chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were unknown. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The patient's initials and date of birth were unknown. The patient experienced severe pain and redness at injection site. The reporter agreed to follow up from GlaxoSmithKline. This case was linked to the case US2018GSK169612, reported by the same reporter.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 14-Sep-2018 regarding an unsolicited valid non-serious case received from a non-health professional (sales representative). This case involves a 11 years old male patient who received adacel as his primary dtap series, while he received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a primary dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route. It was a case of actual medication error due to Inappropriate age at vaccine administration. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Extensive swelling of vaccinated limb, Injection site cellulitis, Injection site erythema, Injection site induration, Injection site inflammation
Clinical narrative: Initial information received on 14-Sep-2018 regarding an unsolicited valid serious case received from pharmacist via phone. This case involves a 67 years old female patient who experienced skin hard, redness from the elbow to the shoulder, temp of 101 Fahrenheit and painful and cellulitis, while she received vaccines PNEUMOVAX 23 and FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 12-Sep-2018, the patient received 0.5 mL dose of suspect FLUZONE HIGH DOSE lot UJ004AA, expiry date 09-MAR-2019 and PNEUMOVAX 23 not produced by Sanofi Pasteur lot number not reported via intramuscular route in the left deltoid. On 14-Sep-2018, 2 days post-vaccination patient reported a serious skin hard (Skin induration), redness from the elbow to the shoulder, temp of 101 fahrenheit and painful (Extensive swelling of vaccinated limb), redness from the elbow to the shoulder, temp of 101 fahrenheit and painful (Fever), redness from the elbow to the shoulder, temp of 101 fahrenheit and painful (PAin), redness from the elbow to the shoulder, temp of 101 fahrenheit and painful (Inflammation) and later it was diagnosed as Cellulitis. These events were assessed as medically significant. Relevant tests were not reported. Final diagnosis was redness from  the elbow to the shoulder, temp of 101 Fahrenheit and painful, skin hard and cellulitis. The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Product used for unknown indication and CLINDAMYCIN (CLINDAMYCIN) for Product used for unknown indication. The outcome of the events was reported as unknown. Documents held by sender: none.; Sender's Comments: This case involves an elderly female patient who presented with cellulitis after vaccination with FLUZONE HIGH DOSE vaccine. Time to onset is compatible. There is, however, no information regarding patient's medical condition at time of vaccination, identification of the causative organism, safety of the vaccination procedure and lab tests ruling out alternate etiologies. There is a possibility that the cellulitis is due to a pre-existing nidus of infection or introduction of skin commensals during inoculation. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Initial information received on 14-Sep-2018 regarding an unsolicited valid serious case received from pharmacist via phone. This case involves a 67 years old female patient who experienced skin hard, redness from the elbow to the shoulder, temp of 101 Fahrenheit and painful and cellulitis, while she received vaccines PNEUMOVAX 23 and FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 12-Sep-2018, the patient received 0.5 mL dose of suspect FLUZONE HIGH DOSE lot UJ004AA, expiry date 09-MAR-2019 and PNEUMOVAX 23 not produced by Sanofi Pasteur lot number not reported via intramuscular route in the left deltoid. On 14-Sep-2018, 2 days post-vaccination patient reported a serious skin hard (Skin induration), redness from the elbow to the shoulder, temp of 101 fahrenheit and painful (Extensive swelling of vaccinated limb), redness from the elbow to the shoulder, temp of 101 fahrenheit and painful (Fever), redness from the elbow to the shoulder, temp of 101 fahrenheit and painful (PAin), redness from the elbow to the shoulder, temp of 101 fahrenheit and painful (Inflammation) and later it was diagnosed as Cellulitis. These events were assessed as medically significant. Relevant tests were not reported. Final diagnosis was redness from  the elbow to the shoulder, temp of 101 Fahrenheit and painful, skin hard and cellulitis. The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Product used for unknown indication and CLINDAMYCIN (CLINDAMYCIN) for Product used for unknown indication. The outcome of the events was reported as unknown. Documents held by sender: none.; Sender's Comments: This case involves an elderly female patient who presented with cellulitis after vaccination with FLUZONE HIGH DOSE vaccine. Time to onset is compatible. There is, however, no information regarding patient's medical condition at time of vaccination, identification of the causative organism, safety of the vaccination procedure and lab tests ruling out alternate etiologies. There is a possibility that the cellulitis is due to a pre-existing nidus of infection or introduction of skin commensals during inoculation. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 19-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 57 years old male patient who was vaccinated with 0.5 ml dose of FLUZONE HIGH DOSE (lot number: UI994AB and expiry date: 09-Apr-2019) via intramuscular route in the left deltoid (dose in series not reported) on 18-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration because a 57 years old patient received the following vaccination. No reaction reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
Sex: F
Vaccine: FLUR4
Symptoms: Exposure during pregnancy
Clinical narrative: Initial information received on 18-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a female patient of an unknown age who was received vaccine FLUBLOK QIV (batch number, expiry date, dose, route and site of administration were unknown) on an unspecified date, while she was pregnant. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was case of vaccine exposure during pregnancy. The patient was 9 months pregnant when she received vaccine. It was unknown whether patient experienced any adverse reaction after the injection. Pregnancy outcome was unknown at the time of report. List of documents held by sender- none.
Sex: U
Vaccine: FLU3
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 18-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a patient (age was not reported) who was vaccinated with a dose of FLUZONE HD (lot UJ006Ab, Expiry date: 14-Apr-2019) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to vaccine underdose. It was reported that when the needle was in the skin giving FLUZONE HD, had some dripping out of the syringe. Pharmacist thought from the hub of the needle. He felt he assembled the needle normally and tight enough. It was also a case of syringe issue. It was not reported whether the patient experienced any adverse events or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Initial information received on 20-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves patient who received expired doses of FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date (also reported as 12-Sep-2018 to 13-Sep-2018), the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UI869AA, expiry date- 05-May-2018 via unknown route. It was a case of actual medication error due to expired vaccine used. The patient outcome is reported as Not Applicable for received expired doses of FLUZONE QUADRIVALENT. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 54.0
Sex: M
Vaccine: FLU4, HEPAB, VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient accidentally received 3 doses of SHINGRIX instead of the recommended 2 doses (administration error).
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion
Clinical narrative: A CAREGIVER CAME INTO THE PHARMACY ON 9/24/18 WITH PICTURES OF HER BRUISED ARM. IT WAS A LARGE BRUISE FROM UPPER DELTOID DOWN TO JUST ABOVE HER ELBOW. SHE SAID PATIENT HAS NO PAIN NOW AND THE BRUISE WAS KIND OF BETTER. SHE CLAIMED THAT THE PHARMACIST MAY HAVE GRABBED HER ARM SO TIGHT.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Dizziness, Hypoacusis, Postictal state, Seizure, Syncope
Clinical narrative: Prior to immunization, client's mother states that client has not had any problems or issues with vaccines in the past. Client's mother states that the client does not have any allergies. Screening checklist for contraindications to vaccines for children and teens completed by client's mother and RN confirms that there are no contraindications to vaccination today. MCV4 (MENACTRA) administered IM in client's right deltoid with alcohol prep per protocol without incident. Influenza vaccine administered IM in client's left deltoid with alcohol prep per protocol. Client seated at time of vaccine administration. Client states "I feel dizzy" and  faints, slumping over in chair. RN calls out for assistance from other staff. RN holds client upright in chair, maintaining client's airway and safety. Client begins seizing. Staff assist RN in safely positioning to  lying on floor. Client vital signs within normal limits. Client temperature 97.2 degrees Fahrenheit. Client states her vision is blurry and she is having difficulty hearing. Over the next 20 minutes, client's vision and hearing return to baseline. Client's vital signs remain stable. Client temperature 97.7 degrees Fahrenheit.  Client remains slightly postictal. Client assisted to standing. Client's mother states she now recalls a similar incident with co-administration of varicella and influenza vaccines on 08/22/2012. Client referred to PCP and/or ED for follow-up. Client and mother walk out of health department office and mother states she will be driving client home.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Vision blurred
Clinical narrative: Prior to immunization, client's mother states that client has not had any problems or issues with vaccines in the past. Client's mother states that the client does not have any allergies. Screening checklist for contraindications to vaccines for children and teens completed by client's mother and RN confirms that there are no contraindications to vaccination today. MCV4 (MENACTRA) administered IM in client's right deltoid with alcohol prep per protocol without incident. Influenza vaccine administered IM in client's left deltoid with alcohol prep per protocol. Client seated at time of vaccine administration. Client states "I feel dizzy" and  faints, slumping over in chair. RN calls out for assistance from other staff. RN holds client upright in chair, maintaining client's airway and safety. Client begins seizing. Staff assist RN in safely positioning to  lying on floor. Client vital signs within normal limits. Client temperature 97.2 degrees Fahrenheit. Client states her vision is blurry and she is having difficulty hearing. Over the next 20 minutes, client's vision and hearing return to baseline. Client's vital signs remain stable. Client temperature 97.7 degrees Fahrenheit.  Client remains slightly postictal. Client assisted to standing. Client's mother states she now recalls a similar incident with co-administration of varicella and influenza vaccines on 08/22/2012. Client referred to PCP and/or ED for follow-up. Client and mother walk out of health department office and mother states she will be driving client home.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: Developed a high fever within 24 hours of the immunizations. Was taken to hospital where the doctor stated it was most likely a reaction to the immunizations.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV9, VARCEL
Symptoms: Dizziness, Dyskinesia
Clinical narrative: He had 3 jerky movements of upper extremities and suddenly woke up and said what happened. The incident lasted for less than 5 seconds then he felt dizzy for another 10 minutes. No sweating, pallor or cyanosis. No apnea, facial twitching's, frothing or sphincter incontinence.
Age: 76.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Skin rash.
Age: 5.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Abdominal discomfort, Pyrexia, Rash, Rash pruritic
Clinical narrative: Fever 9-18-18 upset stomach, rash developed 9-20-18 itching rash, rash still present 9-24-18.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Pain
Clinical narrative: Ache all over. I felt very very achy from my head to my toes. Never have had a reaction from any shot before. I am fine now, just sick for 2 days.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Headache, joint pain, nausea, leg pain, fever. All about 4 hours and then stopped.
Age: 76.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Erythema, Gait disturbance, Headache, Injection site pain
Clinical narrative: Incredible swelling of LF. arm - redness - heat - pain in arm. Headache - nausea. Weakness in extremities - wobbly knees. Shaking (not trembling) - trouble walking. Ache. Eyes - teeth chatter. Arm still sore but - appears to have recovered. These were my second of a series of 2 in two consecutive yrs. - at pharmacy. In 2017, the reaction I had was normal - soreness - reddish - swelling. This year, 2018, it was painful. Even today my arm is a bit sore at site of injection. The weakness and shaking in limbs was severe. My reaction except for pain in LF. arm came after I helped my ambulatory husband get to bed. He is an active healthy orthodontist who needed me to help him. I didn't even had a sniffle, cold, temp, nothing for at least a month prior! Am in good health (use exercise equipment every day).
Age: 76.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Muscular weakness, Nausea, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Incredible swelling of LF. arm - redness - heat - pain in arm. Headache - nausea. Weakness in extremities - wobbly knees. Shaking (not trembling) - trouble walking. Ache. Eyes - teeth chatter. Arm still sore but - appears to have recovered. These were my second of a series of 2 in two consecutive yrs. - at pharmacy. In 2017, the reaction I had was normal - soreness - reddish - swelling. This year, 2018, it was painful. Even today my arm is a bit sore at site of injection. The weakness and shaking in limbs was severe. My reaction except for pain in LF. arm came after I helped my ambulatory husband get to bed. He is an active healthy orthodontist who needed me to help him. I didn't even had a sniffle, cold, temp, nothing for at least a month prior! Am in good health (use exercise equipment every day).
Age: 76.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Skin warm, Tremor
Clinical narrative: Incredible swelling of LF. arm - redness - heat - pain in arm. Headache - nausea. Weakness in extremities - wobbly knees. Shaking (not trembling) - trouble walking. Ache. Eyes - teeth chatter. Arm still sore but - appears to have recovered. These were my second of a series of 2 in two consecutive yrs. - at pharmacy. In 2017, the reaction I had was normal - soreness - reddish - swelling. This year, 2018, it was painful. Even today my arm is a bit sore at site of injection. The weakness and shaking in limbs was severe. My reaction except for pain in LF. arm came after I helped my ambulatory husband get to bed. He is an active healthy orthodontist who needed me to help him. I didn't even had a sniffle, cold, temp, nothing for at least a month prior! Am in good health (use exercise equipment every day).
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Left deltoid injection site. Soreness for first day, ROM pain days following for 2 weeks. Injection site has no redness, swollen, or pain.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A high dose flu vaccine was given to a gentleman that was below the recommended age. Patient was 57 years old and the high dose is recommended for 65 years of age and older.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: On 9/5/18 my left upper arm was swollen. 9/6/18 my mid arm had reddened area, ~3x2" with slight itching.  9/7/18 the area was slightly larger but deeper red color, itching. I took benadryl 25mg x2 that evening, then benadryl 25mg x1 the next day.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Nasal congestion, Pruritus
Clinical narrative: Stuffy nose, itching, and dizziness.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia
Clinical narrative: Gradual onset of diffuse myalgias followed by sudden onset severe and uncontrollable shivering, possible fever.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Rash with itching upper torso.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Discomfort, Insomnia, Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Shortly after being given the 1yr vaccines, my son began slightly convulsing like he was having a seizure. He went completely unresponsive for a minute, he was breathing but just gazing off into space and I couldn't get his attention. He spiked an uncontrollable fever, for 3 days. His limbs were so sore he could not even lift himself up from a laying down position. He was so uncomfortable he couldn't sleep.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Seizure, Staring, Unresponsive to stimuli
Clinical narrative: Shortly after being given the 1yr vaccines, my son began slightly convulsing like he was having a seizure. He went completely unresponsive for a minute, he was breathing but just gazing off into space and I couldn't get his attention. He spiked an uncontrollable fever, for 3 days. His limbs were so sore he could not even lift himself up from a laying down position. He was so uncomfortable he couldn't sleep.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot, Hypoaesthesia oral, Malaise
Clinical narrative: 5 minutes after receiving the vaccination patient felt very warm. She stated she did not feel well. About 2 minutes later she stated her lips and tongue felt numb.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Fatigue, Myalgia
Clinical narrative: Fatigue, muscle and bone aches.
Age: 64.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Syringe issue, Underdose
Clinical narrative: Patient did not have any symptoms of an adverse event, but when using the Pharmajet injector, a significant amount of the vaccine came out of the side of the injector and did not get injected into the patient even though his skin was broken.
Age: 23.0
Sex: F
Vaccine: HEPAB, HPV9
Symptoms: Syncope
Clinical narrative: Syncope.
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous report was received from a consumer via Pfizer refers to a female patient of unknown age. The patient's concurrent conditions, concomitant therapy and medical history were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX strength, frequency, lot # and expiry date was unknown) for prophylaxis. On an unknown date, the patient experienced allergy to vaccine. Outcome of allergy to vaccine was unknown. The reporter considered allergy to vaccine to be related to ZOSTAVAX. Sender's Comments: US-PFIZER INC-2018317829.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a physician referring to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug, allergy history or concomitant medications. On 09-APR-2018, the patient was vaccinated with improperly stored doses of M-M-R II intramuscularly, lot # N020927, expiration date 01-AUG-2019, (strength, dose and frequency were not provided) for prophylaxis. The M-M-R II was reconstituted with properly stored sterile diluent (MRK). The doses of M-M-R II were exposed to a temperature excursion of 47 degree Fahrenheit (°F) to 77°F (53°F) during a time frame of 5 hours. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA001303: Original Case: 1805USA001303; US-009507513-1809USA011187: Original Case: 1809USA010671; US-009507513-1809USA011189: Original Case: 1809USA010671; US-009507513-1809USA011190: Original Case: 1809USA010671; US-009507513-1809USA011186: Original Case: 1809USA010671; US-009507513-1809USA011185: Original Case: 1809USA010671; US-009507513-1809USA011184: Original Case: 1809USA010671; US-009507513-1809USA011188: Original Case: 1809USA010671.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Peroneal nerve palsy, Post herpetic neuralgia
Clinical narrative: Information has been received on 24-SEP-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age and his spouse. The patient's concurrent conditions, medical history and concomitant medications are unknown. On 10-NOV-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a family health facility for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Ten days after receiving the ZOSTAVAX, the patient developed an intermittent, sharp throbbing pain and blisters on the buttocks. Thereafter, the patient was diagnosed with shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment, including but not limited to, diagnoses of sciatic neuropathy, foot drop, and postherpetic neuralgia. 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: Sciatic nerve neuropathy
Clinical narrative: Information has been received on 24-SEP-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age and his spouse. The patient's concurrent conditions, medical history and concomitant medications are unknown. On 10-NOV-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a family health facility for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Ten days after receiving the ZOSTAVAX, the patient developed an intermittent, sharp throbbing pain and blisters on the buttocks. Thereafter, the patient was diagnosed with shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment, including but not limited to, diagnoses of sciatic neuropathy, foot drop, and postherpetic neuralgia. 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: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a physician referring to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug, allergy history or concomitant medications. On 10-APR-2018, the patient was vaccinated with improperly stored doses of M-M-R II intramuscularly, lot # N020927, expiration date 01-AUG-2019, (strength, dose and frequency were not provided) for prophylaxis. The M-M-R II was reconstituted with properly stored sterile diluent (MRK). The doses of M-M-R II were exposed to a temperature excursion of 47 degree Fahrenheit (°F) to 77°F (53°F) during a time frame of 5 hours. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA001303: Original Case: 1805USA001303; US-009507513-1809USA011187: Original Case: 1809USA010671; US-009507513-1809USA011189: Original Case: 1809USA010671; US-009507513-1809USA011190: Original Case: 1809USA010671; US-009507513-1809USA011186: Original Case: 1809USA010671; US-009507513-1809USA011185: Original Case: 1809USA010671; US-009507513-1809USA010671: Original Case: 1809USA010671; US-009507513-1809USA011188: Original Case: 1809USA010671.
Age: 17.0
Sex: M
Vaccine: FLUX, MENB
Symptoms: Feeling abnormal, Injection site pain, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician. A 17-year-old male patient received TRUMENBA, intramuscular in the arm, on 19Sep2018, at 0.5 ml single, for immunisation and influenza vaccine (unspecified trade name), via an unspecified route of administration, on 19Sep2018, at unspecified dose, for immunisation. Medical history and concomitant medications were none. The patient developed a fever 101.9 on an unspecified date, at the site had pain on an unspecified date, pain in his arm on an unspecified date, felt pretty miserable for 48 hours on 20Sep2018. Outcome of the events was unknown. The patient underwent lab tests and procedures which included body temperature: 101.9. Therapeutic measures were taken as a result of the events and included treatment with Advil. The Advil didn't help, so then he took Tylenol. The reporting physician stated there could be a relationship.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Pain, Pyrexia, Urinary tract infection, Vomiting
Clinical narrative: Initial information received on 14-Sep-2014 regarding an unsolicited valid serious case received from a nurse via phone. This case involves a 73 years old male patient who experienced diagnosed as having a UTI and treated with intravascular (iv) leviquin and admitted to the hospital, while he received vaccine FLUZONE HIGH DOSE. It was reported that patient had the same flu shot last year without issues. The patient's other past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 11-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot U1995AA, expiry day 01 April 2019, via intramuscular route in the right deltoid. On an unspecified date, next day post vaccination complaint fever (pyrexia), nausea, vomiting, body ache (pain) and later patient went to emergency room and was diagnosed as UTI (Urinary tract infection). On an unspecified date, patient was hospitalized for this events. Lab data not reported. Final diagnosis was diagnosed as having a UTI. The patient was treated with LEVOFLOXACIN (LEVAQUIN). The event outcome was reported as unknown.; Sender's Comments: This case concerns an elderly patient who was diagnosed with Urinary Tract Infection on an unknown date after vaccination with FLUZONE High Dose vaccine. Considering the unknown latency, age of the patient and the nature of the event, the role of the vaccine is unlikely.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Nausea, Pyrexia
Clinical narrative: Felt flu like symptoms. Low grade fever. Nausea lasted 1 day.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Dizziness, Head injury, Syncope
Clinical narrative: After giving the vaccines, the patient stood up and went to stand next to father. 3 minutes passed by and he felt dizzy and started to kneel down. He fainted and landed on his back. He hit the back of his head. After less than 1 minute he woke up. Parents stated he was fasting.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient reported pain at the injection site for 4 to 5 days. Has never had vaccine cause pain for more than 1-2 days in the past.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Swelling the next day after injection.
Age: 66.0
Sex: F
Vaccine: FLUR4, PPV, FLU4, PPV
Symptoms: Asthenia, Fatigue, Injected limb mobility decreased, Musculoskeletal pain, Neck pain
Clinical narrative: Patient received the PNEUMOVAX vaccine and the FLUBLOK vaccine in the R deltoid on the morning of 9/24/18. By that evening she complained of body aches, fatigue, temp 100.4 F, arm soreness, weakness, neck and shoulder pain. Reports today 9/25/18 continued significant pain, difficulty lifting R arm, fever resolved.
Age: 66.0
Sex: F
Vaccine: FLUR4, PPV, FLU4, PPV
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient received the PNEUMOVAX vaccine and the FLUBLOK vaccine in the R deltoid on the morning of 9/24/18. By that evening she complained of body aches, fatigue, temp 100.4 F, arm soreness, weakness, neck and shoulder pain. Reports today 9/25/18 continued significant pain, difficulty lifting R arm, fever resolved.
Age: 66.0
Sex: F
Vaccine: FLUR4, PPV, FLU4, PPV
Symptoms: Asthenia, Chills, Discomfort, Headache, Injected limb mobility decreased
Clinical narrative: Patient received the PNEUMOVAX vaccine and the FLUBLOK vaccine in the R deltoid on the morning of 9/24/18. By that evening she complained of body aches, fatigue, temp 100.4 F, arm soreness, weakness, neck and shoulder pain. Reports today 9/25/18 continued significant pain, difficulty lifting R arm, fever resolved.
Age: 66.0
Sex: F
Vaccine: FLUR4, PPV, FLU4, PPV
Symptoms: Injection site pain, Insomnia, Myalgia, Pain, Pain in extremity
Clinical narrative: Patient received the PNEUMOVAX vaccine and the FLUBLOK vaccine in the R deltoid on the morning of 9/24/18. By that evening she complained of body aches, fatigue, temp 100.4 F, arm soreness, weakness, neck and shoulder pain. Reports today 9/25/18 continued significant pain, difficulty lifting R arm, fever resolved.
Age: 66.0
Sex: F
Vaccine: FLUR4, PPV, FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: Patient received the PNEUMOVAX vaccine and the FLUBLOK vaccine in the R deltoid on the morning of 9/24/18. By that evening she complained of body aches, fatigue, temp 100.4 F, arm soreness, weakness, neck and shoulder pain. Reports today 9/25/18 continued significant pain, difficulty lifting R arm, fever resolved.
Age: 66.0
Sex: F
Vaccine: FLUR4, PPV, FLU4, PPV
Symptoms: Asthenia, Fatigue, Injected limb mobility decreased, Musculoskeletal pain, Neck pain
Clinical narrative: I also had, in the same right upper arm the Influenze Vaccine (Inactivated or Recombinant); my doctor said that my adverse side effect is most likely due to the Pneumococcal Polysaccharide Vaccine.  I was vaccinated wtih TWO shots - pneumonia/flu in the morning of 9/24/2018 @ 11:20 AM.  All day, I had the normal arm soreness; but into the late evening hours, I began to feel feverish; achy; headache, muscle aches fever of 100.4/chills and then SEVERE pain in the injection site - w/lack of strength and movement - lasting all night; not much sleep - too uncomfortable. I iced my arm at the injection site/shoulder, etc., to no avail. This morning, and all day, my arm is so severly sore I cannot use it or straighten it.
Age: 66.0
Sex: F
Vaccine: FLUR4, PPV, FLU4, PPV
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: I also had, in the same right upper arm the Influenze Vaccine (Inactivated or Recombinant); my doctor said that my adverse side effect is most likely due to the Pneumococcal Polysaccharide Vaccine.  I was vaccinated wtih TWO shots - pneumonia/flu in the morning of 9/24/2018 @ 11:20 AM.  All day, I had the normal arm soreness; but into the late evening hours, I began to feel feverish; achy; headache, muscle aches fever of 100.4/chills and then SEVERE pain in the injection site - w/lack of strength and movement - lasting all night; not much sleep - too uncomfortable. I iced my arm at the injection site/shoulder, etc., to no avail. This morning, and all day, my arm is so severly sore I cannot use it or straighten it.
Age: 66.0
Sex: F
Vaccine: FLUR4, PPV, FLU4, PPV
Symptoms: Asthenia, Chills, Discomfort, Headache, Injected limb mobility decreased
Clinical narrative: I also had, in the same right upper arm the Influenze Vaccine (Inactivated or Recombinant); my doctor said that my adverse side effect is most likely due to the Pneumococcal Polysaccharide Vaccine.  I was vaccinated wtih TWO shots - pneumonia/flu in the morning of 9/24/2018 @ 11:20 AM.  All day, I had the normal arm soreness; but into the late evening hours, I began to feel feverish; achy; headache, muscle aches fever of 100.4/chills and then SEVERE pain in the injection site - w/lack of strength and movement - lasting all night; not much sleep - too uncomfortable. I iced my arm at the injection site/shoulder, etc., to no avail. This morning, and all day, my arm is so severly sore I cannot use it or straighten it.
Age: 66.0
Sex: F
Vaccine: FLUR4, PPV, FLU4, PPV
Symptoms: Injection site pain, Insomnia, Myalgia, Pain, Pain in extremity
Clinical narrative: I also had, in the same right upper arm the Influenze Vaccine (Inactivated or Recombinant); my doctor said that my adverse side effect is most likely due to the Pneumococcal Polysaccharide Vaccine.  I was vaccinated wtih TWO shots - pneumonia/flu in the morning of 9/24/2018 @ 11:20 AM.  All day, I had the normal arm soreness; but into the late evening hours, I began to feel feverish; achy; headache, muscle aches fever of 100.4/chills and then SEVERE pain in the injection site - w/lack of strength and movement - lasting all night; not much sleep - too uncomfortable. I iced my arm at the injection site/shoulder, etc., to no avail. This morning, and all day, my arm is so severly sore I cannot use it or straighten it.
Age: 66.0
Sex: F
Vaccine: FLUR4, PPV, FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: I also had, in the same right upper arm the Influenze Vaccine (Inactivated or Recombinant); my doctor said that my adverse side effect is most likely due to the Pneumococcal Polysaccharide Vaccine.  I was vaccinated wtih TWO shots - pneumonia/flu in the morning of 9/24/2018 @ 11:20 AM.  All day, I had the normal arm soreness; but into the late evening hours, I began to feel feverish; achy; headache, muscle aches fever of 100.4/chills and then SEVERE pain in the injection site - w/lack of strength and movement - lasting all night; not much sleep - too uncomfortable. I iced my arm at the injection site/shoulder, etc., to no avail. This morning, and all day, my arm is so severly sore I cannot use it or straighten it.
Age: 51.0
Sex: F
Vaccine: PNC13
Symptoms: Nodule, Swelling
Clinical narrative: Patient said that at that time is got swollen then turned into a hard knot ball. She did not report it until 2+ years later. Encouraged her to get it checked out.
Age: 63.0
Sex: F
Vaccine: FLU4, UNK, VARZOS
Symptoms: Crying, Injection site pain
Clinical narrative: PATIENT HAS EXPERIENCED SEVERE PAIN AT INJECTION SITE DAYS AFTER ADMINISTRATION ON 04/25/18. ON 09/21 PT CALLED COMPLAINING ABOUT INTERMITTENT PAIN WHERE SOME DAYS IT HAS BEEN SO SEVERE MAKES HER CRY. SHE HAS BEEN EXPERIENCE THIS FOR 3 MONTHS.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect product formulation administered
Clinical narrative: The patient was given the SHINGRIX with the diluent of sterile Diluent instead of the Adjuvant suspention component to form the SHINGRIX given on 9/17/2018 in Right Deltoid. This was the patients #2 vaccine. This was discovered on 09/24/2018 when their was an extra Adjuvant suspention component left in the box. The was a message left for the patient to call back to the clinic. For us to notify the patient what had happen. He had not reported any adverse reaction at this time. On 9/24/2018 I had contacted the immunization program to verify what had happen and how soon the patient could get the corrected dose.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This FLUZONE vaccine expired 6/30/18. The patient exhibited no ill effects. She was made aware and revaccination was offered.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Eye pain, Headache, Myalgia, Pyrexia
Clinical narrative: Fever 100.0; chills, headache, muscle pain -generalized, pain above eyes. Just stayed in bed and increased fluids, recovery 24 hours.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Fibromyalgia
Clinical narrative: Patient states the vaccine caused a flare up of her fibromyalgia. Patient states flare up lasted one week.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Pain, Vomiting
Clinical narrative: Patient experienced redness/edema at the injections sites, pain, and vomiting. Patient was seed at the ER and was prescribed prednisone and antibiotic. Patient feeling better today.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Asthenia, Chills, Dizziness, Headache, Immediate post-injection reaction
Clinical narrative: Immediate discomfort at injection site. Eight hours later ?. Fever (100 degrees), chills, body aches, headache, slight nausea, weakness and dizziness. Lasted about 16 hours.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site discomfort, Nausea, Pain, Pyrexia
Clinical narrative: Immediate discomfort at injection site. Eight hours later ?. Fever (100 degrees), chills, body aches, headache, slight nausea, weakness and dizziness. Lasted about 16 hours.
Age: 68.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Cellulitis, Erythema, Mobility decreased, Peripheral swelling, Skin warm
Clinical narrative: Patient received both PNEUMOVAX and FLUAD injections and said that she could not lift arm for 2 days and developed red swollen hot patches running down arm. Was diagnosed with cellulitis and received doxycycline 100 mg 1 tablet by mouth twice daily for 7 days.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV, TD
Symptoms: Chills, Induration, Injection site pain, Peripheral swelling, Pruritus
Clinical narrative: Patient received a tetanus and flu shot in left arm and a PNEUMOVAX in right arm all in one setting on 9/24/18. Healthcare professional suggested it would be best to put the PNEUMOVAX in a seperate arm, due to potential side effects that were discussed during imz consent review. Patient reported back to the pharmacy the following day (9/25) and Per patient left arm had no side effects at all, but right arm (the arm that received PNEUMOVAX) began itching around an hour after receiving the vaccine. And then that arm started progressively increasing in size and she said at around 9 to 10pm that evening arm got very swollen and was burning up. She also reported chills, arm turning rock hard, burning up in arm, and severe soreness from shoulder down to slightly above the crease of her elbow. Patient said she went to emergency room late that night, where doctor gave her liquid prednisone. Patient reported a notice in improvement in symptoms today, but not complete recovery. I re-reviewed the VIS statement again today with patient to review again that the side effects she experienced have been previously reported with this vaccine. Patient said she is continuing with oral pain relief today of tylenol or ibuprofen and I suggested using ice as well. (these again were discussed during imz consent review, but re-went over again, today).
Age: 60.0
Sex: F
Vaccine: FLU4, PPV, TD
Symptoms: Skin warm
Clinical narrative: Patient received a tetanus and flu shot in left arm and a PNEUMOVAX in right arm all in one setting on 9/24/18. Healthcare professional suggested it would be best to put the PNEUMOVAX in a seperate arm, due to potential side effects that were discussed during imz consent review. Patient reported back to the pharmacy the following day (9/25) and Per patient left arm had no side effects at all, but right arm (the arm that received PNEUMOVAX) began itching around an hour after receiving the vaccine. And then that arm started progressively increasing in size and she said at around 9 to 10pm that evening arm got very swollen and was burning up. She also reported chills, arm turning rock hard, burning up in arm, and severe soreness from shoulder down to slightly above the crease of her elbow. Patient said she went to emergency room late that night, where doctor gave her liquid prednisone. Patient reported a notice in improvement in symptoms today, but not complete recovery. I re-reviewed the VIS statement again today with patient to review again that the side effects she experienced have been previously reported with this vaccine. Patient said she is continuing with oral pain relief today of tylenol or ibuprofen and I suggested using ice as well. (these again were discussed during imz consent review, but re-went over again, today).
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Injection site pain, Injection site swelling, Malaise, Pain
Clinical narrative: Pain, swelling at site of injection, body aches, pain, significant malaise/fatigue, fever.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Pain, swelling at site of injection, body aches, pain, significant malaise/fatigue, fever.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Bladder catheterisation, Blood test, Chills, Lethargy, Pyrexia
Clinical narrative: Sudden onset of fever, temperature spiked so fast it caused the patient to have rigors, lethargy, delayed reactions and responsiveness; patient was transported to emergency room via ambulance; in Emergency Room, patient's temperature was 103 rectally (no fever before calling 911),  patient was given Tylenol, had a urinary catheterization performed to analyze urine, and blood drawn to evaluate blood for an infection. Once patients temperature decreased to a normal temp, patient became more responsive and returned to his baseline behavior. Patient was discharged with instructions to stay hydrated and control fever/symptoms with Tylenol and Motrin. Time frame was 0825-1200.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Slow response to stimuli
Clinical narrative: Sudden onset of fever, temperature spiked so fast it caused the patient to have rigors, lethargy, delayed reactions and responsiveness; patient was transported to emergency room via ambulance; in Emergency Room, patient's temperature was 103 rectally (no fever before calling 911),  patient was given Tylenol, had a urinary catheterization performed to analyze urine, and blood drawn to evaluate blood for an infection. Once patients temperature decreased to a normal temp, patient became more responsive and returned to his baseline behavior. Patient was discharged with instructions to stay hydrated and control fever/symptoms with Tylenol and Motrin. Time frame was 0825-1200.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Dizziness, Headache, Herpes zoster, Hyperaesthesia, Pain
Clinical narrative: Patient received first dose SHINGRIX on 9/12/18. She developed fever, dizziness, headache, body aches within 24 hours of receiving vaccines. Patient then broke out in blotches and rash on left side of body, which is painful and sensitive to touch. She was diagnosed with Shingles on 9/23/2018.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Rash, Rash macular
Clinical narrative: Patient received first dose SHINGRIX on 9/12/18. She developed fever, dizziness, headache, body aches within 24 hours of receiving vaccines. Patient then broke out in blotches and rash on left side of body, which is painful and sensitive to touch. She was diagnosed with Shingles on 9/23/2018.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Dizziness, Formication, Headache, Herpes zoster
Clinical narrative: Patient received first dose SHINGRIX on 9/12/18. She developed fever, dizziness, headache, body aches within 24 hours of receiving vaccines. Patient then broke out in blotches and rash on left side of body, which is painful and sensitive to touch. She was diagnosed with Shingles on 9/23/2018.