chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: Patient hip where injection was given had large swollen rounded area that was red. In the middle was a yellowish circle, DR cared for patient. KEFLEX 500 mg PO three times daily for 7 days, Ibuprofen and Hydrocodone/acetaminophen 7.5/325 for pain given every 6 hours, ten tablets given.
Age: 19.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling, Product administered at inappropriate site
Clinical narrative: Patient hip where injection was given had large swollen rounded area that was red. In the middle was a yellowish circle, DR cared for patient. KEFLEX 500 mg PO three times daily for 7 days, Ibuprofen and Hydrocodone/acetaminophen 7.5/325 for pain given every 6 hours, ten tablets given.
Age: 24.0
Sex: F
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: Vomiting. Patient called today (8/29/18) to report that she has been vomiting since she received the vaccine.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Headache, Nasal congestion, Rhinorrhoea
Clinical narrative: Seven hours after receiving the flu shot she developed SOB that lasted for two hours, also a headache and stuffy/running nose.
Age: 11.0
Sex: F
Vaccine: UNK
Symptoms: Asthma
Clinical narrative: It was Tdap Vaccine, I am not sure what brand. That evening pt had an asthma attack, which is rare for her. Every evening/afternoon for 3 weeks she ended up having an asthma attack. Fortunately the attack was controlled with medication. After about 3 weeks they were happening less often. Now her asthma seems to have improved. I was asked to sign a paper that I received a copy of the vaccine statement, and since I did not receive that statement I put that I did not receive it, they did give it to me when I left, but it was a poor copy with a portion of it not readable.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Blood culture, Blood lactic acid normal, Chest X-ray, Culture urine, Electrocardiogram
Clinical narrative: ED at Regional Medical Center on 8/22 and 8/24/2018, Cellulitis, redness, swelling down right extremity from infection site which he showed this writer and was back of arm, may have missed deltoid muscle, unsure.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Full blood count, Injection site cellulitis, Injection site erythema, Injection site swelling, Metabolic function test
Clinical narrative: ED at Regional Medical Center on 8/22 and 8/24/2018, Cellulitis, redness, swelling down right extremity from infection site which he showed this writer and was back of arm, may have missed deltoid muscle, unsure.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Wheezing
Clinical narrative: ED at Regional Medical Center on 8/22 and 8/24/2018, Cellulitis, redness, swelling down right extremity from infection site which he showed this writer and was back of arm, may have missed deltoid muscle, unsure.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cellulitis, Injection site cellulitis
Clinical narrative: ED at Regional Medical Center on 8/22 and 8/24/2018, Cellulitis, redness, swelling down right extremity from infection site which he showed this writer and was back of arm, may have missed deltoid muscle, unsure.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Muscle spasms
Clinical narrative: I got a second Recombinant Zoster(Shingles) Vaccine RZV and that night I started getting chills, then sweats and chills when I bundled up, and then violent hip flexor muscle spasms for an hour.  I got out of bed and hobbled to the bathroom when my fist cramped in a clenched position and got two ADVIL. Then I went to bed and the my legs stopped the up and down spasm tiring my hip flexors after the medicine kicked in. My head also had a headache in the morning, when I woke up exhausted from all the spasms the night before.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Soreness, redness, swelling from upper right arm down to elbow.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Nausea
Clinical narrative: Tired, muscle pain in my back and neck, shivering, no fever 98.4 F and nausea.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache
Clinical narrative: Headache, chills.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Impaired work ability, Influenza like illness, Injection site erythema
Clinical narrative: Red swollen and sore arm where shot given. Flu like symptoms. Very achey, chills, with headache and nausea. I missed 1 1/2 days of work.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Nausea, Pain
Clinical narrative: Red swollen and sore arm where shot given. Flu like symptoms. Very achey, chills, with headache and nausea. I missed 1 1/2 days of work.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Influenza like illness, Pain
Clinical narrative: Severe flu-like symptoms, body aches, chills, exhaustion, joint pain.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Pt reports redness and swelling below site of injection. Pt reports taking BENADRYL and using ice. Pt reports symptoms getting better.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The injection area back red, warm to the touch and swollen.
Age: 63.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Flank pain, Nausea, Neck pain, Pyrexia
Clinical narrative: Nausea, fever, sore neck and side.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Urticaria
Clinical narrative: She described her reaction as hives on both arms only. Has had hives following stings and said the reaction was hives and not a rash. No other symptoms. Hives same day as vaccination with AVA # 1 and # 4. Symptoms: URTICARIA, UNSPECIFIED, URTICARIA, UNSPECIFIED.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Symptom's started the day after vaccine. She c/o: Right shoulder pain and difficulty moving her right arm. She was seen in office by Dr. and prescribed: Naproxen - 500 mg - BID - for 7 days. Dx: acute pain of right shoulder.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Rt. thigh red, warm to the touch, slightly swollen site measuring approx. 4 cm wide x 3 cm length. S/s x 2 days. Recommended BENADRYL, TYLENOL or IBP OTC as directed on the bottle per Dr.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Shivers, 99.5 fever.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Dysstasia, Erythema, Influenza like illness
Clinical narrative: Flu like feeling, fever, body aches, nausea, dizziness, weakness, unable to open eyes or stand up. Arm swelled up and turned red, very tender. Lasted until 8/21/18.  Arm redness and tenderness lasted one week.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: Flu like feeling, fever, body aches, nausea, dizziness, weakness, unable to open eyes or stand up. Arm swelled up and turned red, very tender. Lasted until 8/21/18.  Arm redness and tenderness lasted one week.
Age: 80.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Dizziness, Dyspnoea, Heart rate increased, Swelling face
Clinical narrative: Swelling of face, difficulty breathing, fast heart beat, dizziness and weakness 20 minutes after vaccination.The weakness and dizziness
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, TDAP
Symptoms: Dizziness, Dyskinesia, Loss of consciousness, Posture abnormal
Clinical narrative: Within 30 seconds of receiving last injection, client reported feeling dizzy and fell sideways, losing consciousness. Slight jerking movements noted. Within 30 seconds, client regained consciousness and sat upright. No injuries sustained. Client reported having no breakfast prior to coming to clinic; juice given. Client observed in clinic for 15 minutes. He denied continued dizziness and left clinic accompanied by mother.
Sex: F
Vaccine: VARZOS
Symptoms: Allergic reaction to excipient, Anaphylactic reaction, Apparent life threatening event, Death, Resuscitation
Clinical narrative: This spontaneous report as received from a physician, who read in an article that was published recently about a female patient of unknown age. The patient's concurrent conditions included an allergy to meat called "alpha-gal allergy" that was transmitted via tick bite. There was no information about the patient's medical history or concomitant medication. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 plaque-forming units (PFU) for prevention of shingles (dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unspecified date in 2006, the patient died after resuscitation attempts in an unspecified emergency room, due to an anaphylactic reaction to the porcine gelatin content of ZOSTAVAX. The reporter considered the aphylactic reaction to be a life threatening event that required intervention to prevent serious criteria. It was unknown if an autopsy was performed. The reporter considered anaphylactic reaction to be related to ZOSTAVAX. Upon internal review, the event anaphylactic reaction was considered to be medically significant. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1808USA009391: Reported Cause(s) of Death: Anaphylactic reaction to the porcine gelatin content of ZOSTAVAX.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 16-OCT-2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster also known as shingles and other complications. In 2016, the patient was treated by a physician for a blistering vesicular outbreak that 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 direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # R009409, expiry date 29-MAR-2020 (also reported as 31-OCT-2018) subcutaneously for prophylaxis. The sterile diluent (manufacturer unknown) used was stored properly. The doses of vaccine were stored between 6 degrees Fahrenheit (F) to 14 F (9.3F) for 5 hours and 2 minutes. Previous temperature excursions were detected: 15 F to 46 F (41.5 F) for 84 hours. Digital data logger was involved. No adverse effects were reported.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 16-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 years old male patient who was vaccinated with a 0.5 ml fourth dose IPOL (Batch number: N28758 and expiry date: 14-Nov-2019) via intramuscular route in the left deltoid on 16-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. Concomitant medications included DTAP for Immunisation; MMR for Immunisation; and VARICELLA VACCINE for Immunisation on an unknown date. It was a case of potential medication error due to incorrect product storage because vaccine was "too long in transit" and 1 vaccine from a MDV was given. No reaction was 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.
Age: 12.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, Product preparation issue
Clinical narrative: Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves female patient received PENTACEL diluent instead of mixing it with the vaccine, while she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-Aug-2018, the patient received a 0.5 ml once dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5324AG, expiry date- 05-Sep-2019 via intramuscular route in the left thigh. It was a case of actual medication error due to Inappropriate reconstitution technique. Final diagnosis was a patient the pentacel diluent instead of mixing it with the vaccine. The patient outcome is reported as Not Applicable for a patient the pentacel diluent instead of mixing it with the vaccine. 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 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: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PNC13
Symptoms: Extra dose administered, Incorrect product formulation administered, Overdose, Product preparation issue
Clinical narrative: Initial unsolicited report received from other healthcare professional on 22-Aug-2018. This case involves a [6 months] male patient who was vaccinated with a 0.7 ml once third dose of suspect vaccine PENTACEL along with sterile water. (Batch number: C507AB, expiration date- 15-Sep-2019, site of administration left thigh and route was intramuscular) and ACT-HIB site of administration right thigh on 21-Aug-2018 . The patients medical history were not reported. Concomitant medications included PREVNAR 13 administered on left thigh. It was an actual medication error due to inappropriate reconstitution technique, extra dose administered and overdose. 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 holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 22-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional, Nurse. This case involves a 6 months old patient who received vaccines PENTACEL and ACT-HIB at same time. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication not reported. On 22-Aug-2018 at 02 PM, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5458AA. On 22-Aug-2018 at 02 PM, the patient received 0.5 ml dose of suspect HIB (PRP/T) VACCINE lot UI817AA. It was a case of actual medication error due to extra dose administered. It was unknown whether patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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: 1.08
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, Product preparation issue
Clinical narrative: Initial information received on 21-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 13 months old patient (gender unknown) who received vaccine PENTACEL which was not reconstituted properly. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication not reported. On 16-Aug-2018, the patient received a 0.5 ml single dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5262AA via intramuscular route in the right thigh. It was a case of actual medication error due to Inappropriate reconstitution technique. It was reported that PENTACEL a Nurse took out Dtap, took powder and mixed it with powder and sterile water made by Merck. It was unknown whether patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Initial information received on 21-Aug-2018 regarding an unsolicited valid non-serious case received from a Pharmacist. This case involves a 11 years old patient (gender not reported) who was given expired dose, while received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies were reported. On 18-Aug-2018, the patient received a dose of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine lot number not reported (exp date: April-2018) via unknown route in unknown administration site. It was a case of actual medication error case due to expired vaccine administered to the patient. It was reported that MENACTRA was dispensed to facility and administered. Nurse noted that on the label the expiration was from APR 18. Pharmacist has not seen the label but just was informed by nurse via word of mouth. It was unknown if the patient experienced any adverse event. Lab test and corrective treatment: not applicable. Outcome: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 56.0
Sex: M
Vaccine: PNC13
Symptoms: Eye pruritus, Eyelid oedema
Clinical narrative: Itchy eyes, edema under eyes.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Dizziness, Dysphonia, Erythema
Clinical narrative: Extreme soreness of the area and arm, Rash & Haves, itching, redness, swollen area, hoarseness, fever and dizziness. tired and weak with headaches and stomach upset. These adverse reactions did not happen with the first SHINGRIX vaccination on April 6, 2018. I HAVE PHOTOS.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Pruritus
Clinical narrative: Extreme soreness of the area and arm, Rash & Haves, itching, redness, swollen area, hoarseness, fever and dizziness. tired and weak with headaches and stomach upset. These adverse reactions did not happen with the first SHINGRIX vaccination on April 6, 2018. I HAVE PHOTOS.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Swelling, Urticaria
Clinical narrative: Extreme soreness of the area and arm, Rash & Haves, itching, redness, swollen area, hoarseness, fever and dizziness. tired and weak with headaches and stomach upset. These adverse reactions did not happen with the first SHINGRIX vaccination on April 6, 2018. I HAVE PHOTOS.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Patient was pregnant when given the vaccine, 33 weeks along, estimated delivery date of 9/30/2018.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Reported a temperature of 101.4 at 6pm (5 hours after immunization) did not take any medications, seek treatment, and was fever free the next morning. Reported to work the next day feeling better and ready for work.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Approx 7 to 8 hrs after injection, I began having headache and fatigue. An hour after that I developed shaking and chills. My temperature read 99.8. I slept fitfully through the night with aches and stabbing pains all over my body. I had mild nausea. The injection site had become sore, but not hot, bruised or swollen looking. Next morning and throughout the following day, until about 7 pm, my temperature remained elevated and I felt achy all over. I canceled previously scheduled activities and remained in the house all day sleeping, resting, eating very little but drinking plenty of water. By 7 pm my temperature was normal at 98.5. I slept better the second night and upon rising, approximately 45 hours after the injection, I feel almost back to normal, although still a little achy and fatigued. The injection site is still somewhat tender.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Nausea, Pain, Poor quality sleep, Tremor
Clinical narrative: Approx 7 to 8 hrs after injection, I began having headache and fatigue. An hour after that I developed shaking and chills. My temperature read 99.8. I slept fitfully through the night with aches and stabbing pains all over my body. I had mild nausea. The injection site had become sore, but not hot, bruised or swollen looking. Next morning and throughout the following day, until about 7 pm, my temperature remained elevated and I felt achy all over. I canceled previously scheduled activities and remained in the house all day sleeping, resting, eating very little but drinking plenty of water. By 7 pm my temperature was normal at 98.5. I slept better the second night and upon rising, approximately 45 hours after the injection, I feel almost back to normal, although still a little achy and fatigued. The injection site is still somewhat tender.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: Patient came in on 8/28/18 and spoke to the pharmacist. He stated that his upper left arm started swelling about 5 days after getting the vaccine and his lower left arm started swelling about 6 days ago. He told pharmacist that he was planning to go to the doctor.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash generalised
Clinical narrative: Patient reporting rash on entire body-arms, legs, chest, stomach, etc.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Mobility decreased, Pain
Clinical narrative: Patient reported to pharmacy 3 days after receiving the flu shot complaining of pain and inability to move arm. Patient had not yet tried any kind of treatment.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased interest, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Events second day. Swollen, red, "hot" at site of injection. Lethargy, feeling of hopelessness, headache, general feeling of not being well. Husband had injection at the same time on the same date. We both had to lay down the next day. General feeling of headache, tiredness, and "don't care" about anything anymore attitude.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Malaise
Clinical narrative: Events second day. Swollen, red, "hot" at site of injection. Lethargy, feeling of hopelessness, headache, general feeling of not being well. Husband had injection at the same time on the same date. We both had to lay down the next day. General feeling of headache, tiredness, and "don't care" about anything anymore attitude.
Age: 12.0
Sex: F
Vaccine: HEP, HEPA, VARCEL
Symptoms: Expired product administered
Clinical narrative: Vaccine was out of date by one day. No reaction was noted. A message was left for Vaccine Coordinator at the Health Department which was returned on 08/29/2018.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: PATIENT EXPERIENCED REDNESS AND SWELLING EXPANDED AROUND THE INJECTION SITE.  REPORTED ARE FELT "ITCHY." PATIENT APPLIED ICE PACK TO THE AREA AND WAS SEEN BY A PHYSICIAN WHO PRESCRIBED ANTIBIOTICS.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site induration, Injection site nodule
Clinical narrative: Patient stated that she had a "knot" or harden area in her left bicep. Upon palpation, it seems like a hard nodule/bump.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Mass, Swelling
Clinical narrative: Patient stated that she had a "knot" or harden area in her left bicep. Upon palpation, it seems like a hard nodule/bump.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Arm was red at the injection site and below. Arm was swollen and hot to the touch and painful to the patient. Area that was red and swollen was about 3 inches in diameter. Patient states it did that with the first injection and stayed like that for a week. I advised ice, an antihistamine such as CLARITIN and ADVIL.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Skin lesion
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 14-year-old female patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date in 2018 (reported as "within the last week or so"), the patient was vaccinated with GARDASIL 9 injection, intramuscularly (indication was reported as vaccination; exact dose, frequency, lot# and expiration date were not reported) for prophylaxis. Immediately after the vaccination, the patient developed a small lesion "like a mosquito bite". No treatment was given for the event. The patient sought medical attention, by visiting the physician's office when reaction occurred. The outcome of the event was reported as recovered on an unknown date in 2018. The relatedness between the event and GARDASIL 9 was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin lesion
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 22-DEC-2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for its intended purpose: the prevention of shingles. As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of her body. The patient did not have a shingles outbreak until 25-NOV-2016. As a direct result of the vaccine, the patient, suffered mental and emotional distress due to resulting physical limitations and seriousness of her condition. The patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Shingles was reported to be disabling. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Hyperhidrosis, Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of fatigue in a 65-year-old female patient who received Shingrix for prophylaxis. On 17th August 2018, the patient received the 1st dose of Shingrix. In August 2018, less than a week after receiving Shingrix, the patient experienced fatigue, fever, sweating, general body pain, injection site pain and chills. On 19th August 2018, the patient experienced blurred vision. The patient was treated with ibuprofen and Tylenol. In August 2018, the outcome of the fatigue, fever, general body pain, injection site pain and chills were recovered/resolved. On an unknown date, the outcome of the blurred vision and sweating were unknown. It was unknown if the reporter considered the fatigue, fever, blurred vision, sweating, general body pain, injection site pain and chills to be related to Shingrix. Additional details were provided as follows: The caller was the patient who left after hours voicemail. The caller reported that she received a dose of Shingrix on Friday (17th August 2018), and experienced fatigue, arm pain at injection site, fever, chills and sweats and body ache that continued throughout the weekend. The caller reported that  she took Tylenol and Ibuprofen to treat those symptoms. The caller reported that Sunday morning (19th August 2018), 2 days after receiving Shingrix, she noted she had blurred vision that affected her ability to read even with her glasses on. The caller stated she had called her physician and would be seen to be examined regarding the vision issues. The caller unable to locate phone number for pharmacy that administered the dose of Shingrix to her.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vision blurred
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of fatigue in a 65-year-old female patient who received Shingrix for prophylaxis. On 17th August 2018, the patient received the 1st dose of Shingrix. In August 2018, less than a week after receiving Shingrix, the patient experienced fatigue, fever, sweating, general body pain, injection site pain and chills. On 19th August 2018, the patient experienced blurred vision. The patient was treated with ibuprofen and Tylenol. In August 2018, the outcome of the fatigue, fever, general body pain, injection site pain and chills were recovered/resolved. On an unknown date, the outcome of the blurred vision and sweating were unknown. It was unknown if the reporter considered the fatigue, fever, blurred vision, sweating, general body pain, injection site pain and chills to be related to Shingrix. Additional details were provided as follows: The caller was the patient who left after hours voicemail. The caller reported that she received a dose of Shingrix on Friday (17th August 2018), and experienced fatigue, arm pain at injection site, fever, chills and sweats and body ache that continued throughout the weekend. The caller reported that  she took Tylenol and Ibuprofen to treat those symptoms. The caller reported that Sunday morning (19th August 2018), 2 days after receiving Shingrix, she noted she had blurred vision that affected her ability to read even with her glasses on. The caller stated she had called her physician and would be seen to be examined regarding the vision issues. The caller unable to locate phone number for pharmacy that administered the dose of Shingrix to her.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. In August 2018, the patient received SHINGRIX. In August 2018, less than a month after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had a dose of SHINGRIX less than 2 weeks ago, and had since developed Shingles. The reporting healthcare professional had no patient or product information available but provided information for the patient's primary doctor for follow up. The healthcare professional requested that safety follow up with the patient's doctor for more information.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site bruising, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Shingrix (batch number C7B9P, expiry date unknown) for prophylaxis. On 17th August 2018, the patient received the 1st dose of Shingrix. In August 2018, immediately after receiving Shingrix, the patient experienced injection site pain, influenza-like symptoms, injection site warmth, fever, injection site bruising and injection site erythema. On an unknown date, the outcome of the injection site pain, influenza-like symptoms, injection site warmth, fever, injection site bruising and injection site erythema were unknown. It was unknown if the reporter considered the injection site pain, influenza-like symptoms, injection site warmth, fever, injection site bruising and injection site erythema to be related to Shingrix. Additional details reported as follows: The patient experienced painful injection, and redness just below injection site that wrapped around the arm. The pharmacist provided lot number as captured in pharmacy database, but could not confirm if it was from antigen vial or carton. The expiration date was not available.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Shingrix (batch number C7B9P, expiry date unknown) for prophylaxis. On 17th August 2018, the patient received the 1st dose of Shingrix. In August 2018, immediately after receiving Shingrix, the patient experienced injection site pain, influenza-like symptoms, injection site warmth, fever, injection site bruising and injection site erythema. On an unknown date, the outcome of the injection site pain, influenza-like symptoms, injection site warmth, fever, injection site bruising and injection site erythema were unknown. It was unknown if the reporter considered the injection site pain, influenza-like symptoms, injection site warmth, fever, injection site bruising and injection site erythema to be related to Shingrix. Additional details reported as follows: The patient experienced painful injection, and redness just below injection site that wrapped around the arm. The pharmacist provided lot number as captured in pharmacy database, but could not confirm if it was from antigen vial or carton. The expiration date was not available.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site cellulitis in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included penicillin allergy. On 15th August 2018, the patient received SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On 21st August 2018, the patient experienced injection site cellulitis, injection site erythema and injection site warmth. The patient was treated with clindamycin. On an unknown date, the outcome of the injection site cellulitis, injection site pain, injection site erythema and injection site warmth were unknown. It was unknown if the reporter considered the injection site cellulitis, injection site pain, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On the morning of 21st August 2018, 6 days after receiving SHINGRIX, the patient noted red hot sensation at injection site and was seen by acute care clinic and diagnosed with cellulitis. The patient was prescribed a week's course of clindamycin for treatment.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Erythema, Eye pain, Feeling hot
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 15th August 2018, the patient received the 1st dose of Shingrix. On 15th August 2018, less than an hour after receiving Shingrix, the patient experienced pain in arm, muscle mass, erythema of extremities, extremities hot feeling of, itchy upper limbs, induration, headache, neck pain, general body pain, eyeball soreness, fever, chills and stomach discomfort. On an unknown date, the outcome of the pain in arm, erythema of extremities, itchy upper limbs and induration were not recovered/not resolved and the outcome of the muscle mass, extremities hot feeling of, headache, neck pain, general body pain, eyeball soreness, fever, chills and stomach discomfort were recovering/resolving. It was unknown if the reporter considered the pain in arm, muscle mass, erythema of extremities, extremities hot feeling of, itchy upper limbs, induration, headache, neck pain, general body pain, eyeball soreness, fever, chills and stomach discomfort to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient got the Shingrix injection in her left lateral deltoid and within hours, her left arm was extremely painful. The patient developed a baseball sized lump in her muscle. It was red, hot, painful to the touch, and itchy. Additionally, she got headache, neck ache, and body aches and even her eyeballs hurt. The patient was feverish and had the chills. She felt sick to her stomach and felt as if she was going to have diarrhea. All that lasted through all of the next day and into 17th August 2018. By 17th August 2018 Friday, the patient was feeling better, enough that she could get out of bed. However, her arm was still painful, red, and hard, it felt encapsulated, and itchy. In fact, the hardness and redness had progressed farther down her arm. The patient was unaware of these side effects and was concerned that Shingrix vaccine might cause further illness. The patient would be reporting this to primary care physician and to the proper authorities.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Induration, Muscle mass, Neck pain, Pain
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 15th August 2018, the patient received the 1st dose of Shingrix. On 15th August 2018, less than an hour after receiving Shingrix, the patient experienced pain in arm, muscle mass, erythema of extremities, extremities hot feeling of, itchy upper limbs, induration, headache, neck pain, general body pain, eyeball soreness, fever, chills and stomach discomfort. On an unknown date, the outcome of the pain in arm, erythema of extremities, itchy upper limbs and induration were not recovered/not resolved and the outcome of the muscle mass, extremities hot feeling of, headache, neck pain, general body pain, eyeball soreness, fever, chills and stomach discomfort were recovering/resolving. It was unknown if the reporter considered the pain in arm, muscle mass, erythema of extremities, extremities hot feeling of, itchy upper limbs, induration, headache, neck pain, general body pain, eyeball soreness, fever, chills and stomach discomfort to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient got the Shingrix injection in her left lateral deltoid and within hours, her left arm was extremely painful. The patient developed a baseball sized lump in her muscle. It was red, hot, painful to the touch, and itchy. Additionally, she got headache, neck ache, and body aches and even her eyeballs hurt. The patient was feverish and had the chills. She felt sick to her stomach and felt as if she was going to have diarrhea. All that lasted through all of the next day and into 17th August 2018. By 17th August 2018 Friday, the patient was feeling better, enough that she could get out of bed. However, her arm was still painful, red, and hard, it felt encapsulated, and itchy. In fact, the hardness and redness had progressed farther down her arm. The patient was unaware of these side effects and was concerned that Shingrix vaccine might cause further illness. The patient would be reporting this to primary care physician and to the proper authorities.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Pyrexia
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 15th August 2018, the patient received the 1st dose of Shingrix. On 15th August 2018, less than an hour after receiving Shingrix, the patient experienced pain in arm, muscle mass, erythema of extremities, extremities hot feeling of, itchy upper limbs, induration, headache, neck pain, general body pain, eyeball soreness, fever, chills and stomach discomfort. On an unknown date, the outcome of the pain in arm, erythema of extremities, itchy upper limbs and induration were not recovered/not resolved and the outcome of the muscle mass, extremities hot feeling of, headache, neck pain, general body pain, eyeball soreness, fever, chills and stomach discomfort were recovering/resolving. It was unknown if the reporter considered the pain in arm, muscle mass, erythema of extremities, extremities hot feeling of, itchy upper limbs, induration, headache, neck pain, general body pain, eyeball soreness, fever, chills and stomach discomfort to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient got the Shingrix injection in her left lateral deltoid and within hours, her left arm was extremely painful. The patient developed a baseball sized lump in her muscle. It was red, hot, painful to the touch, and itchy. Additionally, she got headache, neck ache, and body aches and even her eyeballs hurt. The patient was feverish and had the chills. She felt sick to her stomach and felt as if she was going to have diarrhea. All that lasted through all of the next day and into 17th August 2018. By 17th August 2018 Friday, the patient was feeling better, enough that she could get out of bed. However, her arm was still painful, red, and hard, it felt encapsulated, and itchy. In fact, the hardness and redness had progressed farther down her arm. The patient was unaware of these side effects and was concerned that Shingrix vaccine might cause further illness. The patient would be reporting this to primary care physician and to the proper authorities.
Sex: U
Vaccine: MENB
Symptoms: Erythema
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of localized erythema in an unspecified number of patients who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced localized erythema. On an unknown date, the outcome of the localized erythema was unknown. It was unknown if the reporter considered the localized erythema to be related to BEXSERO. Additional details were provided as follows: The reporter was a Certified Medical Assistant (CMA) or an office manager. The age at vaccination was not applicable for this report. The reporter stated that few patients develop a large circular red ring on their arm after vaccination with BEXSERO. The reporter requested to let her know if GSK had heard anything or if there was a recall on a lot numbers that they might have purchased. The reporter said it was about an average of 2 to 3 patients per box of BEXSERO. The reporter agreed for follow up contact.
Sex: F
Vaccine: MENB
Symptoms: Presyncope
Clinical narrative: This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. A female patient of an unspecified age received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced near syncopal episode (stressed she did not actually pass out) on an unspecified date with outcome of unknown. No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: Headache, myalgia, severe fatigue, limb pain 12-18 hours after injection.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Activated partial thromboplastin time, Contusion, Differential white blood cell count, Full blood count, Impaired healing
Clinical narrative: Mom noticed 3 week ago that patient had new bruises everyday and they were taking a long time to heal. Diagnosed with: Thrombocytopenia.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Prothrombin time, Thrombocytopenia, Von Willebrand's factor multimers test
Clinical narrative: Mom noticed 3 week ago that patient had new bruises everyday and they were taking a long time to heal. Diagnosed with: Thrombocytopenia.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness to left upper arm.