chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE information.; the patient was administered a properly stored but expired dose of PROQUAD; This spontaneous report was received from a medical assistant referrins to a patient of unknown age and unknown gender. Information about medical history and concurrent condition was not provided. The patient's concomitant therapy included sterile diluent.   On 20-MAR-2020, the patient was vaccinated with a properly stored but expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R026717, expiration date 17-MAR-2020, therapy type recombinant Human albumin (rHA); dose detail and route was not reported) for prophylaxis (expired vaccine used). No additional adverse event (AE) information. The outcome of the event was unknown. The causality of the event was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Pain, Pyrexia
Clinical narrative: Felt ill; flu-like symptoms; low grade fever; body aches; This case was reported by a nurse via call center representative and described the occurrence of feeling unwell in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced feeling unwell, influenza-like symptoms, fever and general body pain. On an unknown date, the outcome of the feeling unwell, influenza-like symptoms, fever and general body pain were unknown.   It was unknown if the reporter considered the feeling unwell, influenza-like symptoms, fever and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced flu-like symptoms, a low-grade fever, and body aches. The reporter did not consent to follow up. The health care professional closed chat before more information could be obtained. The patient was asking if he did not get the 2nd Shingrix vaccine would he be protected from the shingles. The reporter going to be calling the patient and need any information you can offer to encourage him to get his 2nd vaccine. This case is linked with case US2020AMR048457, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness at injection site; Itching at injection site; had some pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (receieved vaccine a couple years ago).   On 27th February 2020, the patient received the 1st dose of Shingrix. On 28th February 2020, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site itching and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site itching and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site itching and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 85 or 86 years. After receiving Shingrix, the patient experienced redness and itching at the injection site. The patient also experienced pain at the injection site. The reporter was consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: Patient called this am 3/24 that upon looking at her records she received a 3rd shingles shot on 3/16.  Stated that the next morning patient reported that  she felt ill and had a low grade fever.  Fever reached 99.5 at highest, stayed home from work and was still able to work from that location.  Was concerned because of fever about COVIN-19.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other related health complications; shingles; This spontaneous report as received from a lawyer refers to a 66 year old female patient. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. In July 2013, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) at a pharmacy. As a result of her receipt of zoster vaccine live (ZOSTAVAX), in 2013, patient was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), patient has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions, patient requires and/or will require more health care and services and did incur medical, health, incidental and related expenses. As a foreseeable, direct, and proximate consequence of Company's actions, omissions, and misrepresentations, patient suffered shingles and other related health complications. In addition, patient requires and will continue to require healthcare and services. She has incurred and will continue to incur medical and related expenses. Patient also has suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. Patient's direct medical losses and costs include physician care, monitoring, and treatment. She has incurred and will continue to incur mental and physical pain and suffering.  The outcome of shingles and other related health complications was reported as not recovered/not resolved. The reporter considered shingles and other related health complications to be related to Zoster Vaccine Live(ZOSTAVAX).  Shingles and other related health complications were considered to be disabling.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Dysstasia, Erythema, Fatigue
Clinical narrative: Muscle pain; arm is not as sore and there is not as much redness and swelling; arm is not as sore and there is not as much redness and swelling, although it hurts; arm is not as sore and there is not as much redness and swelling; Shivers; Tiredness; Headaches; upset stomach; feels like she has a fever; feels like throwing up and is afraid that she can't stand up without vomiting; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced muscle pain, swelling arm, pain in arm, erythema of extremities, shivers, tiredness, headache, upset stomach, feeling hot, vomiting and difficulty in standing. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the muscle pain, swelling arm, pain in arm, erythema of extremities and shivers were not recovered/not resolved and the outcome of the tiredness, headache, upset stomach, feeling hot, vomiting and difficulty in standing were unknown.   It was unknown if the reporter considered the muscle pain, swelling arm, pain in arm, erythema of extremities, shivers, tiredness, headache, upset stomach, feeling hot, vomiting and difficulty in standing to be related to Shingrix.  Additional details were provided as follows: The reporter stated that after vaccination, the arm was not as sore and there was not as much redness and swelling, although it hurts. The patient stated that after vaccination, felt like had a fever but was not sure. the patient stated that felt like throwing up and was afraid that could not stand up without vomiting. For the tollerence of 1st dose refer case US2020032222.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Headache, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: Muscle pain; arm is not as sore and there is not as much redness and swelling; arm is not as sore and there is not as much redness and swelling, although it hurts; arm is not as sore and there is not as much redness and swelling; Shivers; Tiredness; Headaches; upset stomach; feels like she has a fever; feels like throwing up and is afraid that she can't stand up without vomiting; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced muscle pain, swelling arm, pain in arm, erythema of extremities, shivers, tiredness, headache, upset stomach, feeling hot, vomiting and difficulty in standing. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the muscle pain, swelling arm, pain in arm, erythema of extremities and shivers were not recovered/not resolved and the outcome of the tiredness, headache, upset stomach, feeling hot, vomiting and difficulty in standing were unknown.   It was unknown if the reporter considered the muscle pain, swelling arm, pain in arm, erythema of extremities, shivers, tiredness, headache, upset stomach, feeling hot, vomiting and difficulty in standing to be related to Shingrix.  Additional details were provided as follows: The reporter stated that after vaccination, the arm was not as sore and there was not as much redness and swelling, although it hurts. The patient stated that after vaccination, felt like had a fever but was not sure. the patient stated that felt like throwing up and was afraid that could not stand up without vomiting. For the tollerence of 1st dose refer case US2020032222.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: Muscle pain; arm is not as sore and there is not as much redness and swelling; arm is not as sore and there is not as much redness and swelling, although it hurts; arm is not as sore and there is not as much redness and swelling; Shivers; Tiredness; Headaches; upset stomach; feels like she has a fever; feels like throwing up and is afraid that she can't stand up without vomiting; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced muscle pain, swelling arm, pain in arm, erythema of extremities, shivers, tiredness, headache, upset stomach, feeling hot, vomiting and difficulty in standing. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the muscle pain, swelling arm, pain in arm, erythema of extremities and shivers were not recovered/not resolved and the outcome of the tiredness, headache, upset stomach, feeling hot, vomiting and difficulty in standing were unknown.   It was unknown if the reporter considered the muscle pain, swelling arm, pain in arm, erythema of extremities, shivers, tiredness, headache, upset stomach, feeling hot, vomiting and difficulty in standing to be related to Shingrix.  Additional details were provided as follows: The reporter stated that after vaccination, the arm was not as sore and there was not as much redness and swelling, although it hurts. The patient stated that after vaccination, felt like had a fever but was not sure. the patient stated that felt like throwing up and was afraid that could not stand up without vomiting. For the tollerence of 1st dose refer case US2020032222.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Injection site pain, Myalgia, Spinal pain
Clinical narrative: back very sore. Especially my spine; Muscles are very sore; Back are very sore. Especially my spine; Injection site hurts a lot; This case was reported by a consumer via call center representative and described the occurrence of back pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd March 2020, the patient received the 1st dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced back pain, muscle pain, pain in spine and injection site pain. On an unknown date, the outcome of the back pain, muscle pain, pain in spine and injection site pain were unknown.   It was unknown if the reporter considered the back pain, muscle pain, pain in spine and injection site pain to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient for self. The age at vaccination was not reported. A day before time of reporting, the patient received a dose of Shingrix. The patient's back and muscles were very sore, especially spine and also injection site hurts too. The patient asked whether to get the 2nd shot in may.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Product supply issue, Pruritus
Clinical narrative: Product supply issue; itch, starting at both wrists, then down to her ankles; had dose number 3 of Shingrix; This case was reported by a consumer via call center representative and described the occurrence of product supply issue in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 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 product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. Due to the shortage the patient was not called for a 2nd dose until November 2018. When the patient went in for her 2nd dose, she was told by the person at the pharmacy that she only needed to get 1 dose, so she did not get the 2nd dose.   Follow up information received from Consumer on 2nd March and 9th March 2020:  The consumer stated that after receiving the third shot (in March of 2020) of Shingrix, she had itching of the ankles, wrists and moved around her upper body and on the back of her arms.  She stated her physician recommended CeraVe cream and Cortisone which she has been using and also a steroid cream that she administered for seven days twice a day.  She stated that the itching around the ankles and wrists subsided some, but she was still itching under her upper arms and behind her thighs. She stated that the day of reporting, she started to itch on the outside of her ears.  She stated that she did not have a rash and that it was just itching.  She said she got the first Shingrix shot at a Hospital pharmacy, the second shot at a Medical Practice and the third at a pharmacy.  She said she had never had allergies before and that she has not changed detergents.  She said her physician had now given her Claritin.  She stated that she never got soreness or redness of the arm with Shingrix, only the itching and the itching only started after the third dose. No other information was provided.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Malaise, Pain, Rash pruritic, Skin warm
Clinical narrative: General malaise; Local itchy rash; Local swelling; Local heat; Pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number 2K9T2, expiry date 9th April 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 8th May 2019 (Batch number; AS9CM, expiry date 25-APR-2020).   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 group was not reported but was selected as adult as per vaccine indication.  The patient received dose one of Shingrix on May 8, 2018 and has not yet received dose 2, which led to incomplete course of vaccination. The reporter was consented to follow up.   Follow up information was received from the pharmacist on 18th February2020: The patient's demographic details were updated. The patient's past medical history included chemotherapy and non-hodgkin's lymphoma (remission).  The reporter stated that the patient received chemotherapy prior to 2nd dose of vaccine. Previously administered products included Rituximab, Acetaminophen, Dexamethasone, Diphenhydramine, Palonosetron, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone (given on day 2 to 5 after each treatment) and Pegfilgrastim (given 2 day after each treatment).  The patient took the chemotherapy treatment on 30th July 2018, 20th August 2018, 10th September 2108, 8th October 2018, 29th October 2018 and on 19th November 2018. Concurrent medical conditions included cancer.  On 26th November 2019, the patient received the 2nd dose of Shingrix .5 ml. On 26th November 2019, 2 hrs after receiving Shingrix, the patient experienced pain.  On 27th November 2019, the patient experienced local swelling and skin warm. On 28th November 2019, the patient experienced itchy rash. On 29th November 2019, the patient experienced general malaise.  On 1st December 2019, the outcome of the pain, local swelling and skin warm were resolved.  On 3rd December 2019, the outcome of the itchy rash was resolved.  On 10th December 2019, the outcome of the general malaise was resolved.  The reporter considered the pain, local swelling, skin warm, itchy rash and general malaise to be related to Shingrix. The VAERS details were updated.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: General malaise; Local itchy rash; Local swelling; Local heat; Pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number 2K9T2, expiry date 9th April 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 8th May 2019 (Batch number; AS9CM, expiry date 25-APR-2020).   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 group was not reported but was selected as adult as per vaccine indication.  The patient received dose one of Shingrix on May 8, 2018 and has not yet received dose 2, which led to incomplete course of vaccination. The reporter was consented to follow up.   Follow up information was received from the pharmacist on 18th February2020: The patient's demographic details were updated. The patient's past medical history included chemotherapy and non-hodgkin's lymphoma (remission).  The reporter stated that the patient received chemotherapy prior to 2nd dose of vaccine. Previously administered products included Rituximab, Acetaminophen, Dexamethasone, Diphenhydramine, Palonosetron, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone (given on day 2 to 5 after each treatment) and Pegfilgrastim (given 2 day after each treatment).  The patient took the chemotherapy treatment on 30th July 2018, 20th August 2018, 10th September 2108, 8th October 2018, 29th October 2018 and on 19th November 2018. Concurrent medical conditions included cancer.  On 26th November 2019, the patient received the 2nd dose of Shingrix .5 ml. On 26th November 2019, 2 hrs after receiving Shingrix, the patient experienced pain.  On 27th November 2019, the patient experienced local swelling and skin warm. On 28th November 2019, the patient experienced itchy rash. On 29th November 2019, the patient experienced general malaise.  On 1st December 2019, the outcome of the pain, local swelling and skin warm were resolved.  On 3rd December 2019, the outcome of the itchy rash was resolved.  On 10th December 2019, the outcome of the general malaise was resolved.  The reporter considered the pain, local swelling, skin warm, itchy rash and general malaise to be related to Shingrix. The VAERS details were updated.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: red circle was drawn around the area of swelling; pain; redness; This case was reported by a other health professional via call center representative and described the occurrence of swelling in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th February 2020, the patient received the 1st dose of Shingrix. On 20th February 2020, 3 days after receiving Shingrix, the patient experienced swelling, pain and erythema. On an unknown date, the outcome of the swelling was recovering/resolving and the outcome of the pain was not recovered/not resolved and the outcome of the erythema was recovered/resolved.   It was unknown if the reporter considered the swelling, pain and erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix red circle was drawn around the area of swelling.  The patient saw the physician again and the swelling had reduced and the redness resolved but the pain was still present. The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: muscle pain at injection site; decrease in mobility / hard to reach for things; This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number P100105209 ?, expiry date 9th June 2020) for prophylaxis.   On 28th October 2019, the patient received the 1st dose of Shingrix. On 29th October 2019, 1 days after receiving Shingrix, the patient experienced injection site muscle pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site muscle pain and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the injection site muscle pain and injected limb mobility decreased to be related to Shingrix.  Additional case details were reported as follows: The reporter stated that the patient after vaccination had muscle pain at injection site and decrease in mobilityand it was hard to reach for things. The patient missed 1 day of work, due to severe pain. The patient provider she remembers hearing a popping noise during administration. The patient had seen her provider twice since the administration date and had received dose 2 from another provider on 28th December 2019.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional case details were reported ad follows: The age at vaccination was not reported. The caller disconnected the call, therefore limited information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: swelling under her ear/ and along her jawline on the right side/ swelling along her jawline; This case was reported by a consumer via call center representative and described the occurrence of local swelling in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th March 2020, the patient received the 1st dose of Shingrix (intramuscular). On 13th March 2020, less than a day after receiving Shingrix, the patient experienced local swelling. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the local swelling was recovered/resolved.   It was unknown if the reporter considered the local swelling to be related to Shingrix.  Additional details were reported as follows: The age at vaccination is not reported but it could be 73 years or 74 years. The patient received Shingrix in right arm and on same evening she noted swelling under her ear and along her jawline on the right side. The patient was advised to use Advil and warm compress on the area which helped and on the next day patient reported that the swelling had resolved. The reporter did not consent to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Facial paralysis, Fatigue, Headache, Hypoaesthesia oral
Clinical narrative: inability to move/unable to move; congestion; tired/exhausted; Bell's palsy; pain on her right arm; swelling; sick; flu like symptoms; fever; sore throat; headache; ear pain; numb tongue; This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included bell's palsy (diagnosed with a very bad case in 2005).   On 26th February 2020, the patient received the 1st dose of Shingrix. On 28th February 2020, 2 days after receiving Shingrix, the patient experienced swelling arm and pain in arm. In March 2020, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the patient experienced sickness, influenza-like symptoms, fever, sore throat, upper respiratory tract congestion, headache, ear pain, numbness of tongue, tiredness and mobility decreased. On an unknown date, the outcome of the bell's palsy, sickness, influenza-like symptoms, fever, sore throat, headache, ear pain and numbness of tongue were recovered/resolved and the outcome of the upper respiratory tract congestion was not recovered/not resolved and the outcome of the swelling arm, tiredness, pain in arm and mobility decreased were unknown.   It was unknown if the reporter considered the bell's palsy, sickness, influenza-like symptoms, fever, sore throat, upper respiratory tract congestion, headache, ear pain, numbness of tongue, swelling arm, tiredness, pain in arm and mobility decreased to be related to Shingrix.  Additional case details were reported as follows: The patient received a dose of Shingrix in right arm. Exactly 14 days after receiving Shingrix, the patient awoke with Bell's palsy.  Less than 3 weeks after receiving Shingrix, the patient was sick with flu like symptoms, had slight fever and sore throat with congestion. Over the weekend following vaccination, the patient had a lot of Bell's Palsy symptoms and experienced a headache, pain in her left ear and a numb tongue.  The patient was extremely tired and exhausted and was unable to move for days after the vaccine.  She also experienced swelling and pain on her right arm.  Within 24 hours, the patient's symptoms cleared up. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Mobility decreased, Oropharyngeal pain, Pain in extremity
Clinical narrative: inability to move/unable to move; congestion; tired/exhausted; Bell's palsy; pain on her right arm; swelling; sick; flu like symptoms; fever; sore throat; headache; ear pain; numb tongue; This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included bell's palsy (diagnosed with a very bad case in 2005).   On 26th February 2020, the patient received the 1st dose of Shingrix. On 28th February 2020, 2 days after receiving Shingrix, the patient experienced swelling arm and pain in arm. In March 2020, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the patient experienced sickness, influenza-like symptoms, fever, sore throat, upper respiratory tract congestion, headache, ear pain, numbness of tongue, tiredness and mobility decreased. On an unknown date, the outcome of the bell's palsy, sickness, influenza-like symptoms, fever, sore throat, headache, ear pain and numbness of tongue were recovered/resolved and the outcome of the upper respiratory tract congestion was not recovered/not resolved and the outcome of the swelling arm, tiredness, pain in arm and mobility decreased were unknown.   It was unknown if the reporter considered the bell's palsy, sickness, influenza-like symptoms, fever, sore throat, upper respiratory tract congestion, headache, ear pain, numbness of tongue, swelling arm, tiredness, pain in arm and mobility decreased to be related to Shingrix.  Additional case details were reported as follows: The patient received a dose of Shingrix in right arm. Exactly 14 days after receiving Shingrix, the patient awoke with Bell's palsy.  Less than 3 weeks after receiving Shingrix, the patient was sick with flu like symptoms, had slight fever and sore throat with congestion. Over the weekend following vaccination, the patient had a lot of Bell's Palsy symptoms and experienced a headache, pain in her left ear and a numb tongue.  The patient was extremely tired and exhausted and was unable to move for days after the vaccine.  She also experienced swelling and pain on her right arm.  Within 24 hours, the patient's symptoms cleared up. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Upper respiratory tract congestion
Clinical narrative: inability to move/unable to move; congestion; tired/exhausted; Bell's palsy; pain on her right arm; swelling; sick; flu like symptoms; fever; sore throat; headache; ear pain; numb tongue; This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included bell's palsy (diagnosed with a very bad case in 2005).   On 26th February 2020, the patient received the 1st dose of Shingrix. On 28th February 2020, 2 days after receiving Shingrix, the patient experienced swelling arm and pain in arm. In March 2020, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the patient experienced sickness, influenza-like symptoms, fever, sore throat, upper respiratory tract congestion, headache, ear pain, numbness of tongue, tiredness and mobility decreased. On an unknown date, the outcome of the bell's palsy, sickness, influenza-like symptoms, fever, sore throat, headache, ear pain and numbness of tongue were recovered/resolved and the outcome of the upper respiratory tract congestion was not recovered/not resolved and the outcome of the swelling arm, tiredness, pain in arm and mobility decreased were unknown.   It was unknown if the reporter considered the bell's palsy, sickness, influenza-like symptoms, fever, sore throat, upper respiratory tract congestion, headache, ear pain, numbness of tongue, swelling arm, tiredness, pain in arm and mobility decreased to be related to Shingrix.  Additional case details were reported as follows: The patient received a dose of Shingrix in right arm. Exactly 14 days after receiving Shingrix, the patient awoke with Bell's palsy.  Less than 3 weeks after receiving Shingrix, the patient was sick with flu like symptoms, had slight fever and sore throat with congestion. Over the weekend following vaccination, the patient had a lot of Bell's Palsy symptoms and experienced a headache, pain in her left ear and a numb tongue.  The patient was extremely tired and exhausted and was unable to move for days after the vaccine.  She also experienced swelling and pain on her right arm.  Within 24 hours, the patient's symptoms cleared up. The reporter consented to follow up.
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The infant was given Hepatitis A vaccine instead of his first Hepatitis B vaccine. No symptoms reported thus far. Family notified.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Dry skin, Papule, Rash
Clinical narrative: Mother states 2 days after pt received vaccinations, she developed a puritic rash to her abdomen. Over time, it spread over her torso, back, bilateral upper and lower extremities. Diffuse raised papules, surrounding skin is dry.  Treatment: Prednisone, Benadryl, Pepcid, TAC cream Outcome: Unknown- came to urgent care center, but received vaccinations at health department
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Abnormal dreams, Fatigue, Hallucination, Headache
Clinical narrative: Stomach ache, headache, fever, exhausted for a week, hallucinations or "crazy" dreaming.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Stomach ache, headache, fever, exhausted for a week, hallucinations or "crazy" dreaming.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to an approximately 72-year-old (also reported as 70-year-old, conflicting information) male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2015, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for prophylaxis, at medical center. As a result of his receipt of zoster vaccine live (ZOSTAVAX), on an unknown date in 2015, the patient was caused to suffer shingles, including any and all of its sequelae. As a result of his receipt of zoster vaccine live (ZOSTAVAX), the patient has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions the patient requires and/or will require more health care and services and did incur medical, health, incidental and related expenses. He was informed and believed and further alleged that he will in the future be required to obtain further medical and/or hospital care, attention, and services. As a foreseeable, direct, and proximate consequence of zoster vaccine live (ZOSTAVAX), the patient suffered shingles and other related health complications. In addition, he requires and will continue to require healthcare and services. He has incurred and will continue to incur medical and related expenses. The patient also has suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient's direct medical losses and costs include physician care, monitoring, and treatment. He has incurred and will continue to incur mental and physical pain and suffering. The outcome of shingles was considered to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The reporter determined the shingles to be disabling.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Arm was only slightly sore and a bit swollen; Arm was only slightly sore and a bit swollen; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 76-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 1st May 2019, refer case US2019080706).   On 17th July 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm and swelling arm. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain in arm and swelling arm were recovered/resolved.   It was unknown if the reporter considered the pain in arm and swelling arm to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient called to reporter few days after vaccination and reported there were no adverse events like after 1st dose.  The patient had premedicated with Ibuprofen before receiving the vaccination. The patient reported icing her arm and continuing with Ibuprofen. The patient's arm was slightly sore and a bit swollen for a day or two.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Gastroenteritis viral
Clinical narrative: I think I had the stomach flu; now I think I had a reaction to the injection; This case was reported by a consumer via call center representative and described the occurrence of stomach flu in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 20th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced stomach flu and adverse drug reaction. On an unknown date, the outcome of the stomach flu and adverse drug reaction were recovering/resolving.   It was unknown if the reporter considered the stomach flu and adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The patient reported that she thought she had stomach flu but now she thought she had a reaction to the injection. The patient asked how long did the side effects last and stated she was doing a little better in the afternoon of day of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: experienced "severe reactions; This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) (batch number HY4GT, expiry date 21st September 2021) for prophylaxis.   On 21st June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication Several patients received the first dose of Shingrix and did not receive the second dose after a two to six months period. Pharmacist mentioned that 4 patients received the first dose in the pharmacy where she works but she only provided the details of one patient.  She did not provide his initials.  After call was transferred, the pharmacist told second line agent the reason patients delayed taking the second dose was because they experienced severe reactions which she described as having problems getting out of bed for three days. She stated she had already provided the information to the first line agent. No further details or information provided, other than what was documented. This case is one out of 4 cases reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: experience severe reactions; This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) (batch number HY4GT, expiry date 21st September 2021) for prophylaxis.   On 21st June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication Several patients received the first dose of Shingrix and did not receive the second dose after a two to six months period. Pharmacist mentioned that 4 patients received the first dose in the pharmacy where she works but she only provided the details of one patient.  She did not provide his initials.  After call was transferred, the pharmacist told second line agent the reason patients delayed taking the second dose was because they experienced severe reactions which she described as having problems getting out of bed for three days. She stated she had already provided the information to the first line agent. No further details or information provided, other than what was documented. This case is one out of 4 cases reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: experienced severe reations; This case was reported by a pharmacist via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) (batch number HY4GT, expiry date 21st September 2021) for prophylaxis.   On 21st June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication Several patients received the first dose of Shingrix and did not receive the second dose after a two to six months period. Pharmacist mentioned that 4 patients received the first dose in the pharmacy where she works but she only provided the details of one patient.  She did not provide his initials.  After call was transferred, the pharmacist told second line agent the reason patients delayed taking the second dose was because they experienced severe reactions which she described as having problems getting out of bed for three days. She stated she had already provided the information to the first line agent. No further details or information provided, other than what was documented. This case is one out of 4 cases reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Feel like I have a fever (but I don't); headache; fatigue; Arm is also sore, feels like someone punched me.; 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 2nd March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced fever, headache, fatigue and pain in arm. On an unknown date, the outcome of the fever, headache, fatigue and pain in arm were unknown.   It was unknown if the reporter considered the fever, headache, fatigue and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had fever, headache, fatigue and pain in arm felt like someone punched after vaccination. The patient did not care much about an achy arm.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling hot, Headache, Herpes zoster, Rash
Clinical narrative: can one get shingle from vaccine; felt warm yet not temp registered; rash on arm shot given; headache; This case was reported by a consumer via call center representative and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced headache. On 1st March 2020, the patient experienced rash. On 2nd March 2020, the patient experienced feeling of warmth. On an unknown date, the patient experienced shingles. On an unknown date, the outcome of the rash, headache, feeling of warmth and shingles were unknown.   It was unknown if the reporter considered the rash, headache, feeling of warmth and shingles to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had rash on his arm, headache, felt warm, and asked can any one get shingle from vaccine. The patient was worried as the daughter in law was pregnant.
Age: 59.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Injection site pain, Pyrexia, Somnolence
Clinical narrative: woke up with fever and tiredness; woke up with fever and tiredness; he slept until noon; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on an unknown date, refer case US2020AMR039722).   On 2nd March 2020, the patient received the 2nd dose of Shingrix. On 3rd March 2020, 1 days after receiving Shingrix, the patient experienced tiredness, fever and sleepiness. The patient was treated with naproxen (Aleve). On 4th March 2020, the outcome of the tiredness, fever and sleepiness were recovered/resolved.   It was unknown if the reporter considered the tiredness, fever and sleepiness to be related to Shingrix.  Additional case details were reported as follows: The patient woke up with a fever and tiredness and slept until noon after vaccination.
Age: 59.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: woke up with fever and tiredness; woke up with fever and tiredness; he slept until noon; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on an unknown date, refer case US2020AMR039722).   On 2nd March 2020, the patient received the 2nd dose of Shingrix. On 3rd March 2020, 1 days after receiving Shingrix, the patient experienced tiredness, fever and sleepiness. The patient was treated with naproxen (Aleve). On 4th March 2020, the outcome of the tiredness, fever and sleepiness were recovered/resolved.   It was unknown if the reporter considered the tiredness, fever and sleepiness to be related to Shingrix.  Additional case details were reported as follows: The patient woke up with a fever and tiredness and slept until noon after vaccination.