chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Sleep disorder, Vertigo, Vomiting
Clinical narrative: I woke up between midnight and 2:00AM with nausea and vomiting for hours. I thought that I had food poisoning at first. I also experienced severe dizziness with weakness on my right side. I had issues getting out the bed. Between 5:00 am and 6:00 am, my husband had to help me get out of the bed and to the bathroom. I was pale and lethargic. I took an 500mg aspirin around 2:30am- 3:00am. I had loss of balance, and the room was spinning. By 8:30am - 9:00am, we called to see a physician. I didn't get to see a physician till noon and was admitted to the emergency room for 12 hours. My physician said I had a cardiac event and gave me medication to stabilize it. I went to get a CT scan the next day where I was told I had a minor stroke. I have since then limited taste and smell on the right side. I also have occasional memory lapses. I don't have the same kind of muscle strength.  I have muscle weakness on the left side. I can only sleep for about three to four hours. I also don't have the stamina I use to have.
Age: 18.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Extra dose administered
Clinical narrative: I asked the patient several times at her check up to clarify if she had the bivalent booster. She told me she had three doses of the covid vaccine and okayed getting the bivalent booster. I saw the three primary series doses in the computer. When we checked the registry, both the nurse and I could not find a bivalent dose so I ordered it. After the vaccine was given her mom brings up that she thinks she had already had a bivalent booster. When the patient was able to find and pull up her card she did have 4 doses on it so we had given her an extra bivalent booster (her 5th covid vaccine). She also got the meningitis B vaccine at the same time. Shortly after the vaccines she got light headed. She laid down for a few minutes and was completely fine after this.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Headache, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: On 11/17/2022 I woke with chills, fever and headache. I took a home test and tested positive for COVID-19. I had a telehealth conference with my Primary Physician and was prescribed Paxlovid. I did not take Paxlovid but I was better after about 3/4 days.I also wanted to note that I tested positive for 11 days since onset.
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Insomnia, Irritability, Panic attack, Weight decreased
Clinical narrative: In early October I started having irritability, panic attacks, weight loss, trouble sleeping.  I choose not to seek help at first thinking it would go away and resolve with time. It progressively got worse over time. I am not sure it this just coincides with my getting the vaccine at the same time or life changes. I started seeing my doctor and we have talked about what I am going through and prescribed some medication. I am waiting on things to get better.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Nausea, Pruritus, Respiratory rate increased, Retching
Clinical narrative: Pt received vaccine at 12:40 pm. Pt works in clinic and alerted another nurse at  2:00 pm of possible allergic reaction.  Face flushed, breathing rapidly, itching at chest. Pt reported nausea with dry heaving. Pt was placed in a room with fan for air circulation, v/s obtained. PCP notified, pt was given benadryl 50mg IM and Zofran 4mg orally. Pt continuously monitored. At 2:36 pm pt symptoms improving, v/s WNL, provider notifed, pt released.
Age: 46.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Blood test, Condition aggravated, Crohn's disease
Clinical narrative: My Crohn's has been in remission for quite a while, but it's no longer in remission. I've been having Crohn's symptoms for the last two weeks. There is also a possibility of ovarian cancer which I still need to investigate further. I have no idea if these are in relation to the vaccine.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood cholesterol increased, Blood pressure increased, Blood test abnormal, Chills, Headache
Clinical narrative: After my shot I got a fever of 101, and chills. My hands and feet felt like ice, and I was having headaches. It lasted about 24 hours. I had a physical on and my doctor noticed increase in my levels. I have recently been experiencing spikes in my cholesterol counts and blood pressure. She had me come for testing on March 10, 2023. The blood pressure is higher than ever before. I have been ordered a CT Cardio Scoring Scan, to see if I have plaque buildup. I am scheduled for this on March 16, 2023.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Peripheral coldness, Pyrexia
Clinical narrative: After my shot I got a fever of 101, and chills. My hands and feet felt like ice, and I was having headaches. It lasted about 24 hours. I had a physical on and my doctor noticed increase in my levels. I have recently been experiencing spikes in my cholesterol counts and blood pressure. She had me come for testing on March 10, 2023. The blood pressure is higher than ever before. I have been ordered a CT Cardio Scoring Scan, to see if I have plaque buildup. I am scheduled for this on March 16, 2023.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Pain in extremity, Pharyngeal enanthema
Clinical narrative: Within 2 hours - severe arm pain lasting 48 hours Within 4 hours - redness below injection site that has lasted 5 days so far and has gotten larger and become itchy and painful. In the same timeframe the back of the tongue and throat developed 1/4 inch + tall white bumps that hurt and went down temporarily after taking Benadryl and resolved by day 4 Within 24 hours - High fever and pulse over 157 lasting 12 hours,
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Tongue disorder
Clinical narrative: Within 2 hours - severe arm pain lasting 48 hours Within 4 hours - redness below injection site that has lasted 5 days so far and has gotten larger and become itchy and painful. In the same timeframe the back of the tongue and throat developed 1/4 inch + tall white bumps that hurt and went down temporarily after taking Benadryl and resolved by day 4 Within 24 hours - High fever and pulse over 157 lasting 12 hours,
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: vomiting ,diarrhea
Age: 47.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: COVID-19, Cough, Fatigue, Pain, Respiratory tract congestion
Clinical narrative: On 03/05/2023, I woke up feeling achy and extra tired even though I had just woken up. I also had a little congestion and cough. I assumed it was allergies and wasn't concerned about exposure since I work from home. As the week progressed my symptoms got worse. By Wednesday, my nose was running constantly, so I took a COVID-19 test and it was positive. I did a telehealth visit and began taking Paxlovid on 03/08/2023. After beginning the Paxlovid, my runny nose began decreasing rapidly. The rest of the symptoms gradually got better. I still have a bit of achiness and soreness but am otherwise feeling pretty normal.
Age: 47.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: On 03/05/2023, I woke up feeling achy and extra tired even though I had just woken up. I also had a little congestion and cough. I assumed it was allergies and wasn't concerned about exposure since I work from home. As the week progressed my symptoms got worse. By Wednesday, my nose was running constantly, so I took a COVID-19 test and it was positive. I did a telehealth visit and began taking Paxlovid on 03/08/2023. After beginning the Paxlovid, my runny nose began decreasing rapidly. The rest of the symptoms gradually got better. I still have a bit of achiness and soreness but am otherwise feeling pretty normal.
Age: 85.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: COVID-19, Chest X-ray normal, Cough, Malaise, Paranasal sinus hypersecretion
Clinical narrative: On a flight home from a trip abroad, I began having severe sinus drainage. At that point, I was taking OTC medicine in the hope it would dry it up. Later that night, I had drainage and coughing. On 3/2/2023 or 3/3/2023, I went to the ER and was diagnosed with COVID-19. I underwent a chest X-ray, and my lungs were clear. I was prescribed a steroid, but not antibiotic or antiviral. I took the steroid twice a day for seven days. At the time of this writing, I still don't feel well. I'm coughing a lot, though I haven't had a fever. I haven't been able to sleep well, though I have found that I rest better sitting up rather than lying down. I have been drinking lots of water and taking lots of cough syrup. I was also prescribed some cough pills, though they don't help much. I took a home antigen test earlier today, and the result was positive.
Age: 85.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: SARS-CoV-2 test positive
Clinical narrative: On a flight home from a trip abroad, I began having severe sinus drainage. At that point, I was taking OTC medicine in the hope it would dry it up. Later that night, I had drainage and coughing. On 3/2/2023 or 3/3/2023, I went to the ER and was diagnosed with COVID-19. I underwent a chest X-ray, and my lungs were clear. I was prescribed a steroid, but not antibiotic or antiviral. I took the steroid twice a day for seven days. At the time of this writing, I still don't feel well. I'm coughing a lot, though I haven't had a fever. I haven't been able to sleep well, though I have found that I rest better sitting up rather than lying down. I have been drinking lots of water and taking lots of cough syrup. I was also prescribed some cough pills, though they don't help much. I took a home antigen test earlier today, and the result was positive.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Headache, Malaise, Oropharyngeal pain, Pain
Clinical narrative: I had horrible headache, sore throat, terrible congestion, and body aches. I tested positive for COVID-19 at home. I talked to my doctor, and they prescribed me PAXLOVID. I was sick for 4 days and then I started feeling better. Then after a couple of days I got sick again. I had the same symptoms, and they were milder.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I had horrible headache, sore throat, terrible congestion, and body aches. I tested positive for COVID-19 at home. I talked to my doctor, and they prescribed me PAXLOVID. I was sick for 4 days and then I started feeling better. Then after a couple of days I got sick again. I had the same symptoms, and they were milder.
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: My symptoms were a lot of coughing, body aches, and low-grade fever. These symptoms lasted for several days. I tested positive for COVID-19 on March 1, 2023. I spoke with the doctor on day 3 of my symptoms and received PAXLOVID.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Cough, Fatigue, Insomnia
Clinical narrative: I was going to my nephew's wedding. I thought I may be having allergies issues not only being in a different area but also maybe because of the dogs that I was around. I was coughing, I had a sore throat, chills, I was able to breath but I was also having a lot of phlegm and I was coughing so hard that it was making it hard to breath but that was really due to the buildup of phlegm, my throat was raw and sore from the coughing. I ended up taking a COVID-19 home test and it was positive. I called my healthcare provider back home since I was out of town and he sent me an RX for PAXLOVID. Sleeping has been hard I did not get the medication until Friday but since being it on it has been helping. I am still testing positive and I am still tired but my cough is better.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, Productive cough, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: I was going to my nephew's wedding. I thought I may be having allergies issues not only being in a different area but also maybe because of the dogs that I was around. I was coughing, I had a sore throat, chills, I was able to breath but I was also having a lot of phlegm and I was coughing so hard that it was making it hard to breath but that was really due to the buildup of phlegm, my throat was raw and sore from the coughing. I ended up taking a COVID-19 home test and it was positive. I called my healthcare provider back home since I was out of town and he sent me an RX for PAXLOVID. Sleeping has been hard I did not get the medication until Friday but since being it on it has been helping. I am still testing positive and I am still tired but my cough is better.
Age: 31.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthma, COVID-19, Condition aggravated, Cough, Dizziness
Clinical narrative: After my vaccine I was feverish and achy, it was about 7-8 hours after my vaccine was administered and it lasted about 24 hours. By the 48 hour mark everything was back to normal. In January I started off with a sore throat and then after that I woke up on the morning of January 22nd, I started to have my asthma flare up and having shortness of breath and coughing. I started to have a stuffy nose and it picked up as time continued. Shortness of breath lasted three weeks after my positive test for COVID-19. I had a fever for about 1-2 days and about 4-5 days after my test I felt very dizzy. My oxygen levels got as low as 97 and I felt dizzy for about a week long. As of now I feel normal past week my throat has been sore but I am feeling well however the shortness of breath lasted a long time but is gone. After my telemedicine visit I was prescribed prednisone 10 mg twice a day, I was using my albuterol nebulizer every 4 hours, and I was also taking a cough syrup as well that had guaifenesin and dextromethorphan. I also would take TYLENOL or ibuprofen for body aches and BENADRYL for stuffiness.
Age: 31.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dyspnoea, Nasal congestion, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: After my vaccine I was feverish and achy, it was about 7-8 hours after my vaccine was administered and it lasted about 24 hours. By the 48 hour mark everything was back to normal. In January I started off with a sore throat and then after that I woke up on the morning of January 22nd, I started to have my asthma flare up and having shortness of breath and coughing. I started to have a stuffy nose and it picked up as time continued. Shortness of breath lasted three weeks after my positive test for COVID-19. I had a fever for about 1-2 days and about 4-5 days after my test I felt very dizzy. My oxygen levels got as low as 97 and I felt dizzy for about a week long. As of now I feel normal past week my throat has been sore but I am feeling well however the shortness of breath lasted a long time but is gone. After my telemedicine visit I was prescribed prednisone 10 mg twice a day, I was using my albuterol nebulizer every 4 hours, and I was also taking a cough syrup as well that had guaifenesin and dextromethorphan. I also would take TYLENOL or ibuprofen for body aches and BENADRYL for stuffiness.
Age: 31.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: After my vaccine I was feverish and achy, it was about 7-8 hours after my vaccine was administered and it lasted about 24 hours. By the 48 hour mark everything was back to normal. In January I started off with a sore throat and then after that I woke up on the morning of January 22nd, I started to have my asthma flare up and having shortness of breath and coughing. I started to have a stuffy nose and it picked up as time continued. Shortness of breath lasted three weeks after my positive test for COVID-19. I had a fever for about 1-2 days and about 4-5 days after my test I felt very dizzy. My oxygen levels got as low as 97 and I felt dizzy for about a week long. As of now I feel normal past week my throat has been sore but I am feeling well however the shortness of breath lasted a long time but is gone. After my telemedicine visit I was prescribed prednisone 10 mg twice a day, I was using my albuterol nebulizer every 4 hours, and I was also taking a cough syrup as well that had guaifenesin and dextromethorphan. I also would take TYLENOL or ibuprofen for body aches and BENADRYL for stuffiness.
Age: 65.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: COVID-19, Cough, Head discomfort, Pyrexia, Respiratory tract congestion
Clinical narrative: On 02/03/2023 I woke up with a fever, coughing and congestion. I went to urgent care on 02/04/2023 and I tested positive for COVID-19. The provider prescribed PAXLOVID. I still had pressure in my head and ears for several weeks.
Age: 65.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: SARS-CoV-2 test positive
Clinical narrative: On 02/03/2023 I woke up with a fever, coughing and congestion. I went to urgent care on 02/04/2023 and I tested positive for COVID-19. The provider prescribed PAXLOVID. I still had pressure in my head and ears for several weeks.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Influenza like illness, Nasal congestion, SARS-CoV-2 test positive
Clinical narrative: Late in the evening on February 10, I had a cough, nasal congestion, it felt like I had the flu. I used an at home COVID-19 test that came back positive. On Saturday I went to a local Immediate Care and had them retest and Rapid PCR COVID-19 test also came back positive.   I was prescribed molnupiravir that I started taking immediately, along with benzonatate for the cough. I was feeling better within nine days and much better today.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event
Clinical narrative: No known adverse effects.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ear pain, Foreign body sensation in eyes, Headache, Magnetic resonance imaging, Migraine
Clinical narrative: On 02/14/2023, started having a thumping and jabbing pain in my left ear. On 02/21/2023 I got the Prevnar Pneumonia vaccination. Then on 02/27/2023 started getting occasional stabbing pain by left temple and thought it was a migraine. Noticed entire left side of face was sensitive to touch. Left eye felt like it had something in it and was uncomfortable. The next day felt an intense stabbing pain in my left ear. Left side of scalp was very sore in certain spots, with the area's constantly changing. At one point the pain did become steady and throbbing. Next day 3/1/2023 started to have a sore throat as well. Started to use warm compresses to help. By the next day 03/02/2023 I couldn't open my jaw wide enough to eat an apple. My head hurt when I turned my head to the left, and my ear hurt when I swallowed. On 03/03/2023 I took 2 EXCEDRIN and it helped. Went to my doctor on 03/06/2023 and was sent to have an MRI. Results were normal. My doctor recommended that I see a Neurologist if pain persisted. I've started feeling better after a week.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ocular discomfort, Oropharyngeal pain, Pain, Pain of skin, Sensitive skin
Clinical narrative: On 02/14/2023, started having a thumping and jabbing pain in my left ear. On 02/21/2023 I got the Prevnar Pneumonia vaccination. Then on 02/27/2023 started getting occasional stabbing pain by left temple and thought it was a migraine. Noticed entire left side of face was sensitive to touch. Left eye felt like it had something in it and was uncomfortable. The next day felt an intense stabbing pain in my left ear. Left side of scalp was very sore in certain spots, with the area's constantly changing. At one point the pain did become steady and throbbing. Next day 3/1/2023 started to have a sore throat as well. Started to use warm compresses to help. By the next day 03/02/2023 I couldn't open my jaw wide enough to eat an apple. My head hurt when I turned my head to the left, and my ear hurt when I swallowed. On 03/03/2023 I took 2 EXCEDRIN and it helped. Went to my doctor on 03/06/2023 and was sent to have an MRI. Results were normal. My doctor recommended that I see a Neurologist if pain persisted. I've started feeling better after a week.
Age: 79.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: COVID-19, Cough, Fatigue, Feeling hot, Nasopharyngitis
Clinical narrative: 02/19/2023 I had a ticklish throat and no other symptoms. 02/20/2023 I had the symptoms of a heavy cold, extreme fatigue, coughing,sneezing, heavy nasal output I also felt feverish but my temp was normal. I took a home COVID-19 and tested positive. I had fatigue for about 2-3 weeks after onset.
Age: 79.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive, Sneezing, Throat irritation
Clinical narrative: 02/19/2023 I had a ticklish throat and no other symptoms. 02/20/2023 I had the symptoms of a heavy cold, extreme fatigue, coughing,sneezing, heavy nasal output I also felt feverish but my temp was normal. I took a home COVID-19 and tested positive. I had fatigue for about 2-3 weeks after onset.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: urticaria
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; 1 dose of the Moderna monovalent vaccine for pediatrics was administered after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose of the Moderna monovalent vaccine for pediatrics was administered after the expiration date.) and NO ADVERSE EVENT (no adverse event) in an infant patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Mar-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose of the Moderna monovalent vaccine for pediatrics was administered after the expiration date.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose of the Moderna monovalent vaccine for pediatrics was administered after the expiration date.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (1 dose of the Moderna monovalent vaccine for pediatrics was administered after the expiration date.).    No concomitant medications were reported. The reporter doesn't have any patient information at this time. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Mar-2023: Non-significant follow up appended
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Nurse reports that they inadvertently administered a monovalent vaccine to a patient which was past the published expiration date.; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse reports that they inadvertently administered a monovalent vaccine to a patient which was past the published expiration date.) and NO ADVERSE EVENT (No Adverse Event) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071B22A and 074B22A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Not that the HCP is aware of.  Previously administered products included for Product used for unknown indication: MODERNA COVID-19 VACCINE on 07-Feb-2023. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE.   On 07-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2023, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse reports that they inadvertently administered a monovalent vaccine to a patient which was past the published expiration date.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse reports that they inadvertently administered a monovalent vaccine to a patient which was past the published expiration date.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported No concomitant medications were reported  Nurse reports that they inadvertently administered a monovalent vaccine to a patient which was past the published expiration date. This would have been the patient's 2nd dose. Lot number 071B22A, expiration date - 12Mar2023 Patient did not report any AE after the administration. 1st dose was administered on 07Feb2023, Lot number -074B22A at their facility. Agree with Safety follow up. Preferred method of contact: email
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Rhinorrhoea, Vaccination site paraesthesia
Clinical narrative: felt tingle sensation to arm where vaccine injected; sniffles; felt really tired; arm feels sore; The initial case was missing the following minimum criteria: no adverse event and only medical inquiry. Upon receipt of follow-up information on 22Dec2020, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Dec2020, outcome "unknown", described as "arm feels sore"; FATIGUE (non-serious) with onset Dec2020, outcome "recovering", described as "felt really tired"; RHINORRHOEA (non-serious) with onset Dec2020, outcome "recovering", described as "sniffles"; VACCINATION SITE PARAESTHESIA (non-serious) with onset 22Dec2020, outcome "recovered" (Dec2020), described as "felt tingle sensation to arm where vaccine injected".  Additional information: The patient reported that within first 10 minutes, she felt tingle sensation to arm where vaccine injected but it lasted only 30 minutes. She did later have sniffles and felt really tired. She laid down for an hour and felt much better. The patient also stated that her arm feels sore but she expected that. At the time of reporting, it had been 10 hours since the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: PNC20
Symptoms: Peripheral swelling
Clinical narrative: swelling in the arm; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  An adult patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling in the arm". It was unknown if therapeutic measures were taken as a result of peripheral swelling.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient received BNT162b2 (BNT162B2), on 31Jan2023 as dose 1, 0.3 ml single (Lot number: FP7136) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "Anemic" (ongoing), notes: Had anemia almost all of her life. Concomitant medication(s) included: FERROCITE taken for anaemia. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "recovered" (2023), described as "Had sore injection arm".  Additional information: Other medicines Ferrocite: She is low in iron. It's to help with iron. The patient had no Prior Vaccinations. For the first dose COVID-19 vaccine:  Had sore injection arm. Lasted for a couple days and went away. The soreness didn't come until the next day after shot. With the COVID-19 BV booster, the soreness in the injection arm came right after the shot, immediately. It's still sore, but thought that was normal because of the being sore also with her first COVID-19 vaccine.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Muscle spasms, Restless legs syndrome
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 at 11:00 as dose 2, single (Lot number: EN6198) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "chemotherapy" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/lot number: EM6204, anatomical location: Left arm), administration date: 12Mar2021, for Covid-19 immunization. The following information was reported: MUSCLE SPASMS (non-serious) with onset Apr2021, outcome "not recovered", described as "Legs cramp"; BURNING SENSATION (non-serious) with onset Apr2021, outcome "not recovered", described as "both legs and both feet burning and feels like feet are fixing to explode"; RESTLESS LEGS SYNDROME (non-serious) with onset Apr2021, outcome "not recovered", described as "restless leg". Therapeutic measures were not taken as a result of burning sensation, muscle spasms, restless legs syndrome.  . Event did not required the initiation of new medication/other treatment/ procedure.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 5 (booster), single (Lot number: 6J6665) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Minimal allergy to peanuts" (unspecified if ongoing), notes: Known allergies: Minimal allergy to peanuts; Other medical history were none. The patient's concomitant medications were not reported. Vaccination history included: moderna (DOSE 4 (BOOSTER), SINGLE, vaccine lot number: 954A22A, vaccine location: Left arm), administration date: 06Jul2022, when the patient was 64-year-old, for COVID-19 Immunization; moderna (DOSE 3 (BOOSTER), SINGLE, vaccine lot number: 012H21B, vaccine location: Left arm), administration date: 03Dec2021, when the patient was 64-year-old, for COVID-19 Immunization; moderna (DOSE 2, SINGLE, vaccine lot number: 021C21A, vaccine location: Left arm), administration date: 29Apr2021, when the patient was 63-year-old, for COVID-19 Immunization; moderna (DOSE 1, SINGLE, vaccine lot number: 030B21A, vaccine location: Left arm), administration date: 31Mar2021, when the patient was 63-year-old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Sore arm"; FATIGUE (non-serious), outcome "recovered", described as "tiredness". Therapeutic measures were not taken as a result of pain in extremity, fatigue.  Additional information: The patient had sore arm and last vaccination (Pfizer bivalent) caused tiredness.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Sore arm; tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 5 (booster), single (Lot number: 6J6665) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Minimal allergy to peanuts" (unspecified if ongoing), notes: Known allergies: Minimal allergy to peanuts; Other medical history were none. The patient's concomitant medications were not reported. Vaccination history included: moderna (DOSE 4 (BOOSTER), SINGLE, vaccine lot number: 954A22A, vaccine location: Left arm), administration date: 06Jul2022, when the patient was 64-year-old, for COVID-19 Immunization; moderna (DOSE 3 (BOOSTER), SINGLE, vaccine lot number: 012H21B, vaccine location: Left arm), administration date: 03Dec2021, when the patient was 64-year-old, for COVID-19 Immunization; moderna (DOSE 2, SINGLE, vaccine lot number: 021C21A, vaccine location: Left arm), administration date: 29Apr2021, when the patient was 63-year-old, for COVID-19 Immunization; moderna (DOSE 1, SINGLE, vaccine lot number: 030B21A, vaccine location: Left arm), administration date: 31Mar2021, when the patient was 63-year-old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Sore arm"; FATIGUE (non-serious), outcome "recovered", described as "tiredness". Therapeutic measures were not taken as a result of pain in extremity, fatigue.  Additional information: The patient had sore arm and last vaccination (Pfizer bivalent) caused tiredness.
Sex: F
Vaccine: COVID19-2
Symptoms: Rash erythematous, Swelling
Clinical narrative: This is a spontaneous report received from a contactable reporter A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: RASH ERYTHEMATOUS (non-serious), outcome "recovered", described as "a young lady who said that she had a red rash and it went away after 4 days."; SWELLING (non-serious), outcome "unknown", described as "swollen up/she had same type of swelling".  Additional information: When the caller went to the pharmacy, the caller heard a young lady who said that she had a red rash, and it went away after 4 days. Said she had the same thing happen with her 3rd booster, it swollen up on her and took 4 days go down, she told her it would go away. Caller does not have the lot number of the vaccine the lady in the pharmacy that said she had the same thing, she was withheld, she was waiting for her medication, she was at the other cash register while she was explaining it to the pharmacist, she had same type of swelling. She looked quite young.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Patient was not having any known allergies. Concomitant medication(s) included: ESCITALOPRAM OXALATE oral. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was treated with Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300112282 Same patient, different drug/event;
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: ER8732, Expiration Date: 31Jul2021) at the age of 51 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Endometrial cyst removed" (not ongoing), notes: Endometrial cyst removed appx 6 years ago; "Endometriosis" (ongoing), notes: Endometrial cyst removed appx 6 years ago. There were no concomitant medications. The following information was reported: PSORIASIS (non-serious) with onset 2021, outcome "not recovered", described as "After dose 1: rash on bottom of left foot that eventually migrated to both feet and after dose 2: diagnosed as psoriasis". Therapeutic measures were taken as a result of psoriasis.  Additional Information: It was reported that after dose 1, the patient developed a rash on bottom of left foot that eventually migrated to both feet though not sure at what point and the patient initially thought it was just Athletes foot and treated it as such. After dose 2 , it was finally diagnosed as psoriasis.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Illness, Sneezing
Clinical narrative: Sneezing; Coughing; sickness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SNEEZING (non-serious), outcome "unknown"; COUGH (non-serious), outcome "unknown", described as "Coughing"; ILLNESS (non-serious), outcome "unknown", described as "sickness".  Additional information: Caller only got the Covid vaccine because at the time her daughter was about to start back with on campus learning after being on online schooling for more than a year and a half. Her school's policy was if you were vaccinated and someone around you had Covid you could stay in school as long as you had no symptoms and of course were not positive with Covid. If you were not vaccinated you had to immediately begin quarantine for a week or however long. Not even a few days into her school year someone around her tested positive so she had to miss school. My daughter hated this so she asked me if she could get the vaccine. Caller said sure but she wouldn't let something foreign be in her daughter that wasn't in her. She was naturally worried and highly concerned about her health but what gives her even more discomfort and anxiety was what if what's happening to her was somehow or some way happening to her daughter. This can not be the case and if it was, she needed to get to the bottom of what this all was sooner than later. Her daughter had been sneezing and coughing and having these little battles of sickness now almost every month. She was never sick before getting the vaccine. The coincidences are far more related than they are not. She wanted to get her daughter screened and tested for everything but she was afraid if she does have something seriously wrong with her or even something kind of serious, she doesn't know what she would do. If her daughter had a Pulmonary Embolism she would completely and totally lose it.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Electrocardiogram, Magnetic resonance imaging heart, Myocarditis, Red blood cell sedimentation rate
Clinical narrative: acute myocarditis; This is a literature report for the following literature source:   A 26-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer Unknwon), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (hospitalization, medically significant), 2 days after the suspect product(s) administration, outcome "unknown", described as "acute myocarditis". The event "acute myocarditis" required emergency room visit. The patient underwent the following laboratory tests and procedures: C-reactive protein: 7.84 mg/dl; Electrocardiogram: inferolateral ST elevation warranting a STEMI, notes: alert; Magnetic resonance imaging heart: mid myocardial enhancement in the mid to distal, notes: inferolateral/ antero lateral segments along with myocardial edema with tissue imaging suggestive of acute myocarditis.(; Red blood cell sedimentation rate: 79, notes: units mm/h; Troponin: 21.37 ng/ml. Background: Increased cases of myocarditis have been reported after mRNA COVID-19 vaccination. Authors presented two cases of post COVID vaccine myocarditis and associated MRI findings. Case 1: 26-year-old male presented after waking up with non radiating, 10/10 ,left sided chest pain. ECG in the emergency department showed inferolateral ST elevation warranting a STEMI alert and left heart catheterization. He had normal coronaries. Decision-making: Case 1: Investigation showed Troponin of 21.37 ng/ml, CRP of 7.84 mg/dl, ESR of 79 mm/h. Patient had received 2nd dose of ,Pfizer 2 days prior. Cardiac MRI late gadolinium imaging showed mid myocardial enhancement in the mid to distal inferolateral/ antero lateral segments along with myocardial edema with tissue imaging suggestive of acute myocarditis. Conclusion: The authors presented this case to educate clinicians about post COVID 19 vaccination myocarditis in young adults and how MRI aids in diagnosis.; Sender's Comments: Based on the available information provided, the causal association between the reported event acute myocarditis and BNT162B2, cannot be excluded. Case to be reassessed should a follow-up 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.,Linked Report(s) : US-PFIZER INC-202300105150 Same article/ drug/event and different patient;
Sex: M
Vaccine: COVID19
Symptoms: Troponin
Clinical narrative: acute myocarditis; This is a literature report for the following literature source:   A 26-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer Unknwon), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (hospitalization, medically significant), 2 days after the suspect product(s) administration, outcome "unknown", described as "acute myocarditis". The event "acute myocarditis" required emergency room visit. The patient underwent the following laboratory tests and procedures: C-reactive protein: 7.84 mg/dl; Electrocardiogram: inferolateral ST elevation warranting a STEMI, notes: alert; Magnetic resonance imaging heart: mid myocardial enhancement in the mid to distal, notes: inferolateral/ antero lateral segments along with myocardial edema with tissue imaging suggestive of acute myocarditis.(; Red blood cell sedimentation rate: 79, notes: units mm/h; Troponin: 21.37 ng/ml. Background: Increased cases of myocarditis have been reported after mRNA COVID-19 vaccination. Authors presented two cases of post COVID vaccine myocarditis and associated MRI findings. Case 1: 26-year-old male presented after waking up with non radiating, 10/10 ,left sided chest pain. ECG in the emergency department showed inferolateral ST elevation warranting a STEMI alert and left heart catheterization. He had normal coronaries. Decision-making: Case 1: Investigation showed Troponin of 21.37 ng/ml, CRP of 7.84 mg/dl, ESR of 79 mm/h. Patient had received 2nd dose of ,Pfizer 2 days prior. Cardiac MRI late gadolinium imaging showed mid myocardial enhancement in the mid to distal inferolateral/ antero lateral segments along with myocardial edema with tissue imaging suggestive of acute myocarditis. Conclusion: The authors presented this case to educate clinicians about post COVID 19 vaccination myocarditis in young adults and how MRI aids in diagnosis.; Sender's Comments: Based on the available information provided, the causal association between the reported event acute myocarditis and BNT162B2, cannot be excluded. Case to be reassessed should a follow-up 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.,Linked Report(s) : US-PFIZER INC-202300105150 Same article/ drug/event and different patient;
Sex: U
Vaccine: PNC20
Symptoms: Pain in extremity
Clinical narrative: Severe arm pain; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Severe arm pain". Additional information: Patient experiencing severe arm pain for 10 days after receiving Prevnar 20. The physician confirmed that the event took place after use of product.   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.