chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was inadvertently vaccinated with a dose of VARIVAX as prophylaxis (Strength, dose, route, lot # and expiration date were not reported) and a dose of sterile diluent (manufacturer unknown) (Strength, dose, indication, route, lot # and expiration date were not reported) instead of a dose of ZOSTAVAX. The physician stated that it was not in his office practice site. No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information is not expected as there was no consent to contact the reporter.; Sender's Comments: US-009507513-1705USA002147:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 01-MAY-2017, the patient was vaccinated with an improperly stored dose of VARIVAX (lot number M042496 with expiration date of 19-OCT-2018; strength, dose, route, and anatomical location were not provided), for prophylaxis. The physician stated that the VARIVAX was reconstituted with properly stored sterile diluent (reported as DILUENT MRK) (lot number reported as M023895 with expiration date of 18-JAN-2019). It was also reported that the administered dose experienced a temperature excursion during 30 minutes at a temperature between -14 degrees Celsius and -10 degrees Celsius on an unspecified date. In addition, the administered dose also experienced a temperature excursion during 6 hours and 30 minutes (reported as 6.5 hours) at a temperature between -9 degrees Celsius and 8 degrees Celsius on an unknown date. A data logger issue was involved. No previous temperature excursion and no adverse events were reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was inadvertently vaccinated with a dose of VARIVAX as prophylaxis (Strength, dose, route, lot # and expiration date were not reported) and a dose of sterile diluent(manufacturer unknown) (Strength, dose, indication, route, lot # and expiration date were not reported) instead of a dose of ZOSTAVAX. The physician stated that it was not in his office practice site. No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information is not expected as there was no consent to contact the reporter.; Sender's Comments: US-009507513-1705USA000380:
Sex: M
Vaccine: PPV
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: This is a spontaneous report from a contactable physician.   A 63-year-old male patient of an unspecified race/ethnicity received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain of right shoulder region, decrease ROM (joint range of motion decreased) potential exists for incorrect site of administration. The outcome of the events was unknown. Pfizer is Marketing Authorization Holder Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has been submitted the same report to the regulatory authorities.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Limb mass, Peripheral swelling, Skin exfoliation, Skin warm
Clinical narrative: Red Hot swollen Lump on Arm lasted for a little over 24 hours and had some skin flaking.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Pain in extremity, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Pain in arm, Swelling and redness to vaccine site with elevated temperature in vaccine site.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: The shot was given on my right side, but it was my left side that went numb after 15 mins, and then went right into a pins and needles feeling mostly in my left arm and left leg as if they were asleep. There was no treatment. I was just monitored and told to call back the clinic. The worst of the sensation lasted ALL day, and decreased a little each day after a period of about 7 days.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Aphasia, Audiogram abnormal, Auditory neuropathy spectrum disorder, Brain stem auditory evoked response normal, Ear tube insertion
Clinical narrative: The second day after vaccines, patient stopped responding to sounds. Within a week she stopped talking. She was irritable, but showed no other signs of being unwell. On July 22, 2016 I took her to the clinic she was being seen at as things were not improving. There is was brushed off by the physician being told "vaccines don't cause autism". She did not address my daughter not responding to sounds or no longer talking so we took her to the ER. There she started running a fever of 104.5 degrees Fahrenheit. We were sent home with a diagnosis of a virus and still no answers as to why my daughter was no longer talking or responding to sound. I went back to her clinic and saw a different practitioner a few weeks later to request an ENT referral. November 3, 2016 patient saw the ENT and failed the booth test. The doctor saw fluid on her ears and suggested tubes and hoped that would help. December 1, 2016 her tubes were placed but did not help. We were then sent to see about hearing aids. At this new clinic, patient passed the ear tests but once again failed the booth test. They now believed she had auditory neuropathy and sent her for an ABR. A sedated ABR was performed on February 17, 2017. Patient passed this with flying colors. We are still trying to find out what happened with our daughter. She has an appointment next month.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Irritability, Middle ear effusion, Pyrexia, Unresponsive to stimuli, Viral infection
Clinical narrative: The second day after vaccines, patient stopped responding to sounds. Within a week she stopped talking. She was irritable, but showed no other signs of being unwell. On July 22, 2016 I took her to the clinic she was being seen at as things were not improving. There is was brushed off by the physician being told "vaccines don't cause autism". She did not address my daughter not responding to sounds or no longer talking so we took her to the ER. There she started running a fever of 104.5 degrees Fahrenheit. We were sent home with a diagnosis of a virus and still no answers as to why my daughter was no longer talking or responding to sound. I went back to her clinic and saw a different practitioner a few weeks later to request an ENT referral. November 3, 2016 patient saw the ENT and failed the booth test. The doctor saw fluid on her ears and suggested tubes and hoped that would help. December 1, 2016 her tubes were placed but did not help. We were then sent to see about hearing aids. At this new clinic, patient passed the ear tests but once again failed the booth test. They now believed she had auditory neuropathy and sent her for an ABR. A sedated ABR was performed on February 17, 2017. Patient passed this with flying colors. We are still trying to find out what happened with our daughter. She has an appointment next month.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Diet refusal, Screaming
Clinical narrative: Baby screamed and refused to eat. This lasted for three days.
Age: 68.0
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a 68-year-old patient of unknown gender. No information regarding the patient's medical history, concomitant medications, concurrent conditions and drug reactions or allergies was provided. On 10-FEB-2017, the patient was vaccinated with a dose of PNEUMOVAX23 injection (route of administration, site, dose, lot number and expiration date were not reported). On 28-MAR-2017, the patient received an additional dose of PNEUMOVAX23 injection (route of administration, site, dose, lot number and expiration date were not reported). No adverse event was reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information was received on 25-APR-2017 from a registered nurse concerning a female patient who is under 18 years of age. No medical history or concomitant medications were reported. On 06-JAN-2017, the patient received a dose of GARDASIL 9 (lot, expiration, dose and therapy route were not reported) for prophylaxis, while she was pregnant. The patient reports that her last menstrual period was in December 2016. No adverse effects have been observed in the patient. The patient has been seen by her physician. No parity reported. No other information is available. The outcome of the pregnancy is unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site pain, Malaise, Nausea, Pyrexia
Clinical narrative: This spontaneous report was received via a company representative (a patient's friend), from a 58-year-old female patient, who was reporting on herself. The patient's concomitant medications and drug reactions or allergies were unknown. The patient's concurrent conditions included getting sick "at the drop of a dime". On 27-APR-2017, the patient was vaccinated with a dose of PNEUMOVAX23 (exact dose, route of administration, lot # and expiry date were not reported). On the same day, within a couple of hours, she experienced injection site soreness. On the following day, the patient still had the injection site soreness and also developed a low grade fever, malaise, chills and nausea. The patient did not seek medical attention and had no lab diagnostics studies performed. It was unknown whether she received a treatment for the event. The outcome of the events was recovering. The causality between PNEUMOVAX23 and the events was not provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report has been received from a medical assistant via a company representative and referred to two patients of unknown ages and genders. The patients' relevant medical history, concurrent conditions, and concomitant therapies were unknown.   It was reported that on unknown dates, the patients were vaccinated with doses of PNEUMOVAX23 (from the same lot number and expiration date that were not reported) (strength and dose were not reported) via a subdermal injection for prophylaxis.  On unknown dates, after the vaccination, both patients experienced cellulitis and were treated with unspecified antibiotics. Subsequently, on an unknown date, the patients recovered from the cellulitis. The causality assessment between cellulitis and PNEUMOVAX23 was unknown. Upon internal review, cellulitis was considered to be medically significant. Additional information is not expected, because no contact details were provided.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-MAY-2017,  the patient was vaccinated with an expired dose of PNEUMOVAX23  (lot # L021367 with expiration date of 05-NOV-2016; strength, dose, route and anatomical location were not provided), for prophylaxis. No adverse symptoms were reported. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Type III immune complex mediated reaction
Clinical narrative: This is a spontaneous report from a contactable physician communicated to a sales representative for two patients, this case is for the first patient. A female patient in her 80's of an unspecified ethnicity received  PREVNAR 13, via an unspecified route of administration at 0.5ml single dose in arm on an unspecified date for immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously received PNEUMOVAX over one year before.  The patient experienced  arthus with redness of upper arm 3-4 days later on an unspecified date with outcome of unknown.; Sender's Comments: A possible contributory role of suspect product cannot be excluded for the event arthus with redness due to temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate,Linked Report(s) : US-PFIZER INC-2017188837 same reporter drug event different patient.
Age: 12.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: CSF test, Electrocardiogram, Laboratory test, Sleep study, Somnolence
Clinical narrative: Excessive Daytime Sleepiness 18+ hours daily.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash pruritic
Clinical narrative: Developed itchy rash left mid-upper back; appearance consistent with herpes zoster.
Age: 1.33
Sex: F
Vaccine: TDAP
Symptoms: Adverse event
Clinical narrative: Unknown adverse events.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised, Swelling face
Clinical narrative: MOTHER STATED ON 5/1/17 HAD A FEVER IN THE EVENING AFTER RECEIVING SHOTS AND IN THE MORNING ON 5/2/17 CLIENT HAD RASH TO HER BODY AND SWELLING TO HER FACE.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Cough, Nausea, Pyrexia
Clinical narrative: Patient reports weakness, fever approx 101F, light coughing, and nausea.
Age: 74.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient has extreme redness, swelling and pain/discomfort in the right shoulder at the site of the injection. The symptoms are ongoing as of this time 05/04/2017 1:00 PM.
Age: 1.33
Sex: F
Vaccine: HEPA, MMR
Symptoms: Rash, Rash erythematous
Clinical narrative: Red rash, mostly on torso. Slowly spreading to arms and legs. Some on face/head. Flat red spots, not itchy. Disappear when pressure applied.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Injection site cellulitis, Pyrexia
Clinical narrative: On first day of injection, developed extreme fatigue, fever, chills, and the following day cellulitis on her arm, surrounding the injection site.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: Pt had an injection site reaction that was the size of half a baseball card. Had a knot in it that was painful to the touch and also was hot to the touch.
Age: 0.33
Sex: M
Vaccine: PNC13, RV5
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient did not have an adverse reaction but was given the diluent to PENTACEL without it being reconstituted.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Hallucination, auditory, Seizure
Clinical narrative: Hearing voices. Feeling out of it. Seizure.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, and drug reactions/allergies. Concomitant therapies included the sterile diluent. On an unknown date, the patient received "on time" the first and second dose of GARDASIL 9. On 03-APR-2017, the patient was vaccinated with the third dose of GARDASIL 9 (lot # M014929 and expiration date 27-MAY-2017) for prophylaxis (dose and route of administration were not reported). However, the third dose was given too early since it was supposed to be administered on 23-MAY-2017. No adverse effects were reported and no further information was provided. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 02-MAY-2017, the patient was vaccinated with  a dose of ZOSTAVAX lot # M001746, expiration date on 07-APR-2017 (strength, dose number and route were not provided) for prophylaxis. Other suspect therapies included sterile diluent(manufacturer unknown). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unspecified date in 2016 (reported as: "One year ago"), the patient was vaccinated with the first dose of GARDASIL intramuscularly (strength, anatomical location, lot number and expiration date were not provided). On 02-MAY-2017, the patient received the second dose of GARDASIL intramuscularly (strength, anatomical location, lot number and expiration date were not provided). No adverse event was reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist reporting for his wife via a Pfizer Sales Representative.  A female patient of unspecified age and race/ethnicity received PREVNAR 13, via an unspecified route of administration, in 2017 (2 months before report), at 0.5 ml single, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced arm hurts at the injection site in 2017 with outcome of recovering. Therapeutic measures were not taken as a result of the event. The reporter assessed the event as related to pneumococcal 13-val conj vac (dipht crm197 protein).
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Vaccination site swelling
Clinical narrative: UPON ADMINISTRATION OF VACCINATION THE AREA TURNED RED AND STARTED SWELLING. PT HAD A GOLF BALL SIZED KNOT AT SITE OF INJECTION WITH REDNESS AND NO OTHER SYMPTOMS.
Age: 69.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PATIENT PRESENTED TO OUR OFFCIE WITH RIGHT UPPER ARM REDNESS, SWELLING AND TENDERNESS FROM SHOULDER TO JUST ABOVE THE ELBOW. HAD RECEIVED PPSV23 YESTERDAY AT COUNTY HEALTH DEPT.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Blood creatine phosphokinase normal, Blood creatinine normal, Blood electrolytes normal, Blood glucose normal, Blood urea normal
Clinical narrative: Awoke with fever, sweating, muscle twitching, headache. Taken to the ED where evaluation showed orthostatic hypotension which was only partially improved with IVF. Evaluated by neurologist. Seen 5/4 with continuing symptoms and begun on FLORINEF.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Full blood count normal, Headache, Hyperhidrosis, Liver function test normal, Muscle twitching
Clinical narrative: Awoke with fever, sweating, muscle twitching, headache. Taken to the ED where evaluation showed orthostatic hypotension which was only partially improved with IVF. Evaluated by neurologist. Seen 5/4 with continuing symptoms and begun on FLORINEF.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Nuclear magnetic resonance imaging brain normal, Orthostatic hypotension, Pyrexia
Clinical narrative: Awoke with fever, sweating, muscle twitching, headache. Taken to the ED where evaluation showed orthostatic hypotension which was only partially improved with IVF. Evaluated by neurologist. Seen 5/4 with continuing symptoms and begun on FLORINEF.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site pain, Pain
Clinical narrative: Significant injection site discomfort in addition to a sore type of catching pain that starts at the deltoid and radiates along the inner upper arm.  The injection site pain went away however she continues to have that discomfort which catches with any functional lifting or flexion of the left upper arm.
Age: 4.0
Sex: F
Vaccine: HEPA, HPV9, MMR, TDAP
Symptoms: Vaccination error
Clinical narrative: HPV and TDAP given in error.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: C-reactive protein increased, Hypoaesthesia, Immediate post-injection reaction, Inflammation, Injection site pain
Clinical narrative: Immediate pain that shot down my left arm. Numbness and tingling in the fingers was observed after receiving the vaccine. The pain worsened after a week. Physical therapy was done to retrieve mobility and cortisone shot to reduce inflammation.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Mobility decreased, Pain in extremity, Paraesthesia, Periarthritis
Clinical narrative: Immediate pain that shot down my left arm. Numbness and tingling in the fingers was observed after receiving the vaccine. The pain worsened after a week. Physical therapy was done to retrieve mobility and cortisone shot to reduce inflammation.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: One day post PCV-13 upper arm started to turn red and swell. Has gotten a little bigger each day and on 27 Apr it measured 4x3 inches. Area is pale red and slightly warm to touch. Full ROM. No systemic symptoms or altered sensation. No fever. Treated with ibuprofen and cool compresses with complete resolution on 29 Apr. LOC swell, Mass and lump, Lf up limb.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pallor
Clinical narrative: One day post PCV-13 upper arm started to turn red and swell. Has gotten a little bigger each day and on 27 Apr it measured 4x3 inches. Area is pale red and slightly warm to touch. Full ROM. No systemic symptoms or altered sensation. No fever. Treated with ibuprofen and cool compresses with complete resolution on 29 Apr. LOC swell, Mass and lump, Lf up limb.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Pain after flu shot in left arm. Reports "pain came on slowly" and is "continuing to grow". And reports it "feels like a thumb tack in the muscle".
Age: 1.0
Sex: M
Vaccine: PNC13
Symptoms: Cough
Clinical narrative: The next morning after the PREVNAR vaccine my son developed a deep cough. It continued for several days. I checked on the vaccine manufacturer's web site and a cough was stated as a possible side effect.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Headache, Staring
Clinical narrative: First vaccine given 2/22/2017 at age 4. Since then patient has developed staring spells and sharp brief pain in head. Referred to Pediatric Neurologist for evaluation.
Age: 47.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Feeding disorder, Joint stiffness
Clinical narrative: A few hours after taking the first dose or oral typhoid vaccine; I experienced fever, chills, terrible stomach cramps, nausea, vomiting, diarrhea. This lasted for 20 hours. Now, 30hours after dose, I have jaw pain and stiffness. I have been unable to eat to eat or drink due to nausea.
Age: 47.0
Sex: F
Vaccine: TYP
Symptoms: Nausea, Pain in jaw, Pyrexia, Vomiting
Clinical narrative: A few hours after taking the first dose or oral typhoid vaccine; I experienced fever, chills, terrible stomach cramps, nausea, vomiting, diarrhea. This lasted for 20 hours. Now, 30hours after dose, I have jaw pain and stiffness. I have been unable to eat to eat or drink due to nausea.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Abdominal distension, Abdominal pain, Crying, Diarrhoea, Irritability
Clinical narrative: Prolonged crying irritability diarrhea watery 5 per day. Lasted thru Sunday night 4/20/2017. Guardian reported extreme irritable crying abdomen pain distention no fever. Returned to normal Monday.
Sex: M
Vaccine: HEP
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a adult male patient who received ENGERIX B adult (batch number Z25GH, expiry date 6th March 2019). Previously administered products included ENGERIX-B adult (1st dose received on an unknown date) and ENGERIX-B adult (2nd dose received on an unknown date). On 25th October 2016, the patient received 3rd dose of ENGERIX B adult. On 25th October 2016, immediately after receiving ENGERIX B adult, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to ENGERIX B adult. Additional details were provided as follows: The age at vaccination was not reported. Six months after the last or 3rd dose of ENGERIX B adult, the patient was complaining of soreness or tenderness of right deltoid (injection site). As per the patient, this reaction occurred immediately following the 3rd dose of ENGERIX-B adult but he did not complain of it because he thought the side effect would wane. The patient was complaining that the soreness or tenderness at the injection site did not wane and he was still experiencing it at the time of reporting.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Erythema, Injection site pain, Pyrexia
Clinical narrative: Vaccine given on Tuesday, Wed. morning pt woke with redness, site tender to touch, fever and dizzy. Thursday-fever and dizziness resolved. Still red and tender. Advised to let us know if it worsens.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Cerebellar ataxia, Nuclear magnetic resonance imaging normal
Clinical narrative: Acute cerebellar ataxia for one month.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4, MENB
Symptoms: Headache, Tremor
Clinical narrative: Patient received shots, chatted with Dr. at checkout for 15 minutes then approximately 10 minutes after leaving office had severe headache, shaking. Went to ER - received ATIVAN and IV fluids. Resolved over approximately 1 hour and has been fine since.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain
Clinical narrative: Diffuse body aches.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Pyrexia, Respiratory syncytial virus infection
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a infant male patient who received PEDIARIX.  Co-suspect products included Rotavirus vaccine. Concomitant products included Hib vaccine and Pneumococcal vaccine. On 21st September 2016, the patient received the 1st dose of PEDIARIX and the 1st dose of Rotavirus vaccine (oral). On an unknown date, less than a year after receiving PEDIARIX and Rotavirus vaccine, the patient experienced fever and respiratory syncytial virus infection. The patient was treated with ibuprofen and TYLENOL. On an unknown date, the outcome of the fever and respiratory syncytial virus infection were unknown. The reporter considered the fever to be related to PEDIARIX. It was unknown if the reporter considered the respiratory syncytial virus infection to be related to PEDIARIX and Rotavirus vaccine. The reporter considered the fever to be probably related to Rotavirus vaccine. Additional details were provided as follows: This case was reported by the patient's mother. The reporter stated that the patient got his first set of vaccines. The patient received DTaP, Hep B, Hib, Polio, pneumococcal and rotavirus in 3 injections and one oral vaccine. After the vaccination the patient experienced a very high fever. Even while taking TYLENOL his fever was still 105 degree F. The patient was taken to the emergency room and administered Ibuprofen, which did not help bring his fever down. The reporter was not told the specific brand of vaccines that were administered, but she thought one was PEDIARIX. The patient had not received the 2nd dose of any of the vaccines as it was suspected that he had respiratory syncytial virus infection when his 2nd appointment was scheduled and the caller has not yet been able to make another appointment, till the time of reporting. The reporter spoke with the health department about the fever, and was advised that the fever was probably caused by the rotavirus vaccine. All the reporter's own research suggested that it was due to the DTaP.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt developed pruritus, redness and swelling at injection site (right arm). Onset about 6 hrs post vaccination. Pt will treat w/hydrocortisone 1% cream and BENADRYL.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Cardiac monitoring normal, Chest pain, Palpitations
Clinical narrative: Exact date for beginning of symptoms unknown. While deployed began having random episodes of sharp, non radiating chest pain and palpitations. No workup was done. Patient continues to have these episodes. Palpitations, chest pain, unspecified.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site atrophy, Injection site induration, Skin disorder
Clinical narrative: Fat atrophy left leg: Mom denied any immediate problems with immunization. Noticed that about 7-10 days later an area of induration began to develop 1/2 inch below the injection site on left thigh. Denies any trauma or other injury to the area, and denied problems with previous immunizations. No problems with ambulation and does not appear to be in any discomfort. Assessed by plastics dx. Fat, atrophy, no immediate treatment.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Inflammation, Pruritus, Skin warm
Clinical narrative: Client had large and reddened area on outer aspect of upper arm. 4 inches x 4 inches with a 1 inch x 1 inch center. Area is inflamed, warm to touch and client stated the area itches. Went to urgent care Dx cellulitis, receiving BACTRIM.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 3 cm x 3 cm red, firm, warm circular area on upper left thigh.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Chills, Paraesthesia, Vomiting
Clinical narrative: Pt. C/O vomiting x 4 episodes 1 hr post injection, tingling all over body and chills. Per provider gave BENADRYL 25 mg now, ZOFRAN 4 mg ODT now. No water/fluids for 30 min. May repeat ZOFRAN every 8 hours prn vomiting. Pt. to lay down for today and offer fluids when vomiting stops. If worsen seek medical attention.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Swelling, redness, itchy and very tender at injection site, per patient c/o headaches and diarrhea, fever.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Swelling, redness, itchy and very tender at injection site, per patient c/o headaches and diarrhea, fever.
Age: 14.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: Hives, redness and swelling.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Arthropathy, Impaired work ability, Joint crepitation, Joint range of motion decreased, Pain
Clinical narrative: Not enough room to list all. Lost range of motion "slippy shoulder". "Crunchy" in joint, felt like slush in joint. Painful moving. Wakes me up I can no longer work at my career of 21 years as a dancer.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Sleep disorder, X-ray
Clinical narrative: Not enough room to list all. Lost range of motion "slippy shoulder". "Crunchy" in joint, felt like slush in joint. Painful moving. Wakes me up I can no longer work at my career of 21 years as a dancer.
Age: 46.0
Sex: M
Vaccine: TTOX
Symptoms: Diarrhoea
Clinical narrative: I sustained a deep wound/laceration on Sunday, April 30, 2017. I went to Hospital on Monday, May 1, 2017 and I received stitches and a Tetanus vaccine. I have severe diarrhea as a result.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Erythema, Swelling
Clinical narrative: Pt. had vaccination 8 day before redness. Less likely vaccination produce redness and swelling, most likely insect bite.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Ultrasound scan normal
Clinical narrative: Pt. was given TDaP 5/1/17. Redness to area of (R) deltoid hours after adm. which progressed to an extensive area of induration which appeared to an extensive area of induration which appeared to be cellulitis. NP was consulted. U/S of (R) arm done which was (-). Cellulitis Dx. KEFLEX x 10 days.
Age: 45.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Initial unsolicited report received from a healthcare professional (medical assistance at physician office) on 21 April 2017. This case involves a 45-year-old female patient who was vaccinated with a 0.5 ml single dose of Influenza Vaccine (QUAD) (Manufacture: unknown, batch number: JU15629NA, expiry date: 30-JUN-2017) in right arm by intramuscularly on 09 November 2016. Patient's ongoing illness, medical history and concomitant medications were not reported. On 09 November 2016, same day following the vaccination, the patient had experienced muscle/ upper right arm soreness at injection site (reported as five month ago) and on an unspecified date, post vaccination patient had difficulty lifting arm. Lab data was not reported. The patient received corrective treatment with FLECTOR patches. The patient was not recovered from the event, it was reported that pain was persists. List of documents held by sender: none.
Age: 45.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Initial unsolicited report received from a healthcare professional (medical assistance at physician office) on 21 April 2017. This case involves a 45-year-old female patient who was vaccinated with a 0.5 ml single dose of Influenza Vaccine (QUAD) (Manufacture: unknown, batch number: JU15629NA, expiry date: 30-JUN-2017) in right arm by intramuscularly on 09 November 2016. Patient's ongoing illness, medical history and concomitant medications were not reported. On 09 November 2016, same day following the vaccination, the patient had experienced muscle/ upper right arm soreness at injection site (reported as five month ago) and on an unspecified date, post vaccination patient had difficulty lifting arm. Lab data was not reported. The patient received corrective treatment with FLECTOR patches. The patient was not recovered from the event, it was reported that pain was persists. List of documents held by sender: none.
Age: 80.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable medical assistant on behalf of a physician. A 80-year-old female patient received on 20Apr2017 14.30 the first dose of PREVNAR 13, (lot number S15227, expiration date 28Feb2018, NDC number 0005-1971-02) at 0.5 ml single dose in the left deltoid intramuscular for standard immunization in the physician office. Concomitant medications included simvastatin for high cholesterol, levobunolol for glaucoma, PLAVIX, ascorbic acid, retinol, OCUVITE, metoprolol tartrate, LUMIGAN, losartan, EPIPEN 2-PAK, dorzolamide, vitamin D3, fish oil, CALCIUM 500 and ASPIRIN, all started on an unspecified date and ongoing. Medical history included high cholesterol from an unknown date, hypertension and pre-glaucoma both from 20Nov2016, all ongoing. On 21Apr2017, the patient experienced redness of left deltoid around the injection site, little bit of swelling and left arm soreness. All the events were considered related to pneumococcal 13-val conj vac (dipht crm197 protein). It was also reported that the patient had an allergic reaction to pneumococcal 13-val conj vac (dipht crm197 protein) (Apr2017). The events were evaluated at the physician office: the patient did not come into the office until 28Apr2017. Outcome was unknown (unsure if the events had resolved at the present time).
Age: 80.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Pain in extremity, Vaccination complication
Clinical narrative: This is a spontaneous report from a contactable medical assistant on behalf of a physician. A 80-year-old female patient received on 20Apr2017 14.30 the first dose of PREVNAR 13, (lot number S15227, expiration date 28Feb2018, NDC number 0005-1971-02) at 0.5 ml single dose in the left deltoid intramuscular for standard immunization in the physician office. Concomitant medications included simvastatin for high cholesterol, levobunolol for glaucoma, PLAVIX, ascorbic acid, retinol, OCUVITE, metoprolol tartrate, LUMIGAN, losartan, EPIPEN 2-PAK, dorzolamide, vitamin D3, fish oil, CALCIUM 500 and ASPIRIN, all started on an unspecified date and ongoing. Medical history included high cholesterol from an unknown date, hypertension and pre-glaucoma both from 20Nov2016, all ongoing. On 21Apr2017, the patient experienced redness of left deltoid around the injection site, little bit of swelling and left arm soreness. All the events were considered related to pneumococcal 13-val conj vac (dipht crm197 protein). It was also reported that the patient had an allergic reaction to pneumococcal 13-val conj vac (dipht crm197 protein) (Apr2017). The events were evaluated at the physician office: the patient did not come into the office until 28Apr2017. Outcome was unknown (unsure if the events had resolved at the present time).
Age: 71.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injection site bruising, Injection site pain, Mobility decreased, Musculoskeletal pain, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer-sponsored program. A 71-year-old male patient received PREVNAR 13; (NDC number 00005197102; Expiry Date Dec 2017; lot N97935), on 26Apr2017 in deltoid of the left arm at 0.5 ml single for pneumonia.  Medical history was none. On an unspecified date the patient complained of left arm bruising and he also experienced upper arm and shoulder pain and trouble lifting that arm despite being treated with ice packs and TYLENOL; on 02May2017 swelling of left foot occurred. Patient was advised to make an appointment with his primary care physician. Patient was still experiencing bruising, upper arm and shoulder pain and swelling of left; outcome of trouble lifting left arm was unknown.
Age: 71.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Contusion, Injected limb mobility decreased, Injection site pain, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer-sponsored program. A 71-year-old male patient received PREVNAR 13; (NDC number 00005197102; Expiry Date Dec 2017; lot N97935), on 26Apr2017 in deltoid of the left arm at 0.5 ml single for pneumonia.  Medical history was none. On an unspecified date the patient complained of left arm bruising and he also experienced upper arm and shoulder pain and trouble lifting that arm despite being treated with ice packs and TYLENOL; on 02May2017 swelling of left foot occurred. Patient was advised to make an appointment with his primary care physician. Patient was still experiencing bruising, upper arm and shoulder pain and swelling of left; outcome of trouble lifting left arm was unknown.
Age: 37.0
Sex: M
Vaccine: HEPAB
Symptoms: C-reactive protein normal, Contusion, Haematocrit normal, Haemoglobin normal, International normalised ratio normal
Clinical narrative: Significant and widespread bruising on forearm of the R arm WITHOUT local reaction at site of injection on R; also with 3 bruises each >1 inch on contralateral (left) arm. no petechiae.
Age: 37.0
Sex: M
Vaccine: HEPAB
Symptoms: Laboratory test normal, Metabolic function test normal, Platelet count normal, Red blood cell sedimentation rate normal
Clinical narrative: Significant and widespread bruising on forearm of the R arm WITHOUT local reaction at site of injection on R; also with 3 bruises each >1 inch on contralateral (left) arm. no petechiae.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding patient's concurrent conditions, medical history and concomitant therapies was reported. On 07-APR-2017, the patient received improperly stored dose of ROTATEQ administered orally (dose was not provided) lot # M039061, expiration date: 28-APR-2018. The vaccine was stored in temperature of 33.8 degrees Fahrenheit (F) for 42 minutes. There was no previous temperature excursion. Temperature excursion was detected by Digital Data Logger. No symptoms were reported. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician (who was the patient's spouse) via a company representative and refers to a 48-year-old female patient. There was no information about the patient's concurrent conditions, drug reactions or allergies or medical history provided. On 10-MAR-2017, the patient was vaccinated with a dose of ZOSTAVAX injection, 0.65 ml, in left arm (lot #: M032139, expiration date: 02-OCT-2017, route of administration was not reported) for prevention of shingles. ZOSTAVAX was reconstituted with a sterile diluent (manufacturer unknown) injection (lot#, expiration date, dose and route of administration were not provided). There were no concomitant therapies reported. On 11-MAR-2017, next day after the vaccination, the patient developed shingles on upper-right side of her body. The patient sought medical attention by seeing a physician. On an unknown date in 2017, the patient was given valacyclovir hydrochloride (VALTREX) for 3 weeks as a treatment of shingles. On an unspecified date in 2017, the patient improved and she discontinued therapy with valacyclovir hydrochloride (VALTREX) for two days. After that (unspecified date in 2017), the symptoms came back. At the time of this report, the patient was back on therapy with valacyclovir hydrochloride (VALTREX). The outcome of shingles (herpes zoster) was reported as not recovered. The relatedness between the event of shingles and the suspect therapies was not reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a female patient of an unknown age. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter stated that on 07-APR-2017, the patient was vaccinated with an expired dose of GARDASIL 9 intramuscularly, lot number reported as: L039066, expiration date: 19-MAR-2017 (strength, anatomical location, dose, and frequency were not provided) for prophylaxis. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of an unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The nurse reported that the patient was vaccinated with a dose of VARIVAX lot number: M039317, expiration date: 20-SEP-2018 (strength, anatomical location, dose, frequency, and route of administration were not provided) for prophylaxis, which was reconstituted with a sterile diluent, instead of a dose of ZOSTAVAX due to a human error. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist and refers to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. It was reported by the pharmacist that from 27-FEB-2017 to 24-APR-2017, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot # N003993, expiration date 20-OCT-2018; dose, route of administration, and frequency were not reported), for prophylaxis. The vaccine data logger measured a temperature range from 47 degrees Fahrenheit (F) to 77 degrees F for a total time frame of 15 minutes. There was no previous temperature excursion. No adverse effects were reported, and a product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA014153:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site reaction, Injection site swelling, Skin lesion
Clinical narrative: Information has been received from an Health Professional referring to a 4 year old male patient. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. On 06-APR-2017, at 16:01 the patient was vaccinated with a third dose of PROQUAD, subcutaneously on the left leg lot # M042500 (expiration date was not provided), for prophylaxis. On that same date, at 14:04 the patient experienced that his lef thig leg was slight swollen with lesion that looked like and was treated like an insect bite. At the time of reporting, the outcome of the events injection site swelling and arthropod bite was unknown. Additionally, the reporter did not provided causal relationship between the events and vaccination with PROQUAD. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old male patient. The patient's concurrent conditions, concomitant medications, drugs reactions and allergies were not reported. The patient received PREVNAR in January 2016. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route and site of administration, lot # and expiry date were not reported) for prophylaxis. On an unspecified date in April 2017, reported as "last week", the patient was hospitalized for an unknown reason. The pharmacist was not sure if the patient received PNEUMOVAX 23 in the hospital. The pharmacist was unable to obtain record of vaccination from the hospital. The outcome of the event that caused hospitalisation was unknown. The relatedness between the event and PNEUMOVAX 23 was not provided. Additional information has been requested.