chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Pain, Pain in extremity
Clinical narrative: Soreness/ pain; Limited range of motion; Lack of strength; Pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th June 2019, the patient received the 1st dose of Shingrix. On 15th June 2019, 1 days after receiving Shingrix, the patient experienced pain in arm, joint range of motion decreased, weakness and pain. The patient was treated with ibuprofen. In June 2019, the outcome of the pain in arm was recovered/resolved. On 17th June 2019, the outcome of the joint range of motion decreased and weakness were recovered/resolved. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain in arm, joint range of motion decreased, weakness and pain to be related to Shingrix.  Additional details were provided as follows: The lot number and expiration date could not be provided. The patient received Shingrix at approximately 0200-0300 hours. The patient experienced soreness, limited range of motion and pain. The soreness was described as the arm being so sore it had to be picked up to move it. Soreness began the day after dose one. At approximately 0600 hours, the patient took ibuprofen and experienced relief from the pain and soreness. By 1500 hours, the patient was beginning to be able to move her arm but did not have a lot of strength. The following day, on 16th June 2019, it took all of the patients strength to lift a mug of water into the microwave at eye level. The following day, on 17th June 2019, full strength and range of motion returned. The soreness and pain resolved within one week of receiving dose one of Shingrix. No additional information was provided. The reporter consented to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: all over body rash; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Concurrent medical conditions included immunodeficiency (the patient was immunocompromised.).   On 2nd October 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. In October 2019, less than a week after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was not recovered/not resolved.   It was unknown if the reporter considered the generalized rash to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not provided. The reporter stated that, the patient was immunocompromised and received dead dose of influenza vaccine and experienced rash all over body. The reporter did not know, what flu vaccine the patient got. There was discrepancy in outcome of generalized rash reported in source document(recovering and resolving) and in database (Not recovered and not resolved).
Sex: F
Vaccine: HEP
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Felt vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received HBV (Engerix B) (batch number 7N5M5, expiry date 16th November 2020) for prophylaxis.   Concomitant products included HBV (Engerix B).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, immediately after receiving Engerix B, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Engerix B.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist administered Engerix B to the patient, and after doing so, the patient felt the shot. The patient stated that, a month ago received 1st dose of Engerix B, but did not felt the needle or medicine. The patient asked to the pharmacist was they gave the shot and the pharmacist said yes. The caller asked if they were to be safe and consider today the first dose, was there any safety information on extra doses of Engerix B. There may be a planned fourth dose based on information provided. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain
Clinical narrative: Neck pain; This case was reported by a pharmacist via call center representative and described the occurrence of neck pain in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced neck pain. The patient was treated with cortisone (non-proprietary). On an unknown date, the outcome of the neck pain was unknown.   It was unknown if the reporter considered the neck pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 53 or 54 years. The reporter did not know the history of the patient and could not confirm if if patient was receiving cortisone shot for neck pain prior to 1st dose of Shingrix. The lot number/expiry date of Shingrix was unknown. In April 2019, the patient received a dose of Shingrix and in July 2019, the patient had cortisone shot in the neck for neck pain. The contact was a floater and did not work full time at this pharmacy. The reporter consented to follow up. This case had been linked to the case US2019180868, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity
Clinical narrative: arm soreness; headache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th October 2019, the patient received Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced pain in arm and headache. On an unknown date, the outcome of the pain in arm and headache were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 63 years or 64 years. The patient received Shingrix in the left arm. The patient now experiencing headache and arm soreness.   The patient called seeking recommendation of what to take for the symptoms. The patient was referred to her physician. The reporter declined DOB and providing phone number.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Lymphadenopathy, Malaise
Clinical narrative: Chills; Fatigue; Not feeling well; Swollen lymph node; This case was reported by a nurse via call center representative and described the occurrence of chills in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included gabapentin.   In August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced chills, fatigue, feeling unwell and enlargement of lymph nodes. On an unknown date, the outcome of the chills, fatigue, feeling unwell and enlargement of lymph nodes were recovered/resolved.   It was unknown if the reporter considered the chills, fatigue, feeling unwell and enlargement of lymph nodes to be related to Shingrix.  Additional details were provided as follows: The reporter was a registered nurse and also the patient. Approximately 2 months before the date of reporting, the patient received Shingrix in an unknown deltoid. After receiving the vaccine, patient developed chills, fatigue, and a swollen lymph node under the injection arm.  The patient states that she did not feel well after receiving the vaccine.  The patient's symptoms resolved within 1 week. The reporter did not consent to follow-up. The reporter did not provide any additional information.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenitis, Lymphadenopathy
Clinical narrative: Lymphadenitis; Swollen lymph nodes in arm pit; This case was reported by a pharmacist via call center representative and described the occurrence of lymphadenitis in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number TB2PK, expiry date 5th October 2021) for prophylaxis.   On 5th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced lymphadenitis and axillary lymph nodes enlarged. On an unknown date, the outcome of the lymphadenitis and axillary lymph nodes enlarged were unknown.   It was unknown if the reporter considered the lymphadenitis and axillary lymph nodes enlarged to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. The patient developed swollen lymph nodes in arm pit.  At the time of reporting the patient had lymphadenitits. The reporter consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Malaise, Pain of skin, Product administered to patient of inappropriate age
Clinical narrative: Inappropriate Age at Vaccine Administration; Malaise; Headache that "made his hair hurt".; Flu-like symptoms; made his hair hurt; This case was reported by a pharmacist via call center representative and described the occurrence of malaise in a 38-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced malaise, headache, influenza-like symptoms, scalp pain and inappropriate age at vaccine administration. On an unknown date, the outcome of the malaise, headache, influenza-like symptoms and scalp pain were resolved with sequelae and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the malaise, headache, influenza-like symptoms and scalp pain to be related to Shingrix.  Additional details were reported as follows: HCP was self-reporting that he got Shingrix and he was under the age of 50 (estimated that he was 38 years old), which led to inappropriate age at vaccine administration.   The day following vaccination the patient experienced malaise, flu-like symptoms, and a headache that made his hair hurt.   The symptoms lasted 1 day and then subsided the next day. This case has been linked with US2019183216, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Red Arm; Swelling of the arm; Itching of the arm; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced erythema of extremities, swelling arm and itchy upper limbs. On an unknown date, the outcome of the erythema of extremities, swelling arm and itchy upper limbs were not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities, swelling arm and itchy upper limbs to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had been experiencing red arm, swelling and itching of the arm. The reporter consent to follow up
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: I know Shingrix causes a lot of side effects; This case was reported by a other health professional via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The staff of state health department made the generalized statement that the Shingrix causes a lot of side effects, that's to be expected. The staff of state health department did not elaborate or provide any additional details. The reporter did not consent to follow-up. No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Autoimmune haemolytic anaemia, Rash
Clinical narrative: patient experienced multiple rash and developed what doctor described as autoimmune hemolytic anemia
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: I woke up this morning and could hardly move my left arm. My arm aches around the injection site and into my left shoulder, but mostly only when I move my arm. The discomfort was minimal after the date of the injection with just a little soreness, but is progressively getting worse. It hurts the most when I lift my arm to reach horizontally for things on a table while I am sitting.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, pain, itching at site of flu vaccine
Age: 26.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Swelling
Clinical narrative: Patient reported large baseball size sore, hot and red area at the injection site. Patient reports significant swelling on Saturday. Patient has been taking ibuprofen and applying ice since then and the swelling has decreased. Area is still warm to the touch and red.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient said her arm was red, swollen, and hot.  She said she went to a doctor , he diagnosed her with cellulitis, and put her on an antibiotic.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Periorbital swelling, Pyrexia
Clinical narrative: patient had significan lip swelling fever and puffy eyes
Age: 67.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Secretion discharge, Throat irritation
Clinical narrative: Next day after receiving a flu shot I developed symptoms of scratchy throat, excessive mucus discharge and chills. As of today, 5 days after vaccination, symptoms persist, but vary in intensity. Chills are no longer present.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Body temperature increased, Hypersensitivity, Influenza virus test negative, Joint range of motion decreased
Clinical narrative: The following day after receiving the vaccine at my place of employment, I woke up with a stiff neck and lack of range of motion. I thought nothing of the vaccine and proceeded with my day. The following day I still had the  stiff neck and lack of range of motion also accompanied by a temperature ranging from 102 plus. I had full body pain, and was so weak I was afraid to attempt the stairs in my household. I went to Clinic. They diagnosed me with a severe allergic reaction to the vaccine. Flu test came back negative. They did a full label panel on me. They gave me an injection of Toradol for pain and sent me home with Diclofenac. I was in no shape to take care of my 3 children. I ended up at the Emergency Department the following day because I was no better and could not hold my head up or stand. They repeated the flu test and it was negative. They too also did lab work. They gave me fluids and an injection of Haldol to try to calm me down from being in so much pain. They also stated I had a severe allergic reaction to the vaccine and they could not tell me what it gave me ultimately, but it would have to run it's course probably over 7-10 days. I was out of work for 2 days at the hospital I am employed at and received the vaccine at, and even with notes from both the Clinic and ED they are not excused. This really put a damper on my well being and work.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of personal independence in daily activities, Musculoskeletal stiffness, Pain, Vaccination complication
Clinical narrative: The following day after receiving the vaccine at my place of employment, I woke up with a stiff neck and lack of range of motion. I thought nothing of the vaccine and proceeded with my day. The following day I still had the  stiff neck and lack of range of motion also accompanied by a temperature ranging from 102 plus. I had full body pain, and was so weak I was afraid to attempt the stairs in my household. I went to Clinic. They diagnosed me with a severe allergic reaction to the vaccine. Flu test came back negative. They did a full label panel on me. They gave me an injection of Toradol for pain and sent me home with Diclofenac. I was in no shape to take care of my 3 children. I ended up at the Emergency Department the following day because I was no better and could not hold my head up or stand. They repeated the flu test and it was negative. They too also did lab work. They gave me fluids and an injection of Haldol to try to calm me down from being in so much pain. They also stated I had a severe allergic reaction to the vaccine and they could not tell me what it gave me ultimately, but it would have to run it's course probably over 7-10 days. I was out of work for 2 days at the hospital I am employed at and received the vaccine at, and even with notes from both the Clinic and ED they are not excused. This really put a damper on my well being and work.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Soreness, red and swollen.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus, Pyrexia
Clinical narrative: Redness and swelling of R Deltoid, student reported mild fever that resolved and slightly pruritic. Erythema across deltoid that is warm to the touch noted at site when student reported reaction- 3 days post injection
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Listless, Loss of personal independence in daily activities
Clinical narrative: marked sleeplessness (entire night) , moderately sore vaccination cite, tired feeling /listlessness and  unable/unwilligness to to undertake common daily activity, upset stomach (moderate, controllable diarrhea)....symptoms reported only to indicate vaccination was not without resulting symptoms....anticipate lasting a day as was the experience with dose no. 1
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Somnolence, Vaccination site pain
Clinical narrative: marked sleeplessness (entire night) , moderately sore vaccination cite, tired feeling /listlessness and  unable/unwilligness to to undertake common daily activity, upset stomach (moderate, controllable diarrhea)....symptoms reported only to indicate vaccination was not without resulting symptoms....anticipate lasting a day as was the experience with dose no. 1
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Reported having pain, redness, swelling, and warmth at injection site
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Chest X-ray abnormal, Pneumonitis, Pyrexia, Upper respiratory tract infection
Clinical narrative: Upper respiratory infection with high fever stared 10/27/12 Taken to doctor 11/1/12, was sent home.  Returned to doctor 11/2/12 for a second opinion. Chest xray was completed 11/2/12 Diagnosed with Pneumonitis Treated with Zithromax Fully recovered
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect; expired dose administered; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 19-SEP-2019, the patient was vaccinated with expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) via intramuscular route (exact dose, injection site, lot # and expiration date were not reported) for prophylaxis. There was no adverse event reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: The physician is reporting that the patient recieved improperly stored vaccine at an unspecified date; This spontaneous report was received from a physician regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On unknown date, the patient was vaccinated with an improperly dose of recombinant Human albumin Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) one dose, lot number S007075, expiration date 06-SEP-2020 (route of administration was not reported). Administered dose of vaccine experienced the temperature excursion of 32.5 degrees Fahrenheit (°F) for 8 hours. Data logger was involved. There were no previous excursions reported.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site rash
Clinical narrative:   History of Present Illness: Rash on right thigh noted yesterday after school (10/10/19)   Received flu vaccine at that site 2 days ago (10/9/19) No other vaccines given that day Has never had issue with her immunizations      No rash present yesterday morning  Noted when she was undressed yesterday evening  Tender, warm and hard to the touch Today looks much worse than yesterday Running, jumping, playing without difficulty Leg only bothers her when touched No fevers No congestion, rhinorrhea, coughing No swelling of face/lips/mouth No coughing or difficulty breathing No vomiting or diarrhea No other rashes or other spots    Patient is a 2 y.o. female presenting for evaluation of rash at the site of her recent flu vaccine. H&P consistent with localized reaction after vaccine with possible cellulitis. Given the rapidity with which the redness, warmth and induration (without abscess) have spread, antibiotic tx is prudent.    1. Local reaction to influenza vaccine, initial encounter 2. Cellulitis of right lower extremity - Educated RE: differential diagnosis, etiology, management, and need for follow up if persistent or worsening symptoms - Rx: cephalexin (KEFLEX) 250 mg/5 mL suspension; Take 5 mLs (250 mg per dose) by mouth 3 (three) times daily for 5 days.  Dispense: 75 mL; Refill: 0 - Measurements = 10.5 cm wide by 9 cm high - Mom drew pen line around the site while here to help with monitoring - Will submit report to VAERS   Instructions: Monitor the site to make sure the redness stays inside the line you drew Give Claritin 5 mg (5 mL) by mouth once per day Give her the antibiotic as prescribed If she has pain, you can give tylenol or motrin Cool compresses may be soothing Follow up tomorrow if symptoms are getting worse If she seems to be getting better, you can cancel the appt and send records update  UPDATE: ADDENDUM: 10/12/19 Parent sent message to say that patient is doing better. Picture included in message. Mom appropriately canceled f/u appt.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Local reaction
Clinical narrative:   History of Present Illness: Rash on right thigh noted yesterday after school (10/10/19)   Received flu vaccine at that site 2 days ago (10/9/19) No other vaccines given that day Has never had issue with her immunizations      No rash present yesterday morning  Noted when she was undressed yesterday evening  Tender, warm and hard to the touch Today looks much worse than yesterday Running, jumping, playing without difficulty Leg only bothers her when touched No fevers No congestion, rhinorrhea, coughing No swelling of face/lips/mouth No coughing or difficulty breathing No vomiting or diarrhea No other rashes or other spots    Patient is a 2 y.o. female presenting for evaluation of rash at the site of her recent flu vaccine. H&P consistent with localized reaction after vaccine with possible cellulitis. Given the rapidity with which the redness, warmth and induration (without abscess) have spread, antibiotic tx is prudent.    1. Local reaction to influenza vaccine, initial encounter 2. Cellulitis of right lower extremity - Educated RE: differential diagnosis, etiology, management, and need for follow up if persistent or worsening symptoms - Rx: cephalexin (KEFLEX) 250 mg/5 mL suspension; Take 5 mLs (250 mg per dose) by mouth 3 (three) times daily for 5 days.  Dispense: 75 mL; Refill: 0 - Measurements = 10.5 cm wide by 9 cm high - Mom drew pen line around the site while here to help with monitoring - Will submit report to VAERS   Instructions: Monitor the site to make sure the redness stays inside the line you drew Give Claritin 5 mg (5 mL) by mouth once per day Give her the antibiotic as prescribed If she has pain, you can give tylenol or motrin Cool compresses may be soothing Follow up tomorrow if symptoms are getting worse If she seems to be getting better, you can cancel the appt and send records update  UPDATE: ADDENDUM: 10/12/19 Parent sent message to say that patient is doing better. Picture included in message. Mom appropriately canceled f/u appt.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Pain in extremity
Clinical narrative: Patient came to pharmacy for flu shot on 10/14/19 at 10:15am complaining of pain in arm that radiated down arm and burned. In discussing with RPH pt reports that she had a recent shoulder transplant in the left arm where she got the immunization, She did not mention to RPH at the time, or disclose this on her Vaccine Consent and Administration Record. Pt planning to reach out to md that did shoulder surgery.
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: Vaccination complication
Clinical narrative: PATIENCE INDICATES THAT THE VACCINE CAUSES DAMAGE TO THE NERVES, THAT SHE WAS HOSPITALIZED BY THE SECONDARY EFFECTS OF THIS VACCINE
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Eyelid contusion, Insomnia, Mobility decreased, Pain
Clinical narrative: on Saturday 10/12/19 patient got the pneumovax23 in right deltoid and a flu shot in the left deltoid. He didn't have any discomfort or signs or symptoms of an adverse reaction until that night, at which time his right arm /elbow became extremely painful to the point he couldn't sleep. He called his doctor but he can't get in to see her until Friday. He showed us today (monday the 14th) at the pharmacy. The right arm /elbow is still red and slightly swollen. His left arm were he got the flu shot has no issues.  He says he is able to move the right armt better today than he could over the weekend. I asked if he had a temperature but he said no. He said after he got a shingles shot last year (at another location) he had a rash on his neck a bruise around his eye. However he has never (and still has not) had any kind of reaction to any flu shot he has gotten to date. He will continue to monitor the area, if it worsens he will seek immediate  medical help, but he said as of today it appears to be getting better.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Rash
Clinical narrative: on Saturday 10/12/19 patient got the pneumovax23 in right deltoid and a flu shot in the left deltoid. He didn't have any discomfort or signs or symptoms of an adverse reaction until that night, at which time his right arm /elbow became extremely painful to the point he couldn't sleep. He called his doctor but he can't get in to see her until Friday. He showed us today (monday the 14th) at the pharmacy. The right arm /elbow is still red and slightly swollen. His left arm were he got the flu shot has no issues.  He says he is able to move the right armt better today than he could over the weekend. I asked if he had a temperature but he said no. He said after he got a shingles shot last year (at another location) he had a rash on his neck a bruise around his eye. However he has never (and still has not) had any kind of reaction to any flu shot he has gotten to date. He will continue to monitor the area, if it worsens he will seek immediate  medical help, but he said as of today it appears to be getting better.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Nausea, diarrhea, headache, body aches, fever
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Arm is still sore after 2.5 weeks
Age: 35.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Areflexia, Fall, Gait inability, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Patient began to experience numbness and tingling on the left arm the day after the injection. The following day the patient was unable to get out the bed due to the complete numbness of the left leg. The patient fell out the bed due to "not feeling" her leg. The patient eventually was able to walk; however, the numbness and tingling sensation to left leg continued. She went to the ER. Her physical exam showed a reflexia of all extremities. She was shipped to Neuro ICU. She was discharged after 2 days with the diagnosis of mild Guillain-Barre' syndrome.
Age: 35.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Intensive care, Laboratory test, Lumbar puncture, Magnetic resonance imaging brain, Magnetic resonance imaging spinal
Clinical narrative: Patient began to experience numbness and tingling on the left arm the day after the injection. The following day the patient was unable to get out the bed due to the complete numbness of the left leg. The patient fell out the bed due to "not feeling" her leg. The patient eventually was able to walk; however, the numbness and tingling sensation to left leg continued. She went to the ER. Her physical exam showed a reflexia of all extremities. She was shipped to Neuro ICU. She was discharged after 2 days with the diagnosis of mild Guillain-Barre' syndrome.
Age: 35.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Paraesthesia
Clinical narrative: Patient began to experience numbness and tingling on the left arm the day after the injection. The following day the patient was unable to get out the bed due to the complete numbness of the left leg. The patient fell out the bed due to "not feeling" her leg. The patient eventually was able to walk; however, the numbness and tingling sensation to left leg continued. She went to the ER. Her physical exam showed a reflexia of all extremities. She was shipped to Neuro ICU. She was discharged after 2 days with the diagnosis of mild Guillain-Barre' syndrome.
Age: 35.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Fall, Guillain-Barre syndrome, Hypoaesthesia, Intensive care, Paraesthesia
Clinical narrative: Patient began to experience numbness and tingling on the left arm the day after the injection. The following day the patient was unable to get out the bed due to the complete numbness of the left leg. The patient fell out the bed due to "not feeling" her leg. The patient eventually was able to walk; however, the numbness and tingling sensation to left leg continued. She went to the ER. Her physical exam showed a reflexia of all extremities. She was shipped to Neuro ICU. She was discharged after 2 days with the diagnosis of mild Guillain-Barre' syndrome.
Age: 8.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Dermatitis, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Mom noticed the injection site to be red, raised, blotchy, warm and painful. Questioning what she can apply/ or recommend. Came into the office,  diagnosis dermatitis; apply Hydrocortisone + Benedryl bid; if fever and or increasing redness and warmth/streaking occurs, will call after hours for abx.
Age: 8.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site warmth, Rash macular
Clinical narrative: Mom noticed the injection site to be red, raised, blotchy, warm and painful. Questioning what she can apply/ or recommend. Came into the office,  diagnosis dermatitis; apply Hydrocortisone + Benedryl bid; if fever and or increasing redness and warmth/streaking occurs, will call after hours for abx.
Age: 8.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Mom noticed the injection site to be red, raised, blotchy, warm and painful. Questioning what she can apply/ or recommend. Came into the office,  diagnosis dermatitis; apply Hydrocortisone + Benedryl bid; if fever and or increasing redness and warmth/streaking occurs, will call after hours for abx.
Age: 8.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Rash macular
Clinical narrative: Mom noticed the injection site to be red, raised, blotchy, warm and painful. Questioning what she can apply/ or recommend. Came into the office,  diagnosis dermatitis; apply Hydrocortisone + Benedryl bid; if fever and or increasing redness and warmth/streaking occurs, will call after hours for abx.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site pruritus
Clinical narrative: Erythema measuring 4.5 in x 7.5 surrounding injection site with edema, itch, and pain
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Headache, Pain, Pyrexia
Clinical narrative: 6 hours after injection I became very dizzy. Heart rate was in 140's for a while. Had a really strange bad headache. By the evening I had 100.7 fever and body aches all night. Woke up next morning with dizziness and fever and aches. Rested that day and next and starting feeling a bit better-almost went to ER but rode it out.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Heart rate increased, Nausea, Pain, Pyrexia
Clinical narrative: 6 hours after injection I became very dizzy. Heart rate was in 140's for a while. Had a really strange bad headache. By the evening I had 100.7 fever and body aches all night. Woke up next morning with dizziness and fever and aches. Rested that day and next and starting feeling a bit better-almost went to ER but rode it out.
Age: 73.0
Sex: F
Vaccine: FLUA3
Symptoms: Lip swelling, Swelling, Swelling face
Clinical narrative: Patient reported swelling in the face, lips and nose the day after vaccination that lasted for 3 days.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash macular, Skin warm
Clinical narrative: The patient did not have a reaction of any kind until 10/14/19.  Upon waking, the patient noticed a rash on her arms, under her armpit on the left side, and down her rib cage on the left side.  As the day progresses, the patient reports the rash is moving down her torso and legs.  The patient describes the rash and large, red, splotches that are hot to the touch.  She states she did not have any reaction following the first Shingrix administered on 6/27/19.
Age: 3.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Asthenia, Chills, Decreased appetite, Dyspnoea, Eye swelling
Clinical narrative: In Friday morning, after vaccination, some allergic reaction happened a few min (5-10 min). After 30 min of the vaccination, the doctor gave a dose of BENADRYL (12.5 mg/ml oral liquid). The patient was transferred to urgent care for observation for 4 hours.  At home, the patient was received 3 doses of BENADRYL (12.5 mg/ml oral liquid) every 6 hours for 3 days.  1) Red Rash with itchiness all over the body  2) low fever (less 101 degrees) 3) shivering with cold 4) Swelling in the face (eyes, mouth) and neck, hard to breathe  5) sleepiness and no energy / appetite
Age: 3.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Hypersensitivity, Mouth swelling, Nasopharyngitis, Pruritus, Pyrexia
Clinical narrative: In Friday morning, after vaccination, some allergic reaction happened a few min (5-10 min). After 30 min of the vaccination, the doctor gave a dose of BENADRYL (12.5 mg/ml oral liquid). The patient was transferred to urgent care for observation for 4 hours.  At home, the patient was received 3 doses of BENADRYL (12.5 mg/ml oral liquid) every 6 hours for 3 days.  1) Red Rash with itchiness all over the body  2) low fever (less 101 degrees) 3) shivering with cold 4) Swelling in the face (eyes, mouth) and neck, hard to breathe  5) sleepiness and no energy / appetite
Age: 3.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash erythematous, Somnolence, Swelling, Swelling face
Clinical narrative: In Friday morning, after vaccination, some allergic reaction happened a few min (5-10 min). After 30 min of the vaccination, the doctor gave a dose of BENADRYL (12.5 mg/ml oral liquid). The patient was transferred to urgent care for observation for 4 hours.  At home, the patient was received 3 doses of BENADRYL (12.5 mg/ml oral liquid) every 6 hours for 3 days.  1) Red Rash with itchiness all over the body  2) low fever (less 101 degrees) 3) shivering with cold 4) Swelling in the face (eyes, mouth) and neck, hard to breathe  5) sleepiness and no energy / appetite
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Laboratory test, Tremor
Clinical narrative: Patient went home after receiving vaccination and  at around 6pm he starting shaking and lost balance. He called his health care dr and he instructed him to go to the er. He received multiple tests  and was admitted for observation
Age: 0.17
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Eye swelling
Clinical narrative: EYE SWELLING
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Swelling
Clinical narrative: Swelling at base of neck and shoulder on my right side only
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: red and swelling to left arm .
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: pt reports breaking out in a rash from head to toe along with severe itching. started approximately 2 days after receiving the flu vaccine on 10/9/19 at pharmacy. she has received flu vaccines in the past with no adverse reactions.
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Blister, Heart rate increased, Musculoskeletal discomfort, Pain, Product quality issue
Clinical narrative: Heart rate shot up last night and had shooting pains every once in a while; Heart rate shot up last night and had shooting pains every once in a while; Blisters on her stomach and shoulder; Dots on her torso; Discomfort; This spontaneous report was received from an 84 year old female patient regarding herself. The patient's medical history was not reported. Drug allergy included codeine. Concurrent conditions included breast cancer and heart problems. Concomitant therapies included ibuprofen(MOTRIN), acetaminophen(TYLENOL), metoprolol and pravastatin. On an unspecified date in April 2011, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, frequency, lot# and expiry date were not provided) in the arm for prophylaxis before she started radiation treatments for breast cancer on an unspecified date in April 2011. She had back discomfort on 05-OCT-2019 and dots on her torso (rash macular) on 06-OCT-2019. She noticed a blister on her stomach and shoulders on 07-OCT-2019 and she had an office visit with her physician on the same day, patient sought medical attention. She reported her heart rate shot up last night on 08-OCT-2019 and she had shooting pains every once in a while and then the pain stops. The patient was treated with valacyclovir hydrochloride (manufacturer unknown) (lot# ST.DEA:BC0389711, expiration date 07-OCT-2020) two tablets every 12 hours. She took two valacyclovir hydrochloride (manufacturer unknown) tablets at 8PM last night 08-OCT-2019, which were like the size of footballs. Her heart rate jumped up to 178, then back down, then back up to 169, then down to 79. It kept going back and forth. The last time she checked before bed, it went down to 77 then back up to 122. She took two more tablets at 7 AM on 09-OCT-2019, and so far it seems OK. Her heart rate had never gone over 124 before this. Outcome of the events were reported as not recovered/not resolved. Causality assessment was not provided. Product quality complaint was not involved in the case.
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Rash
Clinical narrative: Heart rate shot up last night and had shooting pains every once in a while; Heart rate shot up last night and had shooting pains every once in a while; Blisters on her stomach and shoulder; Dots on her torso; Discomfort; This spontaneous report was received from an 84 year old female patient regarding herself. The patient's medical history was not reported. Drug allergy included codeine. Concurrent conditions included breast cancer and heart problems. Concomitant therapies included ibuprofen(MOTRIN), acetaminophen(TYLENOL), metoprolol and pravastatin. On an unspecified date in April 2011, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, frequency, lot# and expiry date were not provided) in the arm for prophylaxis before she started radiation treatments for breast cancer on an unspecified date in April 2011. She had back discomfort on 05-OCT-2019 and dots on her torso (rash macular) on 06-OCT-2019. She noticed a blister on her stomach and shoulders on 07-OCT-2019 and she had an office visit with her physician on the same day, patient sought medical attention. She reported her heart rate shot up last night on 08-OCT-2019 and she had shooting pains every once in a while and then the pain stops. The patient was treated with valacyclovir hydrochloride (manufacturer unknown) (lot# ST.DEA:BC0389711, expiration date 07-OCT-2020) two tablets every 12 hours. She took two valacyclovir hydrochloride (manufacturer unknown) tablets at 8PM last night 08-OCT-2019, which were like the size of footballs. Her heart rate jumped up to 178, then back down, then back up to 169, then down to 79. It kept going back and forth. The last time she checked before bed, it went down to 77 then back up to 122. She took two more tablets at 7 AM on 09-OCT-2019, and so far it seems OK. Her heart rate had never gone over 124 before this. Outcome of the events were reported as not recovered/not resolved. Causality assessment was not provided. Product quality complaint was not involved in the case.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: HPV high risk; This spontaneous report as received from a physician assistant refers to a 30 year old female patient. The patient's pertinent medical history included anaemia. The patient's drug reactions or allergies were reported as none. Concomitant therapies included ethinyl estradiol, norgestimate(ORTHO TRI-CYCLEN). It was reported that the patient was not pregnant.  On an unknown date (reported as 15-16 years ago), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (strength, dose, anatomical location, lot/batch # and expiration date were not reported) via intramuscular route for prophylaxis. There was no overdose.  On 07-MAR-2018, a PAP SMEAR test was performed and the patient was diagnosed with HPV high risk (papilloma viral infection). The patient sought medical attention from a gynecologist, but there was no intervention to prevent the seriousness. The patient had not received any treatment. The outcome of papilloma viral infection was reported as not recovered. The reporter's causality assessment was not reported. There was no product quality complaint (PQC).
Sex: U
Vaccine: UNK
Symptoms: Dizziness, Feeling drunk, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: reporting large golf ball OR SOFTBALL SIZED WELT; hot to touch; swollen at the injection site; drunk/dizzy feeling; drunk/dizzy feeling; This case was reported by a physician via call center representative and described the occurrence of injection site wheal in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number T9N35, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, less than a month after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site wheal, injection site warmth, injection site swelling, feeling drunk and dizziness. On an unknown date, the outcome of the injection site wheal, injection site warmth, injection site swelling, feeling drunk and dizziness were unknown.   It was unknown if the reporter considered the injection site wheal, injection site warmth, injection site swelling, feeling drunk and dizziness to be related to Fluarix Quadrivalent 2019-2020 season.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced large golf ball or softball sized welt, hot to touch, swollen at the injection site. The patient experienced drunk and dizzy feeling. This case is 1 of the 4 linked cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Gastric disorder
Clinical narrative: Flu like side effects; Muscle pain; Dizziness; Weakness; Extreme tiredness; Chills; Stomach issues; Headaches; This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. In October 2019, 4 days after receiving Shingrix, the patient experienced influenza-like symptoms, muscle pain, dizziness, weakness, tiredness, chills, gastric disorder and headache. On an unknown date, the outcome of the influenza-like symptoms, muscle pain, dizziness, weakness, tiredness, chills, gastric disorder and headache were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, muscle pain, dizziness, weakness, tiredness, chills, gastric disorder and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a lot of flu like side effects, lots of muscle pain, dizziness, weakness, extreme tiredness, chills, stomach issues and headaches after vaccination. The patient asked whether it is normal to start events 4 to 5 days after shot and how many days does it usually last. The patient asked will experience the same side effects with the 2nd dose. The patient stated that her husband needs to get the shot but he cannot be out of work for 4 days. The patient asked how many days after shot and for how long events occur and why do people suffer from side effects.