chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient received fluzone high dose vaccine on October 1, 2019. Patient called pharmacy where she received flu vaccine on April 11, 2020 to ask when she had received the vaccine and was stating that her arm was still very sore at the injection site. Patient was asked what she had tried to help with soreness and asked if she had seen a doctor and she had not at this time. We showed our concern and recommended she reach out to her PCP to see about getting her arm checked out and to let us know if she had any further questions.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms during the 12 hours post injection; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 12 hrs after receiving Shingles vaccine, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine.  Additional details were provided as follows: The age at the vaccination was not reported. The patient received shot for the Shingles vaccine. The patient needed to get  second shot.  The 6-month window was now closing in for the patient. The patient was hesitant to get the shot as the first one produced flu like symptoms during the 12 hours post injection. The reporter wanted to know was it ok to wait a little longer past the 6 month or should he/she do it now.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Product administered at inappropriate site
Clinical narrative: shot was injected into her shoulder and shoulder has been sore; Sleep difficult; This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 24th October 2019).   On 4th February 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain and difficulty sleeping. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the difficulty sleeping was unknown.   It was unknown if the reporter considered the injection site pain and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, his wife jumped when the needle was inserted and again when the shot was injected into her shoulder. Her shoulder had been sore and given her pain ever since and at times it was difficult for her to sleep at nights due to this painful shoulder.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass, Injection site pain, Musculoskeletal stiffness, Pain
Clinical narrative: This morning there is soreness in the area of shot; hard lump in area of shot; hard lump in area of shot; Was very stiff; Was very sore; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th April 2020, the patient received Shingrix. On 9th April 2020, 2 days after receiving Shingrix, the patient experienced injection site pain, injection site induration and injection site lump. In April 2020, the patient experienced stiffness and pain. On an unknown date, the outcome of the injection site pain, stiffness, pain, injection site induration and injection site lump were unknown.   It was unknown if the reporter considered the injection site pain, stiffness, pain, injection site induration and injection site lump to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, just got shot on Tuesday (7th April 2020). Was very stiff and sore. This morning (9th April 2020) there was soreness and a hard lump in area of shot.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles after the first dose; This case was reported by a pharmacist via sales rep and described the occurrence of shingles in a adult 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 shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. No patients or vaccine data was available. The pharmacist did not want provide the patient's data. The pharmacist did not consent to follow-up. This case has been linked to US2020062452, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Didn't feel well after the dose; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 58-year-old 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 6 months after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported.  The patient could be 57 or 58 years old of age. The patient received Shingrix at least 6 months ago.  The patient remembered that he did not feel well after the dose. This case is linked to the case US2020062417, reported for the 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Ageusia
Clinical narrative: I can no longer taste any of the food I am eating; This case was reported by a consumer and described the occurrence of taste loss in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 6th March 2020, the patient received the 2nd dose of Shingrix. On 9th March 2020, 3 days after receiving Shingrix, the patient experienced taste loss. On an unknown date, the outcome of the taste loss was not recovered/not resolved.   It was unknown if the reporter considered the taste loss to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient had the 2 part SHINGRIX shot. The patient could no longer taste any of the food after eating. The patient thought it would come back but it has not yet after a month (from the day of reporting).
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: fever of about 100.5; felt achey; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult 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 3 months after receiving Shingrix, the patient experienced fever and pain. On an unknown date, the outcome of the fever and pain were unknown.   It was unknown if the reporter considered the fever and pain to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. It has been just over 2 months since the patient had Shingrix vaccine and had fever of about 100.5 and felt achy.  The patient was afraid to get the second shot until Covid 19 is over.  The patient have heard side effects could be worse for the 2nd vaccine.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Pain in extremity, Rash pruritic
Clinical narrative: shingles / started on his left side and back between his arm and shoulder blade and is spreading towards the center of his back; itchy spot which he described as a nuisance; burning to pain; burning sensation; soreness in the upper arm / felt like he was punched in the arm hard; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced pain in arm. On 25th February 2020, the patient experienced shingles, itchy rash, pain and burning sensation. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the shingles, pain in arm, itchy rash, pain and burning sensation were not recovered/not resolved.   The reporter considered the shingles, itchy rash, pain and burning sensation to be possibly related to Shingrix. It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and had soreness in the upper arm that resolved two days later and claims that it felt like he was punched in the arm hard.  On the night of 25th February 2020, 5 days after receiving vaccination, the patient shingles symptoms started as an itchy spot which he described as a nuisance. Before the day of reporting and on the day of reporting the shingles, rash was spreading and was worse. There was itchiness and burning to pain.  He reported that the shingles started on his left side and back between his arm and shoulder blade and was spreading towards the center of his back but mostly on his left side. He saw his physician today and he prescribed an antiviral medication which he started today at lunchtime.  The patient claims that he has never received any dose of Shingrix previously and has never been diagnosed with shingles before.  The reporter requested information on our legal department because he believes that it was suspect that he received the Shingrix vaccine and then developed shingles.  The reporter inquired if GlaxoSmithKline would be paying for his antiviral medications.  The reporter consented to follow up. This was a legally significant report.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Bronchitis, Conjunctivitis, Malaise, Pain in extremity, Pyrexia
Clinical narrative: bronchitis; sore left arm; fever; sick; pink eye; This case was reported by a consumer via call center representative and described the occurrence of pinkeye in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix (intramuscular). In January 2020, between 1 and 3 months after receiving Shingrix, the patient experienced pinkeye. In February 2020, the patient experienced low grade fever and sickness. On an unknown date, the patient experienced bronchitis and pain in arm. On an unknown date, the outcome of the pinkeye, bronchitis, low grade fever, sickness and pain in arm were recovered/resolved.   It was unknown if the reporter considered the pinkeye, bronchitis, low grade fever, sickness and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. Less than 3 months after vaccination, the patient experienced sore arm and bronchitis. The patient had a sore left arm for a day or so. The patient caught bronchitis due to her mother being sick and she was in and out of the hospital visiting her. In January 2020 and February 2020, the patient experienced pink eye. In the first week of February 2020 (between 2 and 4 months after vaccination), her husband came home with  all the symptoms of coronavirus from his work and she was sick with him for two weeks. She had a low grade fever and it resolved after a couple of weeks. She reported that she was sick all winter long. The reporter consented to follow up. This case has been linked to US2020053230 and US2020053232, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received dose two of Shingrix earlier than the indicated; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a male patient who received Herpes zoster (Shingrix) (batch number H25YE, expiry date 4th December 2021) for prophylaxis.   On 24th March 2020, the patient received the 2nd dose of Shingrix. On 24th March 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were received as follows: The age at vaccination was no applicable for this report.  The patient received dose two of Shingrix earlier than the indicated 2 to 6 month time frame. The reporter did not consented to follow up.  HCP notes the patient received dose two one month after dose one. HCP could not provide date of birth of patient.  No additional details were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: Social problem; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in an adult patients who received Herpes zoster (Shingrix) for an unknown indication.   Previously administered products included Shingrix (received 1st dose on an unknown ).   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. The action taken with Shingrix was unknown. On an unknown date, the outcome of the social problem was unknown.  Additional details were received as follows: The age at vaccination was no applicable for this report.  The patient reported that a number of her patients would not be able to receive the second dose of Shingrix within six months after dose 1 due to the SARS-CoV-19 outbreak.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: fever; body aches; Still doesn't feel well; Arm is also sore; This case was reported by a consumer via call center representative and described the occurrence of fever in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (received 1st dose at least 6 months ago, refer case US2020AMR062690). Concurrent medical conditions included nasal stuffiness (had a stuffy nose for the past few days before vaccination).   On 8th April 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 8th April 2020, less than a day after receiving Shingrix, the patient experienced fever and general body pain. In April 2020, the patient experienced feeling unwell and pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, general body pain and pain in arm were not recovered/not resolved and the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the fever, general body pain, feeling unwell and pain in arm to be related to Shingrix.  Additional details were provided as follows: In the evening of vaccination day, the patient started experiencing fever and body aches. Less than a week after vaccination, the patient experienced feeling unwell and sore arm. The patient stated he still did not feel well in the morning of reporting day. The patient's arm was sore. The reporter consented to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Herpes zoster, Pain, Pain in extremity
Clinical narrative: Tiredness; Weakness; Diagnosed with Shingles / Shingles spread from his torso to chest to waist and to right side of back to the center of spine; Pain in the middle of chest and waist on the ride side of the body / soreness and pain; Itching; Bumps; Soreness on the arm; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included bone marrow transplant (with T cells 3 years before the date of reporting).   On 17th March 2020, the patient received the 1st dose of Shingrix (intramuscular). In March 2020, 4 days after receiving Shingrix, the patient experienced shingles, pain in arm, pain, pruritus and papular rash. On an unknown date, the patient experienced tiredness and weakness. On an unknown date, the outcome of the shingles, pain, papular rash, tiredness and weakness were not recovered/not resolved and the outcome of the pain in arm and pruritus were recovered/resolved.   It was unknown if the reporter considered the shingles, pain in arm, pain, pruritus, papular rash, tiredness and weakness to be related to Shingrix.  Additional details were provided as follows: The patient's wife reported this case.  The patient received Shingrix in the left arm at his oncologist office. Less than a week after vaccination, the patient experienced soreness on the arm that lasted for a day. About 4 days after vaccination, the patient started experiencing pain, itching and bumps in the middle of chest and waist on the ride side of the body. Due to this, the patient went to emergency room on 23rd March 2020. The patient was diagnosed with shingles and was discharged in one hour. Few days later, shingles spread from his torso to chest to waist and to right side of back to the center of spine. Less than a month after vaccination, the patient experienced tiredness and weakness. The shingles were on the right side of the body and were associated with soreness and pain. The patient was still experiencing all of this side effects. The patient had shingles on his forehead, but they had disappeared. The patient also had a virtual visit with his primary care physician and it was confirmed that he had shingles. No further details were provided. The reporter consented to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash papular
Clinical narrative: Tiredness; Weakness; Diagnosed with Shingles / Shingles spread from his torso to chest to waist and to right side of back to the center of spine; Pain in the middle of chest and waist on the ride side of the body / soreness and pain; Itching; Bumps; Soreness on the arm; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included bone marrow transplant (with T cells 3 years before the date of reporting).   On 17th March 2020, the patient received the 1st dose of Shingrix (intramuscular). In March 2020, 4 days after receiving Shingrix, the patient experienced shingles, pain in arm, pain, pruritus and papular rash. On an unknown date, the patient experienced tiredness and weakness. On an unknown date, the outcome of the shingles, pain, papular rash, tiredness and weakness were not recovered/not resolved and the outcome of the pain in arm and pruritus were recovered/resolved.   It was unknown if the reporter considered the shingles, pain in arm, pain, pruritus, papular rash, tiredness and weakness to be related to Shingrix.  Additional details were provided as follows: The patient's wife reported this case.  The patient received Shingrix in the left arm at his oncologist office. Less than a week after vaccination, the patient experienced soreness on the arm that lasted for a day. About 4 days after vaccination, the patient started experiencing pain, itching and bumps in the middle of chest and waist on the ride side of the body. Due to this, the patient went to emergency room on 23rd March 2020. The patient was diagnosed with shingles and was discharged in one hour. Few days later, shingles spread from his torso to chest to waist and to right side of back to the center of spine. Less than a month after vaccination, the patient experienced tiredness and weakness. The shingles were on the right side of the body and were associated with soreness and pain. The patient was still experiencing all of this side effects. The patient had shingles on his forehead, but they had disappeared. The patient also had a virtual visit with his primary care physician and it was confirmed that he had shingles. No further details were provided. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles after the first dose; This case was reported by a pharmacist via sales rep and described the occurrence of shingles in a adult 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 shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. No patients or vaccine data was available. The pharmacist did not want provide the patient's data. The reporter did not consent to follow-up. This case has been linked to US2020AMR062616, reported by the same reporter.
Sex: U
Vaccine: RAB
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: patient, who received their first dose of Imovax, did not come in to receive second dose, no AE; Initial information received on 06-Apr-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of an unknown demographics who received their first dose of RABIES (HDC) VACCINE [IMOVAX RABIES], but did not come in to receive second dose of series.  Medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included IMMUNOGLOBULIN HUMAN ANTI-RABIES (IMOGAM) for Animal bite on 31-Mar-2020.   On 31-Mar-2020, the patient received a first dose of suspect RABIES (HDC) VACCINE (lot number and expiry date were not reported) via unknown route in unknown administration site for post exposure immunization.  It was a case of actual medication error due to incomplete course of vaccination.  Reporter reported that a patient, who received their first dose of Imovax as well as Imogam on 31-Mar-2020, patient had not come in to receive second dose of Imovax. Reporter reported she received a phone call from physician's office with questions on patient's noncompliance. Reporter did not have any patient data or vaccine data.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive  and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case
Age: 1.33
Sex: F
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: administered ActHIB that was mixed with sterile water/no AE; Initial information received on 09-Apr-2020 regarding an unsolicited valid non-serious case received from a nurse.   This case involves a 16 months old female patient who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] that was mixed with sterile water.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Apr-2020, the patient received a 0.5 ml second dose of suspect HIB (PRP/T) VACCINE lot UJ099AA, U6376AA via unknown route.  It was also a case of actual medication error due to Inappropriate reconstitution technique.  It was unknown if adverse event was noted.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directiveand Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine expired on the 4/1/2020 and was mistakenly given to a patient/no AE; Initial information received on 09-Apr-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 72 years old female patient who received an expired dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Apr-2020, the patient received a 0.5 ml single first dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ221AB via unknown route in unknown administration site.  It was of actual medication error due to Expired vaccine used. Nurse said this is the second time patient has been given vaccine because the first dose had been thru a temperature excursion and was considered invalid.  No adverse event was reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: Day after vaccination:  headache,  body aches, tired, soreness near injection site.  Two and three days (so far) after vaccination:  soreness in greater area near vaccine site, at first just further down the deltoid and into bicep, then wrapping  around tricep, into underarm area and further down inside of bicep.
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Boostrix given to newborn instead of Energix-B by nurse.  Poison Control contacted. Stated to monitor infant for apnea, difficulty feeding,, poor tone,  and to keep infant on monitor for about an hour.   infant satting 100% on room air.  no injection site reactions.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Blood test normal, Electroencephalogram normal, Tremor
Clinical narrative: On 4/6/2020 At 9:00 AM I was feeding my son and his arms along with his head began to shake for 15 seconds.   On 4/7/2020 - 04/8/2020, the same thing happened around 12 PM while I was feeding him. It lasted 10-15 seconds   On 04/08/2020 around 3 pm he was sitting while playing and his head/both arms began to shake.   On 04/12/2020 during feeding around 12 pm the same thing happened.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Contusion, Pain in extremity
Clinical narrative: her arm is sore, painful; her arm is burning; her arm is bruised; This case was reported by a consumer via patient support programs and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th March 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced pain in arm, burning sensation and bruising of arm. On an unknown date, the outcome of the pain in arm, burning sensation and bruising of arm were unknown.   It was unknown if the reporter considered the pain in arm, burning sensation and bruising of arm to be related to Shingrix.  Additional case details were reported as follows: The patient experienced pain in arm, burning sensation and bruising of arm after vaccination.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Acne, Back pain, Biopsy skin, Dermatitis bullous, Folliculitis
Clinical narrative: Suspected Bullous Pemphigoid; bullous disorder; Seborrheic Dermatitis unspecified; Folliculitis; Acne; pruritic rash; rash on abdomen and arms; Back pain; Shingles; pruritis on his face and scalp; blistering rash; This case was reported by a lawyer and described the occurrence of suspected bullous pemphigoid in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced suspected bullous pemphigoid (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the suspected bullous pemphigoid was unknown.   It was unknown if the reporter considered the suspected bullous pemphigoid to be related to Shingrix.  The initial information was received on 03 April 2020 via medical records(The case was medically confirmed). As per medical records, the patient had GSK suspect Herpes Zoster (shingrix) vaccine 0.5mL IM given (1st of 2). Left Deltoid on 24 April 2018. On 24 April 2018 the patient had blistering rash. As per progress date 05 September 2018 the patient had biopsy of a blister that developed overnight, seborrheic dermatitis unspecified, acne, pruritic rash, bullous disorder, folliculitis, suspected  bullous pemphigoid. The patient had rash on his abdomen and scattered on his arms, back pain and shingles and pruritis on his face and scalp.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pemphigoid, Pruritus, Rash, Rash pruritic
Clinical narrative: Suspected Bullous Pemphigoid; bullous disorder; Seborrheic Dermatitis unspecified; Folliculitis; Acne; pruritic rash; rash on abdomen and arms; Back pain; Shingles; pruritis on his face and scalp; blistering rash; This case was reported by a lawyer and described the occurrence of suspected bullous pemphigoid in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced suspected bullous pemphigoid (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the suspected bullous pemphigoid was unknown.   It was unknown if the reporter considered the suspected bullous pemphigoid to be related to Shingrix.  The initial information was received on 03 April 2020 via medical records(The case was medically confirmed). As per medical records, the patient had GSK suspect Herpes Zoster (shingrix) vaccine 0.5mL IM given (1st of 2). Left Deltoid on 24 April 2018. On 24 April 2018 the patient had blistering rash. As per progress date 05 September 2018 the patient had biopsy of a blister that developed overnight, seborrheic dermatitis unspecified, acne, pruritic rash, bullous disorder, folliculitis, suspected  bullous pemphigoid. The patient had rash on his abdomen and scattered on his arms, back pain and shingles and pruritis on his face and scalp.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular, Seborrhoeic dermatitis
Clinical narrative: Suspected Bullous Pemphigoid; bullous disorder; Seborrheic Dermatitis unspecified; Folliculitis; Acne; pruritic rash; rash on abdomen and arms; Back pain; Shingles; pruritis on his face and scalp; blistering rash; This case was reported by a lawyer and described the occurrence of suspected bullous pemphigoid in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced suspected bullous pemphigoid (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the suspected bullous pemphigoid was unknown.   It was unknown if the reporter considered the suspected bullous pemphigoid to be related to Shingrix.  The initial information was received on 03 April 2020 via medical records(The case was medically confirmed). As per medical records, the patient had GSK suspect Herpes Zoster (shingrix) vaccine 0.5mL IM given (1st of 2). Left Deltoid on 24 April 2018. On 24 April 2018 the patient had blistering rash. As per progress date 05 September 2018 the patient had biopsy of a blister that developed overnight, seborrheic dermatitis unspecified, acne, pruritic rash, bullous disorder, folliculitis, suspected  bullous pemphigoid. The patient had rash on his abdomen and scattered on his arms, back pain and shingles and pruritis on his face and scalp.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Left arm pain for 4.5 weeks after vaccine, referred to PT
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Formication, Headache, Pain, Pain in extremity
Clinical narrative: Pain arm Achy Headache Crawly skin for 5 days Reaction of bubble painful red rash when doing my 5th rapatha shot since Dec 2019 in left leg 4 days later
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash vesicular
Clinical narrative: Pain arm Achy Headache Crawly skin for 5 days Reaction of bubble painful red rash when doing my 5th rapatha shot since Dec 2019 in left leg 4 days later
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test normal, Carpal tunnel syndrome, Condition aggravated, Loss of personal independence in daily activities, Musculoskeletal disorder
Clinical narrative: Extreme flare up of chronic neuropathic pain in all four extremities, felt like my legs were going to collapse, extreme flare up of carpel tunnel syndrome in both hands, could not use my hands for activities of daily living. Very, very painful.  I have underlying chronic peripheral neuropathy in all four extremities.  Becomes  much, much worse with influenza vaccine and medications.  Maybe I am just too sensitive to vaccines??? My new neurologist, Dr., says I'm too sensitive to medications and vaccines.  But I really need to take them to prevent a fatality.  I am 67 years old.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Nerve conduction studies normal, Neuralgia, Pain
Clinical narrative: Extreme flare up of chronic neuropathic pain in all four extremities, felt like my legs were going to collapse, extreme flare up of carpel tunnel syndrome in both hands, could not use my hands for activities of daily living. Very, very painful.  I have underlying chronic peripheral neuropathy in all four extremities.  Becomes  much, much worse with influenza vaccine and medications.  Maybe I am just too sensitive to vaccines??? My new neurologist, Dr., says I'm too sensitive to medications and vaccines.  But I really need to take them to prevent a fatality.  I am 67 years old.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse effects; one patient was administered improperly stored PROQUAD; This spontaneous report was received from a registered nurse referring to a 4-year old-patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not provided.      On 30-MAR-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S022917, expiration date 19-JAN-2021 (dose, frequency, route of administration were not reported), which was reconstituted with properly stored sterile diluent as prophylaxis.   The reporter stated that vaccine was stored at a temperature of -14.1 degrees Celsius, and the time frame was 26 minutes. There was no previous temperature excursion. No additional adverse effects were reported. No further information was provided.  This call was because of a "data logger".
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction, Tachycardia
Clinical narrative: Serious side effect of tachycardia; Side effects; This case was reported by a consumer via call center representative and described the occurrence of tachycardia in a 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 tachycardia (serious criteria other: Serious per reporter) and adverse reaction. On an unknown date, the outcome of the tachycardia and adverse reaction were unknown.   It was unknown if the reporter considered the tachycardia and adverse reaction to be related to Shingrix.  Additional details were provide as follows: The age at vaccination was not reported. The patient had serious side effect of tachycardia. Also, not only did the patient have the side effects, but have to pay over 200 dollar for the shot which gave the patient side effects and not sure what emergency room and hospital visit bill was yet. The reporter wanted to know, what were the ingredients in it so the patient would know what to be on the alert for in any other products.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Pain in extremity
Clinical narrative: sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in extremity in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix in April 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient wants to receive the second dose, but she was already late according to recommended schedule, which led to incomplete course of vaccination. The reporter consented to follow up. No data available was available.   Follow up information was received from the pharmacist on 28th February 2020: The reporter stated that the 2nd dose was not administered to the patient at her pharmacy even though her safety report states that the 2nd dose was administered.  In April 2018, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in extremity.  Shingrix was discontinued. The reporter elaborated by reporting the patient did not want to receive 2nd dose due to being "under the weather" and having a sore arm after the patient's 1st dose.  No additional information provided regarding 1st dose. The reporter stated that she will not send return correspondence back to GSK since the patient did not receive the 2nd dose.
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Severe Left shoulder pain; Initial information received on 27-Mar-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 62 years old female patient who experienced severe left shoulder pain (musculoskeletal pain), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA ZOSTER VACCINE) for Immunisation.  On 12-May-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot: UT6713NA) via an intramuscular route in the left deltoid for prophylactic vaccintion.  On an unknown date (few days after vaccination), the patient developed a non-serious severe left shoulder pain (musculoskeletal pain) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Final diagnosis was musculoskeletal pain.   It was not reported if the patient received any corrective treatment.  The patient recovered after few months.
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received expired dose of Daptacel; Initial information received on 10-Apr-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 6 months old female patient who received expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number and expiry date were not reported) via unknown route in unknown administration site on 09-Apr-2020 for prophylactic vaccination.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Cardiac monitoring, Catheterisation cardiac, Electrocardiogram, Electroencephalogram
Clinical narrative: flu-like symptoms next day (Wed.). Thurs, felt fine Aug. 20. Took nap (6pm), woke up Thur, 9:30am (39 hr. later) in ICU after being unresponsive for entire time CPR done by husband after breathing stopped, breathing started, 911 EMTs called. Intubated in ambulance to ER where spinal tap was done, intabation again, transfer to Hosp (2+ hr. away) Admitted to ICU.  EEG, EKG, blood work etc. on ventilator until Thurs. am.  released Fri. 08/23/19  Returned for appt. with primary Dr. 08/29/19 follow up with cardiologist and neurologist(9/05).  Cardiac cath on 9/16 with heart monitor for following 2 weeks. sleep study 11/7 w/ EEG. There were no difinitive  results from any of the Testing. All 4 doctors  advised not getting second shot, as did pharmacist. The reason I am reporting this now is that a friend, 80+ yr. old female, just had same symptoms although she had vaccine several months ago.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Endotracheal intubation, Influenza like illness, Intensive care, Lumbar puncture, Mechanical ventilation
Clinical narrative: flu-like symptoms next day (Wed.). Thurs, felt fine Aug. 20. Took nap (6pm), woke up Thur, 9:30am (39 hr. later) in ICU after being unresponsive for entire time CPR done by husband after breathing stopped, breathing started, 911 EMTs called. Intubated in ambulance to ER where spinal tap was done, intabation again, transfer to Hosp (2+ hr. away) Admitted to ICU.  EEG, EKG, blood work etc. on ventilator until Thurs. am.  released Fri. 08/23/19  Returned for appt. with primary Dr. 08/29/19 follow up with cardiologist and neurologist(9/05).  Cardiac cath on 9/16 with heart monitor for following 2 weeks. sleep study 11/7 w/ EEG. There were no difinitive  results from any of the Testing. All 4 doctors  advised not getting second shot, as did pharmacist. The reason I am reporting this now is that a friend, 80+ yr. old female, just had same symptoms although she had vaccine several months ago.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Respiratory arrest, Resuscitation, Sleep study, Unresponsive to stimuli
Clinical narrative: flu-like symptoms next day (Wed.). Thurs, felt fine Aug. 20. Took nap (6pm), woke up Thur, 9:30am (39 hr. later) in ICU after being unresponsive for entire time CPR done by husband after breathing stopped, breathing started, 911 EMTs called. Intubated in ambulance to ER where spinal tap was done, intabation again, transfer to Hosp (2+ hr. away) Admitted to ICU.  EEG, EKG, blood work etc. on ventilator until Thurs. am.  released Fri. 08/23/19  Returned for appt. with primary Dr. 08/29/19 follow up with cardiologist and neurologist(9/05).  Cardiac cath on 9/16 with heart monitor for following 2 weeks. sleep study 11/7 w/ EEG. There were no difinitive  results from any of the Testing. All 4 doctors  advised not getting second shot, as did pharmacist. The reason I am reporting this now is that a friend, 80+ yr. old female, just had same symptoms although she had vaccine several months ago.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Biopsy abdominal wall abnormal, Colitis ulcerative, Colonoscopy, Contusion
Clinical narrative: At time of shot pharmacist told me there were side effects, especially diarrhea & nausea in my age group. Severe diarrhea began next day, 2 medical appts. 1 ER, colonoscopy, Feb 26th. Stomach pain continues. Can only eat soft foods, lots of H2O, diarrhea continues every 2-3 days. Taking Imodium as needed. Biopsy showed ulcerative colitis. My life has been very difficult since Feb. 6th. My left arm was swollen, bruised and painful for 3 weeks but the gut issues are with me everyday after eating.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: At time of shot pharmacist told me there were side effects, especially diarrhea & nausea in my age group. Severe diarrhea began next day, 2 medical appts. 1 ER, colonoscopy, Feb 26th. Stomach pain continues. Can only eat soft foods, lots of H2O, diarrhea continues every 2-3 days. Taking Imodium as needed. Biopsy showed ulcerative colitis. My life has been very difficult since Feb. 6th. My left arm was swollen, bruised and painful for 3 weeks but the gut issues are with me everyday after eating.
Age: 0.25
Sex: M
Vaccine: UNK
Symptoms: Abdominal pain, Abnormal faeces, Autism spectrum disorder, Crying, Decreased eye contact
Clinical narrative: The section above is hard to answer because he was given a lot of vaccines in a short amount of time. 5/5/2016: HIB; pneumococcal PCV; Dip, DTap, DT, Td; Poliomyelitis, Hepatitis B. He had many more 2 months later. I had no idea that his health problems were caused by the vaccinations and I completely trusted the doctor, he acted like all of his symptoms were normal. its been years later and I'm just now finding out that I can report his injuries.  He initially had a fever, was lethargic, and was very fussy, he screamed and cried a lot. He soon developed a very severe case of colic, was projectile vomiting, and had acid reflux-this went on for 2 years. the doctor acted like it wasn't a big deal and prescribed a corn based formula and acid reflux medication, he said he would eventually grow out of it but my son was misreable and in a tremendous amount of pain. all he did was scream at the top of his lungs for the first 2 years of his life. he wouldn't keep eye contact, he always had diarrhea and it was a very foul smell, strange texture, and color. When he was old enough to sit up and play he always wanted to play alone, he didn't talk, he often hit his head many times on the floor or objects and ate gravel and dirt. when he was old enough to walk he would constantly fall and hit his head. showed signs of bein autistic