chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Flushing, Headache, Heart rate increased, Pain in extremity
Clinical narrative: rash & itching all over , face felt flush, fast heartbeat  B/P 180/104 arm sore later that night & headache Given Benadryl 1 dose by employee health nurse  then went to urgent care and received: 80mg Depo Medrol IM given in clinic. Start 40mg Prednisone daily for 3 days. Zyrtec 10mg daily as needed for itching. For your blood pressure, recommend taking medication and rechecking BP in 1-2 hours.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash & itching all over , face felt flush, fast heartbeat  B/P 180/104 arm sore later that night & headache Given Benadryl 1 dose by employee health nurse  then went to urgent care and received: 80mg Depo Medrol IM given in clinic. Start 40mg Prednisone daily for 3 days. Zyrtec 10mg daily as needed for itching. For your blood pressure, recommend taking medication and rechecking BP in 1-2 hours.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Tremor
Clinical narrative: Shaking and nervousness started  3 hours after vaccination.  Vital signs stable: HR: 87 BP:121/87 O2:98
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Patient reports sore throat and runny nose, which has subsided. He also reports fatigue, which is mild, he states all symptoms have been mild.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: initially first day to day 3 had sore arm, some hardness and swelling at site, all of that went away totally.  1/2/21 my left arm was fine, 1/3/21 at 2pm I had an itch and found to have significant hardness and red warm area at injection site about 1 3/4" in diameter. I circled it and then 1/4/21 at 6am noticed the redness and swelling and hardness had increased by an inch.  I contacted my doctor who diagnosed cellulitis and ordered oral antibiotics for 10 days
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site warmth, Pain in extremity, White blood cell count increased
Clinical narrative: initially first day to day 3 had sore arm, some hardness and swelling at site, all of that went away totally.  1/2/21 my left arm was fine, 1/3/21 at 2pm I had an itch and found to have significant hardness and red warm area at injection site about 1 3/4" in diameter. I circled it and then 1/4/21 at 6am noticed the redness and swelling and hardness had increased by an inch.  I contacted my doctor who diagnosed cellulitis and ordered oral antibiotics for 10 days
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: initially first day to day 3 had sore arm, some hardness and swelling at site, all of that went away totally.  1/2/21 my left arm was fine, 1/3/21 at 2pm I had an itch and found to have significant hardness and red warm area at injection site about 1 3/4" in diameter. I circled it and then 1/4/21 at 6am noticed the redness and swelling and hardness had increased by an inch.  I contacted my doctor who diagnosed cellulitis and ordered oral antibiotics for 10 days
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Pruritus
Clinical narrative: C/o itching immediately following vaccine admin.  Benadryl 50mg x 1 po admin per S.O.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, SARS-CoV-2 test negative
Clinical narrative: Patient received the covid vaccine on 12/28/2020.   con 12/29/2020 c/o new onset neck pain.  She described it as "shooting pain at the base of the neck". No hx of neck pain or headache. Neck pain persists until 1/4/2021.  Her PCP at the urgent care started her on Baclofen and gabapentin for pain controlled.  Covid test on 12/29/2020 was negative.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Injection site reactions: Pain, tenderness, swelling of the lymph nodes in the same arm as the injection  General:  fatigue, headache, muscle pain, joint pain, chills
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia
Clinical narrative: Injection site reactions: Pain, tenderness, swelling of the lymph nodes in the same arm as the injection  General:  fatigue, headache, muscle pain, joint pain, chills
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Rash
Clinical narrative: Site of reaction started to itch day 2 to3 of vaccination, but I thought it was because my arm was still sore. I don't think I physically saw the rash until day 5ish...It is also around scar tissue so I don't know what /if it has anything to do with the reaction, I drew a border around the reaction on Friday (when I took the picture) and it is beginning to get smaller and look better.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Musculoskeletal stiffness, Nausea
Clinical narrative: Beginning 4 a.m., extreme nausea, profusive sweating, severe body aches, head ache, muscles stiffness on right side of neck.  No fever until 4 p.m. on 12/31/20. I have been tired sleeping most of 12/31, 1/1/21 and some on 1/2/21.  Ran a fever 103.  At that point I took ibuprofen. Fever subsided. I continue with some stiffness in right neck with a mild headache.  No other known side  effects.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Beginning 4 a.m., extreme nausea, profusive sweating, severe body aches, head ache, muscles stiffness on right side of neck.  No fever until 4 p.m. on 12/31/20. I have been tired sleeping most of 12/31, 1/1/21 and some on 1/2/21.  Ran a fever 103.  At that point I took ibuprofen. Fever subsided. I continue with some stiffness in right neck with a mild headache.  No other known side  effects.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Neck pain
Clinical narrative: Really strong left arm pain around injection site.  Not able to extend or retract my arm for the day after injection. Was really painful, couldn't sleep or apply pressure to arm, also at one point I had an extremely sharp/shooting pain that was in my left arm/neck. Currently 5 months pregnant, due June 7th 2021
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: Slight headache for about 20 minutes ,then developed to a full migrane.  Took one Excedrin migrane pill  at 12:05 pm( 01/04/2021). Migrane relieved  slightly .
Age: 0.33
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Initial reaction sore arm, off balance, tingling in arm, around 2 hours later lower extremities painful - body aches
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Injection site pain, Myalgia
Clinical narrative: muscle aches and myalgia including soreness at injection site  hours after vaccination. Next morning at 5 am, vertigo and dizziness, nausea and fatigue. Today- vertigo resolved. body aches and slight chills.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Vertigo
Clinical narrative: muscle aches and myalgia including soreness at injection site  hours after vaccination. Next morning at 5 am, vertigo and dizziness, nausea and fatigue. Today- vertigo resolved. body aches and slight chills.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Paraesthesia oral, Swollen tongue
Clinical narrative: Swollen, fat lips and swollen/tingling tongue.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: Aching joints and muscles, tingling feeling, pounding headache, sore are.  Extreme tiredness.  Missed two days of work.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Aching joints and muscles, tingling feeling, pounding headache, sore are.  Extreme tiredness.  Missed two days of work.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Vision blurred
Clinical narrative: Recipient described feeling dizzy with blurry vision.  Vitals taken.  All WNL, except blood pressure elevated to 142/90.  He was escorted to wheel chair and remained with us for 15 minutes.  He was still reporting blurry vision and some dizziness. Vital signs remained stable with approximately same elevated BP.   He was taken to Emergency Department for observation.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site warmth, Pruritus, Swelling
Clinical narrative: Reddness, swelling, itching, warmth at injection site only
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Throat tightness
Clinical narrative: Approximately 5 minutes after her Pfizer vaccine, she felt like her throat was closing, flushed and became diaphoretic.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Injection site pain, Paraesthesia, Pruritus
Clinical narrative: For two days after injection the site of injection was very sore, painful at site which finally went away Friday night. I was woken up by a numbness, and tinging sensation in left side of face that continued all day Saturday, and into Sunday. I also experienced fatigue, itching, and a tingling rash sensation in several parts of body on, and off.  On Monday morning I awoke without the facial numbness, and tingling sensations but i do have numbness and tingling in the right lower extremity.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Loss of consciousness, Pyrexia, Syncope
Clinical narrative: Syncopal event at home with LOC approximately 36 hours post vaccination with some fever and chills after. Unsure how long I was out, but estimated to be < 1 minute. All symptoms have resolved at this point.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I was coincidentally exposed to covid prior to the Covid vaccine so I don't think the symptoms were a result from the vaccine. 12/21/2020  I received the vaccine in the AM I started to have a low grade fever, body ache, malayse, next morning I woke up and had a higher degree fever body ache and increasing feeling of sickness. I got worse and contacted my own Dr and he let me know that I may have been exposed and I got tested and I was positive for Covid. I
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Illusion
Clinical narrative: Persistant symptoms of perception off and off-balance
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Fatigue, Headache, Myalgia
Clinical narrative: Fatigue, myalgias, arthralgias, headache, rhinorrhea, scratchy throat, chest tightness - approximately 72 hours duration
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test negative, Throat irritation
Clinical narrative: Fatigue, myalgias, arthralgias, headache, rhinorrhea, scratchy throat, chest tightness - approximately 72 hours duration
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Heart rate increased, Nausea, SARS-CoV-2 antibody test negative, SARS-CoV-2 test positive
Clinical narrative: increased (rapid) heartrate at rest, an hour following administration of vaccine. Symptom persisted for half an hour, followed by flushing of the face and slight nausea.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Left T7 herpes zoster
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Diarrhoea, Influenza like illness, Nasal congestion
Clinical narrative: Reports the following symptoms: Left shoulder pain, diarrhea, nasal congestion, sore throat, cough, Itching all over body, scalp pain and tenderness. 12/28 Began feeling better, mild cough persists. 1/4: Feels as though she has "bad flu" fever of 101 F.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain of skin, Pruritus, Pyrexia
Clinical narrative: Reports the following symptoms: Left shoulder pain, diarrhea, nasal congestion, sore throat, cough, Itching all over body, scalp pain and tenderness. 12/28 Began feeling better, mild cough persists. 1/4: Feels as though she has "bad flu" fever of 101 F.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Joint range of motion decreased, Mobility decreased, Neck pain, Pain in extremity
Clinical narrative: From Saturday through Sunday pain developed up left arm, across latissimus and up neck.  Severe pain in neck developed by Monday morning so that is was difficult to get out of bed due to neck pain.  Pain only on left side of neck.  No head ache, no rash or redness,  Limited range of motion.  Cannot put right ear on shoulder or chin on chest.  Seen by doctor on duty in vaccine clinic.  Taking ibuprofen and self monitoring.  Reported symptoms to employee health.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Severe neck pain.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature increased, Chills, Heart rate increased, Hypertension
Clinical narrative: On 12/23 around 2pm exp chills, higher temp than normal. My heart rate and BP was higher than normal lasted about a hour. I had to miss a day and 1/2 of work.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability
Clinical narrative: On 12/23 around 2pm exp chills, higher temp than normal. My heart rate and BP was higher than normal lasted about a hour. I had to miss a day and 1/2 of work.
Age: 0.58
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling in left fingers
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dysstasia, Fatigue, Headache, Injection site erythema
Clinical narrative: AT 5pm the same day, felt a little fatigued and slight headache. The next morning 12-30-20 at 730, was so fatigued, couldn't hardly stand. Felt like when I had mono. Had headache, back and neck aches, fever of 100.2. Felt like glands were swollen. After 4 hours, symptoms began to subside, but still mildly present. Fever subsided and was gone from 11AM on. Injection site pain still present with redness. Skin felt very sensitive on the arms Today, 12-31, felt good, no fever, slightly tired, but good enough to work. Came to work and when in the process of writing this RL, I was reviewing the side effects and looked at my injection site. It looked red so I asked a coworker, who thought it looked like hives. We had our medical director and PA look at it and although they didn't feel like it looked like hives, I developed hives on my chest, neck and chin while they were in here. Called employee health who recommended either PCP or urgent care. Went to urgent care. During visit, hives began to subside, had 99.6 fever at the beginning of the visit, 98.7 at the end of the visit. Rapid COVID test was negative. Received inhaler for asthma and returned to work at 1245 today.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lymphadenopathy, Neck pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: AT 5pm the same day, felt a little fatigued and slight headache. The next morning 12-30-20 at 730, was so fatigued, couldn't hardly stand. Felt like when I had mono. Had headache, back and neck aches, fever of 100.2. Felt like glands were swollen. After 4 hours, symptoms began to subside, but still mildly present. Fever subsided and was gone from 11AM on. Injection site pain still present with redness. Skin felt very sensitive on the arms Today, 12-31, felt good, no fever, slightly tired, but good enough to work. Came to work and when in the process of writing this RL, I was reviewing the side effects and looked at my injection site. It looked red so I asked a coworker, who thought it looked like hives. We had our medical director and PA look at it and although they didn't feel like it looked like hives, I developed hives on my chest, neck and chin while they were in here. Called employee health who recommended either PCP or urgent care. Went to urgent care. During visit, hives began to subside, had 99.6 fever at the beginning of the visit, 98.7 at the end of the visit. Rapid COVID test was negative. Received inhaler for asthma and returned to work at 1245 today.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Sensitive skin, Urticaria
Clinical narrative: AT 5pm the same day, felt a little fatigued and slight headache. The next morning 12-30-20 at 730, was so fatigued, couldn't hardly stand. Felt like when I had mono. Had headache, back and neck aches, fever of 100.2. Felt like glands were swollen. After 4 hours, symptoms began to subside, but still mildly present. Fever subsided and was gone from 11AM on. Injection site pain still present with redness. Skin felt very sensitive on the arms Today, 12-31, felt good, no fever, slightly tired, but good enough to work. Came to work and when in the process of writing this RL, I was reviewing the side effects and looked at my injection site. It looked red so I asked a coworker, who thought it looked like hives. We had our medical director and PA look at it and although they didn't feel like it looked like hives, I developed hives on my chest, neck and chin while they were in here. Called employee health who recommended either PCP or urgent care. Went to urgent care. During visit, hives began to subside, had 99.6 fever at the beginning of the visit, 98.7 at the end of the visit. Rapid COVID test was negative. Received inhaler for asthma and returned to work at 1245 today.
Sex: F
Vaccine: FLUN4
Symptoms: Influenza, Influenza virus test positive
Clinical narrative: POSITIVE NASAL SWAB FLU TEST; A spontaneous report has been received from a health professional. The report concerns a female patient (age not provided) of Unknown ethnic origin.    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza virus vaccine live, intranasal) (batch number Unknown) 0.2 ml once/single administration, via nasal route, for flu vaccine on 09-NOV-2020.     On 11-NOV-2020, the patient experienced positive nasal swab flu test (preferred term: Influenza).     It is unknown if any action was taken with Flumist Quadrivalent (influenza virus vaccine live, intranasal).     The outcome of the event was unknown.    The event was considered non-serious.     Laboratory values are available.
Sex: U
Vaccine: MENB
Symptoms: Headache, Pain, Peripheral swelling, Pyrexia
Clinical narrative: fever; general aches and pains; headache; swelling in the arm.; This case was reported by a other health professional via sales rep and described the occurrence of fever in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.  Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced fever, general body pain, headache and swelling arm. On an unknown date, the outcome of the fever, general body pain, headache and swelling arm were unknown.   It was unknown if the reporter considered the fever, general body pain, headache and swelling arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable. Medical Assistant mentioned she has had a few patients that have experienced fever, general aches and pains, headache, and swelling in the arm.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019AMR119314:Same Reporter
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: soreness around the flu shot injection site; This case was reported by a consumer via other manufacturer and described the occurrence of injection site pain in a 41-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   In November 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, less than 2 months after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient had flu shot and he had soreness around the flu shot injection site and it lasted for few days, and it was better now.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles 4 times; This case was reported by a consumer via interactive digital media and described the occurrence of shingles 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, immediately after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as adult per the vaccine indication. Since getting the Shingrix shot, the patient gotten shingles 4 times.  The patient asked was the shot to blame.
Sex: F
Vaccine: VARZOS
Symptoms: Dialysis
Clinical narrative: She had a dialysis; This case was reported by a pharmacist via call center representative and described the occurrence of dialysis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced dialysis. On an unknown date, the outcome of the dialysis was unknown.   It was unknown if the reporter considered the dialysis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingrix and had dialysis before she was due for 2nd dose. She had not yet received the 2nd dose. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Rash
Clinical narrative: potential hair loss; mild face rash; This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th November 2020, the patient received the 2nd dose of Shingrix. On 1st December 2020, 1 days after receiving Shingrix, the patient experienced rash. On an unknown date, the patient experienced hair loss. On an unknown date, the outcome of the rash was not recovered/not resolved and the outcome of the hair loss was unknown.   It was unknown if the reporter considered the rash and hair loss to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix and woke up with a mild facial rash. The patient asked if hair loss was a common side effect of Shingrix but refused to answer any further questions about herself or her experience with the vaccine. Did not consent to follow-up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: achy; fever of 99.9 degrees; This case was reported by a consumer via call center representative and described the occurrence of pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 1st December 2020, less than a day after receiving Shingrix, the patient experienced pain and fever. On an unknown date, the outcome of the pain and fever were not recovered/not resolved.   It was unknown if the reporter considered the pain and fever to be related to Shingrix.  Additional details were reported as follows: The patient had a fever of 99.9 degree F and was achy and these events began after receiving the vaccine. Consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix on an unspecified date, and only experienced a sore arm. The reporter did not consent to follow up. For tolerance to 2nd dose refer linked case US2020AMR241957, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR241957:same patient
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Mild pain in his arm at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included short memory loss.   On 8th December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 8th December 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: After receiving the vaccine the patient experienced mild pain in his arm at the injection site that was still ongoing at the time of reporting. The reporter does not have vaccine information for this adverse event, he stated short term memory issues prior to vaccine dose. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Incomplete course of vaccination, Injection site pain, Malaise
Clinical narrative: Felt uncomfortable; Felt / miserable; First Shingrix shot several months ago; Horrible aching and soreness at injection site / pain level of 8 on a 1-10 scale; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain, feeling unwell, feeling miserable and incomplete course of vaccination. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the feeling unwell, feeling miserable and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the injection site pain, feeling unwell and feeling miserable to be related to Shingrix.  Additional details were provided as follows: The patient was health care professional and reported for himself. The age at vaccination was not reported. The patient got his first Shingrix shot several months ago of reporting date and he had horrible aching and soreness at the site of injection. The patient also felt miserable and uncomfortable. The pain at injection site lasted for 4 weeks. The pain level was 8 out of 1 to 10 pain scale. The patient did not receive 2nd dose till the time of reporting, which led to incomplete course of vaccination. No additional information provided. The patient did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020244447:Same reporter. FU1 (deleted)
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Injection site pain, Myalgia, Pain
Clinical narrative: Muscle pain; Headache; Aches everywhere; little soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis (was being treated for it).   On 17th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). In December 2020, less than a week after receiving Shingrix, the patient experienced injection site pain. On 21st December 2020, the patient experienced muscle pain, headache and general body pain. On an unknown date, the outcome of the injection site pain, muscle pain, headache and general body pain were unknown.   It was unknown if the reporter considered the injection site pain, muscle pain, headache and general body pain to be related to Shingrix.  Additional details were reported as follows: The patient received the 2nd dose in his left arm The patient felt terrible after receiving the 2nd dose of the Shingrix. He stated that he aches everywhere, had muscle pain, headache (onset at the time of report) and a little soreness at the injection site.  He did not report fever.  On 21st December 2020, 4 days after receiving Shingrix the patient experienced muscle pain, headache and general body pain. He was unable to open the top of a jar because of the pain.  The reporter did not consent to follow-up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Muscle spasms, Neuropathy peripheral, Paraesthesia, Pyrexia
Clinical narrative: Tingling in lower legs- neuropathy like; Fever 102.9; Tingling in lower legs- neuropathy like; Severe cramping in hands and feet; Severe bone pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female patient received the first dose of bnt162b2 (COVID-19 vaccine) lot no: EL0140, via an unspecified route of administration in left arm on 18Dec2020 15:15 at a single dose for COVID-19 immunization. Medical history included acid reflux and known allergies to PCN, both from an unknown date and unknown if ongoing. The patient was not pregnant at the time of report. Concomitant medication included omeprazole (PROTONIX), ibuprofen (MOTRIN). No other vaccines were administered in four weeks. On 19Dec2020 at 14:30, the patient experienced fever 102.9 "normal for vaccines i know", tingling in lower legs neuropathy like, severe cramping in hands and feet, and severe bone pain. The patient recovered from the events in Dec2020. The patient did not receive treatment for the events. The events were reported as non-serious. The patient didn't have COVID prior to vaccination and was not tested post vaccination.; Sender's Comments: A possible causal association between administration of bnt162b2 and the onset of neuropathy like cannot be excluded, considering the plausible temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Lip pruritus, Throat irritation
Clinical narrative: Scratchy throat; itching lips; This is a spontaneous report from a non-contactable nurse. A 36-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EK5730, via an unspecified route of administration on Right arm from 22Dec2020 to 22Dec2020 as single dose for COVID-19 immunization. Medical history included food allergy (Shrimp). The patient's concomitant medications were not reported. The patient experienced scratchy throat and itching lips for approximately 1.5 hours starting 20 mins post vaccine on 22Dec2020. The event caused prolonged hospitalization. The outcome of the events was recovered on 22Dec2020.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 vaccine cannot be excluded for reported events throat irritation and lip itching.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Ataxia, Chills, Confusional state, Decreased appetite, Delirium
Clinical narrative: delirious; hypoxic; fever; ataxic; incontinent; confused; Chills; HA; anorexia/had no appetite; myalgias; extreme fatigue; slept all and had no appetite; This is a spontaneous report from a contactable physician. A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Dec2020 16:00 at single dose for COVID-19 immunization. Medical history included diabetes mellitus (DM). The patient has no known allergies. The patient's concomitant medications were not reported. He was an ER doctor and the medical director of his hospital. The patient was asymptomatic when he got the vaccine on 15Dec2020. 3 hours after the vaccine he began to get chills, HA, anorexia, myalgias, and extreme fatigue. This worsened and he slept all and had no appetite. On 19Dec2020 he woke up delirious with a fever and was ataxic, hypoxic, incontinent, and confused. The patient was hospitalized due to the events on 15Dec2020. The events also caused prolonged hospitalization due to the events. The patient was not diagnosed with COVID prior to vaccination. The patient was tested for COVID via nasal swab post vaccination with unknown results. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The outcome of the events was not recovered. Therapeutic measures were taken as a result of the events as the patient required oxygen, plasma, and remdisivir.  The batch/lot numbers for the vaccine, BNT162B2, were not provided and will be requested during follow up.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of reported serious events might not be excluded, considering the plausible temporal relationship.  Fever, chills, headache, fatigue and muscle pain are the known adverse event profile of the suspect product.  More information such as detailed underlying medical conditions and concomitant medications are needed for fully medical assessment.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypoxia, Incontinence, Myalgia
Clinical narrative: delirious; hypoxic; fever; ataxic; incontinent; confused; Chills; HA; anorexia/had no appetite; myalgias; extreme fatigue; slept all and had no appetite; This is a spontaneous report from a contactable physician. A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Dec2020 16:00 at single dose for COVID-19 immunization. Medical history included diabetes mellitus (DM). The patient has no known allergies. The patient's concomitant medications were not reported. He was an ER doctor and the medical director of his hospital. The patient was asymptomatic when he got the vaccine on 15Dec2020. 3 hours after the vaccine he began to get chills, HA, anorexia, myalgias, and extreme fatigue. This worsened and he slept all and had no appetite. On 19Dec2020 he woke up delirious with a fever and was ataxic, hypoxic, incontinent, and confused. The patient was hospitalized due to the events on 15Dec2020. The events also caused prolonged hospitalization due to the events. The patient was not diagnosed with COVID prior to vaccination. The patient was tested for COVID via nasal swab post vaccination with unknown results. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The outcome of the events was not recovered. Therapeutic measures were taken as a result of the events as the patient required oxygen, plasma, and remdisivir.  The batch/lot numbers for the vaccine, BNT162B2, were not provided and will be requested during follow up.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of reported serious events might not be excluded, considering the plausible temporal relationship.  Fever, chills, headache, fatigue and muscle pain are the known adverse event profile of the suspect product.  More information such as detailed underlying medical conditions and concomitant medications are needed for fully medical assessment.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: delirious; hypoxic; fever; ataxic; incontinent; confused; Chills; HA; anorexia/had no appetite; myalgias; extreme fatigue; slept all and had no appetite; This is a spontaneous report from a contactable physician. A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Dec2020 16:00 at single dose for COVID-19 immunization. Medical history included diabetes mellitus (DM). The patient has no known allergies. The patient's concomitant medications were not reported. He was an ER doctor and the medical director of his hospital. The patient was asymptomatic when he got the vaccine on 15Dec2020. 3 hours after the vaccine he began to get chills, HA, anorexia, myalgias, and extreme fatigue. This worsened and he slept all and had no appetite. On 19Dec2020 he woke up delirious with a fever and was ataxic, hypoxic, incontinent, and confused. The patient was hospitalized due to the events on 15Dec2020. The events also caused prolonged hospitalization due to the events. The patient was not diagnosed with COVID prior to vaccination. The patient was tested for COVID via nasal swab post vaccination with unknown results. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The outcome of the events was not recovered. Therapeutic measures were taken as a result of the events as the patient required oxygen, plasma, and remdisivir.  The batch/lot numbers for the vaccine, BNT162B2, were not provided and will be requested during follow up.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of reported serious events might not be excluded, considering the plausible temporal relationship.  Fever, chills, headache, fatigue and muscle pain are the known adverse event profile of the suspect product.  More information such as detailed underlying medical conditions and concomitant medications are needed for fully medical assessment.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Loss of consciousness, Myalgia
Clinical narrative: just kind of having blackout; Severe fatigue/fatigue; Severe myalgia; Some congestion; Severe headache; Haziness; This is a spontaneous report from a contactable other healthcare professional (HCP), who is also the patient. This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. In Dec2020, the patient experienced just kind of having blackout, severe fatigue, severe myalgia, some congestion, severe headache and haziness. On day six, symptoms improved and suddenly he/she was having symptoms again, severe myalgia, some congestion severe headaches and fatigue. The outcome of the events was unknown.  The information about batch/lot number has been requested.; Sender's Comments: This report fails to include the basic information that is required for an independent medical evaluation. Assessment is postponed after receipt of a more complete case report. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Respiratory tract congestion
Clinical narrative: just kind of having blackout; Severe fatigue/fatigue; Severe myalgia; Some congestion; Severe headache; Haziness; This is a spontaneous report from a contactable other healthcare professional (HCP), who is also the patient. This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. In Dec2020, the patient experienced just kind of having blackout, severe fatigue, severe myalgia, some congestion, severe headache and haziness. On day six, symptoms improved and suddenly he/she was having symptoms again, severe myalgia, some congestion severe headaches and fatigue. The outcome of the events was unknown.  The information about batch/lot number has been requested.; Sender's Comments: This report fails to include the basic information that is required for an independent medical evaluation. Assessment is postponed after receipt of a more complete case report. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Feeling abnormal, Headache, Immediate post-injection reaction, Influenza like illness
Clinical narrative: Flu like symptoms like myalgia, achy head, mental cloudiness; Flu like symptoms like myalgia, achy head, mental cloudiness; Flu like symptoms like myalgia, achy head, mental cloudiness; Flu like symptoms like myalgia, achy head, mental cloudiness; Deep cough; This is a spontaneous report from a non-contactable physician. A female patient of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date in Dec2020, in left upper arm like deltoid, for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Dec2020, immediately after receiving the vaccine, the patient experienced a deep cough which came on all of a sudden, followed 31 hours post vaccine by flu like symptoms like myalgias, achy head and mental cloudiness. She was feeling a bit better on 22Dec2020 morning and she was back at work. So, it was like a short couple of hours, maybe 24 hours turnaround. The events were resolving at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported flu like symptoms like myalgias, achy head and mental cloudiness and the administration of the COVID 19 vaccine BNT162B2 based on the plausible temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Flu like symptoms like myalgia, achy head, mental cloudiness; Flu like symptoms like myalgia, achy head, mental cloudiness; Flu like symptoms like myalgia, achy head, mental cloudiness; Flu like symptoms like myalgia, achy head, mental cloudiness; Deep cough; This is a spontaneous report from a non-contactable physician. A female patient of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date in Dec2020, in left upper arm like deltoid, for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Dec2020, immediately after receiving the vaccine, the patient experienced a deep cough which came on all of a sudden, followed 31 hours post vaccine by flu like symptoms like myalgias, achy head and mental cloudiness. She was feeling a bit better on 22Dec2020 morning and she was back at work. So, it was like a short couple of hours, maybe 24 hours turnaround. The events were resolving at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported flu like symptoms like myalgias, achy head and mental cloudiness and the administration of the COVID 19 vaccine BNT162B2 based on the plausible temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Blood urine present
Clinical narrative: Urination bleeding; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162b2 (Solution for injection, lot number and expiration date not provided), via an unspecified route of administration at single dose on 22Dec2020 for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced urination bleeding in Dec2020 and wanted to know if it was going to be a side effect. The outcome of the event was unknown.   Information on the lot/batch number has been requested.