chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Nasopharyngitis, Pain in extremity
Clinical narrative: Soreness of Arm, cold like symptoms for 3hrs day after, joint pain
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling, Throat irritation, Urticaria
Clinical narrative: Developed hives on face and both arms.  Released after 30 minutes of monitoring with no further progression of symptoms.  Returned one hour later reporting scratchy throat and feeling of being swollen all over.  Also presented with increased redness on face (blushing). No difficulty with shortness of breath.  Escorted to ER for monitoring.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Moderna Covid-19 Vaccine EUA Swollen lymph node in right arm pit: starting 12/27/20 at 11:00 pm
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: severe vertigo
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Facial paresis, Feeling hot, Flushing
Clinical narrative: Became hot, flushed and felt dizzy,.  Had slight weakness in rt face
Age: 56.0
Sex: M
Vaccine: UNK
Symptoms: Headache, Pain, Pyrexia, Tremor
Clinical narrative: Woke up at 11 pm on 12/28 with a fever of 102.5 Terrible headache  Body aches  Uncontrollable shaking
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives 4 hours post-vaccine. Improved with diphenhydramine. Resolved by the following day
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hyperhidrosis, Palpitations, Paraesthesia, Pharyngeal swelling
Clinical narrative: Adverse reaction post Covid vaccine. Waited for 20 min post vaccine. Experienced S/S Heart palpitations, shortness of breath, tingling in extremities, diaphoretic after leaving clinic observation. Drove back to hospital, escorted by pre surgical testing hospital staff and taken by wheelchair to ED.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: 12/23 Day after vaccine with fatigue, 12/24 with fatigue and muscle aches; ongoing fatigue with chills starting 12/29
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills
Clinical narrative: Body Chills, Joint pain
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Pruritus, Wound complication
Clinical narrative: major confusion 9 hours after first administration continuing on to the next day, pain at wound site, itchy feeling
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Butterfly rash, Fatigue
Clinical narrative: Patient reported developing a "butterfly rash" across the bridge of nose and cheeks approximately 24 hours after COVID-19 vaccine.  Rash resolved without treatment within 10 days.  Also experienced some fatigue.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dyspnoea, Pulmonary pain, Swelling face, Throat clearing
Clinical narrative: Within 1 hr of receiving shot felt heaviness and pain in lungs, gradually getting worse then swollen face and clearing of throat constantly by hr 4.  By hr 7 gradual lung pain and face swelling reduced.  Today 12/29 still have some lung pain little face swelling but still have trouble breathing while walking and talking.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pruritus, Rash, Throat tightness
Clinical narrative: shortness of breath, throat tightening, rash, itching  Pt was seen in the ER and was given Epi IM , benadryl and solumedrol
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Decreased appetite, Dizziness, Headache
Clinical narrative: Throbbing, constant pain with burning from L) shoulder joint to fingertips plus shoulder joint up to left neck; nausea, dizziness, headache, joint pain (all body), muscle aches, throwing up, loss of appetite
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site joint pain, Injection site pain, Myalgia, Nausea, Neck pain
Clinical narrative: Throbbing, constant pain with burning from L) shoulder joint to fingertips plus shoulder joint up to left neck; nausea, dizziness, headache, joint pain (all body), muscle aches, throwing up, loss of appetite
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vomiting
Clinical narrative: Throbbing, constant pain with burning from L) shoulder joint to fingertips plus shoulder joint up to left neck; nausea, dizziness, headache, joint pain (all body), muscle aches, throwing up, loss of appetite
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling cold, Pain, SARS-CoV-2 test negative
Clinical narrative: Achiness, chills and fatigue for 2 days.  Better for 1 day, worked and went for a run, then woke up in middle of night going into 4th day post vaccine with severe aches.   Got Covid tested on day 4, came back negative on day 5.  I am now on day 11 post vaccine and am still having aches in my hip joints.  I?m unsure if it?s related to the vaccine but I haven?t been able to run (I am a regular runner) without pain.  I did not have any pain from running prior to the vaccine.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Achiness, chills and fatigue for 2 days.  Better for 1 day, worked and went for a run, then woke up in middle of night going into 4th day post vaccine with severe aches.   Got Covid tested on day 4, came back negative on day 5.  I am now on day 11 post vaccine and am still having aches in my hip joints.  I?m unsure if it?s related to the vaccine but I haven?t been able to run (I am a regular runner) without pain.  I did not have any pain from running prior to the vaccine.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Malaise, Pain
Clinical narrative: Injection site soreness in the AM 12/23. Later in the day on 12/23, body aches and general malaise. On 12/24 continued malaise and painful headache.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Low grade fever and body aches onset approx 14-16 hours post vaccine
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Hot flush, Pain
Clinical narrative: Lightheaded, body aches, hot flashes, chills, developed a 101 fever, shortness of breath
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Lightheaded, body aches, hot flashes, chills, developed a 101 fever, shortness of breath
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Feeling hot, Nervousness, Palpitations
Clinical narrative: The patient was given the Moderna vaccine.  She then felt very hot around 15 min post vaccine, felt anxious. Felt her HR was racing, so she looked at her Apple Watch, which said it was 103bpm. She let the RN know and it went up to 125 bpm. BP was 140 which is high for the patient, baseline is around 100 systolic.  She then felt shaky. The RN said she saw a few hives on her chest and it was a bit itchy. They gave her some water and juice. She felt better and the hives resolved on their own.  She then was given Zyrtec 10mg.  About 30 min post-vaccine, her HR was 85 and BP was 130 systolic. No wheezing, no SOB, O2 sat was normal the entire time. She still feels shaky and anxious.   2 h later she felt asymptomatic.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: The patient was given the Moderna vaccine.  She then felt very hot around 15 min post vaccine, felt anxious. Felt her HR was racing, so she looked at her Apple Watch, which said it was 103bpm. She let the RN know and it went up to 125 bpm. BP was 140 which is high for the patient, baseline is around 100 systolic.  She then felt shaky. The RN said she saw a few hives on her chest and it was a bit itchy. They gave her some water and juice. She felt better and the hives resolved on their own.  She then was given Zyrtec 10mg.  About 30 min post-vaccine, her HR was 85 and BP was 130 systolic. No wheezing, no SOB, O2 sat was normal the entire time. She still feels shaky and anxious.   2 h later she felt asymptomatic.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Low grade fever to 100.1 the morning after receiving the vaccine, mild body aches and headache. Symptoms dramatically improved within 12hrs and by the following morning (48hrs post receipt of vaccine), I was symptom free.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Experienced numbing of right face and jaw for half a day 2 days post vaccination.  Took ibuprofen 400mg and symptoms eventually resolved.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Arm soreness Feverish Chills Body Aches
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Pt felt lightheaded. Pt did not eat breakfast or lunch prior to vaccine. Pt commonly becomes nauseated after flu shots with no additional adverse effects. Pt was positioned in supine and given Sprite and crackers. After eating, symptoms resolved.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Red itchy spots/hives across abdomen and chest.  Have used topical anti-itch cream, taken over the counter benadryl and zyrtec.  Topical cream and benadryl did not seem to have any effect.  Just took zyrtec this morning so results tbd.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac monitoring, Chest discomfort, Electrocardiogram, Flushing, Hypoaesthesia
Clinical narrative: within 2 minutes after receiving vaccine I became flush, tightness in base of my throat and chest and heart starting racing faster and faster. A few nurses came over and saw my fit bit heart rate going higher (max 136 BPM) my fingertips started to get numb. They quickly injected me with .05 epinephrine.  They brought me up to the emergency room and put me on  a heart monitor. The racing heart subsided after approx. 7 min then started again. It happened 3 times in the emergency room. They ran a few EKG's to try to catch the tachycardia episodes. They started an IV and ran fluids. After 2 hours the symptoms stopped and they released me from the hospital.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Tachycardia, Throat tightness
Clinical narrative: within 2 minutes after receiving vaccine I became flush, tightness in base of my throat and chest and heart starting racing faster and faster. A few nurses came over and saw my fit bit heart rate going higher (max 136 BPM) my fingertips started to get numb. They quickly injected me with .05 epinephrine.  They brought me up to the emergency room and put me on  a heart monitor. The racing heart subsided after approx. 7 min then started again. It happened 3 times in the emergency room. They ran a few EKG's to try to catch the tachycardia episodes. They started an IV and ran fluids. After 2 hours the symptoms stopped and they released me from the hospital.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Rash, Throat tightness
Clinical narrative: within 2 minutes after receiving vaccine I became flush, tightness in base of my throat and chest and heart starting racing faster and faster. A few nurses came over and saw my fit bit heart rate going higher (max 136 BPM) my fingertips started to get numb. They quickly injected me with .05 epinephrine.  They brought me up to the emergency room and put me on  a heart monitor. The racing heart subsided after approx. 7 min then started again. It happened 3 times in the emergency room. They ran a few EKG's to try to catch the tachycardia episodes. They started an IV and ran fluids. After 2 hours the symptoms stopped and they released me from the hospital.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Rash
Clinical narrative: Mild rash all over the body the evening post-vaccination. Alleviated by diphenhydramine. Heart palpitations for 2 days post-vaccination
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Pain, Pain in extremity
Clinical narrative: Sore arm, body aches that are as bad as when I  had covid, chills, stomach ache.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: 12am I woke up with a headache chills body aches and sore arm
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Extrasystoles, Pain, Pain in extremity
Clinical narrative: Sore arm, Heart skipping Beats, Body pain
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Erythema, Pruritus, Urticaria
Clinical narrative: Itching, redness, hives to right side of face and neck, abd pain.  Right upper back pain started almost immediately after vaccination.  Continued through the night.  Itching, redness, and hives resolved in approximately 2 hours with administration of dexamethasone.  Abd pain continues today. Right upper back pain is full today, instead of sharp, and is intermittent today.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: The employee reported difficulty breathing.  She  transferred to the Emergency Department for elevated heart rate and possible syncopal episode.  Symptoms self resolve with no medications required.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Received vaccine on 12/28/2020  @ 930am.  By 7:00pm  left deltoid  was tender to touch. Redness , swelling  at site. on 12/29/2020 the redness and swelling had increased to  1 inch  wide x 3 inch like a band across my deltoid , It is tender to touch and  itchy.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypoaesthesia
Clinical narrative: Facial numbness,redness
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Low grade fever lasting about 24 hours. Highest was 99.7.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Headache
Clinical narrative: terrible headache, pain in the joints, chest tightness.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis
Clinical narrative: Sweating then chills. Back to back. Two days.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling redness and soreness at injection site
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Erythema, Fatigue, Hyperhidrosis
Clinical narrative: Soreness in arm immediately.  13 hours after injection- sweats, chills, increased arm pain, body aches, extremity pain, palm sensitivity, nausea, trouble sleeping.  14 hours after injection- fever, shortness of breath, fatigue, redness in arm, swelling in injection site.  18 hours after injection- stiffness in injection site, extreme fatigue, increased nausea.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injection site reaction, Injection site swelling, Insomnia, Musculoskeletal stiffness
Clinical narrative: Soreness in arm immediately.  13 hours after injection- sweats, chills, increased arm pain, body aches, extremity pain, palm sensitivity, nausea, trouble sleeping.  14 hours after injection- fever, shortness of breath, fatigue, redness in arm, swelling in injection site.  18 hours after injection- stiffness in injection site, extreme fatigue, increased nausea.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Soreness in arm immediately.  13 hours after injection- sweats, chills, increased arm pain, body aches, extremity pain, palm sensitivity, nausea, trouble sleeping.  14 hours after injection- fever, shortness of breath, fatigue, redness in arm, swelling in injection site.  18 hours after injection- stiffness in injection site, extreme fatigue, increased nausea.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Myalgia, Pain in extremity
Clinical narrative: 6 hours post vaccine: sore arm, chills 24 hours post vaccine: fever (101-102), chills, myalgias, headache, severe soreness at injection site (no other symptoms). All symptoms resolved by 48 hours post vaccine.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 6 hours post vaccine: sore arm, chills 24 hours post vaccine: fever (101-102), chills, myalgias, headache, severe soreness at injection site (no other symptoms). All symptoms resolved by 48 hours post vaccine.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Rash
Clinical narrative: cough and a little difficulty breathing rash in the torso (of abdomen and back
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Dizziness, Erythema, Headache, Hypersensitivity
Clinical narrative: Red circle about 3 inches wide and 3 inches long bruising itching, swelling, dizzy headache
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling
Clinical narrative: Red circle about 3 inches wide and 3 inches long bruising itching, swelling, dizzy headache
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Nausea, Pallor, Palpitations
Clinical narrative: COVID vaccine given at 0910 in L deltoid. At 0926 pt reported feeling a heaviness in her chest, tingling around her mouth and palpitations. Denies history of allergies but PMH remarkable for Von Willebrands, only receives medical intervention prior to surgical procedures. Vitals obtained at 0930: 159/94, pulse 77, 100% with 10L non-rebreather. Pt continued to experience pale skin, palpitations, nausea, and lightheadedness. At 0931 she reported swelling/lump in her throat, denied issues breathing but noted that she had 'junk' in her throat. 1 dose of 0.3mg EPIPEN was administered to L leg at 0932. Vitals taken at 0933: 164/94, HR 70, 02 is 88% on RA. 10L on non-rebreather restarted.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pharyngeal swelling, Sensation of foreign body, Throat irritation
Clinical narrative: COVID vaccine given at 0910 in L deltoid. At 0926 pt reported feeling a heaviness in her chest, tingling around her mouth and palpitations. Denies history of allergies but PMH remarkable for Von Willebrands, only receives medical intervention prior to surgical procedures. Vitals obtained at 0930: 159/94, pulse 77, 100% with 10L non-rebreather. Pt continued to experience pale skin, palpitations, nausea, and lightheadedness. At 0931 she reported swelling/lump in her throat, denied issues breathing but noted that she had 'junk' in her throat. 1 dose of 0.3mg EPIPEN was administered to L leg at 0932. Vitals taken at 0933: 164/94, HR 70, 02 is 88% on RA. 10L on non-rebreather restarted.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Nausea
Clinical narrative: Headache and injection site pain, Nausea
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: patient received his second dose  of shingrix on 12/12/20 . He reported today that the following day after he received the vaccine, he experienced  intense itch and chicken pox like spots all over his chest. he has tried anti itching cream without resolution . Pharmacist recommended patient go to his primary doctor to get prescription for antiviral cream/tab for symptoms relief. Will follow up with patient later today.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Moderna has an EUA from the FDA for patients aged 18 and older.  This vaccine was used inappropriately to vaccinate a 17 year old staff member at a clinic hosted by Pharmacy.  Patient experienced no adverse effects, but this improper usage of the vaccination requires reporting to VAERS.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives down bilateral exposed skin - Benadryl oral tab provided with relief.  Hives disappeared by 12:45PM
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: elevated blood pressure to 156/92 following injections.  Experienced dizziness.   BP checked 5 hours after vaccine: 143/88.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Dizziness, Electrocardiogram
Clinical narrative: lightheaded, left lower arm pain chest pain  with burning sensation , increase heart rate to over 190  and High blood pressure  lasting for 2-3 hours
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypertension, Pain in extremity
Clinical narrative: lightheaded, left lower arm pain chest pain  with burning sensation , increase heart rate to over 190  and High blood pressure  lasting for 2-3 hours
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Fever, Nausea, Diarrhea, covid test was negative
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Blood test normal, Magnetic resonance imaging normal, Seizure
Clinical narrative: Seizure x2 in 12 hours. First seizure lasted 30 sec to 1 minute at 8:30 am second seizure lasted 1 minute at 4:30 pm on the same day. Took patient to the ER after both events.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dyspnoea, Heart rate increased, Paraesthesia, Rash
Clinical narrative: Upon receiving vaccination felt tingling in left arm. Within 10 minutes experienced SOB, elevated HR, rash, whelps, elevated BP. Resolved with treatment with IVF, solumedrol, benedryl and Pepcid by ER provider.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Upon receiving vaccination felt tingling in left arm. Within 10 minutes experienced SOB, elevated HR, rash, whelps, elevated BP. Resolved with treatment with IVF, solumedrol, benedryl and Pepcid by ER provider.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: On December 27th I began to have uticaria on my chest, back, legs and neck that respond to oral diphenhydramine but return after 6-8 hours. This is ongoing for three days so far.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis requiring epinephrine
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Headache and Fever (101.4) and extreme chills, shivering, lasting approximately 7 hrs, then fever reduced to 99.1, then no fever approx 3 hours after that.  Still have slight headache.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Body aches, low grade fever 99.5
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Injection sight soreness
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Body aches, chills, slight fever
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Malaise
Clinical narrative: Injection site was red, painful and swollen. Malaise.  Fever started in evening of 12/18/2020, reached 101.0 degrees F. Controlled with Tylenol. 12/20/2020 - fever abated, injection site still swollen and painful. Malaise. 12/21/20 - while injection site was still sore, swelling and redness were less, and malaise was gone.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: a couple days after the vaccine, I developed a rash on the bottom of my abdomen, my neck, and my elbow creases. The rash was worst along my abdomen especially the right hip. The rash is red and looks like tiny red circles.
Age: 42.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site hypoaesthesia, Injection site paraesthesia, Injection site pruritus, Injection site warmth
Clinical narrative: Patient called the pharmacy on 12/28/20 around noon and reported she was having a reaction to the flu shot. She received it around 4pm on 12/26/20. Her right arm developed a hard red area at the injection site, numbness and tingliness, hurt when she moved the arm, and slightly itchy too. We advised her to call her doctor and take allergy medicine. She left work to go to urgent care. They drew a marker around the red area and told her to measure and monitor it. They advised her to pick up benadryl and 650mg tylenol.
Age: 42.0
Sex: F
Vaccine: FLUR4
Symptoms: Pain
Clinical narrative: Patient called the pharmacy on 12/28/20 around noon and reported she was having a reaction to the flu shot. She received it around 4pm on 12/26/20. Her right arm developed a hard red area at the injection site, numbness and tingliness, hurt when she moved the arm, and slightly itchy too. We advised her to call her doctor and take allergy medicine. She left work to go to urgent care. They drew a marker around the red area and told her to measure and monitor it. They advised her to pick up benadryl and 650mg tylenol.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Fatigue, joint pain, muscle aches, headache, nausea and vomiting for three days. Treated  at home with over the counter pain relievers.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fatigue, joint pain, muscle aches, headache, nausea and vomiting for three days. Treated  at home with over the counter pain relievers.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Swelling
Clinical narrative: Neck swelling, labored breathing
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Myalgia
Clinical narrative: Fatigue, Muscle pain and redness at injection site
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: moderate rash to left arm, mild to right arm. Also rash to trunk and legs. Benadryl was taken
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives to face for 1.5 hours - improved after 1 course of Benadryl
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: 5 minutes after the injection I developed tinnitus in both ears. This has continued on since the injection.  It varies in intensity but is constantly there. I had never experienced tinnitus prior to the shot.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Neck pain
Clinical narrative: Vaccine recipient received vaccine on 12/17/2020. Reported that they felt tired the next day. Three days after receiving the vaccine, reported to develop headache and neck/should pain. This was still bothering the vaccine recipient. Directed to follow-up with occupation health.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Influenza like illness, Pain, Pyrexia
Clinical narrative: Rapid heart rate, achy, fever 101, flu like symptoms started about 7 hours after vaccine. She did have Covid on 11/1/2020. She is going to give it today and see how she feels and will let me know if she goes to the DR or ER.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Myalgia
Clinical narrative: Pain at injection site, muscle pain, redness around injection site
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, shortness of breath, headache, myalgias
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Headache, Pruritus, Swelling face, Wheezing
Clinical narrative: itching, face and eye swelling, wheezing, H/A. Treated successfully with Epi X 2 and Benadryl.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis requiring epinephrine
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: tenderness in armpit, specifically upon touch
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nasal congestion, Pain, SARS-CoV-2 test positive
Clinical narrative: Patient received the covid vaccine on 12/20/2020. She reported that she started to have chills (temp reading were in 98.0s), headache, bodyaches, and swelling of the Right groin on 12/21/2020. She was evaluated by her PCP (in person) and treated with Ampicillin x 7 days . She did NOT inform her PCP about her covid vaccination status. HAs, bodyaches, chills, and R groin swelling resolved by 12/26/2020. On 12/28/2020 she c/o new onset of nasal congestion. Denies fevers or cough.  She tested positive for covid on 12/28/2020 at Employee Health. Has FU appt with PCP in one week and EH on on 1/7/2021.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Patient received the covid vaccine on 12/20/2020. She reported that she started to have chills (temp reading were in 98.0s), headache, bodyaches, and swelling of the Right groin on 12/21/2020. She was evaluated by her PCP (in person) and treated with Ampicillin x 7 days . She did NOT inform her PCP about her covid vaccination status. HAs, bodyaches, chills, and R groin swelling resolved by 12/26/2020. On 12/28/2020 she c/o new onset of nasal congestion. Denies fevers or cough.  She tested positive for covid on 12/28/2020 at Employee Health. Has FU appt with PCP in one week and EH on on 1/7/2021.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on  abdomen, back, and ankles; associate reports taking loratadine 10 mg PO from personal stock
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Flushing, Hypoacusis
Clinical narrative: Fell light headed, muffled hearing, flush, warm.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling jittery, Heart rate increased
Clinical narrative: Jittery, Increase heart rate with 20 min after shot.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Burning sensation, Dissociation, Dizziness, Feeling abnormal
Clinical narrative: Light Headed, Cold, burning sensation inside, nausea,  felt like she was going to pass out, rash on chest/neck, she could hear people talking but felt she didn't feel like she was  present - elevated BP 200/110.  Staff member took Metoprolol 25mg.  1/2 hour took medication feels better but feels foggy
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Nausea, Rash
Clinical narrative: Light Headed, Cold, burning sensation inside, nausea,  felt like she was going to pass out, rash on chest/neck, she could hear people talking but felt she didn't feel like she was  present - elevated BP 200/110.  Staff member took Metoprolol 25mg.  1/2 hour took medication feels better but feels foggy
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on the upper chest and neck
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Heart rate increased, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Increased heart rate and blood pressure, syncope, nausea, sore throat, fever
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Increased heart rate and blood pressure, syncope, nausea, sore throat, fever
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Chest pain, Chills, Fatigue
Clinical narrative: I received the Pfizer EK5730 shot at about 11:30 am on 12/28/2020. When I walked out of the office from getting the shot I started feeling like I had walked mile but I was ok. At about 4:00 PM I started feeling some tightness on my chest and some aching like a pulsing aching on my chest. I felt like I had some energy but I also felt I was paying to mush attention to my symptoms. I lay down at 8:30 PM and I fallen to sleep on the couch. When I got up this morning as stood up from my bed my legs were hurting and I feel exhausted. I just want to cuddle and go back to sleep. I force myself to make it to work but I am dealing with leg pain and very very tired with a slight headache and chills.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: I received the Pfizer EK5730 shot at about 11:30 am on 12/28/2020. When I walked out of the office from getting the shot I started feeling like I had walked mile but I was ok. At about 4:00 PM I started feeling some tightness on my chest and some aching like a pulsing aching on my chest. I felt like I had some energy but I also felt I was paying to mush attention to my symptoms. I lay down at 8:30 PM and I fallen to sleep on the couch. When I got up this morning as stood up from my bed my legs were hurting and I feel exhausted. I just want to cuddle and go back to sleep. I force myself to make it to work but I am dealing with leg pain and very very tired with a slight headache and chills.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; improperly stored administered vaccines; This spontaneous report was received from a nurse and refers a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 20-NOV-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD), dose: 0.5 milliliter, lot# S021326, expiry date: 05-JAN-2021 (dose number, route of administration, anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of -10.8 degrees Celsius for 1 hour 30 minutes. There were previous excursions related: -12.3 degrees Celsius for 1 hour and -10.3 degrees Celsius for 10 hours and 30 minutes. Data logger was involved. No adverse events were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA003626: US-009507513-2012USA003635: US-009507513-2012USA003631: US-009507513-2012USA003632: US-009507513-2012USA003633: US-009507513-2012USA003634: US-009507513-2012USA003618: US-009507513-2012USA003617: US-009507513-2012USA003627:
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: no adverse event; received a dose of expired Zostavax; This spontaneous report was received from a medical assistant and refers to a 69-year-old male patient. No information regarding the patient's medical history, concomitant medications and previous drug reactions or allergies was reported. His concurrent conditions included leg swelling.   On 20-DEC-2020, the patient was vaccinated with an expired dose of zoster vaccine live (ZOSTAVAX) for prophylaxis (lot # N035033 was verified to be valid, expiration date reported as 02-MAR-2019, but upon internal validation established as 07-MAR-2020) (strength, dose, frequency and route of administration were not provided). The patient did not experience any additional adverse reactions. It was reported that the reason the patient was initially seen in the urgent care was a leg swelling and he was directed to an Emergency Room to rule out a deep vein thrombosis (DVT), but it was before he received zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient received his 2nd dose of GARDASIL 9 at an interval of 13 months after the initial dose; no additional adverse events reported; This spontaneous report was received from a nurse practitioner and refers to a 12 years old male patient. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (formulation, dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, 13 months after the initial dose, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (formulation, dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration).  There was no additional adverse event reported.
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: hissing and ringing in her ears; This case was reported by a consumer and described the occurrence of ringing in ears in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced ringing in ears. On an unknown date, the outcome of the ringing in ears was unknown.   It was unknown if the reporter considered the ringing in ears to be related to Shingrix.  Additional details were provided as follows: This reporter reported for her neighbor patient. The age at vaccination was not reported. The patient received Shingrix last week and experienced the hissing and ringing in her ears There were no further details for this patient. This is 1 of the 7 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR222005:same reporter US-GLAXOSMITHKLINE-US2020221335:same reporter US-GLAXOSMITHKLINE-US2020AMR230569:same reporter US-GLAXOSMITHKLINE-US2020AMR230567:same reporter US-GLAXOSMITHKLINE-US2020AMR230553:same reporter US-GLAXOSMITHKLINE-US2020AMR221923:same reporter US-GLAXOSMITHKLINE-US2020221342:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: My husband has fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The age at vaccination was not reported. The patient experienced fever after getting Shingrix approximately 14 hours ago. The patient asked was there a safe medicine he can take to bring down the fever.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Insomnia, Monoplegia, Peripheral swelling, Pyrexia
Clinical narrative: ARM SWELLING; extreme pain; exteme pain (unable to sleep); fever of 100.9; headache; This case was reported by a consumer via sales rep and described the occurrence of swelling arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th December 2020, the patient received the 2nd dose of Shingrix. On 5th December 2020, less than a day after receiving Shingrix, the patient experienced swelling arm, pain, sleeplessness, fever and headache. On 6th December 2020, the outcome of the swelling arm, pain, sleeplessness, fever and headache were recovered/resolved.   It was unknown if the reporter considered the swelling arm, pain, sleeplessness, fever and headache to be related to Shingrix.  Additional details were provided as follows: On 5th December 2020, the patient had undergone body temperature test which results 100.9 degree F. After receiving 2nd dose of Shingrix, the patient experienced arm swelling, extreme pain, unable to slee, fever and headache. This continued till Sunday but has since subsided. The reporter consent to follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Musculoskeletal stiffness, Sleep disorder
Clinical narrative: Severe headache woke me from sleep approx. 6 hrs later,  continued till the next day; Severe headache woke me from sleep approx. 6 hrs later,  continued till the next day; severe neck and back stiffness, just did not feel well; severe neck and back stiffness, just did not feel well; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received bnt162b2 (Pfizer Biontech COVID 19 vaccine), lot number: EJ1685, via an unspecified route of administration at the left arm on 20Dec2020 06:30 at a single for COVID-19 immunization. Prior to vaccination the patient was diagnosed with COVID-19. Concomitant medication included levothyroxine sodium (SYNTHROID), carvedilol (COREG), ergocalciferol (VIT D), vitamin b complex (VIT B COMPLEX) and bupropion hydrochloride (WELLBUTRIN). On 20Dec2020, the patient experienced severe headache that woke her from sleep approximately 6 hours later and continued till the next day.  She started having severe neck and back stiffness and just did not feel well. The patient was not hospitalized for the events and did not receive any treatment for the events. The events were reported as non-serious. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The events recovered on an unspecified date in Dec2020.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Dizziness, Dysarthria, Feeling abnormal, Heart rate decreased
Clinical narrative: Her BP went down to 80/60 with a pulse of 50.; sudden light headiness/light headedness; pulse of 50; Slurred speech; extreme sleepiness/sleepiness that there was no other focal deficit; felt like she was under anesthesia, was unable to move her legs/felt like she was under general anesthesia trying to wake up but unable to open her eyes or move her arms or legs; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number and expiration date were not reported, via an unspecified route of administration on unspecified date at a single dose for immunization. Medical history was none. The patient's concomitant medications were not reported. It was reported that the patient (a doctor) received the vaccine and had a sudden light headiness, slurred speech, and extreme sleepiness with outcome of recovered. She felt like she was under anesthesia, and was unable to move her legs. Her BP went down to 80/60 with a pulse of 50. All of these episode lasted about 2 hours. The patient became alert, but she still felt a bit light headed. She felt normal the next day. The patient said that at the sudden onset of the side effects: light headedness, slurred speech, and sleepiness that there was no other focal deficit. She felt like she was under general anesthesia trying to wake up but unable to open her eyes or move her arms or legs. The outcome of the events Her BP went down to 80/60 with a pulse of 50, sudden light headiness/light headedness, Slurred speech, extreme sleepiness/sleepiness that there was no other focal deficit and felt like she was under anesthesia, was unable to move her legs/felt like she was under general anesthesia trying to wake up but unable to open her eyes or move her arms or legs was recovered on an unknown date.  Information about lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of low blood pressure/ low pulse with dizziness 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
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Somnolence
Clinical narrative: Her BP went down to 80/60 with a pulse of 50.; sudden light headiness/light headedness; pulse of 50; Slurred speech; extreme sleepiness/sleepiness that there was no other focal deficit; felt like she was under anesthesia, was unable to move her legs/felt like she was under general anesthesia trying to wake up but unable to open her eyes or move her arms or legs; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number and expiration date were not reported, via an unspecified route of administration on unspecified date at a single dose for immunization. Medical history was none. The patient's concomitant medications were not reported. It was reported that the patient (a doctor) received the vaccine and had a sudden light headiness, slurred speech, and extreme sleepiness with outcome of recovered. She felt like she was under anesthesia, and was unable to move her legs. Her BP went down to 80/60 with a pulse of 50. All of these episode lasted about 2 hours. The patient became alert, but she still felt a bit light headed. She felt normal the next day. The patient said that at the sudden onset of the side effects: light headedness, slurred speech, and sleepiness that there was no other focal deficit. She felt like she was under general anesthesia trying to wake up but unable to open her eyes or move her arms or legs. The outcome of the events Her BP went down to 80/60 with a pulse of 50, sudden light headiness/light headedness, Slurred speech, extreme sleepiness/sleepiness that there was no other focal deficit and felt like she was under anesthesia, was unable to move her legs/felt like she was under general anesthesia trying to wake up but unable to open her eyes or move her arms or legs was recovered on an unknown date.  Information about lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of low blood pressure/ low pulse with dizziness 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
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Malaise, Paraesthesia
Clinical narrative: Hypotensive (diastolic 43, sistolic 103); neurological tingling -upper spine/between shoulder blades; felt crummy; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 21Dec2020 15:45 at single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced hypotensive (diastolic 43,sistolic 103), neurological tingling - upper spine/between shoulder blades and generally felt crummy on 21Dec2020 at 15:45 (also reported as occurred within 5 minutes of shot). The patient underwent lab tests and procedures which included blood pressure measurement: 103/43 on 21Dec2020. Event resulted in emergency room and physician's room visit. Treatment received intravenous (IV) fluid replacement, lab tests (unspecified), 6 hour observation. The outcome of events was unknown.  Information on the lot/batch number has been requested.