chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis normal, Vomiting, Wheezing
Clinical narrative: At 3am on 1/26/2021 I woke up feeling sick I had a fever of 102F, chills, muscle aches, nausea. I understand that these were expected with the second dose. However at 9:40am I began vomiting. By 11am my throat started to close so I went to the ER. I had a minor asthma attack while I was there (coughing fit and slight wheezing). I was evaluated and they gave me IV fluids as well as other medications through the IV. I received solu-medrol, Benadryl, antacid, and anti-nausea. They took blood tests, urinalysis, and chest x-ray, all of which were normal. I did not have a rash around the injection site this time. I was discharged at about 3:10pm
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Migraine, Pain
Clinical narrative: temp, body aches, migraine, chills
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Dizziness, Hyperhidrosis, Muscular weakness
Clinical narrative: A couple hours after I got the second vaccine, I started to feel a little soreness in my shoulder and clavicle area on the right side of my body. A couple hours after that I had lunch for about half and hour and as I got to getting up I started to feel a little dizziness and had general weakness in the knees and in joints of my thumb. Lower back pain and sweats as of me typing this in now.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever; nausea; arm sore; headache; body aches
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Severe body aches 24 hours after the vaccine was administered.  These aches lasted throughout the day.  I took three doses of 800mg Ibuprofen and tow doses of 1000mg Tylenol to get through the day.  They were gone by the next morning (48 hours after administration) and no additional pain medicine was needed.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: Fever, nausea, fatigue, chills, body aches
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site warmth, Mobility decreased, Oedema peripheral
Clinical narrative: Right arm was sore to move and had armpit tenderness the first week. At the end of the first week I started to notice some redness along the injection site. The armpit began to swell about midweek after the vaccine as well. I began to use ice and ibuprofen to relieve the symptoms however yesterday (1-26-2021) I noticed that the redness was really starting to get worse and contacted my physician. Sent pics via patient chart and he suggested to keep doing what I was doing. This a.m. (1-27-2021) the redness was more apparent (quite warm to the touch too) and starting to broaden down my arm. Called Dr, had a visit. He recommended prednisone on top of icing and ibuprofen. Suggested I let CDC know as well.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Right arm was sore to move and had armpit tenderness the first week. At the end of the first week I started to notice some redness along the injection site. The armpit began to swell about midweek after the vaccine as well. I began to use ice and ibuprofen to relieve the symptoms however yesterday (1-26-2021) I noticed that the redness was really starting to get worse and contacted my physician. Sent pics via patient chart and he suggested to keep doing what I was doing. This a.m. (1-27-2021) the redness was more apparent (quite warm to the touch too) and starting to broaden down my arm. Called Dr, had a visit. He recommended prednisone on top of icing and ibuprofen. Suggested I let CDC know as well.
Age: 9.0
Sex: M
Vaccine: JEV1
Symptoms: Fatigue, Hypersomnia, Nausea
Clinical narrative: Extreme fatigue & nausea.  Slept for approximately 22 hours.  Felt nauseous anytime he woke up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: one week post vaccination I developed bacterial cellulitis at the injection site. After a couple days of pain, erythema, heat, swelling at injection site and feeling generally unwell, I contacted my Dr and included photos. She responded to my message Sunday 1/24 and based upon clinical signs and photos dx'd me with the skin infection and rx'd Cefadroxil 500mg BID x 7. I am currently on treatment. Affected area has grown but not rapidly. Awaiting full resolution.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Skin infection
Clinical narrative: one week post vaccination I developed bacterial cellulitis at the injection site. After a couple days of pain, erythema, heat, swelling at injection site and feeling generally unwell, I contacted my Dr and included photos. She responded to my message Sunday 1/24 and based upon clinical signs and photos dx'd me with the skin infection and rx'd Cefadroxil 500mg BID x 7. I am currently on treatment. Affected area has grown but not rapidly. Awaiting full resolution.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Heart rate increased, Injection site warmth
Clinical narrative: Dizziness  Weakness Chills Body aches  High heart rate Body shaking Migraine  Arm swelling Hot at ejection site Nausea
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Pain, Peripheral swelling, Tremor
Clinical narrative: Dizziness  Weakness Chills Body aches  High heart rate Body shaking Migraine  Arm swelling Hot at ejection site Nausea
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Flushing, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Complained of sore arm within a couple hours of vaccination. By early morning hours had chills, body aches and warm/swollen sore left Deltoid. Took Ibuprofen for above symptoms. About 30-45 minutes later became nauseated with projectile vomiting. Continued throughout the day with body aches, chills, flushed skin and sore arm. Able to keep liquids down by noon.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vomiting
Clinical narrative: Complained of sore arm within a couple hours of vaccination. By early morning hours had chills, body aches and warm/swollen sore left Deltoid. Took Ibuprofen for above symptoms. About 30-45 minutes later became nauseated with projectile vomiting. Continued throughout the day with body aches, chills, flushed skin and sore arm. Able to keep liquids down by noon.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Fatigue, Headache, Hypoaesthesia oral, Pharyngeal hypoaesthesia
Clinical narrative: 30 minutes after the shot, the roof of my mouth and back of mu throat went numb. Only lasted 15-20 minutes. Extreme fatigue and headache. Fever and epistaxis
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 30 minutes after the shot, the roof of my mouth and back of mu throat went numb. Only lasted 15-20 minutes. Extreme fatigue and headache. Fever and epistaxis
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pharyngeal paraesthesia
Clinical narrative: 5 minutes after vaccine given patient began experiencing dizziness, throat tingling, nausea, and diaphoretic. BP 127/87, pulse 86, temp 98, resp 20, O2 sat 98%. MD called an in to evaluate pt. Decision made to give patient Benadryl 25mg from kit. Pt reports improvement to symptoms 25 min later. No further care needed.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Initially the area was sore for about two days after I got the shot, then the injection area began itching about 2 weeks after I got the shot,  then a big red  spot appeared in the area, it itched for about 2 days after I noticed it then slightly after that time....stopped itching and red spot left a week after I noticed it.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Immediately light headed, within 2 hours redness/swelling at injection site.  Extreme fatigue at 4 hours followed by nausea/diarrhea. Woke up the following morning with increased swelling/redness (large red circle) around injection site and hives/rash with intense itching from the waist up.  Went to clinic at work sent to allergist.  Started on 2 (24hr Allegra tabs) in am and 2 (24hr Xyzal tabs) in the pm.  High dose antihistamines continued for 1 week then weaned.  Upon weaning the dose the red/raised swollen circle got worse and spread to new tissue.  Presented back to allergist - EPI and Steroids administered and topical antihistamines applied.  Continuing to take AM/PM antihistamines the circle on my arm now is not as raised but continues to spread out from the injection site to new tissues.  Larger and larger with each passing day.  Now on day 13+
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Rash, Soft tissue swelling, Urticaria
Clinical narrative: Immediately light headed, within 2 hours redness/swelling at injection site.  Extreme fatigue at 4 hours followed by nausea/diarrhea. Woke up the following morning with increased swelling/redness (large red circle) around injection site and hives/rash with intense itching from the waist up.  Went to clinic at work sent to allergist.  Started on 2 (24hr Allegra tabs) in am and 2 (24hr Xyzal tabs) in the pm.  High dose antihistamines continued for 1 week then weaned.  Upon weaning the dose the red/raised swollen circle got worse and spread to new tissue.  Presented back to allergist - EPI and Steroids administered and topical antihistamines applied.  Continuing to take AM/PM antihistamines the circle on my arm now is not as raised but continues to spread out from the injection site to new tissues.  Larger and larger with each passing day.  Now on day 13+
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches for approximately 24 hours the day after getting the second dose.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Migraine
Clinical narrative: 8pm: Headache, pain at injection site  3am: Woke up with extreme chills, severe night sweats and fever of 10.5  7am: Chills, fever, severe pain when moving arm at injection site  9am: Chills subsided, severe migraine, and fatigue, low grade fever  3pm: All symptoms subsided except for pain at injection site and headache
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Night sweats, Pain in extremity, Pyrexia
Clinical narrative: 8pm: Headache, pain at injection site  3am: Woke up with extreme chills, severe night sweats and fever of 10.5  7am: Chills, fever, severe pain when moving arm at injection site  9am: Chills subsided, severe migraine, and fatigue, low grade fever  3pm: All symptoms subsided except for pain at injection site and headache
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Hyperventilation, Impaired work ability, Paraesthesia, Presyncope
Clinical narrative: Had tingling, hypertension, and hyperventilating 5 minutes after injection.  Was place on a table in a supine position.  BP was monitored and was down to 165/86 at 45 minutes after injection.   Heart rate = 67 O2 Stat = 100.  indicative of a vasovagal reaction.  Was able to leave clinic after 1 hour and did not work the rest of the day
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Pain in extremity
Clinical narrative: Sore arm and small bruise at injection site
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Nausea, Pain, SARS-CoV-2 test negative
Clinical narrative: States started with side effects that evening around 6pm. Symptoms include fatigue, nausea, tiredness, body aches, feeling unwell. Calling for follow-up because it has been over 48 hours since the vaccine and she still has symptoms. Now having sinus pain and congestion. Advised to follow-up with PCP. Placed order for COVID. COVID test on 1/19/21 resulted negative.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus congestion, Sinus pain
Clinical narrative: States started with side effects that evening around 6pm. Symptoms include fatigue, nausea, tiredness, body aches, feeling unwell. Calling for follow-up because it has been over 48 hours since the vaccine and she still has symptoms. Now having sinus pain and congestion. Advised to follow-up with PCP. Placed order for COVID. COVID test on 1/19/21 resulted negative.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypersensitivity, Peripheral swelling, Pharyngeal swelling, Swollen tongue
Clinical narrative: Dizziness half hour after vaccine mild, lasted through day 4p feelings of allergic reaction started tongue swelling, throat swelling. Swelling of forearms/calves. Medication Benadryl used. Next day symptoms started again by 9am. Bendryl, Prednisone Rx by Dr. on 3 days off 1 day - symptoms of tongue/throat swelling again. Restarted on Prednisone.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Lymph node pain, Lymphadenopathy
Clinical narrative: Patient received Pfizer BioNTech on 12-23-20 & 1-13-21. She woke upon 1-21-21 with Left side Bell's palsy, She did go to the ER and report attached. She also reported a tennis ball size swollen lymph node in R underarm (armpit) on 1-14-21 for a day or two. very tender to touch.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest discomfort, Chills, Injection site pain, Lethargy
Clinical narrative: -extreme nausea/ stomach pain -severe pain at injection site (> 3 days) -chest tightness -fever / chills  -hot to touch -body ache   -lethargic  lasted 3 fulls days before symptoms subsided (tylenol/motrin)
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Skin warm
Clinical narrative: -extreme nausea/ stomach pain -severe pain at injection site (> 3 days) -chest tightness -fever / chills  -hot to touch -body ache   -lethargic  lasted 3 fulls days before symptoms subsided (tylenol/motrin)
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Burning sensation, Chest X-ray, Electrocardiogram, Laboratory test
Clinical narrative: When administered, the shot burned  I have been taking ibuprofin for pain. generally feels like a bruise & irritating nerve pain to sleep. the 21st & 26th I experienced nerve pain going from my shoulder down my arm, up my neck and across my chest 21st-went to ER, 26th came to urgent care
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Neck pain, Neuralgia, Pain in extremity, X-ray limb
Clinical narrative: When administered, the shot burned  I have been taking ibuprofin for pain. generally feels like a bruise & irritating nerve pain to sleep. the 21st & 26th I experienced nerve pain going from my shoulder down my arm, up my neck and across my chest 21st-went to ER, 26th came to urgent care
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Pyrexia, Vomiting
Clinical narrative: Felt chills when I went to bed. Got up had emesis after drinking water. Fever 101.7. No energy or appetite until 7pm last night.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Arm hurting used his oxygen at time of bed appeared vomited.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia oral, Pharyngeal paraesthesia, Pruritus, Throat tightness
Clinical narrative: 10/13/20/ pm - Received FLU vaccine. About 3pm facial itching, lips tingling, throat itching/tight feeling. 5:30 pm took Allegra which resolved symptoms.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19
Clinical narrative: patient is 2 weeks over COVID symptons; This case was reported by a pharmacist and described the occurrence of covid-19 in a 81-year-old female patient who received Herpes zoster (Shingrix) (batch number 7323T, expiry date 6th May 2022) for prophylaxis.   On 7th October 2020, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.  Additional details were provided as follows: The pharmacist stated the patient was 2 weeks over COVID symptoms and they would like the time frame for the second dose of Shingrix.  The reporter did not consent to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed.  At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature.On 04 Jan 2021, th e patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room  temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Haemoptysis, Lymphadenopathy, Sputum discoloured
Clinical narrative: I have had severe lymph node swelling on the right side where I got the vaccine; 24hrs post 2nd vaccination I have had a sudden onset of an extremely violent cough; My sputum is greenish/yellow brown with blood flecks; My sputum is greenish/yellow brown with blood flecks; chest tightness; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular in the right arm on 11Jan2021 15:45 at single dose for COVID-19 immunisation. Medical history included hypothyroidism, asthma, polycystic ovarian syndrome (PCOS), endometriosis, chronic allergies, gastritis, and walnut allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), metformin, loratadine (CLARITINE), spironolactone, and calcium carbonate, colecalciferol (VITAMIN D 2000). The patient previously took first dose of bnt162b2 (lot number and expiry date not reported), intramuscular in the right arm on 21Dec2020 15:15 at single dose for COVID-19 immunisation. The patient verbalized, "I don't know if it's related but I figured I should report just in case. I have had severe lymph node swelling on the right side where I got the vaccine. 24hrs post 2nd vaccination I have had a sudden onset of an extremely violent cough. By sudden onset, I mean I had no desire to cough and over about 30 min I developed the severe need to cough. My sputum is greenish/yellow brown with blood flecks. I've never experienced such a violent cough with so much sudden sputum production. I am using an Albuterol inhalor to help chest tightness." Clinical outcome of chest discomfort was unknown while for the other events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on a close chronological association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Sputum increased
Clinical narrative: I have had severe lymph node swelling on the right side where I got the vaccine; 24hrs post 2nd vaccination I have had a sudden onset of an extremely violent cough; My sputum is greenish/yellow brown with blood flecks; My sputum is greenish/yellow brown with blood flecks; chest tightness; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular in the right arm on 11Jan2021 15:45 at single dose for COVID-19 immunisation. Medical history included hypothyroidism, asthma, polycystic ovarian syndrome (PCOS), endometriosis, chronic allergies, gastritis, and walnut allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), metformin, loratadine (CLARITINE), spironolactone, and calcium carbonate, colecalciferol (VITAMIN D 2000). The patient previously took first dose of bnt162b2 (lot number and expiry date not reported), intramuscular in the right arm on 21Dec2020 15:15 at single dose for COVID-19 immunisation. The patient verbalized, "I don't know if it's related but I figured I should report just in case. I have had severe lymph node swelling on the right side where I got the vaccine. 24hrs post 2nd vaccination I have had a sudden onset of an extremely violent cough. By sudden onset, I mean I had no desire to cough and over about 30 min I developed the severe need to cough. My sputum is greenish/yellow brown with blood flecks. I've never experienced such a violent cough with so much sudden sputum production. I am using an Albuterol inhalor to help chest tightness." Clinical outcome of chest discomfort was unknown while for the other events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on a close chronological association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, C-reactive protein increased, Chills, Fatigue, Gait disturbance
Clinical narrative: unable to work; ESR of 124 mm/hr; CRP of 4 mg/dl; difficulty with ADLs; neck and leg muscle stiffness and pain; neck and leg muscle stiffness and pain; difficulty ambulating; neck and leg muscle stiffness and pain; fatigue; body aches; chills; sweats; This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at left arm on 18Dec2020 at single dose for COVID-19 immunization. No medical history. The patient's concomitant medications were not reported. Patient had been otherwise well prior to receiving the bnt162b2 on 18Dec2020. Within 72 hours, she experienced fatigue, body aches, chills and sweats since 21Dec2020, though she was able to work Xmas week. On 31Dec2020, she contacted her PCP to report neck and leg muscle stiffness and pain, difficulty ambulating, fatigue, chills and sweats. She had a negative COVID test on 02Jan2021 and essentially negative blood work, other than an ESR of 124 mm/hr and CRP of 4 mg/dl. I had a negative PET scan on 12Jan2021. Currently, she had pain/stiffness in her neck and legs, and progressive difficulty w/ ambulation (both of which are worst in the early hours of the AM), and difficulty with ADLs since 31Dec2020. She had been unable to work since 03Jan2021. Her physician had not indicated or endorsed any relationship between her symptoms and the vax. She forewent dose 2 out of an abundance of caution. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: The events muscle stiffness , neck pain and gait disturbance appeared 13 days after administration of single dose BNT162B2. The Company considers that the events are less likely related to suspect BNT162B2 injection given the weak time association. The detailed clinical course and cause of the events would be helpful for further assessment.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Impaired work ability, Loss of personal independence in daily activities, Musculoskeletal stiffness, Myalgia
Clinical narrative: unable to work; ESR of 124 mm/hr; CRP of 4 mg/dl; difficulty with ADLs; neck and leg muscle stiffness and pain; neck and leg muscle stiffness and pain; difficulty ambulating; neck and leg muscle stiffness and pain; fatigue; body aches; chills; sweats; This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at left arm on 18Dec2020 at single dose for COVID-19 immunization. No medical history. The patient's concomitant medications were not reported. Patient had been otherwise well prior to receiving the bnt162b2 on 18Dec2020. Within 72 hours, she experienced fatigue, body aches, chills and sweats since 21Dec2020, though she was able to work Xmas week. On 31Dec2020, she contacted her PCP to report neck and leg muscle stiffness and pain, difficulty ambulating, fatigue, chills and sweats. She had a negative COVID test on 02Jan2021 and essentially negative blood work, other than an ESR of 124 mm/hr and CRP of 4 mg/dl. I had a negative PET scan on 12Jan2021. Currently, she had pain/stiffness in her neck and legs, and progressive difficulty w/ ambulation (both of which are worst in the early hours of the AM), and difficulty with ADLs since 31Dec2020. She had been unable to work since 03Jan2021. Her physician had not indicated or endorsed any relationship between her symptoms and the vax. She forewent dose 2 out of an abundance of caution. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: The events muscle stiffness , neck pain and gait disturbance appeared 13 days after administration of single dose BNT162B2. The Company considers that the events are less likely related to suspect BNT162B2 injection given the weak time association. The detailed clinical course and cause of the events would be helpful for further assessment.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in extremity, Positron emission tomogram normal, Red blood cell sedimentation rate increased
Clinical narrative: unable to work; ESR of 124 mm/hr; CRP of 4 mg/dl; difficulty with ADLs; neck and leg muscle stiffness and pain; neck and leg muscle stiffness and pain; difficulty ambulating; neck and leg muscle stiffness and pain; fatigue; body aches; chills; sweats; This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at left arm on 18Dec2020 at single dose for COVID-19 immunization. No medical history. The patient's concomitant medications were not reported. Patient had been otherwise well prior to receiving the bnt162b2 on 18Dec2020. Within 72 hours, she experienced fatigue, body aches, chills and sweats since 21Dec2020, though she was able to work Xmas week. On 31Dec2020, she contacted her PCP to report neck and leg muscle stiffness and pain, difficulty ambulating, fatigue, chills and sweats. She had a negative COVID test on 02Jan2021 and essentially negative blood work, other than an ESR of 124 mm/hr and CRP of 4 mg/dl. I had a negative PET scan on 12Jan2021. Currently, she had pain/stiffness in her neck and legs, and progressive difficulty w/ ambulation (both of which are worst in the early hours of the AM), and difficulty with ADLs since 31Dec2020. She had been unable to work since 03Jan2021. Her physician had not indicated or endorsed any relationship between her symptoms and the vax. She forewent dose 2 out of an abundance of caution. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: The events muscle stiffness , neck pain and gait disturbance appeared 13 days after administration of single dose BNT162B2. The Company considers that the events are less likely related to suspect BNT162B2 injection given the weak time association. The detailed clinical course and cause of the events would be helpful for further assessment.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: unable to work; ESR of 124 mm/hr; CRP of 4 mg/dl; difficulty with ADLs; neck and leg muscle stiffness and pain; neck and leg muscle stiffness and pain; difficulty ambulating; neck and leg muscle stiffness and pain; fatigue; body aches; chills; sweats; This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at left arm on 18Dec2020 at single dose for COVID-19 immunization. No medical history. The patient's concomitant medications were not reported. Patient had been otherwise well prior to receiving the bnt162b2 on 18Dec2020. Within 72 hours, she experienced fatigue, body aches, chills and sweats since 21Dec2020, though she was able to work Xmas week. On 31Dec2020, she contacted her PCP to report neck and leg muscle stiffness and pain, difficulty ambulating, fatigue, chills and sweats. She had a negative COVID test on 02Jan2021 and essentially negative blood work, other than an ESR of 124 mm/hr and CRP of 4 mg/dl. I had a negative PET scan on 12Jan2021. Currently, she had pain/stiffness in her neck and legs, and progressive difficulty w/ ambulation (both of which are worst in the early hours of the AM), and difficulty with ADLs since 31Dec2020. She had been unable to work since 03Jan2021. Her physician had not indicated or endorsed any relationship between her symptoms and the vax. She forewent dose 2 out of an abundance of caution. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: The events muscle stiffness , neck pain and gait disturbance appeared 13 days after administration of single dose BNT162B2. The Company considers that the events are less likely related to suspect BNT162B2 injection given the weak time association. The detailed clinical course and cause of the events would be helpful for further assessment.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Hypoaesthesia, Pyrexia
Clinical narrative: feeling cold/coldness; increased temperature/she took her temperature and it was 100.2/fever; body numbness/body started to feel numb; This is a spontaneous report from a contactable nurse reported for herself. A 44-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular at left deltoid on 13Jan2021 16:00 at single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient historic vaccine included the first dose of BNT162B2 on 22Dec2020 for covid-19 immunization. The patient body started to feel numb on 13Jan2021, she was feeling cold/coldness on 14Jan2021, increased temperature on 14Jan2021 and she took her temperature and it was 100.2, stated that she knew that a fever is a side effect. She was only concerned with the body numbness and wanted to know if body numbness was anything to be concerned about. The reporter assessed events was related to Pfizer Covid vaccine and as serious due to medically significant. The outcome of the events was not recovered.; Sender's Comments: Based on the compatible temporal association, the Company considers the reported events of hypoesthesia, pyrexia and feeling cold are possibly related to suspect vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: medication error with Pentacel described as receiving only the liquid DTAP-IPV portion and not the powder HIB component with no adverse event; Initial information regarding an unsolicited valid non-serious case received from a nurse via phone at a call center as a Medication Inquiry on 11-Jan-2021.  This case involved a 4 month old male patient for whom medication error was reported with Pentacel described as receiving only the liquid DTaP-IPV portion and not the powder HiB component with no adverse event (Product preparation issue), after receiving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (PENTACEL).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine 13V for prophylactic vaccination.  On 11-Jan-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE 0.5 mL (lot number: UJ317AAA, expiry date: 04-Jun-2021) via intramuscular route in the left thigh for prophylactic vaccination.  On 11-Jan-2021, medication error was reported with Pentacel described as receiving only the liquid DTaP-IPV portion and not the powder HiB component with no adverse event (Product preparation issue).  At the time of reporting, the patient did not involve any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001-83-EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Ocular hyperaemia, Rhinorrhoea, Throat tightness
Clinical narrative: very red eyes with mucus; nasal discharge; tighening of throat; very red eyes with mucus; Initial information regarding an unsolicited valid non-serious case was received from a consumer via The Agency (Reference number- 00418470) and transmitted to Sanofi on 06-Jan-2021.  The case involved a 67 year old male patient who had allergic reactions, nasal discharge (rhinorrhoea), very red eyes with mucus (ocular hyperaemia and eye discharge) and tightening of throat (throat tightness), while he received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.  Concomitant medications included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL).  On 01-Sep-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site prophylactic vaccination.  On 01-Sep-2020, the patient developed non-serious allergic reactions, nasal discharge (rhinorrhoea), very red eyes with mucus (ocular hyperaemia and eye discharge) and tightening of throat (throat tightness), 2 hours following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Relevant laboratory test was not reported.   Around 6pm, he called his doctor, who prescribed Benadryl. He took the antihistamine about 7PM and went to bed. He stated that he had never taken a flu vaccine before.  On 01-Sep-2020, the patient had recovered from all the reported events within 3 or 4 hours of taking the Benadryl.  There would be no information available on batch number for this case.
Age: 1.0
Sex: M
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: His first dose was on 10/14/2020 and the second (booster) was given on 11/9/2020, 26 days later. 0.5 ml was given each time. First use of Fluzone Quad with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health professional and transmitted to Sanofi on 08-Jan-2021.  This case involved a 1 year old male patient who received his first dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] on 14-Oct-2020 and the second (booster) on 09-Nov-2020, 0.5 ml each time, 26 days later instead of 28 days (inappropriate schedule of product administration). It was the first use of FLUZONE QUAD.  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.  It was a case actual medication error due to inappropriate schedule of product administration (latency 26 days post the prior dose).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error was in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party had contributed to or was to be held liable for the occurrence of this medication error.   There would be no information available on batch number for this case.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: dose of PENTACEL was administered last week, only the Dtap/Ipv portion was administered with no AE; Initial information received on 11-Jan-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old male patient who received an dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: UJ319AA, expiry date: 04-Jun-2021) via intramuscular route in the left thigh on 04-Jan-2021 for prophylactic vaccination (Product preparation issue).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  It was an actual medication error due to Product preparation issue(latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU4
Symptoms: Memory impairment
Clinical narrative: Memory issue; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via The Agency (Reference number- 00428032) and transmitted to Sanofi on 13-Jan-2021 via call-center.  This case involves an 81-year-old male patient who experienced memory issue (memory impairment), while he received vaccines influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent].  The patient's medical history, past vaccination(s), past medical treatment, concomitant medication and family history were not provided.  On an unknown date, the patient received a (one dosage form) dose of suspect influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent] (lot number UJ567AA) (0.7 mg) via unknown route at an unknown administration site for prophylactic vaccination.  On 12-Jan-2021, the patient developed a non-serious memory issue (memory impairment), following the administration of influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent].  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Maternal exposure during breast feeding, Myalgia, Pain in extremity
Clinical narrative: sore arm, headache, muscle aches, fatigue. Also breastfeeding and baby seems slightly more fussy than usual unsure if related.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Mild headache. Took 600mg ibuprofen after an hour, and pain quickly subsided. Has not returned. No other effects.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash pruritic, Skin irritation
Clinical narrative: Began with an itchy top left hand (same side as injection site).  Raised bumps began appearing on both hands and up to the right wrist.  Looks similar to heat rash. Extremely itchy.  Irritation and itch continues on both hands and wrist and continue on to the lower back and abdomen three days later.  Topical anti-itch creams have been applied- very little relief.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Nausea, Pyrexia
Clinical narrative: Day of shot later in the afternoon: Pain in right arm at injection site Day after shot: 2:00 pm- fever. 7:30 pm severe fatigue 2 Days after shot: 9:00am-11:00pm- nausea, fatigue, headache, low grade fever
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, COVID-19, Fatigue, Headache, Rash
Clinical narrative: Rash on Back and on sides wrapping around to the front of chest, primarily on the back. Associated with urticaria.  The patient developed headache, lack of taste, fatigue as well as the aforementioned rash on 1/14/2021(6 days after receiving first dose of covid vaccine.  A rapid covid test was positive on 1/14/2021 also.  The patient was prescribed claritin, methylprednisolone for the rash after seeing his family physician virtually and the family physician recommended he contact where he was vaccinated to report these symptoms.  I have reached out to the patient for additional information and he has declined, so I do not have any access to details on his positive covid test or records from that virtual encounter.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Urticaria
Clinical narrative: Rash on Back and on sides wrapping around to the front of chest, primarily on the back. Associated with urticaria.  The patient developed headache, lack of taste, fatigue as well as the aforementioned rash on 1/14/2021(6 days after receiving first dose of covid vaccine.  A rapid covid test was positive on 1/14/2021 also.  The patient was prescribed claritin, methylprednisolone for the rash after seeing his family physician virtually and the family physician recommended he contact where he was vaccinated to report these symptoms.  I have reached out to the patient for additional information and he has declined, so I do not have any access to details on his positive covid test or records from that virtual encounter.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Pyrexia, Sinus headache
Clinical narrative: Fatigue - Severe Headache - Moderate Chills/Fever - Mild Local (injection site) Muscle Pain - Moderate