, and Hep A Ab was positive (reactive). As of 5/16/2017 she no further medical care for myalgia, headaches or diffuse muscular pain was identified in medical records. Her reaction was most likely commonly reported vaccine side effects (body aches, headaches, arthralgia, etc.) that may may not have exacerbated prior musculoskeletal issues (back and leg strains/pain).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash on forehead and on (R) temple area. Observed child for total 30minutes, no further spread or any other symptoms. No itching noted.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash macular
Clinical narrative: Mom called 5-1-17 to report macular rash on cheeks, trunk, arms and legs. Mom state no fever or signs of illness other than rash. Mom states no itching or scratching by child, and she believes rash is fading.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: A few hours after getting the PREVNAR 13 shot her left upper arm became very red, and swollen, was very itchy. Did not call or come to the clinic until 5 days later. Red area measures 4 1/2 in x 4 1/2 in today 6/19/17. Denies fever or any shortness of breath.
Age: 17.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Approx. 1-1.5wks after receiving vacs, patient developed hives on trunk and extremities. Pt took BENADRYL ATC for 2-3 days. Hives were itchy, red, raised, golf ball sized. Denies any other symptoms.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RV1
Symptoms: Pyrexia
Clinical narrative: Patient developed high fever (105.1) 12 hours following vaccines.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: Patient had moderate fever following vaccine within 24 hours (101.5).
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: Pt C/O pain in (L) arm at time of injection. Reaction was 3-4 Hrs after vaccination. She developed pain and aching from Left mid arm to shoulder. Lost ROM and strength in (L) arm. No swelling or redness at injection site. Returned to office 2 wks later and still C/O Left arm pain and ache, but had regained some ROM and strength back. Pt showed injection site was below the deltoid muscle. After 6mos no pain in Left arm but continues to have ache in certain positions. Was given a taper dose of Prednisone 10mg and Tramadol 50mg 1 tab every 6 hours.
Age: 38.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Reported pain worse than tetanus after vaccine given. Days later, redness/swelling appeared. Slowly improving (right deltoid).
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Developed varicella type rash and fever 10 days after MMR, Varicella, Hep A shots.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a male consumer of unknown age reporting on himself. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 01-JUN-2017, the patient was vaccinated with ZOSTAVAX (dose, route of administration, Lot# and expiration date were not provided). Other suspect therapies included sterile diluent (STERILE DILUENT). On 02-JUN-2017, after receiving ZOSTAVAX, he started running a fever. He stated that on 05-JUN-2017 and 06-JUN-2017, his fever was around 100 degrees Fahrenheit and then on 07-JUN-2017 and 08-JUN-2017, his fever went up to the 101-102 degrees Fahrenheit range. The patient stated that he at first started taking an unspecified strength of acetaminophen (TYLENOL) and later on an unspecified date, added an unspecified strength of naproxen sodium (ALEVE) to help relieve the fever. He stated that taking both medications helped to bring his fever down to normal levels for only about 6-7 hours and then his fever would go back up to above normal ranges. At the time of this report, the patient had a fever of 102.6 degrees Fahrenheit. It could not be confirmed where the patient was going to seek medical treatment. The outcome of fever was reported as not recovered. The causality between the fever and ZOSTAVAX was not provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Stomatitis, Swollen tongue, Tongue erythema, Vaccination complication
Clinical narrative: Pt. reports receiving ZOSTAVAX injection on 5-22-17. 2 weeks following the vaccination, the pt. developed a sore with lesions underneath her tongue on the left. This is very painful to the patient. She also felt that her gumline was having discomfort, scant vesicular left temple rash also very painful, non scabbed over. Treated with Magic mouth wash.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Gingival discomfort, Oral disorder, Pain, Rash vesicular, Tongue ulceration
Clinical narrative: Pt. reports receiving ZOSTAVAX injection on 5-22-17. 2 weeks following the vaccination, the pt. developed a sore with lesions underneath her tongue on the left. This is very painful to the patient. She also felt that her gumline was having discomfort, scant vesicular left temple rash also very painful, non scabbed over. Treated with Magic mouth wash.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site swelling, Musculoskeletal stiffness, Nausea
Clinical narrative: Headache, nausea and swollen and stiff arm where Tdap vaccine given 24 hours after shot given.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Abnormal behaviour, Irritability, Pyrexia
Clinical narrative: Cranky, not acting herself, high fever 104 degrees. Unable to get temperature down. Morning after, still low grade fever of 101.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pediatrician who was referring to an 11 year old female patient. There was no information regarding the patient's medical history, concomitant medications, drug reactions or allergies provided. On 23-MAY-2017, the patient was vaccinated with the expired dose of GARDASIL 9 lot number L044475, expiration date 12-MAY-2017, intramuscularly for prophylaxis. There was no adverse event reported. There was no product quality complaint. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, Injection site erythema
Clinical narrative: Information was received 30-MAY-2017 from a pharmacist via a telephone call. The pharmacist reported that on 21-APR-2017 a dose of VARIVAX was administered to a female patient via the muscular route rather than the subcutaneous route (lot # L049532, expiration date 08-DEC-2017).  (The patient's age, date of birth, concomitant medications, medical history and concurrent conditions were not reported.)  On an unknown date after receiving VARIVAX, the patient developed redness at the injection site, lasting for an unknown duration. No treatment for the redness had been received. The pharmacist reported that on an unknown date the redness had resolved completely. No additional information was provided. Additional information was requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (reported as nurse practitioner) and refers to an unspecified patient. No information regarding the patient's medical history, concomitant medications and concurrent conditions was provided. On 05-JUN-2017, the patient was vaccinated with an expired dose of VAQTA lot # M034893 with expiration date on 26-MAY-2017 (dose was not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions or concomitant therapies provided. At an unspecified date in the past patient has received PREVNAR 13. On 08-JUN-2017, the patient was vaccinated with PNEUMOVAX 23 lot # L029306, expiration date 26-MAR-2017, intramuscular (dose was not reported) for prophylaxis. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA007120: Original Case: 1706USA004082.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified group patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. The nurse reported a group of patients received unspecified doses of PNEUMOVAX 23 lot # L029306, expiration date 26-MAR-2017 (dose, route of administration were not reported), on dates in the last 2 weeks (reported as late May to early June 2017). There was no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA004082: Original Case: 1706USA004082.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 12-MAY-2017, the patient was vaccinated with a dose of improperly stored VARIVAX lot # M027344 with expiration date on 01-JUN-2018 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 13 degrees Fahrenheit for 9 hours. Digital data logger was used to record the excursion. The vaccine underwent previous temperature excursion of 7 degrees Fahrenheit for 17 hours and 30 minutes. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002688:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to 3 unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 02-JUN-2017, the patients were vaccinated with doses of improperly stored VARIVAX lot # M027344 with expiration date on 01-JUN-2018 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 13 degrees Fahrenheit for 9 hours. Digital data logger was used to record the excursion. The vaccine underwent previous temperature excursion of 7 degrees Fahrenheit for 17 hours and 30 minutes. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002688:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to 2 unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 28-APR-2017, the patients were vaccinated with doses of improperly stored VARIVAX lot # M032493 with expiration date on 06-JUL-2018 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 13 degrees Fahrenheit for 9 hours. Digital data logger was used to record the excursion. The vaccine underwent previous temperature excursion of 7 degrees Fahrenheit for 17 hours and 30 minutes. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002688:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 03-MAY-2017, the patient was vaccinated with a dose of improperly stored VARIVAX lot # M032493 with expiration date on 06-JUL-2018 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 13 degrees Fahrenheit for 9 hours. Digital data logger was used to record the excursion. The vaccine underwent previous temperature excursion of 7 degrees Fahrenheit for 17 hours and 30 minutes. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002688:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to 2 unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 12-MAY-2017, the patients were vaccinated with doses of improperly stored VARIVAX lot # M032493 with expiration date on 06-JUL-2018 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 13 degrees Fahrenheit for 9 hours. Digital data logger was used to record the excursion. The vaccine underwent previous temperature excursion of 7 degrees Fahrenheit for 17 hours and 30 minutes. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002688:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 19-MAY-2017, the patient was vaccinated with a dose of improperly stored VARIVAX lot # M032493 with expiration date on 06-JUL-2018 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 13 degrees Fahrenheit for 9 hours. Digital data logger was used to record the excursion. The vaccine underwent previous temperature excursion of 7 degrees Fahrenheit for 17 hours and 30 minutes. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002688:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 28-MAY-2017, the patient was vaccinated with a dose of improperly stored ARIVAX lot # M032493 with expiration date on 06-JUL-2018 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 13 degrees Fahrenheit for 9 hours. Digital data logger was used to record the excursion. The vaccine underwent previous temperature excursion of 7 degrees Fahrenheit for 17 hours and 30 minutes. No adverse effects were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1706USA002688: