chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Neck pain, Tenderness
Clinical narrative: Initial unsolicited case received from a physician on 19 Sep 2017. This case involves 42-year-old male patient who was vaccinated with 0.5 ml one dose of ADACEL (Batch number: C5243AA, expiry date and dose in series not reported) intramuscularly in right deltoid on 05 Sep 2017 for immunization. Patient medical history and concomitant medications were not reported. On 07 Sep 2017, two days after the vaccination, the patient developed diffuse tenderness of the entire right arm with limited ROM and decreased use of the right arm. On an unknown date, after the vaccination, the patient developed shoulder pain and neck pain. The patient wife was concerned of cellulitis although no symptoms were seen. On 11 Nov 2017, patient was evaluated in ED (emergency department) with right arm shoulder and neck pain. On 18 Sep 2017, patient was again evaluated in ED by the physician which showed symptoms were ongoing but diminished with opioids/steroids, and ULS of right shoulder negative for infection and again on 19 Sep 2017, the patient was evaluated by orthopedic. Other relevant lab tests were not reported. Other corrective treatment include KEFLEX, steroids and narcotics which he continues to take orally. The outcome of all the events were recovering (Also reported as not recovered). List of documents held by sender: none.
Sex: F
Vaccine: UNK
Symptoms: Cellulitis
Clinical narrative: Initial unsolicited report received from health care professional on 27-Sep-2017. This case involves a female patient (age and gender not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Intradermal flu shot) (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient was diagnosed with cellulitis. Lab data was not reported. The patient received corrective treatment with prescribed antibiotics and hot compresses. The patient's event outcome was not reported. Upon internal review, the company decided to consider the event serious because of important medical event cellulitis. List of documents held by sender: none.; Sender's Comments: The patient experienced cellulitis post vaccination with INTRADERMAL FLU SHOT. Time to onset was not reported. No information regarding product brand name or lot number was reported. Patients medical history and condition at the time of vaccination was also missing. Cellulitis could have an infectious etiology totally unrelated to vaccination. Alternative etiologies should be investigated and ruled out before assessing the case. Additional information regarding patients medical history and product information should be requested. Based upon reported information the role of the vaccine can not be assessed.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site bruising
Clinical narrative: Bruising the size of a tennis ball (dark red splotches with yellow halo) around the site of the vaccination site on right deltoid. Patient noticed next day and stop by the pharmacy 3 days after to display to pharmacist.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: Client reports arm became red, itchy, with "bag of water" on inner aspect of the arm approximately 1 inch above the elbow.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Client presented to HD 10/10/2017 with bruising at all stages of development from axillary area and around the arm extending down to approximately 3inches above antecubital area of Left Arm. Bandaid still in place from where influenza vaccine was given 10/5/17. Bandaid removed. Area around injection site clean and dry. No redness noted. Small dot of old blood on bandaid which covered the injection site. Lt Deltoid area swollen and hard. Sl warmer that Rt arm. States when he woke up on 10/6/17 area was very swollen and tender. Believes the swelling to be worse now than when it started.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Hypoaesthesia, Immediate post-injection reaction, Migraine, Muscle spasms
Clinical narrative: Severe pain and burning in right arm immediately after injection, prolonged numbness and tingling progressing from right arm into neck and right face, migraine without relief since injection, muscle spasms bilateral lower extremities.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Severe pain and burning in right arm immediately after injection, prolonged numbness and tingling progressing from right arm into neck and right face, migraine without relief since injection, muscle spasms bilateral lower extremities.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Nausea, Vomiting
Clinical narrative: At 7 pm following an after school clinic patient experienced shortness of breath, nausea, vomiting, was given an EPIPEN and transported to hospital.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Thigh with significant edema, erythemia and warmth the day after receiving vaccine.  Continued to progress for next few days, finally treated with antibx.
Age: 91.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Pt daughter brought her back in Monday to show us her arm. Her left arm from shoulder to elbow was red and warm.
Age: 32.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Heart rate increased, Local reaction, Pruritus generalised, Swelling
Clinical narrative: Received egg free flu vaccine on 10-9-17 at hospital pharmacy started itching 35 minutes after shot local reaction 2.2X1.6 cm raised redness patient reported increased heart rate and head after injection and still itching all over today.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain of skin, Pruritus, Rash, Rash erythematous, Skin burning sensation
Clinical narrative: Swollen rash that is warm and red from elbow to collarbone. Skin was peeling, itching, burning, painful to touch. Today, Day 4, not as painful but still red and tender and rash still from elbow to collarbone.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin exfoliation, Skin warm, Swelling
Clinical narrative: Swollen rash that is warm and red from elbow to collarbone. Skin was peeling, itching, burning, painful to touch. Today, Day 4, not as painful but still red and tender and rash still from elbow to collarbone.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Asthenia, Blood test, Cerebrovascular disorder, Computerised tomogram head, Computerised tomogram head normal
Clinical narrative: Severe headache, neck hurt, vomiting 8-8-17, to ER 8-8-17-tests and labs performed. Given IV BENADRYL, COMPAZINE, sent home, no relief, to pediatrician next day, given IM TORADOL, sent home, no relief, to ER again next day. MRI, CT scan, labs, transferred to Hosp. by ambulance. Diagnosed abnormal vessels on brain. 8-8-17-patient came home from her job complaining of severe headache, she took OTC meds that were not effective, toward evening her condition got worse with severe headache, neck pain, and her eyes were very sensitive to light. She was taken to Emergency room and on the way there, she began vomiting in car. Hospital ER, ran tests, CT scan of head, lab work, found nothing wrong, gave her IV COMPAZINE/BENADRYL, she slept some time there and was sent home, still having head/neck pain. Next day head/neck pain continued, she was taken to her pediatrician, he gave her IM injection of TORADOL for "migraine" and sent her home. Injection of TORADOL not effective. Next morning, (Day 3) I returned patient to ER, this time she was too weak to walk, had to be wheeled in by wheelchair, severe headache, neck ache, unable to open eyes, unable to eat. Hospital ran more tests, more blood work, recommended ambulance transfer to Hospital for seizures. And having abnormal blood vessels on brain. Spent from 8-10-17 until 8-15-17 in Hosp. neurology department. She is now on anti-seizure medication 2 times/day, and 81 mg aspirin daily. Patient has no history of headache, migraine, or seizures until this all started 8-8-17, just 6 days after injection of BEXSERO, and MENVEO/MENACTRA injections.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Electrocardiogram, Electroencephalogram, Eyelid function disorder, Feeding disorder, Gait inability
Clinical narrative: Severe headache, neck hurt, vomiting 8-8-17, to ER 8-8-17-tests and labs performed. Given IV BENADRYL, COMPAZINE, sent home, no relief, to pediatrician next day, given IM TORADOL, sent home, no relief, to ER again next day. MRI, CT scan, labs, transferred to Hosp. by ambulance. Diagnosed abnormal vessels on brain. 8-8-17-patient came home from her job complaining of severe headache, she took OTC meds that were not effective, toward evening her condition got worse with severe headache, neck pain, and her eyes were very sensitive to light. She was taken to Emergency room and on the way there, she began vomiting in car. Hospital ER, ran tests, CT scan of head, lab work, found nothing wrong, gave her IV COMPAZINE/BENADRYL, she slept some time there and was sent home, still having head/neck pain. Next day head/neck pain continued, she was taken to her pediatrician, he gave her IM injection of TORADOL for "migraine" and sent her home. Injection of TORADOL not effective. Next morning, (Day 3) I returned patient to ER, this time she was too weak to walk, had to be wheeled in by wheelchair, severe headache, neck ache, unable to open eyes, unable to eat. Hospital ran more tests, more blood work, recommended ambulance transfer to Hospital for seizures. And having abnormal blood vessels on brain. Spent from 8-10-17 until 8-15-17 in Hosp. neurology department. She is now on anti-seizure medication 2 times/day, and 81 mg aspirin daily. Patient has no history of headache, migraine, or seizures until this all started 8-8-17, just 6 days after injection of BEXSERO, and MENVEO/MENACTRA injections.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Headache, Laboratory test normal, Migraine, Neck pain, Nuclear magnetic resonance imaging brain
Clinical narrative: Severe headache, neck hurt, vomiting 8-8-17, to ER 8-8-17-tests and labs performed. Given IV BENADRYL, COMPAZINE, sent home, no relief, to pediatrician next day, given IM TORADOL, sent home, no relief, to ER again next day. MRI, CT scan, labs, transferred to Hosp. by ambulance. Diagnosed abnormal vessels on brain. 8-8-17-patient came home from her job complaining of severe headache, she took OTC meds that were not effective, toward evening her condition got worse with severe headache, neck pain, and her eyes were very sensitive to light. She was taken to Emergency room and on the way there, she began vomiting in car. Hospital ER, ran tests, CT scan of head, lab work, found nothing wrong, gave her IV COMPAZINE/BENADRYL, she slept some time there and was sent home, still having head/neck pain. Next day head/neck pain continued, she was taken to her pediatrician, he gave her IM injection of TORADOL for "migraine" and sent her home. Injection of TORADOL not effective. Next morning, (Day 3) I returned patient to ER, this time she was too weak to walk, had to be wheeled in by wheelchair, severe headache, neck ache, unable to open eyes, unable to eat. Hospital ran more tests, more blood work, recommended ambulance transfer to Hospital for seizures. And having abnormal blood vessels on brain. Spent from 8-10-17 until 8-15-17 in Hosp. neurology department. She is now on anti-seizure medication 2 times/day, and 81 mg aspirin daily. Patient has no history of headache, migraine, or seizures until this all started 8-8-17, just 6 days after injection of BEXSERO, and MENVEO/MENACTRA injections.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Photophobia, Seizure, Urine analysis, Vomiting, Wheelchair user
Clinical narrative: Severe headache, neck hurt, vomiting 8-8-17, to ER 8-8-17-tests and labs performed. Given IV BENADRYL, COMPAZINE, sent home, no relief, to pediatrician next day, given IM TORADOL, sent home, no relief, to ER again next day. MRI, CT scan, labs, transferred to Hosp. by ambulance. Diagnosed abnormal vessels on brain. 8-8-17-patient came home from her job complaining of severe headache, she took OTC meds that were not effective, toward evening her condition got worse with severe headache, neck pain, and her eyes were very sensitive to light. She was taken to Emergency room and on the way there, she began vomiting in car. Hospital ER, ran tests, CT scan of head, lab work, found nothing wrong, gave her IV COMPAZINE/BENADRYL, she slept some time there and was sent home, still having head/neck pain. Next day head/neck pain continued, she was taken to her pediatrician, he gave her IM injection of TORADOL for "migraine" and sent her home. Injection of TORADOL not effective. Next morning, (Day 3) I returned patient to ER, this time she was too weak to walk, had to be wheeled in by wheelchair, severe headache, neck ache, unable to open eyes, unable to eat. Hospital ran more tests, more blood work, recommended ambulance transfer to Hospital for seizures. And having abnormal blood vessels on brain. Spent from 8-10-17 until 8-15-17 in Hosp. neurology department. She is now on anti-seizure medication 2 times/day, and 81 mg aspirin daily. Patient has no history of headache, migraine, or seizures until this all started 8-8-17, just 6 days after injection of BEXSERO, and MENVEO/MENACTRA injections.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This spontaneous report was received from a male patient of unknown age who was referring to himself. There was no information regarding the patient's medical history, concomitant medications, drug reactions or allergies provided. On an unknown date, the patient was vaccinated with ZOSTAVAX for prophylaxis (dose, route, lot number and expiration date were not reported). The patient stated, that he received ZOSTAVAX a few months after receiving a corticosteroid shot (the time between the two shots was unspecified). On an unknown date, the patient experienced serious aches and pains on all parts of his body. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not provided.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 69 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 19-SEP-2017 (reported also as 09/19/2017), the patient was vaccinated with expired dose of ZOSTAVAX lot # M028798, expiration date on 18-AUG-2017, for prophylaxis (dose, site and route of administration were not reported). Concomitant therapies included sterile diluent (DILUENT MRK). No adverse effects were reported.
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: Fatigue
Clinical narrative: This spontaneous report was received from a 53 year-old male patient who was reporting on himself. The patient had no pertinent medical history or concomitant medications. He reported having unspecified allergies. On an unknown date in August 2017, the patient was vaccinated with the first dose of RECOMBIVAX HB (Thimerosal status not provided; exact dose, route of administration. lot # and expiration date were not reported), for the prevention of hepatitis B. The patient reported that, on an unspecified date, he felt tired, like he just ran a marathon. The patient was vaccinated with the second dose of RECOMBIVAX HB on 21-SEP-2017, and still felt tired. He did not contact his physician, no treatment was given for the event. The outcome of the event was reported as not recovered. The causality assessment between the event and RECOMBIVAX HB was not provided.
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report was received from a non-pregnant female patient of unknown age referring to herself. There was no information about the patient's concurrent conditions, allergies or medical history provided. On unknown dates, the patient was vaccinated with an unspecified number of doses of M-M-R II (exact dose, route of administration, lot# and expiry date were not reported) for prophylaxis when she was a child. Other suspect therapies included sterile diluent. On an unknown date, reported as "recently", the patient was performed MMR titer drawn and the results showed a negative titer for rubella. The patient reported that she began treatment with "in vitro fertilization" on an unspecified date and she was not pregnant, and she also reported that she was undergoing treatment with "in vitro fertilization" at the reporting time. She sought medical attention (unspecified date). The outcome of the events was unknown. Causality assessment was not provided by the reporter.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse via a radiation technician and refers to a patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB lot# N003702, expiration date: 08-NOV-2019 (dose and route of administration were not provided) for prophylaxis. The vaccine was stored for 10.5 hours in the temperature of 63.7 degrees Fahrenheit. The vaccine underwent previous temperature excursion of 48 degrees Fahrenheit for 90 minutes. Digital Data Logger was involved. No adverse symptoms were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent. On an unknown date (reported as "1 week later"), the patient experienced non-injection site rash. The outcome of rash was unknown. The causality assessment was not provided.
Age: 50.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Vaccination site cellulitis, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Information has been received from a physician, concerning a 50 year old female patient. The patient had no medical history, drug allergies, previously drug reactions, concurrent conditions or concomitant medication reported. On 25-SEP-2017, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23 intramuscularly lot # N005096, (strength, dose, anatomical location and expiration date were unknown) for prophylaxis, at the physician's office. Since that day, the patient experienced raised, red, and warm to touch at vaccination site; then, on 27-SEP-2017, she returned to the physician's office to show him and physician reported that "the site looks like cellulitis"; therefore, as treatment for the cellulitis, it was prescribed doxycycline (manufacturer unknown) 100mg twice daily for 10 days, and PERCOCET 5mg/325mg for vaccination site cellulitis pain (subsequently the patient could sleep). The physician stated that the patient had scheduled appointments in 2 days and 4 days for follow-up. At the time of the report, no laboratory diagnostics or studies were performed, the patient was not recovered from the vaccination site cellulitis and the causal relationship between the vaccination site cellulitis and the PNEUMOVAX23 was not assessed.
Age: 67.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Aphonia, Dysphagia, Erythema, Insomnia, Oral mucosal blistering
Clinical narrative: This spontaneous report was received from a pharmacist, regarding a 67 year old female patient. The patient did not have permitent concurrent conditions, medical history or drug reactions/allergies. On 25-SEP-2017, the patient was vaccinated with an unknown dose of PNEUMOVAX 23 lot # M042599 with expiration date on 17-JUN-2018, intramuscularly in the left arm for prophylaxis.  On the same date the patient was vaccinated with influenza virus vaccine (unspecified manufacturer) also given on left arm. Concomitant therapies included "pain medication", "sleep medication" and other unspecified medications. At the same day of vaccination, the patient experienced pain (pain in extremity), redness (erythema), and swelling in her left arm and hand (peripheral swelling), and "couldn't sleep" (insomnia).The patient was seen at the emergency room on an unspecified date and was treated with Clindamycin. No laboratory diagnostics or studies were performed. On an unknown date in September 2017, she also began having blisters in her mouth (oral mucosal blistering), difficulty drinking (dysphagia), and difficulty talking (aphonia). At the time of reporting, the patient had not recovered of peripheral swelling, aphonia, dysphagia, oral mucosal blistering, insomnia, pain in extremity and erythema. The pharmacist considered peripheral swelling to be serious because of disability or Incapacity. The relatedness between vaccination with PNEUMOVAX 23 and the events was not reported.
Age: 67.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist, regarding a 67 year old female patient. The patient did not have permitent concurrent conditions, medical history or drug reactions/allergies. On 25-SEP-2017, the patient was vaccinated with an unknown dose of PNEUMOVAX 23 lot # M042599 with expiration date on 17-JUN-2018, intramuscularly in the left arm for prophylaxis.  On the same date the patient was vaccinated with influenza virus vaccine (unspecified manufacturer) also given on left arm. Concomitant therapies included "pain medication", "sleep medication" and other unspecified medications. At the same day of vaccination, the patient experienced pain (pain in extremity), redness (erythema), and swelling in her left arm and hand (peripheral swelling), and "couldn't sleep" (insomnia).The patient was seen at the emergency room on an unspecified date and was treated with Clindamycin. No laboratory diagnostics or studies were performed. On an unknown date in September 2017, she also began having blisters in her mouth (oral mucosal blistering), difficulty drinking (dysphagia), and difficulty talking (aphonia). At the time of reporting, the patient had not recovered of peripheral swelling, aphonia, dysphagia, oral mucosal blistering, insomnia, pain in extremity and erythema. The pharmacist considered peripheral swelling to be serious because of disability or Incapacity. The relatedness between vaccination with PNEUMOVAX 23 and the events was not reported.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Mobility decreased, Nausea, Pyrexia
Clinical narrative: Information has been received from a physician, referring to a 67 year old female patient. The patient did not have any known medical history, concurrent conditions or was on any concomitant therapy. On 27-SEP-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # M026317 with expiration date on 11-JAN-2018 (strength, anatomical location, administration route were not reported) for prophylaxis. On an unspecified date in September 2017 (reported as "within 12 hours after vaccination"), the patient experienced fever, nausea, headache and could not get out of bed for three days. On 30-SEP-2017, the patient took an unspecified antihistamine. The outcome of the fever, nausea and headache was reported as recovering (reported as "was improving but was not recovered") and the causality between the vaccination with PNEUMOVAX 23 and the aforementioned events was not reported. The reporting physician considered the events of fever, nausea and headache to be serious due to significant disability or incapacity because the patient could not get out of bed for three days.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, approximately in September 2017 (reported as "about 2 weeks ago"), the patient was vaccinated with the first dose of PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported). On 04-OCT-2017, the patient was vaccinated with the second dose of PNEUMOVAX 23 via intramuscular route, lot# N014188, expiration date: 22-JAN-2019 (dose and route of administration were not reported). No side effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from an administrator, who also works as a medical assistant, referring to an unknown number of patients of unknown age and gender. Information about concurrent condition, concomitant therapies, drug reactions/allergies and medical history was unknown. From 02-JUN-2017 to 22-JUL-2017, the patients were vaccinated with improperly stored VARIVAX (dose, route and lot # were unknown) for prophylaxis. The reporter stated that if the VARIVAX were to go over 14 Fahrenheit (F), the patients who were administered the vaccines would need to be revaccinated (It was also reported that "no doses were administered" (conflict information)). No adverse effect was reported. The vaccines were under the temperature in the range of 6 F to 14 F: 6 F for 1 hour and 30 mins, 8 F for 5 hours, 5.6 F for 45 mins, 8 F for 7 hours, 8 F for 3 hours, 6 F for 1 hour, 9.7 F for 30 mins, 6.4 F for 5 hours. There was no previous temperature excursion. A data logger was used. On 06-OCT-2017, a call was placed to the medical assistant. The medical assistant stated that a patient (unknown age and gender) was vaccinated with an improperly dose of VARIVAX from lot# N000683 with expiry: 06-JAN-2019, on 22-JUN-2017. This is one of two reports received from the same reporter. Patient name, vaccination date and narrative updated. Sender's Comments: US-009507513-1708USA010189.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender wit multiple myeloma. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 04-OCT-2017, the patient was administered with properly stored VARIVAX, lot # N017700 with expiration date 09-JUN-2019(strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (lot # and expiration date were not provided) which was stored appropriately. No adverse reaction reported. No further information was provided. There was no product quality complaint (PQC) involved.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 06-OCT-2017, the patient was vaccinated with a dose of GARDASIL 9 intramuscularly, lot number L014198 with expiration date 05-SEP-2017 (anatomical location was not reported) for prophylaxis. No adverse effects were reported in the patient.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 06-OCT-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine at a pharmacy, 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 28-JUN-2016, the patient was treated by a physician at an ear nose and throat practice for the onset of a severe vesicular outbreak, accompanied by weakened immune systems, which was diagnosed as herpes zoster, or shingles. The patient experienced persistent symptoms and complications of his condition, and has been prescribed gabapentin (manufacturer unknown), VALTREX and tramadol (manufacturer unknown) in an attempt to manage his outbreaks and pain. 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: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for two patients. This is the second of two reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had local redness and swelling at injection site 2 days post dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). The events took place after the use of the product. The outcome of the events was unknown. No follow up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017428821 same reporter/vaccine/event, different patient.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable nurse. A 66-year-old male patient receives PREVNAR 13 (Lot number: S43277, Expiry date 30Sep2018, NDC number 0005197102), intramuscular at 0.5 ml single in the left deltoid on 05Oct2017 15:30 for immunisation. Medical history none. Concomitant medications were not reported. On 06Oct2017, the patient experienced arm swollen, red, hot and painful at the site of injection. The outcome of the events was not recovered.
Age: 22.0
Sex: F
Vaccine: ANTH, FLU4, PPV, SMALL, TYP
Symptoms: Electrocardiogram, Feeding disorder, Feeling hot, Nausea, Pain
Clinical narrative: Pt stated when she received the first 4 immunizations, she felt nauseous. Pt then received Smallpox and states she felt her body felt hot, like a body flash hot. Pt then went home and tried drinking water and hoping she would feel better. Pt then was nauseous and tried going to the restroom to throw up but was unable to. Only was able to dry heave. Pt then went to the ER and was given medication for nausea then sent home. At the hospital she was told it was a normal reaction and unfortunately she would feel like this for a while. Next day pt went to sick call with a fever and was given quarters for 24 hours. Was told to take Motrin. The following day pt felt body aches but then started slowly getting better. Pt was unable to eat due to nausea from administration date which was 03Oct17-06Oct17. Pt only ate crackers and water.
Age: 22.0
Sex: F
Vaccine: ANTH, FLU4, PPV, SMALL, TYP
Symptoms: Pyrexia, Retching
Clinical narrative: Pt stated when she received the first 4 immunizations, she felt nauseous. Pt then received Smallpox and states she felt her body felt hot, like a body flash hot. Pt then went home and tried drinking water and hoping she would feel better. Pt then was nauseous and tried going to the restroom to throw up but was unable to. Only was able to dry heave. Pt then went to the ER and was given medication for nausea then sent home. At the hospital she was told it was a normal reaction and unfortunately she would feel like this for a while. Next day pt went to sick call with a fever and was given quarters for 24 hours. Was told to take Motrin. The following day pt felt body aches but then started slowly getting better. Pt was unable to eat due to nausea from administration date which was 03Oct17-06Oct17. Pt only ate crackers and water.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Influenza like illness, Insomnia, Pain, Pyrexia, Vaccination complication
Clinical narrative: Patient described flu like symptoms (fever, aches and pains), patient also stated he has only slept about 4 hours a night since he has received vaccine. Patient states that he is still have these symptoms and he has had an adverse event from vaccine and wants to know who will compensate him for his bills and pain and suffering.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Left thigh with edema, erythema and warmth that is continue to progress.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Severe bruising and swelling below injection site, possible hematoma.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Mobility decreased, Pain
Clinical narrative: Approx 24 hours after she received the IMZ she developed severe soreness and weakness and could not raise her arm above shoulder height.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Edema and erythema to right thigh.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site streaking
Clinical narrative: 7x5cm area on right thigh of edema, erythema and streaking.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Headache, Pain in extremity
Clinical narrative: Bruising and pain in left arm. Started almost two hours after receiving shot. Spoke to MD at an already scheduled apt. Still has some bruising.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration
Clinical narrative: 110 mm x 80 mm red indurated patch right arm.
Sex: F
Vaccine: PPV
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a pharmacist via company representative and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date in 2017, a few weeks ago, the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, lot# and expiration date were not reported). On an unknown date in 2017, after administration of PNEUMOVAX23, the patient fainted and was taken to an unspecified Emergency Room. It was unknown if the patient was admitted to the hospital from the Emergency Room. The reporter stated that the patient was recovered on an unspecified date. No causality assessment was provided by reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 06-OCT-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 vaccine at a physician office, as recommended for routine adult health maintenance and for the prevention of shingles on 27-APR-2009. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-FEB-2012, the patient was treated at a hospital for the onset of a severe vesicular outbreak, accompanied by weakened immune systems, which was diagnosed as herpes zoster, or shingles. The patient was prescribed acyclovir, prednisone and acetaminophen and oxycodone (PERCOCET) for management of 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: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 06-OCT-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 vaccine at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles on 12-FEB-2015. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-DEC-2016, the patient was treated by a nurse practitioner for the onset of a severe vesicular outbreak, accompanied by weakened immune systems, which was diagnosed as herpes zoster, or shingles. The patient was prescribed gabapentin, valacyclovir, acyclovir, tramadol, and acetaminophen and NORCO for management of 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: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 06-OCT-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 vaccine at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles on 09-OCT-2014. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 27-OCT-2016, the patient was treated at a hospital for the onset of a severe vesicular outbreak, accompanied by weakened immune systems, which was diagnosed as herpes zoster, or shingles. The patient was prescribed acyclovir, gabapentin, oxycodone, and FAMVIR for management of 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: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration unknown) at a pharmacy on or about 08-OCT-2013 as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 18-MAY-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed acyclovir for the management of his painful symptoms. On or about 26-AUG-2016 the patient was treated again for ongoing and worsening symptoms of shingles outbreaks. The patient has been prescribed VALTREX and PERCOCET for management of her persistent and 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, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration unknown) at a pharmacy on or about 31-MAY-2012. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 12-OCT-2012, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed acyclovir for the management of his 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, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration unknown) at a pharmacy on or about 29-JUL-2012 as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 06-NOV-2015, the patient was treated at a medical center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed LIPODERM and famciclovir for management of her painful condition. 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, and pain and suffering, and other damages. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received flu shot in left deltoid and immediately began to have pain at site. Swelling and redness started after 30 minutes of receiving flu shot. Patient was in pain all through the night. When patient came into office his left arm, shoulder, armpit was swollen, red and patient was in pain.
Age: 10.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Skin warm
Clinical narrative: Patient received flu shot in left deltoid and immediately began to have pain at site. Swelling and redness started after 30 minutes of receiving flu shot. Patient was in pain all through the night. When patient came into office his left arm, shoulder, armpit was swollen, red and patient was in pain.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever -102-24hr. Chills-24hr. Aches-24hr.
Age: 87.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Pain, Pruritus, Pyrexia
Clinical narrative: Redness at sight of injection. Itching. Pain. Fever. Both vaccines given at Clinic of MD.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Allergy to vaccine, Hypersensitivity
Clinical narrative: This case was reported by a consumer and described the occurrence of allergy to vaccine in a 11-year-old female patient who received FLUARIX QUADRIVALENT (batch number 27LY3, expiry date unknown). On 23rd September 2017, the patient received FLUARIX QUADRIVALENT. In September 2017, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced allergy to vaccine and allergic reaction. On an unknown date, the outcome of the allergy to vaccine and allergic reaction were unknown. It was unknown if the reporter considered the allergy to vaccine and allergic reaction to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The patient had an allergic reaction to the vaccine as diagnosed by the medical professionals. In order to treat the patient, the allergist would perform necessary allergy testing. The allergist wanted to obtain another vial of the exact same vaccine, same manufacturer and same lot number to perform the allergy testing. The reporter needed a full list including both active and inactive ingredients. The reporter initially requested the facility about the vaccine who referred to GlaxoSmithKline as they did not had information about the ingredients. The reporter asked if there any quad pre-filled syringes of the same lot number because the allergist specified it must be he same lot number. The reporter had doctor's order for this, which they are willing to provide. The reporter also stated that, they understand the vial had to kept refrigerated.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Facial paralysis, Neck pain
Clinical narrative: PER EMPLOYEE, WOKE UP THE NIGHT OF THE 1ST WITH PAIN IN NECK AND LEFT SIDED FACIAL DROOPING WHICH HAS NOT YET RESOLVED. STATES DIAGNOSED AS BELL'S PALSY. IS BEING FOLLOWED BY PCP. WILL HAVE AN MRI DONE THIS WEEK.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event. High dose was given in error to a patient younger than 65.
Age: 12.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Pt was given the varicella vaccination intramuscular and the vaccine should have been given subcutaneously. The pt tolerated the IMM with no reaction. Incident documented and parent notified.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Immune system disorder, Influenza like illness, Nerve injury, Neurostimulator implantation, Pain
Clinical narrative: I have damage to my immune system as a result of the treatment wherein my small nerves are now seen as foreign and are being attacked by my immune system resulting in chronic pain.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia
Clinical narrative: I have damage to my immune system as a result of the treatment wherein my small nerves are now seen as foreign and are being attacked by my immune system resulting in chronic pain.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Influenza like illness, Malaise, Metamorphopsia, Nerve injury
Clinical narrative: I have damage to my immune system as a result of the treatment wherein my small nerves are now seen as foreign and are being attacked by my immune system resulting in chronic pain.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Neurostimulator implantation, Pain, Paraesthesia
Clinical narrative: I have damage to my immune system as a result of the treatment wherein my small nerves are now seen as foreign and are being attacked by my immune system resulting in chronic pain.
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Diarrhoea, Nausea
Clinical narrative: Experienced nausea, stomach cramps & diarrhea one week after receiving flu shot. Reports experienced same symptoms one week after receiving last year's flu shot as well.