chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 pneumonia, Vaccination failure
Clinical narrative: COVID-19 PNEUMONIA; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via a company representative concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker. The patient had no underlying condition. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: unknown) 0.5 ml, 1 total administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-JUL-2021, the patient had exposure to COVID-19. On 07-JUL-2021, the patient had suspected clinical vaccination failure, he started to have symptoms. He was taken to the emergency room and was admitted to the hospital on 13-JUL-2021. The patient had COVID-19 pneumonia with very low oxygen levels and a terrible cough. He was fighting for his life. On 07-JUL-2021, the  experienced suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid-19 pneumonia, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint 90000186453. The suspected product quality complaint has been confirmed not to be voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0- 20210741011-Covid-19 vaccine ad26.cov2.S- Covid-19 Pneumonia. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20210741011- Covid-19 vaccine ad26.cov2. Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Dysphagia, Dyspnoea, Throat tightness
Clinical narrative: Sudden tightness in throat , tongue swole and hard to breathe, , pharmacist used epi pen and then patient went to ER, the next day after pt was prescribed  prednisone and fingers became numb and tingly .  2nd ER visit.  pt also has had reaction to peanut butter never had reaction before.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dyspnoea, Food allergy, Hypoaesthesia, Paraesthesia
Clinical narrative: Sudden tightness in throat , tongue swole and hard to breathe, , pharmacist used epi pen and then patient went to ER, the next day after pt was prescribed  prednisone and fingers became numb and tingly .  2nd ER visit.  pt also has had reaction to peanut butter never had reaction before.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue, Throat tightness
Clinical narrative: Sudden tightness in throat , tongue swole and hard to breathe, , pharmacist used epi pen and then patient went to ER, the next day after pt was prescribed  prednisone and fingers became numb and tingly .  2nd ER visit.  pt also has had reaction to peanut butter never had reaction before.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: positive covid19 test after full vaccination
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13, COVID19
Symptoms: Dyspnoea, Pharyngeal swelling, Rash
Clinical narrative: 30 mins after vax swelling in throat, trouble swallowing  lasting a few hours, sore arm , rash at site of vax, arm swelling
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13, COVID19
Symptoms: Anaphylactic reaction, Dysphagia, Injected limb mobility decreased, Injection site pain, Injection site rash
Clinical narrative: 30 mins after vax swelling in throat, trouble swallowing  lasting a few hours, sore arm , rash at site of vax, arm swelling
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13, COVID19
Symptoms: Injection site vesicles, Pharyngeal swelling, Rash papular, Swelling face
Clinical narrative: 30 mins after vax swelling in throat, trouble swallowing  lasting a few hours, sore arm , rash at site of vax, arm swelling
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13, COVID19
Symptoms: Dysphagia, Injection site rash, Injection site swelling, Pain in extremity, Pharyngeal swelling
Clinical narrative: 30 mins after vax swelling in throat, trouble swallowing  lasting a few hours, sore arm , rash at site of vax, arm swelling
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Bone pain, Chills, Decreased appetite
Clinical narrative: Severe migraine , full body joint /bone pain, extreme fatigue,  Chills so severe resembled causing  strong shivering. Chills followed by severe sweating . Unable to sleep due to these symptoms . Had intermittent episodes of lightheaded ness .  Loose stooling . No appetite . These symptoms went on for 3days starting morning of day after vaccine . The left arm was  also very painful for 5 days . Temperature at highest point 100.8. Pre-treated prior to vaccine with Claritin took 2 hrs prior because of history with reaction to flu vaccine years ago from multi vial .  Treated chills with Tylenol 325mg as needed. Took Ibuprofen prn for joint pain.  Treated migraine with 1dose of Excedrin  which did not take the headache away.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Hyperhidrosis, Migraine
Clinical narrative: Severe migraine , full body joint /bone pain, extreme fatigue,  Chills so severe resembled causing  strong shivering. Chills followed by severe sweating . Unable to sleep due to these symptoms . Had intermittent episodes of lightheaded ness .  Loose stooling . No appetite . These symptoms went on for 3days starting morning of day after vaccine . The left arm was  also very painful for 5 days . Temperature at highest point 100.8. Pre-treated prior to vaccine with Claritin took 2 hrs prior because of history with reaction to flu vaccine years ago from multi vial .  Treated chills with Tylenol 325mg as needed. Took Ibuprofen prn for joint pain.  Treated migraine with 1dose of Excedrin  which did not take the headache away.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Severe migraine , full body joint /bone pain, extreme fatigue,  Chills so severe resembled causing  strong shivering. Chills followed by severe sweating . Unable to sleep due to these symptoms . Had intermittent episodes of lightheaded ness .  Loose stooling . No appetite . These symptoms went on for 3days starting morning of day after vaccine . The left arm was  also very painful for 5 days . Temperature at highest point 100.8. Pre-treated prior to vaccine with Claritin took 2 hrs prior because of history with reaction to flu vaccine years ago from multi vial .  Treated chills with Tylenol 325mg as needed. Took Ibuprofen prn for joint pain.  Treated migraine with 1dose of Excedrin  which did not take the headache away.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Aspiration joint
Clinical narrative: flare of auto immune arthritis that has been difficult to control since vaccine
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Type 1 diabetes mellitus
Clinical narrative: beginning approximately 48 hours after dose 1, insulin requirements increased to more than 200% of usual doses administered by insulin pump.  There were multiple occasions the patient needed to supplement coverage by insulin pen/syringe to maintain usual 'time in range'.  This situation continued until approximately 15 July 2021.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Immediate post-injection reaction, Joint range of motion decreased, Pain, Product administered at inappropriate site
Clinical narrative: Patient reported immediate pain after injection and suspects SIRVA (shoulder injury after recent vaccine administration). The vaccine was administered high in the deltoid (almost to the divot just under the shoulder). Patient has been experiencing shoulder pain and limited range of motion on the left shoulder from time of vaccination to present (currently 18 days). For example, even small motions such as reaching for the turn signal can cause a jolt of pain.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: Patient reported immediate pain after injection and suspects SIRVA (shoulder injury after recent vaccine administration). The vaccine was administered high in the deltoid (almost to the divot just under the shoulder). Patient has been experiencing shoulder pain and limited range of motion on the left shoulder from time of vaccination to present (currently 18 days). For example, even small motions such as reaching for the turn signal can cause a jolt of pain.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Neck pain, Swelling
Clinical narrative: NECK SWELL UP AND NEVER WENT DOWN. NECK GETS REAL SORE WHEN I EXERCISE. LIGHT HEADED ON AND OFF.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Pityriasis rosea
Clinical narrative: Pityriasis Rosea, which began several days to weeks after the vaccine with one spot on the right leg/ankle. Weeks later it developed and spread across body from top of neck to groin area with some lighter occurrences of plaques on arms and legs. Patient's sister developed the same reaction of pityriasis rosea on about the same timeline after her covid vaccinations.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Within a short amount of time after my 2nd Pfizer shot, my lymph node under my right arm swelled like a softball. Over the course of time, the swelling went down, but now I have what feels like another lymph node there... so there are two?
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Joint range of motion decreased, Pain in extremity
Clinical narrative: THE PATIENT EXPERIENCED IMMEDIATE PAIN AFTER THE INJECTION HIGH IN THE LEFT DELTOID (IN THE DIVOT AT THE SHOULDER JOINT). PATIENT ALSO EXPERIENCED LIMITED RANGE OF MOTION IN THE SHOULDER. PAIN AND LIMITED RANGE OF MOTION LASTED 5 DAYS, THEN GOT BETTER ON ITS OWN WITHOUT THE NEED FOR MEDICATION.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Breast enlargement, Mammogram normal
Clinical narrative: Bilateral breast enlargement.  Have gone from an A to B cup.  No nodes felt under arms. No nodes felt in either breast.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever 103, chest pain, body ache, arm pain
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test normal, Cough, Dizziness, Dyspnoea
Clinical narrative: continues cough, heavy body pain ,shortness of breath, dizziness, low blood pressure, high heart rate, pain full boils on body, sore throat,
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Furuncle, Heart rate increased, Hypotension, Laboratory test normal, Monoplegia
Clinical narrative: continues cough, heavy body pain ,shortness of breath, dizziness, low blood pressure, high heart rate, pain full boils on body, sore throat,
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Pain, SARS-CoV-2 test negative
Clinical narrative: continues cough, heavy body pain ,shortness of breath, dizziness, low blood pressure, high heart rate, pain full boils on body, sore throat,
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body height, Breast mass, Headache, Heavy menstrual bleeding, Limb discomfort
Clinical narrative: left  hand pain , I had body pain , hand was heavy , limp nods on both of my shoulders just below my ears (on the collar bone)  , heavy overflowing Menstrual cycle , lump in my left breast.  headach
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Ultrasound scan
Clinical narrative: left  hand pain , I had body pain , hand was heavy , limp nods on both of my shoulders just below my ears (on the collar bone)  , heavy overflowing Menstrual cycle , lump in my left breast.  headach
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Fatigue, Headache, Nausea
Clinical narrative: Headache, nausea, fatigue and chills. About 8 hours she took medicine and fell asleep. She said she was just overall uncomfortable and doesn?t want to get her 2nd dose.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, COVID-19, Cough, Fatigue, Impaired work ability
Clinical narrative: I began to be tired and fatigue the day after the vaccine. I had to take the day off work. I returned back to work on 7/16 for the entire day. Unfortunately I came home and felt tired so slept. That evening I went out with my family for dinner and noticed I couldn?t taste the food. Then in the morning I woke up with severe body aches. I struggled to get out of bed and move around as my body would cramp.  I was able to move somewhat and tried to shake it off. Then the Sunday 7/18 towards afternoon I began a fever and slight cough. I stayed home and ended up sleeping. I woke up for work Monday and about half way through work day my body started to crash. I began vomiting at work, my fever temp spiked dramatically and I had to make my way home immediately. I went and taken a shower and tried to lay down and keep upright. I eventually got fatigued and slept. When I woke the cough/fever and body aches were bad. I decided to check myself into urgent care. They tested me for covid and I was positive. They asked me to quarantine and I did but the next 5 days were the hardest days I?ve had probably ever.  The 5th day I decided to either go back to urgent care and ER as my condition was severe. I went back to  urgent care. The doctor said my o2 level was very low and I had lost 23 lbs since the vaccine. I asked him for something strong and he gave me steroids and a very strong Cough suppression which I?ve been taking and has brought down the symptoms. Ive worked in hospitals pre covid. I never get sick, had not even a fever or Temp and then I get the first dose phifzee and end up almost going into the ER and testing positive with covid.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Muscle spasms, Oxygen saturation decreased, Pain, Pyrexia
Clinical narrative: I began to be tired and fatigue the day after the vaccine. I had to take the day off work. I returned back to work on 7/16 for the entire day. Unfortunately I came home and felt tired so slept. That evening I went out with my family for dinner and noticed I couldn?t taste the food. Then in the morning I woke up with severe body aches. I struggled to get out of bed and move around as my body would cramp.  I was able to move somewhat and tried to shake it off. Then the Sunday 7/18 towards afternoon I began a fever and slight cough. I stayed home and ended up sleeping. I woke up for work Monday and about half way through work day my body started to crash. I began vomiting at work, my fever temp spiked dramatically and I had to make my way home immediately. I went and taken a shower and tried to lay down and keep upright. I eventually got fatigued and slept. When I woke the cough/fever and body aches were bad. I decided to check myself into urgent care. They tested me for covid and I was positive. They asked me to quarantine and I did but the next 5 days were the hardest days I?ve had probably ever.  The 5th day I decided to either go back to urgent care and ER as my condition was severe. I went back to  urgent care. The doctor said my o2 level was very low and I had lost 23 lbs since the vaccine. I asked him for something strong and he gave me steroids and a very strong Cough suppression which I?ve been taking and has brought down the symptoms. Ive worked in hospitals pre covid. I never get sick, had not even a fever or Temp and then I get the first dose phifzee and end up almost going into the ER and testing positive with covid.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Vomiting, Weight decreased
Clinical narrative: I began to be tired and fatigue the day after the vaccine. I had to take the day off work. I returned back to work on 7/16 for the entire day. Unfortunately I came home and felt tired so slept. That evening I went out with my family for dinner and noticed I couldn?t taste the food. Then in the morning I woke up with severe body aches. I struggled to get out of bed and move around as my body would cramp.  I was able to move somewhat and tried to shake it off. Then the Sunday 7/18 towards afternoon I began a fever and slight cough. I stayed home and ended up sleeping. I woke up for work Monday and about half way through work day my body started to crash. I began vomiting at work, my fever temp spiked dramatically and I had to make my way home immediately. I went and taken a shower and tried to lay down and keep upright. I eventually got fatigued and slept. When I woke the cough/fever and body aches were bad. I decided to check myself into urgent care. They tested me for covid and I was positive. They asked me to quarantine and I did but the next 5 days were the hardest days I?ve had probably ever.  The 5th day I decided to either go back to urgent care and ER as my condition was severe. I went back to  urgent care. The doctor said my o2 level was very low and I had lost 23 lbs since the vaccine. I asked him for something strong and he gave me steroids and a very strong Cough suppression which I?ve been taking and has brought down the symptoms. Ive worked in hospitals pre covid. I never get sick, had not even a fever or Temp and then I get the first dose phifzee and end up almost going into the ER and testing positive with covid.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: Shortly after receiving COVID vaccine, I got pregnant.  I suffered a miscarriage on Jun 28th 2021.   I was approximately 7 weeks pregnant.  The date of my last period before pregnancy was May 11, 2021.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: "COVID Arm": Itchy, red, swollen, firm circular area around shot area. Originally occurred DAY OF shot, lasted 2 days and went away. Suddenly resurfaced 8 days later. Appox 3 inches in diameter. No other symptoms.  Ibuprofen taken for discomfort/heat of area. No other treatment.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster activation-shingles. I went to hospital and they gave me antivirals
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE reported; The patient received one dose of GARDASIL 9, which was administered on 07AUG2019.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not provided.   On 07-AUG-2019, the patient received one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml, lot # 1602281 has been verified to be valid, expiration date not reported, but upon internal validation established as 21-JUL-2021; strength and route were unknown) for prophylaxis.   The patient did not complete the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) series (inappropriate schedule of product administration). No additional information was provided. No additional AE was reported. No PQC. 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: 1602281; expirationdate: 21-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events; an expired dose of GARDASIL 9 was administered to a patient; This spontaneous report was received from a healthcare worker (also reported: vaccine coordinator) referring to a 12 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 09-JUL-2021 the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R029515, expiration date 08-JUL-2021, 0.5 milliliter; route was not reported) for prophylaxis (expired product administered). This dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was found supported by memo with no temperature excursion. No additional adverse events were reported. 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: R029515; expirationdate: 08-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: M
Vaccine: FLU3, FLU3, VARZOS
Symptoms: Disability, Gait inability, Walking aid user
Clinical narrative: Unable to walk/he patient developed a serious cannot walk yet without walker.; This spontaneous report was received from a consumer, via Sanofi, and refers to a male patient who would be 76-years-old at the time of this report. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions, or allergies.  On an unknown date, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) as prophylactic vaccination (prophylaxis) (concentration, dose number, vaccination scheme frequency, route and anatomical site of administration, lot number and expiration date were not provided).  On an unspecified date, the patient was vaccinated with a dose of influenza vaccine inact split 3v (FLUZONE HIGH DOSE) suspension for injection in pre-filled syringe as prophylactic vaccination (concentration, dose number, vaccination scheme frequency, route and anatomical site of administration, lot number and expiration date were not provided).  On an unknown date, he was also vaccinated with a dose of influenza vaccine inact sag 3v (FLUVIRINE) as prophylactic vaccination (concentration, dose number, vaccination scheme frequency, route and anatomical site of administration, lot number and expiration date were not provided).  On an unspecified date, the patient experienced (reported as "developed") been unable to walk yet without a walker (Gait inability).   If any lab diagnostics or studies were performed this information was not provided. Additionally, it was not reported if the patient received a corrective treatment for the events.  The outcome of the event was unknown. The causal relationship between zoster vaccine live (ZOSTAVAX) and the event was not reported. Information regarding the other suspect vaccines also was not provided.  Gait inability was considered to be medically significant that leaded to disability by the reporter.
Age: 51.0
Sex: M
Vaccine: HEPA
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: No side effects; HAV adult administered on 07-AUG-2000 and 08-JUN-2002; This spontaneous report was received from a lawyer concerning a 53-year-old male patient.  His concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported.  On 07-AUG-2000, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (manufacturer unknown) as prophylaxis (dose, dosage schedule, lot number, frequency, route and site of administration were not reported). On 08-JUN-2002, the patient was revaccinated with Hepatitis A Vaccine, Inactivated (manufacturer unknown) as prophylaxis (dose, dosage schedule, lot number, frequency, route and site of administration were not reported). No side effects were reported.   On 28-SEP-2009, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). On 14-FEB-2014, the patient was revaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (captured in MARRS # 2107USA007285). Also that date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) and subsequently experienced shingles, vaccination failure along with other events (captured in MARRS # 1809USA008171).; Sender's Comments:  US-009507513-1809USA008171: US-009507513-2107USA007286:
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Herpes zoster, No adverse event, Vaccination failure
Clinical narrative: No side effects; PPSV23 vaccine administered on 28-SEP-2009, 14-FEB-2014 and 30-OCT-2019; This spontaneous report was received from a lawyer concerning a 64-year-old male patient.  His concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported.  On 07-AUG-2000, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (manufacturer unknown) and revaccinated on 08-JUN-2002 (captured in MARRS # 2107USA007285).  On 28-SEP-2009, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) as prophylaxis (dose, dosage schedule, lot number, frequency, route and site of administration were not reported). On 14-FEB-2014, the patient was revaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) as prophylaxis (dose, dosage schedule, lot number, frequency, route and site of administration were not reported) (inappropriate schedule of vaccine administered).   Also that date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) and subsequently experienced shingles, vaccination failure along with other events (captured in MARRS # 1809USA008171).  On 30-OCT-2019, the patient was again revaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) as prophylaxis (dose, dosage schedule, lot number, frequency, route and site of administration were not reported). No adverse effects were reported for any of the pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) vaccinations.; Sender's Comments:  US-009507513-1809USA008171: US-009507513-2107USA007285:
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: first twenty four hours it's really painful. It diminishes after that; This case was reported by a consumer via media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and in first twenty four hours its really painful and it diminishes after that. In two or in less than six months the patient needs to get second shot.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: do they hurt!! Worst shots I've ever had; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and its hurts. The reporter stated that the patient might want to check to see if need a booster.  The patient added that, these were worst shots but better than getting shingles and it was a newer vaccine and was supposed to be much more effective than the previous shingles vaccine.  The reporter advises taking Tylenol or something like it before. For tolerances of 2nd dose, refer case US2021AMR156335, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR156335:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had shingles / had the shingles vacine/Suspected vaccination failure; shingles / doctors told me to wait 1 year and get a boster 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 Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient said that double check, you could get shingles more than once.  The patient sated he/she had Shingles a few months ago from reporting date, the doctors told to wait 1 year and get a booster shot, the patient had the shingles vaccine, so did not get it nearly as bad as most people. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Accidental underdose
Clinical narrative: vaccine came out of the sides; This case was reported by a other health professional via interactive digital media and described the occurrence of accidental underdose in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional details were provided are as follows: The age at vaccination was not reported. It was reported that the Intern (unspecified) administered 1st dose of Shingrix vaccine to the patient and upon administering the vaccine, syringe failed and some of the vaccine came out of the sides where the needle was screwed into the syringe, which led accidental underdose. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: reconstituted Shingrix with other non GSK diluent; reconstituted Shingrix with other non GSK diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number L55HS, expiry date 10th October 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional case details were reported as follows: The reporter was a medical assistant. The age at vaccination was not reported. The nurse reconstituted Shingrix with other non-GlaxoSmithKline diluent and gave it to the patient which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. There was no information about the patient involved at the moment of the reporting or day of occurrence. The reporter need time to gather all these details. The reporter consented to follow up by email.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose / on an unknown date (more than six months ago); This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date more than 6 months ago).   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 had not yet received second dose of Shingrix, which led to incomplete course of vaccination. The reporter consented follow up. This case has been linked with case US2021153987 by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021153987:Same reporter
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Prophylaxis, Rash, Rash pruritic
Clinical narrative: itchy rash on Right side back/chest area; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th July 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th July 2021, 4 days after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was not recovered/not resolved.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional detail were provided are as follows: The case was reported by reporter for herself. The patient received dose of Shingrix in left arm and developed an itchy rash on right side back /chest area. Education provided per Shingrix frequently ask questions (FAQ) and PI. The patient was referred to Health care professional. MI department phone number was provided. The reporter did not consented to follow up.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Chest pain, Herpes zoster, Inappropriate schedule of product administration, Pain
Clinical narrative: the pain continues.; rash; first dose /October 21st 2019 /second dose/July 14th 2020/ Shingles/April 28th 2021/suspected vaccination failure; Shingles; first dose /October 21st 2019 /second dose/July 14th  2020; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 14th July 2020, the patient received the 2nd dose of Shingrix. On 21st October 2019, the patient received the 1st dose of Shingrix. On 14th July 2020, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long. On 28th April 2021, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain and rash. On an unknown date, the outcome of the vaccination failure and drug dose administration interval too long were unknown and the outcome of the shingles and rash were recovered/resolved and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and rash to be related to Shingrix and Shingrix.  Additional details were reported as follows: The case was reported by the patient. The patient reported getting his 1st dose and 2nd dose of Shingrix vaccine in right arm.  Reporter stated that he just got the vaccine later than recommended schedule, which led to lengthening of vaccination schedule. Patient reported that he had an episode of Shingles that started on 28th April 2021. Patient stated the rash was gone but the pain continued. Patient stated the affected area was on the right side of the chest and on the right side of the back.  Patient reported he never had an episode of Shingles before the vaccine. Lot and expiration dates were unknown for both doses. The reporter consented to follow up. The reporter consent to follow up with health care professional (HCP). This case was considered as suspected vaccination failure as details regarding aboratory confirmation was unknown at the time of reporting.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Vaccination failure
Clinical narrative: the pain continues.; rash; first dose /October 21st 2019 /second dose/July 14th 2020/ Shingles/April 28th 2021/suspected vaccination failure; Shingles; first dose /October 21st 2019 /second dose/July 14th  2020; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 14th July 2020, the patient received the 2nd dose of Shingrix. On 21st October 2019, the patient received the 1st dose of Shingrix. On 14th July 2020, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long. On 28th April 2021, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain and rash. On an unknown date, the outcome of the vaccination failure and drug dose administration interval too long were unknown and the outcome of the shingles and rash were recovered/resolved and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and rash to be related to Shingrix and Shingrix.  Additional details were reported as follows: The case was reported by the patient. The patient reported getting his 1st dose and 2nd dose of Shingrix vaccine in right arm.  Reporter stated that he just got the vaccine later than recommended schedule, which led to lengthening of vaccination schedule. Patient reported that he had an episode of Shingles that started on 28th April 2021. Patient stated the rash was gone but the pain continued. Patient stated the affected area was on the right side of the chest and on the right side of the back.  Patient reported he never had an episode of Shingles before the vaccine. Lot and expiration dates were unknown for both doses. The reporter consented to follow up. The reporter consent to follow up with health care professional (HCP). This case was considered as suspected vaccination failure as details regarding aboratory confirmation was unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the 1st dose / about a year and a half ago (2/1/2020) / has not received the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 1st February 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive second dose, which led to incomplete course of vaccination. The pharmacist enquired that if the patient could take the second dose. The reporter consented to follow up via postal.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: got her first dose 2 years ago / does she need to restart the schedule or just get her second dose ASAP; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 2nd January 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. The pharmacist reported that the patient received first dose 2 years ago. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination. The pharmacist enquired that the patient need to restart the schedule or get the second dose as soon as possible. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue, Prophylaxis
Clinical narrative: Antigen was reconstituted with normal saline instead of the adjuvant; Antigen was reconstituted with normal saline instead of the adjuvant; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a female patient who received Herpes zoster (Shingrix) (batch number 9ZJ25, expiry date 23rd January 2023) for prophylaxis.   On 21st July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 21st July 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were p[rovided as follows: The age at vaccination was not reported. Health care professional reported that a patient was administered the antigen was reconstituted with normal saline instead of the adjuvant, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter mentioned that, only information about the patient that was currently available was she was female. Minimal information was available from the reporter. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: LINGERING EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced lingering effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lingering effects. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Cold sweat
Clinical narrative: COLD SWEATS; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced cold sweats, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and cold sweats was not reported. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 65 year old female of unknown race and ethnicity. The patient's weight was 170 pounds, and height was 60 inches. The patient's concurrent conditions included lymphoma type b, sarcoidosis of lungs, diabetes, non alcohol user, and non smoker, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: Unknown) dose was not reported,1 total, administered on 08-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 26-MAY-2021, the patient had her blood work done and her antibody test came back negative (confirmed immunological vaccine failure). Type of antibody test was not known by patient. Laboratory data included: Antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210747864-Covid-19 vaccine ad26.cov2.s-Confirmed Immunological vaccine Failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Blood test, Muscle spasms
Clinical narrative: Bell's Palsy,  Prednisone Nightly leg cramps, sometimes both legs at once. Almost 3 weeks straight after a week of getting second shot.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Blood test, Electrocardiogram, Facial paralysis, Magnetic resonance imaging
Clinical narrative: Bells Palsy Symptoms started 2 days after vaccine, by day 4 entire right side of face paralyzed.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea, Injection site erythema, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Severe
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Laryngitis
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: pt has had laryngitis since 24 hours after first dose given-Mild, Systemic: Weakness-Mild, Additional Details: the patient did not report weakness, however to submit this report, it is requiring me to select at least one option besides other