chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 3rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 3rd May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 4th May 2018, the patient experienced influenza-like symptoms. On 5th May 2018, the outcome of the influenza-like symptoms was recovered/resolved. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be related to SHINGRIX. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided a follows: The reporter reported the case for herself. The patient received SHINGRIX in the left arm and experienced pain in her arm. The pain resolved in a couple of days. The day after receiving the vaccine, the patient experienced flu-like symptoms that resolved in 1 day. The patient had denied permission to contact their physician. This case was linked US2018186332, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and influenza-like symptoms. On an unknown date, the outcome of the pain in arm and influenza-like symptoms were recovered/resolved. The reporter considered the pain in arm to be related to SHINGRIX. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided a follows: The age at the vaccination was not reported. The reporter stated that a pharmacist mentioned to her that 1 day after receiving vaccination, she (the pharmacist or the patient) experienced flu like symptoms. The patient had a lot of arm pain after receiving the SHINGRIX vaccine. The reporter had limited information regarding this event. The reporter reported two adverse events on two different patients. This report was on behalf of a pharmacist that experienced side effects to the SHINGRIX vaccine. This case was linked to the case US2018186330, reported by the same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 61-year-old female patient who received SHINGRIX (batch number ZG47A, expiry date 28th February 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date and did not had any reaction). On 9th October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced erythema of extremities and pain in arm. On an unknown date, the outcome of the erythema of extremities and pain in arm were unknown. It was unknown if the reporter considered the erythema of extremities and pain in arm to be related to SHINGRIX. Additional details were provided a follows: The health care professional reported an adverse event via click to chat. The reporter was reporting an adverse drug reaction for the first time. The patient received a dose of SHINGRIX on Tuesday of reporting week and had a reaction about a 3 inch red band around her arm and it was painful. The patient did not have any reaction like this with the first dose. The patient liked to report it as a adverse drug reaction. But also wanted to know if the patient do anything specific.
Sex: M
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old male patient who received Influenza vaccine for prophylaxis. On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient reported soreness in his arm with flu vaccine. This case has been linked to the US2018170064, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in arm in a adult male patient who received SHINGRIX for prophylaxis. On 30th September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.  It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient returned to the same pharmacy where the vaccination was performed one week later, on 5th October 2018, and got the flu shot. The patient told the pharmacist that they just had their SHINGRIX shot the week before in their left arm so better give me the flu shot in their right arm. Today The patient was told by the pharmacist who gave them the SHINGRIX shot that the patient was supposed to wait at least 2 weeks after the SHINGRIX shot to get a flu shot. The patient asked whether the effectiveness of either of the vaccine be lessened because the patient got them so close together. The patient had not had side effects from either shot except a slightly sore upper arm from the SHINGRIX.
Sex: F
Vaccine: FLUX
Symptoms: Headache, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a adult female patient who received Flu unspecified (Flu vaccine) for prophylaxis. The patient's past medical history included chickenpox (had history of chicken pox). On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced general body pain and headache. On an unknown date, the outcome of the general body pain and headache were unknown. It was unknown if the reporter considered the general body pain and headache to be related to Flu vaccine. Additional details were provided as follows: The age at vaccination was not provided. The patient stated that she had received flu vaccines (unknown manufacturer) in the past and after receiving them, she has experienced body soreness and headache the patient stated that the soreness that she felt after the flu vaccine was different than the body aches that she experienced following the SHINGRIX vaccine (Refer case US2018179223). The patient stated that she had not received a flu vaccine in at least 5 or 6 years. The patient did not have any additional details regarding the adverse reactions that she experienced after receiving the flu vaccines. This case has been linked with case US2018179223 reported by the same reporter for the same patient.
Age: 18.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been downloaded from regulatory authority (US-SEQIRUS-201802318). This spontaneous report was received from a health professional and refers to a 18 year old female patient. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On 29-SEP-2017, the patient was vaccinated with GARDASIL 9 1 dosage form (DF), intramuscular (anatomical location, lot # and expiration date were not provided), and with FLUVIRIN 0.5 ml, intramuscular, lot # 1720701 (anatomical location and expiration date were not provided) both vaccines for an unknown indication. On the same date, the patient experienced loss of consciousness and syncope. The outcome of loss of consciousness and syncope was reported as recovered on an unknown date. The causality between the events loss of consciousness and syncope and the suspect therapies was not reported. The agency considered loss of consciousness and syncope to be medically significant events.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects. Mother had taken child to the clinic for flu shot and was also scheduled at the school for shot. Form was not pulled as mother did not inform the school that she had taken the child to the clinic for flu shot.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Gait disturbance, Gastric disorder, Headache, Lymphadenopathy, Musculoskeletal stiffness
Clinical narrative: 9-26-18 onset; severe back head pain; swelling of glands in neck; stiffness; shakes - told to go to bed for 2 days; 9/28/18 swelling of face - appeared psoriasis was turned into a flare; went to ER - prescribed BENADRYL. 9-30-18 much worse - returned to ER; got high dose of prednisone. Three days psoriasis started to calm down; swelling of face decreased; pains in feet and legs became severe; could hardly walk; this lasted several days; as of 10-16-2018 some pain still in legs (severe foot and leg pain followed by stomach issues that have not resolved).
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Psoriasis, Swelling face, Tremor
Clinical narrative: 9-26-18 onset; severe back head pain; swelling of glands in neck; stiffness; shakes - told to go to bed for 2 days; 9/28/18 swelling of face - appeared psoriasis was turned into a flare; went to ER - prescribed BENADRYL. 9-30-18 much worse - returned to ER; got high dose of prednisone. Three days psoriasis started to calm down; swelling of face decreased; pains in feet and legs became severe; could hardly walk; this lasted several days; as of 10-16-2018 some pain still in legs (severe foot and leg pain followed by stomach issues that have not resolved).
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Nausea, Pain in extremity, Paraesthesia
Clinical narrative: Severe pain at site, radiating down arm. Nausea, fever, malaise, LE tremors with paresth.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor, White blood cell count increased
Clinical narrative: Severe pain at site, radiating down arm. Nausea, fever, malaise, LE tremors with paresth.
Age: 23.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: The area become swollen and hard, red and hot. Patient took 5 days clindamycin treatment, (alternative to penicillin allergy). Today still have a hard area.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Lip swelling, Scab
Clinical narrative: Today (10-16-18) patient telephoned Medical Center to report that eight hours after receiving influenza vaccination on 10-12-18  his lower lip swelled. Never any airway or tongue distress. He also wants the package insert mailed to him. He declined offer of medical care. He stated he is normal today except for a few scabs on his lower lip that are healing. His lip is normal size now.
Age: 0.08
Sex: F
Vaccine: HEPA, HIBV, PNC13, RV5
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Hepatitis A 0.5ml (Ped./ Adol.) 0.5 ml was given IM to 7 week old infant instead of PEDIARIX (DTAP, Polio, Hepatitis B) that was ordered resulting in an early dose of that specific vaccine. Parents have been notified and no harm to child as of the date of this report. Child has been recalled to return to office for PEDIARIX vaccine. Child will be monitored during routine office visits for sick and well child check-ups for potential long term effects from receiving the Hepatitis A vaccine early.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Pharyngeal oedema, Urticaria
Clinical narrative: 0735 Patient presented with c/o hives; throat swelling; flushed feeling; 0740 Patient given 0.3 mg of epinephrine via Epipen auto injector to right outer vastus lateralis; 0745 Patient reported "feeling better" Hives were less visible and she felt less flushed; 0745 Adult Medical Emergency Team transported patient to ED.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Feeling abnormal, Rash erythematous, Rash generalised
Clinical narrative: Patient reported to the Emergency Department approximately three hours after receiving smallpox vaccine. The patient had a red rash to the entire body. Patient did not have throat swelling, but did complain of funny feeling in his chest. Patient was discharged from the Emergency Department with cetirizine and dexamethasone.
Age: 76.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Dyspnoea, Paraesthesia oral, Peripheral swelling, Throat tightness
Clinical narrative: Patient called pharmacy stating she had swollen arm, trouble breathing, lips tingling, and tight throat. Primary care provider contacted. Patient was recommended to go in. She later was taken by ambulance and treated in ER.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever 101 degrees, Muscle Aches, Fatigue.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Pt called a week later and complained of arm aches/pains and that she couldn't get out of bed for 1 day after shot.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 04-DEC-2017, the patient was vaccinated with ROTATEQ (strength were unknown, lot# N004815 and expiration date 07-OCT-2018) 1 dose form orally for prophylaxis. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017 was 47 degree Celsius for max 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an office manager, referring to a multiple patients of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with multiple doses of improperly stored VARIVAX (which had a lot # of R002051 and an expiration date of 22-JAN-2020, N023956 and an expiration date of 01-SEP-2019, R017945 and an expiration date of 24-JUN-2020 and N029630 and an expiration date of 23-OCT-2019, R006221 and an expiration date of 29-FEB-2020, R010466 and an expiration date of 10-APR-2018; (dosage number and route of administration were not reported), for prophylaxis. Another batch of PROQUAD (which had a lot # of R006749 and an expiration date of 03-SEP-2019, R015740 and an expiration date of 02-DEC-2019, R006214 and an expiration date of 28-AUG-2019; (dosage number and route of administration were not reported), for prophylaxis, and had also been improperly stored. Another batch of M-M-R II (which had a lot # of N032747 and an expiration date of 20-NOV-2019, N027780, and an expiration date of 08-AUG-2019, R000554 and an expiration date of 08-JAN-2020, R002049 and an expiration date 22-JAN-2020, N026273 and an expiration date 21-SEP-2019, N025894 and an expiration date of 19-SEP-2019; (dosage number and route of administration were not reported), for prophylaxis. The office manager also reported the sterile diluent (unknown lot number and expiration date) used to reconstitute VARIVAX and PROQUAD did not undergo a temperature excursion. The vaccines experienced the following temperature excursions: -9°C to 8 °C (-7.4°C) for 1 hour and 35 minutes and -9°C to 8°C (-6.1°C) for 1 hour and 55 minutes. Previous temperature excursions were reported: -9°C to 8°C (7.6°C) for 13 hours and 46 minutes. The aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved and no adverse effects were experienced in any patients.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 08-OCT-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 26-JUN-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 14-DEC-2015, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, 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: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 08-OCT-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 01-FEB-2017, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a hospital emergency department as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 15-FEB-2017, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, 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: Herpes zoster, Rash
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with ZOSTAVAX at a physician office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of shingles, or severe herpes zoster. In 2015, the patient was treated in a physician office for the onset of a rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient suffered and continues to suffer painful and ongoing injuries and damages, and required and continues to require extensive medical care and treatment. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 20-NOV-2014, the patient was inoculated with ZOSTAVAX by a pharmacist as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated at a medical center for a vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse prescriber and  refers to a 15-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 10-OCT-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N032744, expiration date 20-NOV-2019 (dose, route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 15 to 46 degrees Fahrenheit for 2 hours and 57 minutes. Data logger was not involved. There were no previous excursions reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1810USA007033:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 07-DEC-2017, the patient was vaccinated with ROTATEQ (strength were unknown, lot# N004815 and expiration date 07-OCT-2018) 1 dose form orally for prophylaxis. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017 was 47 degree Celsius for max 15 hours. And on 07-DEC-2017 was 50 degree Celsius for max 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 28-DEC-2017, the patient was vaccinated with ROTATEQ (strength were unknown, lot# N003984 and expiration date19-NOV-2018) 1 dose form orally for prophylaxis (product storage error). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017 was 47 degree Celsius for max 15 hours and on 07-DEC-2017 was 50 degree Celsius for max 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001958.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 16-NOV-2017, the patient was vaccinated with ROTATEQ (strength were unknown, lot# M042169 and expiration date 22-JUN-2018) 1 dose form orally for prophylaxis (product storage error). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017 was 47 degree Celsius for max 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 18-JAN-2018, the patient was vaccinated with ROTATEQ (strength were unknown, lot# N003984 and expiration date 19-NOV-2018) 1 dose form orally for prophylaxis (product storage error). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017 was 47 degree Celsius for max 15 hours. And on 07-DEC-2017 was 50 degree Celsius for max 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 05-DEC-2017, the patient was vaccinated with ROTATEQ (strength were unknown, lot# N004815 and expiration date 07-OCT-2018) 1 dose form orally for prophylaxis (product storage error). No adverse event was reported. The excursion temperature on 08-NOV-2017 and 16-NOV-2017 was 47 degree Celsius for max 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001958.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 12-JAN-2018, the patient was vaccinated with ROTATEQ (strength were unknown, lot# N003984 and expiration date 19-NOV-2018) 1 dose form orally for prophylaxis (product storage error). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017 was 47 degree Celsius for max 15 hours. And on 07-DEC-2017 was 50 degree Celsius for max 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 04-DEC-2017, the patient was vaccinated with ROTATEQ (strength were unknown, lot# M042169 and expiration date 22-JUN-2018) 1 dose form orally for prophylaxis (product storage error). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017 was 47 degree Celsius for max 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001958.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 08-OCT-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 27-SEP-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route by a physician at a physician's office as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 31-JAN-2014, the patient was treated by a physician at a physician's office for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. The patient was prescribed prednisone and VALTREX for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, 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: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 31-MAY-2011, the patient was inoculated with ZOSTAVAX at a medical facility as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 24-JUL-2014, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or around December 2012, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of shingles, or severe herpes zoster. On or about 16-MAY-2014, the patient was diagnosed with herpes zoster or shingles. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient suffered and continues to suffer painful and ongoing injuries and damages, and required and continues to require extensive medical care and treatment. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The report was first received from practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 01-MAR-2018, the patient was vaccinated with ROTATEQ (strength were unknown, lot# N003984 and expiration date 19-NOV-2018) 1 dose form orally for prophylaxis (product storage error). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017 and 23-JAN-2018 was 47 degree Celsius for max 15 hours. And on 07-DEC-2017 was 50 degree Celsius for max 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature decreased, Cough, Dysphagia, Fatigue, Loss of personal independence in daily activities
Clinical narrative: Severe sore throat, hard to swallow Monday night 10/15. Aches & pains. Heavy general feeling of sickness and cannot function - fatigue and sleeping all da. No fever (in fact, low). Bad congestion/runny nose. Coughing. Usually healthy - this is quite unusual.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Nasal congestion, Oropharyngeal pain, Pain, Rhinorrhoea
Clinical narrative: Severe sore throat, hard to swallow Monday night 10/15. Aches & pains. Heavy general feeling of sickness and cannot function - fatigue and sleeping all da. No fever (in fact, low). Bad congestion/runny nose. Coughing. Usually healthy - this is quite unusual.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Somnolence
Clinical narrative: Severe sore throat, hard to swallow Monday night 10/15. Aches & pains. Heavy general feeling of sickness and cannot function - fatigue and sleeping all da. No fever (in fact, low). Bad congestion/runny nose. Coughing. Usually healthy - this is quite unusual.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Pyrexia
Clinical narrative: Redness, rash, fever and pain on site of injection, given BENADRYL and TYLENOL for pain.
Age: 63.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Blood glucose normal, Dizziness, Electrocardiogram abnormal, Eye movement disorder, Loss of consciousness
Clinical narrative: Patient reported being dizzy then became unconscious, his eyes rolled upward to the left, he begun to shake, especially his right hand and had an episode of urinary incontinence, this happened 3 times. EMS was activated his blood sugar was tested result was 116 and EKG done which showed normal sinus bradycardia. He refused EMS transport to ED.
Age: 63.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Sinus bradycardia, Tremor, Urinary incontinence
Clinical narrative: Patient reported being dizzy then became unconscious, his eyes rolled upward to the left, he begun to shake, especially his right hand and had an episode of urinary incontinence, this happened 3 times. EMS was activated his blood sugar was tested result was 116 and EKG done which showed normal sinus bradycardia. He refused EMS transport to ED.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Incoherent, Lip swelling, Nausea, Pruritus generalised
Clinical narrative: Approx 30 minutes after receiving influenza vaccine Pt broke out in hives and complained of itching all over her body from head to the soles of her feet. Pt had whelps on arms, back, chest, neck and her lips were swollen. Pt never complained of difficulty breathing or swallowing but did start having dizziness and feeling sick to her stomach. We applied a cold compress to the back of her neck, administered BENADRYL topical and oral. Pt did state she was having a hard time feeling her legs and couldn't understand some of the things we were trying to communicate to her. At that time we called EMS. By the time EMS arrived (approx. 10 -15 min) Pt had no symptoms of dizziness, being non-coherent, and could feel her legs. Pt was transported to Emergency room at that time.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Sensory loss, Urticaria
Clinical narrative: Approx 30 minutes after receiving influenza vaccine Pt broke out in hives and complained of itching all over her body from head to the soles of her feet. Pt had whelps on arms, back, chest, neck and her lips were swollen. Pt never complained of difficulty breathing or swallowing but did start having dizziness and feeling sick to her stomach. We applied a cold compress to the back of her neck, administered BENADRYL topical and oral. Pt did state she was having a hard time feeling her legs and couldn't understand some of the things we were trying to communicate to her. At that time we called EMS. By the time EMS arrived (approx. 10 -15 min) Pt had no symptoms of dizziness, being non-coherent, and could feel her legs. Pt was transported to Emergency room at that time.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Patient said her arm was very red and swollen following vaccination and she spiked a fever.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patients upper arm is very red, hot, swollen and painful. From under arm to elbow. Instructed patient to cool compress arm take BENADRYL and we will follow up.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Vomiting
Clinical narrative: Chills, Vomiting, Diarrhea.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Hypotension, Loss of consciousness, Unresponsive to stimuli, Urinary incontinence
Clinical narrative: Patient received FLUZONE HIGH DOSE immunization in the pharmacy, was waiting on husband to get his and had passed out on bench while waiting. We reacted to the patient who was unresponsive but still breathing. Called 911. Patient become alert and was very warm. Pulse was solid. Pt did urinate in the process. EMS came and evaluated her. Patient denied need to go to hospital, but did wait on her daughter to come pick her up rather than drive home. Did test blood pressure and reported to both patient and daughter that is was very low, even a half hour after the incident (while waiting for daughter to come).
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Death
Clinical narrative: Pt had stroke and died 10/3/18.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia oral, Pruritus, Urticaria
Clinical narrative: PT came in the following day at about 10:30 am with itchy hives and tingling lips. OT went to the drug store for BENADRYL. PT came back in and stated the BENADRYL was not working. PT was sent to the ER. PT returned and stated they felt better.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Atrial fibrillation, Condition aggravated, Electrocardiogram normal, Heart rate increased
Clinical narrative: Atrial fibrillation (high, chaotic pulse rate). Additional metoprolol and MULTAQ above normal doses. Returned to normal rhythm around noon on 10/16/2018.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Pt reports pain and weakness on the left arm starting the day after immunization. Pain level of 8 out of 10. No relief with TYLENOL.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site injury, Injection site pain
Clinical narrative: Patient was given the flu shot. Person administering the vaccine hit her bone. Felt resistance with the vaccine instead of take the needle out the person administering the vaccine pushed the syringe extremely had to get fluid inside of her arm. It was extremely painful for patient. She had a provider document the instance. Today, 3 days after instance member is unable to lift her arm straight out due to pain. Patient went to emergency room today. They gave her pain medications and a sling.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Pain, Rash macular, Skin warm
Clinical narrative: Patient called the pharmacy the evening of the day that the vaccine was given with a warm, red arm. She reported a reddish line going around her arm about 5 finger lengths below the bandaid site. She reported some splotchy red spots as well. She ended up taking Tylenol for the pain. When I called her back 10/16 in the morning, her arm was much better. The swelling and pain had gone way down and she was no longer worried about it.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Swelling
Clinical narrative: Patient called the pharmacy the evening of the day that the vaccine was given with a warm, red arm. She reported a reddish line going around her arm about 5 finger lengths below the bandaid site. She reported some splotchy red spots as well. She ended up taking Tylenol for the pain. When I called her back 10/16 in the morning, her arm was much better. The swelling and pain had gone way down and she was no longer worried about it.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Injection was given with 5/8 inch needle, resulting in sub-q administration versus desired IM administration with 1 inch needle.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood glucose increased, Chills, Headache, Pyrexia
Clinical narrative: 1.5 hours after receiving shot Patient had a swollen puffy face. She became weak and "absent". By 6pm he had a big headache and vomiting. Following dinner (which she barely ate - normally has a very healthy appetite) she had vomiting and a low grade fever. She took ibuprophen. At this point we checked her sugar and it had spiked to 241 which for her only happens when she gets sick. She had uncontrollable shakes and chills for several hours into the night. Between the shakes, high sugar and fever it was very scary for several hours. Fever remained elevated, spiked a couple times above 101 - 102 degrees. I slept in her room with her to monitor her all night long. Following morning her sugar started to come back down and fever lifted. By 24 hours later she was back to her normal self.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face, Tremor, Vomiting
Clinical narrative: 1.5 hours after receiving shot Patient had a swollen puffy face. She became weak and "absent". By 6pm he had a big headache and vomiting. Following dinner (which she barely ate - normally has a very healthy appetite) she had vomiting and a low grade fever. She took ibuprophen. At this point we checked her sugar and it had spiked to 241 which for her only happens when she gets sick. She had uncontrollable shakes and chills for several hours into the night. Between the shakes, high sugar and fever it was very scary for several hours. Fever remained elevated, spiked a couple times above 101 - 102 degrees. I slept in her room with her to monitor her all night long. Following morning her sugar started to come back down and fever lifted. By 24 hours later she was back to her normal self.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine was administered with 5/8 inch needle, resulting in sub-q administration versus desired IM administration with 1 inch needle.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Vomiting
Clinical narrative: Reported vomiting about 5-10 hours after vaccine was given. Has a area of erythema and warmth 7cmx4 cm around injection site area. advised to take Benadryl and to use cool compresses.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Acne, Rash, Rash pustular
Clinical narrative: Patient states he broke out in a rash about a week after receiving the flu vaccine, saw his physician for bloodwork, and they couldn't figure out what was going on, so he was referred to a dermatologist as rash turned into pus-filled pimples.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Musculoskeletal stiffness
Clinical narrative: On 10/12/18 patient called pharmacy and reported that since her 2nd dose she experienced a stiff arm from wrist all the way up to shoulder in vaccinated arm. lately, the stiffness has subsided from wrist to elbow, but remains from elbow to shoulder. I suggested she contact her MD for further evaluation.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Hypersomnia
Clinical narrative: Baby was given 2 shots at her 4 month checkup. She was given the DTaP (not sure which version above) and the PREVNAR. She literally slept for an entire weekend only staying up for 4 hours throughout the day in small one hour stretches. She was eating normally and sleeping through the night as well as her excessive napping. This continued for 3 full consecutive days after receiving the shot. She is still mushy on the Tuesday after getting the shots on Friday.