chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Inappropriate schedule of product administration, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: sore arm; elevated temperature; chills; late 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 9th January 2020, please refer the case US2020144317.).   On 15th July 2020, the patient received the 2nd dose of Shingrix. On 15th July 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, body temperature increased, chills and drug dose administration interval too long. Rechallenge with Shingrix was positive. On 17th July 2020, the outcome of the body temperature increased and chills were recovered/resolved. On 19th July 2020, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the pain in arm, body temperature increased and chills to be related to Shingrix.  Additional case details were reported as follows: The patient experienced the events after receiving her second doses of Shingrix. On 15th July 2020, the patient received the 2nd dose of Shingrix late, which led to lengthening of the vaccination schedule. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020144317:same reporter
Age: 53.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: was more painful than the one that received/arm was sore an extra day or two longer; shot "wasn't that bad"; She experienced some shivering/shivering feeling lasted about a day.; She had some fatigue,; This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On 13th July 2020, the patient received the 1st dose of Shingrix and Tdap Vaccine. In July 2020, less than 3 weeks after receiving Shingrix and Tdap Vaccine, the patient experienced pain in arm, feeling abnormal, shivering and fatigue. On an unknown date, the outcome of the pain in arm, feeling abnormal, shivering and fatigue were unknown.   It was unknown if the reporter considered the pain in arm, feeling abnormal, shivering and fatigue to be related to Shingrix and Tdap Vaccine.  Additional case details were reported as follows: The patient received Shingrix shot was not that bad. The arm having received the Tdap vaccine was more painful than the one that received the Shingrix. The Shingrix arm was sore an extra day or two longer, though and experienced some shivering, which improved once she went outside to do her work instead. The shivering feeling lasted about a day. The patient had some fatigue, but it was hot and humid outside and she thought that may be attributed to the fact that The patient had run outside in the heat and humidity.
Age: 58.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Injection site erythema, Injection site swelling
Clinical narrative: Body Ache; Fatigue; Shivering; Feeling cold; Hot injection site; red area at the injection site; Swollen injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Hepatitis A vaccine for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on unknown date, refer case US2020AMR142881).   On 22nd July 2020, the patient received the 2nd dose of Shingrix and Hepatitis A vaccine. In July 2020, 1 day after receiving Shingrix and not applicable after receiving Hepatitis A vaccine, the patient experienced injection site warmth, injection site erythema and injection site swelling. On 23rd July 2020, the patient experienced general body pain, fatigue, shivering and feeling cold. On an unknown date, the outcome of the injection site warmth, injection site erythema, injection site swelling, general body pain, fatigue, shivering and feeling cold were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth, injection site erythema, injection site swelling, general body pain, fatigue, shivering and feeling cold to be related to Shingrix. It was unknown if the reporter considered the general body pain, fatigue, shivering and feeling cold to be related to Hepatitis A vaccine.  Additional details were provided as follows: The patient received Shingrix in her left arm and a Hepatitis A booster vaccine in her right arm and had red area at the injection site of her left arm where she received the Shingrix vaccine.  The area was about the size of the palm of a woman hand and about 2 inches in diameter.  The area was hot to the touch and it was swollen.  The patient reported fatigue, shivering and feeling cold and stated her symptoms had not resolved. The reporter consented to follow up. Lot and expiration unknown for Shingrix vaccine. Lot and Expiration unknown for Hepatitis A Booster vaccine. The patient consent to follow up. This case linked with US2020141489, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020141489:same reporter US-GLAXOSMITHKLINE-US2020AMR142881:
Age: 58.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Injection site warmth, Pain
Clinical narrative: Body Ache; Fatigue; Shivering; Feeling cold; Hot injection site; red area at the injection site; Swollen injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Hepatitis A vaccine for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on unknown date, refer case US2020AMR142881).   On 22nd July 2020, the patient received the 2nd dose of Shingrix and Hepatitis A vaccine. In July 2020, 1 day after receiving Shingrix and not applicable after receiving Hepatitis A vaccine, the patient experienced injection site warmth, injection site erythema and injection site swelling. On 23rd July 2020, the patient experienced general body pain, fatigue, shivering and feeling cold. On an unknown date, the outcome of the injection site warmth, injection site erythema, injection site swelling, general body pain, fatigue, shivering and feeling cold were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth, injection site erythema, injection site swelling, general body pain, fatigue, shivering and feeling cold to be related to Shingrix. It was unknown if the reporter considered the general body pain, fatigue, shivering and feeling cold to be related to Hepatitis A vaccine.  Additional details were provided as follows: The patient received Shingrix in her left arm and a Hepatitis A booster vaccine in her right arm and had red area at the injection site of her left arm where she received the Shingrix vaccine.  The area was about the size of the palm of a woman hand and about 2 inches in diameter.  The area was hot to the touch and it was swollen.  The patient reported fatigue, shivering and feeling cold and stated her symptoms had not resolved. The reporter consented to follow up. Lot and expiration unknown for Shingrix vaccine. Lot and Expiration unknown for Hepatitis A Booster vaccine. The patient consent to follow up. This case linked with US2020141489, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020141489:same reporter US-GLAXOSMITHKLINE-US2020AMR142881:
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash behind both knees; This case was reported by a consumer via call center representative and described the occurrence of rash in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st July 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 22nd July 2020, 1 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in left arm and developed a rash behind both knees. The reporter was unable to provide lot number and expiration date and gives consent to follow up with patient's physician. The reporter consented to follow up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Nausea, Pain
Clinical narrative: Soreness at injection site/Pain at injection site; red area at the injection site; Nausea; Body Ache; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on unknown date, refer case US2020AMR142892).   On 22nd July 2020, the patient received the 2nd dose of Shingrix. On 23rd July 2020, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site erythema, nausea, general body pain and fatigue. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, injection site erythema, nausea, general body pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, nausea, general body pain and fatigue to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in left arm and had a red area at the injection site of his left arm.  The area was about the size of the palm of a man's hand and about 3 inches in diameter. The patient had soreness and pain at the injection site, fatigue, body ache, and nausea. The reporter consented to follow up. Lot and expiration date was unknown. The reporter stated that patient consent to follow up. This case linked with US2020141485, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020141485:same reporter US-GLAXOSMITHKLINE-US2020AMR142892:same patient
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: Soreness at injection site/Pain at injection site; red area at the injection site; Nausea; Body Ache; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on unknown date, refer case US2020AMR142892).   On 22nd July 2020, the patient received the 2nd dose of Shingrix. On 23rd July 2020, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site erythema, nausea, general body pain and fatigue. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, injection site erythema, nausea, general body pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, nausea, general body pain and fatigue to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in left arm and had a red area at the injection site of his left arm.  The area was about the size of the palm of a man's hand and about 3 inches in diameter. The patient had soreness and pain at the injection site, fatigue, body ache, and nausea. The reporter consented to follow up. Lot and expiration date was unknown. The reporter stated that patient consent to follow up. This case linked with US2020141485, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020141485:same reporter US-GLAXOSMITHKLINE-US2020AMR142892:same patient
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Feeling cold, Pyrexia
Clinical narrative: Fever/temperature of 104.5F; feeling cold; feeling crummy/ like she got hit by a truck; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced fever, feeling cold and feeling bad. On an unknown date, the outcome of the fever, feeling cold and feeling bad were unknown.   It was unknown if the reporter considered the fever, feeling cold and feeling bad to be related to Shingrix.  Additional details were reported as follows: A few months ago at 17.30, the patient received the 2nd dose of Shingrix. After receiving the 2nd dose of Shingrix the patient experienced a fever at 104.5 degree F, feeling cold, and feeling crummy. The health care professional noted all adverse events were began the morning after the vaccine and completely resolved two days after vaccine administration. The reporter consent to follow up. This case is linked to case US2020141508, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020141508:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Insomnia, Pain in extremity, Pruritus, Skin swelling
Clinical narrative: arm soreness; could not sleep; stomach pain; itchy palm; bumps on left side of scalp; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, insomnia, stomach pain, itching both hands and scalp swelling. On an unknown date, the outcome of the pain in arm, insomnia, stomach pain, itching both hands and scalp swelling were unknown.   It was unknown if the reporter considered the pain in arm, insomnia, stomach pain, itching both hands and scalp swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had arm soreness, could not sleep, stomach pain, itchy palm and bumps on the left side of her scalp.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Uncontrollable itchiness / on the area she receive the vaccination; Rash on her arm, on the area she receive the vaccination; This case was reported by a nurse via sales rep and described the occurrence of injection site itching in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received the 1st dose of Shingrix. In July 2020, less than a week after receiving Shingrix, the patient experienced injection site itching and injection site rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site itching and injection site rash were unknown.   It was unknown if the reporter considered the injection site itching and injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at he vaccination was not reported. The patient received Shingrix and experienced uncontrollable itchiness and rash on her arm, on the area she received the vaccination. Benadryl was administered to this patient. No further details were reported. This case linked with US2020146796, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020146796:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Uncontrollable itchiness / on the area she receive the vaccination; Rash on her arm, on the area she receive the vaccination; This case was reported by a nurse via sales rep and described the occurrence of injection site itching in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received the 1st dose of Shingrix. In July 2020, less than a week after receiving Shingrix, the patient experienced injection site itching and injection site rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site itching and injection site rash were unknown.   It was unknown if the reporter considered the injection site itching and injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced uncontrollable itchiness and rash on her arm, on the area she received the vaccination.  Benadryl was administered to this patient. No further details were reported. This case linked with US2020146794, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020146794:same reporter
Age: 3.0
Sex: F
Vaccine: MMRV
Symptoms: Epistaxis, Gingival bleeding, Immune thrombocytopenia, Immunoglobulin therapy, Platelet count decreased
Clinical narrative: Patient developed Acute ITP or Immune Thrombocytopenic Purpura within 1.5 weeks of the vaccination with MMRV.  Presented with bleeding gums, nasal bleeding. Seen in ER 6/29/2020 and admitted to Hospital on 6/31/2020 - 7/2/2020. Received IVIG. Recovering.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site reaction, Lip erythema, Penile swelling, Penis disorder
Clinical narrative: about an hour after receiving the vaccine, felt a "prickly" feeling on his penis. noticed his foreskin was swollen. no pain on urination. was instructed by his urologist to wash the area and apply hydrocortisone and to be seen by the physician saw his pcp dr. the following day. now experienceing itching, redness on face and lips. progressed to ear and chin. Dr prescribed a 7 day course of prednisone and recommended cold compress.  6pm same day, rash progressed to entire face and had an injection site reaction.  reported to pharmacy on 8/3/20. states symptoms are getting better, but still not well. still experiencing itching, swelling, and irritation.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Skin irritation
Clinical narrative: about an hour after receiving the vaccine, felt a "prickly" feeling on his penis. noticed his foreskin was swollen. no pain on urination. was instructed by his urologist to wash the area and apply hydrocortisone and to be seen by the physician saw his pcp dr. the following day. now experienceing itching, redness on face and lips. progressed to ear and chin. Dr prescribed a 7 day course of prednisone and recommended cold compress.  6pm same day, rash progressed to entire face and had an injection site reaction.  reported to pharmacy on 8/3/20. states symptoms are getting better, but still not well. still experiencing itching, swelling, and irritation.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site oedema, Injection site pain, Injection site reaction, Rash macular
Clinical narrative: Pain during injection site, edema, and macular rash to anterior left upper extremity Today is day 3 of administration of vaccination and patient seen no changes in pain/edema/redness Treated today with prednisone, famotidine, and loratadine scheduled to return to clinic in 2 days
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Nausea and headache (2 days) Fever of 100*  (2 days) Arm pain  (5 days)
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Lymphadenopathy
Clinical narrative: Pt reported significant swelling in lymph nodes in L clavicle and L armpit 2 days after injection. Still some soreness at injection site and some swelling in clavicle but overall swelling has decreased.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Expired product administered
Clinical narrative: Pt received Pediarix combo vaccine (Diptheria, Tetanus Toxoid and Acellular Pertussis, Hep B, and Polio) on 7/30/2020;  On 7/31/2020, we discovered the patient was given a Pediarix vaccine that expired on 7/3/2020; no known problems related to the expired vaccine to our knowledge
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: She described that she could "feel" the vaccine in her mouth, but stated that she did not have any difficulty breathing. I told her she could take Benadryl if she felt it necessary and to discuss reveicing the 2nd dose with her PCP
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site erythema
Clinical narrative: felt terrible / still feel bad; red spot is the size of a woman's hand; This case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2020, the patient received Shingrix. On 23rd July 2020, 1 days after receiving Shingrix, the patient experienced feels awful and injection site erythema. On an unknown date, the outcome of the feels awful and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the feels awful and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient received Shingrix vaccine 2 days ago and felt terrible. The patient experienced redness around shot size of a woman's hand. The case has been linked with case US2020AMR143189 reported as same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR143189:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site erythema
Clinical narrative: felt terrible / still feel bad; has a red area around his shot; This case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received Shingrix. In July 2020, 1 days after receiving Shingrix, the patient experienced feels awful and injection site erythema. On an unknown date, the outcome of the feels awful was not recovered/not resolved and the outcome of the injection site erythema was recovering/resolving.   It was unknown if the reporter considered the feels awful and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient received Shingrix vaccine 2 days ago and felt terrible. The patient experienced redness around shot size of a man's hand. The patient was feeling better. The case has been linked with case US2020AMR143186 reported as same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR143186:same reporter
Sex: F
Vaccine: TDAP
Symptoms: Formication, Pain in extremity
Clinical narrative: Sore arm; "Crawling sensation" in her left arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 374LB, expiry date 28th June 2022) for prophylaxis.   On 15th July 2020, the patient received Boostrix (intramuscular) .5 ml. On 16th July 2020, 1 days after receiving Boostrix, the patient experienced pain in arm and formication. On an unknown date, the outcome of the pain in arm and formication were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and formication to be related to Boostrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient developed sore arm and the arm soreness continued but was less. The patient was complaining of a crawling sensation in her left arm. The patient stated that all might be in head. The reporter did not consent to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Deafness unilateral
Clinical narrative: One sided hearing loss; This case was reported by a pharmacist via call center representative and described the occurrence of hearing loss in a 59-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2015-2016 season) (batch number 33DR4, expiry date 30th June 2016) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2015-2016 season. On an unknown date, 7 days after receiving Fluarix Quadrivalent 2015-2016 season, the patient experienced hearing loss (serious criteria GSK medically significant). Fluarix Quadrivalent 2015-2016 season was continued with no change. On an unknown date, the outcome of the hearing loss was recovered/resolved.   It was unknown if the reporter considered the hearing loss to be related to Fluarix Quadrivalent 2015-2016 season.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Fluarix Quadrivalent 2015-2016 season, the patient experienced one sided hearing loss beginning 7 days after vaccination and resolving 3 weeks later. The reporter did not consent to follow-up. This case was linked with case US2020145692, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020145692:same reporter
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: first dose of Shingrix more than six months prior; soreness at the site of injection; redness, and swelling at the site of injection; swelling at the site of injection; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number J4D5J, expiry date 8th February 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 11th August 2018, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. In August 2018, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain, injection site erythema and injection site swelling. On an unknown date, the patient experienced incomplete course of vaccination. Shingrix was continued with no change. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site swelling were recovering/resolving and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: On 11th August 2018, within 24 hours after administration, the patient experienced soreness, redness, and swelling at the site of injection, resolving after an unknown time.  The patient received their 1st dose of Shingrix more than six months prior. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. Limited information was available. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020145690:same reporter
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous, Swelling
Clinical narrative: severe swelling; extremely red rash; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. An elderly female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at 0.5 mL, single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced severe swelling and an extremely red rash on an unspecified date, after use of product. The outcome of events was unknown.  No follow-up attempts are needed. information about lot/batch number cannot be obtained
Sex: F
Vaccine: MENB, MENB
Symptoms: Vomiting
Clinical narrative: Vomited; This is a spontaneous report from contactable physician via Pfizer Sales Representative. A female patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on 17Jul2020 at SINGLE DOSE for immunization, or received meningococcal vaccine b rfhbp/nada/nhba omv (BEXSERO), via an unspecified route of administration on 17Jul2020 at unknown dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received meningococcal group b rlp2086 (TRUMENBA) in Aug2019 for immunisation. The doctor mentioned that they had given a Meningitis B vaccine to a patient and the patient vomited. The doctor did not remember if it was Trumenba or Bexsero. The vaccine was given on 17Jul2020, and several hours later they vomited.  The doctor said that in Aug2019, the patient received her first dose of Trumenba. The doctor said she cannot guarantee she got Trumenba as the second dose. They could have grabbed Bexsero. Sometimes they don't always give Trumenba. It should be the same one, but that it not always the case. The doctor said she would check with the nurse to see which one patient received and still has not followed back up with the representative. The patient experienced vomited on 17Jul2020 with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site vesicles
Clinical narrative: itching at the injection site; blistering at the injection site; Initial information was received on 28-Jul-2020 regarding an unsolicited valid non-serious case from a patient.  This case involves a 45-year-old female patient who experienced itching at the injection site and blistering at the injection site, while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not reported.  On 27-Jul-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported via intramuscular route at an unknown administration site.  On an unknown date, the patient developed a non-serious itching at the injection site (injection site pruritus) and blistering at the injection site (injection site vesicles) (latency unknown) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data were not reported.  Final diagnosis was injection site vesicles and injection site pruritus.  It was not reported if the patient received a corrective treatment.  The patient was reported as recovering from both events at the time of reporting.  There will be no information available on the batch number for this case.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: upper arm swollen and hot and red down to the elbow.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Chills, Malaise, Myalgia, Pyrexia
Clinical narrative: Pt reported that started feeling sick with muscle pain in the evening on the same day of administration (Day 0) and had fever and chill overnight; pt drank a pint of water and ASA 325mg. On day 1(7/31/20), pt felt little better but still had fever with 101.4 degrees in the afternoon. On day 2 (8/1), pt felt overexerted with muscle aches but resolved by the afternoon. Day 3 (8/2), pt noticed having sore armpit; which may have been caused by her axillary lymph glands after the immunization in her shoulder. Day 4 on 8/3/2020, pt is feeling back to normal again.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Day after immunizations c/o fever to 101, headache and fatigue.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Ear pruritus, Headache, Paraesthesia, Pruritus
Clinical narrative: Tingling/itching - of ears, nose, vagina Diarrhea/watery stools 7/29-7/31 Headache
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Vulvovaginal pruritus
Clinical narrative: Tingling/itching - of ears, nose, vagina Diarrhea/watery stools 7/29-7/31 Headache
Age: 67.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Malaise, Musculoskeletal stiffness
Clinical narrative: 9 pm (9 hours after shot) - sore/stiff - took Advil 600 mg 12pm - spiked a fever; Rigors; headache "Felt out of it. T - 101.2 at time - 1 AM - T 102.5 - chills, Rest of week - not feeling well; low grade fever 7/21/2020 - notified pharmacist  "FDA/Vaers  8/1/2020 - spoke with Dr
Age: 67.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: 9 pm (9 hours after shot) - sore/stiff - took Advil 600 mg 12pm - spiked a fever; Rigors; headache "Felt out of it. T - 101.2 at time - 1 AM - T 102.5 - chills, Rest of week - not feeling well; low grade fever 7/21/2020 - notified pharmacist  "FDA/Vaers  8/1/2020 - spoke with Dr
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Feeling cold, Headache, Injection site pain, Pyrexia
Clinical narrative: Patient started with fever (tmax 100.81, chills,  severe headache, and pain at the injection  site on the night of 7/30/2020 which  continue to 7/31/2020
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: Body aches; shivering; headache; Body aches; shivering; headache; This spontaneous report was received from a consumer referring to 53-year-old female patient.  The patient's pertinent medical history, concomitant medications and drug reactions/allergies were unknown.  On an unknown date in January 2020 (reported as "6 months ago"), the patient was vaccinated with a dose of zoster vaccine live (manufacturer unknown) (reported as "unknown zoster vaccination") (dose, route of administration, anatomical location, lot # and expiration date were unknown) for prophylaxis. On an unknown date in January 2020, after administration of the zoster vaccine live (manufacturer unknown), the patient experienced body aches (pain), shivering (chills) and a headache. On 20-JUL-2020, the patient was again administered with a dose of zoster vaccine live (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were unknown) for prophylaxis. On 21-JUL-2020, the patient experienced the same symptoms of body ache (pain), shivering (chills), and headache. No product quality complaint (PQC) was involved. The outcome of 2 episodes of events of pain, chills and headache was unknown. The causality assessment was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Extensive swelling of vaccinated limb, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: Swollen Red spot / on his left arm; felt punky for seven to ten days or Malaise; Low grade fever; Swollen Red spot / on his left arm; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, feeling unwell, low grade fever and erythema of extremities. On an unknown date, the outcome of the extensive swelling of vaccinated limb, feeling unwell, low grade fever and erythema of extremities were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, feeling unwell, low grade fever and erythema of extremities to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. One time user of Shingrix reported swollen red spot that measured approximately six inches on his left arm where received the injection.  The patient reported low grade Fever. And felt punky for seven to ten days or malaise.  The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Swollen Red spot / on his left arm; felt punky for seven to ten days or Malaise; Low grade fever; Swollen Red spot / on his left arm; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, feeling unwell, low grade fever and erythema of extremities. On an unknown date, the outcome of the extensive swelling of vaccinated limb, feeling unwell, low grade fever and erythema of extremities were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, feeling unwell, low grade fever and erythema of extremities to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. One time user of Shingrix reported swollen red spot that measured approximately six inches on his left arm where received the injection.  The patient reported low grade Fever. And felt punky for seven to ten days or malaise.  The reporter did not consent to follow up.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain to left upper arms after pneumonia vaccine, swellind, redness and pain at the injection site.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: Site soreness and small red bumps around injection site and spreading towards the shoulder. No swelling, heat or streaking. Symptoms improved after Tylenol.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Hypotonia, Respiratory arrest
Clinical narrative: Patient's mother called me on 8/1/20 in the morning and told me that Patient has had two episodes of lifelessness during the past two nights that she is scared about. She states that on 7/31/20 at 1 am she happened to wake up and went to check on Patient. She said that "he was grey and lifeless, he went limp and i snatched him up. I thought he was dead, and he was still just lifeless and wasn't breathing and I started smacking his back and after about 4 smacks he took a breath and gave a cry then went back to sleep." Mom believes that if she didn't happen to get up and see him at that time, that he would have been dead when she woke up in the morning. She said a similar thing happened the following night, but not as severe. The patient is otherwise acting completely normal and isn't showing any signs of illness. He is eating well and playful and happy.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Insomnia, Monoplegia, Pain in extremity, Pyrexia
Clinical narrative: Paralysis of Left arm -- could not move arm.  Pain in arm -- could not sleep at all during nite. Lasted  a bit over 12 hours.    Low grade fever lasted two days 99.8 F
Age: 20.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: Recipient of vaccine reports mild lightheadedness, mild nausea, and fatigue after waking up the morning after receiving the vaccine. Symptoms still present today.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: no adverse event reported
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Pruritus, Swelling
Clinical narrative: patient reported itching, swollen and heat.  when contacted the following day, the symptoms had subsided considerably.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Patient states that she started developing blisters in her mouth about 3 days after receiving the Shingrix vaccine. Advised patient to make a doctors appointment to be seen
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Rash
Clinical narrative: Patient's provider, called today (8/3/20) stating the patient was seen on 7/31/20 and has a left upper back rash. Patient received the first Shingrix dose on 7/29/20.  Provider also states the patient had a cardioversion on 7/7/20 and is currently in A fib.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Vaccination given was incorrect. INFANRIX (DTaP) was given, 0.5mL in L Arm when patient was supposed to receive BOOSTRIX (TDaP) 0.5mL. Patient had no adverse reactions.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient developed rash/ bumps along her back. She went to an urgent care facility on  8/1 and was diagnosed with shingles. She was given treatment.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Crying, Face and mouth X-ray, Face injury, Fall, Mydriasis
Clinical narrative: AFTER ADMINISTRATING VACCINES PATIENT FAINTED FACE FORWARD ON THE FLOOR LANDING ON HER FACE.. PATIENT WAS UNRESPONSIVE, PUPILS DILATED. EMS WAS CALLED . PATIENT STARTED HAVING TONIC SEIZURE THAT LASTED 30 TO 45 SECONDS, SHE THEN RECOVER CONSCIOUSNESS FOLLOW BY CRIES. PATIENT WAS TRANSPORTED TO THE ER VIA EMS FOR FURTHER EVALUATION DUE TO TRAUMA, SYNCOPY AND TONIC SEIZURE
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Pain, Syncope, Tonic convulsion, Unresponsive to stimuli, X-ray
Clinical narrative: AFTER ADMINISTRATING VACCINES PATIENT FAINTED FACE FORWARD ON THE FLOOR LANDING ON HER FACE.. PATIENT WAS UNRESPONSIVE, PUPILS DILATED. EMS WAS CALLED . PATIENT STARTED HAVING TONIC SEIZURE THAT LASTED 30 TO 45 SECONDS, SHE THEN RECOVER CONSCIOUSNESS FOLLOW BY CRIES. PATIENT WAS TRANSPORTED TO THE ER VIA EMS FOR FURTHER EVALUATION DUE TO TRAUMA, SYNCOPY AND TONIC SEIZURE
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Visual impairment
Clinical narrative: Pt came in for his 2nd dose of Shingrix. He said he was delayed to get the second dose because he has partial loss of his left eye vision after a week received the shingrix. He still loss his vision now. He said he cant see anything below. He sees thing in front or upper are fine.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: rash and fever
Age: 0.67
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Abscess drainage, Bacterial test positive, Injection site abscess, Injection site erythema, Injection site mass
Clinical narrative: Started with redness and Swelling. Turned greenish color and became a big lump. This is the second incident (second report) both times my baby had to have her legs cut open to drain abscess.
Age: 0.67
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site swelling, Laboratory test
Clinical narrative: Started with redness and Swelling. Turned greenish color and became a big lump. This is the second incident (second report) both times my baby had to have her legs cut open to drain abscess.
Age: 49.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Patient became diaphoretic and slighty lightheaded after administration VS 98/62 p 57 R 22 O2 sat 98%  T 98.6 VS monitored last set 1048 98/62 57 20 O2 sat 98% no dizziness or problems.
Age: 1.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Client was given expired vaccine but it was not know until after the family left and the nurse was charting the vaccine administration. No signs or symptoms were noted in the office. Family was  later notified of incident  approx 45 minutes later and child remained symptom free.  Office physician was notified.
Age: 52.0
Sex: F
Vaccine: HEPAB
Symptoms: Cold sweat, Dizziness, Immediate post-injection reaction, Pain, Vomiting
Clinical narrative: Pt complaint of  pain right after Twinrix vaccine administration on the right arm. Pt had x1 episode of Vomiting  . Pt complaint of  s/s  dizziness and felt clammy after the  injection , Pt felt better within minutes and VS were WNL. Pt fully recovered before discharge .
Age: 2.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Child was administered Pediarix in clinic. No adverse reactions noted at that time. It was later found out on 08/03/2020 that the vaccine was given and it was expired. Dr notified. Family was notified of situation and child had remained free of any adverse reactions.
Age: 17.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Accidental exposure to product
Clinical narrative: Immunizations given without provider's order.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Tenderness
Clinical narrative: I noticed about 3-4 hours after the injection that my right upper arm was swelling. My entire upper arm became red, hot to the touch, extremely swollen, and painful. This lasted for about 36 hours after onset, the pain being so severe that I considered seeking emergency care. It has been 72 hours since the vaccination, and the swelling and pain have largely passed, but my arm is still red and tender. The redness, swelling, and pain did not center on the injection site, but rather formed below the area where the shot was administered.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Contusion, Injection site discolouration, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: his injection site it is warm reddish purple and the size of the palm of her hand. Mom reports he did run fevers over the weekend starting 08/01/20.  Today 08/03/20  the fevers have stopped and it is no longer warm to touch. Still vary large bruise looking mark.  Patient was seen in clinic for evaluation 08/03/20, recommendation is to continue to watch and five ibuprofen as needed.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Myalgia, Pain
Clinical narrative: Moderate pain, redness, swelling, tiredness, muscle pain, shivering
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Moderate pain, redness, swelling, tiredness, muscle pain, shivering
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and red patch  2? below injection site. Red Patch is approximately 3?- sore, and hot to the touch. Appeared when I woke up approximately 36 hours after shot
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: patient started noticing some itching around the injection site. then the next day afte itching some redness and warmth has occured. patient was seen by dr on 08/03/20. treating with zyrtec. will f/u with pt
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PATIENT REPORTS EXTREME PAIN, REDNESS, AND SWELLING AT INJETION SITE EVEN 3 DAYS LATER
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, MNQ, HPV9, MNQ, TDAP
Symptoms: Bradycardia, Hypotension, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Patient lost consciousness for approximately one minute right after administration of vaccines. Pt was hypotensive and had bradycardia  during recovery time. Pt was observed for approximately 15 minutes after event. Pt was discharged home in stable condition.