chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Myalgia, Pain, Red blood cell sedimentation rate increased
Clinical narrative: On Sunday March 7, I experienced typical soreness and fatigue.  On Monday March 8, I started to feel muscle soreness and fatigue, primarily in my shoulders and other major muscles.  The soreness and fatigue grew progressively worse during the week, and peaked on Friday and Saturday, March 11 and 12.  On Sunday the 13th I felt somewhat better, with pain and muscle soreness primarily in my shoulders and large muscles in my legs.  The pain level has remained approximately the same since.  The pain is impacting my mobility.  Prior to the shot, I exercised on a regular basis but have not been able to exercise since.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Dizziness, Feeling hot
Clinical narrative: Patient describes feeling dizzy and hot through top of the body.  Patient had a low grade (99.8) temp and was advised by Physician to monitor temp for the next 4-6 hours. Consider a Covid test if temp goes over 100.4 degrees.   Advised Patient to rest.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: Severe headache, fever, joint pain, pain at injection site, fatigue.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cold sweat, Nausea, Pain
Clinical narrative: Body aches, joint pain, nausea and cold sweats. Used heat, massage, stretching, Tylenol & Ibuprofen. Symptoms lasted about 14 hours but eased up after about 6 hours.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Erythema, Fatigue, Peripheral swelling, Pyrexia
Clinical narrative: Arm red, inflammed, swollen with demarkation.  Low grade fevers still at day 6 after immunication.  Now feeling weak and tired along with above effecting the whole right upper arm to 1 inch distal to elbow.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Pain, Pruritus
Clinical narrative: Dizziness, extreme fatigue, body aches, nausea, diarrhea, rash/itchiness (ALL over)
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Dizziness, extreme fatigue, body aches, nausea, diarrhea, rash/itchiness (ALL over)
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Nausea, Pain, Pyrexia
Clinical narrative: Nausea, fever , body aches  , chills loss of appetite fever from 99 to 100 degrees F for over one week
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Fatigue, Headache, Injection site pain
Clinical narrative: developed fever of 100 degrees F by 3:00AM the day following the injection.  developed all over body aches, severe headache, nausea and stomach pains resulting in severe loss of appetite, and deep exhaustion.  pain and sensitivity at the injection site, but no redness or other warning symptoms listed on the handouts.  the symptoms lasted for 24 hours.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: developed fever of 100 degrees F by 3:00AM the day following the injection.  developed all over body aches, severe headache, nausea and stomach pains resulting in severe loss of appetite, and deep exhaustion.  pain and sensitivity at the injection site, but no redness or other warning symptoms listed on the handouts.  the symptoms lasted for 24 hours.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia
Clinical narrative: Muscle pain near injection site. Lasted for about 2-3 days, worst was about 36 hours after injection.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Chills, Feeling abnormal, Sleep disorder
Clinical narrative: Woke with severe chills/trembling. All body joints sore.  Temperature 99.8. Usually 96-97. Didn?t do anything figuring it would be a temporary thing. Managed to get back to sleep after about an hour. Interrupted sleep most of the night. In the morning just felt like someone severely beat my whole body. Temperature was coming down.   Now 03/22/2021 everything is back to normal.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Woke with severe chills/trembling. All body joints sore.  Temperature 99.8. Usually 96-97. Didn?t do anything figuring it would be a temporary thing. Managed to get back to sleep after about an hour. Interrupted sleep most of the night. In the morning just felt like someone severely beat my whole body. Temperature was coming down.   Now 03/22/2021 everything is back to normal.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: no adverse event to report---administration error only. Patient needed to be 18 yrs old to receive vaccine.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Raised red patch at injection sight. Very warm to touch and itchy. By 7:30am on 3/22/21 site become more red and inflamed and itchy. By noon on 3/22/21 redness and swelling has gone down but still very itchy.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Raised red patch at injection sight. Very warm to touch and itchy. By 7:30am on 3/22/21 site become more red and inflamed and itchy. By noon on 3/22/21 redness and swelling has gone down but still very itchy.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: 1/14 vaccination. Later that evening, into 1/15, I woke up and I was sweating. Took temp; 100.6. Chills. HA. I went back to sleep, woke up to very bad HA. I took prescribed meds for HA. Achy, nauseated.  1/15 afternoon, I contacted Neurologist. Took the fioricet didn't work. Took the 230-3pm, I took Ketorolac on advising from Neurologist.  1/18 Neurologist sent over the Norco script;  1/20 went to see Neurologist. HA was gone. But still not feeling 100%. Dr. did want 2nd vaccine due to my job and exposure is high risk.  2 days before 2nd vaccine Neurologist advised to take Frovatriptan 2.5 mg. HA only lasted 2 days.  *COVID + 11/11/2020
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, SARS-CoV-2 test positive
Clinical narrative: 1/14 vaccination. Later that evening, into 1/15, I woke up and I was sweating. Took temp; 100.6. Chills. HA. I went back to sleep, woke up to very bad HA. I took prescribed meds for HA. Achy, nauseated.  1/15 afternoon, I contacted Neurologist. Took the fioricet didn't work. Took the 230-3pm, I took Ketorolac on advising from Neurologist.  1/18 Neurologist sent over the Norco script;  1/20 went to see Neurologist. HA was gone. But still not feeling 100%. Dr. did want 2nd vaccine due to my job and exposure is high risk.  2 days before 2nd vaccine Neurologist advised to take Frovatriptan 2.5 mg. HA only lasted 2 days.  *COVID + 11/11/2020
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: 14 hours after shot, mild headache began. Headache lasted for 12 hours. Also at 16 hours post shot, I had severe chills that lasted for approx 30 min.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Nausea, Night sweats
Clinical narrative: Friday 3/19 7:30-8:00 pm feeling hot 8:00 pm-8:15 pm extreme nausea 8:00pm - 10:00 am extreme chills 12 pm-10 am night sweats  Saturday 3/20 12 pm-10 am chills 12 pm-10 am night sweats  Sunday 3/21 12 pm-10 am night sweats
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fluid retention, Swelling face, Tenderness
Clinical narrative: Sunday morning woke up with swollen checks (cheekbone areas)  in the same areas as having received Juvaderma Voluma fillers on June 16, 2020.  The right cheekbone was more swollen than the left but there was also a pocket of fluid under the right eye.  The areas were very tender to the touch.  Iced the areas for several minutes and called both Dr.'s office and the pharmacist and both told me to take Benedryl, which I did.  Has not helped.  Swelling remains as of Monday morning and the fluid under the right eye feels hard like a knot.  Seeing Dr.  this afternoon.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Got a tingling and numbness feeling  going up into my left cheek. Lasted about half the day.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Death
Clinical narrative: CHF death
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort
Clinical narrative: a 22 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot ER2613 on 3/22/2021. The patient experienced the following reaction(s) during the immediate of observation: 9:32am Patient c/o non-radiating mid "chest discomfort 2/10." Denies difficulty breathing. Patient was treated/managed as follows:   9:33am VS BP 110/60, HR 77, RR 18, 98% on room air. Patient reports symptoms may be anxiety induced. 9:44am VS BP 105/70, HR 74, RR 18, 98% on room air. Patient reports symptoms subsiding. Discomfort improved to 1/10. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Education provided on worsening symptoms and to seek medical attention and call 911. Patient and patient mother states understanding. 9:48am Patient escorted to car with mother and nurse.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Limb discomfort, Lymphadenopathy, Pain in extremity
Clinical narrative: 14 days after vaccine, large red rash on left upper arm, hot and sore.   Low-grade fever x approximately 24 hrs;  chills x app. 36 hrs,;   legs heavy and weak x app. 48 hrs.;  enlarged left axillary lymph nodes x app. 3 days; following blood draw at 18 days, unusual pain and swelling at site in left arm lasting app. 5 days
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Rash, Rash erythematous, Skin warm
Clinical narrative: 14 days after vaccine, large red rash on left upper arm, hot and sore.   Low-grade fever x approximately 24 hrs;  chills x app. 36 hrs,;   legs heavy and weak x app. 48 hrs.;  enlarged left axillary lymph nodes x app. 3 days; following blood draw at 18 days, unusual pain and swelling at site in left arm lasting app. 5 days
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Severe right hip pain that I have never encountered before. Started while in bed Sunday evening.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Headache, Hypersomnia, Illness
Clinical narrative: Within 10 minutes I became nauseous. I left the vaccination center and drove home becoming increasing ill. When I got home I went to bed and slept for two days, nauseous, weak, body aches, a rash under the vaccinated arm and on my back left side,  headaches, fever, sleep interruption, vivid dreams.  The left arm which had been vaccinated was extremely sore and remained so, just recently lessening.  I believe I had Covid 19 in February of 2020 and while I got ill, did not experience the severity of illness that I experienced after vaccination. Now, 17 days later I continue to experience weakness, headaches and recently have had difficulty breathing after exercise. Although the rash has gone away, the left side is still itchy, but less so.     I have discussed this with my Doctor and he informed me that my response to second shot may be stronger, although he did not tell me to avoid the second dose.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pruritus, Rash
Clinical narrative: Within 10 minutes I became nauseous. I left the vaccination center and drove home becoming increasing ill. When I got home I went to bed and slept for two days, nauseous, weak, body aches, a rash under the vaccinated arm and on my back left side,  headaches, fever, sleep interruption, vivid dreams.  The left arm which had been vaccinated was extremely sore and remained so, just recently lessening.  I believe I had Covid 19 in February of 2020 and while I got ill, did not experience the severity of illness that I experienced after vaccination. Now, 17 days later I continue to experience weakness, headaches and recently have had difficulty breathing after exercise. Although the rash has gone away, the left side is still itchy, but less so.     I have discussed this with my Doctor and he informed me that my response to second shot may be stronger, although he did not tell me to avoid the second dose.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Fatigue, Nausea
Clinical narrative: Nausea - but this only lasted about 8 hours or so; Extreme exhaustion - still occurring; The most significant adverse reaction is uncontrolled high blood sugar; Patient is a type 1 diabetic and about 16 hours after receiving first dose, his blood sugar has been between 300-400 mg/dl. He has received large doses of insulin but he is not responding to the insulin as he normally should.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin warm, Tenderness
Clinical narrative: Significant rash on left arm. It's warm to the touch and a little tender. Noticed it today but could have been there yesterday and I didn't see it.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site rash, Rash
Clinical narrative: Rash around vaccination site about a week after injection. Didn?t seem to absorb for about a week and pooled around bruise from pushing on hard on site after injection (from nurse that administered vaccine). But after massaged it in/warm compresses rash 2 days later. Rash on other areas of body including arm/face.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia, Rash, Rash erythematous
Clinical narrative: fatigue, headache, low grade temp{100.2},  fine red rash over torso the next day{2 days after the shot}
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: patient reported that he had ringing in his left ear immediately after receiving 2nd dose
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Fall, Pain in extremity, Pulmonary mass, Upper limb fracture
Clinical narrative: mass on right lung fall, arm fracture arm pain leg pain death
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Erythema, Pruritus, Rash
Clinical narrative: Severely itchy and red skin (rashes) on the front neck at night during sleep. It's gone better after waking up, but it is still bothersome and itchy (not as severe as at night).
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Severely itchy and red skin (rashes) on the front neck at night during sleep. It's gone better after waking up, but it is still bothersome and itchy (not as severe as at night).
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Immediate post-injection reaction, Nervousness, Syncope
Clinical narrative: pt received shot around 8:53 am. She fainted around 9:05 am during her 15 minute after shot waiting period. She said she had not eaten and was nervous. she felt dizzy and lightheaded. an ambulance was called and she refused medical treatment. she was alert and was able to walk out of the store on her own
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Injection site pruritus, Pain in extremity, Rash papular
Clinical narrative: Raised Bump, with rash and ttchness at injection site.  I only became noticable almost exactly 1 full week after I got my first COVID (Moderna) Shot.    Became more red, sore and itchy overnight.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: no adverse event---administration only. Patient needed to be 18 yrs old to receive vaccine and was only 17 at time of administration.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: No additional adverse events reported at this time; an expired dose of V ARlV AX was given to a patient on 03/01/2021 and had expired on 02/19/2021; This spontaneous report was received from a registered nurse referring to a 4 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug allergies/reactions were not reported.      On 01-MAR-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength and route were not reported; lot# was S005084 and expiration date was 19-FEB-2021) 0.5 ml for prophylaxis (expired product administered). There was no temperature excursion. No additional adverse events were reported at this time (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional adverse effect reported.; Caller reported that PROQUAD that underwent a temperature excursion was administered.; This spontaneous report was received from "other" reporter type, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 08-MAR-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), as prophylaxis (formulation, strength, dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not provided, lot number T027112, which has been verified to be valid, expiration date reported and validated as 07-FEB-2022). The vaccine administered underwent a temperature excursion from 5 degrees Fahrenheit (F) to 14 F (11.60 F), for a time frame of 1 hour, 0 minutes and 0 seconds, as recorded by a data logger. There was no previous temperature excursion reported. No additional adverse events were reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; Improperly stored VARIVAX administered to patient; This spontaneous report was received from a nurse referring to a 1-year-old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.      On 11-MAR-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T022312, expiration date 30-JUN-2022; strength, dose and route were not reported) for prophylaxis (product storage error). Temperature excursion was -12 degree Celsius for 6 hours and 30 minutes. There was no previous temperature excursion. Data logger was involved. No adverse event was reported.      This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2103USA004887: US-009507513-2103USA004186: US-009507513-2103USA004233:
Sex: U
Vaccine: HEP, HEP, MMRV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received a dose of PROQUAD; received a dose of PROQUAD; the PROQUAD was in the bin in the freezer where the MMRII was supposed to be stocked; received a pediatric dose of RECOMBIVAX HB; did not experience any other adverse events; This spontaneous report was received from a nurse referring to a 49 years old patient of unknown gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.  On 15-MAR-2021, the patient was scheduled to receive a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) but received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA) (lot # was reported as t027115, but upon internal validation, it was changed to the valid lot# T027115, expiration dates was 07-FEB-2022; route was not reported) for prophylaxis (wrong product administered and product administered to patient of inappropriate age). The reporter said the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was in the bin in the freezer where the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was supposed to be stocked and she grabbed the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) without checking the label and administered the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) to the patient (product storage error). On the same day, the patient received a pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) for (0.5ml/1st dose, lot# was reported as r031056, but upon internal validation, it was changed to the valid lot# R031056, expiration dates was 04-JUN-2021; route was not reported) prophylaxis (incorrect dose administered). The patient did not experience any other adverse events. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: R031056; expirationdate: 04-JUN-2021; 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: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE. No PQC.; Patient was administered improperly stored PROQUAD on 03/11/2021.; This spontaneous report has been received from a nurse, referring about a patient of unknown gender who was 4 years old. Information about the patient's pertinent medical history, concomitant medications and previous drug reactions and allergies was not provided.   On 11-MAR-2021, the patient was vaccinated with an improperly stored (product storage error) measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (Therapy type: rHA), lot number T025221, with expiration date on 19-JAN-2021, for prophylaxis (strength, dose, frequency, route of administration and anatomical location were not provided).  The vaccine was stored at a temperature of -12 degree Celsius (°C), for a time frame of 6 hours and 30 minutes, with no previous temperature excursion. The call was due to a digital data logger.  No adverse events were reported.  This is one case, of several from the same reporter.; Sender's Comments:  US-009507513-2103USA004415: US-009507513-2103USA004233:
Sex: F
Vaccine: HPV9
Symptoms: Head discomfort, Lymphadenopathy, Pain
Clinical narrative: swollen lymph nodes; stuffy head; body aches (specifically in the lower back); This spontaneous report was received from a company representative referring to a friend, a female patient of unknown age. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.     On 12-MAR-2021, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), as prophylaxis (formulation, dose, route of administration, lot number, and expiration date were not provided).         On 15-MAR-2021 , the patient was complaining of swollen lymph nodes (lymphadenopathy), stuffy head (head discomfort), and body aches (specifically in the lower back) (back pain).  At the time of reporting, the outcome of lymphadenopathy, back pain and head discomfort was reported as not recovered/not resolved. The causal relationship between the occurred events and the suspect vaccine was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Nervous system disorder
Clinical narrative: lingering nerve issues; This case was reported by a consumer via interactive digital media and described the occurrence of nervous system disorder in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of nervous system disorder (had 1st original shot of non GSKK on an unknown date and experienced lingering nerve issue).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced nervous system disorder. On an unknown date, the outcome of the nervous system disorder was not recovered/not resolved.   It was unknown if the reporter considered the nervous system disorder to be related to Shingles vaccine.   Additional details were provided as follows: Age at vaccination was not reported. Age group was captured as adult as per vaccine indication. The patient received the 2 shots of shingles vaccine and still had lingering nerve issues that crop up years later.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: arm soreness; Pain; This case was reported by a consumer and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and Shingrix. On an unknown date, immediately after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm and pain. Shingrix was discontinued. On an unknown date, the outcome of the pain in arm and pain were unknown.   It was unknown if the reporter considered the pain in arm and pain to be related to Shingrix and Shingrix.   Additional details were provided as follows: The age at vaccination not reported. The age group has been selected as per vaccine specification. Reporter claims that he knows of 5 different people that did not get the second Shingrix shot because of arm soreness and pain. The soreness in arm and pain AEs came after the first dose of shingrix. This is 1 of 5 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021054377:same reporter US-GLAXOSMITHKLINE-US2021AMR055619:Original Case : US2021054379 US-GLAXOSMITHKLINE-US2021AMR055620:Original Case : US2021054379 US-GLAXOSMITHKLINE-US2021AMR055621:Original Case : US2021054379
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: Reaction to the second Shingrix vaccine / Blisters on her arm at the injection site; This case was reported by a consumer via other manufacturer and described the occurrence of injection site blisters in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included back surgery (in 2016). Previously administered products included Shingrix (received 1st dose on unknwon date), Flu vaccines (received flu vaccine on unknown date) and shingles vaccine (received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site blisters. On an unknown date, the outcome of the injection site blisters was unknown.   It was unknown if the reporter considered the injection site blisters to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix on unknown arm and got blisters on arm at the injection site. The patient received flu shots and both types of shingle shots. The patient received Covid vaccine on right arm on unknown date and experienced pain at injection site.
Sex: U
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: How to treat shivering after Shingrix vaccine; This case was reported by a consumer and described the occurrence of shivering in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shivering. On an unknown date, the outcome of the shivering was unknown.   It was unknown if the reporter considered the shivering to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced shivering after Shingrix vaccine.  Reporter ask how to treat shivering.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza
Clinical narrative: Had awful flu symptoms; Bad headache; This case was reported by a consumer and described the occurrence of flu symptoms in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced flu symptoms and headache. On an unknown date, the outcome of the flu symptoms and headache were recovered/resolved.   The reporter considered the flu symptoms and headache to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient herself. The age at vaccination was not reported but it could be 71 or 72 years old. The patient had awful flu symptoms and bad headache for 2 weeks with first dose of Shingrix. The patient was afraid to get the second dose at the time of reporting. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Pain in extremity
Clinical narrative: My joints ached the next couple days.; it made me very tired; My arm was sore; This case was reported by a consumer via interactive digital media and described the occurrence of joint pain in a adult 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, several days after receiving Shingles vaccine, the patient experienced joint pain, pain in arm and tiredness. On an unknown date, the outcome of the joint pain and tiredness were unknown and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the joint pain, pain in arm and tiredness to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient just received the dose of Shingles vaccine and experienced joints ache in the next couple days and arm soreness for 3 days. On the next day of vaccination, the patient was very tired.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Hyperhidrosis, Insomnia, Mobility decreased
Clinical narrative: high fever; aches; sweats; chills; no sleep; my arm hurts!!!; you will not be able to do anything for a couple of days; feeling crappy for the 24-48 hours after shot; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a adult 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 feeling bad, fever, pain, sweating, chills, sleeplessness, pain in arm and mobility decreased. On an unknown date, the outcome of the feeling bad was recovered/resolved and the outcome of the fever, pain, sweating, chills, sleeplessness, pain in arm and mobility decreased were unknown.   It was unknown if the reporter considered the feeling bad, fever, pain, sweating, chills, sleeplessness, pain in arm and mobility decreased to be related to Shingles vaccine.  Addition details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient reported that bad side effects were experienced after receiving both the doses but it was worth it. The patient experienced high fever, aches, sweats, chills, no sleep and pain in arm after 36 hours of vaccination. The patient stated of feeling creepy for 24 to 48 hours after the shot and not able to do anything for a couple of days. The patient also mentioned that drink water frequently throughout and only take medicine like Tylenol, Advil, Aleve after the dose. If these medicines taken prior to the shot, the proper immunity would not build up. The case is patient link with US2021AMR063134 for second dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063134:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: high fever; aches; sweats; chills; no sleep; my arm hurts!!!; you will not be able to do anything for a couple of days; feeling crappy for the 24-48 hours after shot; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a adult 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 feeling bad, fever, pain, sweating, chills, sleeplessness, pain in arm and mobility decreased. On an unknown date, the outcome of the feeling bad was recovered/resolved and the outcome of the fever, pain, sweating, chills, sleeplessness, pain in arm and mobility decreased were unknown.   It was unknown if the reporter considered the feeling bad, fever, pain, sweating, chills, sleeplessness, pain in arm and mobility decreased to be related to Shingles vaccine.  Addition details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient reported that bad side effects were experienced after receiving both the doses but it was worth it. The patient experienced high fever, aches, sweats, chills, no sleep and pain in arm after 36 hours of vaccination. The patient stated of feeling creepy for 24 to 48 hours after the shot and not able to do anything for a couple of days. The patient also mentioned that drink water frequently throughout and only take medicine like Tylenol, Advil, Aleve after the dose. If these medicines taken prior to the shot, the proper immunity would not build up. The case is patient link with US2021AMR063134 for second dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063134:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Worst shot ever. So much pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult 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, unknown 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 provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received the Shingles vaccine and experienced so much pain and due to this the patient did not receive the 2nd dose.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: Nerve pain was in right arm / Pain started 48 hours after administration; This case was reported by a other health professional via sales rep and described the occurrence of nerve pain in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th February 2021, the patient received the 1st dose of Shingrix. In February 2021, 48 hrs after receiving Shingrix, the patient experienced nerve pain. On an unknown date, the outcome of the nerve pain was unknown.   It was unknown if the reporter considered the nerve pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm. The reporter reported that, the patient received 1st dose of Shingrix and experienced nerve pain in right arm after 48 hours. The patient was consulting hand specialist. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness
Clinical narrative: bad headache; awful flu like symptoms; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache and influenza-like symptoms. On an unknown date, the outcome of the headache and influenza-like symptoms were unknown.   It was unknown if the reporter considered the headache and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication The patient had received first dose of shingrix and experienced Influenza-like symptoms and headache for 2 weeks. The patient was afraid to take second dose of shingrix. No other information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: Shot was painful; Arm was a little sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain during injection in a adult 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, immediately after receiving Shingles vaccine, the patient experienced pain during injection and pain in arm. On an unknown date, the outcome of the pain during injection and pain in arm were recovered/resolved.   It was unknown if the reporter considered the pain during injection and pain in arm to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient herself/himself. The age at vaccination was not reported. The patient received the 1st shot and was painful, but her/his arm was a little sore. The information regarding consent to follow up was not reported. For 2nd dose, refer case US2021AMR064344, reported for the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR064344:same report, same patient, different dose (2nd dose)
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Chest pain
Clinical narrative: Pain in his chest / Pain on the chest; Pain on the chest that goes to the back; This case was reported by a pharmacist via call center representative and described the occurrence of chest pain in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 3K743, expiry date 7th November 2022) for prophylaxis.   On 1st February 2021, the patient received the 1st dose of Shingrix. In February 2021, less than 2 weeks after receiving Shingrix, the patient experienced chest pain and back pain. On an unknown date, the outcome of the chest pain and back pain were unknown.   It was unknown if the reporter considered the chest pain and back pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced pain on the chest that went to the back. The reporter consented to follow up.  The vaccine administration facility was the same as Primary Reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021033076:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: red marks around injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 97C2S, expiry date 14th May 2022) for prophylaxis.   On 22nd December 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details provided as follows: The age at vaccination was not reported but could be 65 or 66 years. The patient was not immunocompromised. Till the time of reporting, the patient still had red marks around injection site. The reporter consented to follow-up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Injection site swelling, Rash
Clinical narrative: radiating shoulder pain; swelling at the injection site; experiencing pain and swelling at the injection site / pain having been a 10 at times; rash; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th October 2020, the patient received the 1st dose of Shingrix. On 26th October 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, rash and injection site swelling. In December 2020, the patient experienced shoulder pain. On an unknown date, the outcome of the injection site pain, injection site swelling and shoulder pain were not recovered/not resolved and the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the injection site pain, rash, injection site swelling and shoulder pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received 1st dose of the Shingrix vaccine in left deltoid and the same day, the patient experienced pain and swelling at the injection site and rash. The rash resolved after approximately 1 week and pain and swelling were ongoing, with pain had been a 10 at times. Less than a month after receiving Shingrix, the patient experienced radiating shoulder pain, that had been occurring for approximately 2 months. The patient reported that the pain, swelling, and radiating shoulder pain had all progressed since their onset. The reporter did not consent to follow-up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache
Clinical narrative: feels fatigued; headache; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th February 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 25th February 2021, 10 hrs after receiving Shingrix, the patient experienced headache. On 26th February 2021, the patient experienced fatigue. On an unknown date, the outcome of the fatigue and headache were not recovered/not resolved.   It was unknown if the reporter considered the fatigue and headache to be related to Shingrix.  Additional details provided as follows: There were no events noted with dose 1. About 10 hours after receiving 2nd dose she experienced headache and after one day she experienced feels fatigued. Outcome of above events were not recovered/not resolved. Consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Rash
Clinical narrative: Painful spots on her forehead and along hairline/contracted shingles; Painful spots on her forehead and along hairline; Painful spots on her forehead and along hairline; headache / intensified the next day; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd March 2021, the patient received the 1st dose of Shingrix. On 6th March 2021, 3 days after receiving Shingrix, the patient experienced headache. On 8th March 2021, the patient experienced shingles, spot-like rash and painful rash. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the shingles, headache, spot-like rash and painful rash were not recovered/not resolved.   The reporter considered the shingles to be related to Shingrix. It was unknown if the reporter considered the headache, spot-like rash and painful rash to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient had received the vaccine on her left arm and contracted shingles after vaccination. The patient experienced a headache and intensified the next day and had not resolved till the time of reporting. In the evening of 8th August 2021, the patient noticed painful spots on her forehead and along hairline and had not resolved till the time of reporting. The patient was prescribed anti-viral and started taking it on 9th March 2021. The reporter wanted that the patient's symptoms should be focused. The reporter did not know lot or expiration date. The reporter consented to follow-up and gave permission to follow-up with health care professional. This case has been linked to US2021009418 (husband's case), reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021009418:same reporter
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal distension, Abdominal pain, Abdominal pain upper, Diarrhoea
Clinical narrative: Bloating; stomach pain and abdominal pain; diarrhea; . This case was reported by a consumer via call center representative and described the occurrence of bloating in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th March 2021, the patient received the 2nd dose of Shingrix. In March 2021, less than a day after receiving Shingrix, the patient experienced bloating, abdominal pain and diarrhea. On an unknown date, the outcome of the bloating, abdominal pain and diarrhea were recovered/resolved.   It was unknown if the reporter considered the bloating, abdominal pain and diarrhea to be related to Shingrix.  Additional details provided as follow: This case was reported by the patient. The patient took second dose of shingrix on 10th March 2021. The patient experienced abdominal pain, stomach ache, diarrhea and bloating after getting second dose of shingrix at night on the same day. The reported events were resolved. No further information was provided
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: pain in the injection site; muscle soreness around the injection site area; Persistent pain; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 9K4T4, expiry date 8th October 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 31st January 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain, injection site muscle pain and pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site muscle pain and pain were unknown.   It was unknown if the reporter considered the injection site pain, injection site muscle pain and pain to be related to Shingrix.  Additional details were reported as follows: The age of vaccination was not reported. The patient received 2nd dose of Shingrix and still had pain in the injection site referred as muscle soreness around the injection site area. The reporter inquired about the persistent pain post Shingrix administration. The reporter did not consent to follow up.