chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Muscle rigidity, Tremor, Unresponsive to stimuli
Clinical narrative: -01/11/2018 MA: I administered HPV into his left arm. After the vaccine was administered the patient started to lean forward, like he was dizzy. I immediately asked him to lay down. He then asked for a glass of water. I got him the water and advised him to stay lying down. I went to the door to grab the pulse ox and the patient stood from the exam table, very unsteady. I again asked him to lay down. He was unresponsive and he slid to the floor near the exam table. I noticed his face was flushed, so I put my hands on the back of his head to lay him down on the floor, making sure he didn't hit his head. He started shaking, and at this point the rest of his body was also flushed. I was close enough to the door where I could open it to call for help and still be near the patient. At this point the patient was shaking and his eyes were rolling in the back of his head. Dr. came into the room and sat down on the floor next to myself and the patient. Dr. checked his pulse and was trying to talk to him, he was unresponsive, but breathing. A few moments later the patient quickly sat up and grabbed onto me, pulling me closer to the ground. He was unaware of what had happened or where he even was. Dr. continued talking to him as I got off the ground and moved aside. Patient asked where he was, and what happened. He was asking if this was a normal reaction to the vaccine, and if he was going to die. Dr. advised him that he was going to be okay but he needed to stay in the office for a while. I exited the room at that point. Dr.: After getting the HPV vaccine, he got up said he did not feel well, and had drank 5 cups of coffee and not eaten today. He laid down. (This part was told to me be staff, I did not witness it). I was called into the room. Patient was lying on the floor. Eyes open. Grunting and non-responsive. I think his arms were rigid. After about 30 seconds he became agitated and grabbed staff trying to put her in a bear hug as I struggled with him. After about 15 seconds of struggle, he became more lucid saying where am I and struggling for his phone and keys. After about 15 seconds of agitated looking for things he became more lucid and got up on the table to rest. He was thinking clearly at this point and remained so as he was observed in our office. I spoke with the neurologist on call Dr., who recommended that he be evaluated in the ED. Mother agrees with this plan and she will take him. 01/11/18 L. Staff: Received call on this date. She confirmed that the patient did not hit their head, and the patient had not had seizures in the past. Asked if person was aware and if she was going to be contactinng the manufacturer? Staff advised person was aware. Reviewed ED report, and patient's MRI was negative for findings and he was discharged home.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Headache, Muscle spasms, Nausea, Vaccination complication
Clinical narrative: Mandatory Flu vaccine received on Monday 12/04/2017, at 1:04 PM. In the middle of the night on 12/05/2017, I started having excruciating headache, severe nausea and vomiting, and spasms in the left arm. I took a Fioricet first, then later in the morning I took Excedrin Tension. nothing was relieving the pain. I called the Dr and he saw me in the clinic around 10:00 am. He told me it was an adverse reaction to the flu vaccine. He prescribed Phenergan. I took it immediately and when I woke up around 2:00 the headache was better. Continued to feel weak and nauseous for the rest of the day. Slight headache relieved with Tylenol.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Mandatory Flu vaccine received on Monday 12/04/2017, at 1:04 PM. In the middle of the night on 12/05/2017, I started having excruciating headache, severe nausea and vomiting, and spasms in the left arm. I took a Fioricet first, then later in the morning I took Excedrin Tension. nothing was relieving the pain. I called the Dr and he saw me in the clinic around 10:00 am. He told me it was an adverse reaction to the flu vaccine. He prescribed Phenergan. I took it immediately and when I woke up around 2:00 the headache was better. Continued to feel weak and nauseous for the rest of the day. Slight headache relieved with Tylenol.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: PATIENT REPORTED TO PHARMACY ON 1/18/2018 THAT HE HAS HAD BACK PAIN STARTING TWO DAYS AFTER IMMUNIZATION WAS ADMINISTERED. BEEN TAKING IBUPROFEN BUT IT'S BEEN TWO WEEKS NOW AND STILL NOW RELIEF. INFORMED HIM TO ALSO REPORT TO DR. GAVE PATIENT ANOTHER COPY OF VIS TO REPORT TO CDC. TO CHECK IN WITH ME IN A FEW DAYS.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Left arm pain and numbness, swollen and warm to touch.
Age: 16.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Disorientation, Hypotonia, Lacrimation increased, Pallor, Unresponsive to stimuli
Clinical narrative: Flaccidity, unresponsive after Imm. responded to ammonia to nares. Awakened teary and disoriented. Placed in supine position with knees bent. A/O, identifying relatives and DOB. Returned to pre Imm. mental status. AMB. Without sequelae. BP 10:35AM 118/60 and 10:15AM 110/70. Warm dry skin-pale in color.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Decreased immune responsiveness, Herpes zoster, Herpes zoster meningomyelitis, Neuropathy peripheral
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. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 15-APR-2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of shingles. On or about 03-FEB-2016, the patient was treated by a family physician for the onset of blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 15-FEB-2016, she sought subsequent treatment by the family physician for ongoing and worsening symptoms of shingles, which was diagnosed as herpes zoster myelitis, a rare and serious condition of herpes zoster virus involved with the spinal segments. On or about 09-MAR-2016, the patient was treated again for ongoing symptoms of shingles and myelitis.  On or about 14-JUL-2016, she received treatment at the family physician's for new and spreading herpes zoster infections. On or about 08-DEC-2016, she was treated for a severe herpes outbreak that had persisted for seven days and was non-responsive to treatment. On or about 16-DEC-2016, the patient sought subsequent  treatment for ongoing and uncontrollable shingles. On or about 13-JAN-2017, she was treated at a medical center for neuropathy and persistent back pain caused by recurrent shingles and post-herpetic neuralgia. She was prescribed gabapentin (in increasing doses), lidocaine (LIDODERM) patches, acyclovir, and valacyclovir for management of her painful and chronic symptoms. As a direct and proximate result of these malfunctions, 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 were unknown at the time of the report.  Causality assessment was related. Upon internal review, herpes zoster myelitis was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Post herpetic neuralgia, Rash vesicular
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. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 15-APR-2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of shingles. On or about 03-FEB-2016, the patient was treated by a family physician for the onset of blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 15-FEB-2016, she sought subsequent treatment by the family physician for ongoing and worsening symptoms of shingles, which was diagnosed as herpes zoster myelitis, a rare and serious condition of herpes zoster virus involved with the spinal segments. On or about 09-MAR-2016, the patient was treated again for ongoing symptoms of shingles and myelitis.  On or about 14-JUL-2016, she received treatment at the family physician's for new and spreading herpes zoster infections. On or about 08-DEC-2016, she was treated for a severe herpes outbreak that had persisted for seven days and was non-responsive to treatment. On or about 16-DEC-2016, the patient sought subsequent  treatment for ongoing and uncontrollable shingles. On or about 13-JAN-2017, she was treated at a medical center for neuropathy and persistent back pain caused by recurrent shingles and post-herpetic neuralgia. She was prescribed gabapentin (in increasing doses), lidocaine (LIDODERM) patches, acyclovir, and valacyclovir for management of her painful and chronic symptoms. As a direct and proximate result of these malfunctions, 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 were unknown at the time of the report.  Causality assessment was related. Upon internal review, herpes zoster myelitis was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
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. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 22-MAY-2007, the patient was inoculated with ZOSTAVAX at a public health clinic as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 18-JAN-2014, the patient was treated at a community health center for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, 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.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Pain (R) deltoid after vaccine administered.
Age: 72.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Back pain, Fatigue, Musculoskeletal pain, Nausea, Vomiting
Clinical narrative: Day 1-3 - Fatigue, pain on back and shoulder. 4 - Nausea and vomiting.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Muscle where vaccine was given is still sore. Whenever she makes a fist or lays on that arm it is sore. Per patient, she consulted with physician, he told patient it will eventually go away. Patient tried applying heat to area and did not help.
Age: 66.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Balance disorder, Dizziness
Clinical narrative: PATIENT BEGAN TO FEEL DIZZY AND UNSTEADY ON FEET AT APPROXIMATELY 10PM DAY AFTER VACCINE.
Age: 66.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Dizziness, Feeling abnormal, Vertigo
Clinical narrative: PATIENT BEGAN TO FEEL DIZZY AND UNSTEADY ON FEET AT APPROXIMATELY 10PM DAY AFTER VACCINE.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Rash erythematous
Clinical narrative: Pt had red rash & flushed on face & chest. Given ZYRTEC 10mg po given. With some relief noted. No further treatment needed. Pt reported improvement.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Sore arm; severe chills, fever (100.6 F), fatigue, nausea, moderately severe headache.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Sore arm; severe chills, fever (100.6 F), fatigue, nausea, moderately severe headache.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given adult Hep  B. She is only 18 years old.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Gingival erythema, Oral mucosal erythema, Oral pain, Rash, Stomatitis
Clinical narrative: My mouth was very irritated. Gums were red. Entire mouth felt like I had burnt it with Hot coffee. Under my tongue was red and hurt. Very uncomfortable. It started the day after the shot and went away when the rash on my arm went away.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Feeling abnormal
Clinical narrative: Vaccinations given. After vaccinations patient stated she felt fine in the room. She left the room and walked out to the waiting room and told her she did not feel good. I immediately laid her down flat on the chairs with knees up and she started to feel better. She laid there for 5 minutes. She sat up and felt  fine. I informed mom if she felt that way again to have her lay down and if condition worsens take her to the ER. Mom stated she understood and I walk patient to the vehicle.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Odynophagia
Clinical narrative: Pt experienced chest pain and heaviness, pain with swallowing and shortness of breath an hour after vaccine administered.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Pain, Pain in extremity, Swelling
Clinical narrative: PT STATED HAVING PAIN AND DIFFICULTY LIFTING ARM IN THE EVENING AFTER SHOT. NEXT DAY WAS SWOLLEN/RED/PAINFUL BUT NOT HOT. INFORMED PT TO TRY BENADRYL AND HYDROCORTISONE. ALSO SUGGESTED ICE/COMPRESSION AND ELEVATION. INFORMED PT TO SEEK MEDICAL ATTENTION IF GOT WORSE AFTER 24 HOURS. PT STOPPED INTO STORE THE NEXT DAY AND HAD GONE TO URGENT CARE WHERE SHE WAS EVALUATED BUT WAS TOLD TO DO NOTHING DIFFERENT THAN WHAT I HAD TOLD HER.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 16-JAN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 24-MAY-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 18-JUL-2017, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, 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: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On an unspecified date, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, he was treated by a physician for the onset of severe vesicular wash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, 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 at the time of the report. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles.  The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 18-JUL-2018, he was treated at a clinic for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, 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 were unknown at the time of the report. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 16-JAN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 03-JUN-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 23-MAR-2015, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed valacyclovir hydrochloride (VALTREX) and prednisone for management of her painful condition. As a direct and proximate result of these malfunctions, 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.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: A 52 year old female received an intramuscular injection of MassBiologics Td (Lot #A096B) in the left deltoid on June 19, 2017 for wound prophylaxis after cutting her index finger while cooking. On June 22, 2017, the patient experienced warmth at the site of injection and pain in her left arm. The patient reported to her provider that she had experienced symptoms for about 2 weeks before recovery. The only treatment the patient received was an ice pack applied to her left arm. No follow-up was required as the patient had fully recovered by the time of the report.; Sender's Comments: Both adverse events reported in this case were assessed as non-serious and labeled. The patient reported receiving an injection of Td (manufacturer unknown, Lot #U4669AA) in January 2016. Please note that reports 'US-MassBiologics-AE1703' and 'US-MassBiologics-AE1705' have been linked to this report. These three adverse events were reported to MassBiologics at the same time by the same primary source reporter.
Age: 4.0
Sex: M
Vaccine: FLU4, TD
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: On October 17, 2017, a 4 year old male incorrectly received an intramuscular injection of MassBiologics' Td vaccine (Lot #A104B1) into his left upper vastus lateralis; the intended drug for this patient was KINRIX. The patient and his older sibling were being seen at the provider's office at the same time when the health professional wrongly injected this patient with the Td vaccine meant for the sibling. The patient received two other vaccines during the same visit, both were GlaxoSmithKline's flu vaccine (Lot #9M3F7), given intramuscularly into his right upper vastus lateralis and his left lower vastus lateralis. The patient did not experience any adverse reactions after Td administration. Sender's Comments: This medication error was assessed as non-serious. The Td vaccine was administered to the wrong patient that was under the prescribed age for the vaccine and administered via the incorrect route.
Sex: F
Vaccine: TD
Symptoms: Injection site bruising, Injection site erythema, Wrong drug administered
Clinical narrative: On November 6, 2017, a woman, age unknown, incorrectly received a 0.1mL injection of MassBiologics' Td vaccine (Lot # A087A2) in her arm instead of Tuberculin Purified Protein Derivative (PPD); the patient was reported to be an employee for the health care provider. The administration of the wrong drug was made apparent when the patient went to have the results of the tuberculosis skin test read and it was reported that the patient experienced redness (10mm) and bruising at the site of injection, however no induration was observed as typically seen with a tuberculosis skin test. A review of the medical records confirmed that the patient had received the Td vaccine by identification of the lot number. MassBiologics queried the reporter for a root cause for the medication error and the reporter indicated that the patient reported that the nurse who administered the Td was having difficulty finding the "needles and the vial for injection". Furthermore, the patient felt that the injection was administered intramuscularly instead of intradermally but was not confirmed. Multiple attempts at follow up with the patient and the facility where Td was administered were made with no response. The patient's recovery status is unknown. Sender's Comments: MassBiologics assessed this adverse event as non-serious and contained both labeled reactions and unexpected reactions.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Angioedema, Urticaria
Clinical narrative: Pt had hives and Angioedema symptoms. Onset within hours of administration of vaccine. He took Benadryl at home that seemed to lessen his symptoms but they lingered for greater than 1 week.
Age: 12.0
Sex: M
Vaccine: HPV9, IPV, MMRV, MNQ
Symptoms: Dizziness, Fear
Clinical narrative: During visit patient was refusing vaccines and scared. The mother and I got him to calm down and receive vaccines. After the 4th vaccine he felt like he was going to pass out. I laid him on the floor with knees up and he laid there for 10 minutes. He then felt better and sat on exam table. BP 115/88. I gave him last vaccines and he felt like fainting again. I laid him on exam table with knees up and he laid there for 5 minutes and felt better. He then sat up and said he felt fine. BP 107/73. I informed mom if he feel that again have him lay down and if condition worsens take him to ER. She said she understood and walked patient to car.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Injection site swelling.
Age: 61.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Dyspnoea, Unresponsive to stimuli
Clinical narrative: Patient stated after 5 hours of receiving the vaccination, he was unable to breathe. He was sent to the hospital after no response for a few minutes. He was giving the treatment at the hospital on 12/1/2017. Patient is stable now.
Age: 22.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Patient was given GARDASIL 9 while pregnant and given in Lt Gluteus Medius IM, last menstral period 12-25-17, has follow up appt with OBGYN 1-23-18 at 2pm EDC 10-1-18.
Age: 22.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: Patient was given GARDASIL 9 while pregnant and given in Lt Gluteus Medius IM, last menstral period 12-25-17, has follow up appt with OBGYN 1-23-18 at 2pm EDC 10-1-18.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Headache, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Patient is still having a serious injection site reaction: redness, swelling, bruising, pain. She has also has headaches and GI distress. It has been almost 4 weeks since her immunization.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Patient is still having a serious injection site reaction: redness, swelling, bruising, pain. She has also has headaches and GI distress. It has been almost 4 weeks since her immunization.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Chills, Pain, Pain in extremity, Tenderness
Clinical narrative: Patient complained of arm soreness and chills after she arrived home yesterday, about an hour following her vaccinations. She said she had chills and body aches last night and today. She said her left arm is tender, even on the inside of the arm and still has a lot of weakness, chills and aching.
Age: 18.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Cough, Dysphonia, Eye pain, Influenza
Clinical narrative: No symptoms prior to flu shot. Within 4 hours of flu shot, I developed a fever of 100.5. I took an Advil at bedtime, and at first seemed better on Monday morning. However, later that day, my fever returned, and for the past few days I have had fever, chills, body aches, cough, eye soreness, horseness, body itching and sore throat.
Age: 18.0
Sex: F
Vaccine: FLUC4
Symptoms: Oropharyngeal pain, Pain, Pruritus, Pyrexia
Clinical narrative: No symptoms prior to flu shot. Within 4 hours of flu shot, I developed a fever of 100.5. I took an Advil at bedtime, and at first seemed better on Monday morning. However, later that day, my fever returned, and for the past few days I have had fever, chills, body aches, cough, eye soreness, horseness, body itching and sore throat.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Induration, Urticaria
Clinical narrative: Developing large hard welt about 5cm, pt. states not painful but firm.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, IPV, MMR, DTAPIPV
Symptoms: Extra dose administered, Headache, Malaise, Skin warm
Clinical narrative: Patient inadvertently given duplicate dose of Polio vaccine. One dose was from a multi-dose vial of single antigen IPV and the other dose was given from a combination vaccine, KINRIX. Both vaccines were given simultaneously in opposite arms. Parent was notified of duplicate dose and patient was observed for 30 minutes in the office before leaving. Dr. followed up with patient and her mother 24 hrs after the dose was given. Mother reports patient generally not feeling well, headache and warm to touch (no temperature obtained). Mother gave the patient a dose of Tylenol.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, IPV, MMR, DTAPIPV
Symptoms: Extra dose administered, Headache, Pyrexia
Clinical narrative: Patient inadvertently given duplicate dose of Polio vaccine. One dose was from a multi-dose vial of single antigen IPV and the other dose was given from a combination vaccine, KINRIX. Both vaccines were given simultaneously in opposite arms. Parent was notified of duplicate dose and patient was observed for 30 minutes in the office before leaving. Dr. followed up with patient and her mother 24 hrs after the dose was given. Mother reports patient generally not feeling well, headache and warm to touch (no temperature obtained). Mother gave the patient a dose of Tylenol.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, IPV, MMR, DTAPIPV
Symptoms: Extra dose administered, Headache, Malaise, Skin warm
Clinical narrative: They gave my daughter double dose of IPV on accident. Resulted in high fever and severe headache. Also stress and scare to the momma.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, IPV, MMR, DTAPIPV
Symptoms: Extra dose administered, Headache, Pyrexia
Clinical narrative: They gave my daughter double dose of IPV on accident. Resulted in high fever and severe headache. Also stress and scare to the momma.
Age: 4.0
Sex: F
Vaccine: HEPA, IPV, MMR, TDAP
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling
Clinical narrative: PT'S THIGHS WERE RED AND IRRITATED AND SWOLLEN (BOTH THIGHS AT SITE ON INJECTION). PT WAS GIVEN BENADRYL, OUTCOME IS UNKNOWN YET.
Age: 35.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Injection site erythema, Injection site mass, Injection site nodule, Injection site pain
Clinical narrative: 12 hours after vaccine admin in left arm (both flu/pneumovax per patient preference) she developed tender, throbbing, red knot that increased to size of an orange. Fever/chills/swollen nodes in groin/axilla L>R. Smaller tender lump at injection site was present on 1/11/18.  Treated with ibuprofen, moist heat, close monitoring for cellulitis.
Age: 35.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: 12 hours after vaccine admin in left arm (both flu/pneumovax per patient preference) she developed tender, throbbing, red knot that increased to size of an orange. Fever/chills/swollen nodes in groin/axilla L>R. Smaller tender lump at injection site was present on 1/11/18.  Treated with ibuprofen, moist heat, close monitoring for cellulitis.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site pain, Injection site swelling, Rash generalised, Urticaria
Clinical narrative: Day after vaccination, pt. mom reported pt. had swelling and pain in the area. The next day (2 days after immunization) had what seems like an urticarial rash over whole body excluding face.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia, Peripheral coldness
Clinical narrative: Patient called the pharmacy today to report numbness/tingling and cold feeling in lower extremities. Symptoms began after vaccine was administered and have not abated since.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Severe redness and warmth over entire upper arm and moving down lower arm past elbow.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: Patient has fever, chills and was throwing up overnight.
Age: 43.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Pain in extremity
Clinical narrative: Sore arm and weakness.
Age: 0.92
Sex: M
Vaccine: FLUX
Symptoms: Cough, Irritability, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Infant seasonal flu shot, not sure specifically what kind. Hours after receiving the shot, the baby was very fussy and had a runny nose. This is now the third day where he has been easily irritable and is very congested and is developing a cough.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local reaction, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: Tenderness in whole upper arm; localized reaction with redness, swollen deltoid and underarm; fever of 100 F starting on day of vaccination.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Headache, Pruritus, Pyrexia
Clinical narrative: Headaches, itchy, fever up to 102.5 (day 3).
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Myalgia, Pyrexia, Respiratory tract congestion
Clinical narrative: This is a 19-year-old male, who recently recovered from a flu like illness with fever and myalgias a week ago. He then received an immunization against meningitis on 12/26/2017. He subsequently developed fever which has persisted and now presents for further care. He has had myalgias and arthralgias. He has had no cough. He denies having any chest pain. He has had some slight congestion. He denies having abdominal pain or urinary symptoms. He has had no rash. No sinus pain or ear pain. No neck stiffness. No other associated symptoms or complaints.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, HEPA, MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pt. was given an adult dose of Hep A vaccine in error. Pt's foster mother, denied any signs/symptoms of adverse effects noted.
Age: 61.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Varicella vaccine was mistakenly administered instead of zoster vaccine. After contacting Merck, it was determined that there was "no specific safety concern that existed and the pt should be given zoster during same visit. No adverse effect occurred.
Age: 65.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Varicella vaccine was mistakenly given instead of zoster vaccine after contacting Merck, it was determined that there was "no specific safety concern that exists and the pt should be given zoster during same visit." No adverse event occurred.
Sex: F
Vaccine: RAB
Symptoms: Balance disorder, Burning sensation, Gait disturbance, Headache, Rash pruritic
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of headache in a female patient who received RABAVERT. On 6th December 2017, the patient received RABAVERT. On an unknown date, less than a year after receiving RABAVERT, the patient experienced headache, sensory loss, staggering, itchy rash, burning sensation, balance difficulty and bladder incontinence. On an unknown date, the outcome of the headache, sensory loss, staggering, itchy rash, burning sensation, balance difficulty and bladder incontinence were unknown. It was unknown if the reporter considered the headache, sensory loss, staggering, itchy rash, burning sensation, balance difficulty and bladder incontinence to be related to RABAVERT. Additional information was reported as follows: The patient received RABAVERT for post exposure prophylaxis. The age at vaccination was not reported. The healthcare professional was the patient herself, who reported that she was bitten at work. After receiving RABAVERT, the patient experienced a number of adverse events like balance issues, bladder leakage, sensory perception loss, itchy and burning rash on the body. Neurologist did not have a treatment option. The healthcare professional just wanted to know which part of the vaccine she had a side effect to. No additional information was provided.
Sex: F
Vaccine: RAB
Symptoms: Sensory loss, Urinary incontinence
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of headache in a female patient who received RABAVERT. On 6th December 2017, the patient received RABAVERT. On an unknown date, less than a year after receiving RABAVERT, the patient experienced headache, sensory loss, staggering, itchy rash, burning sensation, balance difficulty and bladder incontinence. On an unknown date, the outcome of the headache, sensory loss, staggering, itchy rash, burning sensation, balance difficulty and bladder incontinence were unknown. It was unknown if the reporter considered the headache, sensory loss, staggering, itchy rash, burning sensation, balance difficulty and bladder incontinence to be related to RABAVERT. Additional information was reported as follows: The patient received RABAVERT for post exposure prophylaxis. The age at vaccination was not reported. The healthcare professional was the patient herself, who reported that she was bitten at work. After receiving RABAVERT, the patient experienced a number of adverse events like balance issues, bladder leakage, sensory perception loss, itchy and burning rash on the body. Neurologist did not have a treatment option. The healthcare professional just wanted to know which part of the vaccine she had a side effect to. No additional information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Nasopharyngitis, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a adult female patient who received SHINGRIX (batch number P539L, expiry date 30th January 2020). On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, fever, chills and cold symptoms. On an unknown date, the outcome of the injection site pain, injection site erythema, fever, chills and cold symptoms were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, fever, chills and cold symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it was in mid 50s. No further information was reported at this time.
Sex: F
Vaccine: RV1
Symptoms: Laceration, Product container issue, Product quality issue
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of laceration of finger in a adult female patient who received ROTARIX lyophilized formulation (batch number GB374, expiry date 24th February 2019). On an unknown date, the patient received ROTARIX lyophilized formulation. On an unknown date, immediately after receiving ROTARIX lyophilized formulation, the patient experienced laceration of finger and pharmaceutical product complaint. On an unknown date, the outcome of the laceration of finger and pharmaceutical product complaint were unknown. Additional details were provided as follows: The healthcare professional called and reported a defective ROTARIX vaccine. The vial was cracked at the bottom and when the nurse tried to pull the vial out of the box, it shattered and also cut her on the finger. The caller stated that they have not dropped the package, and if it was dropped, it was before they received it. The blister try nor the carton was damaged. She stated that there were a few spots in the package, but did not know if it was leakage or powder from the vial. She stated that there were pieces of glass in the vial, they stored the vaccine in a vaccine-dedicated refrigerator, and she did not know if there was still any product in the vial. She would send pictures to the email provided. The healthcare professional would send defective product back. Credit Request Template completed to arrange credit.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Blood calcium increased, Blood uric acid increased, Joint swelling, Lymph node pain
Clinical narrative: Next afternoon - swollen lympth nodes, very sore. Later knee swollen, twice normal size, cannot bend, extremely painful. Lasted 12 days. Diclofenac gel (no help) from Nov. 7 to Nov. 18. Dec. 3 to Jan. 5 Toe - (same leg) - joint and foot swollen - colchicine (no help). Toe joint back to normal in a few days after taking Prednisone. Over a month - swollen, extreme pain and joint won't bend. Knee injured 4 years ago. Toe joint broken twice. Never had bursitis or gout before and no history.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Lymphadenopathy, Mobility decreased, Peripheral swelling
Clinical narrative: Next afternoon - swollen lympth nodes, very sore. Later knee swollen, twice normal size, cannot bend, extremely painful. Lasted 12 days. Diclofenac gel (no help) from Nov. 7 to Nov. 18. Dec. 3 to Jan. 5 Toe - (same leg) - joint and foot swollen - colchicine (no help). Toe joint back to normal in a few days after taking Prednisone. Over a month - swollen, extreme pain and joint won't bend. Knee injured 4 years ago. Toe joint broken twice. Never had bursitis or gout before and no history.
Sex: U
Vaccine: DTAPIPV
Symptoms: Erythema, Product quality issue
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of redness of legs in a patient who received KINRIX (batch number 7559R, expiry date unknown). On 29th December 2017, the patient received KINRIX. On an unknown date, less than a month after receiving KINRIX, the patient experienced redness of legs and pharmaceutical product complaint. On an unknown date, the outcome of the redness of legs and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the redness of legs and pharmaceutical product complaint to be related to KINRIX. Additional details were provided as follows: Sales rep called to report adverse event for 3 different patients, this was patient 2. The patient experienced baseball size redness on the thigh. This case has been linked to the case US2018005859 and US2018005861 reported by the same reporter.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Extra dose administered, Feeling abnormal
Clinical narrative: This case was reported by a physician via call center representative and described  the occurrence of feeling bad in a 19-year-old female patient who received BEXSERO (batch number 15E301A, expiry date 31st May 2018). Concomitant products included ADDERALL and fluoxetine. On 10th January 2018, the patient received the 3rd dose of BEXSERO .5 ml. On 10th January 2018, less than a day after receiving BEXSERO, the patient experienced feeling bad and extra dose administered. On an unknown date, the outcome of the feeling bad and extra dose administered were unknown. The reporter considered the feeling bad to be probably related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO in right arm. The patient received 3rd dose of BEXSERO, which led to extra dose administered. After receiving BEXSERO, the patient physically felt bad. No further details were known.
Sex: M
Vaccine: FLU4
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer and described the occurrence of vaccination failure in a 74-year-old-male patient who received Influenza vaccine Quadrivalent. Co-suspect products included AVANDIA unknown for diabetes. The patient's past medical history included blood pressure high and blood cholesterol increased. On an unknown date, the patient received Influenza vaccine Quadrivalent. In January 2007, the patient started AVANDIA 8 mg once daily (8 mg daily). On an unknown date, the dose was changed to an unknown dose and frequency. On 1st January 2018, less than a year after receiving Influenza vaccine Quadrivalent and not applicable after starting AVANDIA, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. The action taken with AVANDIA was unknown (Dechallenge was unknown). Rechallenge with AVANDIA was unknown. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was recovering/resolving. The reporter considered the vaccination failure and influenza to be unrelated to Influenza vaccine Quadrivalent. The reporter considered the influenza to be unrelated to AVANDIA. Additional details were provided as follows: The patient was on a lot of pills for his cholesterol and high blood pressure. The patient did not have his list with him. These were historical. The age at vaccination was not reported. The patient was on AVANDIA, taken as 2 to 4mg tablets once daily. It was reported that the patient had a flu shot, but still got the flu. The call was transferred from GlaxoSmithKline patient assistance. Manufacturer of the flu vaccine was unknown and the date received was also unknown. This case was considered as a suspected vaccination failure, since the confirmation of lab test and the exact time to onset for flu were unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and pruritus. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and pruritus. On an unknown date, the outcome of the fever and pruritus were recovered/resolved. It was unknown if the reporter considered the fever and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist did not have lot number or expiration date of the vaccine. The pharmacist reported that the vaccine was given at another facility. The pharmacist did not have exact details as to when events began or ended.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Accidental exposure to product, Exposure via eye contact, Eye irrigation, Eye irritation
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of burning sensation in eye in a 36-year-old female patient who received ENGERIX B (batch number 2KJ42, expiry date 7th April 2019). On 15th November 2017, the patient received ENGERIX B. On 15th November 2017, less than a day after receiving ENGERIX B, the patient experienced burning sensation in the eye, exposure via eye contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the burning sensation in eye, exposure via eye contact and inadvertent exposure to vaccine were unknown. It was unknown if the reporter considered the burning sensation in eye to be related to ENGERIX B. Additional details were provided as follows: The patient while receiving ENGERIX B, some of the vaccine accidentally squirted into an health care professional's eye which led to inadvertent exposure to vaccine and exposure via eye contact. The health care professional flushed her eye with saline, and experienced burning in her eye which continued 30 minutes after the accidental exposure and was ongoing at the time of the report. This was an accidental medication error without harm. Follow up information received from other healthcare professional who was physician assistant on 11th January 2018: The reporter's details were updated. The patient used artificial tears in affected eye for 24 hours and the day following exposure, the patient's eye was back to normal. The VAERS details were updated.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Heart rate increased, Injection site pain, Nausea, Vertigo
Clinical narrative: Increased heart rate up to 120 bpm, dizziness/vertigo, nausea, stinging/burning at site. Symptoms started within 30 min. Post injection and lasted for 2 days.
Age: 1.0
Sex: F
Vaccine: MMR, MMRV, HEPA, HIBV, MMR, MMRV, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: A medication administration error occurred in which this child was administered PROQUAD instead of VARIVAX.
Age: 1.0
Sex: F
Vaccine: MMR, MMRV, HEPA, HIBV, MMR, MMRV, PNC13
Symptoms: Wrong drug administered
Clinical narrative: A medication administration error occurred in which this child was administered PROQUAD instead of VARIVAX.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Impaired work ability, Injection site pain, Mobility decreased, Muscle spasms
Clinical narrative: Severe cramping, pain in injection site. Cannot move arm. Had to call out sick from work.