chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash macular
Clinical narrative: 8 days after first shot I developed red rash all around my arm. Splotchy
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Myalgia, Pyrexia, Vomiting
Clinical narrative: fever, vomit,muscle pain and overall discomfort
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: 8 days post vaccines - Redness, swelling Rash, itching at injection site
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: Moderate arm soreness with onset about 4 hours after vaccination and lasting until 30 hours post vaccination. Moderate headache the 2 mornings following vaccination. Used 500mg x 1 each morning with good affect.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Neuralgia
Clinical narrative: I have had nerve, joint and muscle pain primarily in my left arm down through my fingers and occasionally in my left leg from my hip down through my foot. It comes and goes and often varies in intensity from nothing to more significant pain.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Muscular weakness, Soft tissue swelling
Clinical narrative: Employee's PCP urged her to report headache, soft tissue swelling, muscle weakness, and enlarged lymph nodes.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administration error: received 2nd dose early, 15th day post 1st vaccine. 1st dose on 12/28/2020
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness
Clinical narrative: Chills and dizziness for about 3 days after the shot, no medical  treatment required but plenty of bed rest and hot liquid.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Covid-19 vaccine administered 1/6/21. Injection site swelling, redness and itching started on 01/14/21. Seen in clinic on 1/15/21. 4x4 cm area of swelling and mild redness noted. DX: mild reaction allergy. Conservative treatment: Elevate arm. Apply warm compresses to the upper arm 4 times a dat 20 mins at a time. Return to clinic in five days for re-evaluation.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine, Pain, Pain in extremity
Clinical narrative: Monday, January 25, 2021, three days after the vaccine, I overall physically feel better; however, when I went to the restroom, I noticed that the toilet was filled with blood which concerned me. I do not know if it is related to the vaccine or not. I do not feel ill. I do not have a temperature. I have minor pain in my arm and am somewhat achy, but like I said, blood being in the toilet is not normal so it does worry me.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Cough, Oropharyngeal pain, SARS-CoV-2 test negative
Clinical narrative: On the 26th, I had a sore throat that persisted, cough and loss of voice.  I was out of work for about 5 days.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Gait disturbance, Pyrexia
Clinical narrative: Fever of 103+F, weakness, difficulty walking, joint soreness...patient rested and was given tylenol doses of 975mg 2X
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Lethargy
Clinical narrative: Muscle aches and joint aches, headache, fever of 100.1, chills and lethargic from 11pm Friday the 22nd until Sunday morning of the 24th then tired for the rest of Sunday. 100 percent better by Monday, January 24th, 2021. Took ibuprofen (600mg) and acetaminophen (100g) three times a day which brought fever down to 99.7 but did not do much for aches.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Muscle aches and joint aches, headache, fever of 100.1, chills and lethargic from 11pm Friday the 22nd until Sunday morning of the 24th then tired for the rest of Sunday. 100 percent better by Monday, January 24th, 2021. Took ibuprofen (600mg) and acetaminophen (100g) three times a day which brought fever down to 99.7 but did not do much for aches.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Wheezing
Clinical narrative: Patient began coughing intermittently and then began having difficulty breathing. Was clutching counter and had significant wheeze with each breath. No swelling observed in face but breathing difficulties were significant and concerning. Gave patient one epipen dose in left upper leg. Patient's breathing improved but then was not responding well and appeared to be losing consciousness. Had staff call 911 and EMTs arrived. They gave patient IM diphenhydramine in left upper arm and took patient to ER.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: CELLULITIS TREATED WITH KEFLEX
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: Employee complained of shoulder discomfort in vaccinated arm, which began radiating to her other arm.  She reports being unable to lift any item.  She is seeing her primary physician later today.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fatigue around 8 pm  High fever (exact temp unknown) and chills from about 9 pm to 1:30 am  Tired and fatigued the following day  No effects after the second day
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Hypertension, Hypoaesthesia oral, Nausea, Pain
Clinical narrative: over about an hour increasingly achy, arm pain, fever, nausea, high blood pressure, lower lip numb (sometimes a sign of a TIA), some confusion (sometimes the sign of a TIA) The severe nausea came in waves, lasted a couple of hours and cleared by Midnight before she went to sleep.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: over about an hour increasingly achy, arm pain, fever, nausea, high blood pressure, lower lip numb (sometimes a sign of a TIA), some confusion (sometimes the sign of a TIA) The severe nausea came in waves, lasted a couple of hours and cleared by Midnight before she went to sleep.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chills, Dyspnoea, Headache
Clinical narrative: Thirteen hours after second does of Moderna Covid - 19 vaccine I experienced fever (low-grade 100.6),  chills, headache, body aches, joint pain, nausea with vomiting.  These symptoms lasted for approximately 7 hours.  Headache, body aches, fatigue and tightness in my chest (with some shortness of breath at times) continued for  48 hours after injection of the vaccine.  Of course, significant arm pain at injection site is present as well.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Thirteen hours after second does of Moderna Covid - 19 vaccine I experienced fever (low-grade 100.6),  chills, headache, body aches, joint pain, nausea with vomiting.  These symptoms lasted for approximately 7 hours.  Headache, body aches, fatigue and tightness in my chest (with some shortness of breath at times) continued for  48 hours after injection of the vaccine.  Of course, significant arm pain at injection site is present as well.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: From the very beginning it has itched.  By the next day red or swollen, no pain.  Ignored it but the redness started to spread on the arm, started feeling firmer, decide to see doctor.  Saw him on 1/22/21, who felt like some of the bacteria got under the skin and put her on Benadryl and Doxycycline.  It's a lot lighter as far as redness, and not as firm but redness is spreading 4-5" across the arm.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: welts/hives on the arm where vaccination given
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site joint pain, Injection site pain, Somnolence
Clinical narrative: Patient reports around 11 pm 12/20/2021 began having flu like symptoms, still lingering today, 1/21/20221. Injection site pain, joint pain, muscle pain, drowsiness.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain in extremity
Clinical narrative: Patient reports pain in her left arm that is at a constant 4-5 out of 10 during day, and 8-9 out of 10 while sleeping that started since she received SC varicella vaccine on 12/22/2020. Seen by PCP on 1/20/2021 before presenting to workplace occupational health clinic for 2nd dose of varicella and 2nd booster of Hep B on 1/25/2021.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: Woke up day after injection with chills and fever of 99.7.  Experienced body achiness and general  malaise with fever increasing 100.7 by afternoon.  Took two Tylenol tablets successfully lower fever.  By 9:00 pm that evening felt much better, but "wrung-out" after this  reaction.   Following day, feeling much better but some linering malaise. Looks like I am going to pull through OK.??
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Vein discolouration
Clinical narrative: Caller stated that 24 hours after the injection she noticed that her veins "got really blue"; Caller stated that 24 hours after the injection she noticed that her veins "got really blue" and she had soreness/pain in on the underside of her arm that was asministered the vaccine; that her veins "got really blue" and she had soreness/pain in on the underside of her arm that was asministered the vaccine; she might have got the injection intravenously; This spontaneous report was received from a consumer and refers to a 70-year old female patient. The patient's concurrent conditions, medical history, drugs reactions or allergies were not provided. Concomitant therapies included levothyroxine sodium (SYNTHROID),  On 08-JAN-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, strength, lot # and expiration date were not provided) for the indication reported as:" doctor has recommended it". The reporter was not 100% sure, but she might have got the injection intravenously. She stated that 24 hours after the injection, on 09-JAN-2021, she noticed her veins "got really blue" and she had soreness/pain in on the underside of her arm that was administered the vaccine. She said that she did not have other reactions and her pain has since dissipated. The outcome of the events was reported as recovering.    The causal relationship between adverse events and  pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Sleep disorder
Clinical narrative: Although I'm 50 and age-wise, due to have hot flashes, I had not had them in months, especially since I started losing weight from May 2020 through September 2020.  (total of 20lbs). A few days after getting 1st dose the hot flashes have been relentless; Internal hot flashes literally every 5-10m, daily, consistently throughout the day, even as I fill out this report. Not sure if the dose has anything to do with this starting up again, but I wanted to report it just in case some others report it.  I do not take anything for the flashes. I just seek some form of air conditioning such as a fan. However, the flashes are very annoying as I even get them while sleeping and it interrupts my rest. No sweating though.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs reported; Vaccine experienced temperature excursion and was administered; This spontaneous report was received from a physician (also reported as a site manager) and refers to a patient of an unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.   On 19-JAN-2021, the patient was vaccinated with an improperly stored dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) 0.5 milliliter, lot # R028528 was confirmed to be valid, expiration date 04-JUN-2021, (route and site of administration were not provided) for prophylaxis. The administered dose was exposed to the temperature of 31 degrees Fahrenheit for 1 hour and 15 minutes. There was no previous temperature excursion. The call was because of a digital data logger. No additional adverse event was reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: Skin rash with red, raised and warm site
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Nausea, Vomiting
Clinical narrative: Woke up with Nausea and vomiting all day 4 days later.  Took Zofran for the vomiting.  Also had a migraine and fatigue. Resolved in approx 8 hours
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Chills and body aches
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction: Warm to the touch Red circle (rash) 2 1/1 inch diamter Slight swelling Bruise                   Ongoing and getting worse at 12th day after injection
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Fatigue, Headache, Immediate post-injection reaction
Clinical narrative: throat felt like it was closing up; had issues swallowing; it feels like her throat will close up and open up; felt dizzy; shaky; nauseous; extremely tired; had a strong headache; It's like she is having allergy and hay fever type symptoms; It's like she is having allergy and hay fever type symptoms; The lymph nodes in her neck feel like they are swollen, it feels like she has a big lump in the middle and sides of her throat.; feels like she has a big lump in the middle and sides of her throat; This is a spontaneous report from a contactable other healthcare professional (patient). A 23-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot no: EL1283, via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported she got the Covid vaccine on Saturday, 09Jan2021, and immediately her throat felt like it was closing up, she was instantly reacting to the vaccine. Since then, she has had issues swallowing; it feels like her throat will close up and open up.  She also felt dizzy, shaky, nauseous, extremely tired, and had a strong headache. She stated that diphenhydramine (BENADRYL) helps a lot with the throat symptoms and as long as she takes it, she feels almost normal but as soon as it is out of her system, it starts again.  It's like she is having allergy and hay fever type symptoms.  The lymph nodes in her neck feel like they are swollen, it feels like she has a big lump in the middle and sides of her throat.  She just came back from the emergency room and they gave her diphenhydramine. She wanted to know if she should she get the second vaccine. Outcome of the events was unknown.; Sender's Comments: A causal association between BNT162B2 and throat tightness cannot be excluded based on a compatible temporal relation. 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: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Nervousness, Sensation of foreign body, Throat tightness
Clinical narrative: throat felt like it was closing up; had issues swallowing; it feels like her throat will close up and open up; felt dizzy; shaky; nauseous; extremely tired; had a strong headache; It's like she is having allergy and hay fever type symptoms; It's like she is having allergy and hay fever type symptoms; The lymph nodes in her neck feel like they are swollen, it feels like she has a big lump in the middle and sides of her throat.; feels like she has a big lump in the middle and sides of her throat; This is a spontaneous report from a contactable other healthcare professional (patient). A 23-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot no: EL1283, via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported she got the Covid vaccine on Saturday, 09Jan2021, and immediately her throat felt like it was closing up, she was instantly reacting to the vaccine. Since then, she has had issues swallowing; it feels like her throat will close up and open up.  She also felt dizzy, shaky, nauseous, extremely tired, and had a strong headache. She stated that diphenhydramine (BENADRYL) helps a lot with the throat symptoms and as long as she takes it, she feels almost normal but as soon as it is out of her system, it starts again.  It's like she is having allergy and hay fever type symptoms.  The lymph nodes in her neck feel like they are swollen, it feels like she has a big lump in the middle and sides of her throat.  She just came back from the emergency room and they gave her diphenhydramine. She wanted to know if she should she get the second vaccine. Outcome of the events was unknown.; Sender's Comments: A causal association between BNT162B2 and throat tightness cannot be excluded based on a compatible temporal relation. 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: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster Right forehead, eyelid to up above hair line.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: arm started to itch about midnight,   next day it was slightly pink,  arm felt warm, put neosporin on area,  stayed itching for about three days and it is still slightly pink  as of today (21/25/21) with two  spots of  darker pink at top and below pinkness and covered about a 3" area.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Non itchy, red, slightly raised rash on torso - front and back.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Urinary incontinence
Clinical narrative: Severe shivering lasted several hours Passive urination Giddiness
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Immediate post-injection reaction, SARS-CoV-2 test, Somnolence
Clinical narrative: received 3 shots of COVID vaccine; almost "like fell asleep". She was hardly open her eyes this morning/couldn't eat dinner because people couldn't wake her up; This is a spontaneous report from a contactable consumer (patient's husband).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at SINGLE DOSE for COVID-19 vaccination. The patient's medical history was not reported.  Concomitant medications were not specified (reported the patient was taking bunch of medications, but the reporter did not know exactly what they were). Historical vaccine included first dose bnt162b2 on 24Dec2020 and second dose bnt162b2 on 11Jan2021, both for COVID-19 vaccination. She didn't have any side effect from the first shot or the second shot. The patient received 3 shots of COVID vaccine, received 1st dose of vaccine on 24Dec2020, 2nd dose on 11Jan2021. Then inadvertently given another dose yesterday, on 12Jan2021.  Immediately after the 3rd dose of vaccine, the patient almost "like fell asleep". She was hardly open her eyes this morning. The patient was in a nursing home. The nursing home staff was finding it difficult to feed her now. The patient couldn't eat dinner because people couldn't wake her up. The patient just had the COVID test, no other lab test. The outcome of the events was unknown. Information of lot/batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Feeling cold, Feeling hot, Hyperhidrosis
Clinical narrative: Nausea; diarrhea; vomiting/Throwing up; Hot and sweaty from head to toe; Hot and sweaty from head to toe; Fainted in the bathroom; Chills and could not stay warm; could not stay warm; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 12Jan2021 (reported as yesterday) around 11 AM as a single dose for COVID-19 immunization, lot number: EL0140 3-4. Medical history and concomitant medications were reported as none. First vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on unknown date via an unspecified route of administration for COVID-19 immunization lot number: EL0140. Patient stated that she experienced side effects such as vomiting, diarrhea, fainting while going to the bathroom 14 hours after receiving her second shot of the Covid vaccine. She wanted to know if these were normal side effects and if she should seek medical attention. Patient reported the side effects that she had from the second dose of the Pfizer COVID Vaccine. She has gotten no answers regarding the side effects and she wanted to speak with someone about it. She got the second dose on 12Jan2021 (reported as yesterday) around 11 AM. She felt pretty normal. By 5 PM she got chills and could not stay warm. She thought it was normal. Then over night she got really nauseous, had diarrhea and was throwing up. She was hot and sweaty from head to toe. She tried to get up afterwards and fainted in the bathroom. She was reading what the pharmacy gave her for mild to moderate side effects, and none of what she experienced are listed on there. She also stated that nausea started around 1 AM this morning. It has persisted and is intermittent. Diarrhea occurred a little after 1 AM she got up to pee. Then went back to bed. Then about 10 minutes later had to go to the bathroom, and it started then. It is still occurring this morning. It last happened around 9 AM. She has not eaten anything new. Throwing up Lasted for about 15 minutes and fainted occurred one time. Patient recovered from chills and could not stay warm on 12Jan2021, she recovered from throwing up, hot and sweaty from head to toe and fainted in the bathroom on 13Jan2021, she had not recovered from nausea, diarrhea.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Syncope, Vomiting
Clinical narrative: Nausea; diarrhea; vomiting/Throwing up; Hot and sweaty from head to toe; Hot and sweaty from head to toe; Fainted in the bathroom; Chills and could not stay warm; could not stay warm; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 12Jan2021 (reported as yesterday) around 11 AM as a single dose for COVID-19 immunization, lot number: EL0140 3-4. Medical history and concomitant medications were reported as none. First vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on unknown date via an unspecified route of administration for COVID-19 immunization lot number: EL0140. Patient stated that she experienced side effects such as vomiting, diarrhea, fainting while going to the bathroom 14 hours after receiving her second shot of the Covid vaccine. She wanted to know if these were normal side effects and if she should seek medical attention. Patient reported the side effects that she had from the second dose of the Pfizer COVID Vaccine. She has gotten no answers regarding the side effects and she wanted to speak with someone about it. She got the second dose on 12Jan2021 (reported as yesterday) around 11 AM. She felt pretty normal. By 5 PM she got chills and could not stay warm. She thought it was normal. Then over night she got really nauseous, had diarrhea and was throwing up. She was hot and sweaty from head to toe. She tried to get up afterwards and fainted in the bathroom. She was reading what the pharmacy gave her for mild to moderate side effects, and none of what she experienced are listed on there. She also stated that nausea started around 1 AM this morning. It has persisted and is intermittent. Diarrhea occurred a little after 1 AM she got up to pee. Then went back to bed. Then about 10 minutes later had to go to the bathroom, and it started then. It is still occurring this morning. It last happened around 9 AM. She has not eaten anything new. Throwing up Lasted for about 15 minutes and fainted occurred one time. Patient recovered from chills and could not stay warm on 12Jan2021, she recovered from throwing up, hot and sweaty from head to toe and fainted in the bathroom on 13Jan2021, she had not recovered from nausea, diarrhea.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Patient reports very bad sore throat and low grade fever.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, COVID-19 pneumonia, Chest X-ray abnormal, Incomplete course of vaccination, Pyrexia
Clinical narrative: positive for Covid; positive for Covid; pneumonia; fever; This is spontaneous report from the Pfizer sponsored program, IBCC (Inbound Call Center for HCPs) via a contactable nurse (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EKS730), via an unspecified route of administration in deltoid left on 22Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. Patient received the first dose of the vaccine on 22Dec2020 and a week later she was tested positive for COVID on 29Dec2020. She was due for the second dose the day before the time of the report. She was concerned about the immune system before getting the second dose. She got a significant pneumonia on 29Dec2020 with COVID infection that her coworkers did not get and she was worried about the condition of her lungs and getting the second dose of the vaccine. She had done her research and read what the CDC said about waiting longer for the second dose. Patient had a fever on 26Dec2020, 4 days after getting the vaccine, she was scheduled to get the second dose on 12Jan2021, but she did not go in, since she couldn't get straight answers from anyone about the second dose, her question was: when could she get the second dose?  Patient was feeling better, she didn't get a repeat chest X-ray, but she felt, like she didn't have fevers, she felt like much better. Her fevers started 4 days after the vaccine on 26Dec2020, and lasted 5 days, maybe 2 days into the antibiotics it stopped. She had recovered completely from fevers. Stated her first test, she tested negative, on 27Dec2020, then tested positive on 29Dec2020. She had no test since then, since one could shed the virus for months, and she didn't feel the need to retest, she was past the point on quarantine. Lab data included Chest X-ray: Pneumonia on 29Dec2020, COVID 19: Negative on 27Dec2020, COVID 19: Positive on 29Dec2020. Outcome of event fever was resolved, and of other events was unknown. Causality: She couldn't say for sure no, but she questioned if put her in a more vulnerable state.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be completely excluded for reported "positive for Covid" and pneumonia. 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: positive for Covid; positive for Covid; pneumonia; fever; This is spontaneous report from the Pfizer sponsored program, IBCC (Inbound Call Center for HCPs) via a contactable nurse (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EKS730), via an unspecified route of administration in deltoid left on 22Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. Patient received the first dose of the vaccine on 22Dec2020 and a week later she was tested positive for COVID on 29Dec2020. She was due for the second dose the day before the time of the report. She was concerned about the immune system before getting the second dose. She got a significant pneumonia on 29Dec2020 with COVID infection that her coworkers did not get and she was worried about the condition of her lungs and getting the second dose of the vaccine. She had done her research and read what the CDC said about waiting longer for the second dose. Patient had a fever on 26Dec2020, 4 days after getting the vaccine, she was scheduled to get the second dose on 12Jan2021, but she did not go in, since she couldn't get straight answers from anyone about the second dose, her question was: when could she get the second dose?  Patient was feeling better, she didn't get a repeat chest X-ray, but she felt, like she didn't have fevers, she felt like much better. Her fevers started 4 days after the vaccine on 26Dec2020, and lasted 5 days, maybe 2 days into the antibiotics it stopped. She had recovered completely from fevers. Stated her first test, she tested negative, on 27Dec2020, then tested positive on 29Dec2020. She had no test since then, since one could shed the virus for months, and she didn't feel the need to retest, she was past the point on quarantine. Lab data included Chest X-ray: Pneumonia on 29Dec2020, COVID 19: Negative on 27Dec2020, COVID 19: Positive on 29Dec2020. Outcome of event fever was resolved, and of other events was unknown. Causality: She couldn't say for sure no, but she questioned if put her in a more vulnerable state.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be completely excluded for reported "positive for Covid" and pneumonia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable other health professional. A female patient of an unspecified age (age: 34; unit: unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced bell's palsy in Jan2021 with outcome of unknown. The patient who received first dose of vaccine on Saturday and woke up this morning with Bell's Palsy as confirmed by urgent care. She is wondering about the clinical trial participants and if she can receive the second dose.    Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event facial paralysis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Notice a small one inch red swollen hot circle around the injection site 6 days after injection with headache, nausea, no fever. and two days after that i see it is now about 3 inches in size  on my arm, still hot and swollen and itches.  Still not running fever. Nausea still there but not as bad.
Sex: U
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Developed Bell's Palsy after their first dose of Pfizer/BioNTech vaccine; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter asked if a patient developed Bell's Palsy after their first dose of Pfizer/BioNTech vaccine, should they receive their second dose; if there was any evidence that another episode of Bell's Palsy or any other adverse neurological outcome may recur if a patient receives their 2nd dose; if Should this patient receive an alternative mRNA based vaccine for their booster dose. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of bells palsy cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Skin swelling
Clinical narrative: 8 days later red circle around the site of the shot. Minor puffiness. Looked better next morning
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Feeling hot, Hypoaesthesia, Injection site erythema, Injection site mass
Clinical narrative: 1.  swelling, redness, heat, itching at injection site. Lasting 10 days.  Peak discomfort at day 8.  Hard lump, hot to touch, red,  strong itch.  Was 3 inches by two inches. The arm is now back to normal.  .2. Day 8.  Woke at roughly midnight with extreme heat and burning in all toes.  Quite painful.  Very unusual, as I have never experienced anything like this before.  When pain and burning became overwhelming I took Tylenol.  It helped and I was able to sleep.   The next morning the pain and burning were gone but my toes were, and continue to be quite numb, as is the area of my feet that surrounds my toes.  I can't fully feel my socks, shoes, sheets, etc.  It feel like I have cotton stuffed in my shoes.  It is hard for me to related the level of heat, burning and pain that happened.  I felt like I could melt a block of ice with my feet.  It was severe. I marked "disability or permanent damage" below because I don't know if the nerves in my feet will return to normal.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Pain in extremity, SARS-CoV-2 antibody test negative
Clinical narrative: 1.  swelling, redness, heat, itching at injection site. Lasting 10 days.  Peak discomfort at day 8.  Hard lump, hot to touch, red,  strong itch.  Was 3 inches by two inches. The arm is now back to normal.  .2. Day 8.  Woke at roughly midnight with extreme heat and burning in all toes.  Quite painful.  Very unusual, as I have never experienced anything like this before.  When pain and burning became overwhelming I took Tylenol.  It helped and I was able to sleep.   The next morning the pain and burning were gone but my toes were, and continue to be quite numb, as is the area of my feet that surrounds my toes.  I can't fully feel my socks, shoes, sheets, etc.  It feel like I have cotton stuffed in my shoes.  It is hard for me to related the level of heat, burning and pain that happened.  I felt like I could melt a block of ice with my feet.  It was severe. I marked "disability or permanent damage" below because I don't know if the nerves in my feet will return to normal.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance, Sleep disorder
Clinical narrative: 1.  swelling, redness, heat, itching at injection site. Lasting 10 days.  Peak discomfort at day 8.  Hard lump, hot to touch, red,  strong itch.  Was 3 inches by two inches. The arm is now back to normal.  .2. Day 8.  Woke at roughly midnight with extreme heat and burning in all toes.  Quite painful.  Very unusual, as I have never experienced anything like this before.  When pain and burning became overwhelming I took Tylenol.  It helped and I was able to sleep.   The next morning the pain and burning were gone but my toes were, and continue to be quite numb, as is the area of my feet that surrounds my toes.  I can't fully feel my socks, shoes, sheets, etc.  It feel like I have cotton stuffed in my shoes.  It is hard for me to related the level of heat, burning and pain that happened.  I felt like I could melt a block of ice with my feet.  It was severe. I marked "disability or permanent damage" below because I don't know if the nerves in my feet will return to normal.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis, SARS-CoV-2 test negative, Tinnitus, VIIIth nerve injury
Clinical narrative: everything was muffled and he had constant ringing in the ears; This is a spontaneous report from a contactable nurse (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left deltoid on 15Dec2020 at single dose as his first dose, via an unspecified route of administration at left deltoid on 06Jan2021 at single dose as his second dose for COVID-19 immunization. Medical history reported as none. There included unspecified medications and stopped several of them a week ago on 05Jan2021. The patient was having a side effect that popped up out of the middle of nowhere, and he went through his meds, and he wanted to see if anyone else was having these issues. The patient was having ringing in both ears that happened late Dec2020, and in the beginning of Jan2021, and he had both rounds, he was an RN (registered nurse) at a hospital, and the ringing had gotten louder, and the only thing, medication, drug, that he took PO, over the counter, the only thing that correlates was it happened after both vaccines, later clarified as COVID vaccines. Right before the second dose, it was really really loud, and then he got the second dose, and over the last 1.5 weeks, the ringing has gotten worse in both ears, so he called his primary care, who referred him to ENT (ear, nose and throat), and he saw ENT, and to look in the ear, he said it was the nerve, he didn't know what triggered it in both ears, he said it was usually only in one ear if it's a viral thing, so it's uncommon in both ears, and the doctor asked if he was on medication, and the caller stopped several of them a week ago on 05Jan2021, that would cause it, but it had gotten worse. The patient didn't know etiology or how the vaccine worked, but he tested for COVID and it was negative, and his doctor was asking him if he experienced this any other time, told him to stop medications, and it's gotten worse, asked him if he was on any recreational drugs, he was on no new meds, he was a nurse, and works in ICU, and basically didn't know where it come from, but suddenly, everything was muffled and he had constant ringing in the ears. COVID test was about 2 weeks ago, the rapid was negative, then the PCR was negative. The outcome of event was recovering.
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Tremor, Vomiting
Clinical narrative: had chills, non stop shaking for 2 hours, very disturbing. Vomiting, fever, chills with headache.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pyrexia, Syncope, Tremor
Clinical narrative: Faint; Shaking; Febrile; Rigors; light-headed; This is a spontaneous report from a non-contactable consumer (patient). A 42-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on Dec2020 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and unknown if there is any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and unknown if the patient had been tested for COVID-19 since the vaccination. On Jan2021, the patient experienced faint, shaking, febrile for around 36 hours, rigors, and light-headed. No treatment was received for the adverse events. Outcome of the events was recovered on Jan2021. The events were considered non-serious by the reporter.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Defaecation urgency, Fatigue
Clinical narrative: Unable to get out of bed: She is so sleepy and has no energy; Wiped out of energy; lots of flatulence; Chills; Joint pain; Lower GI symptoms; she is also feeling cold; This is a spontaneous report from a contactable nurse (patient). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#: GL3248 (Caller said that the G may be an E.)), via an unspecified route of administration in the left arm on 07Jan2021 at second single dose for working with cancer patients. Medical history included ongoing diabetic and ongoing hyperthyroidism, both diagnosed about 6 years ago and were under control. There were no concomitant medications. Historical vaccine included BNT162B2 on 18Dec2020 for working with cancer patients (First dose, lot number: EJ1685, injection in the left arm). On 11Jan2021 the patient had chills, joint pain, and lower GI symptoms. Her lower GI symptoms included diarrhea. Then caller clarified that it was not diarrhea but the urge to go. The stools were solid. She also had lots of flatulence. She was also wiped out of energy, around like 2 PM on 11Jan2021 she went up a flight of stairs and was so exhausted. The patient is a nurse. She was in her office that day and had to literally lay on the floor because she was so wiped out of energy. She left work early and went to bed. Then the next day 12Jan2021, she was unable to get out of bed the whole day. She is so sleepy and has no energy. She went to bed last night at 08:30, but is still so sleepy. Today she is feeling better, but still had lower GI symptoms. She was also feeling cold, which she normally is always hot. She was having to put 5 blankets on her. Outcome of the event chills was recovered on 12Jan2021, of events joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed was recovering, of events flatulence and feeling cold was unknown. The reporter considered the event chills, joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed as serious (disability) and related to BNT162B2.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported chills, joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed and the administration of the COVID 19 vaccine, BNT162B2, given the plausible temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Flatulence, Gastrointestinal disorder, Mobility decreased, Somnolence
Clinical narrative: Unable to get out of bed: She is so sleepy and has no energy; Wiped out of energy; lots of flatulence; Chills; Joint pain; Lower GI symptoms; she is also feeling cold; This is a spontaneous report from a contactable nurse (patient). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#: GL3248 (Caller said that the G may be an E.)), via an unspecified route of administration in the left arm on 07Jan2021 at second single dose for working with cancer patients. Medical history included ongoing diabetic and ongoing hyperthyroidism, both diagnosed about 6 years ago and were under control. There were no concomitant medications. Historical vaccine included BNT162B2 on 18Dec2020 for working with cancer patients (First dose, lot number: EJ1685, injection in the left arm). On 11Jan2021 the patient had chills, joint pain, and lower GI symptoms. Her lower GI symptoms included diarrhea. Then caller clarified that it was not diarrhea but the urge to go. The stools were solid. She also had lots of flatulence. She was also wiped out of energy, around like 2 PM on 11Jan2021 she went up a flight of stairs and was so exhausted. The patient is a nurse. She was in her office that day and had to literally lay on the floor because she was so wiped out of energy. She left work early and went to bed. Then the next day 12Jan2021, she was unable to get out of bed the whole day. She is so sleepy and has no energy. She went to bed last night at 08:30, but is still so sleepy. Today she is feeling better, but still had lower GI symptoms. She was also feeling cold, which she normally is always hot. She was having to put 5 blankets on her. Outcome of the event chills was recovered on 12Jan2021, of events joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed was recovering, of events flatulence and feeling cold was unknown. The reporter considered the event chills, joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed as serious (disability) and related to BNT162B2.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported chills, joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed and the administration of the COVID 19 vaccine, BNT162B2, given the plausible temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.