chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received SHINGRIX for prophylaxis. On 30th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st May 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left arm. The next day after receiving the 1st injection, she experienced soreness in her left arm that lasted for approximately 2 to 3 days. This case has been linked to the US2018180185, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Vaccine positive rechallenge
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of feeling unwell in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of malaise (1st dose, refer US2018183676). On an unknown date, the patient received the 2nd dose of SHINGRIX. On 2nd October 2018, less than a year after receiving SHINGRIX, the patient experienced feeling unwell. Rechallenge with SHINGRIX was positive. 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 age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter stated that, another pharmacist told her that, the patient experienced not feeling good after SHINGRIX and even worse after the second dose. Caller did not had additional details about this report, as she mentioned she heard from another pharmacist. This case has been linked to the case US2018183672, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Phantom pain, Vaccine positive rechallenge
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of phantom pain in a male patient who received SHINGRIX for prophylaxis. The patient's past medical history included amputee. Previously administered products included SHINGRIX with an associated reaction of phantom pain (1st dose received on an unknown date, for tolerance refer case US2018181723). Concurrent medical conditions included phantom pain. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced phantom pain and condition aggravated. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the phantom pain and condition aggravated were unknown. It was unknown if the reporter considered the phantom pain and condition aggravated to be related to SHINGRIX. Additional details were provided as follows: This case was reported via text message to the Regulatory Authority. The age at vaccination was not reported. The physician had an amputee patient with a pre-existent condition of phantom pain. The phantom pain became severe on the day of the vaccination. The pain was so severe that he had to be put on medication (not specified). No additional details were provided.
Sex: F
Vaccine: FLUX, HPV9, MEN, TDAP
Symptoms: Generalised tonic-clonic seizure, Immediate post-injection reaction
Clinical narrative: Information has been downloaded from database (US-SEQIRUS-201802757). Information has been received from a physician concerning to a female patient (child). Concurrent conditions included asthma. Medical history was not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (lot number and expiration date not reported), intramuscularly, for papilloma viral infection. Secondary suspects included doses of meningococcal vaccine, diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and influenza virus vaccine for an unknown indication (strength, route, dosage schedule, lot number and expiration date were not reported). Immediately post-injection the patient experienced generalized tonic-clonic seizure (GTCS), an unspecified period after vaccination with influenza virus vaccine, meningococcal vaccine, diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and GARDASIL 9. It was reported that the event GTCS met level 4 of Brighton collaboration diagnostic criteria, therefore the events were considered medically significant. At the time of the report the patient had recovered from tonic clonic movements, seizure, generalized tonic-clonic seizure and immediate post-injection reaction. The relationship between the aforementioned events and suspected therapies was not reported.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Blood urine present, Henoch-Schonlein purpura, Rash, Urine analysis
Clinical narrative: Rash consistent with Henoch-Schonlein Purpura developed the next day.
Age: 31.0
Sex: F
Vaccine: HEPAB
Symptoms: Erythema, Induration, Pain, Skin warm, Swelling
Clinical narrative: Red from shoulder to elbow, hot, hard, swollen and painful for about 3 days.
Age: 13.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness, Pallor, Syncope
Clinical narrative: Immediately following vaccination patient experienced syncope. She went pale and stated she felt dizzy then lost consciousness for about 30 seconds. She was caught and kept seated by her father and myself. She was tapped on the shoulder and spoken to until she regained consciousness (about 30 seconds). She then remained seated and took deep breathes until she began to feel better. After sitting for about 5 minutes in the consultation room, where vaccination occurred. She went out and sat in the pharmacy lobby. She sat with her father for anther 15 minutes until they said she was feeling better and left.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Blood glucose, Blood test, Streptococcus test, Tonic convulsion
Clinical narrative: Tonic Seizure lasting on and off for 10-20 minutes.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient reported redness, soreness/ aches and warmth at injection site. Patient states that side effects have been improving/ lessening when reporting to pharmacy on 10/15/2018. Patient states that they have been taking Tylenol/ ibuprofen to relieve pain. Patient was instructed to watch reaction area and report to Dr if symptoms do not continue to get better or they worsen.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient complained of numbness/tingling in right arm/fingers about 5 min after the injection. She reports typically no numbness/tingling at rest and more so with movement on/off. Patient recommended to go to urgent care to today for further evaluation.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Injection site swelling, Rash, Rash erythematous
Clinical narrative: Patient has red, painful, swollen rash that started below the injection site and is moving down her arm.  Pt was prescribed keflex and prednisone.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Headache, Flu like symptoms, Sore red raised bump on arm at injection site.
Age: 91.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Decreased appetite, Gait inability, Headache, Malaise
Clinical narrative: Severe arm pain with inability to move entire arm; headache, general weakness, excruciating pain; confined to bed for 3 days; loss of appetite; unable to walk with her walker; pain level 10; after 3 days her headache is gone and she is able to get out of bed; due to the C diff history we did not want to go to the hospital but daughter took care of patient 24/7 to monitor vitals; she was very sick; So sick, daughter was prepared to call an ambulance at any moment due to possible life threatening side effects.
Age: 91.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Severe arm pain with inability to move entire arm; headache, general weakness, excruciating pain; confined to bed for 3 days; loss of appetite; unable to walk with her walker; pain level 10; after 3 days her headache is gone and she is able to get out of bed; due to the C diff history we did not want to go to the hospital but daughter took care of patient 24/7 to monitor vitals; she was very sick; So sick, daughter was prepared to call an ambulance at any moment due to possible life threatening side effects.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash onset after flu shot ON 10/5/2018. Initially on body, neck area then now on other parts of arms, legs, trunk. Rash will get worse and then better according to patient.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose, Electrocardiogram, Hemiparesis, Injection site bruising, Injection site pain
Clinical narrative: Exactly 48 hours after receiving the first of 2 injections of the new shingles vaccine, patient suffered a mini-stroke that left his right side very weak. MRI showed it was near the left lobe of the thalamus. By 9/29/18, injection site and upper arm swelled to twice it normal size lasting 4 days with a significant bruise and a lot of pain.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Laboratory test abnormal, Nuclear magnetic resonance imaging abnormal, Transient ischaemic attack
Clinical narrative: Exactly 48 hours after receiving the first of 2 injections of the new shingles vaccine, patient suffered a mini-stroke that left his right side very weak. MRI showed it was near the left lobe of the thalamus. By 9/29/18, injection site and upper arm swelled to twice it normal size lasting 4 days with a significant bruise and a lot of pain.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 38.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Chills, Erythema, Injection site rash, Pain
Clinical narrative: Received immunizations on Wednesday 10/10/18 at noontime, Thursday 10/11/18 became achy and feverish, with chills, next morning felt fine, Friday afternoon 10/12/18 started to feel achy again. As of today 10/15 hips and legs still ache. Also developed a rash on arm around immunization site. Still red today but no longer raised.
Age: 38.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Received immunizations on Wednesday 10/10/18 at noontime, Thursday 10/11/18 became achy and feverish, with chills, next morning felt fine, Friday afternoon 10/12/18 started to feel achy again. As of today 10/15 hips and legs still ache. Also developed a rash on arm around immunization site. Still red today but no longer raised.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Adverse event, Inflammation, Injection site reaction, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Patient began having adverse events about 3 hours after injection. She started having a very sore arm making it difficult to move her arm laterally. The pain also migrated up to her neck and she noticed inflammation/swelling in her left hand and fingers. A friend also noticed that she had muscle was spasms in her deltoid region of her left arm. Since that time the inflammation has gone away in her hand and fingers and she no longer has pain in her neck or muscle spasms. The muscle pain has decreased by about 50% since the initial occurrence, but it is still affecting her abilities to perform and work. For treatment she has been using Ibuprofen 400-600mg three times daily. She has notified her doctor and is waiting on a call back with some direction on what to do. She will also keep me updated.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle spasms, Myalgia, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient began having adverse events about 3 hours after injection. She started having a very sore arm making it difficult to move her arm laterally. The pain also migrated up to her neck and she noticed inflammation/swelling in her left hand and fingers. A friend also noticed that she had muscle was spasms in her deltoid region of her left arm. Since that time the inflammation has gone away in her hand and fingers and she no longer has pain in her neck or muscle spasms. The muscle pain has decreased by about 50% since the initial occurrence, but it is still affecting her abilities to perform and work. For treatment she has been using Ibuprofen 400-600mg three times daily. She has notified her doctor and is waiting on a call back with some direction on what to do. She will also keep me updated.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: Sore arm started right away. A little less now. "Zinging pain."
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site nodule, Injection site pain, Pain in extremity
Clinical narrative: Patient came into pharmacy to report injection site reaction. Surrounding the injection site the patients arm had knot under the skin with soreness of the whole arm. Recommended the patient take some benadryl and ibuprofen for the inflammation. If no resolution advised her to see her primary care physician.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives covering most of my body about 3 hours after the flu shot. I took two Benadryl when I first noticed the hives followed by two more when I went to bed. I awoke at 2am and took two more. By morning the hives were not as red, but still noticeable. I took 2 more Benadryl at breakfast and by noon, there was no sign of hives on my body.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Decreased appetite, Diarrhoea, Vomiting
Clinical narrative: Patient had severe diarrhea, loss of appetite, vomiting status post ROTARIX.
Age: 13.0
Sex: M
Vaccine: FLUC4
Symptoms: Feeling abnormal, Loss of consciousness, Syncope
Clinical narrative: Patient felt uneasy after the shot. After a few minutes once he started walking, he fainted. He was out for a few seconds. He gained conciousness after and rested for a bit with water.
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Syncope, Visual impairment
Clinical narrative: Just after injection, her vision was filled with cloudy brown stuff and then she fainted. Prior to the shot, she felt normal and not visibly nervous.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Eczema, Feeling abnormal, Injection site nodule, Injection site rash, Irritability
Clinical narrative: Had 4 month vaccines the afternoon of 10/10/18- Daughter was fussy that night and seemed to act as if she didn't feel good so did give one dose of TYLENOL (2.5ML as instructed if needed). Morning after on 10/11/18, daughter developed a rash all over chest and the back of neck and ears. Rash was small red bumps. Injection sites to both left and right thighs also developed red bumps with a knot. That day consulted with Pedi via online portal to show pictures etc. Dr. was very nice, stated looked either like heat rash or eczema and said wasn't related to vaccines..offered to have me come in if I was still worried. Got an appointment for 10/12/18, saw one of the doctor's NP's who diagnosed it as eczema and to treat with Aquaphor, Vaseline or what I may have on hand for eczema cream. I had both Aquaphor and Eucerin brand especially for eczema at home (give to me as a baby shower present). It is Monday 10/15/18, bumps are no longer 'red' but still kind of there, injection site bumps are gone... We absolutely adore our pediatric dr office. They seem to think it is not related to vaccines but it is just very much a consequence that this developed the day after vaccines.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Rash, Rash erythematous
Clinical narrative: Had 4 month vaccines the afternoon of 10/10/18- Daughter was fussy that night and seemed to act as if she didn't feel good so did give one dose of TYLENOL (2.5ML as instructed if needed). Morning after on 10/11/18, daughter developed a rash all over chest and the back of neck and ears. Rash was small red bumps. Injection sites to both left and right thighs also developed red bumps with a knot. That day consulted with Pedi via online portal to show pictures etc. Dr. was very nice, stated looked either like heat rash or eczema and said wasn't related to vaccines..offered to have me come in if I was still worried. Got an appointment for 10/12/18, saw one of the doctor's NP's who diagnosed it as eczema and to treat with Aquaphor, Vaseline or what I may have on hand for eczema cream. I had both Aquaphor and Eucerin brand especially for eczema at home (give to me as a baby shower present). It is Monday 10/15/18, bumps are no longer 'red' but still kind of there, injection site bumps are gone... We absolutely adore our pediatric dr office. They seem to think it is not related to vaccines but it is just very much a consequence that this developed the day after vaccines.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Patient had developed a rash after receiving vaccine. We gave her a 50mg dose of BENADRYL liquid. She stayed in our Immunization both for roughly 45 minutes to an hour to make sure she was feeling ok. She has an extensive allergy profile and was concerned that she might have a reaction prior to receiving the vaccine - although she has had the vaccine previously in her lifetime.
Age: 74.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Arthralgia, Fatigue, Influenza like illness, Myalgia, Pain
Clinical narrative: Whole body aches and pains in muscles w/ joint involvement began during the night (estimating 4:00 am as my sleep was disturbed)after the dose was given. Extremely painful in movements on the bed. The pain lasted throughout the day. It felt like having a full-blown case of the Flu. Able to sleep somewhat comfortably the next night (waking up w/ turning around & turning over) w/ about half the aches the following day. Felt fatigued for 4-5 days afterward.
Age: 74.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Sleep disorder
Clinical narrative: Whole body aches and pains in muscles w/ joint involvement began during the night (estimating 4:00 am as my sleep was disturbed)after the dose was given. Extremely painful in movements on the bed. The pain lasted throughout the day. It felt like having a full-blown case of the Flu. Able to sleep somewhat comfortably the next night (waking up w/ turning around & turning over) w/ about half the aches the following day. Felt fatigued for 4-5 days afterward.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Chills, Diarrhoea, Injection site rash
Clinical narrative: Fever- up to 99 lasting 24 hours after injection-treated with APAP, chills, weakness, rash and swelling at injection site lasting 5 days and unresolved at day of reporting, diarrhea and stomach pain.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Fever- up to 99 lasting 24 hours after injection-treated with APAP, chills, weakness, rash and swelling at injection site lasting 5 days and unresolved at day of reporting, diarrhea and stomach pain.
Age: 81.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient is complaining about redness and swelling at the injection site. She said its very painful, red and swollen.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received the high-dose vaccine when it was not indicated for his age range; pt's nursing facility did not report any adverse events as a result.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Erythema, Headache, Induration, Middle insomnia
Clinical narrative: As of Monday at 9:12am - large red area measuring roughly 4 inches by four inches, with a hard center of about 2 inches by 2.5 inches in size. Patient says the area seems to have gone down since Saturday evening when she first noticed the reaction around 4 pm. Saturday evening she had headache and chills that woke her from her sleep.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site warmth, Rash macular
Clinical narrative: Red blotches on arm and left side of face. Sites were sore and hot. Treatment was two shots (steroids) in dr office. This happened ten days after shot. This was the first shot.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site swelling, Injection site warmth, Insomnia, Paraesthesia
Clinical narrative: Patient reported that the night she received the flu vaccine she experienced tingling in the fingers of her right hand. Her right arm was also swollen and warm to the touch at the site of injection. She also reported that she could not sleep at all that night because of the pain to the area.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Diarrhoea, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Profuse sweating, numbness in hands, burning feeling in arms, severe diarrhea. Symptoms alleviated within 24 hours.
Age: 61.0
Sex: F
Vaccine: FLUR4
Symptoms: Abdominal pain, Blood pressure increased, Chest pain, Heart rate increased
Clinical narrative: Patient reported that she suddenly had chest pain and abdominal pain. The pain was significant enough that she had to sit down and was not able to move for about 1 hour after. Pulse and blood pressure were both elevated about 10 minutes after symptoms started - BP systolic was over 180 and pulse was over 120bpm. She reported that she had checked her blood pressure and pulse prior to the vaccine and she was "normal" at about 130s/70s. She did not have any rash or redness around the site of injection, she also did not have any difficulty breathing or any dizziness. She reported that her chest pain was on the left side and after about 20-30 minutes, her chest pain started to subside. Abdominal pain persisted but at about 1 hour after symptoms started, she wanted to go home. Patient was advised to go to the ER or urgent care of symptoms persisted.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Patient stated they had extreme redness and swelling in the arm they received both vaccines in and went to the emergency room where she was diagnosed with cellulitis and treated with antibiotics.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUZONE HIGH DOSE administered to a 45 year old. No side effects or symptoms resulted. No treatment given. Pt is fine.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Condition aggravated, Rash
Clinical narrative: Patient had a rash on her back at time of injection. Patient reports that the rash had been there for a couple weeks. After the injection, the patient perceived that the rash increased in severity and wondered if the vaccine could have caused the intensification. Pharmacist on staff told patient that because there was no reaction at the injection site that spread to the back that her concern was not likely to be true, however, if the rash continued to get worse or did not get better, then she needed to report to her physician for a checkup.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events, no side effects, no treatments given. Patient is just fine.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Erythema, Fatigue, Hyperhidrosis
Clinical narrative: Arm became extremely red, hot, swollen and painful and continued for about 8 days, diminishing slightly each day after about 5 days. I had alternating chills and sweats for about 3 days. Felt tired and lacked energy for about 3 days.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Arm became extremely red, hot, swollen and painful and continued for about 8 days, diminishing slightly each day after about 5 days. I had alternating chills and sweats for about 3 days. Felt tired and lacked energy for about 3 days.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Rash erythematous, Urticaria
Clinical narrative: Site of injection is red, sore, on abdomen, I have a few red welts.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Oedema peripheral
Clinical narrative: Patient said he underarm (armpit and surrounding area) swelled and it felt like it was filling with liquid.  Felt spongy and painfull.
Age: 54.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Borrelia test, Diarrhoea, Dysphagia, Hypoaesthesia, Laboratory test normal
Clinical narrative: I've had flu vaccines in the past with NO adverse reactions. The day after this vaccine I started having fever, diarrhea, aches all over, this lasted for 12 days. Since then I have tingling in feet, hands, arms. throat tightening, pain in neck and throat, arms. numb feet.
Age: 54.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Malaise, Neck pain, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: I've had flu vaccines in the past with NO adverse reactions. The day after this vaccine I started having fever, diarrhea, aches all over, this lasted for 12 days. Since then I have tingling in feet, hands, arms. throat tightening, pain in neck and throat, arms. numb feet.
Age: 54.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Paraesthesia, Pyrexia, Speech disorder, Throat tightness, Tremor
Clinical narrative: I've had flu vaccines in the past with NO adverse reactions. The day after this vaccine I started having fever, diarrhea, aches all over, this lasted for 12 days. Since then I have tingling in feet, hands, arms. throat tightening, pain in neck and throat, arms. numb feet.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Erythema, Injection site warmth, Pain in extremity, Peripheral swelling
Clinical narrative: Patient complained that her arm got very red and swelling. She experience pain in the arm next day after vaccination. Pharmacist observe the site of injection and notice that her arm is red and bruised all of the to the elbow. Also patient complained of hit at the site of injection.
Age: 36.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Anxiety, Exposure during pregnancy, Foetal death, Foetal hypokinesia, Kleihauer-Betke test positive
Clinical narrative: 36 y/o patient EDC 16Nov2018 was seen for routine OB appointment the day of her immunizations. At that time her only concern was anxiety. The week before she had been prescribed ZOLOFT for this but had not started taking it. She was also offered counseling. The week before her fetus was breech. At this appointment, the fetus was noted to now be in cephalic presentation, a visually adequate appearing amount of amniotic fluid was present, and movements observed. The day following immunization, Oct 6th, she presented for evaluation due to no longer feeling fetal movement. An intrauterine fetal demise was subsequently diagnosed.
Age: 36.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Prenatal screening test
Clinical narrative: 36 y/o patient EDC 16Nov2018 was seen for routine OB appointment the day of her immunizations. At that time her only concern was anxiety. The week before she had been prescribed ZOLOFT for this but had not started taking it. She was also offered counseling. The week before her fetus was breech. At this appointment, the fetus was noted to now be in cephalic presentation, a visually adequate appearing amount of amniotic fluid was present, and movements observed. The day following immunization, Oct 6th, she presented for evaluation due to no longer feeling fetal movement. An intrauterine fetal demise was subsequently diagnosed.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Headache, Injection site pain, Injection site pruritus, Pain
Clinical narrative: Itching and burning body wide, achiness, pain and itching at injection site, headache.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised
Clinical narrative: Itching and burning body wide, achiness, pain and itching at injection site, headache.
Age: 60.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Asthenia, Chills, Fatigue, Gastroenteritis viral, Nausea
Clinical narrative: Became nauseous, had chills, aches, and really tired for 24 hours (saturday). Sunday was a bit better, but still had stomach flu symptoms. Monday a bit better but feel weak.
Age: 60.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Pain
Clinical narrative: Became nauseous, had chills, aches, and really tired for 24 hours (saturday). Sunday was a bit better, but still had stomach flu symptoms. Monday a bit better but feel weak.
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Peripheral swelling, Urticaria
Clinical narrative: Patient presented to pharmacy 3 days after vaccine administration. He complained of arm swelling. He did have a large welt that was probably 3-4 inches tall and 2-3 inches wide around the site of administration. I recommended he apply ice and take some ibuprofen to reduce the swelling and told pt we would call him in 2-3 days to see how his arm is doing.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pyrexia, Rash
Clinical narrative: Patient states that a day after injection a rash appeared on the right arm. She felt feverish and monitored her temperature to be over 100 degrees. After two days the fever and rash disappered, however the arm is still sore at the sight of injection.
Age: 79.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site discolouration, Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Patient claimed the next day her arm because black and blue at site of PREVNAR-13. Six days after she claims the site became red, warm and visible red spots. I advised patient to see her primary. Her primary administered an antihistamine shot at the office.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Contusion, Full blood count normal, Henoch-Schonlein purpura, Joint swelling, Peripheral swelling
Clinical narrative: Lower body purpura, petechiae and bruising. Swelling of (L) hand and knees. Dx: HSP (Henoch-Schonlein Purpura).
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Petechiae, Purpura, Urine analysis normal
Clinical narrative: Lower body purpura, petechiae and bruising. Swelling of (L) hand and knees. Dx: HSP (Henoch-Schonlein Purpura).
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal discomfort, Blood test, Chest X-ray, Cough, Electrocardiogram
Clinical narrative: This spontaneous case, initially received from other non-health professional on 07-Oct-2018, concerning a 67-year-old, elderly, male patient. The patient's historical conditions included aortic aneurysm, transient ischaemic attack (TIA) and bicuspid valve. The historical procedures included pig valve replacement and Dacron aorta (on unspecified dates). The concomitant medications included COUMADIN, Metoprolol, lisinopril, levothyroxine sodium and AMBIEN. On 03-Oct-2018, the patient was administered AFLURIA QUADRIVALENT [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid (deltoid left arm as reported), batch number and expiry date: not reported]. On the same day at night, after vaccination, the patient felt difficult to lay on left side. On 04-Oct-2018, at noon, the patient felt discomfort in left quadrant, by 05:00 pm it much worsened and the patient took simethicone, then he felt stabbing cramp in left pectoral when breathing accompanied by the cough. The patient also experienced fatigue. At 08:30 pm, the patient went to the emergency room (ER) and electrocardiogram (EKG), blood tests and chest X-ray was performed, and then the patient was diagnosed with pleurisy. The treatment medications included IV steroids and FLEXERIL. On the next day, the patient felt much better. At the time of this report, the patient was recovering from the events pleurisy and fatigue. The reporter assessed the case as non-serious.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Muscle spasms, Pleurisy
Clinical narrative: This spontaneous case, initially received from other non-health professional on 07-Oct-2018, concerning a 67-year-old, elderly, male patient. The patient's historical conditions included aortic aneurysm, transient ischaemic attack (TIA) and bicuspid valve. The historical procedures included pig valve replacement and Dacron aorta (on unspecified dates). The concomitant medications included COUMADIN, Metoprolol, lisinopril, levothyroxine sodium and AMBIEN. On 03-Oct-2018, the patient was administered AFLURIA QUADRIVALENT [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid (deltoid left arm as reported), batch number and expiry date: not reported]. On the same day at night, after vaccination, the patient felt difficult to lay on left side. On 04-Oct-2018, at noon, the patient felt discomfort in left quadrant, by 05:00 pm it much worsened and the patient took simethicone, then he felt stabbing cramp in left pectoral when breathing accompanied by the cough. The patient also experienced fatigue. At 08:30 pm, the patient went to the emergency room (ER) and electrocardiogram (EKG), blood tests and chest X-ray was performed, and then the patient was diagnosed with pleurisy. The treatment medications included IV steroids and FLEXERIL. On the next day, the patient felt much better. At the time of this report, the patient was recovering from the events pleurisy and fatigue. The reporter assessed the case as non-serious.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Pt complained of great swelling in left shoulder after receiving the shot. The next day (24 hours later) noted the swelling had progressed down the arm to the elbow area.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Scar, Swelling
Clinical narrative: Patient came into pharmacy a week later stating that she had a swollen spot after shot and a scar is now on her arm.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Injection site rash
Clinical narrative: Sx began within one hour of injection. Patient complained of fatigue, fever, chills, vomiting, headaches, muscle aches, arm discomfort on side of injection. The following day developed a rash at and below injection site. Had some diarrhea. Six days later, less tired, rash improved.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Limb discomfort, Myalgia, Pyrexia, Vomiting
Clinical narrative: Sx began within one hour of injection. Patient complained of fatigue, fever, chills, vomiting, headaches, muscle aches, arm discomfort on side of injection. The following day developed a rash at and below injection site. Had some diarrhea. Six days later, less tired, rash improved.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Bacterial infection, Chills, Conjunctivitis, Cough
Clinical narrative: Felt totally fine before flu shot was administered. Within 24 hrs. 10/7/18 Eye-lid swelled up. Was red, irritated and had some mucus in the eye as well. Went to urgent care and was prescribed antibiotics for 7 days. Diagnosed-conjunctivitis. 10/8/18 - Had 100.4 temp. all day. Felt very weak, sore throat, chills, slight cough. Very bad headache, stuffy nose, ear ache and felt very dizzy (had a hard time standing up.) Couldn't take feeling like this all day; so went to the ER at 11:30pm. Was administered IV for dehydration (fluids) and TYLENOL for severe headache. Upon discharged at ER, received an Rx for 600mg. Ibuprofen and ZOFRAN 4mg. for nausea (said it was viral). 10/9/18 - still was not feeling any better. Went to Primary physician. Was prescribed antibiotics. Amoxicillin 875mg. for 7 days. Diagnosed - sinus infection. Took strep test - came back negative. Physician said that I had something Viral that turned into bacterial due to a very low immune system. Missed work for entire week.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Decreased immune responsiveness, Dehydration, Dizziness, Dysstasia, Ear pain
Clinical narrative: Felt totally fine before flu shot was administered. Within 24 hrs. 10/7/18 Eye-lid swelled up. Was red, irritated and had some mucus in the eye as well. Went to urgent care and was prescribed antibiotics for 7 days. Diagnosed-conjunctivitis. 10/8/18 - Had 100.4 temp. all day. Felt very weak, sore throat, chills, slight cough. Very bad headache, stuffy nose, ear ache and felt very dizzy (had a hard time standing up.) Couldn't take feeling like this all day; so went to the ER at 11:30pm. Was administered IV for dehydration (fluids) and TYLENOL for severe headache. Upon discharged at ER, received an Rx for 600mg. Ibuprofen and ZOFRAN 4mg. for nausea (said it was viral). 10/9/18 - still was not feeling any better. Went to Primary physician. Was prescribed antibiotics. Amoxicillin 875mg. for 7 days. Diagnosed - sinus infection. Took strep test - came back negative. Physician said that I had something Viral that turned into bacterial due to a very low immune system. Missed work for entire week.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema of eyelid, Eye discharge, Eyelid irritation, Headache, Loss of personal independence in daily activities
Clinical narrative: Felt totally fine before flu shot was administered. Within 24 hrs. 10/7/18 Eye-lid swelled up. Was red, irritated and had some mucus in the eye as well. Went to urgent care and was prescribed antibiotics for 7 days. Diagnosed-conjunctivitis. 10/8/18 - Had 100.4 temp. all day. Felt very weak, sore throat, chills, slight cough. Very bad headache, stuffy nose, ear ache and felt very dizzy (had a hard time standing up.) Couldn't take feeling like this all day; so went to the ER at 11:30pm. Was administered IV for dehydration (fluids) and TYLENOL for severe headache. Upon discharged at ER, received an Rx for 600mg. Ibuprofen and ZOFRAN 4mg. for nausea (said it was viral). 10/9/18 - still was not feeling any better. Went to Primary physician. Was prescribed antibiotics. Amoxicillin 875mg. for 7 days. Diagnosed - sinus infection. Took strep test - came back negative. Physician said that I had something Viral that turned into bacterial due to a very low immune system. Missed work for entire week.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Nasal congestion, Nausea, Ocular hyperaemia, Oropharyngeal pain, Sinusitis
Clinical narrative: Felt totally fine before flu shot was administered. Within 24 hrs. 10/7/18 Eye-lid swelled up. Was red, irritated and had some mucus in the eye as well. Went to urgent care and was prescribed antibiotics for 7 days. Diagnosed-conjunctivitis. 10/8/18 - Had 100.4 temp. all day. Felt very weak, sore throat, chills, slight cough. Very bad headache, stuffy nose, ear ache and felt very dizzy (had a hard time standing up.) Couldn't take feeling like this all day; so went to the ER at 11:30pm. Was administered IV for dehydration (fluids) and TYLENOL for severe headache. Upon discharged at ER, received an Rx for 600mg. Ibuprofen and ZOFRAN 4mg. for nausea (said it was viral). 10/9/18 - still was not feeling any better. Went to Primary physician. Was prescribed antibiotics. Amoxicillin 875mg. for 7 days. Diagnosed - sinus infection. Took strep test - came back negative. Physician said that I had something Viral that turned into bacterial due to a very low immune system. Missed work for entire week.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Streptococcus test negative, Swelling of eyelid, Urine analysis, Viral infection
Clinical narrative: Felt totally fine before flu shot was administered. Within 24 hrs. 10/7/18 Eye-lid swelled up. Was red, irritated and had some mucus in the eye as well. Went to urgent care and was prescribed antibiotics for 7 days. Diagnosed-conjunctivitis. 10/8/18 - Had 100.4 temp. all day. Felt very weak, sore throat, chills, slight cough. Very bad headache, stuffy nose, ear ache and felt very dizzy (had a hard time standing up.) Couldn't take feeling like this all day; so went to the ER at 11:30pm. Was administered IV for dehydration (fluids) and TYLENOL for severe headache. Upon discharged at ER, received an Rx for 600mg. Ibuprofen and ZOFRAN 4mg. for nausea (said it was viral). 10/9/18 - still was not feeling any better. Went to Primary physician. Was prescribed antibiotics. Amoxicillin 875mg. for 7 days. Diagnosed - sinus infection. Took strep test - came back negative. Physician said that I had something Viral that turned into bacterial due to a very low immune system. Missed work for entire week.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Frequent bowel movements, Headache, Injection site erythema, Injection site pain, Lethargy
Clinical narrative: Lethargy, increase in bowel movements, headache. Redness about a quarter size at injection site with soreness. Painful use of arm. Sx were resolving on their own.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Lethargy, increase in bowel movements, headache. Redness about a quarter size at injection site with soreness. Painful use of arm. Sx were resolving on their own.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, pain, itching, swelling at injection site over 3 days.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None.
Age: 1.67
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Culture throat negative, Pharyngeal erythema, Strawberry tongue, Streptococcus test
Clinical narrative: Vomiting began 10-11-18, headache started 10-10-18. Decreased energy. 10/11/18 exam: Strawberry tongue, erythematous posterior pharynx. Throat culture: negative for Strep. Ibuprofen.
Age: 1.67
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Vomiting began 10-11-18, headache started 10-10-18. Decreased energy. 10/11/18 exam: Strawberry tongue, erythematous posterior pharynx. Throat culture: negative for Strep. Ibuprofen.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Petechiae
Clinical narrative: Petechial rash. Self limited, took 2 weeks to clear. Happened after dose 1 in August, was gone faster.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Blood creatine phosphokinase normal, Full blood count normal, Grip strength decreased, Injected limb mobility decreased, Loss of personal independence in daily activities
Clinical narrative: Right arm pain x 10 days, unable to lift arm overhead. Trouble moving his arm when swimming. Unable to put his shirt on. Slight decrease in strength of right had squeeze vs. left. X-ray done, normal, labs drawn - normal. Referral to Neurology. Treat w/rest, ice, ibuprofen Q 6 hours.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Metabolic function test normal, Pain in extremity, X-ray limb normal
Clinical narrative: Right arm pain x 10 days, unable to lift arm overhead. Trouble moving his arm when swimming. Unable to put his shirt on. Slight decrease in strength of right had squeeze vs. left. X-ray done, normal, labs drawn - normal. Referral to Neurology. Treat w/rest, ice, ibuprofen Q 6 hours.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt. given high-dose vaccine inadvertently.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Swelling
Clinical narrative: Swelling the same day of administered the vaccines - pain regions. Doctor visit and antibiotics.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Full blood count, Metabolic function test, Swelling, Swelling face
Clinical narrative: Patient came to office with swelling on (R) side of neck/jaw. No complaint of pain or visual signs of trauma.
Age: 79.0
Sex: M
Vaccine: FLUA3, VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Patient presented with a hot, red rash approximately 2 inch x 4 inch over interior left bicep. Recommended ice, BENADRYL, visit M.D. to rule out cellulitis.
Age: 17.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Pain in extremity
Clinical narrative: Pain to (L) arm.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue
Clinical narrative: Next day felt fatigued, weak, no energy, drainey, tired. Lasted for 24 hrs.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Painful site where injection; shooting pain going down the arm; lasting for 1 day; very unpleasant experience - will not get 2nd dose.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Lacrimation increased, Pain, Pain of skin, Rash erythematous
Clinical narrative: Had 2nd shingles vaccine on Friday 9/28/18. That night he started developing some pain and sensitivity on the left side of his forehead. Red dots on his eyelid one on his scalp w/radiating pain on left side of head. Eyes are watering. Valacyclovir given to treat.
Age: 51.0
Sex: F
Vaccine: MENB, MNQ, PPV, VARZOS
Symptoms: Injection site erythema, Pain, Pyrexia
Clinical narrative: Fever 101 degrees. Pink erythema in (R) upper arm. Pain.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Fear, Feeling abnormal, Pain
Clinical narrative: Onset 1/2 - 1 hr - mouth felt funny, weak, achy. 6 hrs - heart racing, body aching, scared, started to pray. Next day - Body aching, skin hurt, worn out. Symptoms resolved - 24 hours
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pain of skin, Palpitations
Clinical narrative: Onset 1/2 - 1 hr - mouth felt funny, weak, achy. 6 hrs - heart racing, body aching, scared, started to pray. Next day - Body aching, skin hurt, worn out. Symptoms resolved - 24 hours
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: Patient states 9/19/18 that since vaccinated on 9/17/2018 very severe site reaction including redness, hotness, purple/black/blue bruising the size of a hand stated looked worse than felt. No allergy symptoms.
Age: 35.0
Sex: M
Vaccine: FLUC4
Symptoms: Lymphadenopathy
Clinical narrative: Noticed Lt axillary lymph node swollen the next day after injection.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site 8 cm x 6 cm. Vaccine appears to be given about 8 cm up from pt's elbow in possibly subcutaneous.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site erythema, Joint swelling, Swelling face
Clinical narrative: Big red upper arm - site area. Swelling of right side of pt face and lower wrist area. Bruising around wrist.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising
Clinical narrative: Pt had bruising in arm at injection site. Reported no pain, just a severe bruise.
Age: 12.0
Sex: M
Vaccine: FLUN4
Symptoms: Lymphadenopathy, Parotid gland enlargement
Clinical narrative: 12 year old who developed parotid gland swelling and enlarged cervical lymph nodes within hours of FLUMIST. Improving 24 hours later.
Age: 1.33
Sex: F
Vaccine: DTAP, FLU4, HEPA, VARCEL
Symptoms: Rash generalised
Clinical narrative: Rash all over body except face.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives presented about 11 hrs after injection. Neck, back, behind ears, scalp, a few on face. Used hydrocortisone cream for relief but has resurged 10/15/18 am.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4
Symptoms: Injection site erythema, Injection site vesicles, Local reaction
Clinical narrative: Significant localized injection site reaction of left arm with approx. 5 x 8 mm of erythema and multiple vesicular blisters on 10/15/18 at 11:50 AM.
Age: 80.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site bruising
Clinical narrative: Patient has large bruise at and surrounding injection site. Patient states no pain or heat and doesn't affect his range of motion.