chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: MEN
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 12-year-old female patient who received Men ACWY-CRM NVS (Meningitis ACWY vaccine (potential Menveo)) for prophylaxis. On 24th October 2013, the patient received the 1st dose of Meningitis ACWY vaccine (potential MENVEO). In October 2013, 1 day after receiving Meningitis ACWY vaccine (potential MENVEO), the patient experienced injection site pain, injection site lump, injection site warmth, injection site swelling, injection site erythema and local reaction. On an unknown date, the outcome of the injection site pain, injection site lump, injection site warmth, injection site swelling, injection site erythema and local reaction were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site lump, injection site warmth, injection site swelling, injection site erythema and local reaction to be related to Meningitis ACWY vaccine (potential MENVEO). Additional details were provided as follows: The case was reported by the mother of the patient. The patient got a meningitis vaccine to cover group A about 5 years ago. The mother does not know the brand name. The patient had pain at the injection site and a lot of swelling at the injection site. The patient developed a large red lump on her arm at the injection site. The lump was the size of a golf ball and very warm to the touch. It stayed like that for a couple of weeks. She started having those symptoms the next day after the injection. Reporter believed that her daughter had to go back to the office for a booster dose at 16 years.
Age: 12.0
Sex: F
Vaccine: MEN
Symptoms: Local reaction
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 12-year-old female patient who received Men ACWY-CRM NVS (Meningitis ACWY vaccine (potential Menveo)) for prophylaxis. On 24th October 2013, the patient received the 1st dose of Meningitis ACWY vaccine (potential MENVEO). In October 2013, 1 day after receiving Meningitis ACWY vaccine (potential MENVEO), the patient experienced injection site pain, injection site lump, injection site warmth, injection site swelling, injection site erythema and local reaction. On an unknown date, the outcome of the injection site pain, injection site lump, injection site warmth, injection site swelling, injection site erythema and local reaction were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site lump, injection site warmth, injection site swelling, injection site erythema and local reaction to be related to Meningitis ACWY vaccine (potential MENVEO). Additional details were provided as follows: The case was reported by the mother of the patient. The patient got a meningitis vaccine to cover group A about 5 years ago. The mother does not know the brand name. The patient had pain at the injection site and a lot of swelling at the injection site. The patient developed a large red lump on her arm at the injection site. The lump was the size of a golf ball and very warm to the touch. It stayed like that for a couple of weeks. She started having those symptoms the next day after the injection. Reporter believed that her daughter had to go back to the office for a booster dose at 16 years.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old female patient who received SHINGRIX) for prophylaxis. The patient's past medical history included liver transplant and immunosuppression. On 29th June 2018, the patient received the 1st dose of SHINGRIX. On 30th June 2018, 1 days after receiving SHINGRIX, the patient experienced fever. On 12th July 2018, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The patient experienced fever, primarily at night, which began one day after receiving the SHINGRIX vaccine. The patient took daily temperature readings which averaged about 101 degree F each day. On one unspecified day, the fever reached 103 degree F. At time of reporting, the patient noted that it was her first day without fever since the SHINGRIX injection.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Laboratory test, Pruritus, Rash maculo-papular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 76-year-old male patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. On 26th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 27th June 2018, 1 days after receiving SHINGRIX, the patient experienced headache, maculopapular rash and pruritus. On an unknown date, the outcome of the headache, maculopapular rash and pruritus were recovering/resolving. It was unknown if the reporter considered the headache, maculopapular rash and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine in the left deltoid. The patient experienced macular or papular rash. The patient had been in an out of doctor's office getting tests done for the symptoms he had experienced. No further details were provided. This case has been linked with case US2018124902 (wife's case), reported for by the same reporter. The reported batch number 3AF99 for Shingrix did not exist and updated to 3AF9E as per sales database.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pruritus, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 74-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. On 26th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 27th June 2018, 1 days after receiving SHINGRIX, the patient experienced headache, influenza-like symptoms, fever, chills, pruritus and maculopapular rash. On an unknown date, the outcome of the headache, influenza-like symptoms, fever, chills, pruritus and maculopapular rash were recovering/resolving. It was unknown if the reporter considered the headache, influenza-like symptoms, fever, chills, pruritus and maculopapular rash to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine in the left deltoid. The patient experienced macular or papular rash. The patient had been in an out of doctor's office getting tests done for the symptoms she had experienced. No further details were provided. This case has been linked with case US2018124901 (husband's case), reported for by the same reporter. The reported batch number 3AF99 for SHINGRIX did not exist and updated to 3AF9E as per sales database.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash maculo-papular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 74-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. On 26th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 27th June 2018, 1 days after receiving SHINGRIX, the patient experienced headache, influenza-like symptoms, fever, chills, pruritus and maculopapular rash. On an unknown date, the outcome of the headache, influenza-like symptoms, fever, chills, pruritus and maculopapular rash were recovering/resolving. It was unknown if the reporter considered the headache, influenza-like symptoms, fever, chills, pruritus and maculopapular rash to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine in the left deltoid. The patient experienced macular or papular rash. The patient had been in an out of doctor's office getting tests done for the symptoms she had experienced. No further details were provided. This case has been linked with case US2018124901 (husband's case), reported for by the same reporter. The reported batch number 3AF99 for SHINGRIX did not exist and updated to 3AF9E as per sales database.
Sex: M
Vaccine: MENB
Symptoms: Injection site induration, Injection site mass
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site lump in a 18-year-old male patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO (intramuscular). On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site lump and injection site induration. On an unknown date, the outcome of the injection site lump and injection site induration were unknown. It was unknown if the reporter considered the injection site lump and injection site induration to be related to BEXSERO. Additional information was received as follows: The caller stated that the patient was the son of the physician that the nurse worked with. The age at vaccination was not reported. The patient received BEXSERO on an unknown arm. The nurse reported that the patient experienced a hard lump at the injection site. The caller had limited information regarding the patient's demographics and details surround the event.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Influenza, Pneumonia, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly male patient who received Influenza vaccine Quadrivalent 2017-2018 season for prophylaxis. Co-suspect products included fluticasone propionate, salmeterol xinafoate (Advair Diskus) inhalation powder (batch number 7ZP6165, expiry date 31st March 2019) for product used for unknown indication and PNEUMOCOCCAL VACCINE (PNEUMONIA SHOT) for prophylaxis.  Concomitant products included amlodipine, lisinopril, proair (nos) (Proair) and tiotropium bromide (Spiriva). On 1st December 2017, the patient received Influenza vaccine Quadrivalent 2017-2018 season. In 2014, the patient started Advair Diskus (inhaled) 1 puff(s) twice daily (2 puff(s) daily). On 8th December 2017, the patient received PNEUMONIA SHOT. In January 2018, less than a year after receiving Influenza vaccine Quadrivalent 2017-2018 season and not applicable after starting Advair Diskus, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza and pneumonia (serious criteria GSK medically significant). Advair Diskus was continued with no change. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza and pneumonia were recovered/resolved. It was unknown if the reporter considered the vaccination failure, influenza and pneumonia to be related to Influenza vaccine Quadrivalent 2017-2018 season. It was unknown if the reporter considered the influenza and pneumonia to be related to Advair Diskus. Additional details were provided as follows: The age at vaccination was not reported. The wife of the patient was transferred from GSK PAP. This case was considered as suspected vaccination failure as the laboratory confirmation for influenza was not available at the time of reporting.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pyrexia, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 74-year-old female patient who received SHINGRIX for prophylaxis. On 11th July 2018, the patient received SHINGRIX. On 11th July 2018, less than a day after receiving SHINGRIX, the patient experienced chills, fever and influenza-like symptoms. On 13th July 2018, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved and the outcome of the chills, fever and influenza-like symptoms were recovering/resolving. It was unknown if the reporter considered the rash to be related to SHINGRIX. The reporter considered the chills, fever and influenza-like symptoms to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on an unknown arm. The patient developed flu-like symptoms of chills and fever on Wednesday and Thursday after the vaccination. Two days after vaccination, the patient developed a rash on her chest and neck on Friday.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Pain, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 13th March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, 1 day after receiving SHINGRIX, the patient experienced rash, pain and neuralgia. On an unknown date, the outcome of the rash was recovered/resolved and the outcome of the pain and neuralgia were recovering/resolving. It was unknown if the reporter considered the rash, pain and neuralgia to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that 24 to 72 hours after receiving SHINGRIX, the patient experienced slight rash and mild case of neuralgia. The patient still had lingering pain, at the time of reporting. The health care professional stated that the vaccine was not administered at his pharmacy so he did not have any vaccine information. The health care professional did not know when exactly the rash and neuralgia started but was sure it was within 24 to 72 hours.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 1st April 2018, the patient received SHINGRIX .5 ml. On 2nd April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site tenderness and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site tenderness and injection site warmth were unknown. It was unknown if the reporter considered the injection site erythema, injection site tenderness and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on an unknown arm. Twenty four hours after vaccination, the patient experienced redness, tenderness and hot to the touch at the injection site. There were no hives or signs of anaphylactic reaction. The reporter did not know which arm she was vaccinated. There was no information regarding resolution. The nurse had limited information. The nurse only had another healthcare professional's notes.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes ophthalmic, Vision blurred
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of herpes ophthalmic in a 78-year-old female patient who received SHINGRIX for prophylaxis. On 25th April 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a year after receiving SHINGRIX, the patient experienced herpes ophthalmic (serious criteria GSK medically significant) and blurred vision. The patient was treated with VALTREX, ZIRGAN and prednisone. On an unknown date, the outcome of the herpes ophthalmic was recovering/resolving and the outcome of the blurred vision was recovered/resolved. It was unknown if the reporter considered the herpes ophthalmic and blurred vision to be related to SHINGRIX. Additional details were provided as follow: This case was not reported to anyone previously. The patient received SHINGRIX on left arm. In late May, the patient developed ocular herpes and blurred vision. In June, the patient went to the healthcare professional (HCP) and was diagnosed with ocular herpes and blurred vision. The HCP put her on VALTREX, ZIRGAN and Prednisone. The patient had been advised to contact their physician and Product Information (PI) was offered. The patient had denied permission to contact their physician. No further information was available.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Pruritus, Rash
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of swelling in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced swelling, general body pain, headache, rash, pruritus and tiredness. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the swelling, headache, rash, pruritus and tiredness were recovered/resolved and the outcome of the general body pain was not recovered/not resolved. It was unknown if the reporter considered the swelling, general body pain, headache, rash, pruritus and tiredness to be related to SHINGRIX.  Additional details were reported as follows: The age at vaccination was not reported. Less than a month after vaccination, the patient experienced tiredness. This case has been linked with case US2018GSK127930, reported by the same reporter for the husband.
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of swelling in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced swelling, general body pain, headache, rash, pruritus and tiredness. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the swelling, headache, rash, pruritus and tiredness were recovered/resolved and the outcome of the general body pain was not recovered/not resolved. It was unknown if the reporter considered the swelling, general body pain, headache, rash, pruritus and tiredness to be related to SHINGRIX.  Additional details were reported as follows: The age at vaccination was not reported. Less than a month after vaccination, the patient experienced tiredness. This case has been linked with case US2018GSK127930, reported by the same reporter for the husband.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a 58-year-old male patient who received SHINGRIX for prophylaxis. On 13th July 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 14th July 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, chills, muscle pain, fever and headache. On an unknown date, the outcome of the influenza-like symptoms, chills, muscle pain, fever and headache were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, chills, muscle pain, fever and headache to be related to SHINGRIX. Additional details were reported as follows: The physician reported that the patient experienced side effects with SHINGRIX. Patient experienced symptoms the day after the injection and was still having all the symptoms as of the day of reporting. Transferred to Medical Information for follow up discussions.
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Incorrect route of drug administration, Swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of erythema in a female patient who received BOOSTRIX for prophylaxis. On an unknown date, the patient received BOOSTRIX (subcutaneous). On an unknown date, unknown after receiving BOOSTRIX, the patient experienced erythema, swelling and intramuscular formulation administered by other route. On an unknown date, the outcome of the erythema, swelling and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the erythema and swelling to be related to BOOSTRIX. Additional information was received as follows: This case was reported by Vaccine Program Coordinator. The age at vaccination was not reported. The patient might have received the BOOSTRIX via subcutaneous route, rather than intramuscular route, which led to incorrect route of vaccine administration. The patient's mother was under the impression that the dose was given subcutaneous. The patient's mother contacted the prescriber's office to report that, the patient experienced redness and swelling following the administration of the BOOSTRIX. No other information was reported. The reporter allowed for follow up from GlaxoSmithKline. The reporter was contacted. As there was no answer, a voice message was left.
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Epistaxis, Headache, Injection site pain, Neck pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of epistaxis in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 23 hrs after receiving SHINGRIX, the patient experienced epistaxis, injection site pain, vomiting, fever, neck pain, ear pain and headache. On an unknown date, the outcome of the epistaxis, injection site pain, vomiting, fever, neck pain, ear pain and headache were unknown. It was unknown if the reporter considered the epistaxis, injection site pain, vomiting, fever, neck pain, ear pain and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On Thursday, at 2:00 pm, the patient received the first shot of SHINGRIX. On Thursday, at 8:00 pm, 6 hours after receiving  SHINGRIX the patient experienced extreme pain where shot was given that traveled up neck and into the left side of head. On Thursday night, at 11:00 pm, 9 hours after receiving SHINGRIX the patient experienced threw up and ran a fever of 101. On Friday, at 1:00 pm, 23 hours after receiving, SHINGRIX the patient experienced nose bleed in left nostril. On Friday, at 9:00 pm, 1 days 7 hours after receiving SHINGRIX the patient experienced extreme throbbing pain on left side of brain with stabbing pain in left ear. It seems that patient might had really reacted badly to this vaccine. The patient was asked whether to continued to got the second vaccine if yes, would this happen again. Lab Comments: Lab test was done on an unknown date.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of epistaxis in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 23 hrs after receiving SHINGRIX, the patient experienced epistaxis, injection site pain, vomiting, fever, neck pain, ear pain and headache. On an unknown date, the outcome of the epistaxis, injection site pain, vomiting, fever, neck pain, ear pain and headache were unknown. It was unknown if the reporter considered the epistaxis, injection site pain, vomiting, fever, neck pain, ear pain and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On Thursday, at 2:00 pm, the patient received the first shot of SHINGRIX. On Thursday, at 8:00 pm, 6 hours after receiving  SHINGRIX the patient experienced extreme pain where shot was given that traveled up neck and into the left side of head. On Thursday night, at 11:00 pm, 9 hours after receiving SHINGRIX the patient experienced threw up and ran a fever of 101. On Friday, at 1:00 pm, 23 hours after receiving, SHINGRIX the patient experienced nose bleed in left nostril. On Friday, at 9:00 pm, 1 days 7 hours after receiving SHINGRIX the patient experienced extreme throbbing pain on left side of brain with stabbing pain in left ear. It seems that patient might had really reacted badly to this vaccine. The patient was asked whether to continued to got the second vaccine if yes, would this happen again. Lab Comments: Lab test was done on an unknown date.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follow: The age at vaccination was not reported but as per indication of the vaccine age group was captured as adult. The patient had arm soreness on day 2 to 5 after administration of SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of pain in a 67-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 3 days after receiving SHINGRIX, the patient experienced pain, erythema and swelling. On an unknown date, the outcome of the pain, erythema and swelling were unknown. It was unknown if the reporter considered the pain, erythema and swelling to be related to SHINGRIX. Additional details were provided as follow: The age at vaccination was not reported. The patient experienced pain, redness and swelling 3 days post vaccination. The reporter did not agreed to be followed up.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Product administered at inappropriate site
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site erythema in a patient who received KINRIX for prophylaxis. On 11th July 2018, the patient received KINRIX. On 12th July 2018, 1 days after receiving KINRIX, the patient experienced injection site erythema, injection site swelling and injection site warmth. On an unknown date, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to KINRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter had a patient that was given the KINRIX vaccine, a day before reporting. On the day of reporting, the patient developed redness, large swelling, and warmth to the site. Upon visualizing the site it looked as if the administration could have gone into the vastus intermedius muscle instead of vastus lateralis muscle, which could have contributed to possible irritation to subcutaneous tissue. The reporter wanted to know if this was a situation in which they should report via VAERS or with manufacturer.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in an unspecified adult patients who received SHINGRIX  for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The reporter stated that most of his patients had reported pain after injection. The reporter did not answer about consent to be followed up.
Sex: M
Vaccine: PNC13
Symptoms: Erythema multiforme
Clinical narrative: This is a spontaneous report form a contactable nurse and physician. A 4-year-old male patient received the second dose of PREVNAR 13, lot number and expiration date were not reported), 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 developed rash multiforme in his abdomen, so the physician was looking for recommendations on administering the subsequent doses or not. The information on the batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Antibody test negative
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program "IBCC (Inbound Call Center for HCPs)" from a contactable pharmacist. A 76 year old female patient received one single dose of PREVNAR 13 on an unknown date, in 2017 (about 10 months before this report), for immunization. Relevant medical history and concomitant medications were unknown. For her doctor the patient should be administered another dose of PREVNAR 13 because something did not show up in her blood work. Her titer levels were checked and they did not show up. The information on the lot number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Diarrhoea, Gastrointestinal disorder
Clinical narrative: This is a spontaneous report from a contactable physician. This report was received via a Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13, (batch number and expiration date were not reported), 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 bad diarrhea GI symptoms on an unspecified date. The outcome of the event was unknown. The information on the batch number has been requested.
Sex: U
Vaccine: DTAP
Symptoms: Allergy to vaccine
Clinical narrative: Initial information received on 09-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves patient (age and gender unknown) who experienced allergic to DTaP, while received vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received a injection of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot number, expiry date and dose not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious allergic to DTaP (allergy to vaccine) with unknown latency following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. Final diagnosis was allergic to DTaP. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for allergic to DTaP. List of documents held by sender-none.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: Patient presented to Family Medicine on 07/10/18 for an office visit and it was noted in NP's note that patient presented for questionable reaction to PNA vaccine, stating that hours after the vaccine was placed on 07/09/18, she "Began having low grade fevers of 100, Warmth and Tenderness at site of injection, Myalgia, Headaches and Chills. It does appear she had a local reaction".
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pyrexia
Clinical narrative: Patient presented to Family Medicine on 07/10/18 for an office visit and it was noted in NP's note that patient presented for questionable reaction to PNA vaccine, stating that hours after the vaccine was placed on 07/09/18, she "Began having low grade fevers of 100, Warmth and Tenderness at site of injection, Myalgia, Headaches and Chills. It does appear she had a local reaction".
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Anion gap increased, Computerised tomogram head normal, Dizziness, Flushing, Headache
Clinical narrative: About 90 min post vaccine employee called stating she was feeling light headed, dizzy, flushed, feeling faint and had blurry vision. Employee went to the ED for evaluation. She received a normal saline bolus of 1000 mL. Vitals upon arrival were WNL and did not change. CT of head done for complaints of Headache. Discharged at 13:43 completely asymptomatic.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Monocyte count increased, Red cell distribution width increased, Vision blurred, Vital signs measurement
Clinical narrative: About 90 min post vaccine employee called stating she was feeling light headed, dizzy, flushed, feeling faint and had blurry vision. Employee went to the ED for evaluation. She received a normal saline bolus of 1000 mL. Vitals upon arrival were WNL and did not change. CT of head done for complaints of Headache. Discharged at 13:43 completely asymptomatic.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Headache severe shivering nausea vomiting fever.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy skin, Herpes zoster, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Shortly after receiving the vaccine the patient started complaining of itching/rash near the injection site. She initially thought it was due to the clindamycin that she was taking for her ongoing dental procedures. She followed up with her primary care provider. She mentioned that the Dr. did biopsy the lesions in an attempt to determine what they were as the rash and itching were not going away. The patient is still having the same issues she had in March of 2018 of itching/rash near the injection site but also burning. Her provider is now treating her as if she may have shingles. She has recently filled a prescription for ZOVIRAX 5% cream and Acyclovir 800mg tablets.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Scar
Clinical narrative: Shortly after receiving the vaccine the patient started complaining of itching/rash near the injection site. She initially thought it was due to the clindamycin that she was taking for her ongoing dental procedures. She followed up with her primary care provider. She mentioned that the Dr. did biopsy the lesions in an attempt to determine what they were as the rash and itching were not going away. The patient is still having the same issues she had in March of 2018 of itching/rash near the injection site but also burning. Her provider is now treating her as if she may have shingles. She has recently filled a prescription for ZOVIRAX 5% cream and Acyclovir 800mg tablets.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pyrexia, Rash
Clinical narrative: Patient presented to Emergency Department approximately one week after receiving SHINGRIX vaccine with fevers, now has shingles along T1 dermatome.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Raised red, warm to the touch area surrounding injection; NP would like pt to F/U in 2 days or sooner if symptoms worsen.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Patient received vaccination on 7/11/18 and came to pharmacy 7/18/18 to report event. He said after receiving immunization his arm became painful and red at injection site and hot to touch. He said the next morning there was a hard nodule present at injection site. He went to doctor on 7/18/18 and was given antibiotic and steroid to help with reaction. He said pain is getting better but his arm is still red. BENADRYL and OTC pain relievers were also recommended to the patient.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Abdominal pain, Back pain, Vomiting
Clinical narrative: Pt started vomiting about 5-10 minutes after receiving vaccine, pt was brought basin for fluids and was given EPIPEN. Pt complained of tummy aches and back pain. No other symptoms noticed. Pt threw up small amounts of bile for 20 min after receiving vaccine.
Age: 1.75
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Cyanosis, Irritability, Protrusion tongue, Respiratory arrest, Resuscitation
Clinical narrative: He had his shots on Thursday. He was fine Thursday and Friday. He was fussy during Friday night. He woke up early Saturday. He was fussy. I checked his temperature around 7:30am, no fever. I went to work. Picked him up at 12:15pm and he was warm and clingy. Went home and took his temperature and it was 102. Gave him 5ml of MOTRIN. I went and changed his diaper. Then I started to rock him, before I put him down to nap. He was fussy at first and then he closed his eyes to sleep. He then started having a seizure in my arms. I ran with him to get my phone and called 911. They had me put him on his left side. His tongue was hanging out of his mouth. He stopped breathing and turned blue. The 911 operator to me to start CPR. I started chest compressions. He started breathing. The EMT showed up. He was hospitalized overnight.
Age: 1.75
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Seizure, Skin warm
Clinical narrative: He had his shots on Thursday. He was fine Thursday and Friday. He was fussy during Friday night. He woke up early Saturday. He was fussy. I checked his temperature around 7:30am, no fever. I went to work. Picked him up at 12:15pm and he was warm and clingy. Went home and took his temperature and it was 102. Gave him 5ml of MOTRIN. I went and changed his diaper. Then I started to rock him, before I put him down to nap. He was fussy at first and then he closed his eyes to sleep. He then started having a seizure in my arms. I ran with him to get my phone and called 911. They had me put him on his left side. His tongue was hanging out of his mouth. He stopped breathing and turned blue. The 911 operator to me to start CPR. I started chest compressions. He started breathing. The EMT showed up. He was hospitalized overnight.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Malaise, Myalgia, Pyrexia
Clinical narrative: Muscle and joint aches, Low grade fever, general not feeling well. These symptoms lasted approximately 36 hours.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: FLU-LIKE SYMPTOM DAY AFTER THE VACCINE. IT LASTED 1 DAY.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dyspnoea, Paraesthesia, Paraesthesia oral
Clinical narrative: 10 minutes after administering vaccine patient reported tingling in lips and bilateral fingers, with some shortness of breath. Patient was accessed by APN and taken to a clinical room for further monitoring  of symptoms and vital signs, 25 mg BENADRYL PO given as ordered by APN. Patient was monitored by nursing staff for any worsening of symptoms for approx. 1 hour. Patient reported no longer having shortness of breath and just slight tingling of lips and fingers. Patient was discharged with family member with instructions to follow up in ER due to still having complaint of tingling.
Age: 19.0
Sex: M
Vaccine: HPV9
Symptoms: Eye movement disorder, Loss of consciousness, Pain in extremity, Tension
Clinical narrative: Patient described left arm as hurting and then soon after passed out with tensed body and eye shaking. Patient would not wake up for a few minutes even after braking an Ammonia Inhalant under nose.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Myalgia, Rash macular, Tremor, Urticaria
Clinical narrative: By evening patient got really bad shakes, muscles started hurting like if had the Flu. Patient woke up with hives and still has them. Called the doctor on 7/5 and was given prescription for Prednisone but did not help. Hives kept moving around and showing in different parts of body. Patient had doctor visit on 7/10 and was not prescribed any new medication. Patient is smearing body with Triamcinolone (steroid cream) which at least is providing some relief. Currently, hives are going away, although at night they get inflamed and still has blotches all over body. Patient reports taking a lot of BENADRYL and anti-inflammation meds. Yesterday noticed that vertigo started. Today, in bed resting.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: By evening patient got really bad shakes, muscles started hurting like if had the Flu. Patient woke up with hives and still has them. Called the doctor on 7/5 and was given prescription for Prednisone but did not help. Hives kept moving around and showing in different parts of body. Patient had doctor visit on 7/10 and was not prescribed any new medication. Patient is smearing body with Triamcinolone (steroid cream) which at least is providing some relief. Currently, hives are going away, although at night they get inflamed and still has blotches all over body. Patient reports taking a lot of BENADRYL and anti-inflammation meds. Yesterday noticed that vertigo started. Today, in bed resting.
Age: 32.0
Sex: M
Vaccine: RAB
Symptoms: Feeling abnormal, Headache, Nausea, Tremor, Vision blurred
Clinical narrative: Patient called county Public Health 1.5hrs after having received Day 7 in the Rabies PEP schedule. He stated that "I am having the most horrible headache of my life. I am feeling nauseous and my hands are shaking. My vision is blurry and I don't feel right. How long will this last?" Patient was advised that this is not the normal response to the vaccination and to seek medical evaluation at the closest ER. Patient presented to the ER at Medical Center for evaluation and treatment.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Gait disturbance, Myalgia, Pain in extremity
Clinical narrative: Leg/muscle pain bilaterally. Complained of not wanting to walk because she felt like she would fall or legs were going to give out. Pain has is still ongoing for over 6 hours.
Age: 68.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient reported swelling and heat at injection site that is resolving on its own.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Patient experienced hives all over body in the evening following vaccine administration. She visited her doctor and was prescribed a course of steroids to treat symptoms.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Fatigue, Hypersomnia, Injection site induration, Injection site swelling
Clinical narrative: The injection site for the vaccinations were swollen and hard for 4 days following the vaccine. The baby was exhausted the day after the vaccination and slept a lot. The baby began vomiting and had diarrhea beginning 2 days after the vaccination and it continued through day 4 after the vaccination.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: The injection site for the vaccinations were swollen and hard for 4 days following the vaccine. The baby was exhausted the day after the vaccination and slept a lot. The baby began vomiting and had diarrhea beginning 2 days after the vaccination and it continued through day 4 after the vaccination.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Pruritus, Scratch, Somnolence
Clinical narrative: Patient received vaccine approx 10:25 am, and had slight itchiness during the observation period but said it was not bad and left the clinic location. She returned approx 50 mins later(11:15am) when symptoms became worse. C/O increased itchiness, started in neck area, then spread to arms, hands, legs, then top of head. No hives noted but patient was scratching skin. Skin cool and dry, no hot/red areas, A&Ox3. Vitals normal, BP 120/80, 126/82, P 72 Regular. Lung sounds clear. No tingling to throat or mouth area. 50 Mg BENADRYL administered(4 12.5 mg chewable tablets). tolerated well, but made her very drowsy. 11:25 stated had relief from itching but still remained very sleepy. Vitals normal, BP 120/74, 122/70, P 70. 12:51 BP 122/70 P 70, Patient was sent home with daughter after symptoms improved and she felt much better.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Rash generalised
Clinical narrative: Child was seen in office 7/18/18 for rash, mother reports rash all over started 7/17/18. Immunizations were received same day in clinic. Questioning reaction to MMR per MD, BENADRYL prescribed
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: Pt began feeling faint. We sat her down. She drank some water and cool rag placed on neck and forehead.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Injection site rash, Rash generalised, Urticaria
Clinical narrative: Within 2 hours of receiving vaccine, broke out into a hive like rash nickel size hives. Rash initially started around injection site left thigh, then spread to other leg and randomly over body. Child was given oral BENADRYL and rash improved. Rash returned when BENADRYL wore off. Is redosing with BENADRYL every 6-8 hours for 48 hours. No respiratory issues noted.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Injection site pain, Nausea, Vomiting
Clinical narrative: C/o nausea and vomiting (2x), soreness at injection site, and arthralgia.
Age: 33.0
Sex: F
Vaccine: TYP
Symptoms: Dyspnoea, Erythema, Swollen tongue, Throat irritation
Clinical narrative: Patient received IM injection. 30 minutes later developed "tickle in her throat." Pt sent to clinic; had onset of shortness of breathe, swollen tongue, erythema. Given 5 x IM EPI shots, SOLUMEDROL, albuterol. Transferred to ER and placed on EPI drip at hospital with observation over night.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain
Clinical narrative: Patient stated she had SHINGRIX number 1 injection on 6/29/2018 and c/o fatigue, headache local pain on the left deltoid.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site swelling, Loss of personal independence in daily activities, Nausea
Clinical narrative: Fever, chills, aches and nausea on first day unable to continue daily activities. Injection site swollen painful. Second day symptoms much improved.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, chills, aches and nausea on first day unable to continue daily activities. Injection site swollen painful. Second day symptoms much improved.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling hot, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient stated she had SHINGRIX injection on 6/28/2018, and C/O fatigue, local redness, feel warm and painful on the right deltoid, feel hot (did not take temp). Patient stated she took one TYLENOL 500 mg and used ice pack to relieve pain at the night of 6/28/20118, but symptoms stay the same.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt given wrong meningococcal vaccination. Should have received MENVEO Booster. No true adverse reaction to vaccination, solely administration error.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Tenderness
Clinical narrative: Patient noticed today, 2 days after vaccine, that arm is red, and sore to touch.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Paraesthesia, Swelling
Clinical narrative: Redness, swelling, itching, arm tingling x 5 days.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Bradycardia, Dizziness, Immediate post-injection reaction, Syncope
Clinical narrative: Bradycardia, dizziness; fainting; Immediately after shot was given; Laid down; water given; PEDIALYTE given; better after 15mins of rest/laying down.