chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patients received improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 27-DEC-2018, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0,5 milliliter injection, intramuscularly, lot # R011632, expiration date 02-FEB-2020 (dose, and anatomical location were not reported) for prophylaxis.  The reported vaccines were exposed to the temperature of 35.4 degrees Fahrenheit for 32 hours and 30 minutes. No previous temperature excursions were reported. A digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA014098: US-009507513-1905USA014099: US-009507513-1905USA008566: US-009507513-1905USA014101: US-009507513-1905USA014102: US-009507513-1905USA014103: US-009507513-1905USA014104: US-009507513-1905USA014105: US-009507513-1905USA014097: US-009507513-1905USA014096: US-009507513-1905USA014100:
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site pain, Lethargy
Clinical narrative: pain at injection site; felt bad; lethargic; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain, feeling bad and lethargy. On an unknown date, the outcome of the injection site pain, feeling bad and lethargy were recovered/resolved.   It was unknown if the reporter considered the injection site pain, feeling bad and lethargy to be related to Shingrix.  Additional details were provided as follows: This case was reported by the consumer for himself. After receiving Shingrix, the patient experienced pain at injection site and felt bad and lethargic. This case has been linked with case US2019093427, reported for dose 2 of the same patient.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Headache, Injection site erythema, Injection site mass
Clinical narrative: injection site pain/pain around injectin site/still in pain; injection site warmth; felt bad; injection site is less red; little knot under the skin at the injection site; headache; exhausted; vaccine administered at inappropriate site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure abnormal.   On 21st May 2019, the patient received the 2nd dose of Shingrix (subcutaneous). On 21st May 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On 22nd May 2019, the patient experienced injection site pain, injection site warmth, feels awful, injection site erythema, injection site lump, headache and exhaustion. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the injection site pain and injection site erythema were not recovered/not resolved and the outcome of the injection site warmth, feels awful, injection site lump, headache, exhaustion and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site pain, injection site warmth, feels awful, injection site erythema, injection site lump, headache and exhaustion to be related to Shingrix.  Additional details were reported as follows: The patient reported that she got second Shingrix injections in the fat on the back of their upper arm instead of in the muscle of the deltoid subcutaneously, which led to intramuscular formulation administered by other route. One day after vaccination, the patient experienced injection site pain, injection site warmth, feels awful, injection site erythema, injection site lump, headache and exhaustion. The next day she started to experience pain around the injection site. It was also hot to the touch and had a little knot under the skin at the injection site.  The patient reported that on 22nd May 2019, she felt horrible and was in and out of bed all day.  She felt better and the injection site is less red on 23rd May 2019.  The patient took one Aleve yesterday and felt better in the afternoon. The reporter had consented to follow up, given permission to contact but did not know about the injection yet.  The reporter had given permission to contact pharmacist as well.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: injection site pain/pain around injectin site/still in pain; injection site warmth; felt bad; injection site is less red; little knot under the skin at the injection site; headache; exhausted; vaccine administered at inappropriate site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure abnormal.   On 21st May 2019, the patient received the 2nd dose of Shingrix (subcutaneous). On 21st May 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On 22nd May 2019, the patient experienced injection site pain, injection site warmth, feels awful, injection site erythema, injection site lump, headache and exhaustion. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the injection site pain and injection site erythema were not recovered/not resolved and the outcome of the injection site warmth, feels awful, injection site lump, headache, exhaustion and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site pain, injection site warmth, feels awful, injection site erythema, injection site lump, headache and exhaustion to be related to Shingrix.  Additional details were reported as follows: The patient reported that she got second Shingrix injections in the fat on the back of their upper arm instead of in the muscle of the deltoid subcutaneously, which led to intramuscular formulation administered by other route. One day after vaccination, the patient experienced injection site pain, injection site warmth, feels awful, injection site erythema, injection site lump, headache and exhaustion. The next day she started to experience pain around the injection site. It was also hot to the touch and had a little knot under the skin at the injection site.  The patient reported that on 22nd May 2019, she felt horrible and was in and out of bed all day.  She felt better and the injection site is less red on 23rd May 2019.  The patient took one Aleve yesterday and felt better in the afternoon. The reporter had consented to follow up, given permission to contact but did not know about the injection yet.  The reporter had given permission to contact pharmacist as well.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Mobility decreased, Pain, Pyrexia
Clinical narrative: fever; movement arm; chills; body aches; felt as hit by a truck; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st May 2019, the patient received the 1st dose of Shingrix. On 22nd May 2019, 1 days after receiving Shingrix, the patient experienced fever, mobility decreased, chills, general body pain and feeling abnormal. On an unknown date, the outcome of the fever, mobility decreased, chills and general body pain were recovering/resolving and the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the fever, mobility decreased, chills, general body pain and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The age at vaccination and age group of the patient were not reported. The patient received 1st dose of Shingrix in an unknown arm. On tuesday afternoon, the patient received vaccine and on wednesday morning, he felt as though he had been hit by a truck. The patient had low grade fever, chills, ached all over and could hardly lift his arm. On the day of reporting, the patient felt better. The reporter consented to follow up
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site pain
Clinical narrative: soreness around injection site; vaccine administered at inappropriate site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st May 2019, the patient received the 2nd dose of Shingrix (subcutaneous). On 21st May 2019, 2 hrs after receiving Shingrix, the patient experienced injection site pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced injection site pain. The reporter stated that, the patient was vaccinated in the fat of their upper arm rather than in the muscle which led to intramuscular formulation administered by other route. The patient started to feel soreness around the injection site about 2 hours after the injection. It has improved, but at the reporting time his arm was sore a little bit around the injection site. The reporter mentioned that the pharmacist gave them some paperwork and the lot and expiry for the product could be on it. The reporter consented to follow up. This case has been linked with case US2019093219, reported by the same reporter.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Erythema, Pruritus generalised, Rash generalised, Somnolence
Clinical narrative: diarrhea; drowsy; red due to the scratching; rash; itching; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included cetirizine hydrochloride (Zyrtec) unknown for pruritus.   On 27th February 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient started Zyrtec at an unknown dose once daily. On 1st March 2019, 2 days after receiving Shingrix and not applicable after starting Zyrtec, the patient experienced generalized rash and generalized pruritus. On 2nd March 2019, the patient experienced erythema. On an unknown date, the patient experienced diarrhea and drowsiness. The patient was treated with hydrocortisone and ciprofloxacin hydrochloride (Cipro). On an unknown date, the outcome of the generalized rash and generalized pruritus were recovering/resolving and the outcome of the diarrhea, drowsiness and erythema were unknown.   The reporter considered the generalized rash and generalized pruritus to be related to Shingrix. It was unknown if the reporter considered the diarrhea, drowsiness and erythema to be related to Shingrix. It was unknown if the reporter considered the generalized pruritus to be related to Zyrtec.  Additional details were provided as follows: The patient received 1st dose of Shingrix Two days later she noticed a rash in the evening across her chest and abdomen accompanied by some mild itching. The next morning, the rash was gone but the itching intensified and was spreading to various parts of her body. It started on her right ear lobe that became red due to the scratching. It then moved to her back, shoulders, down the inside of her thighs, genitals, and elbows and eventually went to the bottom of her feet.  She saw the dermatologist on 4th March 2019, and was given hydrocortisone cream. She had to get up several times during the night to apply it to her body. She also had diarrhea for the first time in her life so she saw a gastroenterologist who prescribed Cipro which she took for 3 days. While taking the antibiotics, the itching resolved but started again once she stopped the medication. She started taking Zyrtec once a day and the itching went away. Because it was making her drowsy, she stopped taking Zyrtec and the itching returned. The rash came back across her chest on 21st May 2019, along with the itching which started on her left arm below her elbow She took a half Zyrtec last night which helped. The reporter consented to follow up. The emergency room visit required.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Diarrhoea, Dizziness, Dyspnoea, Headache
Clinical narrative: pain at injection site; pain in sternum; fever of 103; vomitting; diarrhea; headache; body pain; difficulty taking deep breath; dizziness; WBC in urine; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received in February 2019, for tolerance, refer case US2019GSK097510).   On 20th May 2019, the patient received the 2nd dose of Shingrix (intramuscular). In May 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, sternal pain, fever, vomiting, diarrhea, headache, general body pain, shortness of breath, dizziness and white blood cells urine positive. The patient was treated with sulphamethoxazole, trimethoprim (Bactrim), analgesic, nos (Pain Medicine (Medication Unknown)) and intravenous fluid (nos) (Intravenous Fluid). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, sternal pain, fever, vomiting, diarrhea, headache, general body pain, shortness of breath, dizziness and white blood cells urine positive were unknown.   It was unknown if the reporter considered the injection site pain, sternal pain, fever, vomiting, diarrhea, headache, general body pain, shortness of breath, dizziness and white blood cells urine positive to be related to Shingrix.  Additional details were provided as follows: This case was reported by the consumer for himself. After receiving Shingrix, the patient experienced pain at injection site, and then at 2 AM woke up with fever of 103, vomiting, diarrhea, headache, body pain, pain in sternum, difficulty taking deep breath and dizziness. The patient was taken to emergency room (ER) for evaluation and found white blood cells (WBC) in urinalysis and she was prescribed Bactrim. Also the patient was given pain medicines and intravenous (IV) fluids and was sent home by 12 noon the next day. Emergency room visit required. The patient was not admitted to the hospital and did not consent to follow-up until she has a chance to be seen by her physician.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pyrexia, Vomiting, White blood cells urine positive
Clinical narrative: pain at injection site; pain in sternum; fever of 103; vomitting; diarrhea; headache; body pain; difficulty taking deep breath; dizziness; WBC in urine; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received in February 2019, for tolerance, refer case US2019GSK097510).   On 20th May 2019, the patient received the 2nd dose of Shingrix (intramuscular). In May 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, sternal pain, fever, vomiting, diarrhea, headache, general body pain, shortness of breath, dizziness and white blood cells urine positive. The patient was treated with sulphamethoxazole, trimethoprim (Bactrim), analgesic, nos (Pain Medicine (Medication Unknown)) and intravenous fluid (nos) (Intravenous Fluid). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, sternal pain, fever, vomiting, diarrhea, headache, general body pain, shortness of breath, dizziness and white blood cells urine positive were unknown.   It was unknown if the reporter considered the injection site pain, sternal pain, fever, vomiting, diarrhea, headache, general body pain, shortness of breath, dizziness and white blood cells urine positive to be related to Shingrix.  Additional details were provided as follows: This case was reported by the consumer for himself. After receiving Shingrix, the patient experienced pain at injection site, and then at 2 AM woke up with fever of 103, vomiting, diarrhea, headache, body pain, pain in sternum, difficulty taking deep breath and dizziness. The patient was taken to emergency room (ER) for evaluation and found white blood cells (WBC) in urinalysis and she was prescribed Bactrim. Also the patient was given pain medicines and intravenous (IV) fluids and was sent home by 12 noon the next day. Emergency room visit required. The patient was not admitted to the hospital and did not consent to follow-up until she has a chance to be seen by her physician.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abnormal sensation in eye, Heart rate increased, Influenza like illness, Insomnia, Myalgia
Clinical narrative: muscle pain; felt like something stuck in eyes; trouble sleeping; flu like symptoms; pain; fast heart rate; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th May 2019, the patient received the 1st dose of Shingrix. On 20th May 2019, 4 hrs after receiving Shingrix, the patient experienced influenza-like symptoms, pain, heart rate increased and sleeplessness. On 21st May 2019, the patient experienced muscle pain and abnormal sensation in eye. On an unknown date, the outcome of the influenza-like symptoms, pain, heart rate increased, muscle pain, sleeplessness and abnormal sensation in eye were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain, heart rate increased, muscle pain, sleeplessness and abnormal sensation in eye to be related to Shingrix.  Additional details were reported as follows: On 20th May 2019, around 4 pm the patient got 1st dose of Shingrix and around 8 pm experienced flu-like symptoms. The patient stated that during the night she had trouble sleeping because of pain from the injection and she woke up and felt her heart racing. On 21st May 2019, the patient went to the physician and her watch shows her heart rate peaked at 145. The patient felt her heart beating very fast and she slept all day after getting the vaccine, every muscle was screaming and she felt like someone was sticking their fingers in her eyes. The reporter did not consent to follow up. The reporter stated she would ask her physician to call in and provide more information.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: muscle pain; felt like something stuck in eyes; trouble sleeping; flu like symptoms; pain; fast heart rate; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th May 2019, the patient received the 1st dose of Shingrix. On 20th May 2019, 4 hrs after receiving Shingrix, the patient experienced influenza-like symptoms, pain, heart rate increased and sleeplessness. On 21st May 2019, the patient experienced muscle pain and abnormal sensation in eye. On an unknown date, the outcome of the influenza-like symptoms, pain, heart rate increased, muscle pain, sleeplessness and abnormal sensation in eye were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain, heart rate increased, muscle pain, sleeplessness and abnormal sensation in eye to be related to Shingrix.  Additional details were reported as follows: On 20th May 2019, around 4 pm the patient got 1st dose of Shingrix and around 8 pm experienced flu-like symptoms. The patient stated that during the night she had trouble sleeping because of pain from the injection and she woke up and felt her heart racing. On 21st May 2019, the patient went to the physician and her watch shows her heart rate peaked at 145. The patient felt her heart beating very fast and she slept all day after getting the vaccine, every muscle was screaming and she felt like someone was sticking their fingers in her eyes. The reporter did not consent to follow up. The reporter stated she would ask her physician to call in and provide more information.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye pain, Headache, Heart rate increased, Influenza like illness, Insomnia
Clinical narrative: muscle pain; felt like something stuck in eyes; trouble sleeping; flu like symptoms; pain; fast heart rate; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th May 2019, the patient received the 1st dose of Shingrix. On 20th May 2019, 4 hrs after receiving Shingrix, the patient experienced influenza-like symptoms, pain, heart rate increased and sleeplessness. On 21st May 2019, the patient experienced muscle pain and abnormal sensation in eye. On an unknown date, the outcome of the influenza-like symptoms, pain, heart rate increased, muscle pain, sleeplessness and abnormal sensation in eye were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain, heart rate increased, muscle pain, sleeplessness and abnormal sensation in eye to be related to Shingrix.  Additional details were reported as follows: On 20th May 2019, around 4 pm the patient got 1st dose of Shingrix and around 8 pm experienced flu-like symptoms. The patient stated that during the night she had trouble sleeping because of pain from the injection and she woke up and felt her heart racing. On 21st May 2019, the patient went to the physician and her watch shows her heart rate peaked at 145. The patient felt her heart beating very fast and she slept all day after getting the vaccine, every muscle was screaming and she felt like someone was sticking their fingers in her eyes. The reporter did not consent to follow up. The reporter stated she would ask her physician to call in and provide more information.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: muscle pain; felt like something stuck in eyes; trouble sleeping; flu like symptoms; pain; fast heart rate; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th May 2019, the patient received the 1st dose of Shingrix. On 20th May 2019, 4 hrs after receiving Shingrix, the patient experienced influenza-like symptoms, pain, heart rate increased and sleeplessness. On 21st May 2019, the patient experienced muscle pain and abnormal sensation in eye. On an unknown date, the outcome of the influenza-like symptoms, pain, heart rate increased, muscle pain, sleeplessness and abnormal sensation in eye were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain, heart rate increased, muscle pain, sleeplessness and abnormal sensation in eye to be related to Shingrix.  Additional details were reported as follows: On 20th May 2019, around 4 pm the patient got 1st dose of Shingrix and around 8 pm experienced flu-like symptoms. The patient stated that during the night she had trouble sleeping because of pain from the injection and she woke up and felt her heart racing. On 21st May 2019, the patient went to the physician and her watch shows her heart rate peaked at 145. The patient felt her heart beating very fast and she slept all day after getting the vaccine, every muscle was screaming and she felt like someone was sticking their fingers in her eyes. The reporter did not consent to follow up. The reporter stated she would ask her physician to call in and provide more information.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: This case was reported from the patient's friend. The age at vaccination was not reported. The patient experienced flu-like symptoms after her 2nd dose of Shingrix, but she not experienced after her first.  The reporter declined to provide additional information.
Age: 0.83
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Blister, Papule, Pyrexia, Skin lesion
Clinical narrative: 05/25/2019 06:00pm patient had fever, given tylenole: 05/27/2019 7:00am developed skin lesions-papules and some are vesicles, not itchy in the skin, buttocks and lower extremities
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Eye swelling, Full blood count, Gait disturbance, Pain in extremity
Clinical narrative: I saw patient today, not quite 48 hours after his four year vaccines, given as two injections to the left leg (MMRV and DTAP-IPV).  Yesterday he got a swollen right thigh at vaccine site and developed fever to 102.8. He was shaking at the time of fever and--with his seizure history-- parents wondered if could have been seizure (vs shaking with fever). Parents gave him Benadryl and took him to Urgent Care, where he was deemed to be having a vaccine reaction. He has not been walking well, and parents noted some puffiness around his eyes, so they brought him into the office today. He was febrile in the office and was walking holding onto dad's hand, gingerly, not wanting to bear weight on sore leg. There is tenderness, calor and splotchy erythema at his leg, but parents reports I am seeing it the way it looks improved after Benadryl.  No breathing problems/clear chest on exam. Mild periorbital edema bilaterally. No hip, knee or ankle pain. The area does not look like infection/cellulitis at this point, and--especially with the way it responds to Benadryl-- I feel his is a vaccine reaction. I have advised continuing Motrin q 6 hrs and Benadryl q 6 hrs and returning should fever persist in the next one to two days or should pain or symptoms worsen or continue.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Rash macular, Tenderness, Tremor, Vaccination complication
Clinical narrative: I saw patient today, not quite 48 hours after his four year vaccines, given as two injections to the left leg (MMRV and DTAP-IPV).  Yesterday he got a swollen right thigh at vaccine site and developed fever to 102.8. He was shaking at the time of fever and--with his seizure history-- parents wondered if could have been seizure (vs shaking with fever). Parents gave him Benadryl and took him to Urgent Care, where he was deemed to be having a vaccine reaction. He has not been walking well, and parents noted some puffiness around his eyes, so they brought him into the office today. He was febrile in the office and was walking holding onto dad's hand, gingerly, not wanting to bear weight on sore leg. There is tenderness, calor and splotchy erythema at his leg, but parents reports I am seeing it the way it looks improved after Benadryl.  No breathing problems/clear chest on exam. Mild periorbital edema bilaterally. No hip, knee or ankle pain. The area does not look like infection/cellulitis at this point, and--especially with the way it responds to Benadryl-- I feel his is a vaccine reaction. I have advised continuing Motrin q 6 hrs and Benadryl q 6 hrs and returning should fever persist in the next one to two days or should pain or symptoms worsen or continue.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Vaccination site swelling, Weight bearing difficulty, White blood cell count increased
Clinical narrative: I saw patient today, not quite 48 hours after his four year vaccines, given as two injections to the left leg (MMRV and DTAP-IPV).  Yesterday he got a swollen right thigh at vaccine site and developed fever to 102.8. He was shaking at the time of fever and--with his seizure history-- parents wondered if could have been seizure (vs shaking with fever). Parents gave him Benadryl and took him to Urgent Care, where he was deemed to be having a vaccine reaction. He has not been walking well, and parents noted some puffiness around his eyes, so they brought him into the office today. He was febrile in the office and was walking holding onto dad's hand, gingerly, not wanting to bear weight on sore leg. There is tenderness, calor and splotchy erythema at his leg, but parents reports I am seeing it the way it looks improved after Benadryl.  No breathing problems/clear chest on exam. Mild periorbital edema bilaterally. No hip, knee or ankle pain. The area does not look like infection/cellulitis at this point, and--especially with the way it responds to Benadryl-- I feel his is a vaccine reaction. I have advised continuing Motrin q 6 hrs and Benadryl q 6 hrs and returning should fever persist in the next one to two days or should pain or symptoms worsen or continue.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Patient stated that she experienced headaches, muscle and joint aches, chills, sweating, fever, and a sore arm. Patient stated that she took 2 pills of Tylenol (strength unknown) and that symptoms resolved within a day.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Patient stated that she experienced headaches, muscle and joint aches, chills, sweating, fever, and a sore arm. Patient stated that she took 2 pills of Tylenol (strength unknown) and that symptoms resolved within a day.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hyperaesthesia, Nodule, Peripheral swelling, Pruritus
Clinical narrative: Within a few house of receiving vaccine, patient states that arm became fiery red and feverish so bad that she iced her arm. It also was swollen and extremely sensitive to touch (didn't even want her sleeve to touch it) which lasted for 3 weeks. Eventually her arm began to itch and lasted for about a week. There is still a noticeable knot in her arm by sight and touch.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Within a few house of receiving vaccine, patient states that arm became fiery red and feverish so bad that she iced her arm. It also was swollen and extremely sensitive to touch (didn't even want her sleeve to touch it) which lasted for 3 weeks. Eventually her arm began to itch and lasted for about a week. There is still a noticeable knot in her arm by sight and touch.
Age: 1.5
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient presented for wellness check, was due for Pentacil  and Vaqta.  Clinical Team member administered Adacel instead Vaqta. No related signs and symptoms reported. Even after 7 days. Verified with Poision Control Toxicologist, no indication for concern unless symptoms present.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: redness on the underside of upper arm extending to elbow with pain
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient had "frozen arm" from shot and arm was very painful.  Unable to move arm properly or without pain until received a Cortisol shot.  After Cortisol shot, arm did return back to normal.  This info was reported to our pharmacy in May 2019.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Atrioventricular block complete, Blood creatinine normal, Blood electrolytes normal, Blood pressure immeasurable
Clinical narrative: She does complain of some flu like symptoms yesterday but very mild, with mild joint pains and bodyaches Patient reports she awoke in her usual state of health at 0730. She complained about continued pain and irritation at the site of her Shingrix vaccine in her L deltoid which she received on 5/23, along with some flu-like symptoms.  Patient also complained of continued sinus pain for "months"..   On admission to the CCU, patient denies chest pain, SOB, fevers, chills, recent tick exposures, rashes, neck/jaw/arm pain, or vision changes. She does endorse a "sinus headache" and some mild nausea.  Patient does have a significant family history of multiple siblings (x8) with CAD, 2 of which have had pacemakers placed.  Briefly, the patient is a 65-year-old presenting by ambulance after multiple syncopal episodes and extreme fatigue this morning.  She was noted to be bradycardic.  Pre-hospital EKG shows occasional QRS complexes.  She was hypotensive, but arousable.  She received 2 doses of atropine and her heart rate increased from the 20s to 30s.  There is still unable to obtain a blood pressure, however.  They started transcutaneous pacing.  Her blood pressure is in the mid 80s upon arrival.  Her pacing does appear to capture intermittently.  She is awake and arousable when I 1st evaluate her.  Two EKGs were performed, transcutaneous pacer was held for these.  There is no evidence of acute ischemia.  Rhythm is undetermined, some sort of complete heart block.  I spoke with Cardiology.  He evaluated the patient as well.      She was in her usual state of health upon waking up at her usual time at 7 AM this morning and took her Carvedilol and collagen supplement with Coffee and was sitting in a recliner and then does not remember much. Her husband found her confused and pre syncopal and called 911. The patient was placed on a dopamine drip.  This did improve her blood pressure and her heart rate somewhat.  Multiple labs were obtained. No acute electrolyte abnormalities.  Creatinine is normal.   The patient will be taken to the cath lab for emergent pacemaker placement and possible coronary evaluation as well. The patient's husband was at bedside and kept apprised of the findings and plan.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Bradycardia, Confusional state, Electrocardiogram QRS complex, Fatigue, Hypotension
Clinical narrative: She does complain of some flu like symptoms yesterday but very mild, with mild joint pains and bodyaches Patient reports she awoke in her usual state of health at 0730. She complained about continued pain and irritation at the site of her Shingrix vaccine in her L deltoid which she received on 5/23, along with some flu-like symptoms.  Patient also complained of continued sinus pain for "months"..   On admission to the CCU, patient denies chest pain, SOB, fevers, chills, recent tick exposures, rashes, neck/jaw/arm pain, or vision changes. She does endorse a "sinus headache" and some mild nausea.  Patient does have a significant family history of multiple siblings (x8) with CAD, 2 of which have had pacemakers placed.  Briefly, the patient is a 65-year-old presenting by ambulance after multiple syncopal episodes and extreme fatigue this morning.  She was noted to be bradycardic.  Pre-hospital EKG shows occasional QRS complexes.  She was hypotensive, but arousable.  She received 2 doses of atropine and her heart rate increased from the 20s to 30s.  There is still unable to obtain a blood pressure, however.  They started transcutaneous pacing.  Her blood pressure is in the mid 80s upon arrival.  Her pacing does appear to capture intermittently.  She is awake and arousable when I 1st evaluate her.  Two EKGs were performed, transcutaneous pacer was held for these.  There is no evidence of acute ischemia.  Rhythm is undetermined, some sort of complete heart block.  I spoke with Cardiology.  He evaluated the patient as well.      She was in her usual state of health upon waking up at her usual time at 7 AM this morning and took her Carvedilol and collagen supplement with Coffee and was sitting in a recliner and then does not remember much. Her husband found her confused and pre syncopal and called 911. The patient was placed on a dopamine drip.  This did improve her blood pressure and her heart rate somewhat.  Multiple labs were obtained. No acute electrolyte abnormalities.  Creatinine is normal.   The patient will be taken to the cath lab for emergent pacemaker placement and possible coronary evaluation as well. The patient's husband was at bedside and kept apprised of the findings and plan.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site irritation, Injection site pain, Memory impairment, Nausea
Clinical narrative: She does complain of some flu like symptoms yesterday but very mild, with mild joint pains and bodyaches Patient reports she awoke in her usual state of health at 0730. She complained about continued pain and irritation at the site of her Shingrix vaccine in her L deltoid which she received on 5/23, along with some flu-like symptoms.  Patient also complained of continued sinus pain for "months"..   On admission to the CCU, patient denies chest pain, SOB, fevers, chills, recent tick exposures, rashes, neck/jaw/arm pain, or vision changes. She does endorse a "sinus headache" and some mild nausea.  Patient does have a significant family history of multiple siblings (x8) with CAD, 2 of which have had pacemakers placed.  Briefly, the patient is a 65-year-old presenting by ambulance after multiple syncopal episodes and extreme fatigue this morning.  She was noted to be bradycardic.  Pre-hospital EKG shows occasional QRS complexes.  She was hypotensive, but arousable.  She received 2 doses of atropine and her heart rate increased from the 20s to 30s.  There is still unable to obtain a blood pressure, however.  They started transcutaneous pacing.  Her blood pressure is in the mid 80s upon arrival.  Her pacing does appear to capture intermittently.  She is awake and arousable when I 1st evaluate her.  Two EKGs were performed, transcutaneous pacer was held for these.  There is no evidence of acute ischemia.  Rhythm is undetermined, some sort of complete heart block.  I spoke with Cardiology.  He evaluated the patient as well.      She was in her usual state of health upon waking up at her usual time at 7 AM this morning and took her Carvedilol and collagen supplement with Coffee and was sitting in a recliner and then does not remember much. Her husband found her confused and pre syncopal and called 911. The patient was placed on a dopamine drip.  This did improve her blood pressure and her heart rate somewhat.  Multiple labs were obtained. No acute electrolyte abnormalities.  Creatinine is normal.   The patient will be taken to the cath lab for emergent pacemaker placement and possible coronary evaluation as well. The patient's husband was at bedside and kept apprised of the findings and plan.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Presyncope, Sinus headache, Sinus pain, Syncope
Clinical narrative: She does complain of some flu like symptoms yesterday but very mild, with mild joint pains and bodyaches Patient reports she awoke in her usual state of health at 0730. She complained about continued pain and irritation at the site of her Shingrix vaccine in her L deltoid which she received on 5/23, along with some flu-like symptoms.  Patient also complained of continued sinus pain for "months"..   On admission to the CCU, patient denies chest pain, SOB, fevers, chills, recent tick exposures, rashes, neck/jaw/arm pain, or vision changes. She does endorse a "sinus headache" and some mild nausea.  Patient does have a significant family history of multiple siblings (x8) with CAD, 2 of which have had pacemakers placed.  Briefly, the patient is a 65-year-old presenting by ambulance after multiple syncopal episodes and extreme fatigue this morning.  She was noted to be bradycardic.  Pre-hospital EKG shows occasional QRS complexes.  She was hypotensive, but arousable.  She received 2 doses of atropine and her heart rate increased from the 20s to 30s.  There is still unable to obtain a blood pressure, however.  They started transcutaneous pacing.  Her blood pressure is in the mid 80s upon arrival.  Her pacing does appear to capture intermittently.  She is awake and arousable when I 1st evaluate her.  Two EKGs were performed, transcutaneous pacer was held for these.  There is no evidence of acute ischemia.  Rhythm is undetermined, some sort of complete heart block.  I spoke with Cardiology.  He evaluated the patient as well.      She was in her usual state of health upon waking up at her usual time at 7 AM this morning and took her Carvedilol and collagen supplement with Coffee and was sitting in a recliner and then does not remember much. Her husband found her confused and pre syncopal and called 911. The patient was placed on a dopamine drip.  This did improve her blood pressure and her heart rate somewhat.  Multiple labs were obtained. No acute electrolyte abnormalities.  Creatinine is normal.   The patient will be taken to the cath lab for emergent pacemaker placement and possible coronary evaluation as well. The patient's husband was at bedside and kept apprised of the findings and plan.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Erythema, Joint stiffness, Myalgia, Swelling
Clinical narrative: Pt reports muscle aches, stiffness in joints, chills, and swelling. Two days of redness of arm.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Pain, Pyrexia
Clinical narrative: Received the vaccine on 04/02 and got the Shingles on 05/12.  I got the vaccine to prevent the Shingles, Not to Give me the Shingles.  I had the Shingles 25 years ago and got the medicine and it was much less severe then the Shingles outbreak this month from the vaccine.   I  also got sick after getting the vaccine with fever, aches, tiredness for a week.  That was listed as a possible side effect. I kept telling myself "this is better than getting Shingles" and then I got the Shingles. I did not see anything about the possibility of getting Shingles from the vaccine.    I did get Famciclovir on 05/14 which helped but I still had the Shingles.  I don't want a vaccine to give me a disease to get over.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity, X-ray limb normal
Clinical narrative: C/O feeling sharp pain to left are when driving home after the vaccine was given . The next morning on 5/14/19 it is hard  to move left arm and painful to touch.  Took Advil on 5/13/19 around 2:30 pm and at 0730 5/14/19. On examination the following was noted: no red streaking on arm pt can move arm but it hurts no numbness, tingling or change on sensation of L arm, hand or fingers afebrile no HA, nausea, vomiting, abd pain or diarrhea Returned to office on 5/21/19 still c/o left arm pain. Exam noted: pain is along to entire shoulder area, no swelling or redness, able to move FROM, but is very painful to lift arm above shoulder, no tingling, no numbness, no loss of perfusion, has been taking ibuprofen, no n/v, no abd pain, no ha, no fatigue, no other sx
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unspecified date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) for the routine health maintenance and for the prevention of shingles. On an unspecified date after the vaccination, the patient suffered a painful rash. As a result of these symptoms, the patient presented to a medical provider and was diagnosed with Herpes Zoster. Thereafter, the patient has continued to suffer the effects of Herpes Zoster. As a result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; received expired dose of M-M-R II on 06-MAY-2019; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were unknown. Patient's concomitant medications included sterile diluent. On 06-MAY-2019, the patient was vaccinated with an expired doe of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: recombinant human albumin (rHA)) (lot # N013866, expiration date: 04-MAY-2019 (strength, dose, dose number and anatomical location were unknown) via subcutaneously for prophylaxis (expired product administered). The lot number and expiration dates were not known for the properly stored sterile diluent, which was used to reconstitute the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). No adverse effects (no adverse event) were reported. No product quality complaint was involved.   This is one of the two reports from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; Patient was administered an improperly stored dose of VARIVAX; This spontaneous report was received from a physician regarding a patient of unknown demographics. The patient's relevant medical history, concurrent condition were not reported. Concomitant therapy included a sterile diluent (well stored). On 24-MAY-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) data logger (lot # R029519/ expiration date:14-OCT-2020) with a well stored diluent diluted for prophylaxis. The vaccine was stored at a temperature of - 14 degrees centigrade to - 10 degree centigrade for a timeframe of 4 hours and 5 minutes. The previous temperature excursion was reported as no. On an unknown date, the reporter informed that the patient administered an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (improper storage of product in use). No other adverse effects (no adverse event) were reported. This case does not involve a product quality complaint. The outcome of the event was unknown.