chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Muscle twitching
Clinical narrative: When the vaccine was administered, I felt a warm sensation move up my neck and then approx 3 hours later I started having left sided facial muscle twitching.  Then I started having muscle twitching all over my body.  To this day (3 weeks after vaccine) I am still having muscle twitching.  It has improved some.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: fever, chills, nausea
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Pain, Pruritus, Swelling
Clinical narrative: Redness, pain/tenderness, swelling/hardness, itching
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Redness, pain/tenderness, swelling/hardness, itching
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Pain, Parosmia
Clinical narrative: After having a fever, chills, and aches, as those symptoms faded away, I began to perceive a distinct odor. It was intermittent and then was constant from Sunday morning until Friday morning. The odor was strong and differed at times. It varied from a minty smell, to a musty basement type of smell, to a chemical/bleach smell, to something unidentifiable but unpleasant. At times I also could taste it in the back of my throat. It was so strong that I gagged frequently on Tuesday and Wednesday at its peak. I could smell and taste normally, but in the absence of an external smell, I had this other odor in my nose. On Friday, the smell was noticeably less strong and intermittent. 13 days after vaccination, I still sometimes smell it although it is brief and mild. I am tested for COVID weekly, so I know it was not due to the virus.  1/21/21  Vaccine dose #1 1/22-23 Fever, chills, aches, fatigue, mild cough 1/23 Intermittent smell began 1/24-28 Constant perception of bad odor from wake to sleep 1/25 Tested negative for COVID via PCR test 1/29-Present Gradual decline of smell intensity and frequency
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: After having a fever, chills, and aches, as those symptoms faded away, I began to perceive a distinct odor. It was intermittent and then was constant from Sunday morning until Friday morning. The odor was strong and differed at times. It varied from a minty smell, to a musty basement type of smell, to a chemical/bleach smell, to something unidentifiable but unpleasant. At times I also could taste it in the back of my throat. It was so strong that I gagged frequently on Tuesday and Wednesday at its peak. I could smell and taste normally, but in the absence of an external smell, I had this other odor in my nose. On Friday, the smell was noticeably less strong and intermittent. 13 days after vaccination, I still sometimes smell it although it is brief and mild. I am tested for COVID weekly, so I know it was not due to the virus.  1/21/21  Vaccine dose #1 1/22-23 Fever, chills, aches, fatigue, mild cough 1/23 Intermittent smell began 1/24-28 Constant perception of bad odor from wake to sleep 1/25 Tested negative for COVID via PCR test 1/29-Present Gradual decline of smell intensity and frequency
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Muscle twitching, Rash erythematous
Clinical narrative: I woke up in the middle of night with extreme body heat and the next morning I had a beer red rash from my upper chest through the top of my face with itching along my jaw lines.  This did not require any visit to ER although a call was made.  The event lasted 24 hrs.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Itching at the injection site with a rash that started to form around injection site. Patient started Clobetasol propionate 0.05% cream on 2/2/2021 as prescribed by dermatologist after the same reaction occurred after the first dose on 1/5/2021. Patient will continue the cream for a few more days and if the event does not resolve will go back to dermatologist. The cream worked within 4 days after first injection. First injection was on left arm and reported to VAERS.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Head injury, Injection site pain, Injection site swelling, Loss of consciousness
Clinical narrative: Left arm pain, swelling at sight of injection, dizziness, passed out,bump on head
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site rash
Clinical narrative: Right shoulder started itching, later the same day a lump arose and huge area with a red rash. Next day after contacting health provider I started using an ice pack several times daily and taking Bebadryl.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased
Clinical narrative: Blood pressure spiked severely daily since
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pain in extremity
Clinical narrative: Fatigue-18 hours, chills-Intermittent over 18 hours, sweats-Intermittent over 18 hours, headache-Light to Medium over 12 hours, arm soreness-36 hours and counting  Taken ibuprofen to help with arm soreness over the last 2 days
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received Pfizer COVID-19 vaccine on 1/14/2021. Presented for second dose on 2/2/2021 (Day +19) and was erroneously administered Moderna product.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Full blood count normal, Headache, Nausea
Clinical narrative: Headache,  nausea, vomiting, fever, chills, shortness of breath ER visit with IV fluids, Zofran
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Headache,  nausea, vomiting, fever, chills, shortness of breath ER visit with IV fluids, Zofran
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Slight Headache, Minor  Body Ache
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Large node swelling on left collar bone. No pain orredness
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No Adverse event occured, but patient in retrospective review of NJIIS data was discovered to have incorrectly been given Moderna vaccine while under 18 year old as approved in the EUA. The manufacturer was contacted and they provided information about an ongoing clinical trial in patients 12-18 years old receiving the same (100mcg) 2 dose series of Moderna COVID-19 vaccine, however this age group is not currently approved. This is being reported as an error having occurred with the Moderna COVID-19 vaccine. Patient/Guardian will be contacted by a prescriber to inform the patient of the historical event and explain when a 2nd dose can be given.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Throat tightness/ 50mg Benadryl
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Gastrointestinal haemorrhage, SARS-CoV-2 test positive
Clinical narrative: hospitalized for GI Bleed and found to be COVID positive on admission.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash macular
Clinical narrative: Moderna dose 2 (Covid 19)
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Tachycardia
Clinical narrative: Within 10 minutes of receiving vaccine I experienced a rash that spread very quickly all over my chest and traveled up the left side of my face and ear. Experienced tachycardia as well. I had to stay for an hour and be monitored. Later that evening I started running a fever of 102.7 at home and kept the fever for approx 24 hours.
Age: 21.0
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Administration error - 0.25mL administered
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Cerebral infarction, Computerised tomogram abnormal, Death, Pulseless electrical activity
Clinical narrative: 85 year old patient with multiple medical problems. PEA/asystolic arrest 5 days after receiving vaccine, hospitalized. Patient died on 2/1/2021. It is not clear whether the vaccine administration led to the patient's death or not.   "...healthcare professionals are encouraged to report any clinically significant or unexpected events (even if not certain the vaccine caused the event)"
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest
Clinical narrative: 85 year old patient with multiple medical problems. PEA/asystolic arrest 5 days after receiving vaccine, hospitalized. Patient died on 2/1/2021. It is not clear whether the vaccine administration led to the patient's death or not.   "...healthcare professionals are encouraged to report any clinically significant or unexpected events (even if not certain the vaccine caused the event)"
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Cerebral infarction, Computerised tomogram abnormal, Death, Pulseless electrical activity
Clinical narrative: Cardiac arrest
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest
Clinical narrative: Cardiac arrest
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pain
Clinical narrative: 8-9 days after the first vaccine I had flu-like symptoms. Chills, body aches and headaches. No fever. Lasted for 3 days
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing
Clinical narrative: Flushed face after injection.  oral mucosa intact, lungs clear & vitals stable  monitored for every 15mins
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Lymphadenopathy
Clinical narrative: Very enlarged lymph nodes in left axilla size of a grapefruit
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Administration error - 0.25mL administered
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: On February 2, 2021 at approx 12pm I started to get a headache. Later that evening a stiff neck.  This morning I woke at 4:30am with the right arm swollen, red and painful at the injections site.  The pain radiates to my right shoulder and under my arm.  Redness is approx 2.5 in diameter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Laboratory test, Oropharyngeal pain, Pharyngeal erythema
Clinical narrative: had swelling in the neck on opposite side of where i got the vaccine. pain in my throat when i would swallow . Dr said my throat was red. Still have the lump in my neck.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Influenza like illness, Mobility decreased
Clinical narrative: Awakened at night, unable to stand up from bed to walk to bathroom for 45 minutes. Sweating, felt viremic due to Covid vaccine administered approximately 20 hours earlier. BP normal, temp normal, could move extremities but could not bear weight. Incontinent of using. Was able to walk after 45 minutes. Returned to bed, slept, next morning felt flu like symptoms, but largely ok. No more weakness in 28 hours since. Walking fine for last 24 hours.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Administration error - 0.25mL administered
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Feeling abnormal, Hyperhidrosis, Pain in extremity
Clinical narrative: I had zero problems with the 1st dose, besides a little soreness in my arm. The morning after receiving the 2nd dose my arm really really hurt. I just progressively got worse and worse. My joints were hurting. I was in bed all day besides for emergencies. I felt like I was ran over the by a truck. I was having chilly and sweating and but I never took my temperature. I just felt horrible.  It lasted until about 3AM this morning. I got 95% normal today besides my joints are being a little achy.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Visual impairment
Clinical narrative: On 1/28/21, I experienced a temporary blind spot in my left eye, which lasted for about 30-45 minutes. When the vision was restored, I had a frontal headache.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Headache; body aches; fatigue
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pyrexia
Clinical narrative: low grade fever....throughout the 1st night...next day fever, chills, and sweats throughout the night 2nd night
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Administration error - 0.25mL administered
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: original appointment was the week before 2/2/2021.  He rescheduled this appointment himself using a link thinking that we would be giving both Moderna and Pfizer vaccines.  He brought his vaccination card with him, but in the midst of conversation it was overlooked that he had received Moderna as first dose.  could not recall whether or not he was informed that the vaccine he was receiving was Pfizer instead of Moderna.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Rash
Clinical narrative: 4 days post vaccine developed front and back torso rash with burning and itching
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Axillary pain, Decreased appetite, Loss of personal independence in daily activities, Malaise
Clinical narrative: "Pain.  Severe pain that included the entire arm including the fingers, shoulder, axilla and the entire side of the body from the axilla to the waist.  Pain so severa tha with Ibuprofen and Tylenol it would wake me up at night if I  moved in my sleep.  Duration of pain. Severe pain for 4 days. Pain gradually subsided. The injected arm hurt for six weeks although not with that severity. Fever.  High fever and chills for about 4 - 5 days. Lower grade fever lasted for four weeks. Malaize. Severe for a few days. I started feeling ill on Saturday and was not able to get out of bed until Tuesday. Could not eat and forced myself to drink during those days. Malaise lasted for four weeks, like the fever. Pain gradually subsided after the first days. Each day was slightly better than the previous one. Malaise and fever subsided some and plateaued for weeks until quickly went away."
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: "Pain.  Severe pain that included the entire arm including the fingers, shoulder, axilla and the entire side of the body from the axilla to the waist.  Pain so severa tha with Ibuprofen and Tylenol it would wake me up at night if I  moved in my sleep.  Duration of pain. Severe pain for 4 days. Pain gradually subsided. The injected arm hurt for six weeks although not with that severity. Fever.  High fever and chills for about 4 - 5 days. Lower grade fever lasted for four weeks. Malaize. Severe for a few days. I started feeling ill on Saturday and was not able to get out of bed until Tuesday. Could not eat and forced myself to drink during those days. Malaise lasted for four weeks, like the fever. Pain gradually subsided after the first days. Each day was slightly better than the previous one. Malaise and fever subsided some and plateaued for weeks until quickly went away."
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: 1/26/21:  1-2 hours post vaccine- fatigue and heavy body 1/27/21:  5 am woke to extreme headache/migraine. Could not lift my head off the pillow but also could not sleep. Body aches began all over but especially in lower back. Chills and fever that went on and off throughout the day, peeking at 103 degrees.  Spent the entire day in bed. Extreme fatigue and heavy body. Noting slight lift in symptoms enough to get up and eat dinner but then went right back to laying down.   1/28/21: Extreme fatigue and heavy body. Moderate headache. Heart rate racing. Dizzy. Sweating profusely.  1/29/21: Moderate fatigue and heavy body. Moderate headache. Heart rate continues to race. Resting heart rate over 100 bpm just laying down.  Dizzy. Brain fog.  1/30/21: Slight headache. Fatigue and heavy body continue. Heart rate fluttering and elevated.  Dizzy. Brain Fog. 1/31- 2/3/21- Fatigue. Heavy body. Dizzy. Heart Rate elevations and fluttering. Brain Fog. All other symptoms have dissipated.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Migraine, Pain, Palpitations, Pyrexia
Clinical narrative: 1/26/21:  1-2 hours post vaccine- fatigue and heavy body 1/27/21:  5 am woke to extreme headache/migraine. Could not lift my head off the pillow but also could not sleep. Body aches began all over but especially in lower back. Chills and fever that went on and off throughout the day, peeking at 103 degrees.  Spent the entire day in bed. Extreme fatigue and heavy body. Noting slight lift in symptoms enough to get up and eat dinner but then went right back to laying down.   1/28/21: Extreme fatigue and heavy body. Moderate headache. Heart rate racing. Dizzy. Sweating profusely.  1/29/21: Moderate fatigue and heavy body. Moderate headache. Heart rate continues to race. Resting heart rate over 100 bpm just laying down.  Dizzy. Brain fog.  1/30/21: Slight headache. Fatigue and heavy body continue. Heart rate fluttering and elevated.  Dizzy. Brain Fog. 1/31- 2/3/21- Fatigue. Heavy body. Dizzy. Heart Rate elevations and fluttering. Brain Fog. All other symptoms have dissipated.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: I woke up with severe muscle aches and body chills.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: 25 hours after getting the second vaccine, severe chills, high fever, nausea, vomiting,  full body aching,headache
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 25 hours after getting the second vaccine, severe chills, high fever, nausea, vomiting,  full body aching,headache
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Severe Flu like symptoms, chills, fever, headache, body aches
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: fever with body aches, chills sore, swollen, red at injection site
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever with body aches, chills sore, swollen, red at injection site
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Administration error - 0.25mL administered
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash erythematous, Skin warm
Clinical narrative: Red rash, hot to touch and pain radiating down toward my elbow.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pain
Clinical narrative: Chills, body aches , headaches , fatigue , joints hurt
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Gait disturbance, Headache, Malaise, Oral herpes
Clinical narrative: Severe  whole body pain, fever ,chills, fever blister on lip after first day, by day3 had trouble walking, I was sick for about 7 days . Have been not feeling well sence then , about 4 weeks later a rash looking like shingles showed up on my left forearm  and apparently  6 weeks after the shot my whole body is covered  in blisters that resembles chickenpox both the rash and pots are still  present. I have also had a headache  since the vaccine.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: Severe  whole body pain, fever ,chills, fever blister on lip after first day, by day3 had trouble walking, I was sick for about 7 days . Have been not feeling well sence then , about 4 weeks later a rash looking like shingles showed up on my left forearm  and apparently  6 weeks after the shot my whole body is covered  in blisters that resembles chickenpox both the rash and pots are still  present. I have also had a headache  since the vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain
Clinical narrative: feeling like he´d been knocked over a bus; pain / as when he got the Shingrix / feeling like he´d been knocked over a bus; This case was reported by a consumer and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and feeling abnormal. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the pain and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of shingrix and experienced feeling like he´d been knocked over a bus and pain. The information regarding consent to follow up was not reported. No further information was available
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Administration error - 0.25mL administered
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Feeling abnormal, Lymph node pain, Lymphadenopathy
Clinical narrative: 101 degree temperature; left lymph gland became extremely swollen; left lymph gland became extremely swollen, tender and sore; first Shingrix shot was on 02 JUN 2020 / second Shingrix shot was 14 DEC 2020; worst aching; chills; felt miserable; This case was reported by a consumer and described the occurrence of pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (1st dose received on 2nd June 2020, for further information refer case id US2020AMR253295).   On 14th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 14th December 2020, less than a day after receiving Shingrix, the patient experienced pain, chills and drug dose administration interval too long. In December 2020, the patient experienced feeling miserable. On 20th December 2020, the patient experienced fever, enlargement of lymph nodes and lymph node tenderness. On an unknown date, the outcome of the pain and chills were recovering/resolving and the outcome of the feeling miserable was recovered/resolved and the outcome of the fever, lymph node tenderness and drug dose administration interval too long were unknown and the outcome of the enlargement of lymph nodes was not recovered/not resolved.   It was unknown if the reporter considered the pain, chills, feeling miserable, fever, enlargement of lymph nodes and lymph node tenderness to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix in the left arm. The patient experienced worst aching and chills she had ever experienced; she was miserable but after 5 days it was resolving. On 20th December 2020, the patient had left lymph gland became extremely swollen, tender and sore and 101 degree F temperature last night. After 6 days of receiving shingrix patient experienced  fever, lymph node tenderness ,enlargement of lymph nodes and after less than week experienced feeling miserable. The reporter did not have batch number or expiration date. The reporter did not consent to follow up. No further information was available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR253295:same reporter
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: 101 degree temperature; left lymph gland became extremely swollen; left lymph gland became extremely swollen, tender and sore; first Shingrix shot was on 02 JUN 2020 / second Shingrix shot was 14 DEC 2020; worst aching; chills; felt miserable; This case was reported by a consumer and described the occurrence of pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (1st dose received on 2nd June 2020, for further information refer case id US2020AMR253295).   On 14th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 14th December 2020, less than a day after receiving Shingrix, the patient experienced pain, chills and drug dose administration interval too long. In December 2020, the patient experienced feeling miserable. On 20th December 2020, the patient experienced fever, enlargement of lymph nodes and lymph node tenderness. On an unknown date, the outcome of the pain and chills were recovering/resolving and the outcome of the feeling miserable was recovered/resolved and the outcome of the fever, lymph node tenderness and drug dose administration interval too long were unknown and the outcome of the enlargement of lymph nodes was not recovered/not resolved.   It was unknown if the reporter considered the pain, chills, feeling miserable, fever, enlargement of lymph nodes and lymph node tenderness to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix in the left arm. The patient experienced worst aching and chills she had ever experienced; she was miserable but after 5 days it was resolving. On 20th December 2020, the patient had left lymph gland became extremely swollen, tender and sore and 101 degree F temperature last night. After 6 days of receiving shingrix patient experienced  fever, lymph node tenderness ,enlargement of lymph nodes and after less than week experienced feeling miserable. The reporter did not have batch number or expiration date. The reporter did not consent to follow up. No further information was available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR253295:same reporter
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram, Headache, Nausea
Clinical narrative: Pt complained of dizziness, headache, and nausea. Pt had multiple systolic b/p  readings over 200. Ambulance was called and pt was released home from the ambulance .
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: Facial swelling; This case was reported by a consumer and described the occurrence of facial swelling in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced facial swelling. Shingrix was discontinued. On an unknown date, the outcome of the facial swelling was recovered/resolved.   It was unknown if the reporter considered the facial swelling to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient received Shingrix around June of 2019 (reporter was uncertain of exact timeframe).  The patient experienced facial swelling approximately 2-3 days after receiving first dose of Shingrix and it was resolved approximately two days after it began. The patient's doctor and pharmacist advised not to receive the second dose of Shingrix. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hashimoto's disease.   In September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months 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 reporter was patient's daughter. In September 2020, patient received 1st dose Shingrix and experienced sore arm. The patient had history of hashimoto. This case is linked to the case US2021003181.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021003181:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Hypersensitivity
Clinical narrative: Atrial Fibrillation; allergic reaction to the vaccine; This case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date). Concurrent medical conditions included multiple allergies (to OTC products, pharma products and huge allergies).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced atrial fibrillation (serious criteria GSK medically significant) and allergic reaction. On an unknown date, the outcome of the atrial fibrillation was recovered/resolved and the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the atrial fibrillation and allergic reaction to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not reported but could be 76 or 77 years. In late 2019 or the beginning of 2020, the patient received 2nd dose of Shingrix and the next day, she had atrial fibrillation, which resolved within 24 to 48 hours, however, she did go to the emergency room but was not admitted. The patient claimed that she experienced an allergic reaction to the vaccine and also mentioned that up until that point she did not had any reaction to any vaccines and now with vaccines as she was getting older. Emergency room visit required. The reporter consented to follow-up.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood urine present, Epistaxis
Clinical narrative: Had a vaccination in the morning. Took a nap before work that evening and woke up with a nose bleed. That night discovered blood in the urine.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Chest X-ray, Cough, Dyspnoea, Feeling abnormal
Clinical narrative: Acutely and abruptly ill on 12/31/2020, early afternoon. Short of breath, dyspnea, mental fogginess, and dry cough.  Spouse took me to ED.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Illness, Metabolic function test, SARS-CoV-2 test positive, Urine analysis
Clinical narrative: Acutely and abruptly ill on 12/31/2020, early afternoon. Short of breath, dyspnea, mental fogginess, and dry cough.  Spouse took me to ED.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Administration error - 0.25mL administered
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Diarrhoea, Dizziness, Fatigue, Feeling cold
Clinical narrative: About 2-3 hours after injection I noticed an achy low back pain. Not sure if related but my feet and nose were cold and hard to warm up.. The next day my main symptom was tired fatigued.  Arm soreness was more moderate than first injection.  Not sure if related but I had bouts of dizziness or vertigo. I had loose stools the next day.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vertigo
Clinical narrative: About 2-3 hours after injection I noticed an achy low back pain. Not sure if related but my feet and nose were cold and hard to warm up.. The next day my main symptom was tired fatigued.  Arm soreness was more moderate than first injection.  Not sure if related but I had bouts of dizziness or vertigo. I had loose stools the next day.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Migraine, Pain, Pyrexia
Clinical narrative: @ about 12/hrs post shot had fever, chills, aches & a migraine lasting for about 20/hrs. additionally had GI upset for about 30/hrs.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Currently experiencing bodyaches and soreness in the left arm
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Administration error - 0.25mL administered
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Dyspepsia, Headache, Pain
Clinical narrative: Body Aches around 6PM on day of vaccination.  Fever of 101.5 at 9PM.  Fever for the next 18-20 hours, high of 103.  Never going below 100, ever with the helped of ibuprofen.  Some of the worst chills and body aches I have ever had. Also, a bad headache.  Fever broke 24 hours after it began. I also had indigestion and some bowel upset.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Body Aches around 6PM on day of vaccination.  Fever of 101.5 at 9PM.  Fever for the next 18-20 hours, high of 103.  Never going below 100, ever with the helped of ibuprofen.  Some of the worst chills and body aches I have ever had. Also, a bad headache.  Fever broke 24 hours after it began. I also had indigestion and some bowel upset.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: 12hrs after vaccination:  slight body aches, very sore at vaccination sight. 14hrs after vaccination: Fever 99.8F, chills, moderate body aches. Treated with 1000mg acetaminophen. Fever maintained, chills and aches worsened. 16hrs-21hrs after vaccination: Strong chills, strong body aches, sustained fever around 100.8F. 21hrs after vaccination: Fever 101.2F, chills, aches. Treated with additional 1000mg acetaminophen. Fever reduced, chills reduced, aches reduced. 24hrs after vaccination: Temperature 99.2F, slight chill, moderate aches. 27hrs after vaccination: Treated aches with 220mg Naproxen. 36hrs after vaccination: Temperature 98.8F, slight aches. 48hrs after: Temperature 98.3, slight aches.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Administration error - 0.25mL administered
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chest pain, Chills, Eye irritation, Fatigue
Clinical narrative: First dose: tenderness at injection site.  Swelling on the roof of mouth that lasted three hours. Second dose: immediate severe tenderness at injection site. By 5pm, I could barely raise my arm and could not touch it. At 11pm, I began to have chills with uncontrollable shaking that lasted 2 1/2 hours. Temperature of 104 that only came down to 102.9 in a 15 hour span.  I did alternate Tylenol and Ibuprofen that entire time.  Severe headache, sore throat,  thirst, burning ears, fatigue, no energy, and chest pain.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Immediate post-injection reaction, Injection site pain, Mobility decreased, Mouth swelling
Clinical narrative: First dose: tenderness at injection site.  Swelling on the roof of mouth that lasted three hours. Second dose: immediate severe tenderness at injection site. By 5pm, I could barely raise my arm and could not touch it. At 11pm, I began to have chills with uncontrollable shaking that lasted 2 1/2 hours. Temperature of 104 that only came down to 102.9 in a 15 hour span.  I did alternate Tylenol and Ibuprofen that entire time.  Severe headache, sore throat,  thirst, burning ears, fatigue, no energy, and chest pain.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Pyrexia, Tremor
Clinical narrative: First dose: tenderness at injection site.  Swelling on the roof of mouth that lasted three hours. Second dose: immediate severe tenderness at injection site. By 5pm, I could barely raise my arm and could not touch it. At 11pm, I began to have chills with uncontrollable shaking that lasted 2 1/2 hours. Temperature of 104 that only came down to 102.9 in a 15 hour span.  I did alternate Tylenol and Ibuprofen that entire time.  Severe headache, sore throat,  thirst, burning ears, fatigue, no energy, and chest pain.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Administration error - 0.25mL administered
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: 8 days post injection I have a large red circle that is hot to the touch. The spot is itchy but not painful.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Gastrointestinal haemorrhage, Haemorrhage, Headache, Pain
Clinical narrative: Bleeding/ gastro intestinal bleeding; Bleeding/ gastro intestinal bleeding; woke up with chest pain; tachycardia; body ache; headache; This is a spontaneous report from a contactable other HCP reported for self. A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1686), via an unspecified route of administration at left arm on 13Jan2021 12:00 PM (that is 14Jan2021 00:00) at SINGLE DOSE for COVID-19 immunization. No Covid prior vaccination. Medical history included allergy to shellfish and Iodine, Kidney and pancreas transplant 10 years ago. Concomitant medications in two weeks includes mycophenolate sodium (MYFORTIC), Tacrolimus, Prednisone, Trazodone. The patient previously received first dose of BNT162B2 (Lot number: EJ1686), at left arm on 24Dec2020 14:30. No Other vaccine in four weeks. On 14Jan2021 09:30 AM, patient woke up the next morning with chest pain, tachycardia, body ache, headache, bleeding. Symptoms lasted from Thursday to Monday. A total of 5 days. Patient have never suffered from a headache and as of 20Jan2021, patient still had it. Every day got better and no longer have the other symptoms. The only other one is the gastro intestinal bleeding. Patient only see few spots of blood when go to the bathroom. She believed that is gastrointestinal because almost never had a period as a teen. No treatment received. Not tested covid post vaccination. Outcome of "Bleeding", "Gastrointestinal bleeding" was not recovered, of "headache" was recovering, of other events was recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events haemorrhage and gastrointestinal haemorrhage cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Bleeding/ gastro intestinal bleeding; Bleeding/ gastro intestinal bleeding; woke up with chest pain; tachycardia; body ache; headache; This is a spontaneous report from a contactable other HCP reported for self. A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1686), via an unspecified route of administration at left arm on 13Jan2021 12:00 PM (that is 14Jan2021 00:00) at SINGLE DOSE for COVID-19 immunization. No Covid prior vaccination. Medical history included allergy to shellfish and Iodine, Kidney and pancreas transplant 10 years ago. Concomitant medications in two weeks includes mycophenolate sodium (MYFORTIC), Tacrolimus, Prednisone, Trazodone. The patient previously received first dose of BNT162B2 (Lot number: EJ1686), at left arm on 24Dec2020 14:30. No Other vaccine in four weeks. On 14Jan2021 09:30 AM, patient woke up the next morning with chest pain, tachycardia, body ache, headache, bleeding. Symptoms lasted from Thursday to Monday. A total of 5 days. Patient have never suffered from a headache and as of 20Jan2021, patient still had it. Every day got better and no longer have the other symptoms. The only other one is the gastro intestinal bleeding. Patient only see few spots of blood when go to the bathroom. She believed that is gastrointestinal because almost never had a period as a teen. No treatment received. Not tested covid post vaccination. Outcome of "Bleeding", "Gastrointestinal bleeding" was not recovered, of "headache" was recovering, of other events was recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events haemorrhage and gastrointestinal haemorrhage cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Impaired work ability, Pain
Clinical narrative: approximately 3am, about 14 hours post-administration, developed body aches (bones, joints, muscles), stabbing pains in shins, severe headache, fever and chils. Temp 102.6 This persisted for 24 hours. 2nd day of illness (1/28/21), temp 99.4-99.8 3rd day(1/29/21) headache continued, mental fogginess, fatigue, some trouble with words  Symptoms from day 3 are continuing to the point of date of filing this.    Missed 2.5 days of work. (Tried to work on the 2nd day of symptoms, left midday)
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: approximately 3am, about 14 hours post-administration, developed body aches (bones, joints, muscles), stabbing pains in shins, severe headache, fever and chils. Temp 102.6 This persisted for 24 hours. 2nd day of illness (1/28/21), temp 99.4-99.8 3rd day(1/29/21) headache continued, mental fogginess, fatigue, some trouble with words  Symptoms from day 3 are continuing to the point of date of filing this.    Missed 2.5 days of work. (Tried to work on the 2nd day of symptoms, left midday)
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Syncope/a complete syncopal episode while standing.  Then a 2nd one on return; unconscious approximately 30 seconds each time; chills; fatigue; muscle aches; joint aches; headaches; extreme dizziness and nausea; extreme dizziness and nausea; injure a knee when my legs pretzeled on the 2nd syncopal episode.; This is a spontaneous report from a contactable consumer. This consumer reported for self that the 53-year-old male patient received second dose of BNT162B2 (COVID-19 Pfizer/Biontech, Lot#: EL3248), via an unspecified route of administration on 13Jan2021 11:00 AM on Left arm at single dose for COVID-19 immunisation. Medical history included Controlled hypertension and known allergies: Hypersensitive to narcotics. Concomitant medications included Amlodipine, Irbesartan and Atoravastin. The patient previously took first dose of BNT162B2 (COVID-19 Pfizer/Biontech, Lot#: EK9231), via an unspecified route of administration on 23Dec2020 11:00 AM on Left arm at single dose for COVID-19 immunisation. Facility type Vaccine was Hospital. No Other vaccine in four weeks. The patient experienced Syncope. He had the most common severe reactions (chillls, fatigue, muscle aches, joint aches, headaches). But when he walked to bathroom, he had extreme dizziness and nausea, then a complete syncopal episode while standing. Then a 2nd one on return. His wife said he was unconscious approximately 30 seconds each time. EMS was called but refused transport since ERs full. The patient did also injure a knee when his legs pretzeled on the 2nd syncopal episode. The events started from 16Jan2021 01:30 AM. The outcome of th events was recovered. No treatment received. No Covid prior vaccination. No covid tested post vaccination.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Joint injury, Loss of consciousness, Myalgia, Nausea, Syncope
Clinical narrative: Syncope/a complete syncopal episode while standing.  Then a 2nd one on return; unconscious approximately 30 seconds each time; chills; fatigue; muscle aches; joint aches; headaches; extreme dizziness and nausea; extreme dizziness and nausea; injure a knee when my legs pretzeled on the 2nd syncopal episode.; This is a spontaneous report from a contactable consumer. This consumer reported for self that the 53-year-old male patient received second dose of BNT162B2 (COVID-19 Pfizer/Biontech, Lot#: EL3248), via an unspecified route of administration on 13Jan2021 11:00 AM on Left arm at single dose for COVID-19 immunisation. Medical history included Controlled hypertension and known allergies: Hypersensitive to narcotics. Concomitant medications included Amlodipine, Irbesartan and Atoravastin. The patient previously took first dose of BNT162B2 (COVID-19 Pfizer/Biontech, Lot#: EK9231), via an unspecified route of administration on 23Dec2020 11:00 AM on Left arm at single dose for COVID-19 immunisation. Facility type Vaccine was Hospital. No Other vaccine in four weeks. The patient experienced Syncope. He had the most common severe reactions (chillls, fatigue, muscle aches, joint aches, headaches). But when he walked to bathroom, he had extreme dizziness and nausea, then a complete syncopal episode while standing. Then a 2nd one on return. His wife said he was unconscious approximately 30 seconds each time. EMS was called but refused transport since ERs full. The patient did also injure a knee when his legs pretzeled on the 2nd syncopal episode. The events started from 16Jan2021 01:30 AM. The outcome of th events was recovered. No treatment received. No Covid prior vaccination. No covid tested post vaccination.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema and swelling at injection site. Began 7 days after injection and has not resolved yet after two days. Grew larger in day 2
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Ear infection
Clinical narrative: Double ear infection; Mild bronchitis; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored program Pfizer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 002191), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received her first dose of the vaccine and is scheduled for her second dose on Friday (unspecified date). On an unspecified date, the patient was diagnosed with a double ear infection and mild bronchitis and was given penicillin in shot form and is on a Z-Pak. The patient asked if it okay that she gets her second dose as scheduled or if she needs to wait until she is done with her antibiotics. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Cold sweat, Diarrhoea, Nausea
Clinical narrative: Severe stomach cramps, nausea and diarrhea, I also felt clammy and had chills. I Drank water and took some pepto which seemed to help