chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 30th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 16th January 2019, 17 days after receiving SHINGRIX, the patient experienced blister, rash and chest pain. On an unknown date, the patient experienced shingles, injection site pain, headache, influenza-like symptoms and pain in arm. The patient was treated with antivirals for systemic use (Antiviral). On an unknown date, the outcome of the shingles, blister, rash and chest pain were unknown and the outcome of the injection site pain, headache, influenza-like symptoms and pain in arm were recovered/resolved. It was unknown if the reporter considered the shingles, injection site pain, headache, influenza-like symptoms, pain in arm, blister, rash and chest pain to be related to SHINGRIX. Additional information was provided as follows: The reporter was reporting adverse event for her husband. The patient received a dose of SHINGRIX and experienced pain at injection site, headache, flu like symptoms, and sore arm. Everything lasted for one day except the sore arm which lasted for about 3 days. About 2 weeks post vaccination the patient experienced a rash, blisters and chest pain from rib cage to the neck and to the back area. He went to the doctor right away on 16th January 2019. He was then diagnosed with Shingles and he was started on antiviral medications. Consented to follow up was provided. No further details were provided. This is 1 of the 2 cases reported by same reporter. There is an inconsistent information provided by the reporter with respect time to onset. As per reported statement (About 2 weeks post vaccination) it is 14 days for a rash, blisters and chest pain; however, as per narrative description (He went to the doctor right away on 16th January 2019) it is 17 days. As the patient went right away to the physician after experiencing the adverse events the time to onset has been kept according to it.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was unknown. It was unknown if the reporter considered the general body pain to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's wife. The age at vaccination was not reported. After vaccination, the patient experienced body aches. The reporter did not consent to follow-up. Unable to obtain additional information because a reporter needed to end the call.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site swelling, Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 62-year-old female patient who received SHINGRIX (batch number A2JL7, expiry date 22nd March 2021) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site swelling, injection site induration, headache, myalgia, injection site erythema and skin reaction. On an unknown date, the outcome of the injection site swelling, injection site induration, headache, myalgia, injection site erythema and skin reaction were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site induration, headache, myalgia, injection site erythema and skin reaction to be related to SHINGRIX. Additional details were provided as follows: The patient experienced a number of adverse events after her 1st dose of SHINGRIX that lasted for 2 weeks. Consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 62-year-old female patient who received SHINGRIX (batch number A2JL7, expiry date 22nd March 2021) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site swelling, injection site induration, headache, myalgia, injection site erythema and skin reaction. On an unknown date, the outcome of the injection site swelling, injection site induration, headache, myalgia, injection site erythema and skin reaction were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site induration, headache, myalgia, injection site erythema and skin reaction to be related to SHINGRIX. Additional details were provided as follows: The patient experienced a number of adverse events after her 1st dose of SHINGRIX that lasted for 2 weeks. Consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included flu vaccines with an associated reaction of headache (flu vaccines received in the past on an unknown date, refer case US2019GSK013000). On 12th August 2018, the patient received the 1st dose of SHINGRIX. On 12th August 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, headache, general body pain, upset stomach and tiredness. On an unknown date, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the pain in arm, headache, upset stomach and influenza-like symptoms were recovered/resolved and the outcome of the general body pain and tiredness were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, headache, general body pain, upset stomach, tiredness and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient who herself was the Nurse. On the same day of vaccination, at night the patient experienced arm hurts, headache, achy all over, upset stomach and tired. The patient also experienced mild flu like symptoms and which was lasted about 24 to 36 hours. The patient's arm really hurt when she tried to lift her arm and that did not go away until the fifth day or so. The patient did not want to provide her address. The reporter told that, the representative could call her if needed. The reporter consented to follow up. This is 1 of the 2 cases reported by same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included flu vaccines with an associated reaction of headache (flu vaccines received in the past on an unknown date, refer case US2019GSK013000). On 12th August 2018, the patient received the 1st dose of SHINGRIX. On 12th August 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, headache, general body pain, upset stomach and tiredness. On an unknown date, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the pain in arm, headache, upset stomach and influenza-like symptoms were recovered/resolved and the outcome of the general body pain and tiredness were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, headache, general body pain, upset stomach, tiredness and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient who herself was the Nurse. On the same day of vaccination, at night the patient experienced arm hurts, headache, achy all over, upset stomach and tired. The patient also experienced mild flu like symptoms and which was lasted about 24 to 36 hours. The patient's arm really hurt when she tried to lift her arm and that did not go away until the fifth day or so. The patient did not want to provide her address. The reporter told that, the representative could call her if needed. The reporter consented to follow up. This is 1 of the 2 cases reported by same reporter.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received SHINGRIX for prophylaxis. In December 2018, the patient received the 1st dose of SHINGRIX. In December 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however it could be 66 or 67 years. A little over 1 month ago from the date of reporting, the patient received a dose of SHINGRIX. The patient had pain at the injection site that started immediately after receiving the dose of SHINGRIX, and did not resolve at the time of this report. The reporter did not give consent to follow up. At the time of this report, the patient still has a sharp pain in his arm where the shot was injected.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a female patient who received SHINGRIX for prophylaxis. On 20th October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain and influenza like illness. On an unknown date, the outcome of the general body pain and influenza like illness were recovered/resolved. It was unknown if the reporter considered the general body pain and influenza like illness to be related to SINGRIX. Additional details were provided as follows: The case was reported by the patient's husband. The age at vaccination was not reported. The patient experienced body aches and feeling like she had the flu. The patient felt like this for about 4 days after the 1st dose of SHINGRIX. When asked if the patient reported these side effects to her doctor the reporter said no. No additional information was available.
Age: 58.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Lip blister, Malaise, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 58-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included FLUZONE for prophylaxis. On 31st August 2018, the patient received SHINGRIX and FLUZONE (INACTIVATED INFLUENZA VACCINE). On 1st September 2018, 1 days after receiving SHINGRIX, the patient experienced fever, malaise, pain and lip blister. The patient was treated with steroids nos (Steroid (Not Specified)). On an unknown date, the outcome of the fever, malaise, pain and lip blister were recovered/resolved. It was unknown if the reporter considered the fever, malaise, pain and lip blister to be related to SHINGRIX. Additional details were reported as follows: The patient received a dose of SHINGRIX and a dose of FLUZONE and the following day the patient stated they developed fever, malaise, aches, lip blisters. The patient sought medical care on 7th September 2018 that included steroid treatment. The patient's symptoms were resolved in a couple of weeks. The reporter consented to follow up. The reporter did not have vaccine information for this adverse event.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: Severe arm pain in muscles, light fever and chills, some nausea on day one.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pyrexia, Tremor
Clinical narrative: High fever, shivering/shaking, mild headache, some nausea.
Age: 41.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Patient came in for prenatal care at the OB/GYN department. According to OB/GYN provider assessment patient's last menstrual period was on 11/28/18 and patient received Varicella vaccine on 12/19/2018 at her primary care's office at another facility. Patient's estimated date of delivery is 09/04/2019.
Age: 41.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Patient came in for prenatal care at the OB/GYN department. According to OB/GYN provider assessment patient's last menstrual period was on 11/28/18 and patient received Varicella vaccine on 12/19/2018 at her primary care's office at another facility. Patient's estimated date of delivery is 09/04/2019.
Age: 62.0
Sex: M
Vaccine: FLUX
Symptoms: Crying, Injection site pain, Pain, Sleep disorder
Clinical narrative: Received Flu vaccine in November. On 1/19, patient went home, took a nap and woke up 30 minutes later with severe pain on left shoulder. Pain was severe to the point of crying. If lift arm too high it hurt really bad; couldn't sleep on it either. Called doctor that day and went in and was given ice packs by nurse. Put ice packs but did not help at lot. Patient has not gone back yet to doctor; has appointment on 2/17, for possible blood cloth on leg. The pain at this point is mild and there is no visible swelling at injection point. Started taking VICTOZA med the day after vaccination.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Chest discomfort, Skeletal muscle enzymes, Vaccination complication
Clinical narrative: PATIENT FELT TIGHTNESS IN THE CHEST/ARM. WENT TO EMERGENCY ROOM WHERE TESTS SHOWED MUSCLE ENZYMES IN THE BLOOD. CARDIAC EVENT WAS RULED OUT & LUNGS WERE CLEAR. DR ADVISED THAT IT WAS A REACTION TO VACCINE.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Chills, Nausea, Pyrexia
Clinical narrative: Fever 100 to 101 deg., chills, stomach pain, a little nausea, weak. Fever for two days and the rest of the symptoms four days.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Vaccine was received on 1/25/19, patient reported event to pharmacy on 1/28/19. Reported 3 inch circle in diameter, that is red, raised an hot to the touch. Patient did not have a reaction to the first dose of SHINGRIX or to any other past vaccines.
Age: 53.0
Sex: F
Vaccine: HEP, TYP
Symptoms: Abdominal discomfort, Abdominal pain upper, Diarrhoea, Fatigue, Headache
Clinical narrative: One hour after ingesting a single dose of the oral typhoid vaccine developed a headache and abdominal discomfort. Took TYLENOL without relief. Approximately three hours later describes headache as "massive" and severe "stomach pain". Vomiting and loose stools came about in the "late morning" which lasted for "hours". Decided to go to bed to sleep it off. Awakened the following morning feeling fatigued but improved. Felt like her usual self by the evening of 1/25/2019.
Age: 53.0
Sex: F
Vaccine: HEP, TYP
Symptoms: Vomiting
Clinical narrative: One hour after ingesting a single dose of the oral typhoid vaccine developed a headache and abdominal discomfort. Took TYLENOL without relief. Approximately three hours later describes headache as "massive" and severe "stomach pain". Vomiting and loose stools came about in the "late morning" which lasted for "hours". Decided to go to bed to sleep it off. Awakened the following morning feeling fatigued but improved. Felt like her usual self by the evening of 1/25/2019.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site became swollen, enlarged, red, itchy and painful.
Sex: U
Vaccine: HEP, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-JAN-2019, the patient was vaccinated with a dose of VARIVAX, via the intramuscular route in error (lot# and expiration date were not reported) for prophylaxis, and during the same visit, he or she was inadvertently given a dose of RECOMBIVAX HB 10/1.0 microgram/milliliter injection, lot # R015160, expiration date 09-NOV-2020, via the subcutaneous route. No adverse effects were reported in the patient.
Sex: F
Vaccine: PPV
Symptoms: Breast cancer female
Clinical narrative: This spontaneous report was received from a retired nurse referring to herself of unknown age. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided. On an unknown date "years ago", the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date "a few years ago", the patient developed breast cancer. When patient started therapy could not be confirmed to be after she developed breast cancer. The outcome of breast cancer was unknown. The causality between PNEUMOVAX 23 and breast cancer was not provided. Upon internal review, breast cancer was determined to be medically significant.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-JAN-2019, the patient was vaccinated with expired dose of M-M-R II for prophylaxis (dose, strength, route of administration , lot # were not reported, expiration date 22-JAN-2019). The reporter stated that the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) did not have any temperature excursions prior to administration. No adverse symptoms were reported.  The outcome of the events was unknown. Causality assessment was not provided.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: She did not develop rash until 09Dec2018, 6 weeks later. It is all over her body (except face) and itches like crazy; This is a spontaneous report from a contactable consumer who reported for herself, a 71-year-old female patient who received PREVNAR 13, (lot number and expiration date unknown), via an unspecified route of administration on Oct2018 (either 25Oct2018 or 26Oct2018) at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she did not develop rash until 09Dec2018, 6 weeks later. It was all over her body (except face) and itched like crazy. The outcome of the event was unknown. Information on the lot/batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a contactable consumer via a Pfizer Sales representative. A patient of unspecified age (Age: Over 65; Unit: Unknown) and gender received PREVNAR 13 at single dose, PNEUMOVAX at unknown dose, both with route of administration, therapy date unspecified, single for immunization. The patient's medical history and concomitant medications were not reported. The patient had both vaccines, still got pneumonia and was hospitalized on an unspecified date with outcome of unknown. No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A patient of unspecified age and gender started to receive PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain at injection site on an unspecified date. Outcome of the event was unknown.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable physician. An 85-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (trade name unknown, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that patient had allergies: pneumonia vaccine: severe swelling of site. Outcome of the events was unknown. Pfizer is a Marketing Authorization Holder of [Pneumococcal 13-Val Conj Vac] in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of [Pneumococcal 13-Val Conj Vac] has submitted the same report to the regulatory authorities.
Age: 1.5
Sex: F
Vaccine: DTAPIPV, IPV
Symptoms: Wrong product administered
Clinical narrative: DTaP was ordered but the MA mistakenly gave KINRIX. She read Dtap on the box and failed to note it was Dtap-Ipv. The child also received IPV. Patient's mother was contacted when the mistake was discovered on 1/25/19. Patient's mother stated that she did not note any reaction at the site of injection or any other reaction up to that point.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Urinary incontinence
Clinical narrative: Right upper arm redness and swelling, urinary incontinence lasting 4 days. Went to urgent care to receive doxycycline antibiotic.
Age: 47.0
Sex: M
Vaccine: TD
Symptoms: Abdominal pain, Blood test, Colitis, Colonoscopy, Computerised tomogram
Clinical narrative: Shortly after injection area is raised, warm and red. Pt said he felt like toxins were running through his body. By the next morning he was experiencing abdominal, intestinal and rectal pains. He made a number of visits and complaints to his primary care doctor. He now has hard to control Bowel Dysfunctions-IBD & IBS  and colitits, colon inflammation. Tests and scans have been performed with no cure or resolutions. Primary care says we may not figure out what exactly happened and pt may have to deal with the continuous pains and bowel disorders as best as possible through medications, diet etc
Age: 47.0
Sex: M
Vaccine: TD
Symptoms: Functional gastrointestinal disorder, Gastrointestinal pain, Inflammatory bowel disease, Injection site erythema, Injection site swelling
Clinical narrative: Shortly after injection area is raised, warm and red. Pt said he felt like toxins were running through his body. By the next morning he was experiencing abdominal, intestinal and rectal pains. He made a number of visits and complaints to his primary care doctor. He now has hard to control Bowel Dysfunctions-IBD & IBS  and colitits, colon inflammation. Tests and scans have been performed with no cure or resolutions. Primary care says we may not figure out what exactly happened and pt may have to deal with the continuous pains and bowel disorders as best as possible through medications, diet etc
Age: 47.0
Sex: M
Vaccine: TD
Symptoms: Injection site warmth, Irritable bowel syndrome, Proctalgia
Clinical narrative: Shortly after injection area is raised, warm and red. Pt said he felt like toxins were running through his body. By the next morning he was experiencing abdominal, intestinal and rectal pains. He made a number of visits and complaints to his primary care doctor. He now has hard to control Bowel Dysfunctions-IBD & IBS  and colitits, colon inflammation. Tests and scans have been performed with no cure or resolutions. Primary care says we may not figure out what exactly happened and pt may have to deal with the continuous pains and bowel disorders as best as possible through medications, diet etc
Age: 41.0
Sex: F
Vaccine: ANTH, FLU4
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Left arm got swollen, red, warm to touch and itching around the area on Friday - Sunday (two days after vaccine was admnistered).
Age: 21.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Dyspnoea, Erythema, Hypersensitivity, Injection site swelling, Injection site warmth
Clinical narrative: 1/24/19 received Varicella vaccine in left arm and waited 20 min at health center to watch for initial injection reaction, which was none. (pt also received MMR #1 and Hep A #1 in right arm at same time of Varicella administration). 1/25/19 pt woke up in morning to right arm swelling, itching, pain and redness. Pt did not consult clinician or take any medications. 1/26/19- pt decided to self medicate with BENADRYL, which did not help. 1/27/19 pt woke up and noticed "red bumps on jawline" and "felt the need to clear her throat and stated possibly more difficult to breathe". Pt went to urgent care facility and received Dx of allergic reaction to vaccine. She was prescribed Prednisone 50mg PO, ZYRTEC and Famotidine. Pt states "within hours the rash on my face resolved. Pt denies any Shortness of breath or dyspnea. 1/28/19 pt saw Dr. at Health Center where vaccine was given. Some local swelling, warmth noted on right tricep but symptoms are resolving. No Shortness of breath or dyspnea. Rashes resolved. Per Dr., discontinue prednisone today due to potential reaction with varicella and MMR vaccine to reduce their effectiveness. No other medication or treatment needed. Pt to return as needed for additional needs or concerns.
Age: 21.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pain, Peripheral swelling, Pruritus, Rash, Rash erythematous
Clinical narrative: 1/24/19 received Varicella vaccine in left arm and waited 20 min at health center to watch for initial injection reaction, which was none. (pt also received MMR #1 and Hep A #1 in right arm at same time of Varicella administration). 1/25/19 pt woke up in morning to right arm swelling, itching, pain and redness. Pt did not consult clinician or take any medications. 1/26/19- pt decided to self medicate with BENADRYL, which did not help. 1/27/19 pt woke up and noticed "red bumps on jawline" and "felt the need to clear her throat and stated possibly more difficult to breathe". Pt went to urgent care facility and received Dx of allergic reaction to vaccine. She was prescribed Prednisone 50mg PO, ZYRTEC and Famotidine. Pt states "within hours the rash on my face resolved. Pt denies any Shortness of breath or dyspnea. 1/28/19 pt saw Dr. at Health Center where vaccine was given. Some local swelling, warmth noted on right tricep but symptoms are resolving. No Shortness of breath or dyspnea. Rashes resolved. Per Dr., discontinue prednisone today due to potential reaction with varicella and MMR vaccine to reduce their effectiveness. No other medication or treatment needed. Pt to return as needed for additional needs or concerns.
Age: 21.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Throat irritation, Vaccination complication
Clinical narrative: 1/24/19 received Varicella vaccine in left arm and waited 20 min at health center to watch for initial injection reaction, which was none. (pt also received MMR #1 and Hep A #1 in right arm at same time of Varicella administration). 1/25/19 pt woke up in morning to right arm swelling, itching, pain and redness. Pt did not consult clinician or take any medications. 1/26/19- pt decided to self medicate with BENADRYL, which did not help. 1/27/19 pt woke up and noticed "red bumps on jawline" and "felt the need to clear her throat and stated possibly more difficult to breathe". Pt went to urgent care facility and received Dx of allergic reaction to vaccine. She was prescribed Prednisone 50mg PO, ZYRTEC and Famotidine. Pt states "within hours the rash on my face resolved. Pt denies any Shortness of breath or dyspnea. 1/28/19 pt saw Dr. at Health Center where vaccine was given. Some local swelling, warmth noted on right tricep but symptoms are resolving. No Shortness of breath or dyspnea. Rashes resolved. Per Dr., discontinue prednisone today due to potential reaction with varicella and MMR vaccine to reduce their effectiveness. No other medication or treatment needed. Pt to return as needed for additional needs or concerns.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Pain in extremity, Pruritus
Clinical narrative: One day after injection patient had a rash with pain and itching of left arm that worsened over the course of a week; seen in clinic with erythema, induration, and inflammation of left arm noted around injection site; instructed to take BENADRYL PO and apply ice and continue to monitor for signs of infection or worsening inflammation.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Rash
Clinical narrative: One day after injection patient had a rash with pain and itching of left arm that worsened over the course of a week; seen in clinic with erythema, induration, and inflammation of left arm noted around injection site; instructed to take BENADRYL PO and apply ice and continue to monitor for signs of infection or worsening inflammation.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Computerised tomogram, Seizure
Clinical narrative: HAD HPV9 SHOT ON 01/23/2019 AND HAD A FIRST SEIZURE ON 01/24/2019 IN THE MORNING. ON 01/24/2019, PT WENT TO ER AND HAD A 2ND SEIZURE AT ER AROUND 8:30 A.M. PRESCRIBED KEPRA 260MG BY MOUTH. HAD CAT SCAN AND SEEN BY NEUROLOGIST ON 01/26/2019. PT HAD THE 3RD SEIZURE LAST NIGHT ON 01/27/2019 AROUND 7:30 P.M.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Muscle spasms, Pyrexia
Clinical narrative: I had fever, chills and extreme stomach spasms that lasted for 6 to 7 hours.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Musculoskeletal stiffness
Clinical narrative: Arm stiff for several days.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Blood glucose normal, Dizziness, Fall, Injury, Nausea
Clinical narrative: Medical Assistant drew and administered the three vaccines. After the received the 3rd vaccination in his right arm, he had a vasovagal reaction. I was still in the room at the time. We saw that he was going to fall to the floor and he had slow controlled fall to the floor face down. He did hit his left cheek on the floor. He was rolled over onto his back. Within 30 seconds he was awake and alert. He has had one other similar vasovagal episodes while watching movies in health class, and his older bother has had vasovagal episodes when receiving vaccinations. He continued to feel nauseated and light headed for about 30 minutes after the episode. His blood sugar was 129. He was given applesauce and apple juice. He did have on episode of emesis after taking a bite of the applesauce, he was later able to tolerate. He was able to tolerate the apple juice. He remained in the office for 60 minutes after the episode, and was allowed to rest. Upon discharge home his VS BP 108/60, P 84, R 16, O2 sat 99%. He was awake and alert, and color pink. He went home with mom. I called mom around 1345, he was doing well. Again called on 1/25/19, he was doing well.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Presyncope
Clinical narrative: Medical Assistant drew and administered the three vaccines. After the received the 3rd vaccination in his right arm, he had a vasovagal reaction. I was still in the room at the time. We saw that he was going to fall to the floor and he had slow controlled fall to the floor face down. He did hit his left cheek on the floor. He was rolled over onto his back. Within 30 seconds he was awake and alert. He has had one other similar vasovagal episodes while watching movies in health class, and his older bother has had vasovagal episodes when receiving vaccinations. He continued to feel nauseated and light headed for about 30 minutes after the episode. His blood sugar was 129. He was given applesauce and apple juice. He did have on episode of emesis after taking a bite of the applesauce, he was later able to tolerate. He was able to tolerate the apple juice. He remained in the office for 60 minutes after the episode, and was allowed to rest. Upon discharge home his VS BP 108/60, P 84, R 16, O2 sat 99%. He was awake and alert, and color pink. He went home with mom. I called mom around 1345, he was doing well. Again called on 1/25/19, he was doing well.
Age: 24.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Blindness, Skin laceration, Suture insertion, Syncope
Clinical narrative: Patient experience vasovagal syncope and LOS for approximately 10 seconds. Sustained a 4 cm laceration to right forehead. EMS was called and patient was treated in ED. 11 sutures placed. Imaging was not performed. ROS normal except as noted.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema at injection site, swelling of right thigh from hip to knee. Swelling and erythema began to improve within 24 hours. Erythema has resolved but some swelling still noted today.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis right lateral thigh at injection site of VARIVAX. Treated KEFLEX today. Expect it should resolve.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Muscle twitching, Rash vesicular
Clinical narrative: At 2 PM on the date of injection (1/24/19) the mother returned with her child stating that her legs were twitching uncontrollably even while the child slept. The child was evaluated and no loss of motor function or muscle spasms were observed so the mother was asked to return home and continue to monitor. On Monday 1/28/2019 the child returned to the office with a blistery rash on her leg at the injection site.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Hypersensitivity, Pain in extremity, Peripheral swelling
Clinical narrative: PREVNAR was administer on Tuesday 01/22/2019 and 5 days later (Sunday) she came to the pharmacy and refer pain, redness and swelling in right arm. She said that the symptoms of redness and swelling appear in Sunday morning. The pharmacist that assist recommended her to visit the Emergency room. Today, I called the patient and patient Indicated that the Doctor evaluated and administer BENADRYL IV and said that was allergy reaction.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Petechiae, Pruritus
Clinical narrative: Red, swollen from elbow to shoulder on 1/28/19 no skin breakdown, fever or chills pruritus back and arms petechaie front of calves as per patient's description.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Chills, Diarrhoea, Fatigue, Gastroenteritis viral
Clinical narrative: After receiving the injection - they had me sit down and stay for 10-15 minutes to make sure I had no reaction. I left, felt fine and did errands. The next day I woke up with severe chills, weak and tired. And my arm hurt where the shot had been given. I also had diarrhea - which according to the prescription info sheet, is not a side effect. I called the pharmacy - told them what happened and she asked if I was sick when I got the shot and I said "No". She guessed that maybe I had the "stomach flu". My husband heard on TV. that the "norovirus" was going around and that diarrhea was a symptom. So maybe it was that virus. Hard to say. I did feel better on Saturday - still a little bit tired and weak. But better than how I felt on Friday.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: After receiving the injection - they had me sit down and stay for 10-15 minutes to make sure I had no reaction. I left, felt fine and did errands. The next day I woke up with severe chills, weak and tired. And my arm hurt where the shot had been given. I also had diarrhea - which according to the prescription info sheet, is not a side effect. I called the pharmacy - told them what happened and she asked if I was sick when I got the shot and I said "No". She guessed that maybe I had the "stomach flu". My husband heard on TV. that the "norovirus" was going around and that diarrhea was a symptom. So maybe it was that virus. Hard to say. I did feel better on Saturday - still a little bit tired and weak. But better than how I felt on Friday.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Presented at doctor's office on 1-24-19. Leg was red and raised in the injection site on LVL - left thigh. There was no pain present upon touching and pressing. Fever was present in child of 101.3 oral. BENADRYL was recommended if itching became present. Child had all of the vaccines prior with no reaction except the KINRIX was a combined shot of DTAP and Polio. Child has had 5 doses of DTAP and 4 doses of IPV. 2 doses of varicella and 2 doses of MMR. Vaccines given on RVL - Rt thigh was MMR and LVL - Left thigh - KINRIX and varicella.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Injection was given in left arm (possible too low). Caused swelling, redness that spread down the arm.
Sex: U
Vaccine: PNC13
Symptoms: Facial paralysis, Gait inability, Guillain-Barre syndrome, Musculoskeletal stiffness, Swallow study
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer Sales Representative. A patient of unspecified age and gender received PREVNAR 13, expiry date: 30Sep2020, lot number: X11327), via an unspecified route of administration on 27Dec2018 at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously took flu shot for immunization on 28Sep2018. After patient was given PREVNAR 13, the patient presented with muscle stiffness during office visit on 07Jan2019 and then on 08Jan2019, walking became impaired and patient was hospitalized. The patient also experienced Guillain-Barre syndrome, then unable to walk, some facial paralysis, but passed swallow test. Patient was in-patient rehab at time of the report. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected. Sender's Comments: Currently there is no plausible mechanism to establish a causal relationship between the occurrence of the events muscle stiffness, walking became impaired, Guillain-Barre syndrome, facial paralysis and the administration of the suspect vaccine in the individual case. More information such as medical history, concomitant medications and workup details are needed for fully medical assessment. 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.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Pyrexia, Rhinorrhoea
Clinical narrative: Pt experience soreness on back torso, low grade fever and profuse runny nose. Advise pt to take antihistamine (CLARITIN or ZYRTEC) pt have available and take TYLENOL for fever. Advise pt to see medical attention if worsen or doesn't subside in next few days.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Urticaria
Clinical narrative: Shot was given on 9-24-18 - hives started on 9-27-18. Went to local clinic. Was given a short course of prednisone-50mg for 5 days. Helped for one week - then the hives started again. On Nov 27, 2018 went to Dr. - suggested antihistamine and clobetasol topically - helped but no cure. Had blood drawn on Dec. 31, 2018 to look for food allergies.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema multiforme, Pain
Clinical narrative: Erythema multiform and pain. Treatment: Diphenhydramine 25 mg PRN, betamethasone Unknown.
Age: 1.5
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: No difficulty at time of vaccine. Within hours increased redness, swelling and warmth. Pharmacist advised NSAID and BENADRYL at HS. Today area has increased in size presents for eval. Has taken no add'l. meds. Plan: NSAID 2-3 x 1D PO, cold compresses, BENADRYL PM. F/U if not resolved.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Erythema, Oedema, Urticaria
Clinical narrative: Urticaria, edema, erythema.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Pain
Clinical narrative: Pain in upper left arm and shoulder next day, could not lift arm above shoulder for 2 days was very painful lifting arm above head x 4 weeks.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chest X-ray normal, Computerised tomogram head normal, Dizziness, Electrocardiogram abnormal
Clinical narrative: Muscle pain (day of shot). Dizziness and syncope (2 days after shot). (L) arm swelling, weakness.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Peripheral swelling, Sinus bradycardia, Syncope
Clinical narrative: Muscle pain (day of shot). Dizziness and syncope (2 days after shot). (L) arm swelling, weakness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site induration, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Burning, sore, itchy at site. Area was hard and localized rash. Patient felt exhausted for 2 days. Patient took Ibuprofen; will take BENADRYL after work today.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pt states today 1/28/19 that his arm still hurts from the SHINGRIX vaccine given on 8/26/18. He hasn't seen a MD about it, or taken any meds for it. On a scale of 1 to 10 (10 being most severe) he would describe the pain as 2 or 3.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Malaise, Pyrexia
Clinical narrative: Chills began 1/25 evening, felt feverish - temp taken on 1/26/2019 in the morning: 100.2 orally.  Not feeling well. Redness at injection site. Very painful. Redness and pain still present on  1/28/2019. Chills and fever resolved after about 24 hours by evening on 1/26/2019.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Pain, Pruritus
Clinical narrative: Patient developed erythema and swelling over site of IM injection on right arm. No warm. Patient C/O minimal pain to palpation, had normal ROM, and stated arm felt itchy. Improved symptoms with hydrocortisone and BENADRYL given by parents. Afebrile throughout. Advised ice and antihistamines if helpful. No indication of infection of injection site. Spontaneously resolved with time.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection sight was red swollen and painful.
Age: 1.17
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Patient reported with a full body scattered rash and low grade fever.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pain in extremity, Pyrexia
Clinical narrative: Flu-like symptoms: fever, body aches, body chills, arm soreness.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Pyrexia
Clinical narrative: Pain at injection site. Generalized muscular aching. 102 degree fever.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Somnolence, Syncope
Clinical narrative: Patient came in on 1/27/19 and I gave him a SHINGRIX at around 2:30pm. I recommended him to sit for 10 minutes before leaving. His wife told him to sit down while she shopped. I went to get some vinyl gloves and a shopping cart. When I came back, I noticed him very sleepy while sitting on the chair. I settled my shopping cart for trash, and my gloves and paper work. Then I noticed him at the window, and all of a sudden he fainted and was on the floor. I paged his wife, and we stayed with him. He responded to my question, his breathing normal. After 15 minutes lying on the floor, we helped him walk to the chair. His wife mentioned that he had the same problem with drawing blood. He would stress and faint. However, his flu shot in Oct 2018 was fine. We recommended his wife to take him to urgent care to have his head checked out.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Bedridden, Fatigue, Influenza like illness, Injection site pain
Clinical narrative: I received my second SHINGLES shot at Pharmacy by Pharmacist on Friday at 10:00am. I alerted her of my less severe reaction from the first shot in April, 2018. Five hours after injection I began feeling weak and flu-like sensations (without diarrhea or vomiting) but weak and bed ridden. I was unable to play in my Friday night scheduled hockey game. The next day (Saturday) was spent in bed with heaviness and a very sore arm where the injection had taken place. It hurt to touch it or lean on it in bed. On Sunday I was still super weak but was able to walk and eat at the dinner table. We went for a drive at dinner time that wore me out. Monday I began feeling stronger and resumed most activities.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Limb discomfort, Loss of personal independence in daily activities
Clinical narrative: I received my second SHINGLES shot at Pharmacy by Pharmacist on Friday at 10:00am. I alerted her of my less severe reaction from the first shot in April, 2018. Five hours after injection I began feeling weak and flu-like sensations (without diarrhea or vomiting) but weak and bed ridden. I was unable to play in my Friday night scheduled hockey game. The next day (Saturday) was spent in bed with heaviness and a very sore arm where the injection had taken place. It hurt to touch it or lean on it in bed. On Sunday I was still super weak but was able to walk and eat at the dinner table. We went for a drive at dinner time that wore me out. Monday I began feeling stronger and resumed most activities.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Urticaria
Clinical narrative: Hives; urticaria within 24 hours of administration. History of giving elderberry x 1 week to help with immune support. Went to ED started on prednisolone. Continues to have breakthrough hives, managed with BENADRYL.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Gout, Incomplete course of vaccination
Clinical narrative: Patient experienced his gout flare up  within 1 week of getting SHINGRIX vaccine leading to treatment with colchicine.  He decided to skip the subsequent vaccinations in the series due to possible side effect.
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, MENB, TDAP
Symptoms: Dizziness, Pallor
Clinical narrative: Patient is new to country without any vaccine records. She was advised to receive vaccines based on age, school vaccines required and recommendations to which parent and child agreed to. Patient after receiving 4 of 10 vaccines said she felt dizzy and was noted to appear pale. Halted vaccination at this time and proceeded to perform recovery treatment. Patient's head brought down between her knees, applied compress to neck and continually monitoring patient. At patient request, patient laid down on chairs with feet higher than heart until fully recovered.