chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance the intended purpose of the long term prevention of shingles and zoster related injuries (dose, route, and lot number not provided). The vaccine did not prevent shingles or zoster related injuries as intended. On or about 19-OCT-2016, the patient was treated for herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster related injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 07-FEB-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a supermarket, for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. Upon information and belief, on or about 07-FEB-2015, a physician recommended, prescribed, and/or administered the ZOSTAVAX for its intended purpose of long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles or zoster-related injuries as intended. On or about 28-OCT-2016, the patient was treated by a physician for zoster-related rash. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster-related injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin lesion
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 15-MAR-2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for its intended purpose; to prevent shingles. As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of his body. The patient did not have a shingles outbreak until 25-JAN-2017. As a direct result of the vaccine, the patient, suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager referring to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 21-SEP-2018, the patient was vaccinated with an expired dose of VAQTA lot number N020503 and expiration date of 04-SEP-2018 intramuscularly for prophylaxis (dose and anatomical location date were not reported). No adverse effects were reported.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a 1 year old female patient. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On 21-SEP-2018, the patient was accidentally vaccinated with PROQUAD (rHa) lot number: N015624, expiration date: 15-NOV-2018, 0.5 ml once, subcutaneously, for prophylaxis, that was improperly stored in the range -9°C to 8°C for 24 hours (strength was not provided). PROQUAD was administered along with VARIVAX for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported). The VARIVAX did not have a temperature excursion. There was not digital data logger involved. The reporter informed that PROQUAD was given in error instead of the M-M-R II, which was what the child was supposed to receive. The nurse confirmed it was not product confusion but human error. It was unknown if STERILE DILUENT (unknown lot number and expiration date) used for reconstitution of PROQUAD and VARIVAX was properly stored. No adverse effects were reported.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from the patient's mother concerning a 12 month old female patient. The patient's historical conditions, concurrent conditions, concomitant therapies and historical drugs were not reported. With an allergy to egg products. On 21-SEP-2018, the patient was vaccinated with M-M-R II (laterality, strength, dose, route, frequency, lot number and expiration date were not reported) for vaccination against measles, mumps, and rubella. On the same date, the patient's mother reported that the patient had a "reaction" (unspecified) to M-M-R II. Also that she was on the way to get her daughter to a doctor or a hospital (unspecified). The outcome of adverse reaction was reported as not recovered. The causality assessment between M-M-R II and the aforementioned event was not provided.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Confusional state, Headache, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 60-year-old female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than 5 months after receiving SHINGRIX, the patient experienced fever, headache, injection site warmth, injection site erythema, injection site swelling, chills and confusion. On an unknown date, the outcome of the fever, headache, injection site warmth, injection site erythema, injection site swelling, chills and confusion were recovered/resolved. It was unknown if the reporter considered the fever, headache, injection site warmth, injection site erythema, injection site swelling, chills and confusion to be related to SHINGRIX. Additional information was received as follows: The patient had confusion (she did not know who she was) and the injection site area was hot to the touch. The healthcare professional said that all the symptoms lasted 3 days and they resolved on their own.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 60-year-old female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than 5 months after receiving SHINGRIX, the patient experienced fever, headache, injection site warmth, injection site erythema, injection site swelling, chills and confusion. On an unknown date, the outcome of the fever, headache, injection site warmth, injection site erythema, injection site swelling, chills and confusion were recovered/resolved. It was unknown if the reporter considered the fever, headache, injection site warmth, injection site erythema, injection site swelling, chills and confusion to be related to SHINGRIX. Additional information was received as follows: The patient had confusion (she did not know who she was) and the injection site area was hot to the touch. The healthcare professional said that all the symptoms lasted 3 days and they resolved on their own.
Sex: U
Vaccine: MENB
Symptoms: Headache, Pyrexia
Clinical narrative: This is a spontaneous report from a Non-Contactable Physician via Pfizer Sales Representative.  A patient of unspecified age and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced high fever of 103/104 and headache on an unspecified date with outcome of unknown. Description of Event: Physician reported a patient who experience a high fever of 103/104, headache and had to call for help while in the shower in fear of passing after being given the immunization. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Pain, Pruritus, Urticaria
Clinical narrative: Initial information received on 19-Sep-2018 regarding an unsolicited valid non-serious case received from our licensed partner on 19-Sep-2018 and transmitted to Sanofi on 19-Sep-2018. This case involves a 66 years old female patient who experienced allergic reaction, raised white welts between throat and groin, pain, and itchiness, while she received vaccine ADACEL. 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 DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported. On an unknown date, the patient developed a non-serious allergic reaction, raised white welts between throat and groin, pain, and itchiness following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. No lab data reported. Final diagnosis was allergic reaction, raised white welts between throat and groin, pain, and itchiness. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for allergic reaction, raised white welts between throat and groin, pain, and itchiness.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Rash, Sneezing
Clinical narrative: Patient stated after she was given the flu shot on Saturday she suffered from insomnia and sneezing. Sunday morning she had a rash on her chest. She reported the incident on Tuesday and stated it was going away.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Stiffness, redness and sore feeling started 9/19/18 in evening (pt received vaccine in a.m.). Pt woke up in A.M. 9/20/18 with redness swelling and warmth in area of immunization. Redness started at injection site and travels down pt arm to elbow.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Pain
Clinical narrative: Stiffness, redness and sore feeling started 9/19/18 in evening (pt received vaccine in a.m.). Pt woke up in A.M. 9/20/18 with redness swelling and warmth in area of immunization. Redness started at injection site and travels down pt arm to elbow.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Dysstasia, Fatigue, Loss of personal independence in daily activities
Clinical narrative: 1- MUSCULAR PAIN: DEVELOPED 1-2HR POST-INJECTION. MODERATELY SEVERE, INTERFERRED WITH DAILY ACTIVITIES. RESOLVED 24HR POST-INJECTION. 2- CHILLS: STARTED ABOUT 2HR POST-INJECTION, WITH INCREASING INTENSITY. ADDING CLOTHING LAYERS DID NOT HELP ME FEEL COMFORTABLE. RESOLVED 12H POST-INJECTION. 3- GENERAL FATIGUE: STARTED ABOUT 4HR POST-INJECTION. BY 6-7HR POST-INJECTION, STANDING UP WAS A STRUGGLE. WENT TO BED EARLY. RESOLVED BY NEXT MORNING. AFTER READING PACKAGE INSERT ON INTERNET, FOUND THAT AE'S ARE VERY COMMON. DID NOT CONSULT PCP OR ADMINISTERING PHARMACIST. I AM REPORTING THIS AE BECAUSE IT WAS VERY SEVERE. ALL VACCINE INFORMATION SHEETS LIST MANY POSSIBLE AE'S. THE SHINGRIX VIS SAID AE'S WERE COMMON BUT THE SEVERITY OF AE'S I EXPERIENCED SEEMED MORE THAN TYPICAL.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: 1- MUSCULAR PAIN: DEVELOPED 1-2HR POST-INJECTION. MODERATELY SEVERE, INTERFERRED WITH DAILY ACTIVITIES. RESOLVED 24HR POST-INJECTION. 2- CHILLS: STARTED ABOUT 2HR POST-INJECTION, WITH INCREASING INTENSITY. ADDING CLOTHING LAYERS DID NOT HELP ME FEEL COMFORTABLE. RESOLVED 12H POST-INJECTION. 3- GENERAL FATIGUE: STARTED ABOUT 4HR POST-INJECTION. BY 6-7HR POST-INJECTION, STANDING UP WAS A STRUGGLE. WENT TO BED EARLY. RESOLVED BY NEXT MORNING. AFTER READING PACKAGE INSERT ON INTERNET, FOUND THAT AE'S ARE VERY COMMON. DID NOT CONSULT PCP OR ADMINISTERING PHARMACIST. I AM REPORTING THIS AE BECAUSE IT WAS VERY SEVERE. ALL VACCINE INFORMATION SHEETS LIST MANY POSSIBLE AE'S. THE SHINGRIX VIS SAID AE'S WERE COMMON BUT THE SEVERITY OF AE'S I EXPERIENCED SEEMED MORE THAN TYPICAL.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Alopecia
Clinical narrative: My daughter had her second hepB shot May 8,2018 and first Varicella shot May 21,2018. She started to notice hairloss the following week and found her first bald patch June 1, 2018. She was diagnosed with Alopecia at the dermatologist June 5, 2018. She had about 80% hair loss within a month and ended up shaving all her hair off.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concomitant medications or drug reactions/allergies. On an unknown date, the patient was inadvertently vaccinated with an improperly stored dose of VARIVAX lot number R008394 and expiration date on 20-MAR-2020, for prophylaxis (dose, route, and anatomical location were not provided). The lot of VARIVAX was reconstituted with properly stored sterile diluent (DILUENT MRK) (lot number and expiration date were not reported). The administered dose of the vaccine experienced a temperature of -1.9 degrees Celsius (°C) during a time frame of 2 hours and 30 minutes as recorded by a data logger. There was no adverse effect reported. No product quality complaint was involved.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Kawasaki's disease, Meningitis aseptic, Pyrexia
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 4 month old male patient. The patient had not pertinent medical history, drug reactions/allergies or concurrent conditions. The patient's concomitant medications were not reported. On 01-NOV-2016, the  patient was vaccinated with a dose of ROTATEQ lot # M006111 with expiration date 18-NOV-2017, per oral, for prophylaxis. On 23-JAN-2017, the  patient was vaccinated with another dose of ROTATEQ lot # M031807 with expiration date 02-APR-2018, per oral, for prophylaxis. On 13-MAR-2017, the patient was vaccinated with the last dose of ROTATEQ lot # M031807 with expiration date 02-APR-2018, per oral, for prophylaxis. On 27-MAR-2017, the patient developed fever, but the exact patient's body temperature was unknown. On an unspecified date after this, the patient was admitted to a hospital and was diagnosed with Kawasaki disease with aseptic meningitis. It was unknown if any treatment was given to the patient or if any laboratory diagnostic test was performed. On another unspecified date, the patient recovered from the events and was discharged from hospital. At the time of reporting, the causality assessment between the events and ROTATEQ was not provided. The reporter considered Kawasaki disease and aseptic meningitis to be life threatening events. Upon internal review, Kawasaki disease and aseptic meningitis were determined to be medically significant events.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received on 21-SEP-2018 from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In approximately 2015, the patient was inoculated with ZOSTAVAX for routine adult health maintenance and the intended purpose for the long-term prevention of shingles and zoster-related injuries (dose, route, and lot # not provided). The vaccine did not prevent shingles or zoster-related injuries as intended. Later in 2015, the patient was treated at an urgent care for herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles and zoster-related injuries, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Abdominal discomfort, Erythema, Heart rate increased, Myalgia, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received PREVNAR 13, via an unspecified route of administration in left arm on 18Sep2018 at single dose for immunization. Medical history was none. There were no concomitant medications. Tuesday on 18Sep2018, the patient received a dose in left arm and her left arm had been swollen, red, and hot to the touch ever since and the pain was deep in the muscle that hurts and bothers her when she was trying to sleep. Her heart rate was higher than usual, and her tummy was a bit off. She stated that when she went to pick up her kids from teen group someone noticed and said, wow do you have a bee sting your arm was red and swollen. She stated the warmth of her arm can still be felt through her shirt. The patient stated that her heart rate was higher than usual: Heart rate usually hovers around 61 maybe 62 and was pretty consistent. On Tuesday (18Sep2018) it went to 64, Wednesday (19Sep2018) it was 65, Thursday (20Sep2018) it was 66 and today still says 66 (21Sep2018), which was really odd. Stated that her heart rate might drop a little sometimes and it does go up when she was in the mountains but had not been to the mountains lately. No treatment was received for the events. The outcome of the event abdominal discomfort was unknown while the outcome of the other events was recovering.
Sex: F
Vaccine: PNC13
Symptoms: Skin warm, Sleep disorder
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received PREVNAR 13, via an unspecified route of administration in left arm on 18Sep2018 at single dose for immunization. Medical history was none. There were no concomitant medications. Tuesday on 18Sep2018, the patient received a dose in left arm and her left arm had been swollen, red, and hot to the touch ever since and the pain was deep in the muscle that hurts and bothers her when she was trying to sleep. Her heart rate was higher than usual, and her tummy was a bit off. She stated that when she went to pick up her kids from teen group someone noticed and said, wow do you have a bee sting your arm was red and swollen. She stated the warmth of her arm can still be felt through her shirt. The patient stated that her heart rate was higher than usual: Heart rate usually hovers around 61 maybe 62 and was pretty consistent. On Tuesday (18Sep2018) it went to 64, Wednesday (19Sep2018) it was 65, Thursday (20Sep2018) it was 66 and today still says 66 (21Sep2018), which was really odd. Stated that her heart rate might drop a little sometimes and it does go up when she was in the mountains but had not been to the mountains lately. No treatment was received for the events. The outcome of the event abdominal discomfort was unknown while the outcome of the other events was recovering.
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Pain, Swelling
Clinical narrative: This is a spontaneous report from a contactable nurse through a Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13 (Lot number and expiration date were not reported) at the rheumatologist's office, with route of administration unspecified on 06Sep2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. In Sep2018, the patient had pain; swelling to the size of a grapefruit; and redness. The patient was prescribed with steroids as treatment for the events. The outcome of the events, pain, swelling to the size of a grapefruit and redness, was unknown.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Crepitations, Dyspnoea, Dyspnoea exertional, Fatigue, Heart rate irregular
Clinical narrative: Patient described crackle noises heard from lungs audible with out stethoscope starting at bedtime 9/22/18. Patient also listened to heart with stethoscope and heard an irregular beat, more than what she normally has. Patient described that symptoms disappeared when she woke up in the morning, only describing tiredness and breathlessness on exertion more than usual. Bedtime 9/23/2018 symptoms returned but in a less intense fashion. 9/24/2018 at bedtime symptoms were gone except for the continued tiredness and breathlessness upon exertion. 9/25/2018 patient will follow up with MD in afternoon time.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Cough, Decreased appetite, Dyspnoea, Pyrexia
Clinical narrative: Had the Vaccine on Thursday afternoon. Had a fever of 100.5 Friday morning. Fevers lasted until Sunday Night. Stayed around 99.5 to 100.5. Developed a dry cough on Saturday that is tapering today (Tuesday). Poor appetite thru the weekend. Shortness of breath thru the weekend. Lower back pain.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Vaccine expired 9-2-18. Merck was notified and they stated that vaccine was still valid even though expired.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Hyperaesthesia, Influenza like illness
Clinical narrative: Flu like, achy, tired, sensitive all over.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Confusional state, Dizziness, Dry mouth, Generalised erythema
Clinical narrative: High fever, redness all over body, very red, swollen, lumpy right upper arm, dizziness, low blood pressure (104/65) aching joints and muscles, extreme thirst, dry mouth, confusion, nightmares.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypotension, Injection site erythema, Injection site mass, Injection site swelling, Myalgia
Clinical narrative: High fever, redness all over body, very red, swollen, lumpy right upper arm, dizziness, low blood pressure (104/65) aching joints and muscles, extreme thirst, dry mouth, confusion, nightmares.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nightmare, Pyrexia, Thirst
Clinical narrative: High fever, redness all over body, very red, swollen, lumpy right upper arm, dizziness, low blood pressure (104/65) aching joints and muscles, extreme thirst, dry mouth, confusion, nightmares.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Oropharyngeal pain, Pyrexia, Rash, Rash morbilliform
Clinical narrative: Patient claims she became ill and broke out into a rash from the high dose flu vaccine she received. It happened within a week of receiving the vaccine. She narrowed it down to 5 days after receiving the shot. Fever of 103.5 lasted 2 days with a sore throat. Patient still had a significant rash on arms, legs and torso. Measle like rash occurred.  She did not go to see a physician.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral swelling, Product administered at inappropriate site
Clinical narrative: Pt complained of extremely sore arm with swelling and pain and believes that the shot was administered too high on the arm. Symptoms were improving but was still extremely sore as of 9/24/2018. Pt was counseled to seek medical attention if improvement did not continue.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient called and said the night after the shot was given she fainted for about 5 minutes. She is feeling better today (day of phone call next day) and I told her to stay hydrated and sit as much as possible. If she has another syncope episode to call me and/or go get herself checked out by MD. I told her she can come in and I can take a look at the shot or console her in any way possible. She said she will monitor.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: PATIENT REPORTED FEELINGS OF EXTREME WEAKNESS, STOMACH PAIN, SEVERE MUSCLE PAIN, A SORE ARM WITH RASH, AND REDNESS AND SWELLING AT INJECTION SITE LAST GREATER THAN 4 DAYS.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: PATIENT REPORTED FEELINGS OF EXTREME WEAKNESS, STOMACH PAIN, SEVERE MUSCLE PAIN, A SORE ARM WITH RASH, AND REDNESS AND SWELLING AT INJECTION SITE LAST GREATER THAN 4 DAYS.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Crying, Depressed mood, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Flu shot. Noticeable pain at the site when given (have had numerous previous flu shots without this pain). Mood depression in the night. 3 days of crying for no apparent cause. 3 days of weakness and difficulty in performing usual activities. An odd weakness at the gym.
Age: 81.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Erythema, Gait disturbance, Muscular weakness, Pain in extremity
Clinical narrative: Swelling of Lf. arm - red - soreness. Heat. Extreme weakness in extremities - wobbly - shaking severely - needed assistance. Teeth chattering - hives. Extreme - shaking - weakness in extremities. Teeth chattering - making speaking difficult. Soreness - redness of arm. Hives on back and chest. Needed wife's assistance to get to bed. Had every blanket in household to control shaking. Am an active healthy orthodontist who was not suffering from any cold, illness, sniffle etc. for at least a month, in fact longer.
Age: 81.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Peripheral swelling, Skin warm, Tremor, Urticaria, Walking aid user
Clinical narrative: Swelling of Lf. arm - red - soreness. Heat. Extreme weakness in extremities - wobbly - shaking severely - needed assistance. Teeth chattering - hives. Extreme - shaking - weakness in extremities. Teeth chattering - making speaking difficult. Soreness - redness of arm. Hives on back and chest. Needed wife's assistance to get to bed. Had every blanket in household to control shaking. Am an active healthy orthodontist who was not suffering from any cold, illness, sniffle etc. for at least a month, in fact longer.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Eye movement disorder, Fall, Seizure like phenomena, Tremor
Clinical narrative: Had injection administered, pt walked from exam table to chair, gave sibling her injection went to sit and start paperwork. Pt head went down, slumped in chair, eyes rolled back and arms started shaking with seizure like activity. Help was summoned, pt was addressed by pediatrician. Seizure lasted about 30-35 seconds. Patient recovered with no lingering symptoms, physician discharged home with directions to call if symptoms returned.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Anaemia, Barium double contrast, Diarrhoea, Diarrhoea haemorrhagic, Emotional distress
Clinical narrative: On August 24th child started vomiting and diarrhea and was inconsolable. That evening started with bloody diarrhea. Transferred by ambulance to regional hospital due to intussusception - unable to reverse through air barium enema x 3. Had surgery to repair intussusception on August 25th.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Intestinal operation, Intussusception, Vomiting
Clinical narrative: On August 24th child started vomiting and diarrhea and was inconsolable. That evening started with bloody diarrhea. Transferred by ambulance to regional hospital due to intussusception - unable to reverse through air barium enema x 3. Had surgery to repair intussusception on August 25th.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Dysgeusia, Fatigue, Hypersensitivity, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: After leaving the store, first sign of adverse reaction was a weakness in lower left leg/foot. Did not feel like it would support me; followed by numb feeling on left side in face, tongue, teeth and left arm, with metallic taste in mouth. Did not experience slurring or drooping musculature, so sat and waited a bit with my husband to see if it would pass. After about 10 minutes, normalcy returned, but I felt very tired and went home and slept 5 hours. I believe this was an allergic reaction. I have always obtained an annual flu shot with no adverse reaction. Therefore, I am wondering what precautions, if any to take next year and in future.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness
Clinical narrative: After leaving the store, first sign of adverse reaction was a weakness in lower left leg/foot. Did not feel like it would support me; followed by numb feeling on left side in face, tongue, teeth and left arm, with metallic taste in mouth. Did not experience slurring or drooping musculature, so sat and waited a bit with my husband to see if it would pass. After about 10 minutes, normalcy returned, but I felt very tired and went home and slept 5 hours. I believe this was an allergic reaction. I have always obtained an annual flu shot with no adverse reaction. Therefore, I am wondering what precautions, if any to take next year and in future.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got the shot on a Wednesday and got shingles the next day!
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Blister, Herpes zoster, Pain, Pain in extremity
Clinical narrative: Got the shot on a Wednesday and got shingles the next day!
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Got the shot on a Wednesday and got shingles the next day!
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chills, Decreased appetite, Formication, Headache
Clinical narrative: Patient thought she was receiving the Flu vaccine instead; did not get any paperwork related to vaccination. Next day, in the morning at 8am, at site of vaccination right arm was red, warm, and swollenlike size of softball. By noon, patient felt weak, had headache and chills; patient got into bed 12-5pm and took some Ibuprofen. At night, patient felt weaker, head was hurting, used hot compresses and had no appetite. On Saturday, 9/1, felt too weak, had pounding headache so went to ER. Patient realized that day that she received the Pneumonia vaccine when checking doctor online records. Patient admitted 9/1-9/5; patient received saline and antibiotics while in the hospital and released with Keflex (antibiotics) and hydrocodone for pain. Patient reports that in the hospital white blood count was over 21,000. Patient reports changing primary care provider since then. Patient went to new PCP on 9/17. Patient is documenting progress on arm since then. At this point, patient is done with antibiotics; at the site of injection, swelling has reduced but dark redness is there still--looks like that vaccine from the 60s. Patient still reports pain; pain has reduced but patient continues to manage it with medications--hydrocodone. Pain described as prickly/crawling feeling on the inside of the arm that comes every 2 to 3 days. Patient report receiving the Flu vaccine on December 2017 with no problems. Next appointment with PCP scheduled for December 17th.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pain, Paraesthesia, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient thought she was receiving the Flu vaccine instead; did not get any paperwork related to vaccination. Next day, in the morning at 8am, at site of vaccination right arm was red, warm, and swollenlike size of softball. By noon, patient felt weak, had headache and chills; patient got into bed 12-5pm and took some Ibuprofen. At night, patient felt weaker, head was hurting, used hot compresses and had no appetite. On Saturday, 9/1, felt too weak, had pounding headache so went to ER. Patient realized that day that she received the Pneumonia vaccine when checking doctor online records. Patient admitted 9/1-9/5; patient received saline and antibiotics while in the hospital and released with Keflex (antibiotics) and hydrocodone for pain. Patient reports that in the hospital white blood count was over 21,000. Patient reports changing primary care provider since then. Patient went to new PCP on 9/17. Patient is documenting progress on arm since then. At this point, patient is done with antibiotics; at the site of injection, swelling has reduced but dark redness is there still--looks like that vaccine from the 60s. Patient still reports pain; pain has reduced but patient continues to manage it with medications--hydrocodone. Pain described as prickly/crawling feeling on the inside of the arm that comes every 2 to 3 days. Patient report receiving the Flu vaccine on December 2017 with no problems. Next appointment with PCP scheduled for December 17th.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: White blood cell count increased, Wrong product administered
Clinical narrative: Patient thought she was receiving the Flu vaccine instead; did not get any paperwork related to vaccination. Next day, in the morning at 8am, at site of vaccination right arm was red, warm, and swollenlike size of softball. By noon, patient felt weak, had headache and chills; patient got into bed 12-5pm and took some Ibuprofen. At night, patient felt weaker, head was hurting, used hot compresses and had no appetite. On Saturday, 9/1, felt too weak, had pounding headache so went to ER. Patient realized that day that she received the Pneumonia vaccine when checking doctor online records. Patient admitted 9/1-9/5; patient received saline and antibiotics while in the hospital and released with Keflex (antibiotics) and hydrocodone for pain. Patient reports that in the hospital white blood count was over 21,000. Patient reports changing primary care provider since then. Patient went to new PCP on 9/17. Patient is documenting progress on arm since then. At this point, patient is done with antibiotics; at the site of injection, swelling has reduced but dark redness is there still--looks like that vaccine from the 60s. Patient still reports pain; pain has reduced but patient continues to manage it with medications--hydrocodone. Pain described as prickly/crawling feeling on the inside of the arm that comes every 2 to 3 days. Patient report receiving the Flu vaccine on December 2017 with no problems. Next appointment with PCP scheduled for December 17th.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Vertigo positional
Clinical narrative: Patient has to see an Ear, Nose, and Throat specialist because as of 3 days after the vaccine, they experience extreme vertigo when they stand up. Had a falling episode in their bathtub.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site joint pain, Injection site pain, Injection site swelling, Musculoskeletal discomfort
Clinical narrative: My arm became very sore and swollen at the injection site and the following day the rt. side of my neck felt like I had slept wrong Like I had a (crick) this  progressed down across my chest to the left side even though the rt. side became somewhat less painful. To this day a week later I now have crick in the left side of my neck and into my shoulder. The right side is better now. I did not go to Dr. just felt it would resolve soon.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Injection site pain
Clinical narrative: Extreme pain a few inches lower from injection site; dizziness.
Sex: U
Vaccine: HPVX, MENB, TDAP
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse via a sales representative. A patient of unspecified age and gender received TRUMENBA (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history was not reported. Concomitant medication included HPV vaccine (HPV) and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP). The patient experienced fatigue for 3 days, hard pain on arm, body and head although iced administration at the site of the shot and fever. Therapeutic measures were given on hard pain on arm, body and head. The outcome of the events was unknown. Information on the batch number has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: This spontaneous report has been received from a 70 years old female patient referring to herself. The patient's current conditions included high blood pressure (hypertension), arthritis, osteopenia and insomnia. The patient's historical medications included tramadol, hydrocodone and acetaminophen (+) oxycodone hydrochloride (PERCOCET) and with which the patient developed drug allergies. The patient's historical condition included drug allergies. Concomitant therapies included irbesartan and celecoxib (CELEBREX). On 25-JUN-2018, the patient started therapy with suvorexant (BELSOMRA) (lot # 1544472, expiration date was 30-APR-2020; dose, frequency and strength were unknown) orally for insomnia. On 03-JUL-2018, the patient received Zoster Vaccine Live (reported as shingles vaccine) (unknown manufacturer) (dose, route, anatomical location, lot # and expiration date not reported) as prophylaxis and patient experienced redness on her arm on an unknown date in 2018. On 03-JUL-2018, the patient experienced intense itching. The patient was hospitalized on an unknown date (reported as visited ''Med Express''). The patient had spoken with the doctor. There were no lab diagnostics/studies performed. The patient also mentioned that ''other sleep medicines didn't work for her''. Therapy with suvorexant (BELSOMRA) was discontinued on an unknown date in approximately July 2018 (reported as about a month ago). The event of redness on her arm was resolved on an unknown date in 2018 and the event of intense itching was resolved on an unknown date in July 2018. Causality assessment was not provided. Product quality complaint was not involved. Follow-up information has been received from an office manager on 18-SEP-2018 refers to a non-pregnant female patient. The patient's historical medications included valdecoxib (BEXTRA), aspirin (+) hydrocodone and unspecified antihistamines and with these medications the patient developed allergies. Concomitant medications included alendronate, hydrochlorothiazide + Irbesartan, celecoxib and cetirizine hydrochloride (ZYRTEC). On 06-JUL-2018, the patient restarted therapy with suvorexant (BELSOMRA) and on 15-AUG-2018, pruritus reappeared. On 09-AUG-2018, the patient reported about this adverse event (discrepant date reported). Medical/surgical intervention was not required. Therapy with suvorexant (BELSOMRA) was discontinued on an unknown date in 2018. The patient recovered from pruritus on an unknown date in 2018.
Age: 1.08
Sex: F
Vaccine: MMRV
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report was received from a physician and refers to a 13-month-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 10-SEP-2018, the patient was vaccinated with PROQUAD, lot# R012416 with expiration date on 28-OCT-2018 (dose, route and site of administration were not reported) for prevention of measles, mumps, rubella and varicella. On 11-SEP-2018, the patient came to the physician's office with chicken pox-like rash over the lower body. No treatment was given for the event. At the time of the report the patient was recovering from the rash. Causality assessment between the event and vaccination with PROQUAD was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in an unspecified number of adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced pain and headache. On an unknown date, the outcome of the pain and headache were unknown. It was unknown if the reporter considered the pain and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable. The age group was not reported but was captured adult as per vaccine indication. The healthcare professional (HCP) stated that a lot of patients were complaining of feeling sore and experiencing headaches the day after they received a dose SHINGRIX. No other details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer and described the occurrence of adverse reaction in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. The patient was treated with BENADRYL. 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 SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced adverse reaction to 2nd dose of SHINGRIX (all of the indications mentioned: not further specified). The patient contacted pharmacy, the day after shot, described the condition to them and they recommended BENADRYL, and all was well at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dehydration, Feeling cold, Influenza like illness, Injection site pain
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received SHINGRIX (batch number 3NY5G, expiry date unknown) for prophylaxis. Previously administered products included ZOSTAVAX (received about 5 years before the reporting date and had no symptoms) and Flu vaccine (no symptoms). On 13th September 2018, the patient received the 1st dose of SHINGRIX. On 13th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, general body pain, chills, influenza-like symptoms and sickness. On 15th September 2018, the patient experienced thirst, dehydration and fever. On an unknown date, the patient experienced mobility decreased. On an unknown date, the outcome of the injection site pain, general body pain, chills, influenza-like symptoms, mobility decreased, sickness, thirst, dehydration and fever were unknown. It was unknown if the reporter considered the injection site pain, general body pain, chills, influenza-like symptoms, mobility decreased, sickness, thirst, dehydration and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age at vaccination was not reported. The patient experienced mild body aches and pain at the injection site. Within hours, I felt much worse and developed chills and much more flu-like condition. Even though the patient was an active and also a dancer but found it difficult to move about at all and felt very sick. On the morning of day 2, the patient was still very cold with chills and felt very sick. The patient had to turn on the heat in 70 plus degree C weather and wear warm clothing. Again, the patient felt as if I had the flu and could not move about easily. The patient experienced all around body aches. By the end of Day 2, the patient became enormously thirsty and drank about a gallon of water. The patient suddenly became dehydrated and added electrolytes to the water. After that, the patient developed a fever and became overheated for the remainder of the evening. On both days, the patient felt incapacitated with illness. On Day 3, I woke up feeling much better and I am still not quite well and still feel the effects of the vaccine. The patient had no idea I could get this ill by getting the SHINGRIX vaccine. The patient was afraid of having a second dose, and a local pharmacist indicated the 2nd dose could be worse. The patient was not allergic to any drug, medication, or vaccination ever received.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Mobility decreased, Pain, Pyrexia, Thirst
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received SHINGRIX (batch number 3NY5G, expiry date unknown) for prophylaxis. Previously administered products included ZOSTAVAX (received about 5 years before the reporting date and had no symptoms) and Flu vaccine (no symptoms). On 13th September 2018, the patient received the 1st dose of SHINGRIX. On 13th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, general body pain, chills, influenza-like symptoms and sickness. On 15th September 2018, the patient experienced thirst, dehydration and fever. On an unknown date, the patient experienced mobility decreased. On an unknown date, the outcome of the injection site pain, general body pain, chills, influenza-like symptoms, mobility decreased, sickness, thirst, dehydration and fever were unknown. It was unknown if the reporter considered the injection site pain, general body pain, chills, influenza-like symptoms, mobility decreased, sickness, thirst, dehydration and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age at vaccination was not reported. The patient experienced mild body aches and pain at the injection site. Within hours, I felt much worse and developed chills and much more flu-like condition. Even though the patient was an active and also a dancer but found it difficult to move about at all and felt very sick. On the morning of day 2, the patient was still very cold with chills and felt very sick. The patient had to turn on the heat in 70 plus degree C weather and wear warm clothing. Again, the patient felt as if I had the flu and could not move about easily. The patient experienced all around body aches. By the end of Day 2, the patient became enormously thirsty and drank about a gallon of water. The patient suddenly became dehydrated and added electrolytes to the water. After that, the patient developed a fever and became overheated for the remainder of the evening. On both days, the patient felt incapacitated with illness. On Day 3, I woke up feeling much better and I am still not quite well and still feel the effects of the vaccine. The patient had no idea I could get this ill by getting the SHINGRIX vaccine. The patient was afraid of having a second dose, and a local pharmacist indicated the 2nd dose could be worse. The patient was not allergic to any drug, medication, or vaccination ever received.