chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Fatigue, Gait disturbance, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 50-year-old female patient who received SHINGRIX. In April 2018, the patient received SHINGRIX. In April 2018, less than a day after receiving SHINGRIX, the patient experienced fever, headache, generalized muscle aches, tiredness, dizziness and nausea. On an unknown date, the patient experienced difficulty breathing, pain in hand, nail injury, walking difficulty and nail bed bleeding. The patient was treated with dexamethasone. On an unknown date, the outcome of the fever, headache, generalized muscle aches, difficulty breathing, tiredness, dizziness, pain in hand, nail injury, nausea and walking difficulty and nail bed bleeding. The patient was treated with dexamethasone. On an unknown date, the outcome of the fever, headache, generalized muscle aches, difficulty breathing, tiredness, dizziness, pain in hand, nail injury, nausea and walking difficulty were not recovered/not resolved and the outcome of the nail bed bleeding was recovered/resolved. It was unknown if the reporter considered the fever, headache, generalized muscle aches, difficulty breathing, tiredness, dizziness, pain in hand, nail injury, nausea, walking difficulty and nail bed bleeding to be related to SHINGRIX. Additional details were provided as follows: The patient could speak another language. The patient did not get any other vaccine. The patient had the SHINGRIX vaccine about 3 weeks before the date of reporting. The first day patient had the vaccine, the patient experienced fever, nausea, tired, dizzy, headache and pain all over her muscles. The patient went out of counttry. When the patient was at the airport and it was difficult to walk well, her feet were dragging, she almost fell down because it was hard to walk and painful to move her hands. She went to have a massage the day before flying for an hour and a half and that helped a little bit. The patient also said that it was difficult for her to breath. She hurt her toenail yesterday because it was hard to walk. She was even bleeding from her toenail. The patient made a comment that she had never missed work in 15 years. The patient had perfect attendance. However, she missed work twice the week she had the vaccine. The patient said that out of the country she had a shot of dexamethasone and it helped her. However, the patient said that she was still not feeling well due to symptoms reported till the time of reporting. The patient said that she did not have the physician's information with her at the time of the call.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Malaise, Myalgia, Nail bed bleeding, Nail injury
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 50-year-old female patient who received SHINGRIX. In April 2018, the patient received SHINGRIX. In April 2018, less than a day after receiving SHINGRIX, the patient experienced fever, headache, generalized muscle aches, tiredness, dizziness and nausea. On an unknown date, the patient experienced difficulty breathing, pain in hand, nail injury, walking difficulty and nail bed bleeding. The patient was treated with dexamethasone. On an unknown date, the outcome of the fever, headache, generalized muscle aches, difficulty breathing, tiredness, dizziness, pain in hand, nail injury, nausea and walking difficulty and nail bed bleeding. The patient was treated with dexamethasone. On an unknown date, the outcome of the fever, headache, generalized muscle aches, difficulty breathing, tiredness, dizziness, pain in hand, nail injury, nausea and walking difficulty were not recovered/not resolved and the outcome of the nail bed bleeding was recovered/resolved. It was unknown if the reporter considered the fever, headache, generalized muscle aches, difficulty breathing, tiredness, dizziness, pain in hand, nail injury, nausea, walking difficulty and nail bed bleeding to be related to SHINGRIX. Additional details were provided as follows: The patient could speak another language. The patient did not get any other vaccine. The patient had the SHINGRIX vaccine about 3 weeks before the date of reporting. The first day patient had the vaccine, the patient experienced fever, nausea, tired, dizzy, headache and pain all over her muscles. The patient went out of counttry. When the patient was at the airport and it was difficult to walk well, her feet were dragging, she almost fell down because it was hard to walk and painful to move her hands. She went to have a massage the day before flying for an hour and a half and that helped a little bit. The patient also said that it was difficult for her to breath. She hurt her toenail yesterday because it was hard to walk. She was even bleeding from her toenail. The patient made a comment that she had never missed work in 15 years. The patient had perfect attendance. However, she missed work twice the week she had the vaccine. The patient said that out of the country she had a shot of dexamethasone and it helped her. However, the patient said that she was still not feeling well due to symptoms reported till the time of reporting. The patient said that she did not have the physician's information with her at the time of the call.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 50-year-old female patient who received SHINGRIX. In April 2018, the patient received SHINGRIX. In April 2018, less than a day after receiving SHINGRIX, the patient experienced fever, headache, generalized muscle aches, tiredness, dizziness and nausea. On an unknown date, the patient experienced difficulty breathing, pain in hand, nail injury, walking difficulty and nail bed bleeding. The patient was treated with dexamethasone. On an unknown date, the outcome of the fever, headache, generalized muscle aches, difficulty breathing, tiredness, dizziness, pain in hand, nail injury, nausea and walking difficulty and nail bed bleeding. The patient was treated with dexamethasone. On an unknown date, the outcome of the fever, headache, generalized muscle aches, difficulty breathing, tiredness, dizziness, pain in hand, nail injury, nausea and walking difficulty were not recovered/not resolved and the outcome of the nail bed bleeding was recovered/resolved. It was unknown if the reporter considered the fever, headache, generalized muscle aches, difficulty breathing, tiredness, dizziness, pain in hand, nail injury, nausea, walking difficulty and nail bed bleeding to be related to SHINGRIX. Additional details were provided as follows: The patient could speak another language. The patient did not get any other vaccine. The patient had the SHINGRIX vaccine about 3 weeks before the date of reporting. The first day patient had the vaccine, the patient experienced fever, nausea, tired, dizzy, headache and pain all over her muscles. The patient went out of counttry. When the patient was at the airport and it was difficult to walk well, her feet were dragging, she almost fell down because it was hard to walk and painful to move her hands. She went to have a massage the day before flying for an hour and a half and that helped a little bit. The patient also said that it was difficult for her to breath. She hurt her toenail yesterday because it was hard to walk. She was even bleeding from her toenail. The patient made a comment that she had never missed work in 15 years. The patient had perfect attendance. However, she missed work twice the week she had the vaccine. The patient said that out of the country she had a shot of dexamethasone and it helped her. However, the patient said that she was still not feeling well due to symptoms reported till the time of reporting. The patient said that she did not have the physician's information with her at the time of the call.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Anger, Anxiety, Injection site pain, Irritability, Musculoskeletal stiffness
Clinical narrative: Extreme irritability illogical anger and anxiety about these feelings. Injection site soreness and stiffness lasting as long as the irritability: 2 1/2 weeks.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 52-year-old male patient who received SHINGRIX (batch number ML532, expiry date 13th July 2020). Concomitant products included SHINGRIX and AMBIEN. On 20th May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 21st May 2018, 1 days after receiving SHINGRIX, the patient experienced chills, joint pain, fatigue, fever and influenza-like symptoms. On an unknown date, the outcome of the chills, joint pain, fatigue, fever and influenza-like symptoms were not recovered/not resolved. The reporter considered the chills, joint pain, fatigue, fever and influenza-like symptoms to be possibly related to SHINGRIX. Additional details were provided as follows: The case was reported by the pharmacist. The pharmacist stated that the patient received 1st dose of SHINGRIX 2 months ago and did not have any issues with the 1st dose. The pharmacist stated that the patient received the SHINGRIX vaccine yesterday in unknown arm. The patient was experiencing flu-like symptoms that include chills, fatigue, fever, severe joint aches and joint pain.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: 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 71-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 1st March 2018 10:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, 16 hrs after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and injection site warmth. In March 2018, the outcome of the injection site pain, injection site erythema and injection site warmth were recovered/resolved. The reporter considered the injection site pain, injection site erythema and injection site warmth to be almost certainly related to SHINGRIX. Additional information were received as follows: The patient received the vaccine in the left deltoid. At 2:00, the patient experienced pain, redness and some warmth at the injection site after receiving a dose of SHINGRIX. The health care professional (HCP) stated that the involved area was described as the size of a large orange. The health care professional reported that the reaction resolved in approximately one week. The HCP stated that this event was previously reported by VAERS.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 72-year-old male patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020). Concurrent medical conditions included vertigo, hearing loss, multifocal motor neuropathy, mitral regurgitation, hypertension, atrial fibrillation, type ii diabetes mellitus, cardiac failure, hyperlipidemia, gout and swelling. Concomitant products included allopurinol, atorvastatin, colchicine, Diltiazem, furosemide, Magnesium, Metformin, postassium chloride, spironolactone, Vitamin D3, Warfarin, glipizide and metoprolol tartrate. On 2nd May 2018, 10:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a month after receiving SHINGRIX, the patient experienced injection site swelling, injection site pain and swelling arm. On an unknown date, the outcome of the injection site swelling and injection site pain were recovering/resolving and the outcome of the swelling arm was unknown. The reporter considered the injection site swelling and injection site pain to be related to SHINGRIX. It was unknown if the reporter considered the swelling arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Concomitant medication included Multivitamin. The patient received SHINGRIX in the right arm. The patient had a follow up visit to his physician to talk about adverse reactions experienced after the injection of the vaccine. The patient noted that he had noticeable swelling in both arms, but increase swelling in the right arm his where he received the injection. The patient said that he had normal swelling with the conditions he had, but his swelling from the vaccine was worse than normal. It had been sixteen days since the injection was given before the time of reporting. The reporter provided all of the information that he had available to him.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received SHINGRIX. On 17th May 2018, the patient received SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm, general body pain, chills and fever. On an unknown date, the outcome of the pain in arm, general body pain, chills and fever were unknown. It was unknown if the reporter considered the pain in arm, general body pain, chills and fever to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient received SHINGRIX injection at a pharmacy and complained of chills, fever, general achiness, and a sore arm. No other details were available for the patient. The reporter did not wish to provide the patient's demographics. She hung up the call when she got her answer despite of asking her if some questions might be asked. This case is linked to case US2018089389 (wife's case), reported by the same reporter.
Age: 58.0
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). The patient's past medical history included shingles. On 27th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. In April 2018, 3 days after receiving SHINGRIX, the patient experienced injection site pain and stomach pain. On an unknown date, the outcome of the injection site pain and stomach pain were recovered/resolved. It was unknown if the reporter considered the injection site pain and stomach pain to be related to SHINGRIX. Additional details were provided as follows: At 11:00, the patient received SHINGRIX on left arm. The patient reported pain presenting at the injection site and on an area of her stomach where she previously had shingles. This pain presented 3 days after the vaccination and resolved within 7 days.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of intramuscular formulation administered by other route in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, unknown after receiving SHINGRIX, the patient  experienced intramuscular formulation administered by other route and injection site erythema. On an unknown date, the outcome of the intramuscular formulation administered by other route and injection site erythema were unknown. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the registered nurse. The age at vaccination was not reported. The nurse at the practice administered SHINGRIX subcutaneously instead of intramuscular, which led to inappropriate route of vaccine administration. The patient developed erythema surrounding the spot of administration. No other reactions were noted. The reporting nurse agreed to follow up from GlaxoSmithKline.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Erythematous rash on neck, trunk groin, buttocks and Left antecubital region.
Age: 76.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Asthenia, Dizziness, Nausea, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a 76-year-old female patient who received SHINGRIX. Concomitant products PNEUMOVAX. On 16th May 2018, the patient received SHINGRIX .5 ml. On 17th May 2018, 1 days after receiving SHINGRIX, the patient experienced nausea, pain, fever, dizziness and weakness. On an unknown, the outcome of the nausea, pain, fever, dizziness and weakness were recovering/resolving. The reporter considered the nausea, pain, fever, dizziness and weakness to be almost certainly related to SHINGRIX. Additional details were reported as follows: The reporter was GlaxoSmithKline employee reporting about her mother's experience. On 16th May 2018, the patient also received PNEUMOVAX concomitantly. The reporter had limited information regarding her mother experience.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a adult male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. On an unknown date, the oiutcome of the pain was recovered/resolved. The reporter considered the pain to be probably related to SHINGRIX. Additional details were provided as follows: The patient felt a little sore after the SHINGRIX vaccination. The patient declined to provide contact information or additional details. For further tolerance, refer case US2018089468.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Arthralgia, Gait inability, Rash
Clinical narrative: C/O bilaterally ankle pain. Rash on lower legs. Unable to walk.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Mild Rash.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Nausea, Pain
Clinical narrative: Patient reported having sweats, nausea, achiness and headache, developing later in the day administration.
Age: 64.0
Sex: F
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 64-year-old female patient who received SHINGRIX (batch number NX952, expiry date 6th March 2020). Concurrent medical conditions included diabetes and multiple allergies. Concomitant products included glipizide. On 14th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, 30 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: Concomitant medication included allergy pills containing pseudoephedrine and insulin. The pharmacist stated that, the patient received the SHINGRIX vaccine in left arm. A little over 1 month later in March 2018, the patient developed Shingles. The patient was planning to get the second dose.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Myalgia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of headache in a 59-year-old female patient who received SHINGRIX. On 17th May 2018, the patient received SHINGRIX (intramuscular). In May 2018, less than a week after receiving SHINGRIX, the patient experienced headache, chills, muscle pain and influenza-like symptoms. The patient was treated with ibuprofen. In May 2018, the outcome of the headache, chills, muscle pain and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the headache, chills, muscle pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient reported that she had a headache, chills, muscle aches, like she had the flu, so she took an ibuprofen and felt fine at the reporting date. The details of the treating physician were also provided.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site rash in a adult patient who received SHINGRIX. In May 2018, the patient received SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site rash. The patient was treated with Antihistamines. On an unknown date, the outcome of the injection site rash was unknown. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional information were received as follows: The age at vaccination was not reported. The patient received a dose of SHINGRIX earlier in the week of reporting date and came on the day of reporting to visit physician with a large rash on half of her arm. The patient was prescribed with steroids and antihistamines. The reporter was agreed for follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Hypoaesthesia, Insomnia, Musculoskeletal pain, Pain
Clinical narrative: The pain is the worst I've ever experienced in all my 75 yrs and it is still continuing 12 days later, and w/pain relievers to no avail. Can't sleep, sit, rest, etc. No end in sight. I will not get the 2nd shot! If I had been told it would be so unbelievably painful for so long, I never would have gotten it. Still have the rash too. One finger went numb and has not returned to normal. Shoulder blade and armpit pain too.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: The pain is the worst I've ever experienced in all my 75 yrs and it is still continuing 12 days later, and w/pain relievers to no avail. Can't sleep, sit, rest, etc. No end in sight. I will not get the 2nd shot! If I had been told it would be so unbelievably painful for so long, I never would have gotten it. Still have the rash too. One finger went numb and has not returned to normal. Shoulder blade and armpit pain too.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, itching and swelling occurred within a day on the upper arm about 15 mm from spot where vaccine was given (the area is about 10 x 15 cm).
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: VIth nerve paralysis
Clinical narrative: Right nerve palsy lateral rectus.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Hypersensitivity, Injection site bruising, Injection site swelling, Myalgia
Clinical narrative: Pt presented with symptoms of allergic reaction, joint/muscle aches, nausea, left upper arm (deltoid) at injection site (distal to), raised, slightly bruised.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Pt presented with symptoms of allergic reaction, joint/muscle aches, nausea, left upper arm (deltoid) at injection site (distal to), raised, slightly bruised.
Age: 79.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Skin warm
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse, referring to a 79 year old male patient. The patient current condition included allergy to sulfas. None pertinent medical history nor concomitant medication was reported. On 16-MAY-2018, the patient was vaccinated with 1 dose of PNEUMOVAX 23 (lot # N027624 and expiration date 11-MAY-2019), intramuscular for prophylaxis. (Dose was not reported). On an unknown date, in May 2018, the patient developed a "localized injection site reaction", no further details were provided. At the reporting time, treatment details and current status of this patient were unknown. The reporter did not assess the causal relationship between therapy with PNEUMOVAX 23 and the Injection site reaction. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1805USA009377.
Age: 79.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site reaction, Local reaction
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse, referring to a 79 year old male patient. The patient current condition included allergy to sulfas. None pertinent medical history nor concomitant medication was reported. On 16-MAY-2018, the patient was vaccinated with 1 dose of PNEUMOVAX 23 (lot # N027624 and expiration date 11-MAY-2019), intramuscular for prophylaxis. (Dose was not reported). On an unknown date, in May 2018, the patient developed a "localized injection site reaction", no further details were provided. At the reporting time, treatment details and current status of this patient were unknown. The reporter did not assess the causal relationship between therapy with PNEUMOVAX 23 and the Injection site reaction. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1805USA009377.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of generalized pruritus in a 79-year-old female patient who received SHINGRIX. On 14th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, 1 day 12 hrs after receiving SHINGRIX, the patient experienced generalized pruritus, erythema of extremities and hives. The patient was treated with antihistamine. On an unknown date, the outcome of the generalized pruritus, erythema of extremities and hives were recovering/resolving. The reporter considered the generalized pruritus, erythema of extremities and hives to be possibly related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that on 16th May 2018, 1 and half days after receiving SHINGRIX, the patient experienced systemic itchiness from head to toe, mostly in the palms, ankles and soles of the feet. The patient also had a red spot on the arm and dime sized hives which came and went. Less than a month, after receiving SHINGRIX, the patient had been taking antihistamine to try and resolve the itchiness but still had the side effect. The healthcare professional did not have information on the vaccine that was given because it was given at the pharmacy. She would call back if she obtained the information and stated that they did recommend her making a doctor visit. The patient came to see the doctor on 22nd May 2018.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus generalised, Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of generalized pruritus in a 79-year-old female patient who received SHINGRIX. On 14th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, 1 day 12 hrs after receiving SHINGRIX, the patient experienced generalized pruritus, erythema of extremities and hives. The patient was treated with antihistamine. On an unknown date, the outcome of the generalized pruritus, erythema of extremities and hives were recovering/resolving. The reporter considered the generalized pruritus, erythema of extremities and hives to be possibly related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that on 16th May 2018, 1 and half days after receiving SHINGRIX, the patient experienced systemic itchiness from head to toe, mostly in the palms, ankles and soles of the feet. The patient also had a red spot on the arm and dime sized hives which came and went. Less than a month, after receiving SHINGRIX, the patient had been taking antihistamine to try and resolve the itchiness but still had the side effect. The healthcare professional did not have information on the vaccine that was given because it was given at the pharmacy. She would call back if she obtained the information and stated that they did recommend her making a doctor visit. The patient came to see the doctor on 22nd May 2018.
Age: 28.0
Sex: M
Vaccine: RAB, TD, TYP
Symptoms: Adverse food reaction, Body temperature increased, Eosinophil percentage, Feeling abnormal, Lymphocyte percentage decreased
Clinical narrative: 3 hours after administration, and after eating Korean food, pt reports had itchy skin. Perhaps some hives.  he day later he felt poorly. On 3d day he had swelling of face and extensive hives. Went to local hospital ER where he was found to have T 99.9F, HR 112, BP 128/78. They opted to admit him due to extensiveness of rash. Was kept in with IV Cortisone and antihistamine for 3 days. CBC showed WBC 11.32, Neuts 88%, Lymphs 10% and Eos 1%. Discharged day 3 on oral steroids. 11 days later, ate Korean food again and had a more rapid onset of facial swelling and hive development. Went back to ER, and has follow up with local physician today.
Age: 28.0
Sex: M
Vaccine: RAB, TD, TYP
Symptoms: Neutrophil percentage increased, Pruritus, Rash, Swelling face, Urticaria
Clinical narrative: 3 hours after administration, and after eating Korean food, pt reports had itchy skin. Perhaps some hives.  he day later he felt poorly. On 3d day he had swelling of face and extensive hives. Went to local hospital ER where he was found to have T 99.9F, HR 112, BP 128/78. They opted to admit him due to extensiveness of rash. Was kept in with IV Cortisone and antihistamine for 3 days. CBC showed WBC 11.32, Neuts 88%, Lymphs 10% and Eos 1%. Discharged day 3 on oral steroids. 11 days later, ate Korean food again and had a more rapid onset of facial swelling and hive development. Went back to ER, and has follow up with local physician today.
Age: 28.0
Sex: M
Vaccine: RAB, TD, TYP
Symptoms: White blood cell count increased
Clinical narrative: 3 hours after administration, and after eating Korean food, pt reports had itchy skin. Perhaps some hives.  he day later he felt poorly. On 3d day he had swelling of face and extensive hives. Went to local hospital ER where he was found to have T 99.9F, HR 112, BP 128/78. They opted to admit him due to extensiveness of rash. Was kept in with IV Cortisone and antihistamine for 3 days. CBC showed WBC 11.32, Neuts 88%, Lymphs 10% and Eos 1%. Discharged day 3 on oral steroids. 11 days later, ate Korean food again and had a more rapid onset of facial swelling and hive development. Went back to ER, and has follow up with local physician today.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Hypoaesthesia, Immediate post-injection reaction, Injection site hypoaesthesia, Injection site pain
Clinical narrative: Patient described feeling numbness & sharp, shooting pain from injection site (over right deltoid) to elbow and then proximally again towards right shoulder (from elbow), immediately after injection of vaccine started. Also describes weakness from elbow to fingers (hand and arm flexor muscles mostly) & numbness in right hand, palmar & dorsal surfaces, & upper arm, especially over anterior, medial biceps area. Approximately 3 hrs after vaccine, swelling developed in right hand also. She described pain & discomfort in upper arm as worsening in the 2 hrs after vaccination & later included wrist also. Patient went to urgent care & was told her symptoms were beyond their scope and to go to ER. Patient said that she did not feel that symptoms were related to needle stick and instead felt they started once she felt the vaccine fluid being injected, though much of what she described initially sounded like it may have been, at least partially, related to the needle stick. Most of the information recorded on this form was obtained on 5/22/18, though the form is being submitted on 5/29/18. We were waiting to receive information from patient's visit to the ER as she said she would return with the ER paperwork afterwards. However, she has not communicated with us again since 5/22/18.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Limb discomfort, Muscular weakness, Musculoskeletal discomfort, Pain, Pain in extremity
Clinical narrative: Patient described feeling numbness & sharp, shooting pain from injection site (over right deltoid) to elbow and then proximally again towards right shoulder (from elbow), immediately after injection of vaccine started. Also describes weakness from elbow to fingers (hand and arm flexor muscles mostly) & numbness in right hand, palmar & dorsal surfaces, & upper arm, especially over anterior, medial biceps area. Approximately 3 hrs after vaccine, swelling developed in right hand also. She described pain & discomfort in upper arm as worsening in the 2 hrs after vaccination & later included wrist also. Patient went to urgent care & was told her symptoms were beyond their scope and to go to ER. Patient said that she did not feel that symptoms were related to needle stick and instead felt they started once she felt the vaccine fluid being injected, though much of what she described initially sounded like it may have been, at least partially, related to the needle stick. Most of the information recorded on this form was obtained on 5/22/18, though the form is being submitted on 5/29/18. We were waiting to receive information from patient's visit to the ER as she said she would return with the ER paperwork afterwards. However, she has not communicated with us again since 5/22/18.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Peripheral swelling
Clinical narrative: Patient described feeling numbness & sharp, shooting pain from injection site (over right deltoid) to elbow and then proximally again towards right shoulder (from elbow), immediately after injection of vaccine started. Also describes weakness from elbow to fingers (hand and arm flexor muscles mostly) & numbness in right hand, palmar & dorsal surfaces, & upper arm, especially over anterior, medial biceps area. Approximately 3 hrs after vaccine, swelling developed in right hand also. She described pain & discomfort in upper arm as worsening in the 2 hrs after vaccination & later included wrist also. Patient went to urgent care & was told her symptoms were beyond their scope and to go to ER. Patient said that she did not feel that symptoms were related to needle stick and instead felt they started once she felt the vaccine fluid being injected, though much of what she described initially sounded like it may have been, at least partially, related to the needle stick. Most of the information recorded on this form was obtained on 5/22/18, though the form is being submitted on 5/29/18. We were waiting to receive information from patient's visit to the ER as she said she would return with the ER paperwork afterwards. However, she has not communicated with us again since 5/22/18.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Arm swelling (more than injection site reaction), itching, Pt came to ED to have it looked at by doctor.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: Swelling of right side of face.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Nausea, Pain in extremity, Pruritus
Clinical narrative: Sore arm, nausea, fever, diarrhea, tiredness, itchiness.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Sore arm, nausea, fever, diarrhea, tiredness, itchiness.
Sex: M
Vaccine: HPV9
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a nurse and refers to a male patient of unknown age. The patient's pertinent medical history, drug reactions and concomitant medications were not provided. The patient had allergy to bovine products. On 07-MAY-2018, the patient was vaccinated with properly stored GARDASIL 9) (dose, route of administration, lot number and expiration date were not reported), for prophylaxis. On 07-MAY-2018, the patient experienced injection site rash. The outcome of injection site rash was not reported. The relatedness between the event and suspected vaccine was not reported.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a physician refers to a 19 year old male patient. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date, the patient was vaccinated with VAQTA, 25/0.5 DF injection, pediatric dose, for prophylaxis. No adverse event was reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse via a company representative, referring to a 12 month old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On an unknown date, the patient was vaccinated with a dose of PROQUAD (dose, anatomical location, administration route, lot number and expiration date were not reported); on the same date (in the same office visit), the patient was also vaccinated with a dose of VARIVAX (dose, anatomical location, administration route, lot number and expiration date were not reported) both vaccines as prophylaxis. No adverse events were reported.
Sex: U
Vaccine: HPVX
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse Practitioner referring to a 25 year old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On approximately, an unspecified date in 2008 (reported as "10 years ago") the patient received the first dose in the human papillomavirus (HPV) vaccination series with either GARDASIL 9 or GARDASIL (dose, frequency,  lot#, expiration date were not reported) for prophylaxis, but it was unknown which of both vaccines was administered. On 15-MAY-2018, the patient received the second dose in the HPV vaccination series with GARDASIL 9, dose 0.5 ml, lot # N014464, expiration date on 19-DEC-2019,  intramuscularly for prophylaxis (interchange of vaccine products). No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a 93 year old patient of unknown gender, referring to him/herself. The patient's medical history, concurrent conditions, concomitant therapies and drug or allergy reactions were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, dose, dose number, administration route, lot number and expiration date were not reported), for prophylaxis. The patient stated that had had quite a few ZOSTAVAX shots over the years given him/her age. No adverse effects reported.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a multiple patients (children) of unknown age and gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patients were vaccinated with PEDVAXHIB (lot #, expiration date, strength and route of administration were not provided) for prophylaxis. The patients were vaccinated in an altered dosing schedule: "one dose at 2 months of age, one dose of at 4 months of age and one dose at 6 months of age. On an unknown date the same unspecified patients received a booster dose of PEDVAXHIB at 12 to 15 months of age. The reporter stated that the patients did not experienced any adverse events.
Sex: F
Vaccine: HPV9
Symptoms: Headache
Clinical narrative: This spontaneous report was received from a Nurse via a company representative, referring to an 11 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions and concomitant medications. On an unknown date, the patient was vaccinated with GARDASIL 9, intramuscularly for vaccination (strength, dose, frequency, lot number and expiration date were not reported). Afterwards, on an unknown date, the patient experienced a bad headache for an unknown period. At the time of the report, the outcome of bad headache and its causality with GARDASIL 9 were unknown.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Condition aggravated, Headache
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a currently 21 year old female patient. The patient's concurrent conditions included headache, musculoskeletal chest pain, arthralgia and drug hypersensitivity. The patient's medical history included concussion. Concomitant therapies included nortriptylin (NORTRIPTYLINE) and ethinyl estradiol, ferrous fumarate, norethindrone acetate(JUNEL FE 1.5/30). On 27-APR-2015, the patient was vaccinated with the first dose of GARDASIL 9 dose 1, intramuscular, lot # reported as K023435 with expiration date of 05-NOV-2016 (strength, dose, route, and anatomical location were not provided) for prophylaxis. Then on an unknown date, the patient experienced worsening of her pre-existing headaches, therefore, the patient did not continued the series. The patient received nortriptyline as treatment. On 23-MAY-2018, the patient wanted to received her second dose of GARDASIL 9. The outcome of headache was reported as recovered on an unknown date. The causality assessment between therapy with GARDASIL 9 and the events was not reported. Lot number K023435 is an invalid lot number for GARDASIL 9.
Sex: M
Vaccine: DTAPIPV, HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong patient received medication
Clinical narrative: This spontaneous report has been received from a physician referring to a 4 year old male patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. Approximately in 03-MAY-2018 reported as ("3 weeks ago"), the patient was vaccinated with GARDASIL 9 (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. On the same date the patient also received poliovirus vaccine inactivated (unspecified)(POLIOVIRUS VACCINE INACTIVATED (UNSPECIFIED)) and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid(DIPHTHERIA TOXOID (+) PERTUSSIS ACELLULAR VACCINE (UNSPECIFIED) (+) TE). It was reported that the patient received in error an GARDASIL 9 that was intended to be administered to another patient (drug administered to patient of inappropriate age and wrong drug administered). No adverse effects were reported. This is one of two cases from the same reporter.; Sender's Comments:  US-009507513-1805USA012398:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling of the injection site and redness, warm to the touch.
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Eye movement disorder, Grimacing
Clinical narrative: On May 25, 2018, patient was lying in bed with mother when mother noted a period of baby's eyes moving back and forth, side to side, along with grimacing gestures for app. 30 seconds. No fever or illness reported at the time. Quickly recovered and was responsive, alert and "normal" after that.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypersensitivity, Injection site pain, Injection site rash, Rash
Clinical narrative: On day of injection left arm was sore and had a rash about 4 in. around site of injection. Two days later severe hives began to appear over entire body. I went to the Medical Center (on the advice of Ask a Nurse -insurance company). I received a steroid injection and a prescription for prednisone. One week after discontinuing the prednisone I went to a walk-in clinic (Saturday) for a rash on leg and behind ear. The diagnosis was an allergic reaction (rash on leg) and shingles behind ear. A prescription for prednisone was given for the allergy (hives) and a prescription for Valacylovir HCL (1gram) and ointment (Clotrimazole and Betamethasone Dipropionate Cream (1 %).
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: On day of injection left arm was sore and had a rash about 4 in. around site of injection. Two days later severe hives began to appear over entire body. I went to the Medical Center (on the advice of Ask a Nurse -insurance company). I received a steroid injection and a prescription for prednisone. One week after discontinuing the prednisone I went to a walk-in clinic (Saturday) for a rash on leg and behind ear. The diagnosis was an allergic reaction (rash on leg) and shingles behind ear. A prescription for prednisone was given for the allergy (hives) and a prescription for Valacylovir HCL (1gram) and ointment (Clotrimazole and Betamethasone Dipropionate Cream (1 %).
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Client reported severe arm pain starting several hours after injection. Describes pain as a 9/10. Client continues to have arm pain one month after vaccination.
Age: 11.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Erythema, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Pain and swelling in left arm. 3 inch area of redness. hurts to move her arm.
Age: 1.0
Sex: M
Vaccine: MMR, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash erythematous, Rash generalised, Urticaria
Clinical narrative: Small raised red dots which progressed to large red welts. Started on face, around mouth and then progressed to include entire body.
Age: 1.0
Sex: M
Vaccine: MMR, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pallor, Rash, Rash macular
Clinical narrative: Small raised red dots which progressed to large red welts. Started on face, around mouth and then progressed to include entire body.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Injection site swelling
Clinical narrative: SEVERE HEADACHE, INJECTION SITE SWELLING, DIARRHEA
Age: 0.5
Sex: U
Vaccine: RV5, TYP
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received via a company representative from a pediatric nurse practitioner (CPNP) refers to a 6-month-old patient of unknown gender. The patient had no concomitant medications, pertinent medical history or known drug reactions and allergies. On 30-APR-2018, the patient was vaccinated with the third dose of ROTATEQ, one unspecified dose, orally (lot # N030364 with the expiration date of 06-MAR-2019) for prophylaxis. Prior to the vaccine administration, the patient received MOTRIN (dose, frequency, strength, formulation, route of administration and indication for use were not reported). The patient also received regularly scheduled unspecified vaccines at the same time as ROTATEQ. On 30-APR-2018, within 1 hour of receiving ROTATEQ, the patient experienced vomiting, was seen by a physician and was treated with unspecified fluids to prevent dehydration. The vomiting continued for about one day and then subsided. The causality assessment between the event and ROTATEQ was not provided. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1805USA000702.
Age: 15.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 15 year old patient (gender was not reported). The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On an unknown date, the patient inadvertently received an unspecified dose of PROQUAD injection (lot # N022972 with expiration date on 19-FEB-2019; dose and route of administration were not reported), instead of M-M-R II and VARIVAX. No adverse effect was reported.