chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Limb discomfort, Pain
Clinical narrative: weak and tired, cannot get out of bed/hard to raise her head she is so weak; weak and tired, cannot get out of bed; slight shortness of breath; body aches but they have been worse; This is a spontaneous report from a contactable nurse. This 82-year-old female nurse (patient) reported.  An 82-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8734), dose 2 via an unspecified route of administration, administered in Right arm on 31Mar2021 (at the age of 82-years-old) as dose 2, single for covid-19 immunisation. Medical history included rods in back from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN6206), dose 1 via an unspecified route of administration, on 10Mar2021 (at the age of 82-years-old) as dose 1, single for covid-19 immunisation and felt her arm was going to explode, Tired and shortness of breath after first dose of vaccine, she had a rotator cuff in her right arm that needed to be repaired which was an issue prior to the vaccine, and that was probably why it hurt so badly and had gotten better. Exact details were not provided. On an unknown date in Apr2021, the patient experienced weak and tired, cannot get out of bed, slight shortness of breath and body aches but they have been worse. The reporter stated that she had her shots last month, clarifies the Pfizer Covid vaccines, states 31Mar2021 was her second dose, first dose was 10Mar2021, states she felt fine until this past weekend. On an unspecified date on Apr2021, the patient stated that she has slight shortness of breath, is very tired and weak, cannot stay out of bed, has a hard time getting up. Her appetite is great, no nausea or vomiting or anything. States her symptoms started this week, no exact dates provided. The reporter stated she has rods in her back so maybe that is why she cannot get out of bed, she needs help, states it is hard to raise her head she is so weak, has to use her hands, states she typically deals with body aches but they have been worse this week. The reporter states that all of her symptoms have just been persisting since they started this week. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Small rashes appeared inches below the injected area; and it's hot, itchy, and painful; and it's hot, itchy, and painful; and it's hot, itchy, and painful; fever; This is a spontaneous report received from a Pfizer-sponsored program COVAX US Support. A contactable consumer (patient herself).A female patient of an unspecified age received bnt162b2 (COMIRNATY, solution for injection), via an unspecified route of administration, administered in arm left on 06Apr2021 as dose 2, single for covid-19 immunization. The patient previously received Covid-19 Vaccine (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on 15Mar2021 (2nd dose more than 21days) for covid-19 immunization. Patient had no known allergies and no relevant medical history. The patient concomitant medications were not reported. It was reported that after receiving the 2nd dose of the vaccine on 06Apr2021 small rashes appeared inches below the injected area and it was hot, itchy and painful. Now the pain and itchiness subsided but the rash became bigger up to the entire left arm. Therapeutic measures were taken as a result of event fever and included treatment with took 1 paracetamol. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: had a weird reaction on her arm. It started off as a little bit red then grew rash over upper and down left arm; rash over upper and down left arm/ little rash on her right hand and under her ribcage; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number, NDC number, expiry date was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. This report was not from a customer engagement program. The patient experienced a weird reaction on her arm. It started off as a little bit red then grew rash over upper and down left arm. Also, a little rash on her right hand and under her ribcage. It subsided a bit. She asked based on the reaction should she be concerned about the second vaccine. She was upset about being transferred to the person she spoke to. She thought she was being transferred to a doctor or a medical person that could answer her questions. She does not want to do a report she already reported it; no other information provided. Her first vaccination was last Sunday, she asked about the time frame between her first and second vaccinations matter. Investigations were not reported. There was a medical information request. The outcome of both the events was unknown.  No follow up attempts are need; No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: body aches; fever; not feeling good; This is a spontaneous case received from a contactable consumer (patient) via Support. A female patient of unspecified age received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 07Apr2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. Historical vaccine included first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 11Mar2021 as single dose for COVID-19 immunisation. On an unspecified date in Apr2021, the patient experienced body aches, fever and not feeling well. It was reported that, patient had her 1st dose of Covid 19 Vaccine 11Mar2021 and had her 2nd dose 07Apr2021 that was more than the usual 21 days interval between doses and she experienced body aches and had fever. Her doctor prescribed her the medication -Valacyclovir before and she wanted to know if she can take that now since she is not feeling good. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Throat irritation
Clinical narrative: cough; itchiness on her throat; This is a spontaneous report from contactable consumer (patient) from a sponsored program SUPPORT.   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection) via an unspecified route of administration on 18Mar2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient got her first dose last 18Mar2021 and her next dose will be today on 09Apr2021 and she was asking if it was okay to take the second dose even if she had experienced itchiness on her throat as well as cough on an unspecified date. She stated that she will also have a Colonoscopy on Wednesday and she provided number and hours of operation. The clinical outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Gait disturbance, Hypersensitivity, Myalgia
Clinical narrative: Allergic reaction to the Pfizer Vaccine; muscle pain; hard time walking; lower back pain, going down to my legs, the back side of my leg, and the hamstring of the leg; abdomen was in excruciating pain; Mild lower back pain; This is a spontaneous report received from a contactable consumer or other non hcp (patient). A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection) via an unspecified route of administration, administered in upper left arm on 25Mar2021 (Batch/Lot Number: ER8727; Expiration Date: 31Jul2021) as dose 1, single for covid-19 immunisation (at the age of 67-years-old). Medical history included high blood pressure from an unknown date and unknown if ongoing. Patient had no known allergies. The patient's concomitant medications were not reported. It was reported that the patient received first dose of vaccine and stated that the day right after she had the shot on 25Mar2021 within 24 hours she started with mild lower back pain and also had issues with her abdomen, when her back started to hurt her abdomen was in excruciating pain and mentioned that it wasn't much of anything to think about but it was there, as the time went on Saturday it got worse and then started going down to her legs, the back side of her leg and the hamstring of the leg on 27Mar2021. By Sunday, Monday, Tuesday, Wednesday she was on more pain, and on Thursday she was on so much pain and she had really hard time walking on 01Apr2021. Like she had to call my doctor's office and he didn't have an opening until Friday. So, she went to see him on Friday and he told her it has nothing to do with Pfizer Vaccine but she had no issues before she got the Vaccine, it's all in her muscle, her leg, specially the left side of her leg, the back left side hurt. She mentioned that she was having a hard time making this thing to go away. She was purring ice on it, when she put heat on it, it was hurting more, so she just had to stick with the ice. So, she did not know, it was muscle pain which was on an unspecified date, and she knew that the vaccine could cause muscle aches but this was just aches, it was pain. The patient stated that she was not sure she thought she was having, had an allergic reaction to the Pfizer Vaccine on an unspecified date. She further mentioned that by Saturday my abdomen was in excruciating pain and that stayed that way until just the past weekend it went away. The abdomen was now fine but and the lower back was fine right now but the leg pain was still there. The patient was recovered from the events of low back pain and abdominal pain on an unspecified date in 2021 and was not recovered from the event of leg pain and outcome was unknown for rest of the other events.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Allergic reaction to the Pfizer Vaccine; muscle pain; hard time walking; lower back pain, going down to my legs, the back side of my leg, and the hamstring of the leg; abdomen was in excruciating pain; Mild lower back pain; This is a spontaneous report received from a contactable consumer or other non hcp (patient). A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection) via an unspecified route of administration, administered in upper left arm on 25Mar2021 (Batch/Lot Number: ER8727; Expiration Date: 31Jul2021) as dose 1, single for covid-19 immunisation (at the age of 67-years-old). Medical history included high blood pressure from an unknown date and unknown if ongoing. Patient had no known allergies. The patient's concomitant medications were not reported. It was reported that the patient received first dose of vaccine and stated that the day right after she had the shot on 25Mar2021 within 24 hours she started with mild lower back pain and also had issues with her abdomen, when her back started to hurt her abdomen was in excruciating pain and mentioned that it wasn't much of anything to think about but it was there, as the time went on Saturday it got worse and then started going down to her legs, the back side of her leg and the hamstring of the leg on 27Mar2021. By Sunday, Monday, Tuesday, Wednesday she was on more pain, and on Thursday she was on so much pain and she had really hard time walking on 01Apr2021. Like she had to call my doctor's office and he didn't have an opening until Friday. So, she went to see him on Friday and he told her it has nothing to do with Pfizer Vaccine but she had no issues before she got the Vaccine, it's all in her muscle, her leg, specially the left side of her leg, the back left side hurt. She mentioned that she was having a hard time making this thing to go away. She was purring ice on it, when she put heat on it, it was hurting more, so she just had to stick with the ice. So, she did not know, it was muscle pain which was on an unspecified date, and she knew that the vaccine could cause muscle aches but this was just aches, it was pain. The patient stated that she was not sure she thought she was having, had an allergic reaction to the Pfizer Vaccine on an unspecified date. She further mentioned that by Saturday my abdomen was in excruciating pain and that stayed that way until just the past weekend it went away. The abdomen was now fine but and the lower back was fine right now but the leg pain was still there. The patient was recovered from the events of low back pain and abdominal pain on an unspecified date in 2021 and was not recovered from the event of leg pain and outcome was unknown for rest of the other events.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Had a reaction where I am having like a rash; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 69-year-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in arm right on 03Apr2021 (at the age of 69-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced had a reaction where I am having like a rash. Patient stated, Actually I am calling because I took the vaccine on Saturday, and I had a reaction where I am having like a rash. I just want to know is that going to clear up or is this something I can put on it to will it go away or it just have to run its course. Expiration date: Patient stated, there is date 4/3/2021 (Further not clarified, hence not captured in tab). Due date of second shot: April 24th 2021. Treatment: Patient stated, I am just putting ointment on it. It's cortisone cream, I don't remember the name right now, I am just using cortisone cream. The patient received cortisone cream as treatment for the event. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nodule
Clinical narrative: Extreme headache when laying down to go to sleep. Large knot popped up on right side of face in front of right ear just below right temple.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dysphagia, Dyspnoea, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Additional Details: patient passed out momentarly after receiving vaccination in her chair, patient quickly awakened and responded that she is ok. Instructed patient to lay down and elevate legs and had gatorafe. Asked if she wants an ambluance, patient indicated that this is normal when she seees needles, happened before when she gave blood. patient fully recovered and felt no symptoms, asked family members to pick her just incase. Pharmacy will follow up with patient before closing, will follow in the morning
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles on right trunk near bra line
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Tachycardia
Clinical narrative: Systemic: palpitations-Severe, Systemic: Tachycardia-Severe, Additional Details: patient came in seeking 2nd vaccine on 9/28/21. Discussed with patients of risk and advised patient to see doctor prior to recieving 2nd shot
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Eye haemorrhage, Retinal vein occlusion, SARS-CoV-2 test negative, Visual impairment
Clinical narrative: On  Morning of 17th September, found to be partially blinded in left eye. Clotting in retinal vein discovered by ophthalmologist, as well as macular hemorrhage.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Illness, Oropharyngeal pain, Pruritus, Somnolence
Clinical narrative: I had some severe allergies, I start feeling like my usual allergy; An external itch; feels like little ants are crawling all over you head to toe; the external itch from my head to my toe; I then got sick; My throat sore; Swollen tongue; Its persisting may be worsened; Sleepy; This is a spontaneous report from a contactable consumer (patient) or other non hcp.  A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0150 via an unspecified route of administration, administered in Deltoid Right on 07Apr2021 (at the age of 50-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced I had some severe allergies, I start feeling like my usual allergy, an external itch; feels like little ants are crawling all over you head to toe; the external itch from my head to my toe, I then got sick, my throat sore, swollen tongue, its persisting may be worsened and sleepy. Therapeutic measures were taken as a result of I had some severe allergies, I start feeling like my usual allergy. The patient reported that, I understand my allergies and I took Benadryl (treatment) right away, I woke up this morning and I feel the same way. I have been to the emergency room enough to know the test what they gave me because of my allergy. The patient was scheduled for second shot of vaccine on 28Apr2021. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: I had some severe allergies, I start feeling like my usual allergy; An external itch; feels like little ants are crawling all over you head to toe; the external itch from my head to my toe; I then got sick; My throat sore; Swollen tongue; Its persisting may be worsened; Sleepy; This is a spontaneous report from a contactable consumer (patient) or other non hcp.  A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0150 via an unspecified route of administration, administered in Deltoid Right on 07Apr2021 (at the age of 50-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced I had some severe allergies, I start feeling like my usual allergy, an external itch; feels like little ants are crawling all over you head to toe; the external itch from my head to my toe, I then got sick, my throat sore, swollen tongue, its persisting may be worsened and sleepy. Therapeutic measures were taken as a result of I had some severe allergies, I start feeling like my usual allergy. The patient reported that, I understand my allergies and I took Benadryl (treatment) right away, I woke up this morning and I feel the same way. I have been to the emergency room enough to know the test what they gave me because of my allergy. The patient was scheduled for second shot of vaccine on 28Apr2021. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Diarrhoea
Clinical narrative: Systemic: Abdominal Pain-Medium, Systemic: Diarrhea-Medium, Systemic: Weakness-Medium, Additional Details: Pt has fully recovered. talked to patient about general reactions/ ae from vaccine. No major reaction
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Diarrhoea, Paraesthesia
Clinical narrative: Systemic: Abdominal Pain-Medium, Systemic: Diarrhea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: Talked to patient over the phone. Has fully recovered.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Pain, Pyrexia
Clinical narrative: Headache, fever, some body aches , lack of energy
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong patient
Clinical narrative: Error: Wrong Patient (documentation in EMR)-
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear pain, Fatigue, Headache, Pain
Clinical narrative: Chills, fever, arm pain, ear pain, headache, tiredness, body aches
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Chills, fever, arm pain, ear pain, headache, tiredness, body aches
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Condition aggravated, Feeding disorder, Nausea
Clinical narrative: This is a 60-year-old male thats presents to the ED complaining of back pain as well as abdominal pain. Onset of symptoms within the past 3 days. States that he drove up to his cottage 3 days prior & developed symptoms on arrival. He has not been able to eat for the past 3 days. There is associated nausea but no vomiting or diarrhea. He has recurrent bouts of pancreatitis, but is unsure of the cause. He denies alcohol use. He states he is vaccinated for COVID with Pfizer.   Review of Systems  Constitutional: Negative for chills, fatigue and fever.  HENT: Negative for facial swelling and trouble swallowing.   Respiratory: Negative for cough, shortness of breath and wheezing.   Cardiovascular: Negative for chest pain and palpitations.  Gastrointestinal: Positive for abdominal pain. Negative for diarrhea, nausea and vomiting.  Genitourinary: Negative for dysuria and frequency.  Musculoskeletal: Positive for back pain (right paraspinal thoracic). Negative for neck pain.  Skin: Negative for rash and wound.  Neurological: Negative for weakness, light-headedness and headaches.  Psychiatric/Behavioral: Negative for confusion. The patient is not nervous/anxious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pancreatitis, SARS-CoV-2 test
Clinical narrative: This is a 60-year-old male thats presents to the ED complaining of back pain as well as abdominal pain. Onset of symptoms within the past 3 days. States that he drove up to his cottage 3 days prior & developed symptoms on arrival. He has not been able to eat for the past 3 days. There is associated nausea but no vomiting or diarrhea. He has recurrent bouts of pancreatitis, but is unsure of the cause. He denies alcohol use. He states he is vaccinated for COVID with Pfizer.   Review of Systems  Constitutional: Negative for chills, fatigue and fever.  HENT: Negative for facial swelling and trouble swallowing.   Respiratory: Negative for cough, shortness of breath and wheezing.   Cardiovascular: Negative for chest pain and palpitations.  Gastrointestinal: Positive for abdominal pain. Negative for diarrhea, nausea and vomiting.  Genitourinary: Negative for dysuria and frequency.  Musculoskeletal: Positive for back pain (right paraspinal thoracic). Negative for neck pain.  Skin: Negative for rash and wound.  Neurological: Negative for weakness, light-headedness and headaches.  Psychiatric/Behavioral: Negative for confusion. The patient is not nervous/anxious.
Age: 53.0
Sex: M
Vaccine: UNK
Symptoms: Blood test abnormal, Fatigue, Liver function test
Clinical narrative: Blood work off , liver  , fatigued, chest x-ray ordered
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Pyrexia, Tremor
Clinical narrative: Fever of 104. Chills and shaking throughout the night. Fever went down after a day and a half. Body weakness and headache took three days to go away.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Bilateral knee pain
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint injection, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 3 inches below and to the left of the injection site (near armpit) have a hard, hot swelling lump that is spreading. Stabbing pain from site, up to armpit and down to elbow/fingers. GI upset that does not seem normal. Started day after second injection. Also had typical side effects (fever, chills etc) but the arm pain and area of redness seem abnormal. Will be seeing a provider to ensure it is not a blood clot or cellulitis. (Please note always have been up to date on immunizations and flu shots) Last year similar reaction to flu shot. No allergies
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: 3 inches below and to the left of the injection site (near armpit) have a hard, hot swelling lump that is spreading. Stabbing pain from site, up to armpit and down to elbow/fingers. GI upset that does not seem normal. Started day after second injection. Also had typical side effects (fever, chills etc) but the arm pain and area of redness seem abnormal. Will be seeing a provider to ensure it is not a blood clot or cellulitis. (Please note always have been up to date on immunizations and flu shots) Last year similar reaction to flu shot. No allergies
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: When I received my first two vaccines I was given a weblink where I was to check in regularly to report symptoms.  I was given no such instruction for the booster shot I received at pharmacy.  Therefore, I thought I should report the following symptoms I have been experiencing since I have had my booster on Saturday 9/25 at 4:30 pm. CST.  9/25 - some minor pain at injection site and a slight headache  9/26 - minor pain at injection site, fatigue, migraine like headache, general body aches, nausea  9/27 - redness and swelling around injection site, slight fatigue, minor headache  9/28 - redness, swelling and hardness in muscle around injection site, slight fatigue  9/29 - continued redness, itching, swelling and hardness in muscle around injection site  While I don?t think any of these side affects to be major or long lasting at this point, I do want to point out that the migraine headache, nausea and injection site reactions (aka COVID Arm) are not symptoms I had from my first two Pfizer shots and I think this may be significant to follow in case there is the potential for multiplying side effects occurring in future booster shot recommendations (like a 2nd, 3rd or more booster).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Myosclerosis, Nausea, Pain, Vaccination complication
Clinical narrative: When I received my first two vaccines I was given a weblink where I was to check in regularly to report symptoms.  I was given no such instruction for the booster shot I received at pharmacy.  Therefore, I thought I should report the following symptoms I have been experiencing since I have had my booster on Saturday 9/25 at 4:30 pm. CST.  9/25 - some minor pain at injection site and a slight headache  9/26 - minor pain at injection site, fatigue, migraine like headache, general body aches, nausea  9/27 - redness and swelling around injection site, slight fatigue, minor headache  9/28 - redness, swelling and hardness in muscle around injection site, slight fatigue  9/29 - continued redness, itching, swelling and hardness in muscle around injection site  While I don?t think any of these side affects to be major or long lasting at this point, I do want to point out that the migraine headache, nausea and injection site reactions (aka COVID Arm) are not symptoms I had from my first two Pfizer shots and I think this may be significant to follow in case there is the potential for multiplying side effects occurring in future booster shot recommendations (like a 2nd, 3rd or more booster).
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Hepatic enzyme increased, Hepatic steatosis, Laboratory test abnormal, Ultrasound liver abnormal
Clinical narrative: 1 month after my second dose, I was experiencing chest pain. Went to the ER and my systolic blood pressure was in the high 180's and diasystolic was 110's. They did a liver ultrasound and lab work. Found that i have elevated liver enzymes and a fatty liver.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Limb discomfort, Pain in extremity
Clinical narrative: Pain and a heavy feel to left arm.  A headache came on around 12 PM.  I am usually an energetic individual.  But around the same time as the headache, I felt fatigued and stayed home and rested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Computerised tomogram, Eye inflammation, Gait disturbance
Clinical narrative: Starting In May 2021, I had a very strange red inflammation in my eyes that I went to the doctor 2 times for.  It was nothing like red allergy eyes at all and not pink eye.  Then End of June 2021, I ended up going to the ER because I had excruciating back pain that radiated around my sides to stomach.  I was given a CAT scan and some pain meds and sent home told to rest.  I was fine for about a week and then it started back up on July 9th and eventually got worse causing serious issues with walking, sleeping and sitting.  It took. me almost a month to get to a spinal surgeon to get an MRI to find out that I had Myeomalacia or Spinal Stenosis, with Cysts that were compromising my spine.  I had not had any falls over the last year that could have caused this and it literally came out of nowhere
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Magnetic resonance imaging abnormal, Myelomalacia, Ocular hyperaemia, Pain
Clinical narrative: Starting In May 2021, I had a very strange red inflammation in my eyes that I went to the doctor 2 times for.  It was nothing like red allergy eyes at all and not pink eye.  Then End of June 2021, I ended up going to the ER because I had excruciating back pain that radiated around my sides to stomach.  I was given a CAT scan and some pain meds and sent home told to rest.  I was fine for about a week and then it started back up on July 9th and eventually got worse causing serious issues with walking, sleeping and sitting.  It took. me almost a month to get to a spinal surgeon to get an MRI to find out that I had Myeomalacia or Spinal Stenosis, with Cysts that were compromising my spine.  I had not had any falls over the last year that could have caused this and it literally came out of nowhere
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Sitting disability, Spinal operation, Spinal stenosis, Spinal synovial cyst
Clinical narrative: Starting In May 2021, I had a very strange red inflammation in my eyes that I went to the doctor 2 times for.  It was nothing like red allergy eyes at all and not pink eye.  Then End of June 2021, I ended up going to the ER because I had excruciating back pain that radiated around my sides to stomach.  I was given a CAT scan and some pain meds and sent home told to rest.  I was fine for about a week and then it started back up on July 9th and eventually got worse causing serious issues with walking, sleeping and sitting.  It took. me almost a month to get to a spinal surgeon to get an MRI to find out that I had Myeomalacia or Spinal Stenosis, with Cysts that were compromising my spine.  I had not had any falls over the last year that could have caused this and it literally came out of nowhere
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Axillary pain, Breast pain, Pain
Clinical narrative: 1 week after receiving the Moderna injection I started with pain under my left arm and left breast. The pain in my breast is a severe sharp stinging pain that goes through out my breast. The pain has not resolved as of today and I was told to report the adverse reaction per employee health. I had a normal mammogram 2 weeks prior to having the injection.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Insomnia, Pain
Clinical narrative: Immediate pain at site of injection.  Pain increased over next 24-72 hours.  Could barely lift my arm above shoulder height.  Continued to have soreness at spot of injection and then on 9/22/21 pain increased and now having problem raising my arm without pain.  Difficult to sleep without taking Alieve.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: Error: Booster Given Too Early-
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Endotracheal intubation, Intensive care
Clinical narrative: Patient presented to emergency room on 8/30/2021 with shortness of breath, cough, and bilateral lower extremity edema. She was admitted for further management and found to be COVID-19 positive. On 9/1/2021, her condition worsened and she was transferred to ICU and was intubated on 9/4/2021. She was extubated on 9/5/2021 and transferred out of the ICU on 9/6/2021. Patient underwent a pulseless respirator arrest on 9/8/2021 and returned to the ICU. Patient was intubated and underwent tracheostomy. Patient was discharged to LTAC facility on 9/27/2021.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral, Respiratory arrest, SARS-CoV-2 test positive, Tracheostomy
Clinical narrative: Patient presented to emergency room on 8/30/2021 with shortness of breath, cough, and bilateral lower extremity edema. She was admitted for further management and found to be COVID-19 positive. On 9/1/2021, her condition worsened and she was transferred to ICU and was intubated on 9/4/2021. She was extubated on 9/5/2021 and transferred out of the ICU on 9/6/2021. Patient underwent a pulseless respirator arrest on 9/8/2021 and returned to the ICU. Patient was intubated and underwent tracheostomy. Patient was discharged to LTAC facility on 9/27/2021.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: broken out in a rash on her neck and chin; broken out in a rash on her neck and chin; This is a spontaneous report from a contactable consumer (patient) received through Regulatory Agency. A female patient of an unspecified age received BNT162B2 (, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2 SINGLE, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1 SINGLE for covid-19 immunizations. The patient medical history and concomitant medications were not reported.  The patient experienced broken out in a rash on her neck and chin on an unspecified date with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Cough, Dyspnoea, Echocardiogram, Fatigue
Clinical narrative: heart palpitations; SOB; nausea; intermittent dry cough; headache; runny nose; extreme fatigue; Joint tenderness; malaise; muscle aches; This is a spontaneous report from a contactable other hcp. A 33-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8732), dose 2 via an unspecified route of administration, administered in Arm Left on 27Mar2021 15:30 as SINGLE DOSE, dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 (Batch/Lot Number: EN6202) as an unspecified dose for covid-19 immunisation. Patient received dose for CETIRIZINE HCL via an unspecified route of administration, administered in unspecified location of administration as an unspecified dose for unspecified indication. List of any other medications the patient received within 2 weeks of vaccination: Cetirizine HCl, Olly Multi-vitamin, joint supplements. Medical history included hypersensitivity from an unknown date and unknown if ongoing known allergies: Codeine. Information was available for Vaccine Facility, Ethnicity and Race. Patient was not pregnant at the time of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive other medications in two weeks of vaccination. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. On 28Mar2021 the patient experienced joint tenderness, malaise, muscle aches, extreme fatigue on 30Mar2021, heart palpitations on 03Apr2021, sob on 03Apr2021, on 01Apr2021 intermittent dry cough, headache, runny nose, nausea on 02Apr2021. The patient underwent lab tests and procedures which included echocardiogram: normal, sars-cov-2 test: negative on 02Apr2021, sars-cov-2 test: negative on 06Apr2021. He said was probably a neurological response to vaccine and prescribed a beta blocker (propanolol) to help with heart palpitations. Extreme fatigue and muscle aches lasted through 4/10, still experiencing slight SOB and heart palpitations upon exertion. Therapeutic measures were taken as Covid test, EKG, zofran, propanolol as a result of the events. The outcome of the events were recovering. No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Malaise, Myalgia, Nausea, Palpitations
Clinical narrative: heart palpitations; SOB; nausea; intermittent dry cough; headache; runny nose; extreme fatigue; Joint tenderness; malaise; muscle aches; This is a spontaneous report from a contactable other hcp. A 33-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8732), dose 2 via an unspecified route of administration, administered in Arm Left on 27Mar2021 15:30 as SINGLE DOSE, dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 (Batch/Lot Number: EN6202) as an unspecified dose for covid-19 immunisation. Patient received dose for CETIRIZINE HCL via an unspecified route of administration, administered in unspecified location of administration as an unspecified dose for unspecified indication. List of any other medications the patient received within 2 weeks of vaccination: Cetirizine HCl, Olly Multi-vitamin, joint supplements. Medical history included hypersensitivity from an unknown date and unknown if ongoing known allergies: Codeine. Information was available for Vaccine Facility, Ethnicity and Race. Patient was not pregnant at the time of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive other medications in two weeks of vaccination. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. On 28Mar2021 the patient experienced joint tenderness, malaise, muscle aches, extreme fatigue on 30Mar2021, heart palpitations on 03Apr2021, sob on 03Apr2021, on 01Apr2021 intermittent dry cough, headache, runny nose, nausea on 02Apr2021. The patient underwent lab tests and procedures which included echocardiogram: normal, sars-cov-2 test: negative on 02Apr2021, sars-cov-2 test: negative on 06Apr2021. He said was probably a neurological response to vaccine and prescribed a beta blocker (propanolol) to help with heart palpitations. Extreme fatigue and muscle aches lasted through 4/10, still experiencing slight SOB and heart palpitations upon exertion. Therapeutic measures were taken as Covid test, EKG, zofran, propanolol as a result of the events. The outcome of the events were recovering. No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: heart palpitations; SOB; nausea; intermittent dry cough; headache; runny nose; extreme fatigue; Joint tenderness; malaise; muscle aches; This is a spontaneous report from a contactable other hcp. A 33-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8732), dose 2 via an unspecified route of administration, administered in Arm Left on 27Mar2021 15:30 as SINGLE DOSE, dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 (Batch/Lot Number: EN6202) as an unspecified dose for covid-19 immunisation. Patient received dose for CETIRIZINE HCL via an unspecified route of administration, administered in unspecified location of administration as an unspecified dose for unspecified indication. List of any other medications the patient received within 2 weeks of vaccination: Cetirizine HCl, Olly Multi-vitamin, joint supplements. Medical history included hypersensitivity from an unknown date and unknown if ongoing known allergies: Codeine. Information was available for Vaccine Facility, Ethnicity and Race. Patient was not pregnant at the time of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive other medications in two weeks of vaccination. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. On 28Mar2021 the patient experienced joint tenderness, malaise, muscle aches, extreme fatigue on 30Mar2021, heart palpitations on 03Apr2021, sob on 03Apr2021, on 01Apr2021 intermittent dry cough, headache, runny nose, nausea on 02Apr2021. The patient underwent lab tests and procedures which included echocardiogram: normal, sars-cov-2 test: negative on 02Apr2021, sars-cov-2 test: negative on 06Apr2021. He said was probably a neurological response to vaccine and prescribed a beta blocker (propanolol) to help with heart palpitations. Extreme fatigue and muscle aches lasted through 4/10, still experiencing slight SOB and heart palpitations upon exertion. Therapeutic measures were taken as Covid test, EKG, zofran, propanolol as a result of the events. The outcome of the events were recovering. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash
Clinical narrative: Rashes over her body; maybe she was having an allergic reaction; This is a spontaneous report received from a contactable consumer. This consumer (patient) reported for herself.  A female patient of unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on Apr2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, after the vaccination, the patient experienced rashes over on her body. She just thought maybe she was having an allergic reaction. She brought it up to someone who told her that is a side effect of the Pfizer-BioNTech Covid-19 Vaccine. She asked for information on rashes, if that is a side effect of the Pfizer-BioNTech Covid-19 Vaccine, and if the rashes over her body get worse. The outcome of the event was unknown.  No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain lower, Arthralgia, Myalgia, Nausea
Clinical narrative: Joint pain; Muscle pain; Nauseated; pain of lower abdominal; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported) via an unspecified route of administration on 16Mar2021 as dose 1, single for COVID-19 immunization, and patient had received medication include paracetamol (TYLENOL), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced joint pain, muscle pain, nauseated and pain of lower abdominal. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.