chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes, Pruritus, Skin lesion
Clinical narrative: Developed cold sore on lip within 18 hours of vaccination.  Then 24 hours later started getting lesions on right arm that itched and within another 24 hours lesions started appearing on left arm.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Nausea
Clinical narrative: Severe chills and fatigue first night. Mild nausea and fatigue ending 28 hours after injection.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Rash erythematous, Skin warm
Clinical narrative: Patient presented 2 days after receiving SHINGRIX with a red rash approximately 2 inches in diameter that was hot to the touch. The area was outlined and the patient was told to seek further help if the rash grew due to the possibility of cellulitis. She was given BENADRYL for an allergic reaction.
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Herpes zoster, Hypoacusis, Rash, Visual impairment
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient was inoculated with the ZOSTAVAX for routine health maintenance and for the prevention of shingles (lot number, dosage and route of administration not provided). On an unknown date after receiving the ZOSTAVAX, the patient broke out in a painful rash on his right side, encompassing the right side of his head, face and scalp. Since his initial outbreak, the patient has suffered several additional attacks of shingles, as well as vision, hearing and balance issues. As a result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. As a direct and proximate result of ZOSTAVAX, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using ZOSTAVAX. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was considered to be not recovered. Causality assessment was related. Shingles, vision issues, hearing issues, and balance issues were considered to be disabled. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: Information was received on 05-APR-2019 from a lawyer regarding a case in litigation involving a female patient (age and history unknown) who in 2015 the patient was inoculated with ZOSTAVAX for routine health maintenance and prevention of shingles. Shortly after receiving vaccine, the patient broke out in a painful rash and presented to a medical provider and was diagnosed with herpes zoster and post herpetic neuralgia. As a result the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. As a result of ZOSTAVAX the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using the product. As a direct result of ZOSTAVAX the patient sustained severe and permanent personal injuries. The patient suffered serious, progressive, permanent, and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment, and injury. The patient incurred and will continue to incur medical expenses and other economic harm as a result of ZOSTAVAX. Herpes zoster and post herpetic neuralgia was considered to be disabling. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: no adverse event; patient was received a dose of Rotateq on 3/18/2019 and inadverently administered another dose on 4/9/2019; patient was received a dose of Rotateq on 3/18/2019 and inadverently administered another dose on 4/9/2019; This spontaneous report was received from an other health professional referring to a 4-month-old male patient. His pertinent medical history, concomitant medication and drug reactions/allergies were not reported.  On 18-MAR-2019, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, unit, route, anatomical location, lot # and expiration date were not reported) for prophylaxis. On 09-APR-2019, the patient came to the office for the remaining unspecified vaccines and inadvertently received another dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot # R022221 and expiration date:23-MAY-2020 (strength, dose, unit, route, anatomical location were not reported) (wrong product administered and extra dose administered). No adverse effects were reported. No product quality complaint (PQC) was involved.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning an elderly male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2010, at approximately 78 years of age, the patient was administered the zoster vaccine live (ZOSTAVAX) by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from his zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to himself, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster is unknown.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 4th April 2019, the patient received the 1st dose of SHINGRIX. In April 2019, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, pain, fever, shivers, tiredness, headache and muscle pain. On an unknown date, the outcome of the injection site erythema, injection site pain, pain, fever, shivers, tiredness, headache and muscle pain were not reported. It was unknown if the reporter considered the injection site erythema, injection site pain, pain, fever, shivers, tiredness, headache and muscle pain to be related to SHINGRIX. Additional details were provided as follows: On 4th April 2019, afternoon, the patient received 1st dose of SHINGRIX. The patient experienced expected side effects of injection site redness and soreness, aches, low fever, shivery, tired, headache and muscle pain. The patient was wondering if the events would last for 24 hours, 48 hours or more. The patient did not feel like she needed a doctor. The patient did not give her contact number to receive the call from product specialist. The patient would take rest and drink fluids to get through these events.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 4th April 2019, the patient received the 1st dose of SHINGRIX. In April 2019, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, pain, fever, shivers, tiredness, headache and muscle pain. On an unknown date, the outcome of the injection site erythema, injection site pain, pain, fever, shivers, tiredness, headache and muscle pain were not reported. It was unknown if the reporter considered the injection site erythema, injection site pain, pain, fever, shivers, tiredness, headache and muscle pain to be related to SHINGRIX. Additional details were provided as follows: On 4th April 2019, afternoon, the patient received 1st dose of SHINGRIX. The patient experienced expected side effects of injection site redness and soreness, aches, low fever, shivery, tired, headache and muscle pain. The patient was wondering if the events would last for 24 hours, 48 hours or more. The patient did not feel like she needed a doctor. The patient did not give her contact number to receive the call from product specialist. The patient would take rest and drink fluids to get through these events.
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Incorrect route of product administration, Product administered at inappropriate site, Scar
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of bruising of arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (subcutaneous). On 5th April 2019, unknown after receiving SHINGRIX, the patient experienced skin scarring. On an unknown date, the patient experienced bruising of arm, intramuscular formulation administered by other route and vaccine administered at inappropriate site. On an unknown date, the outcome of the bruising of arm, skin scarring, intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the bruising of arm and skin scarring to be related to SHINGRIX. Additional case details were provided as follows: The age at vaccination was not reported. The patient received the dose of SHINGRIX vaccine subcutaneously at the doctor's office, which led to intramuscular formulation administered by other route. Based on the reaction, it looks like they either administered it subcutaneously in the back of her upper arm, or either way below the deltoid where it should have been, which might led to vaccine administered at inappropriate site. The patient experienced some bruising on the side of her arm just above the elbow. On the day of reporting, it almost looked like a scar from a burn that was healing. The reporter was unable to provide product details, as he did not give the vaccine. The reporter identity not disclose patient details other than gender, when asked. The reporter was also asked if this was the patient's first or second dose, and did not respond.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 3rd December 2018, the patient received the 2nd dose of SHINGRIX. On 4th December 2018, 1 days after receiving SHINGRIX, the patient experienced chills, fever, pain and influenza-like symptoms. On 10th December 2018, the patient experienced leg pain. On an unknown date, the outcome of the chills, fever and influenza-like symptoms were recovered/resolved and the outcome of the leg pain was not recovered/not resolved and the outcome of the pain was unknown. It was unknown if the reporter considered the chills, fever, leg pain, pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The patient received SHINGRIX in left arm. The patient reported that he experienced flu like symptoms. The flu symptoms consisted of chills, fever, and achiness. Less than a month after receiving SHINGRIX, the patient also experienced a sore arm for a few days. The patient also reported leg pain, which began about 7-10 days after the injection. Did not consent to follow up. The case was closed. The start date mentioned in the narrative as 3rd December 2019, which is future date, so we captured 3rd December 2018 as vaccine start date.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Fever up to 103 for about 28hr. Treated with Motrin. Another fever came on the 20th. Also lasted about 24hrs. Advised it could be the reaction to rubella from MMR.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pyrexia
Clinical narrative: fever, chills, headache, - lasted about 1 1/2 days - similar to flu but without nausea.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Erythema, Urticaria
Clinical narrative: Red raised hives noticed to Left arm 10 minutes after administration of vaccine, within 5 minutes hives were spreading to upper chest/neck area and back. No other complaints verbalized. BENADRYL 50 mg IM administered to Right arm at 12:47 PM. Hives to Lt. arm began to faint in color to pale pink after 5 minutes of BENARYL IM administration. Student was picked up by father at 1305 PM. Student ambulatory no complaints voiced.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: Body aches, chills, mild headache for 1.5 days.
Age: 78.0
Sex: F
Vaccine: HEPA
Symptoms: Hyperhidrosis
Clinical narrative: Patient started sweating profusely and leaned back in her chair as if she was going to faint
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced 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 follows: The age at vaccination was not reported. The patient experienced mild sore arm after receiving 1st dose of SHINGRIX. This case is linked to case US2019056560, due to same patient.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Balance disorder, Blood test normal, Chest X-ray normal, Dehydration
Clinical narrative: Shaky, unstable, muscles sore, no control of balance, sweating profusely, very tired and no energy. Unable to pull himself out of chair or bed. Little strength.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Hyperhidrosis, Mobility decreased, Myalgia, Tremor
Clinical narrative: Shaky, unstable, muscles sore, no control of balance, sweating profusely, very tired and no energy. Unable to pull himself out of chair or bed. Little strength.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Urine analysis abnormal
Clinical narrative: Shaky, unstable, muscles sore, no control of balance, sweating profusely, very tired and no energy. Unable to pull himself out of chair or bed. Little strength.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect reported; A dose of PNEUMOVAX 23 which expired on 16-FEB-2019, was inadvertently administered to the patient on 26-MAR-2019.; This spontaneous report has been received from a medical assistant regarding to a patient of unknown gender and age. The patient's concurrent condition, medical history, drug allergies and concomitant medication was not reported.  On 26-MAR-2019, the patient was inadvertently vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and anatomical location of vaccine were not provided) lot # N019838 which expired on 16-FEB-2019, for prophylaxis. No adverse effects were reported.  This case was considered as non-valid since not patient identifier were reported.
Sex: U
Vaccine: HEP, HEPA, HPV9, MMR, PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous has been received from a nurse regarding to an unknown number patient of unknown age. The patients' concurrent condition, medical history, concomitant medication and drug allergies or reaction were not provided. On unknown dates, an unspecified number of patients were vaccinated with improperly stored dose of  GARDASIL 9 (lot # R020200, expiration date 05-MAY-2021 and lot # R004689, expiration date 29-NOV-2020), VAQTA (Lot # R021233, expiration date 05-SEP-2019, Lot # R025518, expiration date 15-NOV-2020, lot # R030120, expiration date 15-NOV-2019 and lot # R027431, expiration date 08-SEP-2019), ROTATEQ Orally (Lot # R017955, expiration date 05-MAY-2020, Lot # R016790, expiration date 20-APR-2020, Lot # R021650, expiration date 27-MAY-2020, Lot # R021649, expiration date 27-MAY-2020 and lot # R021390, expiration date 02-SEP-2020), PNEUMOVAX 23 (Lot # R024025, expiration date 02-SEP-2020), RECOMBIVAX HB (thimerosal free) (lot # R021372, expiration date 25-MAY-2021 and Lot # R001530, expiration date 07-NOV-2020) and M-M-R II (rHA)(lot # R024906, expiration date 30-AUG-2020). The administered doses of the vaccines experienced a temperature excursion at the lowest temperature 2 °C (-1.2 °C) for 2 hours and 43 minutes, and at the highest  temperature above 47 Fahrenheit degrees or 9°C (11.2°C) for 3 hours and 29 minutes. This report was called because of a data logger. Previous temperature excursion was involved. There were no adverse effects reported. No further information would be expected. This case is a non-valid, since there was no patient identifiers reported.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; Information has been received regarding a case in litigation from a lawyer, a female patient of unknown age, and her husband. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 12-SEP-2012, at age 63, the patient was administered the zoster vaccine live (ZOSTAVAX) by a healthcare provider at a physician's office (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from the patient's zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster is unknown.  Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2009, at approximately 61 years of age, the patient was administered the zoster vaccine live (ZOSTAVAX) by a healthcare provider at a physician's office. On an unknown date, the patient was treated by a physician for the following injury resulting from his zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to himself, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster is unknown.  Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; Information has been received regarding a case in litigation from a lawyer, an elderly male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 16-JAN-2013, at age 67, the patient was administered the zoster vaccine live (ZOSTAVAX) by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a nurse practitioner for the following injury resulting from his zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster is unknown.  Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Viral titre decreased
Clinical narrative: The patient had titres drawn on an unspecified date and they were low; This spontaneous report was received from a nurse and refers to a male patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On an unspecified date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) for prophylaxis (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported).   The patient was working in a place where there was a measles outbreak, consequently a titers were drawn on an unknown date and they were low (viral titre decreased). It was unknown if the patient sought medical attention or if treatment was given for the event.    On an unknown date, the patient was vaccinated again with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) for low titers (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported).  At the time of reporting, the outcome of the event and the causal relationship between the event and vaccination with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) were not reported.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Inappropriate schedule of product administration, Influenza like illness, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included SHINGRIX with an associated reaction of injection site swelling (1st dose received on 29th August 2018, refer linked case US2019061889). On 3rd April 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 3rd April 2019, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, pain in arm, injection site swelling and drug dose administration interval too long. On 4th April 2019, the patient experienced fever, chills, influenza-like symptoms, general body pain and tiredness. The patient was treated with ADVIL. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site erythema, pain in arm, fever, chills, influenza-like symptoms, general body pain, tiredness and injection site swelling were recovering/resolving and the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the injection site erythema, pain in arm, fever, chills, influenza-like symptoms, general body pain, tiredness and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The batch number was not reported. The patient received SHINGRIX vaccine on left arm and same day she experienced some arm soreness, redness at the injection site, a bump on the injection site. After 1 day after vaccination, the patient had flu like symptoms consisting of chills, feverish, tired, and body aches. The injection site reactions occurred on the same day, and the other events occurred the next day. The patient received 2nd dose more than the recommended schedule, which led to lengthening of vaccination. At time of report, events are improving after the patient took ADVIL. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included SHINGRIX with an associated reaction of injection site swelling (1st dose received on 29th August 2018, refer linked case US2019061889). On 3rd April 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 3rd April 2019, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, pain in arm, injection site swelling and drug dose administration interval too long. On 4th April 2019, the patient experienced fever, chills, influenza-like symptoms, general body pain and tiredness. The patient was treated with ADVIL. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site erythema, pain in arm, fever, chills, influenza-like symptoms, general body pain, tiredness and injection site swelling were recovering/resolving and the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the injection site erythema, pain in arm, fever, chills, influenza-like symptoms, general body pain, tiredness and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The batch number was not reported. The patient received SHINGRIX vaccine on left arm and same day she experienced some arm soreness, redness at the injection site, a bump on the injection site. After 1 day after vaccination, the patient had flu like symptoms consisting of chills, feverish, tired, and body aches. The injection site reactions occurred on the same day, and the other events occurred the next day. The patient received 2nd dose more than the recommended schedule, which led to lengthening of vaccination. At time of report, events are improving after the patient took ADVIL. The reporter consented to follow up.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash papular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of papular rash in a 68-year-old male patient who received SHINGRIX (batch number 2YN4S, expiry date 9th July 2021) for prophylaxis. On 22nd March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). In March 2019, less than a week after receiving SHINGRIX, the patient experienced papular rash. On an unknown date, the outcome of the papular rash was unknown. It was unknown if the reporter considered the papular rash to be related to SHINGRIX. Additional details were provided as follows: The patient developed little bumps on the leg which appeared after the 2nd dose and might be like chicken pox.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Injection site bruising, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a 63-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included Crohn's disease. On 2nd April 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 3rd April 2019, 1 days after receiving SHINGRIX, the patient experienced tiredness and weakness. On 5th April 2019, the patient experienced painful rash. In April 2019, the patient experienced injection site bruising. On an unknown date, the outcome of the injection site bruising and painful rash were not recovered/not resolved and the outcome of the tiredness and weakness were recovered/resolved. It was unknown if the reporter considered the injection site bruising, tiredness, weakness and painful rash to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient for himself. The patient received a dose of SHINGRIX vaccine on the left shoulder. Next day of vaccination he started experiencing tiredness and weakness, which had resolved. At the time of reporting 3 days after receiving SHINGRIX, the patient experienced a round rash associated with pain about 2 to 3 inches below the injection site which was 3 inches in diameter. The patient also mentioned less than a week after receiving SHINGRIX, the site below the injection site was black and blue. The reporter consented to follow up. This case has been linked with case US2019061869, reported by same reporter.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Fatigue, Injection site induration, Injection site swelling
Clinical narrative: This is a spontaneous report from a Pfizer Sponsored Program by a contactable physician. A 72-year-old female patient received PREVNAR 13, via an unspecified route of administration at single dose in her Gluteus Medius Left in Mar2019 for immunisation. Medical history none. There were no concomitant medications. The patient previously took SHINGRIX for immunisation. In Mar2019, the patient experienced cellulitis with outcome of unknown, possible shingles with outcome of unknown, induration and swelling at the injection site with outcome of unknown, erythema in a separate area from the injection site in the inguinal fold with outcome of recovered, they were a bit painful and about 3inches/1inch with outcome of unknown, 2 areas of redness with outcome of recovering, itchy with outcome of unknown, malaise, tired, maybe myalgia and low grade fever with outcome of recovered. Therapeutic measures were taken as a result of cellulitis, possible shingles, erythema in a separate area from the injection site in the inguinal fold, 2 areas of redness, itchy. No hospitalization occurred. The events were described as follows: 40 hours after receiving the vaccine the patient experienced "induration and swelling at the injection site, which became quite big 5-7 in across". There was also erythema in a separate area from the injection site in the inguinal fold, which had 2 areas of redness and they were a bit painful and about 3 inches/1inch. The patient went to the ER, it was thought to be Cellulitis or Shingles. She was prescribed Prednisone, VALTREX and Clindamycin. Two days after starting her prescribed medications she stopped taking them it appeared to be better. After 24 hrs the erythema located in the inguinal fold was gone and the site of injection had "less redness and decreased in size". Since the medications were stopped the patient had 2 additional regions of redness that were "non-tender but itchy and was using hydrocortisone". The patient also had systemic reactions 40 hours after the vaccine, such as "malaise, tired, maybe myalgia and low grade fever" which resolved 24 hours later. The information on the lot number has been requested. Sender's Comments: 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: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Malaise, Pain, Pruritus
Clinical narrative: This is a spontaneous report from a Pfizer Sponsored Program by a contactable physician. A 72-year-old female patient received PREVNAR 13, via an unspecified route of administration at single dose in her Gluteus Medius Left in Mar2019 for immunisation. Medical history none. There were no concomitant medications. The patient previously took SHINGRIX for immunisation. In Mar2019, the patient experienced cellulitis with outcome of unknown, possible shingles with outcome of unknown, induration and swelling at the injection site with outcome of unknown, erythema in a separate area from the injection site in the inguinal fold with outcome of recovered, they were a bit painful and about 3inches/1inch with outcome of unknown, 2 areas of redness with outcome of recovering, itchy with outcome of unknown, malaise, tired, maybe myalgia and low grade fever with outcome of recovered. Therapeutic measures were taken as a result of cellulitis, possible shingles, erythema in a separate area from the injection site in the inguinal fold, 2 areas of redness, itchy. No hospitalization occurred. The events were described as follows: 40 hours after receiving the vaccine the patient experienced "induration and swelling at the injection site, which became quite big 5-7 in across". There was also erythema in a separate area from the injection site in the inguinal fold, which had 2 areas of redness and they were a bit painful and about 3 inches/1inch. The patient went to the ER, it was thought to be Cellulitis or Shingles. She was prescribed Prednisone, VALTREX and Clindamycin. Two days after starting her prescribed medications she stopped taking them it appeared to be better. After 24 hrs the erythema located in the inguinal fold was gone and the site of injection had "less redness and decreased in size". Since the medications were stopped the patient had 2 additional regions of redness that were "non-tender but itchy and was using hydrocortisone". The patient also had systemic reactions 40 hours after the vaccine, such as "malaise, tired, maybe myalgia and low grade fever" which resolved 24 hours later. The information on the lot number has been requested. Sender's Comments: 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: 1.58
Sex: M
Vaccine: PNC13
Symptoms: Bronchitis, Inappropriate schedule of product administration
Clinical narrative: Was not vaccinated according to Pfizer's product insert and the CDC guidelines / First dose: 28Nov2018, Second dose: 19Dec2018; Bronchitis; This is a spontaneous report from a contactable consumer (patient's mother). A 19-month-old male patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13); with unknown lot number and expiration date, via an unspecified route of administration on 28Nov2018 (first dose) and on 19Dec2018 (second dose) at single doses for routine vaccination. The patient had no  medical history. There were no concomitant medications. The patient's mother called about pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). She was trying to determine if her son had an adverse reaction because of the vaccine or if it was a result of not being vaccinated in accordance with the guidelines from the CDC and the guidelines in Pfizer's insert from the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). In Dec2018, he ended up with bronchitis when he had his second round of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in 19Dec2019. The outcome of the event bronchitis was unknown.   Information on the batch/lot number has been requested.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Blood cholesterol increased, Injection site induration, Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: It is hard for the patient to turn her head on the side she got the injection; The injection site was hard; She had more pain in her arm; Fever; Pain at the injection site; This is a spontaneous report via a Pfizer-sponsored program by a contactable pharmacist. This pharmacist reported similar events for 2 patients. This is the 2nd of 2 reports.  A 67-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number: X64930, expiration date: Nov2020), intramuscular on 25Mar2019 19:30 on left deltoid at 0.5 ml, single for pneumonia. Medical history included high cholesterol and dry eye. It was reported that on 25Mar2019, around 7:30 PM, the patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) injection.  Around, 9:00 PM, the patient had pain at the injection site, and the next morning the injection site was hard and the pain was worse at the injection site.  It was hard for the patient to turn her head on the side that she got the injection and that last night (27Mar2019), the patient had more pain and fever. She also had more pain in her arm (states that the patient reported that if 10 is the highest number for pain, the pain she is experiencing is 8).  All of the adverse events are improving a little bit but not a lot. The outcome of the event was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019046468 same reporter/drug, similar event, different patient
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: It is hard for the patient to turn her head on the side she got the injection; The injection site was hard; She had more pain in her arm; Fever; Pain at the injection site; This is a spontaneous report via a Pfizer-sponsored program by a contactable pharmacist. This pharmacist reported similar events for 2 patients. This is the 2nd of 2 reports.  A 67-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number: X64930, expiration date: Nov2020), intramuscular on 25Mar2019 19:30 on left deltoid at 0.5 ml, single for pneumonia. Medical history included high cholesterol and dry eye. It was reported that on 25Mar2019, around 7:30 PM, the patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) injection.  Around, 9:00 PM, the patient had pain at the injection site, and the next morning the injection site was hard and the pain was worse at the injection site.  It was hard for the patient to turn her head on the side that she got the injection and that last night (27Mar2019), the patient had more pain and fever. She also had more pain in her arm (states that the patient reported that if 10 is the highest number for pain, the pain she is experiencing is 8).  All of the adverse events are improving a little bit but not a lot. The outcome of the event was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019046468 same reporter/drug, similar event, different patient
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: pain at the injection site; This is a spontaneous report from a contactable pharmacist (pharmacy floater) via a Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13; batch number unknown), 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 pharmacist reported that pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) tends to have a higher rate of pain at the injection site on an unknown date than other vaccines. It was clarified that event took place after the use of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein). The outcome of the event was unknown.  Information on the batch number has been requested.
Sex: F
Vaccine: MENB
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (parent) from a Pfizer sponsored program. A female patient of an unspecified age received TRUMENBA, Lot number and expiration date was 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. On an unspecified date, the patient experienced running a low fever of 99.3 degree Fahrenheit and diarrhea. According to the consumer the patient received the vaccine in school. The outcome of the events was unknown. Information on the lot number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine
Clinical narrative: Drug Allergies: Prevnar 13; This is a spontaneous report from contactable physicians received from a Pfizer-sponsored program. A 70-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number and expiry 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's drug allergies included pneumococcal 13-val conj vac (dipht crm197 protein). The outcome of the event was unknown.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was on nursing schedule to come in for 2nd SHIGNRIX injection, Patient's name was one list for 2nd injection, vaccine set aside for patient with name on it in refrig. Patient brought into room, confirmed with patient that she was here for 2nd SHINGRIX vaccine, patient said yes, verified patient, allergies, current meds, visits. SHINGRIX given with no problems or concerns. Documented in chart, when documenting, realized it was patients 3rd SHINGRIX vaccine. She had received the other two vaccines on 7/13/18 and 2/7/19. Tried to call immunization staff, unable to reach anyone, tried to call staff, no one available, was given the name of from Health Dept, spoke with him about it and he recommended what to do. Dr. Immunization Provider know, called and spoke with patient husband. Primary care provider, Dr. notified on 3/15/19. On 4/15/19 called patient to check in with her, no adverse effects or concerns.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Injection site swelling
Clinical narrative: Patient was on nursing schedule to come in for 2nd SHIGNRIX injection, Patient's name was one list for 2nd injection, vaccine set aside for patient with name on it in refrig. Patient brought into room, confirmed with patient that she was here for 2nd SHINGRIX vaccine, patient said yes, verified patient, allergies, current meds, visits. SHINGRIX given with no problems or concerns. Documented in chart, when documenting, realized it was patients 3rd SHINGRIX vaccine. She had received the other two vaccines on 7/13/18 and 2/7/19. Tried to call immunization staff, unable to reach anyone, tried to call staff, no one available, was given the name of from Health Dept, spoke with him about it and he recommended what to do. Dr. Immunization Provider know, called and spoke with patient husband. Primary care provider, Dr. notified on 3/15/19. On 4/15/19 called patient to check in with her, no adverse effects or concerns.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain in right arm. Took OTC Acetaminophen 250mg/Aspirin 250mg/Caffeine 65mg as regular intervals duration 2 days.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, soreness, warmth at injection site which increased overnight.  Edema in arm.  Affected arm was 1 1/2" larger around than right arm.  Redness, pain, swelling extended from shoulder to elbow.   Unable to use arm.  Touch to it unbearable.  Called doctor's office day after vaccination and was told to come in.  Dx:  cellulitis  Prescribed doxycycline 7 days.  Today is day 5.  Arm size has returned to normal.  Some fluid and soreness remains on inner arm at elbow.  Still sore at injection site.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Oedema peripheral
Clinical narrative: Redness, soreness, warmth at injection site which increased overnight.  Edema in arm.  Affected arm was 1 1/2" larger around than right arm.  Redness, pain, swelling extended from shoulder to elbow.   Unable to use arm.  Touch to it unbearable.  Called doctor's office day after vaccination and was told to come in.  Dx:  cellulitis  Prescribed doxycycline 7 days.  Today is day 5.  Arm size has returned to normal.  Some fluid and soreness remains on inner arm at elbow.  Still sore at injection site.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: patient got swelling and redness that was not at the shot site but lower on her arm near her elbow.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain, Pityriasis rosea, Pyrexia
Clinical narrative: 4/3/19 Body aches, shaking, fever, redness and swelling at injection site. Temp 98.8 at office visit. 4/7/19 Rash (pitryriasis Rosea). Pt told to alternate TYLENOL and ADVIL for fever, body aches.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Tremor
Clinical narrative: 4/3/19 Body aches, shaking, fever, redness and swelling at injection site. Temp 98.8 at office visit. 4/7/19 Rash (pitryriasis Rosea). Pt told to alternate TYLENOL and ADVIL for fever, body aches.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Feeling hot, Swelling
Clinical narrative: Redness swelling heat and black and blue bruise.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Swelling face
Clinical narrative: Patient showed image of face swollen; bumps on skin over thighs and midsection of stomach.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Lymph node pain
Clinical narrative: Injection site became red raised and warm to touch as well as pt started feeling sick (headache, left side neck/gland pain/fatigue, nausea) at around 5:30 pm the day she got the vaccine. Rash started 2 days later mid torso under breasts and sternum area.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Neck pain, Rash
Clinical narrative: Injection site became red raised and warm to touch as well as pt started feeling sick (headache, left side neck/gland pain/fatigue, nausea) at around 5:30 pm the day she got the vaccine. Rash started 2 days later mid torso under breasts and sternum area.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Haematochezia
Clinical narrative: Bloody stools. two days after Rotavirus vaccine.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of (R) arm noticed the next day after the shot Seen office March 21, 2019 and March 23, 2019 Given Clavile 1 ty daily. Hot moist compress to area March 23, 2019, Swelling gone
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site induration
Clinical narrative: 7.5 CM form induration of (R) deltoid 24 hours after vaccine administered.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis allergic, Fatigue
Clinical narrative: Severe allergic rash. Fatigue.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site papule
Clinical narrative: Localized pink papule left deltoid lump beneath skin approx. 2cm x 2cm left deltoid area. Mild tenderness no redness no warmth. 4-15-19
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reports soreness left deltoid after injection. Four days after injection reports redness, swelling, and itchiness. Took Benadryl which was effective for itching. States the arm is not as sore today.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: Patient reports soreness left deltoid after injection. Four days after injection reports redness, swelling, and itchiness. Took Benadryl which was effective for itching. States the arm is not as sore today.