chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: 6/8/18-right arm "extremely sore," felt tired and low fever; 6/9/18-nauseous, but did not throw up; 6/10/18-nausea resolved, arm still sore; 6/11/18-right arm red around injection site, some itching, spread towards elbow area also developed fever blister; 6/15/18-both left and right elbows itching with little red blisters, painful to touch 6/23/18--all symptoms resolved.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: Immediate fever, 102.5, aches, flu-like symptoms for 7 days.
Sex: F
Vaccine: DTAPIPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from an-other health professional. This case is linked to case 2018SA226817 (same reporter). This case involves adult female patient (age not reported) who was vaccinated with a 0.5 ml dose of QUADRACEL (Batch number: C5248AA and expiry date: 21-Aug-2019) via intramuscular route on an unknown date. 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 incorrect product storage because stability on QUADRACEL, the excursion was actually for 9 days, starting in May, and ranged from 48-49 F. It was unknown if any adverse event was occurred or not following the vaccination. 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 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: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient stating she has a temperature of 101 deg, mild fever.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain, Chills, Fatigue, Headache
Clinical narrative: Patient complained of myalgia, headache, shivering, abdominal pain, upset stomach, and shoulder and neck pain. These symptoms worsened overnight to were the patient stayed in bed the next morning due to the fatigue and nausea.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Myalgia, Nausea, Neck pain
Clinical narrative: Patient complained of myalgia, headache, shivering, abdominal pain, upset stomach, and shoulder and neck pain. These symptoms worsened overnight to were the patient stayed in bed the next morning due to the fatigue and nausea.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site irritation, Musculoskeletal pain, Neck pain
Clinical narrative: Patient complained of shoulder and neck pain as well as injection site irritation starting shortly after the vaccination.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Dizziness, Pyrexia, Vomiting
Clinical narrative: Patient was administered MENACTRA Vaccine on 08/14/2018 that night patient ran a fever of 103.0. Mother called the office on 08/15/2018 to report fever and was advised to give TYLENOL and MOTRIN. 08/15/2018 fever reached 105.0. Patient also experienced dizziness, weakness and had one episode of vomiting. Physician was called on 08/18/2018 mother was advised  to give TYLENOL and ALEVE to reduce fever. Physician called mother back on 08/19/2018 to check on condition of patient. Patient had not run any more fever on 08/19/2018.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site vesicles, Pyrexia, Rash
Clinical narrative: SHINGRIX vaccine given 8/10/2018, patient noticed arm rash/redness on 8/11/2018 with following small blister like eruptions on 8/12/2018. Area involved was from injection site down to elbow, continued for 5 to 7 days. Also patient had fever reported.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site
Clinical narrative: A university employee received the second vaccine in the shingles series from a pharmacist. After the dose, the employee was unable to move his/her arm. The patient observed the injection in his/her peripheral vision and it appeared that it was 2 inches above the appropriate site and at about a 45 degree angle. The patient had immediate pain and after returning home could not move his/her arm. The patient used ice and took ibuprofen. The patient could not describe the actual site more in detail but the patient visited urgent care and the provider there confirmed the site appeared to be 2 inches too high. The provider in urgent care made no interventions. The patient had improvements in his/her pain the following day.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dysarthria, Dysphagia, Dyspnoea, Hypoaesthesia
Clinical narrative: She describes the predominant symptom as bilateral arm weakness (both arms at same time),  bilateral facial ('T zone') numbness, and slurred speech. Symptoms initially began Friday, 9/15/2017. Symptoms came on gradually 5 days after receiving TDaP vaccine. Associated symptoms include dysphagia, neurasthenia, both hands involuntarily clenching in flexion contracture, shortness of breath, palpitations. Treatment consists of physical and speech therapy; she has recovered 95% back to baseline as of current date.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Joint contracture, Muscular weakness, Palpitations
Clinical narrative: She describes the predominant symptom as bilateral arm weakness (both arms at same time),  bilateral facial ('T zone') numbness, and slurred speech. Symptoms initially began Friday, 9/15/2017. Symptoms came on gradually 5 days after receiving TDaP vaccine. Associated symptoms include dysphagia, neurasthenia, both hands involuntarily clenching in flexion contracture, shortness of breath, palpitations. Treatment consists of physical and speech therapy; she has recovered 95% back to baseline as of current date.
Age: 45.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Doctors office called and reported acute redness, warmth and itchy to left upper arm from deltoid to elbow.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Patient told us on August 21 when she came to pick up her medication that she had pain from the arm up to the neck on the second day after receiving the vaccine. And the pain is still there, but gets better. She is not sure if the pain is due to her carpal tunnel or due to the vaccine.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Measles, Rash erythematous, Rash generalised
Clinical narrative: Approximately 2 hrs after the injections my daughter developed red bumps on her body. I spoke with her pediatrician about her symptoms and he said she had developed measles. Every year since she has broken out in red bumps on the back of her right thigh, approximately 10 - 12 episodes per year.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: 8-7-18 SHINGRIX GIVEN IM...8-10-18 PT SAYS HE HAD SHINGLES ON HIS HEAD, FOREHEAD AND RIGHT EYE. HE CONTACTED DR. PHYSICAN STARTED HIM ON GABAPENTIN, VALACYCLOVIR, TOPICAL ACYCLOVIR...PHYSICAN ALSO REFERRED PT TO EYE DOCTOR AND WAS GIVEN "ANTIVIRAL EYE DROPS"....PT CAME TO PHARMACY 8-22-18 SAYING HE IS DOING MUCH BETTER BUT WANTED TO TELL US WHAT HAPPENED AND THAT HE IS UNDER THE CARE OF DR. HE ASKED FOR THE LOT # AND EXPIRATION DATE OF THE SHINGRIX THAT WAS ADMINISTERED. PT WAS IN VERY GOOD SPIRITS AND VERY KIND.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Vomiting
Clinical narrative: Patient was vaccinated at 10:30 am. She felt pain as vaccine was injected into the deltoid muscle, but that is typical. She was fine in the store but an hour and a half to two hours later she started to have bad pain in her left shoulder. It got to the point where she vomited and thinks that the pain is what caused it. By 2:00pm she called back and the pain was worse and she had very intense pain in her left shoulder. After speaking with her primary care physician it was decided that she go to the ER. Her pain was managed there with oxycodone and cyclobenzaprine. I spoke with the husband at 6:30pm and he said the medication was helping her arm. There was still significant pain but it was improving. I spoke with him again at 8:15pm and he said that the pain was quite a bit better and that patient was resting. We will follow up with her tomorrow to see how she is doing.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cognitive disorder, Disturbance in attention, Headache, Influenza like illness
Clinical narrative: Flu like symptoms - high fever - chills - severe body ache - headache - cognitive impairment - lasting 2 days - headache lasting 4 days - on-going cognitive impairment - forgetful/ focus-issues.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Memory impairment, Pain, Pyrexia
Clinical narrative: Flu like symptoms - high fever - chills - severe body ache - headache - cognitive impairment - lasting 2 days - headache lasting 4 days - on-going cognitive impairment - forgetful/ focus-issues.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Patient reported large red area and hot to touch. Patient had pain for 1 week before syptoms stopped.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Myalgia, Nausea, Vomiting
Clinical narrative: Patient came into pharmacy to let us know that she had experienced normal muscle pain lasting for approximately 3 days after which she states that she experienced nausea not associated with vomiting that lasted from about 8/13/18 - 8/20/18. Patient stated that during this time she was unable to eat regularly more than 1-2 bites of food per day. She did not experience any dizziness or fever but did experience 1 episode of diarrhea on 8/19/2018. Patient stated that she was able to manage the nausea with over the counter antacids and her omeprazole.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Injection site pain, Malaise, Myalgia
Clinical narrative: Pain at injection site, swelling/redness 6 cm, fever/malaise, muscle and joint pain.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: Pain at injection site, swelling/redness 6 cm, fever/malaise, muscle and joint pain.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Headache, extremely sore arm, nausea, body aches, fever.
Age: 0.92
Sex: M
Vaccine: PNC13
Symptoms: Decreased appetite, Irritability, Pyrexia, Rash generalised
Clinical narrative: Mother of the patient reported that patient had loss of appetite and was irritable after receiving the vaccine. Fever started two (2) days after with temperature at 104 deg F (rectal). Mother administered a single dose of 1.85 ml of MOTRIN (50mg/1.25ml) and gave lukewarm baths. Fever resolved after two days but noticed a generalized rash that appears to have started in the torso. No signs and symptoms of shortness of breath nor difficulty breathing was reported. Rash resolved after a week.
Age: 66.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Red rash on arm around injections sites.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea
Clinical narrative: Patient feels throat possibly swollen and had difficulty breathing 20 minutes after Tdap. Patient only ever had this one vaccine. Mom never vaccinated in past.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Patient experienced aches and a rash starting approximately 6 hours after injection and lasting 2-3 days before completely resolving with no lasting after effect.
Age: 16.0
Sex: F
Vaccine: HPV4, MENB, MNQ
Symptoms: Injection site erythema, Injection site warmth, Vaccination site swelling
Clinical narrative: The patient's mother called on 08/21/18. She specifies that at the vaccination site for the TRUMENBA vaccine on the right arm, the area is red and swollen. We recommended to the mother to use cold compresses in the area and in case no improvement is observed to take the patient to the pediatrician so the area is evaluated and they can determine if treatment is needed. The mother brings the patient to our site on 8/22/18 so that we can evaluate her arm. The area where the TRUMENBA vaccine was administered previously has a slight erythema and the area is also slightly warm to touch. The mother took the patient to the doctor who prescribed antibiotics for 7 days and BENADRYL to treat the side effects the patient experienced after the administration of the TRUMENBA vaccine. The doctor recommended the administration of the 2nd dose of the vaccine against Meningitis B (TRUMENBA) according to schedule on the opposite arm where the prior vaccine was administered.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Impaired driving ability, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient arrived at pharmacy stating his left arm was extremely sore. To the point that he had trouble turning the steering wheel of his car. He took TYLENOL to relieve the pain. The pain has improved somewhat today.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Abscess, Soft tissue swelling, Vaccination complication, X-ray limb abnormal
Clinical narrative: At one month exam had a mobile 1.25 cm soft tissue swelling at one and two months. Well child check, parents stated it was there shortly after receiving shot but there is no mention at 1 wk well child exam. Area was never erythematous or tender to touch. At two months xray confirm soft tissue swelling with no bony involvement or mass. On 8/21/18 discussed with physician who feels this is a sterile abscess, likely secondary reaction to aluminum hydroxide contained in vaccine with body reaction treating it as a foreign body. It is still present and similar in size at three months of age. Recommendation at this time is not to drain and to follow clinically. Pediatrician will recommend follow up with another Dr. for further vaccine recommendations. Currently infant is deficient on vaccines because we cannot use left thigh.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to (L) arm. Dr wanted reported as adverse event.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Patient was given a single DTaP instead of KINRIX, our clinic is out of stock on IPV so patient was sent down the street for IPV vaccine.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Nausea, Pallor
Clinical narrative: Approximately 5 minutes after vaccines were administered pt became nauseous, dizzy and pale. Smelling salts done, Juice and crackers given. Cold towels to head. Took pt about 20 minutes to recover.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Rash
Clinical narrative: On 8/21/18, patient experienced fever, chills and "white spots near injection site." Pt was counseled on management - antipyretic PRN, topical BENADRYL, ice pack, and to monitor.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema
Clinical narrative: Patient was given KINRIX (DTaP/IPV) on 8/20/18 in left thigh. Came in 8/22/18 red spot measuring 5 cm. No complaints, just redness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest X-ray, Chest pain, Electrocardiogram, Injection site pain, Laboratory test
Clinical narrative: Left chest pain and left lower jaw pain. Tested for heart attack but everything was negative. Pain at injection site was excruciating and lasted for 4 days. Shoulder pain improved each day. Chest and jaw was gone by 11:30 pm that first night.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain in jaw, Troponin
Clinical narrative: Left chest pain and left lower jaw pain. Tested for heart attack but everything was negative. Pain at injection site was excruciating and lasted for 4 days. Shoulder pain improved each day. Chest and jaw was gone by 11:30 pm that first night.
Age: 22.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Abdominal pain, Asthenia, Feeling hot, Hypoaesthesia, Paraesthesia
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 22-year-old female patient. The patient's pertinent medical history or concomitant therapies were not reported. The patient's drug reactions or allergies included amoxicillin allergy. On 12-JUL-2018, the patient was vaccinated with one dose of GARDASIL 9 intramuscularly (lot # N028567, expiration date: 17-MAY-2020) for prevention of HPV. Immediately after receiving the GARDASIL 9, the patient experienced weakness and tachycardia. The patient sought medical attention through physician visit. No lab tests were performed. There was no treatment given for the adverse events. The outcome of weakness and tachycardia was reported as recovered on 13-JUL-2018. The relatedness between weakness and tachycardia and GARDASIL 9 was not reported.
Age: 22.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Presyncope
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 22-year-old female patient. The patient's pertinent medical history or concomitant therapies were not reported. The patient's drug reactions or allergies included amoxicillin allergy. On 12-JUL-2018, the patient was vaccinated with one dose of GARDASIL 9 intramuscularly (lot # N028567, expiration date: 17-MAY-2020) for prevention of HPV. Immediately after receiving the GARDASIL 9, the patient experienced weakness and tachycardia. The patient sought medical attention through physician visit. No lab tests were performed. There was no treatment given for the adverse events. The outcome of weakness and tachycardia was reported as recovered on 13-JUL-2018. The relatedness between weakness and tachycardia and GARDASIL 9 was not reported.
Age: 22.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Asthenia, Tachycardia
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 22-year-old female patient. The patient's pertinent medical history or concomitant therapies were not reported. The patient's drug reactions or allergies included amoxicillin allergy. On 12-JUL-2018, the patient was vaccinated with one dose of GARDASIL 9 intramuscularly (lot # N028567, expiration date: 17-MAY-2020) for prevention of HPV. Immediately after receiving the GARDASIL 9, the patient experienced weakness and tachycardia. The patient sought medical attention through physician visit. No lab tests were performed. There was no treatment given for the adverse events. The outcome of weakness and tachycardia was reported as recovered on 13-JUL-2018. The relatedness between weakness and tachycardia and GARDASIL 9 was not reported.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of welts in a 84-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) and (batch number 97H72, expiry date 8th February 2021) for prophylaxis. On 27th July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced welts, pain in arm, axillary pain and back pain. The patient was treated with antivirals for systemic use (Antiviral). On an unknown date, the outcome of the welts and pain in arm were not recovered/not resolved and the outcome of the axillary pain and back pain were unknown. The reporter considered the welts, pain in arm, axillary pain and back pain to be almost certainly related to SHINGRIX. Additional details reported as follows: The patient experienced pain and welts on arm, under arm and back. The doctor prescribed an antiviral and pain medication.  On 13th August 2018, the patient came into the pharmacy with the same welts on the arm, under arm and back along with pain at the same sites. The healthcare professional would like to know if GlaxoSmithKline had reports of Shingles after the 1st dose of SHINGRIX. No additional information provided.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Axillary pain, Back pain, Pain in extremity, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of welts in a 84-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) and (batch number 97H72, expiry date 8th February 2021) for prophylaxis. On 27th July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced welts, pain in arm, axillary pain and back pain. The patient was treated with antivirals for systemic use (Antiviral). On an unknown date, the outcome of the welts and pain in arm were not recovered/not resolved and the outcome of the axillary pain and back pain were unknown. The reporter considered the welts, pain in arm, axillary pain and back pain to be almost certainly related to SHINGRIX. Additional details reported as follows: The patient experienced pain and welts on arm, under arm and back. The doctor prescribed an antiviral and pain medication.  On 13th August 2018, the patient came into the pharmacy with the same welts on the arm, under arm and back along with pain at the same sites. The healthcare professional would like to know if GlaxoSmithKline had reports of Shingles after the 1st dose of SHINGRIX. No additional information provided.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 62-year-old female patient who received SHINGRIX (batch number ZG47A, expiry date 12th February 2021) for prophylaxis. On 13th August 2018, the patient received SHINGRIX. On 13th August 2018, 2 hrs after receiving SHINGRIX, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were unknown. It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were reported as follows: This case was previously reported to a physician. The patient received SHINGRIX on the left arm. The patient experienced redness at the injection site, which was about the size of a half-dollar and the site was warm to the touch. This case was one of the 3 cases, reported by the same reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Feeling cold, Headache
Clinical narrative: Arm started aching, went into shoulder and up the neck. Terrible lower back ache. All joints hurt/ached, fingers, toes, knees, elbows, hips etc. I was exhausted. I was tired but could not sleep from the discomfort. Symptoms started at 9:00 p.m. night of injection. Day after injection was the worst. Two days after injection was better and third day symptoms better and gone the fourth day.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Chills, Discomfort, Drug ineffective
Clinical narrative: Arm started aching, went into shoulder and up the neck. Terrible lower back ache. All joints hurt/ached, fingers, toes, knees, elbows, hips etc. I was exhausted. I was tired but could not sleep from the discomfort. Symptoms started at 9:00 p.m. night of injection. Day after injection was the worst. Two days after injection was better and third day symptoms better and gone the fourth day.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Headache, Insomnia, Mobility decreased, Pain
Clinical narrative: Arm started aching, went into shoulder and up the neck. Terrible lower back ache. All joints hurt/ached, fingers, toes, knees, elbows, hips etc. I was exhausted. I was tired but could not sleep from the discomfort. Symptoms started at 9:00 p.m. night of injection. Day after injection was the worst. Two days after injection was better and third day symptoms better and gone the fourth day.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm started aching, went into shoulder and up the neck. Terrible lower back ache. All joints hurt/ached, fingers, toes, knees, elbows, hips etc. I was exhausted. I was tired but could not sleep from the discomfort. Symptoms started at 9:00 p.m. night of injection. Day after injection was the worst. Two days after injection was better and third day symptoms better and gone the fourth day.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Discomfort, Fatigue, Insomnia
Clinical narrative: Arm started aching, went into shoulder and up the neck. Terrible lower back ache. All joints hurt/ached, fingers, toes, knees, elbows, hips etc. I was exhausted. I was tired but could not sleep from the discomfort. Symptoms started at 9:00 p.m. night of injection. Day after injection was the worst. Two days after injection was better and third day symptoms better and gone the fourth day.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Arm started aching, went into shoulder and up the neck. Terrible lower back ache. All joints hurt/ached, fingers, toes, knees, elbows, hips etc. I was exhausted. I was tired but could not sleep from the discomfort. Symptoms started at 9:00 p.m. night of injection. Day after injection was the worst. Two days after injection was better and third day symptoms better and gone the fourth day.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: With both doses, in addition to the not unexpected swelling and soreness in the arm, I started feeling chills and body aches the evening of the day I received it (second dose was 8/21/2018). The following day, body aches were worse, and with the first injection I also had a fever of up to 100.1F on the second day. With the second injection in the series (8/21/2018) symptoms were not as severe but followed the same pattern. Fever was only around 99.1. By the second day after injection, I felt normal with only slight residual soreness in the arm.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Full blood count, Injection site hypoaesthesia, Injection site pain, Metabolic function test
Clinical narrative: Patient states she began with pain and numbness in the injection site a few minutes after administration. Around 5:00pm she began with stomache pain and nausea which lead to various vomits.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: Patient states she began with pain and numbness in the injection site a few minutes after administration. Around 5:00pm she began with stomache pain and nausea which lead to various vomits.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Fatigue, Headache, Pain in extremity
Clinical narrative: HA, Dizzy, Fatigue, Arm Pain.
Age: 28.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Pain at injection sight, warm and swollen, fever.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity, Pyrexia, Tenderness
Clinical narrative: Slight fever. Redness and swelling at injection site. Arm soreness  and tenderness in upper arm.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning multiple patients of unknown age and genders. The patients' medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. Between 01-AUG-2018 and 06-AUG-2018, the patients were administered improperly stored PROQUAD, subcutaneously, for prophylaxis, lot #R002936, albumin status rHA and expiration date 29-JUL-2019 (strength, dose and frequency were not reported), which was reconstituted with a properly stored Merck Sterile Diluent. No adverse effects were reported. The temperatures of excursion were reported as 6 degrees F to 14 degrees F during a time frame of 1 hour and 15 minutes and 28.5 degrees F during a time frame of 45 minutes. There was no previous temperature excursion reported. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA009440; US-009507513-1808USA009441; US-009507513-1808USA009442; US-009507513-1808USA009443; US-009507513-1808USA009444; US-009507513-1808USA009445; US-009507513-1808USA009446; US-009507513-1808USA009447.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes simplex test negative, Polymerase chain reaction positive, Rash vesicular, Varicella virus test positive
Clinical narrative: This spontaneous report was received from a microbiologist, concerning a 2 year old female patient, with no medical history, concurrent conditions or concomitant medication. On an unspecified date in 2017 (reported as "at one year of age"), the patient was vaccinated with VARIVAX, subcutaneously, for varicella vaccination (dose, anatomical location, lot number and expiration date were not reported). On 05-AUG-2018, the patient made a visit to the emergency room experiencing vesicular rash, with dermatomal distribution. The patient was treated with acyclovir, 20mg/kg every six hours. The microbiologist requested a Varicella Zoster Virus Identification Program (VZVIP) packet, and the polymerase chain reaction (PCR) testing was performed in the hospital laboratory, showing that the sample was positive for varicella zoster virus (VZV) and negative for herpes simplex virus (HSV) 1 and HSV 2. The reporter stated that the patient was at home, however, the outcome of varicella zoster virus infection was not provided. The causal relationship between VARIVAX and the event was unknown.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Product storage error
Clinical narrative: Information was received from a licensed practical nurse referring to a 4 year old female patient. The patient's concomitant medication, historical and concurrent conditions were not reported. On 06-AUG-2018, the patient was vaccinated at a private doctor's office/hospital with an improperly stored dose of (rHA) PROQUAD (lot # R002935) subcutaneously in the left arm with public funds for prophylaxis. The patient was also administered KINRIX concomitantly on the same day. It was reported that the patient was previously administered a dose of PROQUAD and a dose of KINRIX on unknown dates. No prescription drug treatment for the experience was required. Details of the temperature excursions were not reported. Data logger was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On 16-AUG-2018, the patient was vaccinated with expired PNEUMOVAX 23 lot # M040804, expiration date 20-MAY-2018, for prophylaxis (route of administration and exact dose were not provided). No adverse event reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1808USA009711.
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from the patient's friend via a company representative referring to a 15 year old non pregnant female patient. Information regarding the patient's medical history, concurrent conditions or concomitant medications was unknown. On an unspecified date in 2009, (also reported as "sometime in the year 2009") the patient was vaccinated with the first dose of GARDASIL for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). On the same date, after receiving the dose of GARDASIL the patient experienced a fever that lasted for one day. Furthermore, it was unknown whether the patient received treatment to the aforementioned event. At the time of the report, the outcome of pyrexia was reported as resolved. Additionally, the reporter did not provide causality assessment between the event and vaccination with GARDASIL.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported. On 17-AUG-2018, the patient was vaccinated with an expired VARIVAX for prophylaxis (lot number M033906 and expiration date 20-JUL-2018) (dosage schedule, route of administration and anatomical location were not reported). No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning multiple patients of unknown age and genders. The patients' medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. Between 01-AUG-2018 and 06-AUG-2018, the patients were administered improperly stored PROQUAD subcutaneously, for prophylaxis, lot #R002936, albumin status rHA and expiration date 29-JUL-2019 (strength, dose and frequency were not reported), which was reconstituted with a properly stored sterile diluent (MERCK). No adverse effects were reported. The temperatures of excursion were reported as 6°F to 14°F during a time frame of 1 hour and 15 minutes and 28.5°F during a time frame of 45 minutes. There was no previous temperature excursion reported. There was a digital data logger involved. Sender's Comments: US-009507513-1808USA009441: US-009507513-1808USA009442: US-009507513-1808USA009443: US-009507513-1808USA009444: US-009507513-1808USA009445: US-009507513-1808USA009446: US-009507513-1808USA009447: US-009507513-1808USA003515.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. Between 01-AUG-2018 and 06-AUG-2018, the patients were vaccinated with an improperly stored vaccinated with VARIVAX subcutaneosly, for prophylaxis, lot #N035940 and expiration date 18-DEC-2019 (strength, dose and frequency were not reported), which was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT). No adverse effects were reported. The temperatures of excursion were reported as 6°F to 14°F during a time frame of 1 hour and 15 minutes and 28.5°F during a time frame of 45 minutes. There was no previous temperature excursion reported. There was a digital data logger involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1808USA009440: US-009507513-1808USA009442: US-009507513-1808USA009443: US-009507513-1808USA009444: US-009507513-1808USA009445: US-009507513-1808USA009446: US-009507513-1808USA009447: US-009507513-1808USA003515:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. Between 01-AUG-2018 and 06-AUG-2018, the patients were vaccinated with an improperly stored VARIVAX subcutaneosly, for prophylaxis, lot #N035940 and expiration date 18-DEC-2019 (strength, dose and frequency were not reported), which was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT). No adverse effects were reported. The temperatures of excursion were reported as 6°F to 14°F during a time frame of 1 hour and 15 minutes and 28.5°F during a time frame of 45 minutes. There was no previous temperature excursion reported. There was a digital data logger involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1808USA009440: US-009507513-1808USA009441: US-009507513-1808USA009443: US-009507513-1808USA009444: US-009507513-1808USA009445: US-009507513-1808USA009446: US-009507513-1808USA009447: US-009507513-1808USA003515:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. Between 01-AUG-2018 and 06-AUG-2018, the patients were vaccinated with an improperly stored VARIVAX subcutaneously, for prophylaxis, lot #N035940 and expiration date 18-DEC-2019 (strength, dose and frequency were not reported), which was reconstituted with a properly stored sterile diluent (MERCK). No adverse effects were reported. The temperatures of excursion were reported as 6 degree F to 14 degree F during a time frame of 1 hour and 15 minutes and 28.5 degree F during a time frame of 45 minutes. There was no previous temperature excursion reported. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA009440: US-009507513-1808USA009441: US-009507513-1808USA009442: US-009507513-1808USA009444: US-009507513-1808USA009445: US-009507513-1808USA009446: US-009507513-1808USA009447: US-009507513-1808USA003515.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. Between 01-AUG-2018 and 06-AUG-2018, the patients were vaccinated with an improperly stored VARIVAX subcutaneously, for prophylaxis, lot #N035940 and expiration date 18-DEC-2019 (strength, dose and frequency were not reported), which was reconstituted with a properly stored sterile diluent (MERCK). No adverse effects were reported. The temperatures of excursion were reported as 6°F to 14°F during a time frame of 1 hour and 15 minutes and 28.5°F during a time frame of 45 minutes. There was no previous temperature excursion reported. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA009440: US-009507513-1808USA009441: US-009507513-1808USA009442: US-009507513-1808USA009443: US-009507513-1808USA009445: US-009507513-1808USA009446: US-009507513-1808USA009447: US-009507513-1808USA003515.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. Between 01-AUG-2018 and 06-AUG-2018, the patients were vaccinated with an improperly stored VARIVAX subcutaneously, for prophylaxis, lot #N035940 and expiration date 18-DEC-2019 (strength, dose and frequency were not reported), which was reconstituted with a properly stored sterile diluent (MERCK). No adverse effects were reported. The temperatures of excursion were reported as 6°F to 14°F during a time frame of 1 hour and 15 minutes and 28.5°F during a time frame of 45 minutes. There was no previous temperature excursion reported. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA009440: US-009507513-1808USA009441: US-009507513-1808USA009442: US-009507513-1808USA009443: US-009507513-1808USA009444: US-009507513-1808USA009446: US-009507513-1808USA009447: US-009507513-1808USA003515.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. Between 01-AUG-2018 and 06-AUG-2018, the patients were vaccinated with an improperly stored VARIVAX subcutaneously, for prophylaxis, lot #N035940 and expiration date 18-DEC-2019 (strength, dose and frequency were not reported), which was reconstituted with a properly stored sterile diluent (MERCK). No adverse effects were reported. The temperatures of excursion were reported as 6 degrees F to 14 degrees F during a time frame of 1 hour and 15 minutes and 28.5 degrees F during a time frame of 45 minutes. There was no previous temperature excursion reported. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA009440: US-009507513-1808USA009441: US-009507513-1808USA009442: US-009507513-1808USA009443: US-009507513-1808USA009444: US-009507513-1808USA009445: US-009507513-1808USA009447: US-009507513-1808USA003515.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. Between 01-AUG-2018 and 06-AUG-2018, the patients were vaccinated with an improperly stored VARIVAX subcutaneosly, for prophylaxis, lot #N035940 and expiration date 18-DEC-2019 (strength, dose and frequency were not reported), which was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT). No adverse effects were reported. The temperatures of excursion were reported as 6°F to 14°F during a time frame of 1 hour and 15 minutes and 28.5°F during a time frame of 45 minutes. There was no previous temperature excursion reported. There was a digital data logger involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1808USA009440: US-009507513-1808USA009441: US-009507513-1808USA009442: US-009507513-1808USA009443: US-009507513-1808USA009444: US-009507513-1808USA009445: US-009507513-1808USA009446: US-009507513-1808USA003515:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On 16-AUG-2018, the patient was vaccinated with expired PNEUMOVAX 23 lot # M040804, expiration date 20-MAY-2018, for prophylaxis (route of administration and exact dose were not provided). No adverse event reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1808USA008493.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 51-year-old male patient who received SHINGRIX (batch number 37KL2, expiry date 12th February 2021) for prophylaxis. Concurrent medical conditions included multiple sclerosis. Concomitant products included SHINGRIX. On 18th July 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and injected limb mobility decreased. The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the injection site pain, injection site erythema and injected limb mobility decreased were unknown.  It was unknown if the reporter considered the injection site pain, injection site erythema and injected limb mobility decreased to be related to SHINGRIX. Additional information was reported as follows: The patient was vaccinated with the 2nd dose of SHINGRIX at the right arm. In 2018, the patient experienced redness and pain in right arm at injection site. The patient experienced limited range of motion of the arm. The physician saw the event and prescribed antibiotics which did not help. This case was linked with case US2018GSK151987, reported for the same patient (1st dose case).
Sex: F
Vaccine: HEPAB
Symptoms: Abdominal distension, Flatulence, Nausea
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of bloating in a 43-year-old female patient who received TWINRIX (batch number 3HG77, expiry date 3rd July 2020) for prophylaxis. Concomitant products included VIVOTIF and hormonal contraceptives for systemic use (Oral Contraceptives). In March 2018, the patient received the 2nd dose of TWINRIX 1 ml. In March 2018, less than a month after receiving TWINRIX, the patient experienced bloating, nausea and gas. On an unknown date, the outcome of the bloating, nausea and gas were recovered/resolved. It was unknown if the reporter considered the bloating, nausea and gas to be related to TWINRIX. Additional details were reported as follows: The age at vaccination was not reported, but it could be 42 or 43 years old. The patient had no drug allergies. In 2018, around same time frame of vaccination with TWINRIX, the patient received VIVOTIF (other manufacturer). The reporting nurse administered TWINRIX to the patient in the left deltoid and she reported that, the patient experienced bloating, gas and slight nausea at the end of March. The patient made some dietary changes and her symptoms were resolved on unknown date in 2018.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 56-year-old female patient who received SHINGRIX (batch number ZG47A, expiry date 12th February 2021) for prophylaxis. On 14th August 2018, the patient received SHINGRIX. On 14th August 2018, several hours after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were reported as follows: This case was previously reported to a physician. The patient received SHINGRIX on the left arm. The patient experienced redness at the injection site which was about the size of a quarter. The symptoms began after a few hours of receiving SHINGRIX vaccine. This case was one of the 3 cases, reported by the same reporter.