chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 8-weeks-old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 04-NOV-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial of lot # S004398 with expiration date 31-OCT-2020 (strength, dose, dose number and route of administration were unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: patient was administered an improperly stored dose of MMRII; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 03-APR-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S006048, expiration date 27-FEB-2020, for prophylaxis (dose, strength, frecuency androute of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent.    On an unknown date, the  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) vaccine was stored at a temperature of 47.3F for 14 minutes, no previous temperature excursions were reported. Digital data logger was involved.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: running a low grade temperature; This case was reported by a nurse via call center representative and described the occurrence of low grade fever in a 74-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma.   On 2nd March 2020, the patient received the 1st dose of Shingrix. In March 2020, less than a day after receiving Shingrix, the patient experienced low grade fever. On an unknown date, the outcome of the low grade fever was not recovered/not resolved.   It was unknown if the reporter considered the low grade fever 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, however the patient could be 73 or 74 years old. The patient received Shingrix in the afternoon. The patient was enquiring that how long she should expect the fever if it was from Shingrix. The reporter stated if it was influenza then she needs to take quick action since she had asthma. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Myalgia, Rash pruritic
Clinical narrative: running a low grade temperature; This case was reported by a nurse via call center representative and described the occurrence of low grade fever in a 74-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma.   On 2nd March 2020, the patient received the 1st dose of Shingrix. In March 2020, less than a day after receiving Shingrix, the patient experienced low grade fever. On an unknown date, the outcome of the low grade fever was not recovered/not resolved.   It was unknown if the reporter considered the low grade fever 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, however the patient could be 73 or 74 years old. The patient received Shingrix in the afternoon. The patient was enquiring that how long she should expect the fever if it was from Shingrix. The reporter stated if it was influenza then she needs to take quick action since she had asthma. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Chicken pox on my chest; This case was reported by a consumer and described the occurrence of varicella-like rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th January 2020, the patient received the 1st dose of Shingrix. On 14th January 2020, less than a day after receiving Shingrix, the patient experienced varicella-like rash. The patient was treated with calamine. On an unknown date, the outcome of the varicella-like rash was not recovered/not resolved.   It was unknown if the reporter considered the varicella-like rash to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. Within a short period of time the patient developed what felt like a couple of chicken pox on his/her chest. The patient had them in spite of putting on calamine lotion regularly. The patient wanted to knowwould he/she experience same when receive second dose of vaccine.
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: The office manager reported this case on behalf of physician. 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 reaction which was lasted for all day. This case had been linked with US2020041827, reported by same reporter.
Age: 56.0
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: nausea; FEVER; headache; aches for five days.; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 56-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced nausea, fever, headache and general body pain. On an unknown date, the outcome of the nausea, fever, headache and general body pain were recovered/resolved.   It was unknown if the reporter considered the nausea, fever, headache and general body pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the first Shingrix shot on November 4th and had until May 4th to receive the booster.  However, given the pandemic Ipatient was wondering if I should proceed with it.  The patient had received conflicting advice from my physician and their pharmacist.  The patient did have a fairly strong reaction to it the first round, i.e., fever, nausea, headache, aches for five days.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: feel like flu today; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 20th April 2020, the patient received Shingles vaccine. On 21st April 2020, 1 days after receiving Shingles vaccine, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine.  Additional details were 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. The patient got shingles vaccine the day before reporting and feel like flu the day of reporting.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site rash, Injection site reaction, Injection site warmth
Clinical narrative: rash measured 9 CM long / was two inches below the injection site; had a bruise at the injection site; she awoke with redness; rash was flat and not raised but was warm / rash was warm and hot pink; rash was a little blotchy; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number XN4FP, expiry date 19th March 2022) for prophylaxis.   On 24th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 29th February 2020, 5 days after receiving Shingrix, the patient experienced injection site rash, injection site bruising, erythema, skin warm and blotchy. On an unknown date, the outcome of the injection site rash was recovering/resolving and the outcome of the injection site bruising, erythema, skin warm and blotchy were unknown.   It was unknown if the reporter considered the injection site rash, injection site bruising, erythema, skin warm and blotchy to be related to Shingrix.  Additional information was provided as follows: The patient woke with redness that was two inches below the injection site and to the left. The rash measured 9 centimetre long and was flat and not raised but was warm and a little blotchy.  The patient claimed that the rash was warm and hot pink. The patient also had a bruise at the injection site. The reporter consented to follow up. This case had been linked with US2019169152, reported by same reporter.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: rash measured 9 CM long / was two inches below the injection site; had a bruise at the injection site; she awoke with redness; rash was flat and not raised but was warm / rash was warm and hot pink; rash was a little blotchy; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number XN4FP, expiry date 19th March 2022) for prophylaxis.   On 24th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 29th February 2020, 5 days after receiving Shingrix, the patient experienced injection site rash, injection site bruising, erythema, skin warm and blotchy. On an unknown date, the outcome of the injection site rash was recovering/resolving and the outcome of the injection site bruising, erythema, skin warm and blotchy were unknown.   It was unknown if the reporter considered the injection site rash, injection site bruising, erythema, skin warm and blotchy to be related to Shingrix.  Additional information was provided as follows: The patient woke with redness that was two inches below the injection site and to the left. The rash measured 9 centimetre long and was flat and not raised but was warm and a little blotchy.  The patient claimed that the rash was warm and hot pink. The patient also had a bruise at the injection site. The reporter consented to follow up. This case had been linked with US2019169152, reported by same reporter.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bone pain, Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: Extreme pain when she lifted a small pharmacy bag; Hurts when she moves her arm / to reach for things, holding the phone or when she sleeps on her left side; Hurts to touch at the indentation of the left clavicle; hurts to touch at left shoulder joint; This case was reported by a consumer via call center representative and described the occurrence of pain in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 22S3B, expiry date 25th March 2022) for prophylaxis.   On 13th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 13th January 2020, immediately after receiving Shingrix, the patient experienced pain, pain in arm, bone pain and pain in joint involving shoulder region. On an unknown date, the outcome of the pain, pain in arm, bone pain and pain in joint involving shoulder region were recovering/resolving.   It was unknown if the reporter considered the pain, pain in arm, bone pain and pain in joint involving shoulder region to be related to Shingrix.  Additional details were reported as follows: The patient received her first Shingrix vaccine on in her left arm. Immediately after receiving the injection she experienced extreme pain when she lifted a small pharmacy bag. Since the injection she was experiencing extreme pain all the time, it hurts when she moves her arm to reach for things, holding the phone or when she sleeps on her left side. The patient also reported that it hurts to touch at the indentation of the left clavicle and left shoulder joint. The reporter did not consent to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Extreme pain when she lifted a small pharmacy bag; Hurts when she moves her arm / to reach for things, holding the phone or when she sleeps on her left side; Hurts to touch at the indentation of the left clavicle; hurts to touch at left shoulder joint; This case was reported by a consumer via call center representative and described the occurrence of pain in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 22S3B, expiry date 25th March 2022) for prophylaxis.   On 13th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 13th January 2020, immediately after receiving Shingrix, the patient experienced pain, pain in arm, bone pain and pain in joint involving shoulder region. On an unknown date, the outcome of the pain, pain in arm, bone pain and pain in joint involving shoulder region were recovering/resolving.   It was unknown if the reporter considered the pain, pain in arm, bone pain and pain in joint involving shoulder region to be related to Shingrix.  Additional details were reported as follows: The patient received her first Shingrix vaccine on in her left arm. Immediately after receiving the injection she experienced extreme pain when she lifted a small pharmacy bag. Since the injection she was experiencing extreme pain all the time, it hurts when she moves her arm to reach for things, holding the phone or when she sleeps on her left side. The patient also reported that it hurts to touch at the indentation of the left clavicle and left shoulder joint. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity
Clinical narrative: CHILLS; arm became sore; This case was reported by a consumer via call center representative and described the occurrence of chills in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced chills and pain in arm. On an unknown date, the outcome of the chills and pain in arm were recovered/resolved.   It was unknown if the reporter considered the chills and pain in arm to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient was either 63 or 64 years old. The patient's arm became sore the day after the injections and lasted a day. The patient also experienced chills the morning after receiving the shot. The reporter did not consent to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pruritus, Myalgia, Pyrexia, Urticaria
Clinical narrative: Itching; induration at the injection site; Hives on top of induration; Muscle Pain; mild fever; This case was reported by a physician via call center representative and described the occurrence of injection site itching in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th February 2020, the patient received the 1st dose of Shingrix. On 4th March 2020, 5 days after receiving Shingrix, the patient experienced injection site itching, injection site induration and hives. In March 2020, the patient experienced muscle pain and fever. On an unknown date, the outcome of the injection site itching, injection site induration and hives were unknown and the outcome of the muscle pain and fever were recovered/resolved.   It was unknown if the reporter considered the injection site itching, injection site induration, muscle pain, fever and hives to be related to Shingrix.  Additional information was provided as follows: The patient experienced muscle pain and a mild fever that resided after 48 hours of receiving the vaccine. On 4th March 2020, she then developed itching and induration at the injection site which also had what appeared to be hives on top of the induration. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous, Swollen tongue
Clinical narrative: itching palms and soles; erythematic rash / eruption; tongue swelling; This case was reported by a physician via call center representative and described the occurrence of pruritus in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included sulfonamide allergy (allergic reactions to sulfa drugs).   On 4th March 2020, the patient received the 1st dose of Shingrix. On 4th March 2020, less than a day after receiving Shingrix, the patient experienced pruritus, red rash and swollen tongue. On an unknown date, the outcome of the pruritus, red rash and swollen tongue were not recovered/not resolved.   It was unknown if the reporter considered the pruritus, red rash and swollen tongue to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient started experiencing itching palms and soles, erythema rash, tongue swelling. The patient was treated in the emergency room. Eruption was ongoing at the time of reporting.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Malaise, Memory impairment, Pyrexia
Clinical narrative: fever of 102 (F); Joint Pain; Outer body experience; Poor memory; Fatigue; does not feel completely right; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number PF454, expiry date 26th January 2022) for prophylaxis.   On 11th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 28th February 2020, 109 days after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the patient experienced fever, joint pain, sensation of foreign body, memory deficit and fatigue. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the joint pain, sensation of foreign body, memory deficit, fatigue and feeling unwell were unknown.   It was unknown if the reporter considered the fever, joint pain, sensation of foreign body, memory deficit, fatigue and feeling unwell to be related to Shingrix.  Additional information was provided as follows: This case was reported by Medical assistant. The age at vaccination was not reported. The patient received vaccine in left deltoid and developed a fever, joint pain, poor memory, fatigue and an outer body experience. Fever reportedly lasted for a couple days. On 28th Febrauary 2020, the patient stated she did not feel completely right.      Lab Comments: On an unknown date, the lab test was perform
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Sensation of foreign body
Clinical narrative: fever of 102 (F); Joint Pain; Outer body experience; Poor memory; Fatigue; does not feel completely right; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number PF454, expiry date 26th January 2022) for prophylaxis.   On 11th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 28th February 2020, 109 days after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the patient experienced fever, joint pain, sensation of foreign body, memory deficit and fatigue. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the joint pain, sensation of foreign body, memory deficit, fatigue and feeling unwell were unknown.   It was unknown if the reporter considered the fever, joint pain, sensation of foreign body, memory deficit, fatigue and feeling unwell to be related to Shingrix.  Additional information was provided as follows: This case was reported by Medical assistant. The age at vaccination was not reported. The patient received vaccine in left deltoid and developed a fever, joint pain, poor memory, fatigue and an outer body experience. Fever reportedly lasted for a couple days. On 28th Febrauary 2020, the patient stated she did not feel completely right.      Lab Comments: On an unknown date, the lab test was perform
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Itching; Redness; Large welts; This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a 60 year-old female patient who received Herpes zoster (Shingrix) (batch number 7L27G, expiry date 27th February 2022) for prophylaxis.   On 28th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pruritus, erythema and welts. On an unknown date, the outcome of the pruritus, erythema and welts were recovered/resolved.   It was unknown if the reporter considered the pruritus, erythema and welts to be related to Shingrix.  Additional details were reported as follows: Pharmacist called in to report patient experienced large welts, redness and itching that lasted for 3 weeks after first dose of Shingrix.   Pharmacist stated patient has a lot of reactions to a lot of vaccines and was thinking about postponing until COVID-19 calmed down. Did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: How long will muscle pain last after do you have the vaccine?; This case was reported by a consumer via call center representative and described the occurrence of myalgia in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, between 3 and 5 months after receiving Shingrix, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was unknown.   It was unknown if the reporter considered the myalgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient asked how long would the muscle pain last after do you have the vaccine. For tolerance after 2nd dose refer case US2020AMR072631.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: How long will muscle pain last after do you have the vaccine?; This case was reported by a consumer via call center representative and described the occurrence of myalgia in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of myalgia (1st dose received in December 2019, refer case US2020AMR069288).   On 21st April 2020, the patient received the 2nd dose of Shingrix. In April 2020, less than a week after receiving Shingrix, the patient experienced myalgia. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the myalgia was unknown.   It was unknown if the reporter considered the myalgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient asked how long would the muscle pain last after do you have the vaccine.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Burning sensation, Headache, Pain, Pyrexia
Clinical narrative: Joint hurt; Nervous system felt as if it was on fire; headache; fever; Body ached all over; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox. Concurrent medical conditions included lyme disease.   On 20th April 2020 09:30, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In April 2020, 17 hrs after receiving Shingrix and an unknown time after starting Acetaminophen, the patient experienced general body pain. On 21st April 2020, the patient experienced joint pain, burning sensation, headache and fever. The patient was treated with ibuprofen (Ibuprofen Unknown Manufacturer) and paracetamol (Acetaminophen). On an unknown date, the outcome of the general body pain, joint pain, burning sensation, headache and fever were not recovered/not resolved.   The reporter considered the general body pain, headache and fever to be related to Shingrix. It was unknown if the reporter considered the joint pain and burning sensation to be related to Shingrix.  Additional details were provided as follows: The patient stated she had the first dose of Shingrix on left arm on Monday of this week around 9:30am.   The patient woke up at 2:30 on Tuesday morning and her body ached all over.   On 21st April 2020, 1 day after vaccination, the patient's joints started to hurt and her nervous system felt as if it was on fire and the feeling was similar to that when she had chicken pox, also had a headache and fever.   The patient had been alternating ibuprofen and acetaminophen which had resulted in her symptoms improving but they were still present.   The patient only takes the ibuprofen every six hours.   The patient was diagnosed last week with Lyme disease and started on some medication so was unsure if this affected her reaction to the vaccine but her physician who diagnosed the Lyme disease advised her to proceed with the Shingrix vaccination. The reporter consented to follow up.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Paraesthesia, Pruritus, Rash
Clinical narrative: tingling nerve pain; itching; rash on arm and body; tingling nerve pain; This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included breast cancer. Concomitant products included denosumab (Prolia).   In December 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced nerve pain, pruritus, generalized rash and tingling sensation. On an unknown date, the outcome of the nerve pain, pruritus, generalized rash and tingling sensation were unknown.   It was unknown if the reporter considered the nerve pain, pruritus, generalized rash and tingling sensation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient who had her second dose of Shingrix in early Dec 2019 on left arm.   Caller reports that she experienced rash on her left arm around end of Dec 2019 or beginning of Jan 2020 that spread across rest of her body.  Caller reports that she also had itching and tingling nerve pain nerve pain associated with the rash. The reporter consented to follow up.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out about 2 minutes after all vaccines given. He came out of it in less than a minute.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Gingival swelling, Headache, Lip swelling
Clinical narrative: Fever, chills, body aches for 10 hours, headache, tiredness, swelling of lips/gums/fingers/toes for 3 hours, mild nausea
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Fever, chills, body aches for 10 hours, headache, tiredness, swelling of lips/gums/fingers/toes for 3 hours, mild nausea
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Multiple sclerosis relapse, Muscle spasticity, Rash
Clinical narrative: Exacerbation of  MS-spasticity  right leg and arm,  rash below injection site and elbow-right arm.  Spasticity returned to pre-vaccination status  in 48 hours.  Rash still evident 5 days post-vaccination despite decreasing intensity.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Abnormal behaviour, Hallucination, visual, Pyrexia
Clinical narrative: Mom stated that he started hallucinating that evening and stated he was seeing bugs on the wall.  And the next day he was still not acting himself. He did have a low grade temperature but it was not high enough that it should have caused the hallucination.
Age: 90.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fall, Guillain-Barre syndrome, Immunoglobulin therapy, Muscular weakness
Clinical narrative: Suspected Guillain Barre Syndrome.  BLE weakness with multiple falls prior to hospital admission on 4/1/2020.  Treated with IVIG x 6 doses, last dose reported on 3/30.  Reported having "shingles shot" about a week prior to symptoms.  Unable to locate exact information.
Age: 90.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Death, Guillain-Barre syndrome, Loss of control of legs, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Suspected Guillain Barre Syndrome.  BLE weakness with multiple falls prior to hospital admission on 4/1/2020.  Treated with IVIG x 6 doses, last dose reported on 3/30.  Reported having "shingles shot" about a week prior to symptoms.  Unable to locate exact information.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Balance disorder, Dizziness, Erythema, Limb discomfort, Local reaction
Clinical narrative: Local reaction: swelling/redness approximately 1" x 1.5".  R arm feels weak/heavy. Employee noticed the previous symptoms evening of 4/28/2020 and have continued into today. Employee started experiencing nausea, unbalanced, dizziness 4/29/2020 at approximately 8 am.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Muscular weakness, Nausea, Swelling
Clinical narrative: Local reaction: swelling/redness approximately 1" x 1.5".  R arm feels weak/heavy. Employee noticed the previous symptoms evening of 4/28/2020 and have continued into today. Employee started experiencing nausea, unbalanced, dizziness 4/29/2020 at approximately 8 am.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Bedridden, Myalgia
Clinical narrative: Muscle aches; unable to get out of bed; stomach issues; This case was reported by a consumer and described the occurrence of muscle pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced muscle pain, bedridden and stomach discomfort. On an unknown date, the outcome of the muscle pain, bedridden and stomach discomfort were recovered/resolved.   It was unknown if the reporter considered the muscle pain, bedridden and stomach discomfort to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and in early February. Three or four days later was unable to get out of bed. Muscle aches like I had never felt before paralyzed me. The side effect of the shingrix vaccination, it was like no side effect I had ever experienced from a vaccination. However, two days after the onset of the side effects were completely free of the aches and stomach issues.  This case linked with US2020AMR070663, reported by same reporter.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: feeling achy; headache; fever; This case was reported by a consumer via call center representative and described the occurrence of pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 4th November 2019, less than a day after receiving Shingrix, the patient experienced pain, headache and fever. On an unknown date, the outcome of the pain, headache and fever were recovered/resolved.   It was unknown if the reporter considered the pain, headache and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the morning and started feeling achy with a mild fever and headache in the evening.  The symptoms lasted about 3 days before resolving. The reporter consented to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: I awakened with chills and fever, that climbed to 102.8 within a couple of hours.  I had headache, muscle and joint pain, nausea that lasted for 18 hours.  All symptoms slowly remitted, and by early afternoon on 4/28, I felt fine again.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: I awakened with chills and fever, that climbed to 102.8 within a couple of hours.  I had headache, muscle and joint pain, nausea that lasted for 18 hours.  All symptoms slowly remitted, and by early afternoon on 4/28, I felt fine again.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Cyanosis, Feeling cold, Hyperhidrosis, Injection site erythema, Injection site swelling
Clinical narrative: Patient received  vaccine this morning and patient leg started to swell in the left leg and red with warm to touch . Patient also was cold and sweaty to touch and normal here in the office. Patient has also been very fussy and very pale in color. Patient has been turning blue in the lips and sucking her lips more than normal since the vaccines
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site warmth, Irritability, Pallor
Clinical narrative: Patient received  vaccine this morning and patient leg started to swell in the left leg and red with warm to touch . Patient also was cold and sweaty to touch and normal here in the office. Patient has also been very fussy and very pale in color. Patient has been turning blue in the lips and sucking her lips more than normal since the vaccines
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Malaise, Skin ulcer
Clinical narrative: Patient claims to have been in perfect health prior.  pt had complete physical on 08/09/2019 - pt was offered shingrix and has been sick ever since - pt was hospitalized one week after immunization (quarantined).  Pt was discharged 6 days later, still not feeling better.  Patient has active sores all over both arms, shoulders, back, and legs.  Pt claim this is eating him away and stealing his energy to death.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: got the shot on 4/27/20 at 1am woke up with muscle pain, headache, chills.  at 6am low grade fever 99.7.  after that her temp was normal.  Patient felt better within 48 hours after vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache
Clinical narrative: I have had a headache; tiredness; chills for five days now; This case was reported by a consumer via sales rep and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 5 days after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced headache, tiredness and chills. The patient was treated with ibuprofen. On an unknown date, the outcome of the headache, tiredness and chills were unknown.   It was unknown if the reporter considered the headache, tiredness and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had headache, tiredness and chills after vaccination. The patient was concerned that these symptoms have continued for 5 days.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: some swelling, warm at site of injection lasting 48 hours; reaction was redness, some swelling, warm at site of injection lasting 48 hours; warm at site of injection lasting 48 hours; This case was reported by a consumer via sales rep and described the occurrence of injection site swelling in a 75-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure (taking medicine daily).   On 25th November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site warmth to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced injection site swelling, injection site erythema and injection site warmth after vaccination. The patient asked when should get the 2nd dose to complete the vaccination. The patient was taking blood pressure control meds daily.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Myalgia, Vomiting
Clinical narrative: Muscle aches; threw upa  number of times.; stomach issues; This case was reported by a consumer and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received Shingrix. In February 2020, 1 day after receiving Shingrix, the patient experienced muscle pain, vomiting and stomach discomfort. On an unknown date, the outcome of the muscle pain, vomiting and stomach discomfort were recovered/resolved.   It was unknown if the reporter considered the muscle pain, vomiting and stomach discomfort to be related to Shingrix.  Additional details were provided as follows: This case was reported by the husband of the patient. The age at the vaccination was not reported. The patient received Shingrix and in early February and had aching the following day. Prior to her aching she threw up many times. However, two days after the onset of the side effects the patient was completely free of the aches and stomach issues.  This case linked with US2020AMR070653, reported by same reporter (husband's case). The patient had just returned from a trip to where she had gone for a vacation. The reporter concern was that she may have picked up the coronavirus on trip. She had not been tested. If she did pick up the virus, shingrix shot might have played a key role in killing the virus. Might be worth a little research.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Astigmatism, Cataract, Choroidal neovascularisation, Hypermetropia, Macular cyst
Clinical narrative: Cystoid macular degeneration; Neovascular age-related macular degeneration; Choroidal Neovascularization; Posterior Vitreous Detachment; Adult-onset vitelliform macular dystrophy; Blurred Vision; Hypermetropia; Macular pseudohole Bilateral; Regular astigmatism; Presbyopia; foveomacular vitelliform dystrophy/ vitelliform lesions; Macular cyst; Macular hole; cataract Bilateral; Serous retinal detachment; This case was reported by a lawyer and described the occurrence of macular cyst in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information was received on 22 April 2020 via medical record. As per record the patient prescribed with Shingrix vial kit on 12 June 2018 and on 12 October 2018. The patient had Macular cyst, hole or pseudohole Bilateral, Hypermetropia Bilateral, Regular astigmatism, Presbyopia, Combined forms of age-related cataract Bilateral dated on 05 September 2018. The patient diagnosed with Serous retinal detachment, bilateral dated on 19 September 2018. The patient had Cystoid macular degeneration, bilateral dated on 30 May 2019. On 18 December 2019 the patient visited to doctor for Neovascular (AMD-Age-Related Macular Degeneration) with Active CNV(Choroidal Neovascularization), Adult-Onset Foveomacular Vitelliform Dystrophy, he had Blurred Vision gradual during 1 to 2 years. Artificial Tears 1 gtt prn OU. The patient had Posterior Vitreous Detachment dated on 15 may 2019. The patient had vitelliform lesions in the central macula of both eyes dated on 04 October 2018.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Macular degeneration, Macular dystrophy congenital, Macular hole, Macular pseudohole, Maculopathy
Clinical narrative: Cystoid macular degeneration; Neovascular age-related macular degeneration; Choroidal Neovascularization; Posterior Vitreous Detachment; Adult-onset vitelliform macular dystrophy; Blurred Vision; Hypermetropia; Macular pseudohole Bilateral; Regular astigmatism; Presbyopia; foveomacular vitelliform dystrophy/ vitelliform lesions; Macular cyst; Macular hole; cataract Bilateral; Serous retinal detachment; This case was reported by a lawyer and described the occurrence of macular cyst in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information was received on 22 April 2020 via medical record. As per record the patient prescribed with Shingrix vial kit on 12 June 2018 and on 12 October 2018. The patient had Macular cyst, hole or pseudohole Bilateral, Hypermetropia Bilateral, Regular astigmatism, Presbyopia, Combined forms of age-related cataract Bilateral dated on 05 September 2018. The patient diagnosed with Serous retinal detachment, bilateral dated on 19 September 2018. The patient had Cystoid macular degeneration, bilateral dated on 30 May 2019. On 18 December 2019 the patient visited to doctor for Neovascular (AMD-Age-Related Macular Degeneration) with Active CNV(Choroidal Neovascularization), Adult-Onset Foveomacular Vitelliform Dystrophy, he had Blurred Vision gradual during 1 to 2 years. Artificial Tears 1 gtt prn OU. The patient had Posterior Vitreous Detachment dated on 15 may 2019. The patient had vitelliform lesions in the central macula of both eyes dated on 04 October 2018.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Neovascular age-related macular degeneration, Presbyopia, Serous retinal detachment, Vision blurred, Vitreous detachment
Clinical narrative: Cystoid macular degeneration; Neovascular age-related macular degeneration; Choroidal Neovascularization; Posterior Vitreous Detachment; Adult-onset vitelliform macular dystrophy; Blurred Vision; Hypermetropia; Macular pseudohole Bilateral; Regular astigmatism; Presbyopia; foveomacular vitelliform dystrophy/ vitelliform lesions; Macular cyst; Macular hole; cataract Bilateral; Serous retinal detachment; This case was reported by a lawyer and described the occurrence of macular cyst in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information was received on 22 April 2020 via medical record. As per record the patient prescribed with Shingrix vial kit on 12 June 2018 and on 12 October 2018. The patient had Macular cyst, hole or pseudohole Bilateral, Hypermetropia Bilateral, Regular astigmatism, Presbyopia, Combined forms of age-related cataract Bilateral dated on 05 September 2018. The patient diagnosed with Serous retinal detachment, bilateral dated on 19 September 2018. The patient had Cystoid macular degeneration, bilateral dated on 30 May 2019. On 18 December 2019 the patient visited to doctor for Neovascular (AMD-Age-Related Macular Degeneration) with Active CNV(Choroidal Neovascularization), Adult-Onset Foveomacular Vitelliform Dystrophy, he had Blurred Vision gradual during 1 to 2 years. Artificial Tears 1 gtt prn OU. The patient had Posterior Vitreous Detachment dated on 15 may 2019. The patient had vitelliform lesions in the central macula of both eyes dated on 04 October 2018.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Injection site reaction, Pain, Pyrexia
Clinical narrative: injection site reaction; body aches; fever; stomach ache; This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site reaction, general body pain, fever and stomach pain. On an unknown date, the outcome of the injection site reaction, general body pain, fever and stomach pain were recovered/resolved.   It was unknown if the reporter considered the injection site reaction, general body pain, fever and stomach pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced body aches, fever, stomach ache, and an injection site reaction all of which lasted approximately 12 hours. The reporter was not calling about her adverse event, just happened to report it in passing but said she expected all these side effects so had never reported them.
Sex: U
Vaccine: MENB
Symptoms: Headache, Pyrexia
Clinical narrative: temperature at 101.5F; mild frontal headache; This is a spontaneous report from a contactable nurse.  A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on 27Apr2020 at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced mild frontal headache on 28Apr2020 and temperature at 101.5 F on an unspecified date.  It was reported that the patient got mild frontal headache in the morning. On unspecified date temperature was at 101.5 F, and 2h later came down to 99.2F. The events were non serious. The outcome of the event mild frontal headache was unknown. The outcome of the event fever was recovered on unspecified date.   No follow-up attempts are needed. No further information is expected. information about lot/batch number cannot be obtained.