chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: On april 28th I received my vaccine at 12:05 and within 5 mins I had a slight dull headache. April 29th I woke up sweaty and running fever, had sore throat and chills and runny stuffy nose, felt like a bus hit me. April 30th woke up worse, I had all the same symptoms and a cough developed. May 1st I attempted to go to work  but was so exhausted and symptoms and cough had progressed and now my chest had a full ache to it, I felt as tho something was sitting on my chest. May 2nd symptoms elevated somewhat. May 3rd symptoms elevated alot, still have slight cough, was able to return to work but was not fully myself. May 4th only have slight glen and cough.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Headache, Insomnia, Musculoskeletal stiffness
Clinical narrative: Right arm ache 5 hour after inject.  By 12 hours, unable to sleep.  24 hour after inject fever 101-102.  Headache.  Stiff neck.  72 hour after inject - fever gone, neck minor ache, arm mobile with minor residual pain, headache gone.  Shoulder pain similar to dislocating shoulder (done 10 years ago).N
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Right arm ache 5 hour after inject.  By 12 hours, unable to sleep.  24 hour after inject fever 101-102.  Headache.  Stiff neck.  72 hour after inject - fever gone, neck minor ache, arm mobile with minor residual pain, headache gone.  Shoulder pain similar to dislocating shoulder (done 10 years ago).N
Sex: U
Vaccine: RV5
Symptoms: Constipation
Clinical narrative: constipation; This spontaneous report was received from a physician via company representative, referring to a child patient of unspecified age and gender.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.      On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter, oral, for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported).   On an unspecified date, the patient experienced constipation.  The patient's mother call into the physician's office seeking medical attention.  The outcome of constipation was reported as recovered (date not provided).   The reporter did not assess the causal relationship between therapy with  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and the event.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Herpes zoster, Myocardial infarction, Post herpetic neuralgia
Clinical narrative: heart attack; postherpetic neuralgia; dizziness; herpes zoster; Information has been received from a lawyer concerning a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX), patient suffered from: herpes zoster, postherpetic neuralgia, heart attack, and dizziness. As a result of these symptoms, patient was seen and treated by medical providers and is still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), Patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experience mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of company's wrongful conduct, 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. As a direct and proximate result of company's conduct, patient have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The events were considered to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of heart attack was determined to be medically significant.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Palpitations
Clinical narrative: heart was throbbing a lot; waves of lightheadedness; This is a spontaneous report from a contactable consumer based on information received by Pfizer   This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart was throbbing a lot) and DIZZINESS (waves of lightheadedness) in 84-year-old female patient who received apixaban (Eliquis) tablet for Cerebrovascular accident prophylaxis.  CO-SUSPECT PRODUCTS included Covid-19 Vaccine for COVID-19 immunisation.  Concurrent medical conditions included Thyroid disorder, Blood pressure high and Cholesterol.  On 14-Mar-2021, the patient started Eliquis (oral), 5 milligrams twice a day. On an unknown date, the patient started Covid-19 Vaccine (unknown route). On 19-Mar-2021, 5 days after starting Eliquis, the patient experienced PALPITATIONS (heart was throbbing a lot) and DIZZINESS (waves of lightheadedness). The action taken with Eliquis (oral) was unknown. At the time of the report, PALPITATIONS resolved and DIZZINESS outcome was unknown.  For Eliquis (oral), the reporter did not provide any causality assessments.  Concomitant Drugs for thyroid, high blood pressure and cholesterol.  Most recent information was received on 29-MAR-2021 from a consumer incorporated the above: Patient attributes, concomitant drug added, and event attributes updated.  Further company follow-up with the consumer is not possible.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site vesicles, Wrong technique in product usage process
Clinical narrative: i asked the nurse if she stuck the needle all the way in she said yes, i say no; Blister with fluid in it on TBE outside if the injection site/ blister dime size at the injection site / Blister is liquid filled; This case was reported by a consumer via call center representative and described the occurrence of injection site blisters in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included disability and aortic dissection.   On 27th April 2021, the patient received Shingrix. In April 2021, less than a week after receiving Shingrix, the patient experienced injection site blisters. On 27th April 2021, the patient experienced wrong injection technique. On an unknown date, the outcome of the injection site blisters and wrong injection technique were unknown.   It was unknown if the reporter considered the injection site blisters to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received the dose of Shingrix and experienced fluid filled blister of dime size at the injection site. The nurse stated that she stuck the needle all the way in however patient stated that needle was not went in, which led to wrong injection technique. No other information was reported.
Sex: F
Vaccine: FLUX
Symptoms: Bronchitis, Cough, Illness, Nasopharyngitis
Clinical narrative: Got bronchitis; Was still sick even after Christmas; Freaking cough / would't go away; Freaking / cold would't go away; This case was reported by a consumer via other manufacturer and described the occurrence of bronchitis in a 61-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   The patient's past medical history included low blood pressure (Family History) (mother has low BP) and anaphylactic shock. Concurrent medical conditions included metastatic breast cancer, migraine, glossopharyngeal neuralgia (allergies to other substances) and allergy. Concomitant products included gabapentin, montelukast sodium (Singulair), levothyroxine sodium (Synthroid), allergy medication {nos} (Claritin (Allergy Medication Nos)) and oxycodone.   In November 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than 2 years after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced bronchitis, sickness, cough and cold. The patient was treated with calcium carbonate (Caltrate (Calcium)) and vitamins nos (Vitamins). On an unknown date, the outcome of the bronchitis, sickness, cough and cold were unknown.   It was unknown if the reporter considered the bronchitis, sickness, cough and cold to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The case was reported by patient herself. The patient did not receive many vaccines in past. The patient had history of anaphylactic shock. The patient had allergies to other substances. The patient's mother has low blood pressure. The patient concurrent conditions included of metastatic breast cancer, migraine in 2011 or 2012 and neuralgia. The concomitant medication included Gabapentin 300mg for glossopharynx neuralgia , 3 times a day, Singulair 10mg 2 times a day for migraines, Synthroid 112mcg for thyroid, Oxycodone 1 and 1/2 tablets a day for neuropathy and Claritin for allergic to the decongestant. The patient received the dose of Flu vaccine in November 2019 and patient got bronchitis. The patient was still sick, freaking cough and with cold. The patient never complained about her arm hurting. The patient received the vitamins and calcium caltrate as treatment for bronchitis. On 15th April 2021, the patient received the dose Covid-19 pfizer vaccine and experienced events. This case was 1 of 3 cases reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR095136:Same reporter US-GLAXOSMITHKLINE-US2021AMR095212:Same reporter. Flu shot mother's case.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Gastrointestinal disorder, Lower respiratory tract infection, Nasopharyngitis, Night sweats
Clinical narrative: chest cold; head cold; Poor appetite; Night sweats twice; Guts are messed up; Started with eyes; This case was reported by a other health professional and described the occurrence of chest cold in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chest cold (serious criteria GSK medically significant), head cold, decreased appetite, night sweat, gastrointestinal disturbance and eye discomfort. On an unknown date, the outcome of the chest cold, head cold, decreased appetite, night sweat, gastrointestinal disturbance and eye discomfort were unknown.   It was unknown if the reporter considered the chest cold, head cold, decreased appetite, night sweat, gastrointestinal disturbance and eye discomfort to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received Shingrix vaccine and experienced poor appetite, guts are messed up started with eyes, feeling like going to bug out of head, then went to head cold, chest cold and night sweats. The patient has not had flu in years and no fevers, really that he knows of.
Sex: M
Vaccine: VARZOS
Symptoms: Ocular discomfort
Clinical narrative: chest cold; head cold; Poor appetite; Night sweats twice; Guts are messed up; Started with eyes; This case was reported by a other health professional and described the occurrence of chest cold in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chest cold (serious criteria GSK medically significant), head cold, decreased appetite, night sweat, gastrointestinal disturbance and eye discomfort. On an unknown date, the outcome of the chest cold, head cold, decreased appetite, night sweat, gastrointestinal disturbance and eye discomfort were unknown.   It was unknown if the reporter considered the chest cold, head cold, decreased appetite, night sweat, gastrointestinal disturbance and eye discomfort to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received Shingrix vaccine and experienced poor appetite, guts are messed up started with eyes, feeling like going to bug out of head, then went to head cold, chest cold and night sweats. The patient has not had flu in years and no fevers, really that he knows of.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the liquid part of Shingrix; received only the liquid part of Shingrix; This case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter was a medical assistant. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The reporter informed that the patient accidentally received only the liquid part of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consent to follow up. No further information available. This case had been linked with US2021AMR095814 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021095331:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia, Neuralgia
Clinical narrative: Diffuse nerve and muscle pain; Diffuse nerve and muscle pain; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain and nerve pain. On an unknown date, the outcome of the muscle pain and nerve pain were unknown.   It was unknown if the reporter considered the muscle pain and nerve pain to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient experienced diffuse nerve and muscle pain after the Shingrix vaccine. The follow-up would not possible as no contact details were available.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient / was administrated with Pediarix instead of Kinrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number K7TF9, expiry date 24th May 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th April 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 28th April 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that the patient  was administrated with Pediarix instead of Kinrix, which led to wrong vaccine administered. No adverse event was reported. The reporter Consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Disturbance in attention, Dizziness, Headache, Influenza like illness
Clinical narrative: Headache; Unfocused feeling; Cramping in back of both thighs / back cramps; Nausea; Dizziness; Diffuse skin hypersensitivity; Anorexia; Flu-like feeling; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Internal shingles 2 years ago, was ill for 8 weeks with this). Concomitant products included covid-19 vaccine (Covid 19 Vaccine).   On 28th April 2021, the patient received the 1st dose of Shingrix. In April 2021, 12 hrs after receiving Shingrix, the patient experienced headache, mental concentration impaired, cramp, nausea, dizziness, hypersensitive skin, anorexia and influenza like illness. The patient was treated with ibuprofen and excedrin (nos) (Excedrin). On an unknown date, the outcome of the headache and mental concentration impaired were not recovered/not resolved and the outcome of the cramp, nausea, dizziness, hypersensitive skin, anorexia and influenza like illness were recovered/resolved.   It was unknown if the reporter considered the headache, mental concentration impaired, cramp, nausea, dizziness, hypersensitive skin, anorexia and influenza like illness to be related to Shingrix.  Additional details were provided as follows: The patient was the reporter. The patient completed her COVID vaccination in January 2021, she did not provided date. On 29th Apr 2021, the patient experienced headache and unfoccused feeling. On the same day, 16 hours post vaccination with Shingrix, the patient had cramps in back of thigh and also had back cramps, nausea, dizziness, diffuse hypersensitive skin, anorexia and flu like feeling. The patient did not provide lot and expiration dates of Shingrix vaccine. The patient gave consent to follow up with her HCP (health care provider).
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Nausea, Sensitive skin
Clinical narrative: Headache; Unfocused feeling; Cramping in back of both thighs / back cramps; Nausea; Dizziness; Diffuse skin hypersensitivity; Anorexia; Flu-like feeling; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Internal shingles 2 years ago, was ill for 8 weeks with this). Concomitant products included covid-19 vaccine (Covid 19 Vaccine).   On 28th April 2021, the patient received the 1st dose of Shingrix. In April 2021, 12 hrs after receiving Shingrix, the patient experienced headache, mental concentration impaired, cramp, nausea, dizziness, hypersensitive skin, anorexia and influenza like illness. The patient was treated with ibuprofen and excedrin (nos) (Excedrin). On an unknown date, the outcome of the headache and mental concentration impaired were not recovered/not resolved and the outcome of the cramp, nausea, dizziness, hypersensitive skin, anorexia and influenza like illness were recovered/resolved.   It was unknown if the reporter considered the headache, mental concentration impaired, cramp, nausea, dizziness, hypersensitive skin, anorexia and influenza like illness to be related to Shingrix.  Additional details were provided as follows: The patient was the reporter. The patient completed her COVID vaccination in January 2021, she did not provided date. On 29th Apr 2021, the patient experienced headache and unfoccused feeling. On the same day, 16 hours post vaccination with Shingrix, the patient had cramps in back of thigh and also had back cramps, nausea, dizziness, diffuse hypersensitive skin, anorexia and flu like feeling. The patient did not provide lot and expiration dates of Shingrix vaccine. The patient gave consent to follow up with her HCP (health care provider).
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: received/ subcutaneously instead of intramuscularly; This case was reported by a consumer via call center representative and described the occurrence of intramuscular formulation administered by other route in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: This case was reported by patient itself. The age at vaccination was not reported. The patient received Shingrix subcutaneously instead of intramuscularly which led to intramuscular formulation administered by other route. The reporter declined to provide any other additional information or answer adverse event questions when asked.   She stated that, she wanted to speak to her healthcare professional first and would call back later with further details.   Provided caller with phone number to for healthcare professional to call for advice. The reporter declined to provide healthcare professional information. The reporter did not consent to follow up with her healthcare professional.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Product administered at inappropriate site
Clinical narrative: pain at the site of injection; swelling at the site of injection; experiencing extreme heat at the site of injection; vaccine was administered 4 inches below from the upper arm; This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th April 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 28th April 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site warmth and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site warmth were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient self reported this case. The Shingrix vaccine was administered 4 inches below from the upper arm which led to vaccine administration at inappropriate site.  The patient experienced extreme heat, swelling, and pain at the site of injection.  The reporter seemed as she was in hurry and ready to get off the call.  The reporter asked for different department to answer her additional questions, therefore was provided contact information to Medical information for her healthcare professional to consult if there were any additional questions.  The patient refused to provide her full mailing address, date of birth, email address or fax number and stated that if required her healthcare professional would provide her information to Medical information when they call.  The reporter refused to give a consent for safety department to follow up with healthcare professional, therefore, did not ask further questions about healthcare professional's contact information.  The reporter did not know the lot number or expiration date of the vaccine. Also, there was no information on dose or route of administration.  The patient stated that the pharmacists who gave her 1st dose of Shingrix and 2nd dose of Shingrix were different individuals.  The reporter did not consent to follow up and did not give consent to follow up with healthcare professional.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the liquid part of Shingrix; received only the liquid part of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The medical assistant reported that patient accidentally received only the liquid part of Shingrix, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication.  No further information was reported. The reporter consent to follow up. This case was linked with US2021AMR095814, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR095814:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: shivering; fatigue; myalgia; headache; This case was reported by a physician and described the occurrence of shivering in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th April 2021, the patient received the 1st dose of Shingrix. In April 2021, less than a week after receiving Shingrix, the patient experienced shivering, fatigue, myalgia and headache. On an unknown date, the outcome of the shivering, fatigue, myalgia and headache were recovered/resolved.   It was unknown if the reporter considered the shivering, fatigue, myalgia and headache to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's neighbor. The patient received the 1st dose of Shingrix and experienced shivering, fatigue, myalgia and headache. All symptoms had resolved. The reporter would like to know if she had a reaction to the first injection, does that mean that she would also have a worse reaction on the second injection. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose of Shingrix on 23Ju2019 and is late for the 2nd dose; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 23rd July 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The HCP stated that, the patient received the 1st dose somewhere else, lot and expiration date was unknown. No symptoms were reported. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient is here to get his 2nd dose / has been 1.5 years since 1st dose; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix 1.5 years prior to reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. No vaccine details, lot and expiration date were provided. The VAERS details for 1st dose were updated. The reporter asked if it was too late. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose of shingrix received on  8/20/2019 and Dose 2 on 2/27/2021; This case was reported by a pharmacist via and described the occurrence of drug dose administration interval too long in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number EZ4TD, expiry date 4th November 2022) for an unknown indication.   Previously administered products included Shingrix (received 1st dose on 20th August 2019).   On 27th February 2021, the patient received the 2nd dose of Shingrix. On 27th February 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received 2nd dose of Shingrix, more than the recommended interval, which led to lengthening of vaccination schedule. The reporter asked if patient needs another 2nd dose. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: administrated subcutaneously with the second dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 9H3Z4, expiry date 27th August 2022) for prophylaxis.   On 29th April 2021, the patient received the 2nd dose of Shingrix (subcutaneous). On 29th April 2021, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional information was provided as follows: The patient received a dose of Shingrix subcutaneously instead of intramuscular route which led to intramuscular formulation administered by other route. No adverse event was reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient / is past due for dose two; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18th December 2019, batch number 29RD5, expiration date 16th April 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter mentioned that, the patient was past due for dose 2. The reporter consented to follow up.
Age: 23.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Patient / received a dose / expired during March 2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 23-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA268A, expiry date 31st March 2021) for prophylaxis.   On 30th April 2021, the patient received Menveo. On 30th April 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient received expired vaccine of Menveo. The reporter asked if dose was valid or not. The reporter was concerned regarding how to proceed in case when Menveo was administered after expiration date. The reporter consented to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: administration of an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 31-year-old female patient who received HAB (Twinrix) (batch number 3C422, expiry date 27th April 2021) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th April 2021, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 30th April 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. On 30 April 2021, the patient received Twinrix, which was expired on 27th April 202. No further events were reporter.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Herpes zoster, Product administered at inappropriate site, Rash erythematous
Clinical narrative: Vaccine was provided on the outside of the left arm; Developed Shingles 48 hours later / diagnosed with Shingles; A "red rash on his arm" / right on the opposite side of the injection site; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 11-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th April 2021, the patient received Bexsero (intercostal) and Bexsero Pre-Filled Syringe Device. On 7th April 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced vaccine administered at inappropriate site. In April 2021, the patient experienced shingles and red rash. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles and vaccine administered at inappropriate site were unknown and the outcome of the red rash was recovering/resolving.   It was unknown if the reporter considered the shingles and red rash to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was patient's parent. The reporter states that the patient got the Bexsero GlaxoSmithKline Meningitis vaccine on the outside of the left arm, which led to vaccine administered at inappropriate site and developed Shingles 48 hours later. On 9th April 2021, the patient developed red rash on his arm. The reporter stated that the rash developed right on the opposite side of the injection site but on the inside of the arm, on the same arm where the patient was vaccinated.   The patient was taken first to the Urgent Care during the weekend and on 12th April 2021, was taken then to the Pediatrician and was diagnosed with Shingles. The healthcare professional recommended a dermatologist to get a 2nd opinion and he confirmed it was Shingles. The reporter stated that the patient was given a 7-day course of Acyclovir. The reporter stated that the rash was clearing up. Reporter consented to follow up and also with the healthcare professional.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Pt fainted for 2 minutes immediately after getting the vaccine . Was okay after that
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Refusal of treatment by patient
Clinical narrative: The vaccine dose was given to patient approximately 2 hours after its beyond use time. The manufacturer was contacted to seek best practice protocols. Patient was informed of the situation and options to get a replacement dose were discussed as per Pfizer's literature. For now, patient declined another dose but will let us know if she changes her mind.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pruritus, Taste disorder
Clinical narrative: Sleeplessness with no energy loss ,itching without rash.  Strange taste. Self monitoring no treatment.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site mass, Myalgia, Pain, Pain in extremity
Clinical narrative: Arm was sore, red, swollen & itched quite a bit. There was a large lump where the injection was given.  This lasted for 4-5 days.  The evening of the 28th every bone in my body ached severly overnight, by the 29th my entire body was just sore from the muscle aches
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Arm was sore, red, swollen & itched quite a bit. There was a large lump where the injection was given.  This lasted for 4-5 days.  The evening of the 28th every bone in my body ached severly overnight, by the 29th my entire body was just sore from the muscle aches
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Fatigue, Full blood count, Headache
Clinical narrative: subjective fever, fatigue, bodyache, chills, headache, nausea, vomiting, epigastric pain
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lipase, Metabolic function test, Nausea, Pain, Pyrexia
Clinical narrative: subjective fever, fatigue, bodyache, chills, headache, nausea, vomiting, epigastric pain
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis, Vomiting
Clinical narrative: subjective fever, fatigue, bodyache, chills, headache, nausea, vomiting, epigastric pain
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Bradyphrenia, Feeling abnormal, Headache, Hypoaesthesia, Memory impairment
Clinical narrative: It has been one week since the injection.  I continue to have moderate/hi tinnitus.  I continue to have memory problems, thinking challenges, edgy, low grade headache, 'numbiness' of the brain, 'hollowness' of the brain.  I feel like the chemicals of my brain have been significantly impacted.   The severity of the symptoms are 99% leaning me not to have the second vaccine injection.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Tension, Tinnitus
Clinical narrative: It has been one week since the injection.  I continue to have moderate/hi tinnitus.  I continue to have memory problems, thinking challenges, edgy, low grade headache, 'numbiness' of the brain, 'hollowness' of the brain.  I feel like the chemicals of my brain have been significantly impacted.   The severity of the symptoms are 99% leaning me not to have the second vaccine injection.
Age: 65.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Metamorphopsia, Ocular discomfort, Photopsia, Vision blurred
Clinical narrative: Within 3 hrs after receiving the vaccine my vision in what seemed to be both eyes was 80% cloudy and I was very exhausted. The following day most of the vision issued returned to normal but I had distortion and floating objects in my right eye along with bright flashes and  pressure in my right eye. After following up with our prescribed online health care service twice I was told to contact a specialists. I was able to get into the eye ER Clinic and have had 3 visits including one with a Retina specialist. I still have lost part of my peripheral vision in my right eye and continue to have follow up care.
Age: 65.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Visual field defect, Vitreous floaters
Clinical narrative: Within 3 hrs after receiving the vaccine my vision in what seemed to be both eyes was 80% cloudy and I was very exhausted. The following day most of the vision issued returned to normal but I had distortion and floating objects in my right eye along with bright flashes and  pressure in my right eye. After following up with our prescribed online health care service twice I was told to contact a specialists. I was able to get into the eye ER Clinic and have had 3 visits including one with a Retina specialist. I still have lost part of my peripheral vision in my right eye and continue to have follow up care.
Age: 65.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Eye haemorrhage, Fatigue, Injection site pain, Retinal detachment, Retinal tear
Clinical narrative: Within 3 hrs after receiving the vaccine my vision in what seemed to be both eyes was 80% cloudy and I was very exhausted. The following day most of the vision issued returned to normal but I had distortion and floating objects in my right eye along with bright flashes and  pressure in my right eye. After following up with our prescribed online health care service twice I was told to contact a specialists. I was able to get into the eye ER Clinic and have had 3 visits including one with a Retina specialist. I still have lost part of my peripheral vision in my right eye and continue to have follow up care.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Dyspnoea, Myalgia
Clinical narrative: Fever or Chills  Cough  Shortness of Breath  Muscle or body aches  Congestion or running nose
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Fever or Chills  Cough  Shortness of Breath  Muscle or body aches  Congestion or running nose
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: High pitched ringing in ears lasted 20 minutes.  Less high pitch ringing in ears after.wards; continuous.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Anticoagulant therapy, Aphasia, Balance disorder, Cerebrovascular accident
Clinical narrative: Shortly after getting the shot she reported feeling "off" as she was driving she started feeling short of breath and her heart was racing. When she got home around 5 PM she was still feeling short of breath and reported that her heart was racing. She was unable to speak clearly, but was stating that it was due to be being short of breath.  She also reported feeling lethargic and fell asleep until the next morning. She slept until approximately 12 pm the next day. When she woke up she reported feeling right sided cheek tingling. At that time she thought she had just slept wrong. When she attempted to walk down stairs she was limping and reported just feeling very weak on her left side. On Wednesday she slept in late again complaining of lethargy. When she awoke that Wednesday (3/10) her speech was markedly slurred. She was also saying things that didn't make sense. She was dragging her left leg when she tried to walk. We immediately took her to the ER and she was worked up for stroke. When she was triaged in the ER we mentioned that she had just had her COVID vaccine and voiced concerned that maybe she had a reaction to her COVID vaccine. She was admitted to hospital on 3/10 for a possible stroke.  Her MRI was done later on 3/11, Her MRI showed that she has strokes on both sides of her brain in the frontal, parietal and occipital lobes. The doctor referred to her stroke as being caused by a "showering of clots". The doctor said this usually only happens to someone with cardiac issues. My mom has no cardiac history. Her doctor ordered an 2D Echo of her heart and no abnormalities were found (3/12).   She is still disabled from her stroke. She was hospitalized from 3/10 - 3/16. She was the discharged to other care facility from 3/16-3/26. She is currently needing outpatient rehab in a day neuro program. She attends this at outpatient facility. She has to walk with a cane due to persistent left leg weakness. Her speech has a slight slur, and she suffers from short term memory loss. She intermittently has trouble with her equilibrium and reports feeling dizzy. She sometimes has a hard time swallowing or says that it doesn't feel right when  she swallows. She also trouble with word retrieval. She has left-sided neglect which correlates  left eye visual deficits. She currently requires care from a general physician, neurologist, physical therapist, occupational therapist, speech therapist, neuro ophthalmologist and neuo psychologist. She was started on a new medication regime 325 mg aspirin daily, plavix for 21 days (now completed), metformin, amlodipine, coreg and losartan. She is going to need outpatient rehab until at least June from the last update we received from her rehab doctor.