chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Temperature regulation disorder, Tilt table test, Tremor, Troponin, Tryptase
Clinical narrative: Patient felt chilled and light headed. She was brought to a room and laid in a bed. She complained of nausea and dizziness with standing. Vital signs were monitored. Oxygen saturation remained at 100%. BP 120s-130s/80s. She did not complain of any shortness of breath or wheezing. She did not complain of any itching. No skin or mucocutaneous findings. She was monitored for 4 hours and given 1L of IV fluids, zofran and ativan. She returned to baseline over the monitoring period.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine analysis
Clinical narrative: Patient felt chilled and light headed. She was brought to a room and laid in a bed. She complained of nausea and dizziness with standing. Vital signs were monitored. Oxygen saturation remained at 100%. BP 120s-130s/80s. She did not complain of any shortness of breath or wheezing. She did not complain of any itching. No skin or mucocutaneous findings. She was monitored for 4 hours and given 1L of IV fluids, zofran and ativan. She returned to baseline over the monitoring period.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Received injection on 12/29/2020 with no adverse event until 10 days post injection on 1/7/2021.  Woke up with strong dull headache; raised, red injection site with heat to the touch and severe itching of site.  Experienced severe fatigue for 24-48 hours.  Following day, 1/8/2021, site is less red, warm still, less itchy, and fatigue is better.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: Received injection on 12/29/2020 with no adverse event until 10 days post injection on 1/7/2021.  Woke up with strong dull headache; raised, red injection site with heat to the touch and severe itching of site.  Experienced severe fatigue for 24-48 hours.  Following day, 1/8/2021, site is less red, warm still, less itchy, and fatigue is better.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue
Clinical narrative: Chills, generalized weakness, fatigue
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Pruritus, Scratch, Sleep disorder
Clinical narrative: My body had started itching  and I didn't know why.  I had not eaten anything new or changed any shampoo or soap. Finally on Thursday night I realized maybe it is the shot that is giving me all the itching. My whole body was flushed I kept scratching my arms and legs, especially  around my ankle, knee, under arm and goin area.  I took an allergy pill  and called Kaiser and spoke with an advice nurse. she   mentioned that taking an allergy pill will relief some of the itching.   I fell asleep around after midnight normally I go to bed around 9:30.  I also called pfizer and explained and the person took all my information and symptoms.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Groin pain, Pain in extremity, Pruritus
Clinical narrative: My body had started itching  and I didn't know why.  I had not eaten anything new or changed any shampoo or soap. Finally on Thursday night I realized maybe it is the shot that is giving me all the itching. My whole body was flushed I kept scratching my arms and legs, especially  around my ankle, knee, under arm and goin area.  I took an allergy pill  and called Kaiser and spoke with an advice nurse. she   mentioned that taking an allergy pill will relief some of the itching.   I fell asleep around after midnight normally I go to bed around 9:30.  I also called pfizer and explained and the person took all my information and symptoms.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Dizziness, Feeling hot, Hyperhidrosis, Musculoskeletal stiffness
Clinical narrative: Fifteen minutes after vaccine administration, patient was sitting outside and had an episode of vasovagal syncope. He became diaphoretic, thousand yard stare, limbs stiff, and then slumped for less than 5 seconds while sitting. He was lowered to the ground and legs elevated, supplemental oxygen provided. He came to within 15 seconds of initial symptoms. He stated he felt hot and ?woozy.? Vital signs: BP 107/69, HR 88, SpO2: 99, Resp: 16, temp 98.8. Blood glucose 127. Patient states he was out in the sun the day prior and did not hydrate as he should have. Cool water was provided and he received 500mL of saline IV.  Patient was monitored for 2 hours post episode and was released back to work feeling good without any further issues. Patient stated he had a previous sync opal episode upon receiving some anxiety producing news in the past and states that this episode felt similar.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Posture abnormal, Staring, Syncope
Clinical narrative: Fifteen minutes after vaccine administration, patient was sitting outside and had an episode of vasovagal syncope. He became diaphoretic, thousand yard stare, limbs stiff, and then slumped for less than 5 seconds while sitting. He was lowered to the ground and legs elevated, supplemental oxygen provided. He came to within 15 seconds of initial symptoms. He stated he felt hot and ?woozy.? Vital signs: BP 107/69, HR 88, SpO2: 99, Resp: 16, temp 98.8. Blood glucose 127. Patient states he was out in the sun the day prior and did not hydrate as he should have. Cool water was provided and he received 500mL of saline IV.  Patient was monitored for 2 hours post episode and was released back to work feeling good without any further issues. Patient stated he had a previous sync opal episode upon receiving some anxiety producing news in the past and states that this episode felt similar.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Headache, Nausea
Clinical narrative: Developed intense chills that caused shaking around midnight after receiving vaccine. Took temperature and it was 100.1 F. Also felt nauseous and had a headache. Worst of the symptoms lasted for about 7 hours.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: L arm injection site red, swelling, pain, erythema
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: After first dose of Moderna COVID-19 vaccine, patient started to experience dizziness and lightheadedness. Patient stated that she had Botox injections in the previous 2 weeks. Patient was given water/juice and was subsequently discharged to home.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Impaired work ability
Clinical narrative: Started feeling dizzy the morning after injection.  Her Blood pressure was up161/96. Dizziness remained all morning, BP did come down to 138/79. She left a message with her PCP and had to call of work for today.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Developed increased swelling at the injection site, with warmth;  tender to touch.  Noted that mildly itchy and ?indurated about 1 day later.  Swelling and firmness persisted several days.  At 2 weeks out,  visually can see circular red rim, larger than silver dollar size but swelling inside the circle is decreased and less hard to touch.  Feels overall warm to touch compared to non-injected side.  No fevers or other symptoms noted during this time.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Developed increased swelling at the injection site, with warmth;  tender to touch.  Noted that mildly itchy and ?indurated about 1 day later.  Swelling and firmness persisted several days.  At 2 weeks out,  visually can see circular red rim, larger than silver dollar size but swelling inside the circle is decreased and less hard to touch.  Feels overall warm to touch compared to non-injected side.  No fevers or other symptoms noted during this time.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Patient received her 1st dose of the COVID-19 Moderna vaccine at her employer's on-site vaccination clinic today, 1/8/21.  Patient was observed for 30 minutes following vaccine administration per recommendations, and did not report feeling any reaction.  Patient has a known bee sting allergy.  Approximately 1 hour following administration, patient began to experience "numbness and tingling in the tongue, and difficulty swallowing" but did not experience tongue swelling.  She contacted school nurse who immediately recommended patient go to the emergency department at Hospital for evaluation.  Hospital evaluated patient,  and prescribed Benadryl 50 mg every 6 hours for the reaction.  The emergency department at Hospital may be reached for additional information as needed.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Anaphylactic reaction, Dysphagia, Endotracheal intubation, Heart rate increased
Clinical narrative: 1/6/21 Pt received vaccine and complained of difficulty swallowing  and rapid heart rate.  Pt received methylprednisolone 125mg IVP, diphenhydramine 25mg IVP, & famotidine 20mg IVP.  Pt reported improvement and was discharged.  Sent home on diphenhydramine and oral prednisone.  1/7/21 Pt unable to swallow her own secretions and experienced eyelid swelling.  Pt vomitted. Pt received epinephrine and Benadryl X 1 dose each.  Pt then transported to hospital via ambulance.  Reason for admission - acute respiratory failure secondary to anaphylactic reaction.  Decision was made to emergently intubate the patient for airway protection despite aggressive intervention.  Pt successfully extubated 1/8/21.  Plan to discharge home  and start Medrol Dose Pack 1/9/21.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid, Vomiting
Clinical narrative: 1/6/21 Pt received vaccine and complained of difficulty swallowing  and rapid heart rate.  Pt received methylprednisolone 125mg IVP, diphenhydramine 25mg IVP, & famotidine 20mg IVP.  Pt reported improvement and was discharged.  Sent home on diphenhydramine and oral prednisone.  1/7/21 Pt unable to swallow her own secretions and experienced eyelid swelling.  Pt vomitted. Pt received epinephrine and Benadryl X 1 dose each.  Pt then transported to hospital via ambulance.  Reason for admission - acute respiratory failure secondary to anaphylactic reaction.  Decision was made to emergently intubate the patient for airway protection despite aggressive intervention.  Pt successfully extubated 1/8/21.  Plan to discharge home  and start Medrol Dose Pack 1/9/21.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: local site reaction with discomfort and worsening erythema, induration, and warmth later developing itching and I still have this topical steroid applied with resolution of most of the induration and warmth, some of the erythema and itching; in the last 48hours I have developed a second and much larger ring of erythema surrounding the central 3-4cm patch of erythema; the outer ring measures about 6-7cm in diameter; no other symptoms
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: redness, warmth and soreness at injection site. Redness doubled in size 48 hrs after . Prickly sensation reported without itching.  Hard lump under reddened area.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: redness, warmth and soreness at injection site. Redness doubled in size 48 hrs after . Prickly sensation reported without itching.  Hard lump under reddened area.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deafness neurosensory, Deafness unilateral, Tinnitus
Clinical narrative: Sudden onset of tinnitus followed by complete hearing loss in Right ear upon awaking from sleep (7 hours)
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deafness neurosensory
Clinical narrative: Sudden onset of tinnitus followed by complete hearing loss in Right ear upon awaking from sleep (7 hours)
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deafness neurosensory, Deafness unilateral, Dry mouth, Fatigue, Headache
Clinical narrative: Sudden onset of tinnitus followed by complete hearing loss in Right ear upon awaking from sleep (7 hours)
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Nasal congestion, Otitis externa, Pain in extremity, Temperature intolerance
Clinical narrative: Sudden onset of tinnitus followed by complete hearing loss in Right ear upon awaking from sleep (7 hours)
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus, Upper-airway cough syndrome
Clinical narrative: Sudden onset of tinnitus followed by complete hearing loss in Right ear upon awaking from sleep (7 hours)
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deafness neurosensory, Deafness unilateral, Tinnitus
Clinical narrative: Patient awoke with a neurosensory deafness in right ear on Jan 7, 2021.  Patient then saw ENT AND AND started on high dose steroids  in the evening of Jan 7, 2021
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deafness neurosensory
Clinical narrative: Patient awoke with a neurosensory deafness in right ear on Jan 7, 2021.  Patient then saw ENT AND AND started on high dose steroids  in the evening of Jan 7, 2021
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deafness neurosensory, Deafness unilateral, Dry mouth, Fatigue, Headache
Clinical narrative: Patient awoke with a neurosensory deafness in right ear on Jan 7, 2021.  Patient then saw ENT AND AND started on high dose steroids  in the evening of Jan 7, 2021
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Nasal congestion, Otitis externa, Pain in extremity, Temperature intolerance
Clinical narrative: Patient awoke with a neurosensory deafness in right ear on Jan 7, 2021.  Patient then saw ENT AND AND started on high dose steroids  in the evening of Jan 7, 2021
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus, Upper-airway cough syndrome
Clinical narrative: Patient awoke with a neurosensory deafness in right ear on Jan 7, 2021.  Patient then saw ENT AND AND started on high dose steroids  in the evening of Jan 7, 2021
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash back of neck and both arms with itching.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: fever, chills, headache, muscle pain
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Pain
Clinical narrative: Temp max 103.7 averaged 101 with Tylenol. Lasted approximately 36 hrs. Severe body aches/chills/shaking. Severe headache for 4 days. Severe fatigue.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Temp max 103.7 averaged 101 with Tylenol. Lasted approximately 36 hrs. Severe body aches/chills/shaking. Severe headache for 4 days. Severe fatigue.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, SARS-CoV-2 test, Sinusitis
Clinical narrative: Three days after I became very tired and had chills. Also I felt very achy and did not have a fever. The next morning I felt a little better. I had sinus infectious .
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Dyspnoea, Eczema eyelids, Eye pruritus, Eye swelling
Clinical narrative: AWOKE DAY 2 FOLLOWING VACCINE WITH POSSIBLE ALLERGIC REACTION: THROAT SORENESS/TIGHTNESS AND HOARSE VOICE, EYES SWOLLEN, ITCHY AND RED.   C/O DIFFICULTY BREATHING.  DENIED FEVER, CHILLS OR BODY ACHES.  MEDICATED WITH BENEDRYL 50 MG AND NO RELIEF.  SENT TO ER WITH DIFFICULTY BREATHING.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Laryngitis viral, Ocular hyperaemia, Oropharyngeal pain, Throat tightness, Vaccination complication
Clinical narrative: AWOKE DAY 2 FOLLOWING VACCINE WITH POSSIBLE ALLERGIC REACTION: THROAT SORENESS/TIGHTNESS AND HOARSE VOICE, EYES SWOLLEN, ITCHY AND RED.   C/O DIFFICULTY BREATHING.  DENIED FEVER, CHILLS OR BODY ACHES.  MEDICATED WITH BENEDRYL 50 MG AND NO RELIEF.  SENT TO ER WITH DIFFICULTY BREATHING.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Exposure during pregnancy, Fatigue, Injection site pain, Injection site pruritus
Clinical narrative: G3P1010, currently pregnant at 9 weeks. Vaccine was administered at 9 1/7 weeks. Due date is 8/9/2021. Had normal arm soreness starting about 4 hours after received the vaccine, limited to deltoid region of left arm, plus some mild fatigue. Soreness was significantly better by about 30 hours post-vaccine, and gone by 48 hours.  On 1/6/2021, one week after receiving the vaccine, I started to develop itching in my left arm around the vaccine site. By 1/7/2021, there was erythema, mild edema, ongoing pruritus and felt warm to the touch. Today, 1/8/2021, all symptoms are gone.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema, Pruritus, Skin warm
Clinical narrative: G3P1010, currently pregnant at 9 weeks. Vaccine was administered at 9 1/7 weeks. Due date is 8/9/2021. Had normal arm soreness starting about 4 hours after received the vaccine, limited to deltoid region of left arm, plus some mild fatigue. Soreness was significantly better by about 30 hours post-vaccine, and gone by 48 hours.  On 1/6/2021, one week after receiving the vaccine, I started to develop itching in my left arm around the vaccine site. By 1/7/2021, there was erythema, mild edema, ongoing pruritus and felt warm to the touch. Today, 1/8/2021, all symptoms are gone.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness and swelling in right arm after Covid vaccine administered in incorrect injection site.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: the morning after receiving the vaccine, developed chills, low grade fever and vomiting: progressed to include diarrhea
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Headache, Pain in extremity, Palpitations
Clinical narrative: Patient states that her symptoms started about 6 pm. She said she had a headache, shortness of breath, racing heart, arm ache, shivers, and head shakes.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pain
Clinical narrative: Pain @ injection site. pain to move arm. Pain did not relieve w/ OTC IBU OR ICe.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient had initial redness at injection site which disappeared then on 1/1/21, the area became red, swollen, and hot all over. The area continues to be red and patient describes significant itching at the injection sight.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock, Dysphagia, Respiratory distress
Clinical narrative: After 4 minutes of vaccine administration (at 10:00am) patient developed respiratory difficulty and swallowing problems. A Rapid Response code was activated for an Anaphylactic Shock. One dose of Epinephrine 0.3mg IM and two doses of Benadryl 50mg IV were administrated. Vital Signs at 10:02a.m: BP 197/107mmhg, HR 103bpm and O2 Saturation:99%. Vitals Signs at 10:07a.m: BP 211/110mmhg, HR 110bpm and O2 Saturation:98%. At 10:07a.m patient was transfer to the ER by the Rapid Response team.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Right upper arm in vaccination injection area sore for 3 days then  tender to touch, 2.5 cm hard red  palpable swollen area and itchy started 3 days after injection and then redness and soreness for 4 days, today redness starting to diffuse and becoming less red and tender but still a bit swollen. No other side effects noted.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush
Clinical narrative: ON 1/5/21 AT 12:30PM, DEVELOPED HOT FLASHES THAT LASTED 20 MINUTES BEFORE RESOLVING.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Joint stiffness, Muscle tightness
Clinical narrative: Woke up this morning with a throbbing headache and tightness/soreness from my shoulder to up my neck. It feels like I slept funny and have a bad kink in my neck. I am also feeling a little light headed and slightly nauseous. I ate some oatmeal for breakfast and took 1000mg of Acetaminophen and it has not helped. Its been almost 2 hours since I took the tylenol with no result.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Neck pain
Clinical narrative: Woke up this morning with a throbbing headache and tightness/soreness from my shoulder to up my neck. It feels like I slept funny and have a bad kink in my neck. I am also feeling a little light headed and slightly nauseous. I ate some oatmeal for breakfast and took 1000mg of Acetaminophen and it has not helped. Its been almost 2 hours since I took the tylenol with no result.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling hot, Headache, Oropharyngeal pain, Streptococcus test
Clinical narrative: Throat hurting , really hot Neck Swollen , back of Neck hurt really bad  Joint Pains  Headache
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Throat hurting , really hot Neck Swollen , back of Neck hurt really bad  Joint Pains  Headache
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Heart rate increased, Tachycardia
Clinical narrative: Increased heart rate, tight chest, dizzy more noticeable for 24 hours and then mainly night time tachycardia for 3-4 nights so far, ongoing.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased
Clinical narrative: pain in shoulder, decreased range of motion
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: No adverse reaction noted. Facility notified on 1/7/21 by agent that she did not give permission for patient to receive COVID-19 vaccine.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: (L) shoulder site became red, hot, swollen, hard w/definable edges the night of the injection; improved after a few days, but never resolved completely. On 1/6/2021, became increasingly itchy, w/increased swelling, redness, heat.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Erythema, Headache, Pain, Pruritus
Clinical narrative: soreness itchiness redness x 9 days swollen headaches axillary pain/ swelling
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: soreness itchiness redness x 9 days swollen headaches axillary pain/ swelling
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Severe body ache, especially calf muscles,  chills, head ache, exhaustion injection site pain including shoulder and shoulder blades.
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Myalgia, Pain
Clinical narrative: Severe body ache, especially calf muscles,  chills, head ache, exhaustion injection site pain including shoulder and shoulder blades.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Lip swelling, Swollen tongue, Throat tightness
Clinical narrative: Swelling of lips & tongue, tightening of throat. Quivering of arms & legs. Tightening of chest. Dizzyness lightheaded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Swelling of lips & tongue, tightening of throat. Quivering of arms & legs. Tightening of chest. Dizzyness lightheaded.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Pain, Pyrexia
Clinical narrative: Fever, chills, bodyaches & shortness of breath - approx. 24 hours after receiving vaccine. Referred to ER for treatment.
Sex: U
Vaccine: HPV9, UNK
Symptoms: Product storage error
Clinical narrative: GARDASIL 9 and verbalized that it was administered after the temp excursion had ocurred; This spontaneous report was received from a medical assistant and  refers to a patient of unknown age and gender. No information was given regarding the patient's concurrent conditions, concomitant medications or medical history.      On 29-DEC-2020, the patient was vaccinated with an improperly stored  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) with lot # 1687292 and expiration date on 25-AUG-2022 for prophylaxis (dose and route of administration were not reported).  The administered dose experienced temperature excursion on 22-DEC-2020 at 22.7 F for 35 minutes and a previous temperature excursion was reported for 07-DEC-2020 at 32.6 F for 30 minutes. This call was because of a data logger. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2101USA001792: US-009507513-2101USA001777:
Age: 0.17
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A nurse inadvertently gave a dose of VAQTA to a 2-month-old; no other AE reported; This spontaneous report was received from a physician referring to a 2-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.}  On 05-JAN-2021, a nurse inadvertently gave a dose of hepatitis a vaccine, inactivated (VAQTA), 0.5 milliliter (additional dosage regimen information was not reported) for prophylaxis. It was mentioned that the physician ordered an hepatitis B vaccine, however, it was not reported that the patient also received this vaccine.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Flatulence, Headache, Illness
Clinical narrative: cramps; gas; diarrhea; headache; fever; chills; started to feel sick; This case was reported by a consumer via call center representative and described the occurrence of cramp in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included diverticulitis and renal stone. Concurrent medical conditions included constipation. Concomitant products included plantago ovata (Metamucil).   In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced cramp, gas, diarrhea, headache, fever, chills and sickness. On an unknown date, the outcome of the cramp, gas, diarrhea, headache, fever, chills and sickness were unknown.   It was unknown if the reporter considered the cramp, gas, diarrhea, headache, fever, chills and sickness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in her right arm and within 2 days started to feel sick with chills, fever, headache, diarrhea, gas, cramps.  The patient had a history of kidney stones and history of diverticulitis and she has to take Metamucil to help with her constipation. The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Pyrexia
Clinical narrative: cramps; gas; diarrhea; headache; fever; chills; started to feel sick; This case was reported by a consumer via call center representative and described the occurrence of cramp in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included diverticulitis and renal stone. Concurrent medical conditions included constipation. Concomitant products included plantago ovata (Metamucil).   In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced cramp, gas, diarrhea, headache, fever, chills and sickness. On an unknown date, the outcome of the cramp, gas, diarrhea, headache, fever, chills and sickness were unknown.   It was unknown if the reporter considered the cramp, gas, diarrhea, headache, fever, chills and sickness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in her right arm and within 2 days started to feel sick with chills, fever, headache, diarrhea, gas, cramps.  The patient had a history of kidney stones and history of diverticulitis and she has to take Metamucil to help with her constipation. The reporter consented to follow up.
Age: 95.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Gait disturbance, Walking aid user
Clinical narrative: Dizzy; "Wobbly on his feet." / needs to use a walker or cane; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 95-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th November 2020, the patient received the 2nd dose of Shingrix. On 20th November 2020, 1 days after receiving Shingrix, the patient experienced dizziness and unsteady gait. On an unknown date, the outcome of the dizziness and unsteady gait were not recovered/not resolved.   It was unknown if the reporter considered the dizziness and unsteady gait to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and feeling dizzy and wobbly on his feet needs to use a walker or cane to steady himself.  The events had not resolved at time of report. The reporter unable to remain on the phone and did not provide demographics or any other information for this AE.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness at injection site; Swelling at injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age group was captured as adult as per vaccine indication. The reporter did not consent to follow-up. There was no vaccination date, injection site, patient's identifiers, lot number nor expiration date provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; Headache; feeling unwell; muscle pain; This is a spontaneous report from a contactable nurse reporting on himself. A 61-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 28Dec2020 at 08:15 AM (at the age of 61 years old) as a single dose in the left arm for COVID-19 vaccination. Relevant medical history and concomitant medication were not provided.  The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Jan2021, the patient experienced mild side effects consisting of headache with feeling unwell and muscle pain. The patient reported this happened on 01Jan2021, and 02Jan2021 and on 03Jan2021 and later, the patient did not experience any side effect. Since the vaccination, the patient was tested for COVID-19 on 02Jan2021 with a Nasal Swab Rapid Test and tested positive for COVID-19. The adverse events resulted in Emergency room/department or urgent care visit. The patient did not receive any treatment for these events. The outcome of the events headache with feeling unwell and muscle pain and tested positive for COVID-19 was recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: felt the need to have a COVID test, which turned out positive; felt the need to have a COVID test, which turned out positive; felt the need to have a COVID test, which turned out positive; Chills; Fever; This is a spontaneous report from a contactable Other HCP. A 55-year-old female patient received frist dose of BNT162B2 (Batch/lot number: EK5730) via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications.  The patient explained receiving the COVID-19 vaccine on the 21Dec2020 and experienced fever and some chills. She pursed explaining that she was fine afterwards but felt the need to have a COVID test, which turned out positive of the 31Dec2020. The patient stated that she only had chills and fever the evening of 29Dec2020 and had been fine every since. Her fever that night did not hit 100 degrees. She thought that it would be better if she did not go to work on that Wednesday since she had had a fever the night before. She called her doctor who told her to come into the office on 31Dec2020 to have a rapid COVID test done and it came back positive. She only had fever and chills that one night and has not had any other symptoms. She received no treatment and did not take anything for the fever. This all happened during the night. She felt fine when she got up the next morning. Because she had received the first dose of the COVID vaccine, she thinks that this helped her. She thinks if she had not had the vaccine, then the virus would have been a lot worse. She stated that her second dose of the vaccine is scheduled on the 11Jan2021, and asked if it is safe to get the second dose of the COVID-19 vaccine.  The outcome of events chills and fever was recovered; of other events was unknown.; Sender's Comments: The association between lack of effect (suspected COVID-19, SARS CoV2 test positive) with BNT162b2 can not be completely excluded.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Caller tested positive for COVID after the first dose; Caller tested positive for COVID after the first dose; This is a spontaneous report from an other Health Care Professional  (HCP).  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number and expiration date unknown) via an unspecified route of administration on an unspecified date (at an unknown age) at an unspecified dose for COVID-19 vaccination. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient tested positive for COVID after the first dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive  on  an unspecified date. The clinical outcome was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Night sweats, Pain
Clinical narrative: Caller tested positive for COVID after the first dose; Caller tested positive for COVID after the first dose; This is a spontaneous report from an other Health Care Professional  (HCP).  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number and expiration date unknown) via an unspecified route of administration on an unspecified date (at an unknown age) at an unspecified dose for COVID-19 vaccination. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient tested positive for COVID after the first dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive  on  an unspecified date. The clinical outcome was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Pollakiuria, Pyrexia, SARS-CoV-2 test positive, Sluggishness
Clinical narrative: Caller tested positive for COVID after the first dose; Caller tested positive for COVID after the first dose; This is a spontaneous report from an other Health Care Professional  (HCP).  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number and expiration date unknown) via an unspecified route of administration on an unspecified date (at an unknown age) at an unspecified dose for COVID-19 vaccination. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient tested positive for COVID after the first dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive  on  an unspecified date. The clinical outcome was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Weight decreased
Clinical narrative: Caller tested positive for COVID after the first dose; Caller tested positive for COVID after the first dose; This is a spontaneous report from an other Health Care Professional  (HCP).  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number and expiration date unknown) via an unspecified route of administration on an unspecified date (at an unknown age) at an unspecified dose for COVID-19 vaccination. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient tested positive for COVID after the first dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive  on  an unspecified date. The clinical outcome was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: got the 1st dose of the vaccine then tested positive after; got the 1st dose of the vaccine then tested positive after; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the 1st dose of the vaccine then tested positive after. She was asking if she can get the 2nd dose even if she is tested positive. She asked if it can cause to have a false positive result if she received the vaccine. Outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache
Clinical narrative: there is pain radiating down the right side of her back and in the right side of her head and temple; Bad pain on right side of head, neck, and back; mild - moderate headache; This is a spontaneous report from a contactable consumer.  A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 11:15 on the left arm at single dose for COVID-19 immunisation.  Medical history included immune disorder with high inflammatory markers, gluten intolerance, she is ANA positive (last time she was tested it was 2800) and allergic to sulfites.  The patient's concomitant medications were not reported.  The patient stated "she received vaccine on 30Dec2020. For the first 24 hours had no side effects, then developed a mild headache after 24 hours and 24 hours after that it worsened and developed pain on the right side of her neck that is like the stem of her headache and there is pain radiating down the right side of her back and in the right side of her head and temple. States that since this developed, it has persisted, not gotten worse or better. Wants to clarify that this does not involve her arms just her neck, head and back. States no amount of pain medication is working to relieve the pain. Ibuprofen is normally her go to and it did not work, she then tried the ADVIL LIQUIGELS, she took 400mg, states it was not working, she then got Bayer Back and Body to try because it has Aspirin in it, took 1500mg, three total pills, helped for an hour and then pain came back. Also tried a daytime THERAFLU just trying to get rid of the body aches, Good Sense Daytime Cold and Flu". The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Tingling in mouth, numb tongue and lips; numb tongue and lips; This is a spontaneous report from a contactable pharmacist. A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL0142), intramuscular on 04Jan2021 14:30 at single dose at left arm for COVID-19 immunization. There was no medical history reported. Concomitant medication included pravastatin, levothyroxine, colecalciferol (VITAMIN D [COLECALCIFEROL]), calcium, glucose oxidase, lactoferrin, lactoperoxidase, lysozyme, sodium fluorophosphate (BIOTENE [GLUCOSE OXIDASE;LACTOFERRIN;LACTOPEROXIDASE;LYSOZYME;SODIUM FLUOROPHOSPHATE]). On 04Jan2021 14:45, within 15 min observation period, the patient experienced tingling in mouth, numb tongue and lips. No throat swelling. The patient was given 25mg diphenhydramine. Therapeutic measures were taken as a result of tingling in mouth, numb tongue and lips. The outcome of the event was recovered in Jan2021.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dermatitis contact, Fatigue, Vaccination site erythema, Vaccination site rash, Vaccination site swelling
Clinical narrative: Swollen; redness, slightly swollen, and a small rash around injection site; redness, slightly swollen, and a small rash around injection site; redness, slightly swollen, and a small rash around injection site; Tiredness; rash from the face mask; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as Age: 77, Unit: Unspecified) received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included tested positive for covid on 01Jul2020. The patient's concomitant medications were not reported. The patient received Covid 19 vaccine on 02Jan2021. In Jan2021, she experienced still swollen, redness, slightly swollen, and a small rash around injection site. She felt tiredness. She also got a rash from the face mask. She is calling to inquire if these side effects are common and how to treat. The outcome of the events tiredness and rash from the face mask was unknown, while for the other events was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling, Vaccination site rash
Clinical narrative: Swollen; redness, slightly swollen, and a small rash around injection site; redness, slightly swollen, and a small rash around injection site; redness, slightly swollen, and a small rash around injection site; Tiredness; rash from the face mask; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as Age: 77, Unit: Unspecified) received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included tested positive for covid on 01Jul2020. The patient's concomitant medications were not reported. The patient received Covid 19 vaccine on 02Jan2021. In Jan2021, she experienced still swollen, redness, slightly swollen, and a small rash around injection site. She felt tiredness. She also got a rash from the face mask. She is calling to inquire if these side effects are common and how to treat. The outcome of the events tiredness and rash from the face mask was unknown, while for the other events was not recovered.  Information on the lot/batch number has been requested.