chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: GAURDIAN CALLED CLINIC AT 9AM ON 10/22/20 REPORTING THAT THE PRIOR EVENING THE CHILDS ARM HAD BECOME RED, SWOLLEN, AND ITCHY. ASKED GAURDIAN TO BRING CHILD TO CLINIC SO WE CAN ASSESS THE CHILD. THE LATERAL SIDE OF CHILDS ARM WAS RED AND SWOLLEN. HE STATES IT HAS BEEN ITCHING. NO SOB OR RESPIRATORY ISSUES PRESENT. ENCOURAGED GAURDIAN TO GIVE CHILD CHILDRENS BENADRYL AND REPORT TO PCP OR ER IF WORSENS OR CHANGES. GUARDIAN VERBALIZES UNDERSTANDING. EACH CHILD WAS REQUIRED TO HAVE PARENT FILL OUT FLU FORMS PRIOR TO SCHOOL FLU DAY. GAURDIAN HAD MARKED NO ON PRIOR REACTIONS TO FLU SHOT.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Injection site urticaria, Swelling
Clinical narrative: Immediate redness at injection site with 3mm wheal. By 15 minutes, erythema was palm size and local swelling started. Within 4 hours large local swelling at site, child not bearing weight. Swelling worsened over course of 24 hours despite ibuprofen ATC and ZYRTEC twice daily. No systemic symptoms. Similar reaction in 2019 from a preservative free influenza vaccine given by PCP.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Weight bearing difficulty
Clinical narrative: Immediate redness at injection site with 3mm wheal. By 15 minutes, erythema was palm size and local swelling started. Within 4 hours large local swelling at site, child not bearing weight. Swelling worsened over course of 24 hours despite ibuprofen ATC and ZYRTEC twice daily. No systemic symptoms. Similar reaction in 2019 from a preservative free influenza vaccine given by PCP.
Age: 68.0
Sex: M
Vaccine: FLUA4
Symptoms: Malaise, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, night of 10/23. Fever 99.1 deg, day of 10/24. malaise, 10/24 - 10/25.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Hyperhidrosis, Injection site pain
Clinical narrative: Severe chills, shivering, body aches, slight nausea. Extreme fatigue, zero appetite.  Very painful at injection site.  Severe sweating
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: Severe chills, shivering, body aches, slight nausea. Extreme fatigue, zero appetite.  Very painful at injection site.  Severe sweating
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site pruritus, Injection site swelling, Rash
Clinical narrative: Swelling, and discomfort at site. Few days later, started itching in neck area on same side of vax. Traveled down to the shoulder area. Applied lotion to help with the itching etc. Took a few days to subside. Could feel the bumpy rash area on neck. Then daughter started having same symptoms.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and warmth localized to injection site, diphenhydramine administered
Age: 28.0
Sex: M
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: HIVES
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Limb discomfort, Pain, Paraesthesia, Sleep disorder
Clinical narrative: 28-year-old female RN was received a flu shot on 10/09/2020. She reports that the bandied from the shot was located on the superior margin of the deltoid, she did not watch as they inserted the needle. She does report that she had significant pain during and after the injection, which was unusual from previous experiences.  She reports the pain worsened over the next two days and has not improved since.  She tells me that she has been using Ibuprofen 600mg once per day and heat which helps a little.  She also reports that the pain is associated with tingling of the hand involving the middle, ring and pinky finger. She denies numbness. On presentation she reports that she had constant pain rated 2/10 aching pain while sitting. The pain is worsened with over the shoulder movement and direct pressure as well as sleeping on it. The pain can radiate into the neck at times as well.  She further reports that the arm feels heavy.  She is tolerating full duty. She denies any recent illness or possibility of being pregnant. She takes Prozac for anxiety and depression, otherwise denies any further PMH or Med use.  She has allergies to grapes and red wine and denies allergies to medications .
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: 28-year-old female RN was received a flu shot on 10/09/2020. She reports that the bandied from the shot was located on the superior margin of the deltoid, she did not watch as they inserted the needle. She does report that she had significant pain during and after the injection, which was unusual from previous experiences.  She reports the pain worsened over the next two days and has not improved since.  She tells me that she has been using Ibuprofen 600mg once per day and heat which helps a little.  She also reports that the pain is associated with tingling of the hand involving the middle, ring and pinky finger. She denies numbness. On presentation she reports that she had constant pain rated 2/10 aching pain while sitting. The pain is worsened with over the shoulder movement and direct pressure as well as sleeping on it. The pain can radiate into the neck at times as well.  She further reports that the arm feels heavy.  She is tolerating full duty. She denies any recent illness or possibility of being pregnant. She takes Prozac for anxiety and depression, otherwise denies any further PMH or Med use.  She has allergies to grapes and red wine and denies allergies to medications .
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Injection site pain, Injection site warmth, Myalgia
Clinical narrative: Muscle soreness, heat and pain at injection site, tiredness
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Irritability, Pruritus, Rash, Rash erythematous
Clinical narrative: Patient guardian  called 10/28/2020 and reported patient was sent home from school with mild rash to right side of neck (front and back) and ear that was fine red bumps and mildly irritating/itchy. She reports patient had a mild headache when sent home. No fever, no swelling, no problems breathing or swallowing/eating.  No irritation, redness, rash, or drainage at site of vaccine admin. She states she took him to fast pace to be evaluated and nurse advised to monitor and continue regular meds and patient was cleared to go back to school next day on 10/28/2020. HD RN contacted patients guardian 10/29/2020 to check up on patient and she reports patients rash is going away and he was back in school 10/28/2020 with no concerns.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: patient experience vasovagal response after flu shot between 3-5 minutes after shot
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Headache, Impaired work ability, Nausea, Pain
Clinical narrative: Employee developed pain in her right arm following flu vaccination. By 12:00pm she developed a headache. She took Tylenol and said it did not touch her headache. At 1:30pm she started feeling dizzy and by 2:00pm she was nauseous. At this time, she left work early to go home and go to bed. Employee stated her headache did ease up, but movement would exacerbate the nausea. On 10/22/20 she was feeling better but a residual headache remained.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity, Somnolence
Clinical narrative: Employee developed pain in her right arm following flu vaccination. By 12:00pm she developed a headache. She took Tylenol and said it did not touch her headache. At 1:30pm she started feeling dizzy and by 2:00pm she was nauseous. At this time, she left work early to go home and go to bed. Employee stated her headache did ease up, but movement would exacerbate the nausea. On 10/22/20 she was feeling better but a residual headache remained.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Gait disturbance, Injection site erythema, Injection site pruritus, Pain in extremity
Clinical narrative: redness around injection site; itching around the injection site the top of the arm down to the elbow,; swelling in both arms/swelling in both legs; pain in both legs / pain in her legs / pain in both feet; hip pain /  pain in her hips; she had to use a walker; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included knee operation, hip surgery and shingles. Previously administered products included Shingrix with an associated reaction of peripheral swelling (received 1st dose in August 2020, refer case US2020210332).   On 9th October 2020, the patient received the 2nd dose of Shingrix. On 9th October 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site itching, swelling arm, leg pain and pain in hip. On an unknown date, the patient experienced walking difficulty. The patient was treated with hydrocortisone and neosporin (nos) (Neosporin). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the injection site itching and walking difficulty were unknown and the outcome of the swelling arm, leg pain and pain in hip were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site itching, swelling arm, leg pain, pain in hip and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right arm and had swelling in both arms, itching around the injection site from the top of the arm down to the elbow, redness around the injection site, hip pain, pain in both feet, and swelling in both arms and these have resolved at this time.  The patient reported the same day she received the second dose she had pain and swelling in both legs and these are still ongoing currently.  The patient reported she was still having to use a walker due to the pain.  The patient reported she used Neosporin and Hydrocortisone cream for the itching around the injection site. The reporter consented to follow up. Emergency room visit required. The Patient did not had lot number or expiration date information to provide.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020210332:same reporter
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Walking aid user
Clinical narrative: redness around injection site; itching around the injection site the top of the arm down to the elbow,; swelling in both arms/swelling in both legs; pain in both legs / pain in her legs / pain in both feet; hip pain /  pain in her hips; she had to use a walker; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included knee operation, hip surgery and shingles. Previously administered products included Shingrix with an associated reaction of peripheral swelling (received 1st dose in August 2020, refer case US2020210332).   On 9th October 2020, the patient received the 2nd dose of Shingrix. On 9th October 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site itching, swelling arm, leg pain and pain in hip. On an unknown date, the patient experienced walking difficulty. The patient was treated with hydrocortisone and neosporin (nos) (Neosporin). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the injection site itching and walking difficulty were unknown and the outcome of the swelling arm, leg pain and pain in hip were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site itching, swelling arm, leg pain, pain in hip and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right arm and had swelling in both arms, itching around the injection site from the top of the arm down to the elbow, redness around the injection site, hip pain, pain in both feet, and swelling in both arms and these have resolved at this time.  The patient reported the same day she received the second dose she had pain and swelling in both legs and these are still ongoing currently.  The patient reported she was still having to use a walker due to the pain.  The patient reported she used Neosporin and Hydrocortisone cream for the itching around the injection site. The reporter consented to follow up. Emergency room visit required. The Patient did not had lot number or expiration date information to provide.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020210332:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Injection site discomfort, Pain in extremity
Clinical narrative: arm is sore where I received a Shingrix vaccine; Discomfort; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2020, the patient received Shingrix. In October 2020, less than a day after receiving Shingrix, the patient experienced injection site discomfort. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm and injection site discomfort were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and injection site discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but taken as adult as per vaccine indication. The patient received Shingrix and experienced pain in arm and injection site discomfort. The patient inquired about use of ice or heat to help alleviate the discomfort. The information regarding consent to follow up was not reported. No further information was available.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like body aches; This case was reported by a consumer via call center representative and described the occurrence of flu-like aching in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis multiple joint. Concomitant products included paracetamol (Tylenol) and diclofenac (Voltaren Gel).   On 6th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 7th October 2020, 1 days after receiving Shingrix, the patient experienced flu-like aching. On 9th October 2020, the outcome of the flu-like aching was recovered/resolved.   It was unknown if the reporter considered the flu-like aching to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had flu like body aches during the day and these resolved. The reporter stated this pain interferes with sleep.  The patient was able to sleep and arthritis pain resolved and it did come back. The reporter consents to HCP follow up and did not had address.  No additional information was available from customer. This case linked with US2020208339, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020208339:same reporter
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash, Vaccination failure
Clinical narrative: diagnosed as a mild case of Shingles/suspected vaccination failure; diagnosed as a mild case of Shingles; small rash to her chest wall; burning sensation to her left side / burning rash on her chest; This case was reported by a physician via call center representative and described the occurrence of suspected vaccination failure in a 80-year-old female patient who received SHINGRIX for prophylaxis.   Co-suspect products included SHINGRIX for prophylaxis.   On 2nd April 2020, the patient received the 2nd dose of SHINGRIX. On 16th January 2020, the patient received the 1st dose of SHINGRIX. On 21st October 2020, 202 days after receiving SHINGRIX and 279 days after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and burning sensation. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, rash and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash and burning sensation to be related to SHINGRIX and SHINGRIX.  Additional details were reported as follows: The patient received both doses in her left arm and developed a burning rash on her chest which was diagnosed as a mild case of Shingles.  The reporter wanted to know if the vaccine could have caused this and the percentage of patients who experienced these events. The reporter did not administer the vaccine to patient hence he did not have any of the lot/expiry date information. The reporter consented to follow up. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were not not provided.; Sender's Comments:  US2020212016:same patient
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Blood pressure systolic increased, Migraine, Pain in extremity
Clinical narrative: migraine headache; leg pain; increase in blood pressure /  has ranged from the upper 140s to 160; systolic blood pressure increased /; This case was reported by a consumer via call center representative and described the occurrence of migraine headache in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 4ME42, expiry date 14th November 2021) for prophylaxis.   On 13th October 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 14th October 2020, 1 days after receiving Shingrix, the patient experienced migraine headache, leg pain, increased blood pressure and blood pressure systolic increased. On an unknown date, the outcome of the migraine headache, leg pain and increased blood pressure were not recovered/not resolved and the outcome of the blood pressure systolic increased was unknown.   It was unknown if the reporter considered the migraine headache, leg pain, increased blood pressure and blood pressure systolic increased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had migraine headache, leg pain and increase in blood pressure and these are all still ongoing currently.  The patient reported the leg pain had subsided some but was still ongoing.  The patient reported his systolic blood pressure increased and had ranged from the upper 140s to 160. The reporter consented to follow up and gave consent to follow up with HCP.
Sex: F
Vaccine: VARZOS
Symptoms: Hypertension, Pain in extremity, Tachycardia
Clinical narrative: soreness of the arm injected arm; her blood pressure was 174/114/high blood pressure; Tachycardia  with heart rate at 140,163,110 beats per minute; This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 23rd October 2020, unknown after receiving Shingrix, the patient experienced pain in arm, blood pressure high and tachycardia. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the blood pressure high and tachycardia were recovered/resolved.   It was unknown if the reporter considered the pain in arm, blood pressure high and tachycardia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Physician stated a customer received the 1st dose of the Shingrix vaccine in an unknown date, and in unknown arm and was seen by the physician on 23th October 2020, and the patient reported that she got the Shingrix vaccine and experienced tachycardia with heart rate at 140 beats per minute which sustained for 5 minutes and then the heart rate went upto 163 beats per minute which sustained for 20 minutes and then the heart rate went to 110 beats per minute. During this time, her blood pressure was 174/114 and then she laid down to rest and then her vital signs returned to normal.  The patient also reported soreness of the arm injected arm. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Swelling
Clinical narrative: soreness; swelling; This case was reported by a pharmacist via call center representative and described the occurrence of pain in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain and swelling. On an unknown date, the outcome of the pain and swelling were recovered/resolved.   It was unknown if the reporter considered the pain and swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. Pharmacist stated that she had patients complained of soreness or swelling for about a week following Shinhgrix administration.  She stated they seen a lot of older patients. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020212977:same reporter
Age: 64.0
Sex: M
Vaccine: FLUA4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient dropped in at the drive through flu clinic as he was getting registered I took his completed consent form for the flu vaccine. took a look at his age written on the form to me looked like 69 so gave the patient a high dose vaccine. When entering the vaccine later in the day noticed he was only 64 years of age.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Dizziness, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: moments after receiving the vaccination, patient became dizzy, was sweating all over (arms and face/neck were damp with sweat). I checked the patients blood pressure, it was low at 70/45. Patient was given water to drink followed by orange juice to drink. Over about 15 minutes time, patent began feeling better, and blood pressure increased to a normal reading of 120/72. She stood up and sat back down a couple of times, then felt well enough to leave. She was escorted to her vehicle by a member of management. She was contacted 2 hours later, she was feeling much better.
Age: 80.0
Sex: F
Vaccine: UNK
Symptoms: Induration
Clinical narrative: local arm induration
Age: 10.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Pt got light-headed and then passed out about 5 minutes after administration of vaccine. Pt laid on floor and was given water until he felt better. Pt seemed to recover after about 15 minutes and walked out of store OK.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Burning sensation, Injected limb mobility decreased, Pain
Clinical narrative: Initial burning and pain radiating to elbow and neck. Currently still having pain resulting in decreased range of motion and strength to left arm.
Age: 24.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Chills, Dyspnoea, Immediate post-injection reaction, Lymphangitis, Myalgia
Clinical narrative: Immediately after, I experienced achiness in bilateral arms, which was expected. However, 4 hours following the vaccination, I started experiencing fever, chills, and additional muscle aches. Tylenol 500mg 2 tablets in the early evening and Ibuprofen 2 tablets before bed improved symptoms slightly. The next morning/today, I awoke with more fever, chills, muscle aches, accompanied by dyspnea and what appears to be lymphangitis in the left deltoid to the axilla.
Age: 24.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Immediately after, I experienced achiness in bilateral arms, which was expected. However, 4 hours following the vaccination, I started experiencing fever, chills, and additional muscle aches. Tylenol 500mg 2 tablets in the early evening and Ibuprofen 2 tablets before bed improved symptoms slightly. The next morning/today, I awoke with more fever, chills, muscle aches, accompanied by dyspnea and what appears to be lymphangitis in the left deltoid to the axilla.
Age: 66.0
Sex: F
Vaccine: FLUR4
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: fever and very painful arm
Age: 6.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Syncope, Vomiting
Clinical narrative: Pt fainted and then said her head hurt and started vomiting about 5 minutes after vaccine. Pt was given water and appeared to recover.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Immunization that was given was out of date. No adverse reaction.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 34-year-old female psychologist received a flu shot on 10/12/2020. She reports that the following day she started to develop redness, swelling, and pain in the Left Shoulder. She also reported a fever but did not take her temperature. Her symptoms continue to worsen through 10/15/2020 despite use of antihistamines.  She ultimately presented to the ED. She was treated with Keflex 500mg Q 6hrs for cellulitis which improved her symptoms.  She reports a significant amount of Allergies as well totaling 21 foods as well as plants and seasonal allergies. She has since completed the antibiotics and is presently reporting resolution of her symptoms. She reports an occasional itch in the area in questions but on presentation denies any further pain, redness swelling or aggravating factors.  She denies any allergies to medications and uses spironolactone for acne, she also uses Zyrtec and Allegra.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: 34-year-old female psychologist received a flu shot on 10/12/2020. She reports that the following day she started to develop redness, swelling, and pain in the Left Shoulder. She also reported a fever but did not take her temperature. Her symptoms continue to worsen through 10/15/2020 despite use of antihistamines.  She ultimately presented to the ED. She was treated with Keflex 500mg Q 6hrs for cellulitis which improved her symptoms.  She reports a significant amount of Allergies as well totaling 21 foods as well as plants and seasonal allergies. She has since completed the antibiotics and is presently reporting resolution of her symptoms. She reports an occasional itch in the area in questions but on presentation denies any further pain, redness swelling or aggravating factors.  She denies any allergies to medications and uses spironolactone for acne, she also uses Zyrtec and Allegra.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Lethargy, Pyrexia
Clinical narrative: Fever, headache, lethargy
Age: 67.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site inflammation
Clinical narrative: Pt states inflammation in left arm after administration of flu shot. MD advised pt immunization administered high in bursa sac of left arm. Being treated with cortisone cream for 3 months.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: fatigue,  weakness, mild GI discomfort, sleepiness, painful area 3" below injection site with erythema and slight swelling x3 days
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Somnolence
Clinical narrative: fatigue,  weakness, mild GI discomfort, sleepiness, painful area 3" below injection site with erythema and slight swelling x3 days
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: The injection site is red, sore, redness spreading Down right arm and under right Arm. Took Benadryl & iced side. Redness is better the next day as well as less soreness.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (L) deltoid where Tdap given @ 48 hours - swelling & redness. No fever. Length at exam of affected site is 8cm.
Age: 53.0
Sex: M
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: Subject felt immediate pain down arm that received vaccine.  Did not lose feeling or range of motion with arm but continued to hurt for at least an hour afterwards when he contacted our clinic.   Subject stated that he took ibuprofen with relief that day The next morning the subject stated that pain has gone away  Self sealing band aid on arm was over center of left deltoid muscle.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular, Rash pruritic, Urticaria
Clinical narrative: Diffuse rash predominently papular on legs and urticatial on thorax, mildly pruritic, approximately 7 days after immunization, treated with ceterizine and 40mg depo triamcinolone acetate,
Age: 80.0
Sex: F
Vaccine: FLUA3
Symptoms: Chills, Tremor
Clinical narrative: At 9 pm, took a shower and immediately after shower had terrible chills for about an hour. Experienced shakes that last for about 1 day.
Age: 0.58
Sex: F
Vaccine: FLU4
Symptoms: Eye movement disorder, Musculoskeletal stiffness, Somnolence, Tremor
Clinical narrative: Mother reports child had an episode in which her whole body stiffened and then rhythmically shook for 10 seconds with backward eye deviation. No loss of bowel/bladder or vomiting during episode. Went directly to sleep after the episode. Was not associated with fever (before, during, or after).  The event took place approximately 12 hours after the vaccination was given. She has had no further episodes as of 10/29/20.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Burning sensation, Erythema, Joint range of motion decreased, Joint swelling
Clinical narrative: severe pain, burning and  swelling of entire arm.  The arm was very warm and the triceps was red and tender. My elbow swelled up to size of a baseball and the joint hurt.  I could hardly move my arm-the muscles wouldn't contract.  The pain and bicep swelling started 7 pm the day of vaccination.  Pain continued the next day (friday) with severe burning, swollen and red along triceps. On Saturday morning my elbow was swollen,  warm, painful and triceps were sore.  I contacted a doctor(virtual visit) on Sunday-i was afraid I had an infection, prescribed Keflex 500mg 4 times/day. Swelling, redness subsided so didn't take it. Took over 7 days for arm to feel better.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: severe pain, burning and  swelling of entire arm.  The arm was very warm and the triceps was red and tender. My elbow swelled up to size of a baseball and the joint hurt.  I could hardly move my arm-the muscles wouldn't contract.  The pain and bicep swelling started 7 pm the day of vaccination.  Pain continued the next day (friday) with severe burning, swollen and red along triceps. On Saturday morning my elbow was swollen,  warm, painful and triceps were sore.  I contacted a doctor(virtual visit) on Sunday-i was afraid I had an infection, prescribed Keflex 500mg 4 times/day. Swelling, redness subsided so didn't take it. Took over 7 days for arm to feel better.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Rash erythematous
Clinical narrative: Patient said she had a mild, red rash at injection site 1 day after vaccine administration.  No itching or pain was reported.  The rash went away on its own with no treatment within 1 day after it appeared.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Diarrhoea, Dizziness, Fatigue, Gait inability
Clinical narrative: Fever and exhaustion began the next day.  Fever was intermittent through 10/27.   Exhaustion ended  by 10/27. Extreme dizziness and diarrhea began on 10/15.  Unable to walk, just laid on the bathroom floor for a couple of hours. So weak, I was unable to place a phone call, but was able to text my sister in another state.  Problematic dizziness and diarrhea continued through 10/24.   Still feeling a little dizziness occasionally, but greatly improved over 10/15 onset.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired driving ability, Pyrexia
Clinical narrative: Fever and exhaustion began the next day.  Fever was intermittent through 10/27.   Exhaustion ended  by 10/27. Extreme dizziness and diarrhea began on 10/15.  Unable to walk, just laid on the bathroom floor for a couple of hours. So weak, I was unable to place a phone call, but was able to text my sister in another state.  Problematic dizziness and diarrhea continued through 10/24.   Still feeling a little dizziness occasionally, but greatly improved over 10/15 onset.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Dyskinesia, Fall
Clinical narrative: Patient reports that upon rising in the morning she has no control over her right side of body.  She fell on 10/21/20 and went to ER.  Upon arrival at ER patient could walk fine and received no treatment.  She states that she experiences the same lacking of functioning of right side every morning upon awaking.  After she is up for a couple hours she functions normally and has no lingering effects.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Conjunctival haemorrhage
Clinical narrative: Hours post injection patient noted a subconjunctival hemorrhage on the left eye. Patient does not present with any other symptoms an allergic reaction, or vision strain.
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Dyspnoea, Heart rate increased, Pyrexia
Clinical narrative: Patient has exp difficulty breathing, rapid heart beats, dizziness and weakness. Also had a fever of 99.0 on 10/27/20
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Pruritus
Clinical narrative: x4 days of mild induration around side of injection, some erythema, and pruritis.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Pruritus, Skin irritation
Clinical narrative: shortness of breath, arm irritation, and itching
Age: 65.0
Sex: F
Vaccine: PPV, FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site
Clinical narrative: Severe pain where the shot was given. Hurt very bad when given the shot. Severe started about 5 hours after the shot was given. Can not lift my arm. Shot was given very high up on the shoulder. Even the Dr.  at urgent care said it probably should not have been given at that spot. Urgent care said I should give it a few more days. Been taken Acetaminopen 500 mg as per Dr. Still in a lot of pain. Please help me.
Age: 65.0
Sex: F
Vaccine: PPV, FLU4, PPV
Symptoms: Chest pain, Injection site induration, Pain
Clinical narrative: Severe pain where the shot was given. Hurt very bad when given the shot. Severe started about 5 hours after the shot was given. Can not lift my arm. Shot was given very high up on the shoulder. Even the Dr.  at urgent care said it probably should not have been given at that spot. Urgent care said I should give it a few more days. Been taken Acetaminopen 500 mg as per Dr. Still in a lot of pain. Please help me.
Age: 57.0
Sex: F
Vaccine: FLUR4
Symptoms: Arthralgia, Back pain, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: within 10 hours, large red raised circle (hot to touch) around injection site and upper arm very sore (normal reaction). Next morning, pain radiating from injection site, up shoulder to neck, down neck to lower back. Lower back pain worse with movement of neck up and down. Neck and back pain strongly persist for 3 days, starting to improve on day 4.
Age: 57.0
Sex: F
Vaccine: FLUR4
Symptoms: Neck pain, Pain in extremity
Clinical narrative: within 10 hours, large red raised circle (hot to touch) around injection site and upper arm very sore (normal reaction). Next morning, pain radiating from injection site, up shoulder to neck, down neck to lower back. Lower back pain worse with movement of neck up and down. Neck and back pain strongly persist for 3 days, starting to improve on day 4.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Dry eye, Excessive eye blinking, Tic
Clinical narrative: Tic - Blinking eyes due to  DRY EYES
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Telehealth visit for mild fever and rash over body for two days. Pt received MMR and Varicella vaccines on 09/09/2020. Video with mother and infant due to COVID-19 pandemic. Infant's skin is clear now, no fever. Toddler is doing well. No fever, rash, vomiting or diarrhea.
Age: 71.0
Sex: F
Vaccine: PNC, PPV
Symptoms: Abdominal pain upper, Chest pain, Headache, Injection site pain, Pain
Clinical narrative: pain in her stomach; chest pain; aching; tenderness at injection site; headache; low grade fever; Inappropriate schedule of product administration; This spontaneous report as received from a consumer referring to herself a 71- year-old female patient. Information regarding patient's medical history,drug allergies or reaccions was not provided. Patient's concomitant medications included vitamins.     On 14-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), intramuscular (strength, dose, frequency, lot number and expiration date were not provided).  Other suspect therapies included pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVENAR) (strength, dose, frequency, administration route, lot number and expiration date were not provided). Both as prophylaxis.   Within 24 hours from the vaccination with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23),  the patient experienced headache,   tenderness at injection site (vaccination site pain), aching , chest pain, abdominal pain upper and pyrexia (low grade of 105 (units not provided)). Also the patient reported that she had pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVENAR) about 2-3 years ago and did not has problems (inappropriate schedule of product administration).   At the reporting time the patient symptoms were better .The causal relationship between the events and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not provided..
Age: 71.0
Sex: F
Vaccine: PNC, PPV
Symptoms: Pyrexia
Clinical narrative: pain in her stomach; chest pain; aching; tenderness at injection site; headache; low grade fever; Inappropriate schedule of product administration; This spontaneous report as received from a consumer referring to herself a 71- year-old female patient. Information regarding patient's medical history,drug allergies or reaccions was not provided. Patient's concomitant medications included vitamins.     On 14-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), intramuscular (strength, dose, frequency, lot number and expiration date were not provided).  Other suspect therapies included pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVENAR) (strength, dose, frequency, administration route, lot number and expiration date were not provided). Both as prophylaxis.   Within 24 hours from the vaccination with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23),  the patient experienced headache,   tenderness at injection site (vaccination site pain), aching , chest pain, abdominal pain upper and pyrexia (low grade of 105 (units not provided)). Also the patient reported that she had pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVENAR) about 2-3 years ago and did not has problems (inappropriate schedule of product administration).   At the reporting time the patient symptoms were better .The causal relationship between the events and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not provided..
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Product temperature excursion issue
Clinical narrative: No adverse event/ pt is fine; Caller reported administration of PROQUAD after product experienced temperature excursion.; This spontaneous report was received from a medical assistant and refers to a 5-year-old male patient. The patient had no pertinent medical history, concomitant medications and drug reactions or allergies.  On 06-OCT-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) subcutaneously in left vastus lateralis (LVA) (also reported as left vast laterials), lot # T015598, expiry date 02-NOV-2021 (dose was not provided) as immunization for the prevention of measles, mumps, rubella and varicella at public health clinic/ hospital. On the same day, the patient was vaccinated with diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (KINRIX) and influenza virus split virion 3v vaccine inactivated (FLULAVAL). The dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced temperature excursion of 23.7 Fahrenheit degrees (range 15 to 46 Fahrenheit degrees) for 2 hours and 19 minutes. There was no previous temperature excursion. Digital data logger was involved. The patient did not sought medical attention and did not receive any treatment (also reported as it was unknown if the patient required any treatment). The patient was fine. No adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE reported; gave PNEUMOV AX 23 vaccine yesterday, 10/15/2020 and it expired 9/17/2020; This spontaneous report was received from a pharmacist who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 15-OCT-2020, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter, intramuscularly (anatomical location and strength were not provided; lot number S026366 was confirmed to be valid, expiration date 19-SEP-2020, was also confirmed) for prophylaxis.  There were no other adverse event reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S026366; expirationdate: 17-SEP-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 0.17
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaqta administered to 2 month old child; no additional adverse effects; This spontaneous report was received from a nurse and refers to a 2-month-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 20-OCT-2020, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not reported) injection (dose, route of administration, lot number and expiry date were not reported) for prophylaxis. No additional adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles; Information has been received from a lawyer and a female patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 15-NOV-2012, the pt was inoculated with ZOSTAVAX (strength, dose, lot#, expiration date and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles. Shortly after receiving the ZOSTAVAX vaccine, the pt suffered painful rash across her abdomen and was diagnosed with shingles. As a direct and proximate result of the ZOSTAVAX vaccine, the pt's symptoms had resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the ZOSTAVAX, the pt sustained severe and permanent personal injuries. Further, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the product, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. Outcome of the event was not reported. The reporter considered the event to be related to ZOSTAVAX.  The event of shingles was considered disabling by the reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster oticus
Clinical narrative: Ramsay Hunt Syndrome; Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 10-AUG-2015, the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: to prevent shingles (strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported). On an unknown date, reported as shortly after received ZOSTAVAX vaccine, the patient suffered herpes zoster and Ramsay Hunt Syndrome. As a result of these symptoms, the patient was seen and treated and was still under their care. As a direct and proximate result of the patient's use of the ZOSTAVAX vaccine, the patient symptoms have resulted in physical limitations not presented prior to use the vaccine. The patient also experienced mental and emotional distress due to resulted physical limitations and seriousness of patient condition. Patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury, also the patient had suffered and incurred damages, included medical expenses, the loss of accumulations; and other economic and non-economic damages.  The outcome of herpes zoster and herpes zoster oticus were not recovered. The reporter considered herpes zoster and herpes zoster oticus to be related to ZOSTAVAX.  Upon internal review, herpes zoster oticus was determined to be a medically significant event.