chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pain at injection site; Swelling at injection site; injection was red covering 3 inches in diameter along; Itching; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th February 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 24th February 2020, immediately after receiving Shingrix, the patient experienced injection site pain and injection site swelling. On 25th February 2020, the patient experienced injection site erythema and injection site itching. On 26th February 2020, the outcome of the injection site pain and injection site swelling were recovered/resolved. In March 2020, the outcome of the injection site erythema and injection site itching were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and injection site itching to be related to Shingrix.  Additional information was provided as follows: The patient experienced pain at injection site during vaccination and swelling at site of injection. The pain and swelling lasted for total of 2 days. The next day of vaccination, site of injection was red covering 3 inches in diameter along with itching, this lasted for total of 5 days. The reporter did not consent to follow-up. No further details were provided.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: deep tissue pain still at the site of the injection; pain radiates up to her shoulder; radiating pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 88-year-old female patient who received Herpes zoster (Shingrix) (batch number 2N9CT, expiry date 18th March 2022) for prophylaxis.   On 1st February 2020, the patient received Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm, shoulder pain and radiating pain. On an unknown date, the outcome of the pain in arm and radiating pain were unknown and the outcome of the shoulder pain was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, shoulder pain and radiating pain to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix vaccine and had deep tissue pain still at the site of the injection. The pain radiates up to her shoulder a little bit.  It also radiates from the injection site down and up.  It bothers her when she sleeps.  It was not unbearable, but it wasn't the surface of the skin, it was deep pain.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Pruritus
Clinical narrative: itching; she received the 1st dose of Shingrix in April 2018, a late 2nd dose in November 2019; Extra dose administered; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in April 2018).   In November 2019, the patient received the 2nd dose of Shingrix. In March 2020, the patient received the 3rd dose of Shingrix. In March 2019, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced extra dose administered. In November 2019, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced pruritus. On an unknown date, the outcome of the pruritus, drug dose administration interval too long and extra dose administered were unknown.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional details were received as follows: The patient received late 2nd dose in November 2019, which led to  lengthening of vaccination schedule and an extra 3rd dose in March 2020, which led to extra dose administered.  One week after receiving the 3rd dose, she developed itching all over her body; no rash.  The itching is ongoing at the time of report. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site dryness, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: has a small red rough spot at injection site; injection site taht is tender\ injection site pain; has a small red rough spot at injection site; has a small red rough spot at injection site; Incomplete vaccination schedule; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 28th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site erythema, injection site tenderness, injection site dryness, injection site rash and incomplete course of vaccination. On an unknown date, the outcome of the injection site erythema, injection site tenderness, injection site dryness and injection site rash were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site erythema, injection site tenderness, injection site dryness and injection site rash to be related to Shingrix.  Additional details were reported as follows: The age of vaccination was not applicable for 2nd dose. The patient received 2nd dose of Shingrix and still had a small, red, rough spot at the injection site that was tender. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 32.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Antibody test negative, Product administered to patient of inappropriate age, Therapy non-responder
Clinical narrative: did not developed antibody titers against the virus; The patient is 32 years old; The patient is 32 years old; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 32-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunosuppression.   On an unknown date, the patient received the 1st dose of Shingrix. On 3rd December 2019, the patient received the 2nd dose of Shingrix. On 3rd December 2019, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced therapy non-responder and inappropriate age at vaccine administration. On an unknown date, the outcome of the therapy non-responder, inappropriate age at vaccine administration and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported for 1st dose of Shingrix. The pharmacist reported a patient, who completed the vaccination schedule of Shingrix, did not developed antibody titers against the virus. The patient received the second dose of Shingrix on 3rd December 2019. After that, she went to the doctor and performed some studies that shown she had no titers for Herpes Zoster Virus. The patient was 32 years old.      Lab Comments: Lab test performed on an unknown date.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Loss of personal independence in daily activities, Pain, Pyrexia
Clinical narrative: I had a mild fever, body aches, chills  and exhaustion for almost 4 days.  I was barely able to conduct my daily routines.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Musculoskeletal pain
Clinical narrative: pain in my shoulder; flu like symptoms; This case was reported by a consumer and described the occurrence of shoulder pain 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 shoulder pain and influenza-like symptoms. On an unknown date, the outcome of the shoulder pain and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the shoulder pain and influenza-like symptoms to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient had a very bad response to the first injection, a lot of pain in shoulder, flu like symptoms, so patient would have expected the same with the second injection. For tolerane of 2nd dose, refer case US2020AMR035045.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haematoma, Sensitive skin, Skin discolouration
Clinical narrative: hematoma at injection site; slight sensitivity; Skin discoloration; This case was reported by a consumer via call center representative and described the occurrence of injection site hematoma in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site hematoma, sensitive skin and skin discoloration. On an unknown date, the outcome of the injection site hematoma, sensitive skin and skin discoloration were unknown.   It was unknown if the reporter considered the injection site hematoma, sensitive skin and skin discoloration to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient after vaccination experienced injection site hematoma, sensitive skin and skin discoloration. This case has been linked with case US2020AMR039698, reported for same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: most people have more side effects with the second dose; This case was reported by a consumer and described the occurrence of adverse drug reaction 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 adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not applicable for this report. The pharmacist told to the reporter that most people have more side effects with the second dose of Shingrix. This case has been linked with case US2020AMR033844 and US2020AMR041746, reported by same reporter.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of headache in a 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included metaplastic breast carcinoma.   On 24th February 2020, the patient received the 2nd dose of Shingrix. On 25th February 2020, 1 days after receiving Shingrix, the patient experienced headache and pain in arm. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the headache and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient was diagnosed with metaplastic carcinoma of breast in January of 2018. She was now in remission. The patient received dose of Shingrix vaccine and day after vaccination experienced headache and sore arm. The patient took Tylenol for her headache and it got better. On the day of reporting morning she has an headache again.  The sore arm was getting better.  The follow up consent was not granted
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Product colour issue, Product complaint, Pyrexia
Clinical narrative: fever; chills; received a dose of bright orange -red Shingrix; This case was reported by a physician via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a day after receiving Shingrix, the patient experienced fever, chills and pharmaceutical product complaint. On an unknown date, the outcome of the fever, chills and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the fever and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of bright orange,red Shingrix and complained fever and chills on the day after vaccination. The follow up consent was not granted.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site reaction, Local reaction, Muscle spasms
Clinical narrative: local reactions in the injection site; muscle spasms/ involuntary muscle spasms; shivering; This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number B4TT5, expiry date 10th April 2022) for prophylaxis.   Concurrent medical conditions included asthma. Concomitant products included cannabidiol.   On 28th February 2020, the patient received the 1st dose of Shingrix. In February 2020, 12 hrs after receiving Shingrix, the patient experienced muscle spasm and shivering. On 1st March 2020, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction, muscle spasm and shivering were unknown.   It was unknown if the reporter considered the injection site reaction, muscle spasm and shivering to be related to Shingrix.  Additional information was provided as follows: The health care professional provided lot number and expiration date of the vaccine. The patient received vaccine between 3 to 4 pm, that night the patient woke up in middle of the night (around 3 am)  with muscle spasms (parkinson like) and shivering.  Two days after that, the patient developed local reactions in the injection site. The health care professional was especially concerned about the muscle spasms since she did not find information about that in the prescribing information. The reporter consented to follow up.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Labelled drug-drug interaction medication error, Rash vesicular
Clinical narrative: Rash that really looks like Shingles; Vesicles; patient was followed and immunosuppressive treatment; This case was reported by a physician via call center representative and described the occurrence of vesicular rash in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunosuppression (Patient under Immunosuppressive treatment).   On 20th February 2020, the patient received the 1st dose of Shingrix. On 20th February 2020, unknown after receiving Shingrix, the patient experienced labeled drug-drug interaction medication error. On 23rd February 2020, the patient experienced vesicular rash and vesicles. On an unknown date, the outcome of the vesicular rash, vesicles and labeled drug-drug interaction medication error were unknown.   It was unknown if the reporter considered the vesicular rash and vesicles to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of vaccine and 3 days after that started with the adverse reaction. The HCP described it as a rash that really looks like Shingles, and also mentioned vesicles. The doctor already knows that Shingrix was a non live vaccine. The patient was followed and immunosuppressive treatment. The reporter was concerned whether the patient can receive the second shot. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Influenza like illness, Malaise, Pain, Paraesthesia
Clinical narrative: achey; lightheaded; flu like symptoms; skin tingling; felt pretty bad; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included acyclovir.   In October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a day after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced general body pain, light headedness, influenza-like symptoms and tingling skin. On an unknown date, the patient experienced feeling unwell. On an unknown date, the outcome of the general body pain, light headedness, influenza-like symptoms, tingling skin and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the general body pain, light headedness, influenza-like symptoms, tingling skin and feeling unwell to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported, however it could be 58 or 59 years. The patient recived Shingrix and within 24 hours the patient experinced general body pain, light headedness, influenza-like symptoms and tingling skin. The patient felt pretty bad for a few days. The patient was on Acyclovir for years for shingles preventive, usually about 400mg per day and up to two 800 mg per day if needed. Patient enquired for if he would to take Acyclovir the day of his 2nd dose of shingrix, does this have an effect on the effectiveness of the Shingrix vaccine. This case has been linked with case US2020040962 and US2020AMR041605, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: not feeling well; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th March 2020, the patient received Shingrix. On 5th March 2020, 1 days after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was not recovered/not 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 age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix and on the day of reporting was not feeling well.  Reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Feeling run down after receiving Shingrix and it putting them on the couch; This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was unknown.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not applicable.  No additional information on patients or product. Pharmacist stated patients have reporting feeling run down after receiving Shingrix and it putting them on the couch. Pharmacist stated the side effects mentioned are on the VIS so they were expected. Consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: Severe adverse reaction; This case was reported by a physician via sales rep and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was recovered/resolved.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional information was provided as follows: Field rep was the reporter and was notified of the event last night from the reporting date. The age at vaccination was not reported. No patient identifiable information provided in the e-mail. The age group was captured as an adult as per vaccine indication. The patient complained of unspecified severe adverse reactions. The severe adverse reactions are unknown. This case had been linked with US2020AMR042482, reported by same reporter.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of left lower limb. Cephalexin prescribed: 125mg/5mL. Q12 hrs for 7 days. BACTROBAN ointment 2% 1 application to left leg TID for 14 days.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: became red, hot swollen after injection. 7 days later it is still red, swollen; no medication or treatment was done
Age: 1.08
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Inadvertently gave HepA instead of Hib, no adverse reactions noted
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Symptoms began 2 hours after same day as injection.  Upper left arm from elbow to shoulder and into back was swollen, painful, hot, and itchy with patches of red.  Few hives appeared on back.   Pain and swelling lasted 4 days.  Doctor said to ice arm, take tylenol, and take benedryl. I was lethargic and I felt miserable.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Lethargy, Urticaria
Clinical narrative: Symptoms began 2 hours after same day as injection.  Upper left arm from elbow to shoulder and into back was swollen, painful, hot, and itchy with patches of red.  Few hives appeared on back.   Pain and swelling lasted 4 days.  Doctor said to ice arm, take tylenol, and take benedryl. I was lethargic and I felt miserable.
Sex: F
Vaccine: VARZOS
Symptoms: Bronchospasm, Cough, Dyspnoea, Pneumonia, Pyrexia
Clinical narrative: pneumonia of both lungs due to infectious organism; bronchospasm; sepsis; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a female patient of an unspecified age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or around 11-NOV-2016, the patient was vaccinated with a dose of vaccine live (ZOSTAVAX) (the dosage regimen was not reported) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date, shortly after to patient's inoculation, the patient experienced suffered severe shortness of breath, cough and fever; additionally, the patient was ultimately hospitalized and diagnosed with bronchospasm, pneumonia of both lungs due to infectious organism and sepsis. As a direct and proximate result use of the vaccine live (ZOSTAVAX) vaccine, the patient's had resulted in physical limitation not present prior to vaccination, The patient had also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  At the time of the report, the outcome of bronchospasm, pneumonia of both lungs due to infectious organism and sepsis were not recovered. The reporter considered the events previously mentioned to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review the events pneumonia and sepsis were considered as medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Sepsis
Clinical narrative: pneumonia of both lungs due to infectious organism; bronchospasm; sepsis; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a female patient of an unspecified age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or around 11-NOV-2016, the patient was vaccinated with a dose of vaccine live (ZOSTAVAX) (the dosage regimen was not reported) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date, shortly after to patient's inoculation, the patient experienced suffered severe shortness of breath, cough and fever; additionally, the patient was ultimately hospitalized and diagnosed with bronchospasm, pneumonia of both lungs due to infectious organism and sepsis. As a direct and proximate result use of the vaccine live (ZOSTAVAX) vaccine, the patient's had resulted in physical limitation not present prior to vaccination, The patient had also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  At the time of the report, the outcome of bronchospasm, pneumonia of both lungs due to infectious organism and sepsis were not recovered. The reporter considered the events previously mentioned to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review the events pneumonia and sepsis were considered as medically significant.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was recovered/resolved.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient reported that, after vaccination had extreme diarrhea for 48 hours. The reporter stated that, diarrhea might be from a pre existing condition prior to the vaccine. For the tollerence of 2nd dose refer case US2020037844, reported by same reporter for the same patient.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Pain
Clinical narrative: flu like symptoms; Aching; overall yucky; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, general body pain and feeling abnormal. On an unknown date, the outcome of the influenza-like symptoms, general body pain and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, general body pain and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's husband. The reporter stated that, within 24 hours after vaccination, the patient experienced flu like symptoms including aching and overall yucky. The reporter stated that, the symptoms were resolved within 3 to 4 days. For the tollerence of 2nd dose refer case US2020040962, reported by same reporter for same patient. This case has been linked with case US2020040957, reported for the patient's husband.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: had some significant side effects from the first dose; This case was reported by a nurse and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The reporting nurse was the concerned patient. The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The patient experienced significant side effects.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: headache; low fever; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult 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 headache and fever. On an unknown date, the outcome of the headache and fever were unknown.   It was unknown if the reporter considered the headache and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported but it was selected as adult as per vaccine indication. The patient experienced low fever. The patient asked if it was contagious to a chemo patient.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: how long the soreness lasts after the shot?; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult 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 pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not provided but selected as an adult as per vaccine indication. The patient reported that, after vaccination had soreness and asked how long it would last.
Age: 70.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Immunisation reaction, Incomplete course of vaccination
Clinical narrative: I had a strong immune reaction to the first; Doctor recommended that I wait the full 6 months before getting the second. Then I lost track and didn't get it; This case was reported by a consumer via call center representative and described the occurrence of immunization reaction in a 71-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 19th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced immunization reaction and incomplete course of vaccination. On an unknown date, the outcome of the immunization reaction and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the immunization reaction to be related to Shingrix.  Additional details were provided as follows: The patient had a strong immune reaction to the first injection therefore the doctor recommended that he/she should wait the full 6 months before getting the second dose. Then the patient lost the track and did not received 2nd dose, which led to incomplete course of vaccination. The patient was being told to stay at home because of Covid 19. The patient asked to wait for it or received the dose.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Pyrexia
Clinical narrative: redness at the injection site; Fever; Chills; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number TJ35Z, expiry date 1st December 2021) 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 injection site erythema, fever and chills. On an unknown date, the outcome of the injection site erythema, fever and chills were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, fever and chills to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and experienced redness at the injection site, fever, chills. The physician wanted to know the prevalence of these adverse events and how long they could last. The follow up consent was granted.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: left arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received dose 1 around November of 2018.).   On 24th April 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 24th April 2019, 2 hrs after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient reports arm soreness which began a few hours after the dose the patient experienced a sore arm. It went away after a few days.  Two weeks after vaccination , the patient reports the arm soreness returned, and now intermittently comes and goes. The reporter did not consent to follow up
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: headache; muscle aches; nausea; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 25th February 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On 26th February 2020, the patient experienced headache, muscle pain and nausea. On an unknown date, the outcome of the injection site pain, headache and muscle pain were recovering/resolving and the outcome of the nausea was unknown.   It was unknown if the reporter considered the injection site pain, headache, muscle pain and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient wanted to remain anonymous and did not want to provided demographic information. The patient received dose of shingrix in the right arm and 1 day after receiving vaccination experienced headache, muscle pain and nausea. The patient planned to follow-up with his healthcare provider on an unknown date. Did not consent to follow-up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Generalized rash of vesicles on both arms and legs; This case was reported by a physician via call center representative and described the occurrence of vesicular rash in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix in left deltoid at a local pharmacy sometime within the last month, and 3-4 days post-vaccination the patient developed a generalized rash of vesicles on both arms and legs.  Currently, the rash was only localized to lower left extremity. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Mobility decreased, Movement disorder, Myalgia
Clinical narrative: feeling tired; muscle pain; chills; sore arm; difficulty lifting arm; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 5 months after receiving Shingrix, the patient experienced tiredness, muscle pain, chills, pain in arm and movement disorder. On an unknown date, the outcome of the tiredness, muscle pain, chills, pain in arm and movement disorder were recovered/resolved.   It was unknown if the reporter considered the tiredness, muscle pain, chills, pain in arm and movement disorder to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix about 4 months ago and experienced feeling tired, muscle pain, chills and sore arm, difficulty lifting her arm.   The caller reported that issues resolved within one day except for arm issues which took about 3 days to resolve. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: feeling tired; muscle pain; chills; sore arm; difficulty lifting arm; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 5 months after receiving Shingrix, the patient experienced tiredness, muscle pain, chills, pain in arm and movement disorder. On an unknown date, the outcome of the tiredness, muscle pain, chills, pain in arm and movement disorder were recovered/resolved.   It was unknown if the reporter considered the tiredness, muscle pain, chills, pain in arm and movement disorder to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix about 4 months ago and experienced feeling tired, muscle pain, chills and sore arm, difficulty lifting her arm.   The caller reported that issues resolved within one day except for arm issues which took about 3 days to resolve. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: Muscle pain at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 31st August 2019, the dose was an unknown dose. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was unknown.   It was unknown if the reporter considered the injection site muscle pain to be related to Shingrix.  Additional details were received as follows: HCP stated that a patient got Shingrix dose 1 in May 2019 and dose 2 in August 2019 (did not provide which day in the months) and experienced muscle pain at the injection site after each injection. The reporter did not consented to follow up.  This case was linked with case US2020053282, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Neuralgia, Pain
Clinical narrative: Neuralgia; pain irradiating from the injection site; Neuralgia and pain irradiating from the injection site; pain in hip; This case was reported by a pharmacist via call center representative and described the occurrence of neuralgia in a 67-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, unknown after receiving Shingrix, the patient experienced neuralgia, injection site pain, radiating pain and pain in hip. On an unknown date, the outcome of the neuralgia, injection site pain, radiating pain and pain in hip were unknown.   It was unknown if the reporter considered the neuralgia, injection site pain, radiating pain and pain in hip to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Pharmacist did not provide date of birth of the patient or date of vaccination. The batch number and expiry date of Shingrix was not provided. The pharmacist reported that, the patient received dose of Shingrix over last year and experienced neuralgia and pain irradiating from  the injection site to the hip.
Sex: F
Vaccine: PNC13
Symptoms: Condition aggravated, Pneumonia
Clinical narrative: who was vaccinated with Prevnar 13 one year ago and reports to have recurrent Pneumonia needs to be revaccinated.; who was vaccinated with Prevnar 13 one year ago and reports to have recurrent Pneumonia needs to be revaccinated.; This is a spontaneous report from a contactable pharmacist.  A 41-year-old female patient receive first dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date in 2019 at single dose for immunisation. Medical history included recurrent Pneumonia infections previous to the initial vaccination.  The patient's concomitant medications were not reported. The patient who was vaccinated with of pneumococcal 13-val conj vac (dipht crm197 protein) one year ago in 2019 had recurrent Pneumonia on an unknown date and needed to be revaccinated. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: The association between the event drug ineffective (pneumonia) with pneumococcal 13-valent conjugate vaccine can not be fully excluded.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Dehydration, Dizziness, Fatigue, Hypotension
Clinical narrative: I experienced high fever 101 for two days after vaccine was given, severe body aches of joints, low blood pressure, and extreme fatigue.  I had dizziness that was later diagnosed as Vertigo.  Went to Hospital's ER and was put on IV for dehydration, given muscle relaxers, and pills for dizziness.  Now experiencing Vertigo and was recently diagnosed with  Vestibular Neuritis and Vestibular Unilateral Hypofunction  (right ear).  Currently, out on short term disability and FMLA.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Impaired work ability, Pyrexia, Vertigo, Vestibular disorder, Vestibular neuronitis
Clinical narrative: I experienced high fever 101 for two days after vaccine was given, severe body aches of joints, low blood pressure, and extreme fatigue.  I had dizziness that was later diagnosed as Vertigo.  Went to Hospital's ER and was put on IV for dehydration, given muscle relaxers, and pills for dizziness.  Now experiencing Vertigo and was recently diagnosed with  Vestibular Neuritis and Vestibular Unilateral Hypofunction  (right ear).  Currently, out on short term disability and FMLA.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Night sweats, Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: later the night of the vaccine and next day, both arms very sore and hurt to raise them up, started getting night sweats/fever 3/26, but did not take actual temperature.  left arm/shingrix is still sore, but feels better.  right arm/pneumo 23 still very sore/feels like bad bruse/6 inch raised area, but not red/hot to the touch.  he said he was going to give it anther day or so and see if it gets better.
Age: 11.0
Sex: F
Vaccine: UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: CERTIFICATE SHOWS THAT PATIENT RECEIVED TRUMENBA AT 11 YEARS OF AGE. PATIENT'S ARE NOT SUPPOSE TO RECEIVE THIS VACCINE UNTIL AGE 16. THIS MAY HAVE BEEN ENTER IN ERROR AND MAY NEED PROOF.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: (1) Pain in (L) upper arm - (2) Pain in (R) upper arm - Pharmtist aware in pain continuing in (L) arm when shingle shot given in (R) arm - Nurse doesn't take pain serious - neither did pharmistis. Is this the normal? Pain level 5.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: None reported
Age: 18.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; patients received an improperly stored dose of MMR II on unspecified dates; This spontaneous report was received from a nurse practitioner referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and previous drug reaction, and allergies were not reported. The patients' concomitant therapy included sterile diluent injection.  On unspecified dates, the patients were vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant Human albumin (M-M-R II) of lot # R028382, expiration date reported as 02-OCT-2020 but upon internal validation established as 10-MAR-2020 (therapy type: rHA; exact dose, dose number and route of administration were not reported) for prophylaxis (product storage error). The sterile diluent injection used to reconstitute the vaccine was stored in the recommended temperature range. On an unknown date, the vaccines administered to the patients were exposed to the temperature excursion of -58 degree Fahrenheit and +46 degree Fahrenheit (35.1 Fahrenheit (F)) for 30 minutes, and at highest temperature above 47.1 degree Fahrenheit (47.1 F) for 30 minutes. There was previous temperature excursion at -58 degree Fahrenheit and +46 degree Fahrenheit (-35.8 F) for 30 minutes. There was no adverse effect reported (no adverse event). Digital data logger was involved. No product quality complaint was involved.  This is a non-valid report due to lack of patient identifiers.  Upon receipt of follow-up information from nurse practitioner on 26-MAR-2020, it was determined that this case is now valid as patient identifier was reported. The case is regarding a 18-years-old male patient. On 28-AUG-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant Human albumin (M-M-R II).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA010101: