chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Nasal congestion, Throat tightness, Vaccination site pain
Clinical narrative: site soreness; nasal stuffiness; difficulty breathing; throat began closing up; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient (also reported as age at vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982), via an unspecified route of administration on 14Jan2021 at 12:00 at a single dose on the left arm for COVID-19 immunization. Medical history included two recent right shoulder surgeries. Concomitant medication included oxaprozin. The patient previously took oxycontin and experienced allergies and an unspecified allergy shot last 06Jan2021 on the left & right arm. The patient was not diagnosed with COVID-19 prior to vaccination. On 15Jan2021 at 01:30, the patient was having difficulty breathing and throat began closing up. Patient's wife was going to call 911 but after about an hour, incident appeared to be getting better. On the next day (16Jan2021), the patient felt better with minor site soreness and nasal stuffiness. The patient did not receive any treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Severe arm pain; unable to move arm without excruciating pain; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231, expiry date not reported), via an unspecified route of administration on the left arm on 15Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included was not reported. Concomitant medication included ibuprofen, vitamin D NOS, magnesium and fish oil. The patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) on the right arm on 25Dec2020 for COVID-19 immunization. The patient experienced severe arm pain; unable to move arm without excruciating pain on 15Jan2021 15:00. The outcome of the event was unknown.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Tongue pruritus, Urticaria
Clinical narrative: hives; itching; itchy feeling tongue; This is a spontaneous report from a contactable nurse. A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: LEK5230), intramuscular  at the right arm on 18Dec2020 08:00 at a single dose for COVID-19 immunization at a hospital. Medical history included allergies with latex, sulfa., and penicillin (PCN). Concomitant medications were unspecified. The patient previously took erythromycin (ERY) and experienced allergies. The patient experienced hives, itching and itchy feeling tongue on 18Dec2020 09:30. Patient took 50 mg of diphenhydramine (BENADRYL), 20 mg famotidine (PEPCID) and 10 mg of cetirizine (ZYRTEC). The patient has not been tested prior and post vaccination. The patient was recovering from the events.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer (patiet).  A 73-years-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248) in the Public Health Clinic/Veterans Administration facility, via an unspecified route of administration on 16Jan2021 09:15 AM at a single dose on the left arm for COVID-19 immunization.  The patient's medical history was not reported. The patient has not had COVID-19 prior to vaccination. The patient did not have any other vaccine in four weeks. Concomitant medication included losartan (manufacturer unknown), levothyroxine (manufacturer unknown), hctz (manufacturer unknown), montelukast (manufacturer unknown, also reported as 'monounsatu').  The patient experienced sore arm on 16Jan2021 at 09:45 AM. The patient did not receive any treatment for the event. The outcome of the event was recovering. The patient has not been tested for COVID-19 post vaccination.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: left arm where the injection was, was swollen and itchy and painful most of the night; left arm where the injection was, was swollen and itchy and painful most of the night; left arm where the injection was, was swollen and itchy and painful most of the night; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on left arm on 15Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of Pfizer-Biontech Covid19 vaccine yesterday (15Jan2021). She was reporting symptoms that started yesterday evening at 21:00. On her left arm where the injection was, was swollen, itchy and painful most of the night and hurts even when she's not moving it. She wanted to know if this is normal, how long does it last and what she can do to treat it. She doesn't know if she can put icepack on it or take a shower. She asked if she can use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Sensation of foreign body
Clinical narrative: Restriction in normal breezing when sleeping, feels like a lump in my lower throat; Restriction in normal breezing when sleeping, feels like a lump in my lower throat; This is a spontaneous report from a contactable other healthcare professional (patient herself).  A 77-year-old female patient (not pregnant) received her second dose of bnt162b2 (BNT162B2 also reported as Covid19 Brand: Pfizer, lot EK4176), intramuscular in left arm on 15Jan2021 15:45 at SINGLE DOSE for Covid-19 vaccination. Medical history included Irritable Bowel Syndrome, Sinal Stenosis, Atrial Fibrillation, Lactose intolerant and Gluten intolerant. She received her first dose of bnt162b2 on 23Dec2020 (lot number: EL128), given via IM in left arm. Concomitant medications included paracetamol (TYLENOL), atropine sulfate, diphenoxylate hydrochloride (DIPHENOXYLATE/ATROPINE) and metoprolol tartrate. The patient experienced restriction in normal breezing when sleeping and felt like a lump in her lower throat on 15Jan2021 22:00. No treatment given. The outcome of events was not recovered.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Neck pain
Clinical narrative: Headache; shivering; sweats; glandular pain in neck; Sore throat; Fatigue; This is a spontaneous report from a contactable other healthcare professional(patient). A 56-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283) intramuscularly into the left arm on 11Jan2021 08:00 at a single dose for covid-19 immunisation. The patient's medical history was not reported. Patient was not pregnant. Concomitant medication included bupropion (BUPROPION). The patient previously took her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Ek5730) intramuscularly into the left arm on 21Dec2020 at a single dose for covid-19 immunization and morphine (MORPHINE) and experienced drug allergy. On 13Jan2021, patient experienced headache, shivering, sweats, glandular pain in neck, sore throat and fatigue. Patient did not receive treatment for the reported events. Outcome of events recovered on an unspecified date in Jan2021.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Headache; shivering; sweats; glandular pain in neck; Sore throat; Fatigue; This is a spontaneous report from a contactable other healthcare professional(patient). A 56-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283) intramuscularly into the left arm on 11Jan2021 08:00 at a single dose for covid-19 immunisation. The patient's medical history was not reported. Patient was not pregnant. Concomitant medication included bupropion (BUPROPION). The patient previously took her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Ek5730) intramuscularly into the left arm on 21Dec2020 at a single dose for covid-19 immunization and morphine (MORPHINE) and experienced drug allergy. On 13Jan2021, patient experienced headache, shivering, sweats, glandular pain in neck, sore throat and fatigue. Patient did not receive treatment for the reported events. Outcome of events recovered on an unspecified date in Jan2021.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Little queasy; Swelling arm; Pain in arm; Little headache; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (16Jan2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EK5730), via an unspecified route of administration on an unspecified date in Jan2021 for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that he was better during administration (Thursday) and by Friday (Jan2021), the patient had a little pain in his arm and little headache. Morning of 16Jan2021, the patient felt a little queasy. The patient reported that he felt a little bit different on Friday. The swelling in his arm was not a problem that's gone down and little pain not much. The patient would like to know the extent of effects the shot could take. The outcome of the event swelling arm was unknown; all other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Illness, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for two patients. This is the second of the two reports.  A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 31Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. This patient was vaccinated and has tested positive for Covid-19 on an unspecified date, not sure when she tested positive for the Covid-19. She was asymptomatic. It was also reported that she got sick on 03Jan2021. The second dose is due 21Jan2021, is it ok for her to receive it? How long can she wait if she does not get the vaccine at 21 days? The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.,Linked Report(s) : US-PFIZER INC-2021051642 same reporter/product, similar events and different patient
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was receiving his second dose on the day same as his surgery (unspecified). Patient was going to postpone his second shot because he had fever after receiving the first shot on an unknown date. The patient wanted to know the maximal interval between doses. The events were reported as non-serious. The outcome of the event fever was unknown.   Information about batch/lot number has been requested.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Joint stiffness, Joint swelling, Laboratory test, Nocturia
Clinical narrative: My knee joints and elbow joints feel very stiff and feel as if they were swollen but they're not/My joints do not look physically swollen up but they feel; My knee joints and elbow joints feel very stiff and feel as if they were swollen but they're not/My joints do not look physically swollen up but they feel; I'm having trouble walking; got up every 15 minutes after that with frequent urination/ I got up 5 or 6 times and even could not get bathroom fasten up and couple of occasion is very unusual for me; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received BNT162B2 (lot number: EL3249), via an unspecified route of administration on 14Jan2021 at single dose in the arm for COVID-19 immunization. Medical history included atrial fibrillation, diabetes and a heart attack 30 years ago. Concomitant medication included dabigatran etexilate mesilate (PRADAXA) for A-fib, empagliflozin (JARDIANCE) for Diabetes, metformin hydrochloride (METFORMIN ER) for Diabetes. It was reported that the patient had no after effects the day he had the shot. In the morning of 16Jan2021, he got some things going on but he was not sure if it is connected with Pfizer or not. Usually he wakes up and go to the bathroom once in middle of a night. Last night he got up 5 or 6 times because he had to go and couple of times, he did not even get to the bathroom on time so he really had to urinate. Stated this is very unusual for him. And when he woke up this morning, her joints do not look physically swollen up but they feel, stated "how do I describe it, they feel very (incomplete sentence)". His knee joints and elbow joints felt very stiff and felt as if they were swollen but they're not. Stated that he's having trouble walking. Stated that it may be totally unrelated. The patient stated, "The only thing I had was, every year they make me go to a lab and make sure I have no issues with Pradaxa because it is a blood thinner. I have that lab. Work done couple of weeks ago. I have not gotten the answers yet". Also stated that he had lab test because he has acid. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Crying, Depressed mood
Clinical narrative: upset stomach; I literally cried all day. I cried even at work for a whole 24 hours, crying for no reason/When I woke up I was crying; like I was depressed; This is a spontaneous report from a contactable healthcare professional (patient). A 53-years-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), 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. The patient reported the side effects she experienced from the first shot. She stated that it wasn't real severe. The first day she was fine, upset stomach. On the second day, she literally cried all day. She cried even at work for a whole 24 hours, cried for no reason, like she was depressed. She didn't think anything about it. She mentioned it during the second shot and they told her to report it. She was fine after that, it was just for that whole day, when she woke up she was crying. Outcome of the events crying and depressed mood was recovered, while for the event abdominal discomfort was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: arm pain; redness; itchiness; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (Age: 70, Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 14Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced arm pain, redness and itchiness on Jan2021. The patient wanted to know if she can still receive second vaccine. She asked if these are common side effects and the efficacy after one dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Investigation, Pain, Peripheral swelling, Pruritus
Clinical narrative: it hurts a little bit if she touches it; arm got red and it was little bump and then it spread and got itchy, and it was a little swollen/It is a big red mark, probably the size of a lemon; arm got red and it was little bump and then it spread and got itchy, and it was a little swollen; arm got red and it was little bump and then it spread and got itchy, and it was a little swollen; felt like she was going to come down with something, she didn't feel right; This is a spontaneous report from a contactable consumer (patient) reported that a 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at a single dose as the patient don't want to have COVID. Medical history included arrhythmia, mitral valve prolapse, acid reflux, high cholesterol, and heart murmur; all from an unknown date. Concomitant medications included verapamil, rosuvastatin, pantoprazole, estradiol (ESTRACE), and acetylsalicylic acid; all were taken from an unspecified date for an unspecified indication. The patient had the first dose of the vaccine 3 days ago (13Jan2021) and stated that her arm got red and it was little bump and then it spread and got itchy, and it was a little swollen on 14Jan2021. She also felt like she was going to come down with something, she didn't feel right. It is not swollen today (16Jan2021) but it hurts a little bit if she touches it. It is a big red mark, probably the size of a lemon. The patient took Tylenol, Zyrtec, and put ice on it all last night (15Jan2021), and it became little itchy and this morning (16Jan2021) it's little itchy, still red but the bump is gone. The patient was asked if she still experiencing the events and she stated that the bump was gone, but now it's like red and a little itchy, the red got bigger, it was also like she was coming down with something but so far today she feel okay. The patient underwent lab test with an unknown results on an unspecified date. The outcome of the event 'it hurts a little bit if she touches it' was unknown; event 'it was a little swollen' was recovered and not recovered for the rest of the events.   Information on the batch number/lot number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: it hurts a little bit if she touches it; arm got red and it was little bump and then it spread and got itchy, and it was a little swollen/It is a big red mark, probably the size of a lemon; arm got red and it was little bump and then it spread and got itchy, and it was a little swollen; arm got red and it was little bump and then it spread and got itchy, and it was a little swollen; felt like she was going to come down with something, she didn't feel right; This is a spontaneous report from a contactable consumer (patient) reported that a 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at a single dose as the patient don't want to have COVID. Medical history included arrhythmia, mitral valve prolapse, acid reflux, high cholesterol, and heart murmur; all from an unknown date. Concomitant medications included verapamil, rosuvastatin, pantoprazole, estradiol (ESTRACE), and acetylsalicylic acid; all were taken from an unspecified date for an unspecified indication. The patient had the first dose of the vaccine 3 days ago (13Jan2021) and stated that her arm got red and it was little bump and then it spread and got itchy, and it was a little swollen on 14Jan2021. She also felt like she was going to come down with something, she didn't feel right. It is not swollen today (16Jan2021) but it hurts a little bit if she touches it. It is a big red mark, probably the size of a lemon. The patient took Tylenol, Zyrtec, and put ice on it all last night (15Jan2021), and it became little itchy and this morning (16Jan2021) it's little itchy, still red but the bump is gone. The patient was asked if she still experiencing the events and she stated that the bump was gone, but now it's like red and a little itchy, the red got bigger, it was also like she was coming down with something but so far today she feel okay. The patient underwent lab test with an unknown results on an unspecified date. The outcome of the event 'it hurts a little bit if she touches it' was unknown; event 'it was a little swollen' was recovered and not recovered for the rest of the events.   Information on the batch number/lot number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: tender, visible left supraclavicular lymphadenopathy; This is a spontaneous report from a contactable physician. A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EK9231, intramuscular on 04Jan2021 15:00 to at a single dose on left arm for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant. The patient ha no known allergies, no prior vaccination and did not have a covid test post vaccination. Concomitant medication included sertraline, lamotrigine, melatonin and biotin. The patient experienced tender, visible left supraclavicular lymphadenopathy on 16Jan2021 12:00AM. The patient did not receive treatment for the event. The outcome of the event was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Bronchitis
Clinical narrative: Asthmas/having asthma attacks; bronchitis; This is a spontaneous report from a contactable consumer (patient) via Medical Information team and Pfizer sponsored program, Pfizer First Connect. A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm on 13Jan2021 at single dose for COVID-19 immunization. The patient's medical history  included asthma. Concomitant medication includes a bunch of medications for asthma. The patient had her first dose of COVID vaccine on 13Jan2021. The patient said that she does have asthma anyway and her asthma goes into bronchitis in 2021 very quickly. So she was just put on Prednisone. She is wondering if she can start Prednisone and an antibiotic for her asthma. The patient already had asthma but she is starting Prednisone and an antibiotic. And antibiotic is not something that she normally takes. The patient stated, "I took the Pfizer vaccine on Wednesday, the first dose and I am having a bad asthma attack (in Jan2021) and I don't know what my doctor put me on, wanted me to take Prednisone and an antibiotic (Unspecified Medication). The patient ask, "Can I take those after taking the vaccine?" The patient was asked about treatment for the event and stated, "Not until 2 days but right now I am having one. I just want to know if I can take Prednisone and antibiotic to get rid of this. Just my regular asthma medications that I am taking. My Albuterol inhaler, my Nebulizer and that's it." The outcome of the events was unknown.  Information about Lot/Batch has been requested.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: Mild swelling of face and lips; Mild swelling of face and lips; This is a spontaneous report from a contactable physician. A 21-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249, expiry date: unknown), intramuscular in the right arm, on 15Jan2021 11:00 at a single dose for covid-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient is not pregnant. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 post vaccination. The patient had no known allergies. On 16Jan2021, the patient experienced mild swelling of face and lips. Both the events resulted in emergency room visit. Therapeutic measures were taken as a result of mild swelling of face and lips which included steroid shot, told to take ZYRTEC and PEPCID. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Coronavirus infection
Clinical narrative: ended up getting coronavirus; ended up getting coronavirus; This is a spontaneous report from the Pfizer marketing program. Information received from a contactable consumer reporting for the mother.  A female patient of an unspecified age received the first dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on an unspecified date  at single dose for Covid-19 immunisation .  The patient medical history and concomitant medications were not reported.   It was reported that the patient took the first dose of the vaccine but ended up getting Coronavirus a week after her first dose.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Laboratory test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 virus test positive; COVID-19 virus test positive; This is a spontaneous report from a Pfizer-sponsored program "Pfizer RXPathways" from a contactable other health professional. A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 24Dec2020, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced COVID-19 virus test positive on 13Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 13Jan2021.   The information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported events.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Headache, Thinking abnormal
Clinical narrative: Severe headache; confusion; unable to get clear thoughts communicated; This is a spontaneous report from a contactable other healthcare professional. An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) intramuscular on the left arm on 15Jan2021 10:45 at a single dose for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. On 16Jan2021 08:00 AM, the patient experienced severe headache, confusion, unable to get clear thoughts communicated. No treatment was received. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the events was not recovered.   Information on Lot/Batch has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Ear pain, Fatigue, Headache
Clinical narrative: rigors; muscle aches; head ache; pain in my inner ears; photophobia; feeling of exhaustion; too weak to walk further than the bathroom; This is a spontaneous report from a contactable other hcp. A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 09Jan2021 13:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension and atrial fibrillation from an unknown date and unknown if ongoing. Concomitant medication included benazepril (BENAZEPRIL), diltiazem (DILTIAZEM), rivaroxaban (XARELTO) and estrogen/methyl te. The patient previously had the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 21Dec2020. The patient stated, "I woke from sleep about 12 hours later (10Jan2021) with rigors, muscle aches, head ache and pain in my inner ears as well as photophobia and feeling of exhaustion. The rigors had resolved by 8am but other symptoms persisted. I was too weak to walk further than the bathroom. I was able to consume only warm liquids, although I had no nausea, vomiting or diarrhea. Note that since onset post infectious irritable bowel symptoms in February after visiting a city, weeks before the pandemic was recognized, I have had very abnormal but not absent sense of taste and smell, making me wonder whether I was infected in February without the usual symptoms." The patient recovered from rigors on 10Jan2021, outcome of the event weakness was unknown while other events were not recovered.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Photophobia
Clinical narrative: rigors; muscle aches; head ache; pain in my inner ears; photophobia; feeling of exhaustion; too weak to walk further than the bathroom; This is a spontaneous report from a contactable other hcp. A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 09Jan2021 13:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension and atrial fibrillation from an unknown date and unknown if ongoing. Concomitant medication included benazepril (BENAZEPRIL), diltiazem (DILTIAZEM), rivaroxaban (XARELTO) and estrogen/methyl te. The patient previously had the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 21Dec2020. The patient stated, "I woke from sleep about 12 hours later (10Jan2021) with rigors, muscle aches, head ache and pain in my inner ears as well as photophobia and feeling of exhaustion. The rigors had resolved by 8am but other symptoms persisted. I was too weak to walk further than the bathroom. I was able to consume only warm liquids, although I had no nausea, vomiting or diarrhea. Note that since onset post infectious irritable bowel symptoms in February after visiting a city, weeks before the pandemic was recognized, I have had very abnormal but not absent sense of taste and smell, making me wonder whether I was infected in February without the usual symptoms." The patient recovered from rigors on 10Jan2021, outcome of the event weakness was unknown while other events were not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Swollen tongue, Vaccination site erythema
Clinical narrative: swelling of the hands and tongue; swelling of the hands and tongue; some injection site redness; This is a spontaneous report from a contactable consumer. A 69 old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient received the first dose of vaccine on 12Jan2021 and developed swelling of the hands and tongue as well as some injection site redness on unspecified dates. Pharmacist gave her Benadryl and symptoms resolved. Her doctor has advised her not to receive the second vaccine. She had previous history of having an allergic reaction to the tetanus shot and was unable to receive the shingles shot. The patient recovered from the events on unspecified date.   Information about lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Episcleritis, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Soreness in the arm; Conjunctivitis; Episcleritis; This is a spontaneous report from a contactable physician (dentist, dental surgeon/patient's husband).  A 57-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1284), via an unspecified route of administration on 30Dec2020 at 57-years-old at a single dose for COVID-19 immunization.  Medical history included blood pressure increased, and blood cholesterol increased; both from an unknown date and unknown if ongoing. Concomitant medications included atenolol (MANUFACTURER UNKNOWN) taken for blood pressure from an unspecified date to an unspecified date, "normal hormones" from an unspecified date to an unspecified date, "statin for cholesterol" from an unspecified date to an unspecified date. On 10Jan2021, the patient experienced conjunctivitis (non-serious). In Jan2021, the patient experienced episcleritis (non-serious). On an unspecified date, the patient experienced soreness in the arm (non-serious). The clinical course was reported as follows: The physician (patient's husband) stated that he and his wife received the Pfizer COVID-19 vaccine on 30Dec2020; and both had "a little bit of soreness in the arm, nothing spectacular." The patient developed a pink eye and was diagnosed with conjunctivitis 12 days (also reported as "approximately 10Jan or so") later after getting the vaccine (as reported). The doctor prescribed some topical cortical steroid eye drop. The eye was still swollen, and not totally resolved; "continually got worse." The patient consulted an ophthalmologist who gave the patient some prednisone ophthalmic (also reported as cortisone) and over the counter lubricant for the eyes. The patient was still symptomatic. The patient was diagnosed with episcleritis. The ophthalmologist classified the episcleritis as an autoimmune disease. Regarding the causality between the vaccine and the events, the patient's husband stated that his wife did not think it was related, and that the events could be totally idiopathic and there could be no correlation. The patient underwent lab tests and procedures which included COVID test: negative   on an unspecified date.  Therapeutic measures were taken as a result of conjunctivitis and episcleritis. The clinical outcome of the events was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain, Pyrexia
Clinical narrative: fever between 103 to 103 F; Severe body aches; fatigue; generalized weakness; This is a spontaneous report from a contactable physician (patient). A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231 and expiration date not provided), via an unspecified route of administration in the left arm on 07Jan2021 17:30 at a single dose for COVID-19 immunization. Medical history included Meniere's disease, and allergies to Latex. The patient previously took cefalexin (KEFLEX) and codeine and experienced allergies. The patient also took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 17Dec2020 17:30 in the left arm for COVID-19 immunization. The patient is not pregnant. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified medications. On 08Jan2021 03:00, about 10 hours post vaccine, the patient experienced fever between 103 to 103 f, severe body aches, fatigue, and generalized weakness which lasted until about 60 hours post vaccination. The patient has not undergone COVID testing post vaccination. The outcome of the events was recovered on 10Jan2021 15:30.; Sender's Comments: Based on a compatible temporal association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: two inches of redness and swelling at the injection site that is tender to touch; two inches of redness and swelling at the injection site that is tender to touch; two inches of redness and swelling at the injection site that is tender to touch; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 13Jan2021 at 16:45 at a single dose on the left arm for COVID-19 immunization. The patient's medical history was reported as none. The patient has no known allergies. Concomitant medication included topiramate (TOPAMAX). The patient was not diagnosed with COVID-19 prior to vaccination. On 15Jan2021, the patient had two inches of redness and swelling at the injection site that is tender to touch. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site macule
Clinical narrative: very red circle around injection site; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration in the left arm on 05Jan2021 16:00 at a single dose for COVID-19 immunization. The patient was vaccinated in a hospital facility. Medical history included anxiety. The patient has no known allergies. The patient had no covid prior vaccination. The patient was not tested for covid post vaccination. The patient is not pregnant at the time of vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO), curcumin, vitamin b12, vitamin c (also known as ascorbic acid), vitamin d, and biotin. The patient did not receive other vaccine in four weeks. On 16Jan2021 at 12:00 (also reported as day 12; possibly discrepant), the patient experienced very red circle around injection site. The patient did not receive treatment for the reported adverse event. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a Pfizer-sponsored program from a contactable nurse reporting for herself. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the vaccine and 2 days later developed positive COVID-19 test and go bed. The patient wanted to know how many days she needs to wait until she receives the 2nd vaccine. The outcome of the event was unknown.   Information on lot number/batch number was requested.; Sender's Comments: The patient developed positive COVID-19 test two days after vaccination of BNT162B2.  No complete protection can be achieved to prevent from the targeted infection/disease due to the very short time lag. The company considers that the COVID-19 is more likely pre-existing condition prior to vaccine use, and unrelated to BNT162B2.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Pain, Pain in extremity
Clinical narrative: Arm soreness; Aches; Exhaustion; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in left arm on 15Jan2021 11:30 at single dose for COVID-19 immunization. Medical history included drug allergy to Quinolones, asthma and thyroid cancer from an unknown date and unknown if ongoing. Concomitant medication included omeprazole, levothyroxine sodium (SYNTHROID), topiramate (TOPAMAX) and sertraline hydrochloride (ZOLOFT). The facility where the most recent COVID-19 vaccine was administered was in the Public Health Clinic/Veterans Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 15Jan2021 02:00 PM, the patient experienced arm soreness, aches, exhaustion, diarrhea. No treatment was received for the events. The outcome of the events was recovering. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and were not a congenital anomaly/birth defect.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: Pain at injection; headache; fatigue; nausea; chills; brain fog; diarrhea; joint pain; This is a spontaneous report from a contactable other healthcare professional (hcp). A 42-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported), intramuscular on 18Dec2020 16:00 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included depression, anxiety, and known allergies to IVP dye. The patient was not pregnant at the time of the vaccination. The patient had no COVID prior to vaccination. Concomitant medications (reported as other medications in two weeks) included bupropion hydrochloride (WELLBUTRIN), sertraline hydrochloride (ZOLOFT) and unspecified multivitamin. The patient had no other vaccine in four weeks. The patient previously took cefalexin (KEFLEX) but had known allergies. On 19Dec2020 08:00 AM, the patient experienced pain at injection, headache, fatigue, nausea, chills, brain fog, diarrhea, and joint pain. No treatment received in response to the events. The patient was not tested for COVID post vaccination. The outcome of the events pain at injection, headache, fatigue, nausea, chills, brain fog, diarrhea, and joint pain was recovered on an unknown date.   Information on the Lot/Batch Number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vaccination site pain
Clinical narrative: Pain at injection; headache; fatigue; nausea; chills; brain fog; diarrhea; joint pain; This is a spontaneous report from a contactable other healthcare professional (hcp). A 42-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported), intramuscular on 18Dec2020 16:00 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included depression, anxiety, and known allergies to IVP dye. The patient was not pregnant at the time of the vaccination. The patient had no COVID prior to vaccination. Concomitant medications (reported as other medications in two weeks) included bupropion hydrochloride (WELLBUTRIN), sertraline hydrochloride (ZOLOFT) and unspecified multivitamin. The patient had no other vaccine in four weeks. The patient previously took cefalexin (KEFLEX) but had known allergies. On 19Dec2020 08:00 AM, the patient experienced pain at injection, headache, fatigue, nausea, chills, brain fog, diarrhea, and joint pain. No treatment received in response to the events. The patient was not tested for COVID post vaccination. The outcome of the events pain at injection, headache, fatigue, nausea, chills, brain fog, diarrhea, and joint pain was recovered on an unknown date.   Information on the Lot/Batch Number has been requested.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Gait inability, Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling in left leg; Numbness and tingling in left leg; burning sensation all over leg; unable to walk; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302 and expiration date not provided), via an unspecified route of administration (right arm) second dose on 09Jan2021 17:15 at single dose for covid-19 immunisation. The patient medical history was not reported.  There were no concomitant medications.  Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140) via an unspecified route of administration (left arm) first dose on 21Dec2020. On 09Jan2021 22:30, the patient experienced Numbness and tingling in left leg, burning sensation all over leg, unable to walk. The patient did not received treatment for the events.  The outcome of the events was not recovered.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Insomnia, Migraine, Pain
Clinical narrative: Fever of 103.5; severe body aches; Migraine; Fatigue; Insomnia; This is a spontaneous report from a contactable other health professional (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), via an unspecified route of administration on 29Dec2020 at 15:00 at a single dose on the right arm for COVID-19 immunization. The patient's medical history included GERD and allergy to latex. The patient was also diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has concomitant medications but were not specified. On 01Jan2021 at 02:00, the patient experienced fever of 103.5, severe body aches, migraine, fatigue, and insomnia. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 103.5; severe body aches; Migraine; Fatigue; Insomnia; This is a spontaneous report from a contactable other health professional (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), via an unspecified route of administration on 29Dec2020 at 15:00 at a single dose on the right arm for COVID-19 immunization. The patient's medical history included GERD and allergy to latex. The patient was also diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has concomitant medications but were not specified. On 01Jan2021 at 02:00, the patient experienced fever of 103.5, severe body aches, migraine, fatigue, and insomnia. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.