chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Pruritus
Clinical narrative: feeling itchy; redness to left deltoid of injection site which then spread to left shoulder and across chest; Initial information received on 18-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case involves an unknown age female patient who experienced feeling itchy (pruritus) and redness to left deltoid of injection site which then spread to left shoulder and across chest (erythema), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ209AA via unknown route in the left arm.  On an unknown date, the patient experienced a non-serious feeling itchy (pruritus) and redness to left deltoid of injection site which then spread to left shoulder and across chest (erythema) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Patient remained in clinic for 15 minutes after injection of DECADRON.  (Other relevant tests included no lab data.)  Final diagnosis was redness to left deltoid of injection site which then spread to left shoulder and across chest and feeling itchy.   The patient was treated with 150 mg twice daily RANITIDINE HYDROCHLORIDE (ZANTAC) and 8 mg DEXAMETHASONE ACETATE (DECADRON A) to left dorogluteal.  The patient outcome was not reported for redness to left deltoid of injection site which then spread to left shoulder and across chest and feeling itchy.  List of documents held by sender: none.
Age: 74.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Joint stiffness, X-ray
Clinical narrative: Patient received vaccine on 7/10/19. She reports waking up with polyarthralgias in "all joints" a few days later, not sure of exact date, but it was within a week of receiving vaccine. She described this as an aching feeling and stiffness, improved during day, worsened after sleeping. This lasted for 3.5 weeks, resolving in mid-August. She had no joint redness or swelling. No fever, rash or other symptoms. Aching joint pain and stiffness completely resolved, except for aching pain in her left knee. She sought medical care on 9/25/19 for her left knee. She is also an avid golfer, which may be contributing to left knee symptoms. Her exam was normal, x-ray is pending. She has been referred to physical therapy for her knee.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Rash
Clinical narrative: Rash, fever,chills
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Syncope
Clinical narrative: PATIENT WAS UNABLE TO LIFT ARM AND HAD A FAINTING SPELL LATER THAT EVENING AT DINNER TIME
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Musculoskeletal stiffness, Mydriasis
Clinical narrative: Patient received Menactra booster, HPV 9, Bexsero (MEN B) vaccines.  After HPV vaccine administered, patient became stiff and eyes became dilated; lasted approx.4-5 seconds.  Post episode patient stated he was "fine" and was hungry.  No other side effects were noted.  RN recommended that patient call family PCP in regards to same.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyskinesia, Ear pain, Eyelid function disorder, Facial paralysis, Hypoaesthesia
Clinical narrative: On Monday, 9/16/19, she had an ear ache, put some drops in it, resolved after a couple of days, but then couldn't wink w/her right eye, and right side of face was numb, felt like she had been to the dentist & she couldn't put her lips together to whistle & can't drink well from a glass.  Went to see provider on 9/19/19 and patient was diagnosed w/Bell's Palsy.  Her left eye is super sensitive to light.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Photophobia
Clinical narrative: On Monday, 9/16/19, she had an ear ache, put some drops in it, resolved after a couple of days, but then couldn't wink w/her right eye, and right side of face was numb, felt like she had been to the dentist & she couldn't put her lips together to whistle & can't drink well from a glass.  Went to see provider on 9/19/19 and patient was diagnosed w/Bell's Palsy.  Her left eye is super sensitive to light.
Age: 1.5
Sex: F
Vaccine: MMR
Symptoms: Hyperacusis, Hyperaesthesia, Immediate post-injection reaction, Irritability, Personality change
Clinical narrative: My daughter went from having no fear of loud noises, no issues with being wet or feeling textures, confident away from her mom, always happy.   The day of her vaccine it was like flipping a switch.   She was immediately fussier, afraid of loud noises, aggravated by wet clothing, and clingy with her mom.   This was not just a few days after her MMR shot.  It has changed her and she is only slowly getting back to her normal personality.    I am not reporting this because I want compensation.   I am reporting this because you need data.    I am pro public health and have both of my children fully vaccinated.   I am not imagining this.  It was not coincidental.   Her nervous system was adversely impacted by the MMR shot.
Age: 12.0
Sex: M
Vaccine: HPV9, MENB, TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient given a Men B vaccine and should have received a MCV4 vaccine
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Insomnia, Migraine, Myalgia
Clinical narrative: Almost 22 hours after receiving the shot, I started to get a sore throat. 4 hours after the sore throat I was hit with strong fatigue. An hour later I had a high fever (100.8 degrees). Took alkaselzer which only cured the runny nose and sore throat. Muscle aches and fever persisted. 48 hours after the shot, fever subsided but congestion and headache on right side of head continued. Took alkaselzer when headache was too much to sleep. This is day three, woke up with migraine, congestion and runny nose. Everything I've read said symptoms only last 1-2 days.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Almost 22 hours after receiving the shot, I started to get a sore throat. 4 hours after the sore throat I was hit with strong fatigue. An hour later I had a high fever (100.8 degrees). Took alkaselzer which only cured the runny nose and sore throat. Muscle aches and fever persisted. 48 hours after the shot, fever subsided but congestion and headache on right side of head continued. Took alkaselzer when headache was too much to sleep. This is day three, woke up with migraine, congestion and runny nose. Everything I've read said symptoms only last 1-2 days.
Sex: F
Vaccine: DTAP, FLU4, UNK
Symptoms: Viral infection, Vomiting
Clinical narrative: Vomiting after any and every type of feeding of normally tolerated Elecare formula in 6 month old infant baby girl occurred at approximately 6 hours after receiving these three vaccines. Beginning Thursday 9/19 at approximately 5PM EST.  Contacted pediatrician that administered vaccines the following day on Friday 9/20 and did not receive adequate care or medical guidance. My husband and I have thought about moving the patient to a new pediatrician and made a follow up call on Friday 9/20 to Dr. We brought patient to Dr. at 1:30PM on Friday 9/20 where she was evaluated. As this was not yet even 24 hours of the vomiting, we were sent home for monitoring. Dr remained in close contact through the next 24 hours through to Saturday 9/21 where patient continued to vomit. Saturday late afternoon/early evening 9/21 we decided in partnership with Dr to bring patient to the ER at Medical Center for the primary reason to assess dehydration levels and rule out any immediate medical or surgical emergency. We were discharged Saturday 9/21 due to no surgical emergency and to keep giving pedialyte to patient through a bottle. We continued to monitor patient Saturday night through Monday 9/23 with following up with the Doctor for medical guidance, Bringing patient to an allergist appointment Monday 9/23 to rule out an my potential allergic reactions. Throughout this entire time, patient has continued vomiting after eating. Fast forward as my form time is expiring- we went back to hospital ER Monday evening and were admitted. It is Thursday 9/26 and still here in the hospital. The doctors will have exact findings but everything is pointing to complications from a viral infection. Patient has to have many points of radiation through xrays and ultrasound and an Upper GI study.
Age: 28.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site pruritus, Muscle twitching, Vaccination site swelling
Clinical narrative: red, swollen and itchy area (about the size of a large grapefruit) surrounding the vaccination site.  Also caused some muscle twitching.  The next day, the area of swelling grew larger and wrapped around her bicep.  She is now taking Benadryl and has started to apply a topical steroid cream.  she will follow up with the office if her symptoms do not dissipate.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Swelling
Clinical narrative: swollen, redness
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pain, Pyrexia, Vomiting
Clinical narrative: Soreness; Vomiting; Fever; Became sick; This case was reported by a consumer and described the occurrence of pain in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th September 2019, the patient received the 2nd dose of Shingrix. On 13th September 2019, less than a day after receiving Shingrix, the patient experienced pain, vomiting, fever and sickness. On an unknown date, the outcome of the pain, vomiting, fever and sickness were unknown.   It was unknown if the reporter considered the pain, vomiting, fever and sickness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced soreness and became sick with fever and vomiting on the same day as the vaccine was administered. The outcome of the events was unknown. The GSK employee who reported the event noted that the patient exercised in the gym regularly and appeared to be in good health. The GlaxoSmithKline employee would request the patient contact GlaxoSmithKline with additional information.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Limb discomfort
Clinical narrative: arm discomfort; limited range of motion of arm; This case was reported by a pharmacist via call center representative and described the occurrence of arm discomfort in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number JC55P, expiry date 15th November 2021) for prophylaxis.   On 15th August 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 16th August 2019, 1 days after receiving Shingrix, the patient experienced arm discomfort and joint range of motion decreased. On an unknown date, the outcome of the arm discomfort and joint range of motion decreased were recovering/resolving.   It was unknown if the reporter considered the arm discomfort and joint range of motion decreased to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the patient experienced arm discomfort and limited range of motion of his arm. The reporter stated that the events had slightly improved but has not resolved at the time of reporting. The reporter consented to follow up. This case is 1 of the 2 linked cases, reported by the same reporter.
Age: 41.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Insomnia, Sensitive skin
Clinical narrative: joint pain; sensitive skin; Trouble sleeping; This case was reported by a pharmacist via call center representative and described the occurrence of joint pain in a 41-year-old female patient who received Rabies NVS (RabAvert) (batch number ARBA181A, expiry date 30th September 2022) for prophylaxis.   On 14th September 2019, the patient received the 2nd dose of RabAvert. On 15th September 2019, 1 days after receiving RabAvert, the patient experienced joint pain, sensitive skin and difficulty sleeping. On an unknown date, the outcome of the joint pain, sensitive skin and difficulty sleeping were recovering/resolving.   It was unknown if the reporter considered the joint pain, sensitive skin and difficulty sleeping to be related to RabAvert.  Additional details were reported as follows: The reporter stated that, the patient experienced joint pain, sensitive skin and trouble sleeping after the 2nd dose of Rabavert.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: Since receiving vaccine, directly after Patient has had moderate Pain from injection site to upper neck, and down to elbow, and in left shoulder blade. Patient took ibuprofen today, throughout day with no relief, Patient has to keep arm still due to movement of shoulder hurts.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Abnormal behaviour, Anxiety, Crying, Dyspnoea, Feeling abnormal
Clinical narrative: My daughter fainted 15 minutes after the vaccination as we were checking out at the doctors office.  We had difficulty getting her to become conscious, it took over 30 minutes before I could even get her to the car and then the nurse used a wheelchair.  My daughter slept for hours after that incident and felt foggy.  She did not act the same for months after and began having panic attacks within 48 hrs of the vaccine, which we had never experienced before.  She would experience shortness of breath, severe crying, nausea, headaches, and said she just felt foggy for months.  We began therapy after as she could not walk into or talk about going to a doctors office without having a panic attack.  She still, over a year later, experiences anxiety and panic attacks.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Hypersomnia, Loss of consciousness, Nausea, Panic attack
Clinical narrative: My daughter fainted 15 minutes after the vaccination as we were checking out at the doctors office.  We had difficulty getting her to become conscious, it took over 30 minutes before I could even get her to the car and then the nurse used a wheelchair.  My daughter slept for hours after that incident and felt foggy.  She did not act the same for months after and began having panic attacks within 48 hrs of the vaccine, which we had never experienced before.  She would experience shortness of breath, severe crying, nausea, headaches, and said she just felt foggy for months.  We began therapy after as she could not walk into or talk about going to a doctors office without having a panic attack.  She still, over a year later, experiences anxiety and panic attacks.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: My daughter fainted 15 minutes after the vaccination as we were checking out at the doctors office.  We had difficulty getting her to become conscious, it took over 30 minutes before I could even get her to the car and then the nurse used a wheelchair.  My daughter slept for hours after that incident and felt foggy.  She did not act the same for months after and began having panic attacks within 48 hrs of the vaccine, which we had never experienced before.  She would experience shortness of breath, severe crying, nausea, headaches, and said she just felt foggy for months.  We began therapy after as she could not walk into or talk about going to a doctors office without having a panic attack.  She still, over a year later, experiences anxiety and panic attacks.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Body temperature increased, Dizziness, Feeling abnormal, Feeling hot
Clinical narrative: On the 13th, I felt lethargic and "out of it" all day, more specifically -  weak and dizzy when up and walking around.  I felt very warm all day, and because of the other symptoms, I didn't think to take my temperature until later that afternoon. I didn't have a  proper thermometer, so I took my temperature under my arm with a scientific field thermometer - it registered approximately 104.5 degrees - between 104-105 degrees Fahrenheit. This was the best measurement I could get as the thermometer is graduated every 2 degrees (i.e., I was reading between 104-106). My regular "medical" thermometer had a dead battery.  I didn't seek treatment, but took 2-200mg tablets of ibuprofen every 4 hours  (4pm, 8pm, then again at 8am the next day).  The second day (9/14), I took my temperature again and it had come down to a little over 100 degrees. I took the last ibuprofen dose of 400mg at that time.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Lethargy
Clinical narrative: On the 13th, I felt lethargic and "out of it" all day, more specifically -  weak and dizzy when up and walking around.  I felt very warm all day, and because of the other symptoms, I didn't think to take my temperature until later that afternoon. I didn't have a  proper thermometer, so I took my temperature under my arm with a scientific field thermometer - it registered approximately 104.5 degrees - between 104-105 degrees Fahrenheit. This was the best measurement I could get as the thermometer is graduated every 2 degrees (i.e., I was reading between 104-106). My regular "medical" thermometer had a dead battery.  I didn't seek treatment, but took 2-200mg tablets of ibuprofen every 4 hours  (4pm, 8pm, then again at 8am the next day).  The second day (9/14), I took my temperature again and it had come down to a little over 100 degrees. I took the last ibuprofen dose of 400mg at that time.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pain
Clinical narrative: Body aches, rigors
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Angiogram, Arterial occlusive disease, Chest X-ray, Chills
Clinical narrative: Approximately 12 hours after the injection I awoke with fever, chills, severe pain wherever I was touched, nausea, and severe abdominal pain. After 24  hours the fever, chills, and severe pain wherever I was touched abated but I still had the nausea and severe abdominal pain. 4 days later I went to the emergency room with these symptoms. A CAT scan revealed a clot had blocked an artery leading to my spleen and I had a partially dead spleen. I am a heart patient and had an ejection fraction in the 40s. It was now 25-30. I also now have a pericardial effusion.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Computerised tomogram abdomen abnormal, Computerised tomogram pelvis, Computerised tomogram thorax, Echocardiogram, Ejection fraction decreased
Clinical narrative: Approximately 12 hours after the injection I awoke with fever, chills, severe pain wherever I was touched, nausea, and severe abdominal pain. After 24  hours the fever, chills, and severe pain wherever I was touched abated but I still had the nausea and severe abdominal pain. 4 days later I went to the emergency room with these symptoms. A CAT scan revealed a clot had blocked an artery leading to my spleen and I had a partially dead spleen. I am a heart patient and had an ejection fraction in the 40s. It was now 25-30. I also now have a pericardial effusion.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain, Pericardial effusion, Pyrexia, Spleen disorder
Clinical narrative: Approximately 12 hours after the injection I awoke with fever, chills, severe pain wherever I was touched, nausea, and severe abdominal pain. After 24  hours the fever, chills, and severe pain wherever I was touched abated but I still had the nausea and severe abdominal pain. 4 days later I went to the emergency room with these symptoms. A CAT scan revealed a clot had blocked an artery leading to my spleen and I had a partially dead spleen. I am a heart patient and had an ejection fraction in the 40s. It was now 25-30. I also now have a pericardial effusion.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tenderness, Thrombosis, Ultrasound Doppler
Clinical narrative: Approximately 12 hours after the injection I awoke with fever, chills, severe pain wherever I was touched, nausea, and severe abdominal pain. After 24  hours the fever, chills, and severe pain wherever I was touched abated but I still had the nausea and severe abdominal pain. 4 days later I went to the emergency room with these symptoms. A CAT scan revealed a clot had blocked an artery leading to my spleen and I had a partially dead spleen. I am a heart patient and had an ejection fraction in the 40s. It was now 25-30. I also now have a pericardial effusion.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Computerised tomogram abdomen, Echocardiogram, Pericardial effusion, Pyrexia
Clinical narrative: Approximately 12 hours after the injection I awoke with fever, chills, severe pain wherever I was touched, nausea, and severe abdominal pain. After 24  hours the fever, chills, and severe pain wherever I was touched abated but I still had the nausea and severe abdominal pain. 4 days later I went to the emergency room with these symptoms. A CAT scan revealed a clot had blocked an artery leading to my spleen and I had a partially dead spleen. I am a heart patient and had an ejection fraction in the 40s. It was now 25-30. I also now have a pericardial effusion.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Splenic infarction
Clinical narrative: Approximately 12 hours after the injection I awoke with fever, chills, severe pain wherever I was touched, nausea, and severe abdominal pain. After 24  hours the fever, chills, and severe pain wherever I was touched abated but I still had the nausea and severe abdominal pain. 4 days later I went to the emergency room with these symptoms. A CAT scan revealed a clot had blocked an artery leading to my spleen and I had a partially dead spleen. I am a heart patient and had an ejection fraction in the 40s. It was now 25-30. I also now have a pericardial effusion.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Lip swelling, Rash, Rash macular
Clinical narrative: swollen lips, red and blotchy chest, increased work of breathing
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Blister, Erythema, Headache, Injection site swelling, Injection site warmth
Clinical narrative: Started running a fever.  Site of injection was swollen. Size of a golf ball. Extreme pain.  Day two Fever, muscle cramps site growing. Size of grapefruit.  Looked like a spider bite.  Warm to the touch.  Thru the night extreme pain.  Redness and swelling was impressive.  Horrible headache with muscle cramps.   Red, swollen blistered.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Muscle spasms, Pain, Pyrexia
Clinical narrative: Started running a fever.  Site of injection was swollen. Size of a golf ball. Extreme pain.  Day two Fever, muscle cramps site growing. Size of grapefruit.  Looked like a spider bite.  Warm to the touch.  Thru the night extreme pain.  Redness and swelling was impressive.  Horrible headache with muscle cramps.   Red, swollen blistered.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site urticaria, Insomnia
Clinical narrative: patient states she got a huge hive and a lot of pain at the site that did not let her sleep
Age: 63.0
Sex: M
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Patient experienced pain at the time of injection and has been feeling numbness/pins and needles in the left hand.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Skin: Inspection and palpation: right upper arm with ~7cm x 4.5cm area of erythema and warmth, tender to palpation at site of injection of Tdap. No induration. Patient Instructions Apply ice to the area, 20 minutes on and then at least 20 minutes off. Start the claritin and motrin Recheck if symptoms worsen or do not improve in 3 to 5 days.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Erythema, Injection site pain, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: Patient verbalizes "lot of pain at the injection site, moderate swelling of the left arm, erythema (5.5 (l) x 2.5 (w)), joint pain mostly in her fingers, left hand stiffness, knots beneath the skin of her left arm.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Skin mass
Clinical narrative: Patient verbalizes "lot of pain at the injection site, moderate swelling of the left arm, erythema (5.5 (l) x 2.5 (w)), joint pain mostly in her fingers, left hand stiffness, knots beneath the skin of her left arm.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: On unspecified dates an unspecified number of patients may have administered improperly stored GARDASIL 9.; No adverse events reported; This spontaneous report was received from a registered nurse regarding an identifiable patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis, lot number R020947, expiration date 04-MAY-2021 (strength, dose and route of administration was not reported). There was no adverse events reported. On 20-JUN-2019, the administered doses of vaccines experienced the temperature excursion of -13.33 Celsius degrees for 2 minutes. On 10-MAY-2019, the previous excursion of 9.12 Celsius degrees for 3 hours and 15 minutes was reported. No data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA001880: US-009507513-1909USA001305:
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: arm pain at the site of injection; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient's wife reported the case. The patient received Shingrix in left arm.   The patient experienced arm pain at the site of injection that had persisted. The reporter did not consent to follow-up. This case has been linked to US2019168251, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Got quite sick; This case was reported by a consumer and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced twice).   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 sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient got quite sick after receiving the 1st dose of Shingrix, but decided better to receive the 2nd dose of Shingrix or wouldnt be protected. For tolerance of 2nd dose of Shingrix, refer case US2019AMR170744.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Back pain, Bone pain, Headache
Clinical narrative: I really got sick; Had to go to bed because I was weak; Had the worst headache of my life; My back hurt something terrible; Was very sick to my stomach; Ached in every bone in my body; I felt like I had the worst case of flu; This case was reported by a consumer and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced twice). Previously administered products included Shingrix with an associated reaction of malaise (1st dose received years before the date of reporting and was quite sick, for tolerance of 1st dose refer case US2019AMR170739).   On 16th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced sickness, weakness, headache, back pain, upset stomach, bone pain and influenza like illness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the sickness, weakness, headache, back pain, upset stomach and bone pain were unknown and the outcome of the influenza like illness was recovered/resolved.   It was unknown if the reporter considered the sickness, weakness, headache, back pain, upset stomach, bone pain and influenza like illness to be related to Shingrix.  Additional details were provided as follows: The patient got sick after receiving the 2nd dose of Shingrix.  The patient was also weak, had the worst headache of life, back hurted terriblly. The patientI was very sick to the stomach and ached in every bone in the body. The patient's friends did not get sick and so the patient wondered. The patient thaught it could it be because had shingles twice and the friends never had, or it could be an allergy to the drugs in the vaccine. The patient was just curious about experiencing sick from the vaccine, and felt like had the worst case of flu that lasted 24 hrs. At the time of reporting, the patient was still  little weak yet.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Vaccine positive rechallenge
Clinical narrative: I really got sick; Had to go to bed because I was weak; Had the worst headache of my life; My back hurt something terrible; Was very sick to my stomach; Ached in every bone in my body; I felt like I had the worst case of flu; This case was reported by a consumer and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced twice). Previously administered products included Shingrix with an associated reaction of malaise (1st dose received years before the date of reporting and was quite sick, for tolerance of 1st dose refer case US2019AMR170739).   On 16th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced sickness, weakness, headache, back pain, upset stomach, bone pain and influenza like illness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the sickness, weakness, headache, back pain, upset stomach and bone pain were unknown and the outcome of the influenza like illness was recovered/resolved.   It was unknown if the reporter considered the sickness, weakness, headache, back pain, upset stomach, bone pain and influenza like illness to be related to Shingrix.  Additional details were provided as follows: The patient got sick after receiving the 2nd dose of Shingrix.  The patient was also weak, had the worst headache of life, back hurted terriblly. The patientI was very sick to the stomach and ached in every bone in the body. The patient's friends did not get sick and so the patient wondered. The patient thaught it could it be because had shingles twice and the friends never had, or it could be an allergy to the drugs in the vaccine. The patient was just curious about experiencing sick from the vaccine, and felt like had the worst case of flu that lasted 24 hrs. At the time of reporting, the patient was still  little weak yet.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Feel pretty crummy; This case was reported by a consumer and described the occurrence of feeling unwell in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2019, the patient received the 1st dose of Shingrix. On 18th September 2019, 1 days after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient felt pretty crummy after receiving Shingrix.
Sex: M
Vaccine: TDAP
Symptoms: Loss of personal independence in daily activities
Clinical narrative: Has struggled his entire life; This case was reported by a consumer via interactive digital media and described the occurrence of activities of daily living impaired in a child male patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced activities of daily living impaired (serious criteria disability). On an unknown date, the outcome of the activities of daily living impaired was unknown.   It was unknown if the reporter considered the activities of daily living impaired to be related to DTPa vaccine.  Additional information was reported as follows: The age at vaccination was not reported. The reporter's child was injured by the DPT and had struggled his entire life as a result. But of course it was dismissed as unrelated coincidence.
Sex: U
Vaccine: TDAP
Symptoms: Adverse reaction
Clinical narrative: Severe reaction; This case was reported by a consumer via interactive digital media and described the occurrence of adverse reaction in a child patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to DTPa vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe reaction to DTPa vaccine and was too dangerous to go back to and if the new one did not work.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Injection site bruising, Injection site discolouration
Clinical narrative: localized bruising at the site of the injection; Area is very sensitive to touch; Skin is discolored; This case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced injection site bruising, touch sensitivity increased and injection site discoloration. On an unknown date, the outcome of the injection site bruising, touch sensitivity increased and injection site discoloration were unknown.   It was unknown if the reporter considered the injection site bruising, touch sensitivity increased and injection site discoloration to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's son. The reporter stated that, the patient had localized bruising at the site of the injection. The area was very sensitive to touch and the skin was discolored. Additional information was not provided.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number AP257, expiry date 26th November 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The reporter was filing in at the pharmacy and had no additional information on the topic including address. The reporter did not consent to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injected limb mobility decreased, Injection site pain, Myalgia, Neuralgia
Clinical narrative: pain during injection/ arm pain/ hurts to sleep on that side at night; tiredness; nerve pain in arm muscle where she received the injection/ nerve and muscle pain in arm; nerve pain in arm muscle where she received the injection/ nerve and muscle pain in arm; decreased mobility of arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (about 5 years ago) and nerve pain (due to shingles infection).   On 8th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 8th June 2019, immediately after receiving Shingrix, the patient experienced injection site pain. In June 2019, the patient experienced tiredness, nerve pain, muscle pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and tiredness were recovered/resolved and the outcome of the nerve pain, muscle pain and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, tiredness, nerve pain, muscle pain and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The patient received Shingrix in left arm. During the injection, the patient felt pain. Less than a week after the shot, the patient felt tired and that resolved. About one week later, she developed nerve pain in her arm muscle where she received the injection. Since then, this muscle or nerve pain had persisted and she had decreased mobility of the arm and it hurt to sleep on that side at night. The patient did not consent to follow-up. This case has been linked to US2019168255, reported by the same reporter.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Pruritus, Urticaria
Clinical narrative: Itchy,  hives,  blistering of hands. Treated with Solu-medrol injection, prednisone and antihistamines
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Eye irritation, Hyperhidrosis, Pain
Clinical narrative: Fever 101.5?, burning in the eyes, sweats and chills, aches, joint pains
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever 101.5?, burning in the eyes, sweats and chills, aches, joint pains
Age: 81.0
Sex: F
Vaccine: FLUA3
Symptoms: Decreased appetite, Dizziness, Nausea, Vaccination complication
Clinical narrative: Pt. complained of significant dizziness, nausea, and anorexia beginning 12-24 hours after the vaccination and continuing for 5 days post-vaccination. The patient visited their PCP on 09/23/2019 who diagnosed the patient with a significant immune response to the vaccination, not requiring follow-up. The PCP documented "dizziness" as the reason for pt. visit.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: pt had severe pain in arm and could not lift it for a day
Age: 36.0
Sex: F
Vaccine: FLUR4
Symptoms: Arthralgia, Neck pain, Pain in extremity, Rash
Clinical narrative: Day after vaccination the patient said she started to develop rash on her arms and legs, small and red, but mostly beneath the skin.  Also pretty bad joint pain in her shoulders, knees, feet, hands and neck.  At this point, the neck pain has decreased greatly and the other pains are easing up as of today. The patient has not seen at dr yet.  I was just notified of the symptoms today.  I informed her today that if the symptoms do not continue to improve or if they get worse to seek medical attention.
Age: 43.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Paraesthesia, Rash
Clinical narrative: Patient had to go to the Emergency room because she had a rash all over her arm and tingling sensation in her arm.  Patient had to follow up with 3 doctors and had to take medication.  Tingling lasted many days and still was present in hand after a couple weeks.  Rash has gone down but still present at last interaction with patient.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Decreased appetite, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Red, swollen, warm to the touch around the injection site the morning after receiving the vaccination. Patient mentioned experiencing some nausea and loss of appetite also. Patient was seen by a doctor and received a steroid dose pack.
Age: 0.33
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Skin warm, Swelling
Clinical narrative: Mother described the adverse events as redness, swelling, hot to the touch about 1" above the administration site. Next day on September 19, 2019 she took the baby to the ER for the symptoms and was diagnosed with "Cellulitis". Prescribed antibiotics treatment and benadryl on September 19, 2019 medication she had not picked up yet.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Vertigo, Vomiting
Clinical narrative: Had mild vertigo that started around 09/19/19. But on Saturday 09/21/2019 the vertigo was so bad, I could not get out of bed and I was vomiting all day. I stayed in bed the whole Saturday until Sunday morning. Feeling better, no vomiting, but up until today I still have  periods of Vertigo, that have not stopped. My daughter got the same Flu shot, she had some dizziness too, but she caught the Flu symptoms and she was sick for mre than a week.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Aphasia, Chills, Diaphragmalgia, Diarrhoea, Hypoaesthesia
Clinical narrative: per pt's fiance/boyfriend pt started to have severe pain in diaphragm, numbness in legs and arms, couldn't speak because she was in so much pain. Her and her fiance thought she was having a heart attack. He checked her blood pressure several times before the ambulance got there. He did not tell me what her blood pressure was. Pt went in ambulance to hospital. Pt then had chills from fever, throwing up and diarrhea (at the same time per pt fiance). Per pt fiance the hospital wanted to airlift her to a larger hospital but she stabilized.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: per pt's fiance/boyfriend pt started to have severe pain in diaphragm, numbness in legs and arms, couldn't speak because she was in so much pain. Her and her fiance thought she was having a heart attack. He checked her blood pressure several times before the ambulance got there. He did not tell me what her blood pressure was. Pt went in ambulance to hospital. Pt then had chills from fever, throwing up and diarrhea (at the same time per pt fiance). Per pt fiance the hospital wanted to airlift her to a larger hospital but she stabilized.
Age: 69.0
Sex: M
Vaccine: FLUA3
Symptoms: Feeling abnormal, Pneumonia
Clinical narrative: pt is currently in hospital with double pneumonia...pt wife stated that she thinks it is related to the flu shot. Pt was feeling poorly right after the flu shot was given
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Hypoaesthesia, Middle insomnia, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: "Got flu shot on Wed 9-18-19. On Thursday 9-19-arm sore and woke me up from sleep that night. On Friday 9-20 started numbness (SIC) inside index and middle finger up to hand and arm pain some neck and shoulder and wrist pain, neck stiffness and shoulder, thumb pain.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Pain in extremity
Clinical narrative: "Got flu shot on Wed 9-18-19. On Thursday 9-19-arm sore and woke me up from sleep that night. On Friday 9-20 started numbness (SIC) inside index and middle finger up to hand and arm pain some neck and shoulder and wrist pain, neck stiffness and shoulder, thumb pain.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Confusional state, Erythema, Hyperhidrosis, Lip swelling, Rash macular
Clinical narrative: This gentleman returned to the pharmacy 1 hour after administration of the vaccine.  His lips were very swollen and he said he felt terrible.  His face was also getting red and blotchy.  He also told us that he was having trouble seeing.  We asked him to sit down so we could call 911 but he insisted on returning to his car to be with his wife.  He was sweaty and confused.  911 arrived and took over the situation.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: This gentleman returned to the pharmacy 1 hour after administration of the vaccine.  His lips were very swollen and he said he felt terrible.  His face was also getting red and blotchy.  He also told us that he was having trouble seeing.  We asked him to sit down so we could call 911 but he insisted on returning to his car to be with his wife.  He was sweaty and confused.  911 arrived and took over the situation.
Age: 81.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site and limited range of motion in left arm (nothing above horizontal). As of 9-26-2019, patient states redness and swelling has subsided and full range of motion is back, but with soreness in elbow of left arm.
Age: 64.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, Malaise, Myalgia
Clinical narrative: PATIENT RECEIVED 2 DOSES OF ADACEL WITHIN 3 MONTHS.  PATIENT WAS NOTIFIED ON 9/24/19 ABOUT ADDITIONAL DOSE.  UPON SPEAKING TO HIM, HE COMPLAINED OF NO ADVERSE EVENTS.  HOWEVER, HE PHONED ON 9/25/19 TO LET ME KNOW HE WAS NOT FEELING WELL THAT MORNING AND HAD GONE TO HOSPITAL TO RECEIVE CARE.  HE STATED HE HAD MUSCLE PAIN.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: red, swollen arm
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Erythema, Fatigue, Myalgia, Pain
Clinical narrative: Swollen, red, soreness, feel exhausted, muscles ached, pinprick pain, unable to lift arm without pain, sleep disturbances, and feel tightness in the chest (may be from rain and asthma though). Not yet recovered, but it's been <2 days since vaccinated.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder, Swelling
Clinical narrative: Swollen, red, soreness, feel exhausted, muscles ached, pinprick pain, unable to lift arm without pain, sleep disturbances, and feel tightness in the chest (may be from rain and asthma though). Not yet recovered, but it's been <2 days since vaccinated.
Age: 14.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; received improperly stored VARIVAX; This spontaneous report was received from a medical assistant and refers to a 14-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 13-AUG-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R023513, expiration date 16-AUG-2020, strength, route of administration and dose were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot 3 S00130, expiration date 23-AUG-2021). No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14 Celsius degrees (C) to -10 C (also reported as -13.2 C) for 46 minutes. The digital data logger was involved in recording the temperature excursion details. There were no previous excursions reported.    This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA007512: US-009507513-1909USA007177: US-009507513-1909USA007312: US-009507513-1909USA006939: US-009507513-1909USA007312: