chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Palpitations, Swollen tongue
Clinical narrative: Swollen tongue, racing heart, lightheaded
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Paraesthesia, Throat irritation
Clinical narrative: The patient was sitting in a chair and began feeling flushed, scratchy throat, and tingling in bilateral arms. Treatment included 25mg Benadryl by mouth at 1851, repeat dose at 1902.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Vaccination site swelling
Clinical narrative: Developed chills, body aches, swelling at vaccine site. Improved after 2 days.  She did have COVID in April 2020.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: NO ADVERSE EVENT; Patient was vaccinated with a dose of Proquad that had a temperature excursion; This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concurrent therapies were not provided.   On 05-OCT-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status rHA; 0.5 milliliter, lot # S027465 expiration date 02-MAR-2021) for prophylaxis. No adverse event or product quality complaint was reported.     The temperature excursion lasted 14 hours at a temperature of 5.7 F and was due to a data logger issue.  Measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # reported as S0317056 expiration date 06-APR-2021 was also improperly stored.   Lot number S0317056 is an invalid lot number for Measles, mumps, rubella and varicella (oka-merck) virus vaccine live.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Dysstasia, Gait inability, Headache
Clinical narrative: Leg pain, back pain, chills, fever, headache. Unable to walk or stand still for more than a minute. Unable to sit upright back pain travels to mid back.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Leg pain, back pain, chills, fever, headache. Unable to walk or stand still for more than a minute. Unable to sit upright back pain travels to mid back.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Left knee pain when standing up
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA.  Symptoms: shaking, chills, sore arm, fever: 101 beginning at 11:30pm. Took Tylenol Extra Strength prior to bed at 2am. Woke up with headache and fever of 99.4 approximately 6 hours later and took more Tylenol Extra Strength. Felt tired during the day. Rechecked temperature at 8:00pm (12/19) and fever remained at 99.4 , but did not take Tylenol.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA.  Symptoms: shaking, chills, sore arm, fever: 101 beginning at 11:30pm. Took Tylenol Extra Strength prior to bed at 2am. Woke up with headache and fever of 99.4 approximately 6 hours later and took more Tylenol Extra Strength. Felt tired during the day. Rechecked temperature at 8:00pm (12/19) and fever remained at 99.4 , but did not take Tylenol.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE; temperature excursion/vaccines were administered to patients; This spontaneous report was received from a certified medical assistant and a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 30-NOV-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) prefilled syringe, dose: 0.5 milliliter, lot # 1637642, expiry date: 28-MAY-2022 (route of administration was not provided) for prophylaxis. Administered dose of vaccine experienced an unknown temperature excursion. The medical assistant stated that there had been multiple temperature excursions recently. The previous excursions were related. Data logger was involved. No adverse events were reported. It was also stated, that remaining vaccines were ok to use because they were still stored within recommended temperature guidelines. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637642; expirationdate: 28-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Body temperature increased, Dizziness
Clinical narrative: Patient experienced Temperature increase to 99.3 oral; increased blood pressure 136/94 with dizziness about 30 minutes after injection.  Blood pressure remained elevated for about 2 hours; normal blood pressure 112/64 for this young man. Vitals were taken every 30 minutes. BP and temp 134/84, 99.5  140/92, 99.1 128/92, 99.1 112/76, 97.8 vitals prior to patient leaving. Dizziness improved and patient taken home by friend.   Dizziness continued. Patient taken home and told to report to ER if symptoms return
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: The day after injection (Wednesday), pt stated she had swelling the size of a softball at injection site, redness, slight itching. She took Tylenol prn for discomfort. Symptoms resolved by monday
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: no additional AE; administered PROQUAD and did not realize the expiration was dated for December 1, 2020; This spontaneous report was received from a reporter of unknown role and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  09-DEC-2020, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # S017255, expiration date 01-DEC-2020, dose of 0.5 milliliter (formulation and route of administration were not reported) for prophylaxis (expired product administered). There was no other adverse event reported. The outcome of the event was unknown. It was unknown whether the patient received treatment or had any lab diagnostics/studies performed.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Fatigue, Pyrexia
Clinical narrative: Dry Cough, Fatigue, Arthralgia, Low Grade Fever.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; herpes zoster; Information has been received from a lawyer regarding a case in litigation and referring to an adult patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On or about 16-NOV-2016, the patient was administered with zoster vaccine live (ZOSTAVAX) (dose, route, lot # and expiration date were not reported) by a pharmacist for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by health providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX): herpes zoster and postherpetic neuralgia. The outcome of the events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Chills, Fatigue, Headache
Clinical narrative: I developed a temp as high as 101 degrees. Terrible headache that lasted for 5 days Muscle aches Fatigue, Weak                                     (I did have covid on March 27- was ill for 3 weeks.   Had antibodies still present when tested in August) Chills alternating with sweating
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myalgia
Clinical narrative: I developed a temp as high as 101 degrees. Terrible headache that lasted for 5 days Muscle aches Fatigue, Weak                                     (I did have covid on March 27- was ill for 3 weeks.   Had antibodies still present when tested in August) Chills alternating with sweating
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: 12/18/2020 10:30PM body aches, chill, left arm pain. 3:00 AM pain in arm 800mg Tylenol. AM next day, arm still sore . 12/20/20 midday discomfort in l armpit. 11:30 12/20 swelling  in l armpit. 9:00 Ice swelling of  l armpit -- Tylenol.  Some swelling persists at area of l armpit.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoacusis, Nervous system disorder, Post herpetic neuralgia
Clinical narrative: other serious neurological problems; herpes zoster; post herpetic neuralgia; hearing problems; Information has been received regarding a case in litigation from a lawyer and the pt on 14-DEC-2020, referring to a currently 73 year old pt of unknown gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 27-FEB-2012, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot# and route unknown) for long-term prevention of shingles and zoster-related conditions. The pt suffered the following injuries as a result of the zoster vaccine live (ZOSTAVAX) vaccine: herpes zoster, postherpetic neuralgia, hearing problems and other serious neurological problems. The outcome of herpes zoster, postherpetic neuralgia, hearing problems and other serious neurological problems was unknown. The causality assessment between herpes zoster, postherpetic neuralgia, hearing problems and other serious neurological problems with zoster vaccine live (ZOSTAVAX) was reported as related.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: 0650-Within 5 min of vaccination: Lightheadedness, dizziness, "floaty" feeling, cleared after sitting 15 more minutes. 0900-Returned to clinic,  after vaccination :  recurrence of lightheadedness,  sudden onset of HA 6/10 (no migraine aura), nausea and 2 episodes of watery stool, diaphoresis. No rash, no Shortness of breath, no difficulty swallowing, no throat swelling. 1000- taken to ED for continued monitoring: given Zofran 4mg SL, Benadryl 25 mg PO,  Pepcid 10 mg PO, Tylenol 975 mg PO ,  ibuprofen 600 mg PO.  DC'd from ED at 1335 with Zofran for continued nausea. Other symptoms resolved.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: 0650-Within 5 min of vaccination: Lightheadedness, dizziness, "floaty" feeling, cleared after sitting 15 more minutes. 0900-Returned to clinic,  after vaccination :  recurrence of lightheadedness,  sudden onset of HA 6/10 (no migraine aura), nausea and 2 episodes of watery stool, diaphoresis. No rash, no Shortness of breath, no difficulty swallowing, no throat swelling. 1000- taken to ED for continued monitoring: given Zofran 4mg SL, Benadryl 25 mg PO,  Pepcid 10 mg PO, Tylenol 975 mg PO ,  ibuprofen 600 mg PO.  DC'd from ED at 1335 with Zofran for continued nausea. Other symptoms resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster
Clinical narrative: arthralgias in her knuckles, hands, hips, and all major joints in her body; Information has been received from a lawyer, regarding a case in litigation, and refers to female patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or around 19-NOV-2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered and was diagnosed with arthralgias in her knuckles, hands, hips, and all major joints in her body. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt 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, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered/not resolved. The reporter considered the event of shingles (herpes zoster) to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered the event of herpes zoster to be disabling.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Rash
Clinical narrative: I developed a rash on both arms  right away.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No side effect reported; Per the nurse a patient was given an expired PNEUMOVAX 23 vaccine; This spontaneous report was received from a nurse and refers to an identifiable patient of unknown age and gender. No information regarding the patients pertinent medical history, concomitant therapies, drug reactions, or allergies was provided.  On 17-DEC-2020, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), lot # S005856, expiration date 03-DEC-2020 (strength, dose and route of administration were not provided) for prophylaxis. No side effects were reported. The reporter asked if they needed to revaccinate the patient or not. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S005856; expirationdate: 03-DEC-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Yes; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Lip blister, Oral discomfort, Paraesthesia, Paraesthesia oral
Clinical narrative: c/o of tingling and burning to right side of face and lips  Covid Vaccine injection was administered. Pt. She also states develop a small blister inside her lower lip.  She denies any SOB or swelling to  face and throat she states   has allergies to red dyes  and  has a hx. of DM, HTN, Anemia and breast CA. VS were taken BP 154/90 , 02 sat 100 %, HR 56. Pt. had some water and walked to the restroom, she stated was feeling much better, and said her husband was driving her home. BP recheck again  139/89 pulse 62, sats 100. She left via   walking without any difficulty.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: no adverse event; inappropriate schedule of vaccine administration; This spontaneous report was received from a lawyer and refers to a 66-year-old female patient. On 05-JAN-2012, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (exact dose, site and route of administration, lot# and expiration date were not reported) for prophylaxis. On 28-JAN-2013, she received another dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). On an unknown date in October 2015, the patient was vaccinated with another dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as pneumonia vaccine). No adverse event was reported.  This is one of two reports referring to the same patient.; Sender's Comments:  US-009507513-1704USA009884:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Malaise, Tremor
Clinical narrative: Patient said that she felt sick while in observation. She ended up dizzy, shaky, and a fast heart rate.  We got her to get a drink and lay down for a bit. Her initial bp was 143/107 with a heart rate of 108.  After resting for some time,  she felt back to normal.
Age: 1.0
Sex: F
Vaccine: MMR, UNK
Symptoms: Body temperature increased, Febrile convulsion, Staring, Unresponsive to stimuli
Clinical narrative: Single febrile seizure; This 12-month-old female subject was enrolled in a blinded study to Assess the Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine when Administered Concomitantly with Routine Vaccines to Healthy Infants. The subject received the 4th dose of Bexsero vs Placebo co-administered with PCV and routine vaccines (intramuscular) on 4th November 2019, for prophylaxis.   Co-suspect products included Mmr Ii for prophylaxis.   Concurrent medical conditions included upper respiratory tract infection.   On 17th November 2019 20:00, 13 days after receiving Bexsero vs Placebo co-administered with PCV and routine vaccines, the subject developed severe - grade 3 febrile seizure. Serious criteria included clinically significant/intervention required. The outcome of febrile seizure was recovered/resolved on 17th November 2019 20:03.   The investigator considered that there was no reasonable possibility that the febrile seizure may have been caused by Bexsero vs Placebo co-administered with PCV and routine vaccines.   Other possible cause(s) of the febrile seizure included concurrent medication MMR II  and medical condition upper respiratory tract infection.   INVESTIGATOR TEXT Subject reported a temperature of 100.7F in their e_Diary the evening of 17Nov2019 and then subject experienced a febrile seizure (not tonic-clonic, simply blank stare and unresponsiveness for 2 to 3 minutes). Subject did not go to the emergency room for this but did have a visit with the PCP on 18Nov2019. According to the PCP's exam, subject has an upper respiratory infection. It is not known definitively if the fever and associated febrile seizure was a result of the URI or a reaction to MMR vaccination (timing of reaction falls with in parameters of a possible reaction to MMR vaccine). - Single febrile seizure - related to - MMR II;  This case contains an event assessed by the investigator as a serious Adverse Event of Special Interest (AESI).    Additional details:  On 17th November 2019 20:00, 13 days after 1st dose of MMR II (non GSK product, taken as prophylaxis), the subject  experienced febrile seizure.; Sender's Comments: A case of Febrile convulsion, 13 days after receiving 4th dose of Bexsero vs Placebo co-administered with PCV and routine vaccines, in a 12-month-old female subject. Causal relation to the vaccine product is indeterminate, considering possible alternative etiologies (MMR administration and upper respiratory tract infection) based on medical history.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia
Clinical narrative: c/o problems swallowing despite drinking water. Sat pt in chair, VS taken and monitored. Epinephrine IM given when pt c/o problems swallowing worsening. 9-1-1 called and responded but pt declined escort to ED because he stated he was feeling better after Epi  so instead I and patient transport escorted pt to ED via wheelchair.
Sex: U
Vaccine: FLU4
Symptoms: Syringe issue, Underdose
Clinical narrative: We re-administered second doses due to those patients not receiving first vaccine / seemed to be leaking hubs; medication leaked out / ran down the patient's arm; seemed to be leaking hubs; seemed to be leaking hubs; This case was reported by a nurse and described the occurrence of exposure via skin contact in a patient who received FluLaval Tetra 2020-2021 season (batch number 2J3TT, expiry date unknown). This case was associated with a product complaint.   On an unknown date, the patient received FluLaval Tetra 2020-2021 season. On an unknown date, unknown after receiving FluLaval Tetra 2020-2021 season, the patient experienced exposure via skin contact, accidental underdose, syringe leak and pharmaceutical product complaint. On an unknown date, the outcome of the exposure via skin contact, accidental underdose, syringe leak and pharmaceutical product complaint were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter mentioned that, Flulaval prefilled syringes needle was inserted into unknown arm of patient, the user pushed on the plunger and all of the medication leaked out of the hub/luer lok and ran down the patient's arm, which led to exposure via skin contact, accidental underdose and syringe leak. Another dose was administered to the patient successfully. The prefilled syringes were pre-assembled immediately prior to administration, needles used for all suspect products were 25-gauge, 1 inch. The reporter had returned the one prefilled syringe from lot 2J3TT and syringes had the needles still attached, no known damage to the blister/carton, no damage noted to the syringe barrels. The consent to follow-up was granted. This case had been linked with US2020AMR208088, reported by the same reporter.   Follow up information was received from QA department on 30th November 2020: Conclusions of the QA statement were received as follows: GlaxoSmithKline Biologicals considered this complaint as unsubstantiated.  A customer reported a complaint which falls within the following product technical complaint category: PRTC syringe/needle connectivity issue based on the defect description. An investigation has been conducted, including review of the reported defect trends, the returned sample, the retained samples and our production records, which has demonstrated that the subject batch was produced in compliance with the applicable procedures and met all required specifications. Additionally, no deviation which could be related to the reported complaint has been identified and all of applicable verifications confirmed the conformity of the batch to specifications. Given the outcome of its investigation, GSK Biologicals considers the complaint that is the object of this report as unsubstantiated.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR208088: same reporter
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Dizziness
Clinical narrative: Dizziness occurring approximately 4 hours after receiving vaccine.  Patient presented back to vaccine clinic.  Blood pressure lower than patient's reported normal blood pressure.   Close monitoring by nurse.  Blood pressure increased during monitoring period.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Vaccine recipient reported experiencing numbness, tingling of the arm after receiving the COVID-19 vaccine. Vaccine recipient thinks that the vaccinator most likely hit a nerve when administering the vaccine. The vaccine recipient went to the emergency department for further evaluation. The vaccine recipient was monitored, felt better, and was discharged to home subsequently the same day. On Monday, I called the vaccine recipient to follow-up and they report that they no longer have the numbness or tingling.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Not feeling well; This case was reported by a other health professional via other manufacturer and described the occurrence of feeling unwell in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis. Concomitant products included tofacitinib citrate (Xeljanz Xr).   On 24th November 2020, the patient received Shingles vaccine. In November 2020, less than a week after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional details were details provided as follows: The age at the vaccination was not reported. The age group was selected as an adult as per vaccine indication. Patient reported had shingles shot and was not feeling well.  Patient was back on Xeljanz with samples from medical doctor office until funding paperwork by medical doctor was completed.  Patient stated missed approximately 2 weeks of Xeljanz due to copay issues, no relapse in symptoms reported. Medical doctor was aware of this only information received from patient.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pyrexia, Respiratory tract congestion
Clinical narrative: Developed fever , cough, congestion 1 day after vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Got a red bump; red bump; This case was reported by a other health professional via interactive digital media and described the occurrence of local swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced local swelling and erythema. On an unknown date, the outcome of the local swelling and erythema were unknown.   It was unknown if the reporter considered the local swelling and erythema 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 the vaccine indication. The patient got a red bump two weeks after Shingrix vaccine.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: 12/16/2020 I had a fever at night I woke up with fever and chills and body aches and I also had a pretty bad headache,  it lasted throughout the next day 12/17 I took tylenol and just felt tired, my headache was also off and on it just depended when I took tylenol
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were received as follows: The patient has fever after getting Shingrix approximately 14 hours ago from the reporting. The reporter was asking, was there a safe medicine he can take to bring down the fever.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear pruritus, Nausea, Paraesthesia, Pruritus
Clinical narrative: Patient felt some dizziness 15min post vaccination, itchiness behind both ears, some nausea, tingling feeling all over body. Pt denies worsening of symptoms 10 minutes later, reports itchiness behind ears feeling slightly better. Does report an area on abdomen feeling itchy as well as random spots on both legs. Pt agreed to 50mg of Diphenhydramine, tabs, PO 20 minutes after first sx developed. Lot# 205355, exp. 05/2023, NDC 0904-5306-61. Patient was monitored for an extra 15 minutes post medication, was feeling better and had her husband outside waiting for her to drive her home. Advised to continue to monitor sx and call PCP with new sx or for emergent sx, go to ED. Patient denied trouble breathing, chest pain/tightening, trouble swallowing throughout whole event.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: Suspected vaccination failure; Patient got the flu after getting the shot; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had one and only flu shot and it was not as bad as what the other person went through, but the patient did get the flu after getting the shot.  The patient then decided to never take the vaccine again because they believed that they were filled with things that ppl would otherwise, never put in their bodies. This case was considered as suspected vaccination failure as the exact time to onset and confirmation of lab test was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing
Clinical narrative: Flushing and lightheadedness
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Feeling hot, Palpitations, Vision blurred
Clinical narrative: Patient became dizzy, vital signs -10:32 am  162/101, P-96, sat 98% on room air, hot clammy, blurry vision, heart palpitations, repeat vitals 1036- 171/102 P-85 sat 98% on room air, transferred to Emergency Room 10:43 am
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dupuytren's contracture
Clinical narrative: Patient developed fibrous tissue on both hands  3 days after receiving vaccine and was informed by Physician assistant it  was Dupuytren Contracture.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Malaise, Vaccination failure
Clinical narrative: Suspected vaccination failure; Seldom get flu; feel sick; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza and feeling unwell. On an unknown date, the outcome of the vaccination failure and influenza were unknown and the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, influenza and feeling unwell to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were received as follows: The age at vaccination was not reported. The patient received flu, I have had a flu shot in the past just made me feel sick for 3 to 4 days.  This case was considered as suspected vaccination failure as time to onset, and laboratory confirmation test were unknown at the time of reporting.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Balance disorder, Fall, Upper limb fracture
Clinical narrative: Possible syncope event after vaccine on 12/18/2020. Patient fell when exiting the store. She appears to have lost her balance when reaching for the wall/door to help stabilize her. Could have been due to her Parkinson's disease. She fell and the ambulance was called but disregarded and taken to the clinic instead by caregiver.  She did not complain of shortness of breath or loss of consciousness. Only her pain in her arm. A broken arm was confirmed by the caregiver on 12/21/2020.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Computerised tomogram normal, Magnetic resonance imaging normal, Mobility decreased, Musculoskeletal disorder
Clinical narrative: Thursday night at around 11pm I lost control of my right arm. Friday I spent the day in Urgent Care doing CT scans and MRI scans of my brain and body and also did some blood work. All test came back negative. It is now Monday the 21st and the mobility in my right arm is extremely limited and I am slowly regaining the use of my right arm.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Hypoaesthesia, Magnetic resonance imaging, Musculoskeletal disorder
Clinical narrative: Thursday night at around 11pm I lost control of my right arm. Friday I spent the day in Urgent Care doing CT scans and MRI scans of my brain and body and also did some blood work. All test came back negative. It is now Monday the 21st and the mobility in my right arm is extremely limited and I am slowly regaining the use of my right arm.
Sex: F
Vaccine: FLU4
Symptoms: Accidental underdose, Product complaint, Syringe issue
Clinical narrative: Because of the leakage, the patient did not receive a full dose of the vaccination; Syringe leak; vaccine was leaking between the Leur Lock and the syringe; This case was reported by a nurse via sales rep and described the occurrence of accidental underdose in a 55-year-old female patient who received FluLaval Tetra 2020-2021 season (batch number 55R79, expiry date 30th June 2021). This case was associated with a product complaint.   On an unknown date, the patient received FluLaval Tetra 2020-2021 season. On an unknown date, unknown after receiving FluLaval Tetra 2020-2021 season, the patient experienced accidental underdose, syringe leak and pharmaceutical product complaint. On an unknown date, the outcome of the accidental underdose, syringe leak and pharmaceutical product complaint were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The FluLaval vaccine was leaking between the Leur lock and the syringe, which led to syringe leak and pharmaceutical product complaint. Because of the leakage, the patient did not receive a full dose of the vaccination and the employee would need to be re-vaccinated, which led to accidental underdose. This occurred right before administration. The nurse confirmed that the office was using a 25-gauge needle and there was no damage to the carton evident. The needle was still attached to the syringe and was available for return to GSK. There was no damage or breakage to the syringe barrel. The syringe was pre-assembled with the needle right before administration. GSK to credit their wholesaler account for one dose of the FluLaval Quadrivalent vaccine. The reporter consented to follow up.   Follow up information was received from QA department on 30th November 2020: Conclusions of the QA statement were received as follows: GlaxoSmithKline Biologicals considered this complaint as unsubstantiated.  A customer reported a complaint which falls within the following product technical complaint category: PRTC syringe/needle connectivity issue based on the defect description. An investigation has been conducted, including review of the reported defect trends, the returned sample, the retained samples and our production records, which has demonstrated that the subject batch was produced in compliance with the applicable procedures and met all required specifications. Additionally, no deviation which could be related to the reported complaint has been identified and all of applicable verifications confirmed the conformity of the batch to specifications. Given the outcome of its investigation, GSK Biologicals considers the complaint that is the object of this report as unsubstantiated.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: Weakness; fatigue lasting about 1 hour.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: "felt like throat scratching"
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Lip swelling, Swelling face
Clinical narrative: One hour post vaccination my top lip felt tight. On inspection my buccal mucosa of my top and bottom lips were swollen greater on the top lip.  My soft palate felt numb as well as my tongue from the tip to middle.  My nose was also slightly swollen.  24 hours later the I have a slight swelling of areas mentioned with the exception of my nose.   I was instructed to take Benadryl on the day of the event 25mg  x 2 doses.   the day after 12/21 I was given Claritin 10mg x 1 dose and Famatodine 20mg x 1 dose by mouth.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperaesthesia, Injection site pain, Pyrexia
Clinical narrative: 1) while taking 2 naproxin sodium every 12 hours: reasonably high fever (101-103F) with headache and skin sensitivity for two days, followed by low fever (99-100F) with headache for another day, and no fever with headache a fourth day 2) moderate localized pain in the muscle at the injection site - continuing into the 6th day
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chills, Computerised tomogram normal, Headache, Impaired work ability
Clinical narrative: The evening of 12/16 my headache begin at the next day fever of 103 stayed for 7 hrs took  administered Tylenol  exp chills, body aches, and rash on face around the eye spread to right side of nose, side went to hand area lasted from 12/17 to 12/21.The headache started effecting my neck contacted my PCP on 12/19. I went to ER on 12/19 ran tests CT scan check for clots negative, lumbar puncture and chest X-ray was fine and dint exp respiratory problems. I missed 3 days of from work 12/9 to 12/21.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lumbar puncture normal, Pain, Pyrexia, Rash, SARS-CoV-2 test negative
Clinical narrative: The evening of 12/16 my headache begin at the next day fever of 103 stayed for 7 hrs took  administered Tylenol  exp chills, body aches, and rash on face around the eye spread to right side of nose, side went to hand area lasted from 12/17 to 12/21.The headache started effecting my neck contacted my PCP on 12/19. I went to ER on 12/19 ran tests CT scan check for clots negative, lumbar puncture and chest X-ray was fine and dint exp respiratory problems. I missed 3 days of from work 12/9 to 12/21.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Headache, Pain
Clinical narrative: Day after the vaccine I had body aches, fatigue , headache  and temp of 101.5
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Rash, Rash erythematous, Rash pruritic
Clinical narrative: itching red rash front of her leg under the knee; itching red rash front of her leg under the knee; burning sensation continues; This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 91-year-old female patient who received Herpes zoster (Shingrix) (batch number 924T3, expiry date 3rd June 2022) for prophylaxis.   On 19th November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced burning sensation. On 21st November 2020, the patient experienced itchy rash and red rash. The patient was treated with hydrocortisone (Hydrocortisone Cream). On 23rd November 2020, the outcome of the itchy rash and red rash were recovered/resolved. On an unknown date, the outcome of the burning sensation was not recovered/not resolved.   It was unknown if the reporter considered the itchy rash, red rash and burning sensation to be related to Shingrix.  Additional details were provided as follows: The patient received first dose on 19th November 2020 early afternoon and on saturday night, 21st November 2020 she started with a itching red rash front of her leg under the knee. At the time of reporting, the itching improved but the burning sensation was continued. The reporter consented to follow-up.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face, Swelling of eyelid, Swollen tongue
Clinical narrative: Patient had swelling of tongue 45-60 minutes after vaccination.   Received PO benadryl.  Had eyelid and facial swelling requiring IV Solu-medrol.   Monitored for short period of time in emergency department and released.  No further symptoms.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th November 2020, the patient received the 2nd dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced injection site pain. In November 2020, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported.  The patient had received the a dose of Shingrix vaccine, unknown arm and he had soreness at the injection site which has resolved. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020236518:same reporter
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Sore arm, could not sleep on it about 8-10 hour post vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder
Clinical narrative: Loss of balance; This case was reported by a pharmacist via call center representative and described the occurrence of loss of balance in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number CL335, expiry date unknown) for prophylaxis.   On 29th October 2020, the patient received the 1st dose of Shingrix. On 2nd November 2020, 4 days after receiving Shingrix, the patient experienced loss of balance. On an unknown date, the outcome of the loss of balance was unknown.   It was unknown if the reporter considered the loss of balance to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported.  The patient developed loss of balance within the first week after receiving the first dose of Shingrix, exact date or number of days was not specified. The reporter consented to follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Spontaneous hives on face, Associate does have a hx of spontaneous hives and has been seen by allergist. Had an episode in January, February, May and October of spontaneous hives. Hives noted 5.5 after vaccine and about 1.5 hours after taking Advil
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Injection site pain, Myalgia
Clinical narrative: She was sore  at injection site later on day of injection (12/20) that developed into whole body muscle aches the next day (12/21). She also reported a cough started on 12/20 and this has persisted and slight Shortness of breath started 12/20 that has become worse today 12/21 where if she is moving around she needs to stop and take a few breaths.  She denied any feeling of life threatening shortness or breath or need to go to ER.  She has been instructed to contact employee health prior to coming back to work given cough/SOB not typically a reaction to vaccine.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Bedridden, Chills, Distractibility, Dizziness
Clinical narrative: her head got under so much pressure / felt like it was going to blow up.; dizzy and very distracted with the head pressure; very distracted with the head pressure; blood vessel in her nose burst in her nostril; spent 5 days in bed; spent 5 days in bed with fever; chills; feeling like she had the flu; side effects including / respiratory; Her lung / hurt.; body hurt.; had a headache; was worried / to have a stroke because her brother had a stroke years ago.; This case was reported by a consumer via call center representative and described the occurrence of head pressure in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (family history) and family history of seizure.   On 24th June 2020, the patient received the 1st dose of Shingrix (intramuscular). On 24th June 2020, less than a day after receiving Shingrix, the patient experienced head pressure, dizziness, distractibility, vascular rupture, bedridden, fever, chills, influenza like illness, respiratory symptom, pulmonary pain, general body pain, headache and strength loss of. On an unknown date, the outcome of the head pressure, dizziness, distractibility, vascular rupture, bedridden, fever, chills, influenza like illness, respiratory symptom, pulmonary pain, general body pain, headache and strength loss of were recovered/resolved.   It was unknown if the reporter considered the head pressure, dizziness, distractibility, vascular rupture, bedridden, fever, chills, influenza like illness, respiratory symptom, pulmonary pain, general body pain, headache and strength loss of to be related to Shingrix.  Additional details were received as follows: After vaccination with Shingrix, within 20 minutes the patient headed towards home and her head got under so much pressure that it felt like it was going to blow up. The patient was dizzy and very distracted with the head pressure.  The blood vessel in her nose burst in her nostril.  She spent 5 days in bed with a fever, chills and everything we list as side effects including feeling like she had the flu, respiratory and fever with chills, lung and body hurt.  The patient was worried that she was going to have a stroke because her brother had a stroke years ago.  She had a headache and two weeks later everything resolved and she got her strength back.  She was wondering at the time if her symptoms were COVID related but she was not exposed to anyone and was very careful. The reporter consented to follow up.