chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite
Clinical narrative: Loss of appetite; This case was reported by a consumer via call center representative and described the occurrence of appetite lost in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on 18 January 2019, refer case US2019163762), Afluria quadrivalent with an associated reaction of fatigue (received the year before the date of reporting and experienced nausea, vomiting,  itching, fatigue, flu like symptoms and achiness) and Benadryl (pre-medicate with 50mg). Concurrent medical conditions included chronic spontaneous urticaria.   On 3rd May 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced appetite lost. On an unknown date, the outcome of the appetite lost was unknown.   It was unknown if the reporter considered the appetite lost to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had the issues were milder, she had no nausea, but did have loss of appetite and again lasted for about 2 days.      She states she has been told by her physician that due to the idiopathic urticaria that she has, her mast cells de-granulate when she gets a vaccination and that was what causes a more pronounced reaction that she gets. The reporter consented to follow up. This case linked with US2019163706, US2019AMR165479, US2019163762, US2019AMR165480, reported by same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Musculoskeletal pain, Swelling
Clinical narrative: Tiredness; sore shoulder; Swelling; This case was reported by a consumer via call center representative and described the occurrence of shoulder soreness in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2019, the patient received the 1st dose of Shingrix. On 8th July 2019, less than a day after receiving Shingrix, the patient experienced shoulder soreness and swelling. On 9th July 2019, the patient experienced tiredness. On 10th July 2019, the outcome of the tiredness was resolved with sequelae. On 12th July 2019, the outcome of the shoulder soreness was resolved with sequelae. On an unknown date, the outcome of the swelling was resolved with sequelae.   It was unknown if the reporter considered the shoulder soreness, swelling and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient recevied Shingrix vaccine on right arm. The patient reported swelling, shoulder pain and feeling tired after receiving vaccine. The patient consented to follow up. For tolerance to the 2nd dose of Shingrix, refer case US2019169168.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Influenza like illness, Myalgia, Sinusitis
Clinical narrative: Flu-like symptoms; Severe headache; Sore muscles; Swollen sinuses; No energy; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, headache, muscle soreness, sinusitis and loss of energy. On an unknown date, the outcome of the influenza-like symptoms, headache, muscle soreness, sinusitis and loss of energy were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, headache, muscle soreness, sinusitis and loss of energy to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced horrible side effects like flu-like symptoms, severe headache, sore muscles, swollen sinuses and no energy. The patient asked if there was anything that she could take to relieve these symptoms.
Age: 51.0
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Oral herpes
Clinical narrative: Fever blister on mouth; This case was reported by a consumer and described the occurrence of fever blister in a 51-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (about 5 months ago) and fever blister (several before the vaccination but they were healed).   On 24th September 2019, the patient received the 1st dose of Shingrix. On 27th September 2019, 3 days after receiving Shingrix, the patient experienced fever blister. On an unknown date, the outcome of the fever blister was unknown.   It was unknown if the reporter considered the fever blister to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on the right upper arm. The patient experienced fever blisters on mouth. The patient asked whether the vaccine could cause fever blister afterwards. The patient experienced no fever just the blisters on mouth. The patient was not sure if it was related or not. The patient told the fever blisters were several before the vaccination but they were healed and then on Friday several popped up above where the others had been. The patient had already sent the doctor a message earlier. The reporter gave consent for follow up.
Sex: U
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: injection site redness; injection site swelling; injection site heat; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA151A, expiry date 31st July 2020) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, less than 6 months after receiving Menveo, the patient experienced injection site erythema, injection site swelling and injection site warmth. The patient was treated with benadryl (nos) (Benadryl) and ibuprofen. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to Menveo.  Additional details were provided as follows: The patient had redness, swelling and heat at the injection site. At the time of reporting the patient told to continue Benadryl and Ibuprofen. The reporter did not agree to follow up. This case is 1 of the 3 linked cases, reported by the same reporter.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site induration, Injection site pain, Pyrexia
Clinical narrative: fever; numbness in fingertips; soreness at injection site; induration at the injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax.   On 19th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In September 2019, 1 day 12 hrs after receiving Shingrix, the patient experienced numbness in fingers. On 19th September 2019, the patient experienced injection site pain and injection site induration. On 20th September 2019, the patient experienced fever. On an unknown date, the outcome of the injection site pain, injection site induration, fever and numbness in fingers were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site induration, fever and numbness in fingers to be related to Shingrix.  Additional details were provided as follows: Twenty four hours after receiving the vaccine, the patient developed a fever of 101 degree F.  Approximately 36 hours after receiving the vaccine, she developed numbness in the fingertips on her left hand that lasted for a few hours before resolving. In September 2019, soreness at the injection site resolved after lasting for 4 days and induration at the injection site resolved after lasting for 5 days. The reporter did not consent to follow up. The caller did not provide any additional information. There is discrepancy between the outcome reported in the structured field of database (recovered) and the outcome reported in the source document (recovered with sequel).
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: sore arm; muscle aches; chills; shakiness; nausea; vomiting; fatigue; fainted; headache; This case was reported by a consumer via call center representative and described the occurrence of fainting in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (for tolerance, refer case US2019178966).   On 25th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). In July 2019, less than a day after receiving Shingrix, the patient experienced fainting (serious criteria GSK medically significant), headache, muscle pain, chills, tremor, nausea, vomiting and fatigue. On an unknown date, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fainting, headache, pain in arm, muscle pain, chills, tremor, nausea, vomiting and fatigue were recovered/resolved.   It was unknown if the reporter considered the fainting, headache, pain in arm, muscle pain, chills, tremor, nausea, vomiting and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid and within six hours started to experience headache, muscle pain, chills, shakiness, nausea, vomiting, fatigue and fainting spells. Less than 3 months after vaccination, the patient experienced sore left arm. It took a couple of days for the adverse events to resolve. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Syncope, Tremor, Vaccine positive rechallenge, Vomiting
Clinical narrative: sore arm; muscle aches; chills; shakiness; nausea; vomiting; fatigue; fainted; headache; This case was reported by a consumer via call center representative and described the occurrence of fainting in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (for tolerance, refer case US2019178966).   On 25th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). In July 2019, less than a day after receiving Shingrix, the patient experienced fainting (serious criteria GSK medically significant), headache, muscle pain, chills, tremor, nausea, vomiting and fatigue. On an unknown date, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fainting, headache, pain in arm, muscle pain, chills, tremor, nausea, vomiting and fatigue were recovered/resolved.   It was unknown if the reporter considered the fainting, headache, pain in arm, muscle pain, chills, tremor, nausea, vomiting and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid and within six hours started to experience headache, muscle pain, chills, shakiness, nausea, vomiting, fatigue and fainting spells. Less than 3 months after vaccination, the patient experienced sore left arm. It took a couple of days for the adverse events to resolve. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Feeling like a mini stroke; Numbness extended from mouth and teeth down to legs; Teeth numbness; This case was reported by a physician via sales rep and described the occurrence of feeling abnormal in a 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, less than a day after receiving Shingrix, the patient experienced feeling abnormal, numbness localized and numbness oral. On an unknown date, the outcome of the feeling abnormal, numbness localized and numbness oral were unknown.   It was unknown if the reporter considered the feeling abnormal, numbness localized and numbness oral to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and later that day the left side of the patient's body went numb described as feeling like a mini stroke. The numbness extended from mouth and teeth down to legs. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 54H72, expiry date 1st October 2021) for prophylaxis.   On 15th August 2019, the patient received the 1st dose of Shingrix. On 3rd October 2019, 49 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix and developed shingles symptoms over the last 4 to 5 weeks and was officially diagnosed with shingles on 3rd October 2019. The outcome reported for shingles in the structured field of XML is recovering/resolving instead of not recovered/ not resolved (outcome uploaded).
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Pyrexia
Clinical narrative: Fever over 101 F; Bed-bound; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number J225D, expiry date 22nd October 2021) for prophylaxis.   On 5th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced fever and bedridden. On an unknown date, the outcome of the fever and bedridden were recovered/resolved.   It was unknown if the reporter considered the fever and bedridden to be related to Shingrix.  Additional details were provided as follows: Following 1st dose of Shingrix vaccination in left deltoid, the patient complained of fever over 101 Fahrenheit for over 1.5 days and that she was bed-bound. The reporter had very limited event information and did not know onset of events. The outcome reported for all events in the structured field of XML is resolved with sequelae instead of recovered/ resolved (outcome uploaded in Argus).      Lab Comments: On an unknown date, the patients body temperature was checked
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Pain at the injection site; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for two patients (parents). This is second of two reports.   A male patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVENAR 13, lot number and expiration date were unknown) via an unspecified route of on an unspecified date in 2018 at single dose for immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported that his parents came in to be vaccinated and they experienced the typical pain at the injection site. This event occurred a year ago on an unspecified date in 2018. The pharmacist stated it was typical to experience pain at the injection site. The outcome of the event was unknown.  Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019433156 same reporter/drug/event, different patient
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: pain at the injection site; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar events for two patients (parents). This is first of two reports.   A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVENAR 13, lot number and expiration date were unknown) via an unspecified route of on an unspecified date in 2018 at single dose for immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported that his parents came in to be vaccinated and they experienced the typical pain at the injection site. This event occurred a year ago on an unspecified date in 2018. The pharmacist stated it was typical to experience pain at the injection site. The outcome of the event was unknown.  Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019432636 same reporter/drug/event, different patient
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Autism spectrum disorder, Developmental delay, Seizure
Clinical narrative: regressive autism; seizure; developmental delay; Initial information received on 02-Oct-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a 30 months old female patient who experienced regressive autism (Autism spectrum disorder), seizure activity (seizure) and developmental delay (Developmental delay), while she received vaccines IPV (VERO) [IPOL], HIB (PRP/T) VACCINE [ACT-HIB] and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 06-Jun-2017, the patient received a dose of suspect IPV (VERO) lot number not reported via unknown route in unknown administration site, a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site and a dose of suspect HIB (PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a serious regressive autism (autism spectrum disorder) and seizure  activity (Unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE, HIB (PRP/T) VACCINE and IPV (VERO). Both the events were assessed as medically significant. On an unknown date, the patient developed a non serious developmental delay (developmental delay) (Unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE, HIB (PRP/T) VACCINE and IPV (VERO).  Other relevant tests included No lab data.  Final diagnosis was developmental delay, seizure activity and regressive autism.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for all the events.  Information on the batch number was requested  List of documents held by sender: none.; Sender's Comments: This case concerns a 30 months old female patient who presented with regressive autism, seizure and developmental delay after vaccination with IPOL, ACT-HIB and DAPTACEL. The time to onset is compatible with the role of vaccine. However, patient's birth history, medical condition at time of vaccination and lab data ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccines cannot be individually assessed.
Age: 16.0
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: Erythema, Peripheral swelling, Product administered at inappropriate site
Clinical narrative: According to student + confirmed w/Dr. Varicella shot was given in (R) Volar aspect of arm. Patient had a red raised reaction measuring 4 inches wide by 3 1/2 inches long. Varicella shot should only be administered SQ in lateral aspect back of arm + outer thighs per package insert.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Malaise, Retching, Tremor
Clinical narrative: Pt reports that morning after the vaccine he got up and was shaking and chilling despite being in the shower, malaise, dry heaving, was on hands and knees without energy.  Got on the couch and stayed there for the rest of the day.
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: About an hour after receiving the flu shot, the employee experienced itching on the same are as the flu shot was received. She developed redness and swelling below and to the right of where we believe she received the flu shot. A bandaid from the flu shot was removed from the upper deltoid area when symptoms began but warmth, redness and swelling occurred in an area lower than the injection. Hydrocortisone applied to site today.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Influenza like illness, Malaise, Pain, Rash
Clinical narrative: Patient received vaccine on 10/07/19 around 09:00 am. She developed Flu like symptoms (body aches, Malaise, fatigue) around 4:30 am on 10/08/19. Today she was seen in clinic with a flat, pink/red, non-pruritic, non-painful rash on stomach, lower back, inner thighs and upper arms. She states she feels fine today but was concerned about the rash.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Streptococcus test negative
Clinical narrative: Patient received vaccine on 10/07/19 around 09:00 am. She developed Flu like symptoms (body aches, Malaise, fatigue) around 4:30 am on 10/08/19. Today she was seen in clinic with a flat, pink/red, non-pruritic, non-painful rash on stomach, lower back, inner thighs and upper arms. She states she feels fine today but was concerned about the rash.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Rash
Clinical narrative: Child received five vaccines on this doctor visit. But Hepatitis A (Havrix) and MMR+Varicella ( Proquad) were two new vaccines child received on this date 10/08/2019. Child started experiencing a rash on her back, arms and face maybe about 5 minutes after vaccines were given. Provider was called to look at her and Benadryl was given to child. She was checking out and had her wait a couple of minutes after Benadryl was given. Rash started disappearing.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Erythema, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Vax - Shingrix (dose 2 of 2)  Unable to enter information in box 17.  Initially experienced arm soreness and redness. Next day had fever, chills, and nausea at work. Returned to work the following day. Feverish, so left early and went to bed around 4:30pm. Currently, arm is still painful, red, sore, and hot to the touch.    Will visit Urgent Care today.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Vax - Shingrix (dose 2 of 2)  Unable to enter information in box 17.  Initially experienced arm soreness and redness. Next day had fever, chills, and nausea at work. Returned to work the following day. Feverish, so left early and went to bed around 4:30pm. Currently, arm is still painful, red, sore, and hot to the touch.    Will visit Urgent Care today.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pyrexia, Swelling
Clinical narrative: significant local swell, fevers, chills  family reports similar reaction after last year's influenza vaccine given  10/3/18 Fluarix lot 794A3 left deltoid
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Ear pain, Hyperaesthesia, Hyperhidrosis
Clinical narrative: I received the second dose of Shingrix and had severe flu symptoms beginning 12 hours after the injection, and lasting 24 hours after the injection. I had sweats, chills, a 100 degree fever, body aches, ear ache, skin sensitive to touch, ringing in ears, weakness, nausea, and redness/swelling/pain at the injection site. These symptoms were severe, like I had a bad case of flu. After the first day post-vaccine, I had only itching, redness, swelling and pain at the injection site.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: I received the second dose of Shingrix and had severe flu symptoms beginning 12 hours after the injection, and lasting 24 hours after the injection. I had sweats, chills, a 100 degree fever, body aches, ear ache, skin sensitive to touch, ringing in ears, weakness, nausea, and redness/swelling/pain at the injection site. These symptoms were severe, like I had a bad case of flu. After the first day post-vaccine, I had only itching, redness, swelling and pain at the injection site.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Tinnitus
Clinical narrative: I received the second dose of Shingrix and had severe flu symptoms beginning 12 hours after the injection, and lasting 24 hours after the injection. I had sweats, chills, a 100 degree fever, body aches, ear ache, skin sensitive to touch, ringing in ears, weakness, nausea, and redness/swelling/pain at the injection site. These symptoms were severe, like I had a bad case of flu. After the first day post-vaccine, I had only itching, redness, swelling and pain at the injection site.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Blood potassium increased, Blood thyroid stimulating hormone normal, Blood urine present, Chills
Clinical narrative: Severe immune system reaction, starting slow and continuing to get worse, requiring Prednisone treatment. 01/21/2019: Shingrix vaccination #1. Lot # N79Z5 01/22/2019 ? 01/23/2019: Significant fatigue and body aches for 2 days. Feb/March/April 2019: Low energy & fatigue continuing to get worse. 05/08/2019: Shingrix vaccination #2: Lot # F3D7H 05/09/2019 ? 5/10/19: Severe fatigue, body aches, fever, chills and sweats for 2 days 05/13/2019: Colitis symptoms, blood in stool, fatigue. May/June/July 2019: Colitis symptoms continuing to worsen, blood in stool, pain, fatigue. 08/06/19: Begin Prednisone treatment. 09/15/2019: Pulmonary embolisms - due to Colitis inflammation.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Clostridium test negative, Colitis, Computerised tomogram abdomen abnormal, Computerised tomogram thorax abnormal, Condition aggravated
Clinical narrative: Severe immune system reaction, starting slow and continuing to get worse, requiring Prednisone treatment. 01/21/2019: Shingrix vaccination #1. Lot # N79Z5 01/22/2019 ? 01/23/2019: Significant fatigue and body aches for 2 days. Feb/March/April 2019: Low energy & fatigue continuing to get worse. 05/08/2019: Shingrix vaccination #2: Lot # F3D7H 05/09/2019 ? 5/10/19: Severe fatigue, body aches, fever, chills and sweats for 2 days 05/13/2019: Colitis symptoms, blood in stool, fatigue. May/June/July 2019: Colitis symptoms continuing to worsen, blood in stool, pain, fatigue. 08/06/19: Begin Prednisone treatment. 09/15/2019: Pulmonary embolisms - due to Colitis inflammation.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Culture stool negative, Electrocardiogram normal, Eosinophil count increased, Eosinophil percentage increased, Fatigue
Clinical narrative: Severe immune system reaction, starting slow and continuing to get worse, requiring Prednisone treatment. 01/21/2019: Shingrix vaccination #1. Lot # N79Z5 01/22/2019 ? 01/23/2019: Significant fatigue and body aches for 2 days. Feb/March/April 2019: Low energy & fatigue continuing to get worse. 05/08/2019: Shingrix vaccination #2: Lot # F3D7H 05/09/2019 ? 5/10/19: Severe fatigue, body aches, fever, chills and sweats for 2 days 05/13/2019: Colitis symptoms, blood in stool, fatigue. May/June/July 2019: Colitis symptoms continuing to worsen, blood in stool, pain, fatigue. 08/06/19: Begin Prednisone treatment. 09/15/2019: Pulmonary embolisms - due to Colitis inflammation.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Haematochezia, Helicobacter test negative, Hyperhidrosis, Lymphocyte percentage decreased, Metabolic function test normal
Clinical narrative: Severe immune system reaction, starting slow and continuing to get worse, requiring Prednisone treatment. 01/21/2019: Shingrix vaccination #1. Lot # N79Z5 01/22/2019 ? 01/23/2019: Significant fatigue and body aches for 2 days. Feb/March/April 2019: Low energy & fatigue continuing to get worse. 05/08/2019: Shingrix vaccination #2: Lot # F3D7H 05/09/2019 ? 5/10/19: Severe fatigue, body aches, fever, chills and sweats for 2 days 05/13/2019: Colitis symptoms, blood in stool, fatigue. May/June/July 2019: Colitis symptoms continuing to worsen, blood in stool, pain, fatigue. 08/06/19: Begin Prednisone treatment. 09/15/2019: Pulmonary embolisms - due to Colitis inflammation.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Monocyte count increased, Pain, Pleural effusion, Pulmonary embolism, Pyrexia
Clinical narrative: Severe immune system reaction, starting slow and continuing to get worse, requiring Prednisone treatment. 01/21/2019: Shingrix vaccination #1. Lot # N79Z5 01/22/2019 ? 01/23/2019: Significant fatigue and body aches for 2 days. Feb/March/April 2019: Low energy & fatigue continuing to get worse. 05/08/2019: Shingrix vaccination #2: Lot # F3D7H 05/09/2019 ? 5/10/19: Severe fatigue, body aches, fever, chills and sweats for 2 days 05/13/2019: Colitis symptoms, blood in stool, fatigue. May/June/July 2019: Colitis symptoms continuing to worsen, blood in stool, pain, fatigue. 08/06/19: Begin Prednisone treatment. 09/15/2019: Pulmonary embolisms - due to Colitis inflammation.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Red blood cell count decreased, Serum ferritin decreased, Urine ketone body present, Vitamin B12 normal, White blood cell count increased
Clinical narrative: Severe immune system reaction, starting slow and continuing to get worse, requiring Prednisone treatment. 01/21/2019: Shingrix vaccination #1. Lot # N79Z5 01/22/2019 ? 01/23/2019: Significant fatigue and body aches for 2 days. Feb/March/April 2019: Low energy & fatigue continuing to get worse. 05/08/2019: Shingrix vaccination #2: Lot # F3D7H 05/09/2019 ? 5/10/19: Severe fatigue, body aches, fever, chills and sweats for 2 days 05/13/2019: Colitis symptoms, blood in stool, fatigue. May/June/July 2019: Colitis symptoms continuing to worsen, blood in stool, pain, fatigue. 08/06/19: Begin Prednisone treatment. 09/15/2019: Pulmonary embolisms - due to Colitis inflammation.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Immediate post-injection reaction, Pain, Peripheral swelling, Skin warm
Clinical narrative: PATIENT PRESENTED TO PHARMACY  2 DAYS AFTER INJECTION TO COMPLAIN ABOUT SORENESS AND REACTION. WHOLE UPPER ARM WAS VERY SWOLLEN FROM ELBOW TO SHOULDER AND SKIN WAS RED AROUND ENTIRE CIRCUMFERENCE OF THE UPPER ARM. SWOLLEN AREA WAS HOT TO THE TOUCH.  PATIENT STATED THAT IT STARTED RIGHT AFTER THE INJECTION BUT THAT IS DOES NOT APPEAR TO BE GETTING WORSE. SHE WILL SEE HER DR IF CONDITION DOES NOT IMPROVE
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: WHEN CHILD WOKE UP THIS MORNING, HE HAD A RED, RAISED PATCH AROUND INJECTION SITE THAT WAS ITCHY.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Joint noise, Pain
Clinical narrative: Limited rotation with pain, cant sleep on left arm without waking up in pain, shoulder joint occasionally pops
Age: 54.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Night of/Day after patient developed rash, swelling, and pain in arm. Went to walk-in and given Keflex on 10/8/19
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient received injection on 10/3 and came into pharmacy today on 10/9 stated she had not had any soreness or redness until yesterday when she was at a scheduled dermatology appointment and showed to her physician during visit at which time the doctor gave her a sample of a topical steroid to try and suggested she come to show us the reaction site the site is red and somewhat fevered and did not appear this way until yesterday she states she does not believe she has been bitten by an insect and it is most likely a delayed reaction to the injection but is not sure
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Lip swelling, Malaise, Pain, Pyrexia, Urticaria
Clinical narrative: At 9:00 PM patient told the mother he was not feeling well, c/o body aches, swollen lips, he was noted to have a fever and broke out in hives.  At some point, he began to vomit.  Dad is a physician assistant and administered Benadryl which helped some.  Speaking to the mother at 1:30 on 10/09/2019, he was much improved.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: At 9:00 PM patient told the mother he was not feeling well, c/o body aches, swollen lips, he was noted to have a fever and broke out in hives.  At some point, he began to vomit.  Dad is a physician assistant and administered Benadryl which helped some.  Speaking to the mother at 1:30 on 10/09/2019, he was much improved.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Patient reported redness and swelling at injection site and surrounding area. Patient also reported stiffness and pain at shoulder and elbow a day after injection.
Sex: U
Vaccine: CHOL, FLU4
Symptoms: Pain in extremity
Clinical narrative: Persistent arm pain for three weeks with increasingly sharp pains
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Nausea, Pain in extremity, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Nausea, drowsiness, leg pain, red itchy bumps on 10/5/2019 on ankles, legs, abdomen, shoulders
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Somnolence
Clinical narrative: Nausea, drowsiness, leg pain, red itchy bumps on 10/5/2019 on ankles, legs, abdomen, shoulders
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Administered an expired vaccine.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Mobility decreased, Swelling
Clinical narrative: erythema at site, swelling, difficulty lifting arm
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: She received the flu vaccine and came back after she was done shopping (about 45 mins after) and said her arm was sore and she felt it was swollen. I asked to look at it and after seeing the swelling in her upper arm I asked her if she had hives anywhere else and if she had trouble breathing. She denied any other symptoms other than having a sore arm with swelling. I advised her to take some Benadryl when she gets home. I told her if she is uncomfortable or if she feels that it is getting worse she should seek medical attention. I called the patient about 2 hours later to follow up and she said she took the Benadryl and was feeling much better and the swelling went down.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Nausea, Peripheral swelling, Pyrexia, Urticaria
Clinical narrative: Swelling of arm from shoulder to elbow, hives, nausea, fever 101
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Erythema multiforme, Pyrexia
Clinical narrative: 6 DAYS AFTER VACCINATION DEVELOPED  ERYTHEMA  MULTIFORME AND FEVER.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Dizziness postural, Face injury, Fall, Fatigue, Headache
Clinical narrative: Mom brought pt in for HPV#2 and flu shot this morning at 0850. I gave her the shots with her sitting on the exam table. Pt was answering my questions right after the shots. When I turned around and attempted to write a school note for pt, pt fell down from the exam table which is 3 to 3.5 feet tall to the carpeted floor. It happened so quickly that I did not see her fall. She was already on the floor.  It happened about 20 seconds after pt got the shots. Pt was staring forward, not responding, her body tense up for about 5 seconds. She regained her consciousness afterward. I helped her lie on the floor with her leg elevated.  She looked pale and could not remember what had happened.She stated she hit the L cheek of her face, around her L jaw. MD  was called into the room to assess pt. Pt's BP 122/66. SpO2 95-98%, P 58-65. Pt complained of her L cheek hurting, headache, and dizziness. She did not eat before coming in. Pedialyte, cracker and candy were offered.Ibuprofen 200mg was given for headache. Ice was applied to L cheek.  Pt was on the floor for about 1.5hours due to dizziness when she sat then attempted to stand. Recheck BP 96/58. MD reassessed pt. Mom was told by MD pt might have mild concussion from the fall. Pt was assisted to sit on the floor, and stand up 2min after sitting. Her BP when standing was 94/62. Pt still acted very tired. Pt stated she felt ok and would like to go home. Pt left the office with mom at about 1015. I walked them out. She was able to walk to their car while holding to mom.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Pallor, Staring, Tension, Unresponsive to stimuli
Clinical narrative: Mom brought pt in for HPV#2 and flu shot this morning at 0850. I gave her the shots with her sitting on the exam table. Pt was answering my questions right after the shots. When I turned around and attempted to write a school note for pt, pt fell down from the exam table which is 3 to 3.5 feet tall to the carpeted floor. It happened so quickly that I did not see her fall. She was already on the floor.  It happened about 20 seconds after pt got the shots. Pt was staring forward, not responding, her body tense up for about 5 seconds. She regained her consciousness afterward. I helped her lie on the floor with her leg elevated.  She looked pale and could not remember what had happened.She stated she hit the L cheek of her face, around her L jaw. MD  was called into the room to assess pt. Pt's BP 122/66. SpO2 95-98%, P 58-65. Pt complained of her L cheek hurting, headache, and dizziness. She did not eat before coming in. Pedialyte, cracker and candy were offered.Ibuprofen 200mg was given for headache. Ice was applied to L cheek.  Pt was on the floor for about 1.5hours due to dizziness when she sat then attempted to stand. Recheck BP 96/58. MD reassessed pt. Mom was told by MD pt might have mild concussion from the fall. Pt was assisted to sit on the floor, and stand up 2min after sitting. Her BP when standing was 94/62. Pt still acted very tired. Pt stated she felt ok and would like to go home. Pt left the office with mom at about 1015. I walked them out. She was able to walk to their car while holding to mom.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, pain, extreme swelling to injection site.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Dizziness, Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: Repeated vomiting, severe nausea, dizziness, moderate to severe muscle pain throughout body, pain at site of injection, severe headache
Age: 16.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Vomiting
Clinical narrative: Repeated vomiting, severe nausea, dizziness, moderate to severe muscle pain throughout body, pain at site of injection, severe headache
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness in injection site and along entire upper arm, hot to touch
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; patient was administered improperly stored VAQTA; This spontaneous report was received from a medical assistant, referring to a 16-year-old adolescent patient of unknown gender. The patient's  pertinent medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not reported. On 26-SEP-2019, the patient was vaccinated with an improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) of lot # S007770 having expiration date 24-JUL-2020 (strength, dose, schedule and route of administration were unknown) for prophylaxis (product storage error). The vaccine underwent temperature excursion below 36-degree Fahrenheit/2 degree celsius: 35.4 Fahrenheit for a duration of 10 minutes. There was no previous temperature excursion. There was no involvement of data logger. No product quality complaints (PQC) were involved. There was no adverse event.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: improper stored vaccine administered; This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant therapies and drug reactions/allergies were unknown. On an unknown date, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (therapy type: digital data logger) 1 dose (route of administration unknown) (lot # S007075 and expiration date 06-SEP-2019) for prophylaxis (product storage error). The administered dose of the vaccine experienced a temperature excursion of 32.5 degree Fahrenheit (°F) for 8 hours, as recorded by a data logger. The vaccines had no previous temperature excursion.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: NO ADVERSE EVENT; IMPROPERLY STORED proquad; This spontaneous report was received from a medical assistant regarding a 4 year old patient. The patient's medical history, concurrent conditions were not reported. Concomitant medications included sterile diluent. On 19-SEP-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (product storage error) therapy type rha and lot # S013715 and expiry date 01-NOV-2020, (strength, dose, route, were not reported) for prophylaxis. The medical assistant described that diluent that was used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was properly stored. No adverse events reported. The measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was stored at temperature of 5 degree foreign heat to 46 degree foreign heat for 6 hours and 15 minutes, there was no previous temperature excursion and no data logger.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: the patient received improperly stored vaccine at an unspecified date; This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's concurrent condition, concomitant medication and medical history were unknown. On an unknown date, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), one dose of lot # S003865 with expiry date 08-AUG-2020 (frequency, route of administration unspecified) for prophylaxis (product storage error). On an unknown date, the vaccine was exposed to 32.5 Fahrenheit temperature for 8 hours. No previous temperature excursion was reported. Digital data logger was involved. The outcome of product storage error was unknown.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Patient received improperly stored vaccine; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug allergy/reaction and concomitant medication were not reported. On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (strength, dose, frequency, route were unknown) lot # S007075, expiry date: 06-SEP-2020 for prophylaxis. On an unknown date, the patient recived improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live(PROQUAD) vaccine (product storage error). The outcome of product storage error was unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: muscle pain; This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was unknown.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number was not reported. The reporter consented to follow up. The reporter was calling from home and did not have other details about the product or patient details at the time of the initial report. For tolerances of 2nd dose of Shingrix, refer case US2019177117.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Vaccine positive rechallenge
Clinical narrative: injection site pain on the left arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 15th May 2019, refer linked case US2019131759).   On 18th July 2019, the patient received the 2nd dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. The patient experienced injection site pain on left arm. Additional information not provided. The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Incorrect dose administered, Product preparation error
Clinical narrative: feeling tired; headache; product preparation issue; inappropriate dose of vaccine administered; This case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 7PS9E, expiry date 10th September 2021) for prophylaxis.   On 14th May 2019, the patient received Shingrix. On 14th May 2019, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter gathered patient's information. The healthcare professional reconstituted Shingrix with sterile diluent instead of supplied diluent and maladminister to a patient, this led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered  The reporter asked information to proceed with series and about details to look for with patient.   Follow up report received from pharmacist on 10th July 2019: Batch number was updated. On 14th May 2019, the patient received 1st dose of Shingrix. It was reported that the Shingrix was accidentally mixed and administered with the Merck diluent intended for Zostavax and MMR, NDC 00006-4309-0D. It was not the Shingrix approved diluent. It was erroneous administration. Less than a year after vaccination, the patient felt a little tired and headache which could be related or unrelated to the error or the fact that the patient received 3 other vaccines that day. On an unknown date, the outcome of the tiredness, headache were unknown. It was unknown if the reporter considered the tiredness and headache to be related to Shingrix. This was medication error with adverse event. The VAERS details were updated.   Upon instream quality review for the month July 2019, following correction was performed on 9th October 2019: Classification from exclude from general tab was removed.