chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Visual impairment
Clinical narrative: I had typical side effects the day of the vaccine-chills, fever, pain at injection site. I was very tired for the next few days, had trouble focusing my eyes. I felt a dry, scratchy feeling in my chest. The feeling of being ill, dry, scratchy chest, dizziness and exhaustion went on for a few weeks when I sought care from my primary care physician in March 2020. In April, the scratchy feeling in my chest became chest pain and difficulty breathing. I went back to my primary care and also made 4 visits to the emergency room.  The first ER visit I thought I might be having a food allergy but it did not resolve. Currently, I still have pain in the center of my chest and the right side both front near the sternum and back along the thoracic vertebrae. I still have difficulty pulling in a full breath sometimes and have a scratchy feeling in my chest. I break out in a sweat during pain/breathing difficulties.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Antibody test negative, Blood test, Chest X-ray, Chest discomfort, Chest pain
Clinical narrative: I had typical side effects the day of the vaccine-chills, fever, pain at injection site. I was very tired for the next few days, had trouble focusing my eyes. I felt a dry, scratchy feeling in my chest. The feeling of being ill, dry, scratchy chest, dizziness and exhaustion went on for a few weeks when I sought care from my primary care physician in March 2020. In April, the scratchy feeling in my chest became chest pain and difficulty breathing. I went back to my primary care and also made 4 visits to the emergency room.  The first ER visit I thought I might be having a food allergy but it did not resolve. Currently, I still have pain in the center of my chest and the right side both front near the sternum and back along the thoracic vertebrae. I still have difficulty pulling in a full breath sometimes and have a scratchy feeling in my chest. I break out in a sweat during pain/breathing difficulties.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Computerised tomogram, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: I had typical side effects the day of the vaccine-chills, fever, pain at injection site. I was very tired for the next few days, had trouble focusing my eyes. I felt a dry, scratchy feeling in my chest. The feeling of being ill, dry, scratchy chest, dizziness and exhaustion went on for a few weeks when I sought care from my primary care physician in March 2020. In April, the scratchy feeling in my chest became chest pain and difficulty breathing. I went back to my primary care and also made 4 visits to the emergency room.  The first ER visit I thought I might be having a food allergy but it did not resolve. Currently, I still have pain in the center of my chest and the right side both front near the sternum and back along the thoracic vertebrae. I still have difficulty pulling in a full breath sometimes and have a scratchy feeling in my chest. I break out in a sweat during pain/breathing difficulties.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Hyperhidrosis, Injection site pain, Irritability, Pulmonary function test
Clinical narrative: I had typical side effects the day of the vaccine-chills, fever, pain at injection site. I was very tired for the next few days, had trouble focusing my eyes. I felt a dry, scratchy feeling in my chest. The feeling of being ill, dry, scratchy chest, dizziness and exhaustion went on for a few weeks when I sought care from my primary care physician in March 2020. In April, the scratchy feeling in my chest became chest pain and difficulty breathing. I went back to my primary care and also made 4 visits to the emergency room.  The first ER visit I thought I might be having a food allergy but it did not resolve. Currently, I still have pain in the center of my chest and the right side both front near the sternum and back along the thoracic vertebrae. I still have difficulty pulling in a full breath sometimes and have a scratchy feeling in my chest. I break out in a sweat during pain/breathing difficulties.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, SARS-CoV-2 test negative, Spinal pain, Vision blurred
Clinical narrative: I had typical side effects the day of the vaccine-chills, fever, pain at injection site. I was very tired for the next few days, had trouble focusing my eyes. I felt a dry, scratchy feeling in my chest. The feeling of being ill, dry, scratchy chest, dizziness and exhaustion went on for a few weeks when I sought care from my primary care physician in March 2020. In April, the scratchy feeling in my chest became chest pain and difficulty breathing. I went back to my primary care and also made 4 visits to the emergency room.  The first ER visit I thought I might be having a food allergy but it did not resolve. Currently, I still have pain in the center of my chest and the right side both front near the sternum and back along the thoracic vertebrae. I still have difficulty pulling in a full breath sometimes and have a scratchy feeling in my chest. I break out in a sweat during pain/breathing difficulties.
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site reaction, Rash, Rash erythematous, Rash macular
Clinical narrative: Rash is described as "red", "papular" and "itchy".; Rash is described as "red", "papular" and "itchy".; This spontaneous report was received from a nurse and refers to a 66-year-old female patient with diabetes mellitus. The patient's concomitant therapies included saccharomyces boulardii (FLORASTOR), atorvastatin (TORVATIN), levobunolol hydrochloride, dicyclomine hydrochloride, aspirin (ECOTRIN) and aspirin (CARTIA). On 11-JUL-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, dose number, lot #, expiration date, route of administration and anatomical location were not reported) for standard vaccination for age. On unspecified date in July 2020, between 11-JUL-2020 and 21-JUL-2020, the patient experienced rash like patches all over her body. Rash was described as red, papular and itchy. On 21-JUL-2020, patient came to dermatologist office regarding rash. As a treatment the patient received triamcinolone and over the counter antihistamines, but it didn't work. On the same day, skin biopsy was performed, results were pending. On unspecified date, after 21-JUL-2020, patient came back in to dermatology office and rash was getting worst. The patient had no cancer or overdose. The patient did not recover from the events at the reporting time. The causality assessment between the events and suspect therapy was not provided.
Sex: F
Vaccine: PPV, PPV
Symptoms: Biopsy skin, Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Rash is described as "red", "papular" and "itchy".; Rash is described as "red", "papular" and "itchy".; This spontaneous report was received from a nurse and refers to a 66-year-old female patient with diabetes mellitus. The patient's concomitant therapies included saccharomyces boulardii (FLORASTOR), atorvastatin (TORVATIN), levobunolol hydrochloride, dicyclomine hydrochloride, aspirin (ECOTRIN) and aspirin (CARTIA). On 11-JUL-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, dose number, lot #, expiration date, route of administration and anatomical location were not reported) for standard vaccination for age. On unspecified date in July 2020, between 11-JUL-2020 and 21-JUL-2020, the patient experienced rash like patches all over her body. Rash was described as red, papular and itchy. On 21-JUL-2020, patient came to dermatologist office regarding rash. As a treatment the patient received triamcinolone and over the counter antihistamines, but it didn't work. On the same day, skin biopsy was performed, results were pending. On unspecified date, after 21-JUL-2020, patient came back in to dermatology office and rash was getting worst. The patient had no cancer or overdose. The patient did not recover from the events at the reporting time. The causality assessment between the events and suspect therapy was not provided.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Became quite sleepy around 7pm same day. Went to sleep and woke up around 4 am the next morning. Felt feverish, headache, muscles pain. Just like typical influensa. Stomach symptoms gradually worse, with diarrea and slight vomitting.. This is precisely the same reaction I got formy first shot, which I believe was in August 2019.   I was gradually  feeling less bad, but spent most of the day in bed .  Even in the evening yesterday , I had a slight fever and muscle pain.  Much better today, but still lingering symtoms and will not leave the house.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence, Vaccine positive rechallenge, Vomiting
Clinical narrative: Became quite sleepy around 7pm same day. Went to sleep and woke up around 4 am the next morning. Felt feverish, headache, muscles pain. Just like typical influensa. Stomach symptoms gradually worse, with diarrea and slight vomitting.. This is precisely the same reaction I got formy first shot, which I believe was in August 2019.   I was gradually  feeling less bad, but spent most of the day in bed .  Even in the evening yesterday , I had a slight fever and muscle pain.  Much better today, but still lingering symtoms and will not leave the house.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pain, redness, swelling at injection site starting about 5 hours post injection.  Fever >100.5 °, shivering, starting around 10 hours post injection, during sleep.  Treated with Tylenol and Advil upon waking.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza, Pain, Rash erythematous
Clinical narrative: Within 24 hours of Shingles vaccines, I experienced a red rash from neck to torso  in addition to the mild flu symptoms (head ache, fatigue, body pain).  I did not get medical attention because the rash did not extend to my face and mouth, but I was concerned.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Headache, Hypoacusis, Malaise, Photophobia
Clinical narrative: Initially he had symptoms of pre-syncope, light-headed, sounds muffled, and then headache, not feeling well, light sensitivity, and fever developed.  Continues to have symptoms today.  No treatment at this time.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Presyncope, Pyrexia
Clinical narrative: Initially he had symptoms of pre-syncope, light-headed, sounds muffled, and then headache, not feeling well, light sensitivity, and fever developed.  Continues to have symptoms today.  No treatment at this time.
Age: 50.0
Sex: M
Vaccine: DTAP
Symptoms: Axillary pain, Injection site pain, Injection site swelling, Swelling
Clinical narrative: swelling  and pain  around where the the short is given on the following  day which is Tuesday  then swelling  and pain on  my armpit  no the same left arm the following day which is Thursday morning
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site urticaria
Clinical narrative: About 15 minutes after patient received vaccines mom noted a hive on his right thigh. Varicella vaccine was given at this site 10ml of liquid Benadryl was given, within 10 minutes the hive was resolving
Age: 1.33
Sex: M
Vaccine: HIBV, MMR
Symptoms: Rash erythematous, Urticaria
Clinical narrative: 7/29/20 4:15PM mother reported two small red dots on ankles. Was advised by Pediatricians office to monitor to and seek care if worsening. CHN spoke to patients mother 4:30PM and mother at that time reported spots were looking much better and believed they may have been bug bites. CHN advised to monitor and seek care if needed 7/29/20 6:30PM Patient mother reported hives on extremities. Was advised by an Urgent Care facility via telephone to administer Benadryl and Tylenol.  7/30/20 9AM patient mother reports hives have gone away within the last 2 hours and no fever.  7/30/20 10AM mother called CHN again and reported Hives reappeared and are primarily on ankles and hands. Patient being seen by pediatrician this AM.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PNC13, RV5
Symptoms: Wrong product administered
Clinical narrative: Pedvax  Hib was given in error instead of Hepatitis B.  Patient's mother was called and told of incident.  She was to call us if any kind of symptoms occurred such as fever, vomiting, redness at injection site, etc.  Dr. called the mother.  No report from mother of any problems.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: About 15 minutes after patient received vaccines mom noted a hive on his right thigh. Varicella vaccine was given at this site10ml of liquid Benadryl was given, within 10 minutes the hive was resolving
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Face and mouth X-ray abnormal, Facial bones fracture, Fall, Head injury
Clinical narrative: Approx 1 minute following vaccine administration, patient fainted and fell off exam table onto floor without warning. Patient did hit head.  Patient was unconscious for approx 10 seconds. When patient regained consciousness, he was unsure of what happened. Patient did remember getting vaccine but thought he fell asleep. He was slightly slow to respond to questions after regaining consciousness. Patient did become dizzy when sat up, became nauseous and vomited.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Loss of consciousness, Nausea, Slow response to stimuli, Syncope, Vomiting
Clinical narrative: Approx 1 minute following vaccine administration, patient fainted and fell off exam table onto floor without warning. Patient did hit head.  Patient was unconscious for approx 10 seconds. When patient regained consciousness, he was unsure of what happened. Patient did remember getting vaccine but thought he fell asleep. He was slightly slow to respond to questions after regaining consciousness. Patient did become dizzy when sat up, became nauseous and vomited.
Age: 50.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt stated she has redness, swelling, pain, slight itch, and warm to touch to injection site. Pt is applying ice packs to area 15-20 minutes three times a day. Pt states after 8 days since injection she is feeling a little better, still feeling warmth to area, redness, swelling, itching. Pt is not having breathing difficulties.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: hives, no anaphylaxis developed within few hours of vaccination
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Injection site swelling, Pain
Clinical narrative: Achy body, temp 99.3 on 7/29/20 and 100.1 on 7/30/20, Swollen arm at injection site.
Age: 5.0
Sex: M
Vaccine: DT
Symptoms: Erythema, Feeling hot, Oedema, Pain
Clinical narrative: Upper arm developed circular area of erythema, edema, heat and pain.  Approximately 2 inches in diameter.  Mom noticed reddened area when putting child to bed.  Reports she has administered Ibuprofen and Benadryl.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: Headache, fatigue, body ache, pain at the injection site, dizziness
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: developed fever of 100.3 the day after the vaccine, arm very sore and somewhat swollen. Low grade fever came and went for 2.5 days
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Mobility decreased, Pain, Skin tightness, Skin warm
Clinical narrative: Cellulitis type reaction. hot to touch , pain, tightness and swelling, hard to move arm. given Doxycycline 100 BID for 10 days
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Cellulitis type reaction. hot to touch , pain, tightness and swelling, hard to move arm. given Doxycycline 100 BID for 10 days
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin mass
Clinical narrative: Red and swollen arm area below the injection site and down entire length of arm. Small knot under skin approximately 3 inches below injection site.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Fatigue, Headache, Lower respiratory tract infection, Pain
Clinical narrative: Pt had PPSV23 on 07/21. the next morning he suddenly felt exhausted. Later, he began feeling achy all over and feverish. Pt thought it was a rxn to vaccine. That night he started coughing deeply like a chest cold. It went on for a while. The following morning (07/23), he felt fine with just a headache. 07/24 he felt fine.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Pt had PPSV23 on 07/21. the next morning he suddenly felt exhausted. Later, he began feeling achy all over and feverish. Pt thought it was a rxn to vaccine. That night he started coughing deeply like a chest cold. It went on for a while. The following morning (07/23), he felt fine with just a headache. 07/24 he felt fine.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: A 4th dose of HPV vaccine given, unaware of first 3 doses Immunization given by accident.
Age: 55.0
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: RED RASH AT INJECTION SITE AND ON RIGHT FOREARM
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Pain
Clinical narrative: Chills, body ache, upset stomach,  headache,
Age: 18.0
Sex: F
Vaccine: HEP, HPV9, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Erythema, swelling and pruritus just inferior to injection site beginning 24-36 hours after injection. No treatment given, watchful waiting.
Age: 52.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site discharge, Product administered at inappropriate site, Vaccination site pain, Vaccination site warmth
Clinical narrative: Shingrix vaccination claimed to be given too low.  Vaccine area is hot to touch, seeping, wet, and sore. Boostrix vaccination claimed to be given too high.  No side effects stated. Side effects noticed Thursday 7/30/20 around 9am.  Patient works in a doctor's office.  Nurses claimed vaccine administration was too high and too low.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Patient states she had pretty noticeable arm swelling with redness and pain. Breathing was okay and swelling started to go down after 24 hours. Told patient to keep it under her radar and to give us a call if it gets worse. If breathing is affected, to go to the ER
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Pain, redness, swelling, tenderness in the left arm that has spread to involve a large area of the arm. Symptoms started 2 days after vaccine administration.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood glucose normal, Dizziness, Immediate post-injection reaction, Nausea, Nervousness
Clinical narrative: Immediately after vaccinations patient was near syncopal and started having full body tremors. Vitals, including blood glucose, were stable. Patient reported nausea and dizziness. After about 20 minutes tremors were reduced but continued. Examined by MD x 3 over this period of time. Follow up call 3 hours later tremor and feeling of shakiness continue. Dizziness and nausea resolved.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Presyncope, Tremor
Clinical narrative: Immediately after vaccinations patient was near syncopal and started having full body tremors. Vitals, including blood glucose, were stable. Patient reported nausea and dizziness. After about 20 minutes tremors were reduced but continued. Examined by MD x 3 over this period of time. Follow up call 3 hours later tremor and feeling of shakiness continue. Dizziness and nausea resolved.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Cough, Headache, Nausea
Clinical narrative: Patient had Shingrix in left deltoid and TDap in right deltoid on 7/26/20. Patient started to experience that day headache, fever above 100 degrees, chills, body aches, cough. These symptoms remained for 24 hours. Then symptoms became less severe. On 7/28/20, patient had nausea, body aches, and upset stomach. On 7/29/20, hives, body aches, cough, and itching all over became sypmtoms. Patient is seeing PCP today.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Pyrexia, SARS-CoV-2 test negative, Urticaria
Clinical narrative: Patient had Shingrix in left deltoid and TDap in right deltoid on 7/26/20. Patient started to experience that day headache, fever above 100 degrees, chills, body aches, cough. These symptoms remained for 24 hours. Then symptoms became less severe. On 7/28/20, patient had nausea, body aches, and upset stomach. On 7/29/20, hives, body aches, cough, and itching all over became sypmtoms. Patient is seeing PCP today.
Age: 1.25
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Pain, Pyrexia, Rash, Urticaria
Clinical narrative: Baseball sized hives all over my sons body. Fever, swollen bumps all over body, aches.
Age: 64.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Blister, Pustule, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: day 1- Red, warm, itchy rash with puss-filled blisters. On second day the blister subsided and flattened but rash spread
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Anti-cyclic citrullinated peptide antibody, C-reactive protein, Chiropractic, Full blood count, Injection site pain
Clinical narrative: within 2 weeks of the vaccine the patient noticed soreness in the shoulder on the side of the injection along with discomfort in back of the neck.  She's had persistent neck discomfort and shoulder soreness.  she also has stiffness and achiness in the fingers which improves as the day progresses but never resolves. She sought help from a chiropractor afterwards.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Metabolic function test, Musculoskeletal discomfort, Musculoskeletal stiffness, Pain in extremity, Red blood cell sedimentation rate
Clinical narrative: within 2 weeks of the vaccine the patient noticed soreness in the shoulder on the side of the injection along with discomfort in back of the neck.  She's had persistent neck discomfort and shoulder soreness.  she also has stiffness and achiness in the fingers which improves as the day progresses but never resolves. She sought help from a chiropractor afterwards.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rheumatoid factor
Clinical narrative: within 2 weeks of the vaccine the patient noticed soreness in the shoulder on the side of the injection along with discomfort in back of the neck.  She's had persistent neck discomfort and shoulder soreness.  she also has stiffness and achiness in the fingers which improves as the day progresses but never resolves. She sought help from a chiropractor afterwards.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Blister, Erythema, Local reaction, Swelling
Clinical narrative: Large localized reaction to Dtap given 7/27/2020. Photos scanned into chart. Redness and swelling mild at hour 28. Became severe with blisters by hour 36. No fever.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Computerised tomogram, Erythema, Magnetic resonance imaging, Mobility decreased, Myalgia
Clinical narrative: she also has a rash on her neck and stomach; Indication: For the new symptoms of asthma; her arm that was not injected with the vaccine is experiencing pain in her bicep and tricep; Caller also stated she is not able to bend or move her arm; her arm that was not injected with the vaccine is experiencing pain in her bicep and tricep and it is a bright red; This spontaneous report was received from a consumer who refers herself, a 65-year-old female patient. Her concurrent condition included asthma, allergy to penicillin, morphine and sulfa drugs. Concomitant medication included ibandronate sodium (BONIVA) and unspecified inhaler for asthma. Medical history included morphine, penicillin and sulfa drugs.  On 06-JUL-2020, the patient was vaccinated with one dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection for the new symptoms of asthma and as precaution (exact dose, route of administration, lot number and expiration date were not provided).  On 07-JUL-2020, the patient's arm that was not injected with the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was experiencing pain in her bicep and triceps and it was a bright red. The patient was not able to bend or move her arm.  On 09-JUL-2020 (reported as yesterday), the patient noticed a rash on her neck and stomach. The patient sought for medical attention and she spoke with her primary care doctor who informed her to put ice on it. The patient went to get a second opinion and spoke with a dermatologist and she it was prescribed to her an oral steroid to use. On an unknown date in July 2020, the patient had performed computer tomography (CT) and magnetic resonance imaging (MRI) but no results were provided.  The outcome of the events was reported as not recovered. The causality assessment was not provided.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: she also has a rash on her neck and stomach; Indication: For the new symptoms of asthma; her arm that was not injected with the vaccine is experiencing pain in her bicep and tricep; Caller also stated she is not able to bend or move her arm; her arm that was not injected with the vaccine is experiencing pain in her bicep and tricep and it is a bright red; This spontaneous report was received from a consumer who refers herself, a 65-year-old female patient. Her concurrent condition included asthma, allergy to penicillin, morphine and sulfa drugs. Concomitant medication included ibandronate sodium (BONIVA) and unspecified inhaler for asthma. Medical history included morphine, penicillin and sulfa drugs.  On 06-JUL-2020, the patient was vaccinated with one dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection for the new symptoms of asthma and as precaution (exact dose, route of administration, lot number and expiration date were not provided).  On 07-JUL-2020, the patient's arm that was not injected with the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was experiencing pain in her bicep and triceps and it was a bright red. The patient was not able to bend or move her arm.  On 09-JUL-2020 (reported as yesterday), the patient noticed a rash on her neck and stomach. The patient sought for medical attention and she spoke with her primary care doctor who informed her to put ice on it. The patient went to get a second opinion and spoke with a dermatologist and she it was prescribed to her an oral steroid to use. On an unknown date in July 2020, the patient had performed computer tomography (CT) and magnetic resonance imaging (MRI) but no results were provided.  The outcome of the events was reported as not recovered. The causality assessment was not provided.
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache, Influenza like illness, Nausea, Pyrexia
Clinical narrative: she experienced flu like symptoms such as fever, nausea, headache, and fatigue after receiving the first dose of GARDASIL; she experienced flu like symptoms such as fever, nausea, headache, and fatigue after receiving the first dose of GARDASIL; she experienced flu like symptoms such as fever, nausea, headache, and fatigue after receiving the first dose of GARDASIL; she experienced flu like symptoms such as fever, nausea, headache, and fatigue after receiving the first dose of GARDASIL; she experienced flu like symptoms such as fever, nausea, headache, and fatigue after receiving the first dose of GARDASIL; This spontaneous report was received from a consumer who refers to herself, a 36-year-old female patient. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On an unknown date in 2006, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (exact dose, route of administration, lot number and expiration date was not provided).  On unknown date in 2006, the patient experienced flu like symptoms such as, fever, nausea, headache, and fatigue after receiving the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  The outcome of the events was unknown. The causality assessment was not provided.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Unspecified patients were inadvertently administered doses of VARIVAX and PROQUAD, on unspecified dates, that had been improperly stored.; No additional adverse event; This non-valid spontaneous report was received from a registered nurse concerning multiple unspecified patients. The patients' concurrent conditions, medical history and historical drug were not provided.  On an unknown dates, the patients were vaccinated for prophylaxis with the following inappropriately stored vaccines: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot # S030211 (therapy type rha), expiration date 25-MAR-2021; or varicella virus vaccine live (oka/merck) (VARIVAX) lot # S030227, expiration date 26-SEP-2021. Strengths, doses, and routes of administration were not provided. Both vaccines were reconstituted with a properly stored sterile diluent.  The temperatures involved were: -12.5 degrees Celsius in a time frame of 47 minutes. A previous temperature excursion was reported with a temperature involved of -14 degrees Celsius in a time frame of 23 minutes. A data logger was involved. No additional adverse events were reported.  This case was classified as non-valid since it does not have patient identifiers.  Follow-up information was received on 17-JUL-2020. As of 17-JUL-2020, all telephone attempts to obtain follow-up information have been unsuccessful.
Sex: F
Vaccine: MMR, MMRV, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: the patient was inadvertently administered PROQUAD; the blood work showed that the patient was not immune to VARIVAX; the blood work showed that the patient was not immune to MMRII; the blood work showed that the patient was not immune to MMRII; the blood work showed that the patient was not immune to MMRII; This spontaneous report was received from a nurse,referring to an 18-year-old female patient. The patient's pertinent medical history, concomitant medication and previous drug reactions or allergies were not reported.   On an unspecified dates, during the patient's childhood, she was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), administered via subcutaneous, (strength, dose, anatomical location, vaccination scheme, lot number and expiration date were not reported); and varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, anatomical location, vaccination scheme, route of administration, lot number and expiration date were not reported). Both vaccines were administered as prophylaxis reported as "vaccination".  On 05-JUN-2020, the patient went to her physician for blood work to assess titers and her immunity, the blood work showed that, the patient was not immune to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (measles antibody negative, mumps antibody test negative and rubella antibody negative) and varicella virus vaccine live (oka/merck) (VARIVAX). The patient did not received any treatment for the events.  On 15-JUN-2020, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, (lot number S017238, which has been verified to be valid, expiration date reported and validated as 01-DEC-2020) (strength, dose, anatomical location, vaccination scheme, route of administration were not reported) as prophylaxis reported as "vaccination" (product administered to patient of inappropriate age).  The outcome of measles antibody negative, mumps antibody test negative, rubella antibody negative and antibody test negative and the casual relationship between the aforementioned events and therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) were not reported, ; however the causality assessment between the events and therapy withfor measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was not related.
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects; Expired vaccine administered; This spontaneous report as received from a medical assistant concerning a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported.      On 17-JUL-2020 the patient was vaccinated with an properly stored but expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # reported and validated as R018584, expiration date reported and validated as 12-JUL-2020, administered intramuscularly as prophylaxis (dose, dosage schedule and site of administration were not reported) (expired vaccine used). No adverse effects reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events.; On 20-JUL-2020 a patient was administered an improperly stored VARIVAX; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reaction, or allergies was not provided.  On 20-JUL-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, dose, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number S035125, which have been verified to be valid, expiration date reported and validated as 04-NOV-2021) as prophylaxis (product storage error). It was reported that the sterile diluent (MERCK STERILE DILUENT) used to reconstitute the vaccine was properly stored (lot number and expiration date was not provided).  On 17-JUL-2020, the vaccine was stored in a temperatures of 6 degrees Fahrenheit (F) (9.0 degrees F) for 1 hour, from 15 degrees F to 46 degrees F (45.9 degrees F) for 10 hours and 30 minutes; and starting at 10:07 pm, in a temperature from -47 degrees F to 77 degrees F (77 degrees F) for 15 hours. On 18-JUL-2020, starting at 2:52 pm, the vaccine was stored in a temperature of -78 degrees F/26 degrees Celsius or warmer (79.5 degrees F) for 32 hours. There was no previous temperature excursion and a digital data logger was not involved. No adverse events were reported.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Nurse calling because expired oral vaccine administered to patient.; This spontaneous report was received from a nurse (conflicting information, also reported as "MD") referring to a 4-month-old male patient. It was reported that the patient did not have any medical history, concomitant therapies neither any known drug allergies.  On 20-JUL-2020, the patient was vaccinated with one expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral solution (strength, number of doses, and vaccination scheme frequency were not reported; lot number R026541 has been verified to be a valid, expiration date reported and validated as 11-JUL-2020) as prevention of rotavirus (expired product administered). The nurse stated that the patient did not seek medical attention, no laboratory tests were performed and no received treatment for the event. Additionally, it was reported that, there was no temperature excursion with this vaccine and that the other vaccines had been removed from inventory. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; patient was administered an improperly stored VARIVAX; This spontaneous report as received from an office manager refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history and drug reactions or allergies was reported. On 17-JUL-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # S035125, expiration date 04-NOV-2021 (dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT). On 17-JUL-2020, the vaccine underwent a temperature excursion with the temperature from 15 Fahrenheit degrees to 46 Fahrenheit degrees (45.9) for 10 hours and 30 minutes. There was no previous temperature excursion. The call was not because of a data logger. No additional adverse events were reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms; the patient was administered a dose of improperly stored PROQUAD; This spontaneous report was received from a nurse concerning a 4 years old patient. No concurrent condition or medical history was reported. Concomitant therapy included sterile diluent (manufacturer unknown).       On 13-JUL-2020, the patient was administered a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot# S022917, expiration date 19-JAN-2021; dose and frequency were not reported) as prophylaxis (product storage error). The temperature was reported as 9 degrees Celsius to 25 degrees Celsius (18.5 degrees Celsius). The time frame was reported as 20 minutes. No previous temperature excursion was reported. There was a call because of data logger. Properly stored sterile diluent (manufacturer unknown) (Lot# S030249, expiration date 02-JUN-2022) was used to reconstitute improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). No adverse symptoms were reported (no adverse event).   This is one of two reports received from the same reporter.
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; Improperly stored dose of PNEUMOVAX23 was administered to a patient; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender. The patient'ss concurrent conditions, concomitant therapies, medical history, drug allergies or reactions were not reported.  On 07-JUL-2020, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, strength, route of administration and anatomical location of vaccine were unknown) (lot # S029265 has been verified to be a valid lot number, expiration date was reported 31-MAR-2021), for prophylaxis.  The vaccine was exposed to a temperature between 12.1 °C for 2 hours and 20 minutes. No previous temperature excursion was reported. No adverse effects were reported. The report was received due to a data logger. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S029265; expirationdate: 31-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; incorrect product storage; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.    On 23-JUN-2020, the patient was administered an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S029265, expiration date on 31-MAR-2021, for prophylaxis. Vaccine was improperly stored at a temperature of 12.1°C during a time frame of 2 hours and 20 minutes. There was no previous temperature excursions neither additional adverse effects reported. The call was because of a data logger. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S029265; expirationdate: 31-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; Nurse reports on 15-JUL-2020 a patient was administered an improperly stored VARIVAX; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reaction, or allergies was not provided.  On 15-JUL-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, dose, vaccination scheme frequency, route of administration, and anatomical site of vaccination were not reported; lot number S036635, which have been verified to be valid, expiration date reported and validated as 14-NOV-2021) as prophylaxis (product storage error). It was reported that the sterile diluent (MERCK STERILE DILUENT) used to reconstitute the vaccine was properly stored (lot number and expiration date was not provided).  On an unknown dates, the vaccine was stored in a temperatures of -14 degrees Celsius to -10 degrees C (-11.1 degrees C) for 2 hours; -9 degrees C to 8 degrees C (2.2 degrees C) for 9 hours and 30 minutes; -14 degrees C to -10 degrees C (-9.8 degrees C) for 2 hours and 30 minutes; and -9 degrees C to 8 degrees C (0.4 degrees C) for 3 hours; as recorded by a digital data logger. The previous temperature excursion was of -9 degrees C to 8 degrees C (-6.1 degrees C) for 8 hours. No adverse events were reported.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event.; the patient was inadvertently administered a dose of PNEUMOVAX 23, that was expired; This spontaneous report was received from a medical assistant referring to a 43-year-old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.      On 22-JUL-2020, the patient was inadvertently vaccinated with a dose of expired pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # R036943 with expiration date 09-APR-2020; dose detail, frequency and route were not reported) for prophylaxis (expired product administered). No additional adverse event was reported.
Sex: U
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects were reported; the patient received improperly stored VAQTA; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 23-JUL-2020, the patient was vaccinated with a dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided) vial (upon internal validation process, the formulation was established as prefilled syringe) (lot# T008698, was established as valid, with expiration date: 04-JUN-2021) (dose, dose number, route of administration and anatomical location were not reported) for prophylaxis. The temperature to which the vaccines was exposed was 62.2 degrees of Fahrenheit and the time frame was reported as 3 hours 50 minutes. No previous temperature excursions were reported. A digital data logger was involved. No additional adverse effects were reported.   This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T008698; expirationdate: 04-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA010267: US-009507513-2007USA010269: US-009507513-2007USA010268:
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: no side effects; adult dose of VAQTA given to a pedriatric patient; This spontaneous report has been received from a nurse regarding a 17-years-old pediatric of unknown gender patient. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.  On 24-JUL-2020, the patient was vaccinated with an adult dose of Hepatitis A Vaccine, Inactivated (VAQTA) 1 milliliter (frequency and route of administration were not reported; Lot # S030588  has been verified to be a valid lot number for Hepatitis A Vaccine, Inactivated (VAQTA), expiration date 20-OCT-2020). It was reported that the patient's pediatrician was concerned with the dose administered. The patient did not experience any side effects.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA010018:
Age: 36.0
Sex: M
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: the third dose would have been due on 22-JUN-2020; This spontaneous report as received from a pharmacist refers to a 36 year old male patient. No information was given regarding the patient's concurrent conditions, concomitant medications or medical history.  In 2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter for prophylaxis (route of administration, lot number and expiration date were not reported). 22-DEC-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  0,5 milliliter for prophylaxis (route of administration, lot number and expiration date were not reported). On 22-JUN-2020, the patient was supposed to received the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) but at the time of this report had not received yet.