chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Feeling cold, Feeling hot
Clinical narrative: ears have been burning; she checked her temperature and it is lower than normal, her temperature is usually 96 and she just checked it and it was 91 degrees Fahrenheit; feels like her ears are hot; low iron; it feels like someone is pouring ice on her back/ she finds herself so cold; chills; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231, expiration date not reported) intramuscular on 30Dec2020 at, single for COVID. The patient had no medical history. There were no concomitant medications. The patient said that calling she was having a side effect that is not on the list of side effect. She does not know if it was from the chills but her ears have been burning ever since had the shot. She feels like her ears were hot. Can the vaccine cause this to happen? She clarified she was not having chills, it doesn't feel like chills, she said on the second day after the vaccine she had chills but right now it felt like someone was pouring ice on her back and she checked her temperature and it is lower than normal, her temperature is usually 96 and she just checked it and it was 91 degrees Fahrenheit. Her ears have been burning. Her first dose was given 30Dec2020. That was another reason she was calling should she get the second dose if she was feeling this way. She said her ears began burning sometime last week and it has not stopped. Sometimes it will go away and come back but she find herself so cold she has to get under the covers and it takes forever to warm up. Today she put a hat and a scarf around her ears to warm up in doors. She has low iron. She doesn't know with her having low iron all her life and she has never experienced this before. Outcome of the event ears have been burning was not recovered while unknown for the other events.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: some mild pain at the injection site; This is a spontaneous report from contactable nurses (one is patient). A 62-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced some mild pain at the injection site on 15Jan2021 shortly after injection. The outcome of event was unknown.  Information on the Lot/Batch number has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Feeling Unwell; This is a spontaneous report from a contactable consumer (patient's husband). An 83-year-old female patient received bnt162b2 (reported as COVID vaccine), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's husband stated, she just received a Covid shot yesterday and she was not feeling well on 15Jan2021. The outcome of the event was unknown.  Pfizer is a marketing authorization holder of [COVID vaccine] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [COVID vaccine] has submitted the same report to the regulatory authorities.  No follow-up attempts are possible. Information about batch/lot number cannot be obtained.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: painful hip; sore arm; This is a spontaneous report from a contactable consumer (Patient's wife).  A 84-years-old male patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 12Jan2021 at single dose (Left arm) for COVID-19 immunization (for coronavirus). The patient medical history was not reported. There were no concomitant medications. The reporter was calling about the Covid-19 vaccine. The reporter stated that her husband had a sore arm from the covid-19 vaccine on an unspecified date and that he had a different reaction. She said that he ended up with a painful hip and it was a side effect that was listed on the paperwork. She said that he is in really good shape for his age and that he is much better now. She said that he has very little soreness in his arm still. The pain in his hip has resolved. The outcome of the event painful hip was recovered and sore arm was recovering.  Information on the Lot/Batch number has been requested.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling jittery, Tremor
Clinical narrative: Shakiness; Chills; Feeling jittery; This is a spontaneous report from a contactable consumer. This consumer reported for self that the 76-year-old female patient received first dose of bnt162b2 (BNT162B2, Pfizer BioNtech Covid-19 vaccine) via unknown route of adminsitration on 15Jan2021 11:30AM on left upper arm at a single dose  for covid-19 immunization(lives in senior center and because of his age). Medical history and concomitant medications were none. He is a little shaky, but not had any dizziness or anything. He wanted to make sure it's okay and not interfere with him getting the next dose. Is this normal. Has also had a few chills, but not feeling too bad. Is a little jittery, but is staring to feel better. He did not receive any other vaccines the same time or 4 weeks prior. Did get a flu shot last October (Oct2020) with no problems or reaction. States no history of problems with vaccines in past. Vaccination Facility Type was unknown. No Vaccine Administered at Military Facility. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No AE(s) require a visit to Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks prior to the first administration date of the suspect vaccine(s)) was none. AE(s) following prior vaccinations was none. Patient's Medical History (including any illness at time of vaccination; Provide other relevant medical history including but not limited to these conditions:  diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity) was none. Family Medical History Relevant to AE(s) was none. Relevant Tests was none. The events started from 15Jan2021 with outcome of not recovered.   Information on the lot/batch number has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Vomiting
Clinical narrative: Threw up 4 times; Had diarrhea 3 times; Tired; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) at 79-year-old via an unspecified route of administration in the left arm on 14Jan2021, 9:03 AM at a single dose for COVID-19 immunization/ because people are dying. The patient's medical history was not reported. Patient however stated he is familiar with cancer, epileptic seizures, and heart attacks (pending confirmation if referring to medical history). The patient lives alone and has nobody. Concomitant medications were not reported. On 15Jan2021, from 2:00AM, the patient threw up 4 times, had diarrhea 3 times, and was tired. The patient recovered from the events "threw up" and "diarrhea" on 15Jan2021 (time unspecified). Outcome of the event "tired" was not recovered. It was reported that the patient was scheduled for his second dose on 04Feb2021 at 3:30 PM.   Information on the lot/batch number has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Headache, Laboratory test
Clinical narrative: Lightheadedness; Headache; tightness in his chest; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK4176, via an unspecified route of administration in the left arm/ shoulder area on 15Jan2021 at 11:15 at single dose for COVID-19 immunization. Medical history included ongoing epilepsy, patient has epilepsy that has been controlled since 1977; and issues with his blood pressure. He has no allergies. Concomitant medications included phenobarbital and phenytoin (DILANTIN), both for epilepsy. He takes HTZ TRI something, it is a long word but is basically 2 diuretic. He is also being followed by a cardiologist. Patient has no prior vaccinations within 4 weeks. The patient got the COVID injection 2.5 hours ago on 15Jan2021 and after that he had a slight case of lightheadedness. He was instructed to drink water and walk if he was able, he did that and it helped. The patient relays that he was fasting that morning and thinks that had some degree of relatedness in the lightheaded feeling. He ate lunch and the light headedness resolved but now he has a slight headache. He was reading the paperwork and on the form under severe reactions, it mentions dizziness, weakness, and difficulty breathing. While he is breath ok, he has noticed a slight degree of tightness in his chest. He did not see this listed but wants to know if this is normal or if it would be related to the difficulty breathing. His main concern is if this is a severe reaction. He had lab work done prior to getting the vaccine, then none afterward. The events did not require visit to emergency room and physician office. The outcome of the event 'lightheadedness' was recovered while unknown for the other events.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; body pain; temperature is dropping; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on Jan2021 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, Caller said he received his vaccine last week, Since then he is experiencing fever, body pain and his temperature is dropping. He wanted to know what he needed to do about it. Because last Mar2020 He was positive for COVID. The outcome of the events was unknown.   Information on the batch/lot number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: 2 to 3 days of hip discomfort; unable to sit for any length of time, or lay on side for any length of time; This is a spontaneous report from a contactable nurse (reporting for herself).  A non-pregnant 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK4176), via an unspecified route of administration, on 08Jan2021 11:00 at a single dose for COVID-19 immunization.  The patients medical history was not reported.  Concomitant medication included venlafaxine hydrochloride (EFFEXOR), calcium (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), curcuma longa root (TURMERIC CURCUMIN), calcium pantothenate, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (B COM) , polycarbophil calcium (FIBER).  The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EH9899), on 18Dec2020 at 11:00 AM in the left arm for COVID-19 immunization. The patient has no known drug allergies. The patient experienced, 2 to 3 days of hip discomfort; unable to sit for any length of time, or lay on side for any length of time on 09Jan2021 07:30.  No treatment was received for the event.  The outcome of the event was recovered in Jan2021.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Disease recurrence, Headache, Pain, Vaccination site erythema
Clinical narrative: the redness around the site came back; the redness around the site came back; headache; body aches; chills; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EL3246 and Expiration Date unknown) via intramuscularly on 12Jan2021 08:15 AM (Left arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EK5730 and Expiration Date unknown) via intramuscularly on 21Dec2020 05:15 PM (Right arm) at single dose for COVID-19 immunisation. With first dose, patient had redness to the site the day after injection. It was probably about a quarter to half dollar in size and was red and inflamed but went away and faded as the week went on. Then about a week after that vaccine, the redness came back but it was itchy, hot to touch, and hard. Over the next day or so it grew quite large (have pictures for comparison throughout the days). Treatment included oral antibiotic and it slowly began to fade and go away. Other medical history was reported as Attention deficit hyperactivity disorder (ADD), eczema, psoriasis. The concomitant medications included unspecified Birth control, vitamin b complex (VITAMIN B) and ergocalciferol (VIT D). No other vaccine in four weeks. After second vaccine patient had a typical immune response- headache, body aches, chills, etc on the first day after vaccination and then on the second day post vaccination the redness around the site came back. Patient worried it was going to continue to grow again. The outcome of events was unknown.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Vaccination site swelling
Clinical narrative: That same type of swelling happened the following day directly at the injection site with minor muscle and joint pain and fatigue. Heat pad applied to lower the swelling./Left forearm swelling; joint pain; minor muscle and joint pain; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 29-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on right arm on 12Jan2021 at 15:45 at single dose for COVID-19 immunization. Medical history included shellfish allergy. There were no concomitant medications. The patient previously received his first dose of BNT162B2 intramuscularly on left arm on 22Dec2020 at 09:00 AM for COVID-19 immunization, two weeks later a mass grew within the muscle at the forearm region. No ecchymosis with minor pain. Heat pad applied to lower the swelling. After the second shot on unknown date in Jan2021, same type of swelling happened the following day directly at the injection site with minor muscle and joint pain and fatigue. Heat pad applied to lower the swelling. There has been significant relief with just rest and applications of heat to both locations. Left forearm swelling is almost completely gone. The outcome of event vaccination site swelling was recovered on unknown date in Jan2021. The outcome of rest events was unknown.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Influenza, Musculoskeletal discomfort, Nausea, Pain in jaw
Clinical narrative: slow onset of left earache; mild tooth/jaw pain on the left side of the mouth; mild tooth/jaw pain on the left side of the mouth; mild flu symptoms but never ran a fever; shoulder discomfort and nausea; shoulder discomfort and nausea; This is a spontaneous report from a contactable consumer. This consumer reported information for both husband and wife. This is the wife report. A female patient (wife of the reporter) of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unknown date via an unknown route at left arm (reported as left shoulder) for Covid-19 immunization. Medical history was not provided. No covid prior vaccination. Patient did not have covid tested post vaccination. Other medications in two weeks included potassium. No other vaccine received in four weeks. Patient had slow onset of left earache, mild tooth/jaw pain on the left side of the mouth, mild flu symptoms but never ran a fever, shoulder discomfort and nausea. The event clinical course was as follows: both reporter and his wife both received BNT162B2. The reporter had no known allergies, and medical history included artery disease, sleep apnea, acid reflux. The wife had slow onset of left earache, and reporter soon had "crinkle' sounds in left ear. And they both experienced mild tooth/jaw pain on the left side of the mouth. Injection for both was in "left shoulder" (as reported). It was reported that if she had not matched my symptoms, reporter would not have attributed these two things to the vaccine. Their prescription meds did not match at all except for potassium. Otherwise the reporter had sore shoulder, extreme tiredness on the 14th. She had mild flu symptoms but never ran a fever. She experienced shoulder discomfort and nausea. Today (17Jan2021), all symptoms are gone except the reporter still had some "crinkle" in left ear. Outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Toothache
Clinical narrative: slow onset of left earache; mild tooth/jaw pain on the left side of the mouth; mild tooth/jaw pain on the left side of the mouth; mild flu symptoms but never ran a fever; shoulder discomfort and nausea; shoulder discomfort and nausea; This is a spontaneous report from a contactable consumer. This consumer reported information for both husband and wife. This is the wife report. A female patient (wife of the reporter) of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unknown date via an unknown route at left arm (reported as left shoulder) for Covid-19 immunization. Medical history was not provided. No covid prior vaccination. Patient did not have covid tested post vaccination. Other medications in two weeks included potassium. No other vaccine received in four weeks. Patient had slow onset of left earache, mild tooth/jaw pain on the left side of the mouth, mild flu symptoms but never ran a fever, shoulder discomfort and nausea. The event clinical course was as follows: both reporter and his wife both received BNT162B2. The reporter had no known allergies, and medical history included artery disease, sleep apnea, acid reflux. The wife had slow onset of left earache, and reporter soon had "crinkle' sounds in left ear. And they both experienced mild tooth/jaw pain on the left side of the mouth. Injection for both was in "left shoulder" (as reported). It was reported that if she had not matched my symptoms, reporter would not have attributed these two things to the vaccine. Their prescription meds did not match at all except for potassium. Otherwise the reporter had sore shoulder, extreme tiredness on the 14th. She had mild flu symptoms but never ran a fever. She experienced shoulder discomfort and nausea. Today (17Jan2021), all symptoms are gone except the reporter still had some "crinkle" in left ear. Outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus, Toothache
Clinical narrative: slow onset of left earache; mild tooth/jaw pain on the left side of the mouth; mild tooth/jaw pain on the left side of the mouth; mild flu symptoms but never ran a fever; shoulder discomfort and nausea; shoulder discomfort and nausea; This is a spontaneous report from a contactable consumer. This consumer reported information for both husband and wife. This is the wife report. A female patient (wife of the reporter) of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unknown date via an unknown route at left arm (reported as left shoulder) for Covid-19 immunization. Medical history was not provided. No covid prior vaccination. Patient did not have covid tested post vaccination. Other medications in two weeks included potassium. No other vaccine received in four weeks. Patient had slow onset of left earache, mild tooth/jaw pain on the left side of the mouth, mild flu symptoms but never ran a fever, shoulder discomfort and nausea. The event clinical course was as follows: both reporter and his wife both received BNT162B2. The reporter had no known allergies, and medical history included artery disease, sleep apnea, acid reflux. The wife had slow onset of left earache, and reporter soon had "crinkle' sounds in left ear. And they both experienced mild tooth/jaw pain on the left side of the mouth. Injection for both was in "left shoulder" (as reported). It was reported that if she had not matched my symptoms, reporter would not have attributed these two things to the vaccine. Their prescription meds did not match at all except for potassium. Otherwise the reporter had sore shoulder, extreme tiredness on the 14th. She had mild flu symptoms but never ran a fever. She experienced shoulder discomfort and nausea. Today (17Jan2021), all symptoms are gone except the reporter still had some "crinkle" in left ear. Outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Exposure via breast milk, Pyrexia
Clinical narrative: nursing her infant and he developed fever; nursing her infant and he developed fever; This is a spontaneous report from a contactable other health professional. This other-HCP reported events for mother and baby. This is baby case. An infant male patient of unspecified age received the first dose BNT162B2 (lot number: EK5730), via transmammary on 22Dec2020 at 18:15 in right arm for covid-19 immunization, and the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via transmammary on 11Jan2021 at 18:15 at single dose in left arm for covid-19 immunization. The mother's medical history included hypothyroid, and known allergies: penicillin. The mother's concomitant medication included levothyroxine, biotin, ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS), ergocalciferol (VIT D), lactobacillus acidophilus (PROBIO). The patient's mother received the first dose BNT162B2 on 22Dec2020, and received the second dose BNT162B2 on 11Jan2021. The patient's mother had myalgias 16 hours after receiving the 2nd vaccine. The patient's mother was nursing her infant and he developed fever for 3 days without any other symptoms following her vaccination. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021034793 Same reporter/drug, different patient/event.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia, Rash, SARS-CoV-2 antibody test
Clinical narrative: light headed; Tingling of body and face; rash on right arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 34-year-old female patient (no pregnancy) received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: El0142), via an unspecified route of administration at site of left arm on an unspecified date at single dose for COVID-19 immunization. Medical history included COVID-19 (COVID-19 antibody test with positive result) and allergies; Iodine. Concomitant medication included vitamin c [ascorbic acid] and calcium. Both received within two weeks if vaccination. The patient experienced lightheaded, tingling of body and face and rash on right arm on 17Jan2021. Facility type vaccine was in hospital. No other vaccine received in four weeks. No treatment received for adverse event. No covid tested post vaccination. The outcome of events was recovering.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Nausea
Clinical narrative: fatigue; Pain at injection site; chills; body aches; headache; neck pain; joint pain; nausea; This is a spontaneous report from a non-contactable nurse (patient). A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 13Jan2021 09:45 at single dose in left arm for COVID-19 immunization. The patient medical history was not reported. The patient had no known allergies. There were no concomitant medications. The patient had no covid prior vaccination and no covid tested post vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248), via an unspecified route of administration on 23Dec2020 14:45 at single dose in left arm for COVID-19 immunization. The patient experienced pain at injection site, chills, body aches, headache, neck pain, joint pain, nausea, fatigue on 14Jan2021 02:00. The outcome of the events was recovered in Jan2021. The patient did not receive treatment for the events.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Vaccination site pain
Clinical narrative: fatigue; Pain at injection site; chills; body aches; headache; neck pain; joint pain; nausea; This is a spontaneous report from a non-contactable nurse (patient). A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 13Jan2021 09:45 at single dose in left arm for COVID-19 immunization. The patient medical history was not reported. The patient had no known allergies. There were no concomitant medications. The patient had no covid prior vaccination and no covid tested post vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248), via an unspecified route of administration on 23Dec2020 14:45 at single dose in left arm for COVID-19 immunization. The patient experienced pain at injection site, chills, body aches, headache, neck pain, joint pain, nausea, fatigue on 14Jan2021 02:00. The outcome of the events was recovered in Jan2021. The patient did not receive treatment for the events.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Swollen lymph node in right armpit.; Tender to touch and doubled in size when compared to left armpit.; This is a spontaneous report from a contactable Other HCP (patient). This 31-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL3249) at single dose on 15Jan2021 at 02:45 PM on right arm for COVID-19 immunisation. The first dose was on 28Dec2020 at 03:00 PM at age of 30 years old, on right arm, lot number: EL0140. Medical history included Crohn's disease. Known allergies was Tegaderm. Concomitant medications in two weeks included azathioprine, verapamil. There was no other vaccine in four weeks. There was no COVID prior vaccination. There was no COVID tested post vaccination. The patient experienced swollen lymph node in right armpit on 17Jan2021 at 01:00 AM. Tender to touch and doubled in size when compared to left armpit. There was no treatment received. The outcome of events was recovering.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Myalgia, Nausea
Clinical narrative: Fever; Muscle pain; Joint pain; Headache; Nausea; Dizziness; This is a spontaneous report from a Non-contactable Other Healthcare Professional (HCP, also the patient). A 50-year-old female patient (not pregnant) received bnt162b2, via an unspecified route of administration on 16Jan2021 12:00 at single dose in left arm for COVID-19 immunisation. Medical history included known allergies to penicillin. The patient's concomitant medications were not reported. The patient didn't have other vaccines in four weeks. The patient didn't have COVID prior vaccination. The patient experienced fever, muscle pain, joint pain, headache, nausea and dizziness on 17Jan2021 04:00 AM . No treatment was received for the events. The outcome of the events was recovering. COVID was not tested post vaccination.  Information on lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Muscle pain; Joint pain; Headache; Nausea; Dizziness; This is a spontaneous report from a Non-contactable Other Healthcare Professional (HCP, also the patient). A 50-year-old female patient (not pregnant) received bnt162b2, via an unspecified route of administration on 16Jan2021 12:00 at single dose in left arm for COVID-19 immunisation. Medical history included known allergies to penicillin. The patient's concomitant medications were not reported. The patient didn't have other vaccines in four weeks. The patient didn't have COVID prior vaccination. The patient experienced fever, muscle pain, joint pain, headache, nausea and dizziness on 17Jan2021 04:00 AM . No treatment was received for the events. The outcome of the events was recovering. COVID was not tested post vaccination.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extreme fatigue; This is a spontaneous report from a non-contactable healthcare professional (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), intramuscularly on the left arm on 14Jan2021 (14:00) at a single dose for COVID-19 immunization at the urgent care center. Medical history included sulfa allergy. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 15Jan2021, the morning after the vaccination, the patient had extreme fatigue. The patient did not receive any treatment for the reported event. The outcome of the event, extreme fatigue, was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested post-vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: Headache/headache feels like migraine; Headache/headache feels like migraine; This is a spontaneous report from a contactable healthcare professional (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 (19:00) (Lot number: EH9899; Expiration date was not reported), and then the second dose on 12Jan2021 (18:45) (Lot number: EK4176; Expiration date was not reported), both intramuscularly on the left arm at a single dose for COVID-19 immunization at the hospital. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On an unspecified date, after the first dose of vaccination, the patient had a headache/headache that felt like migraine. The patient had experienced a similar headache (headache that felt like migraine) on 17Jan2021, after the second dose of vaccination. The patient had received bultalbital, acetaminophen, caffeine (FIORICET) as treatment for the events. The outcome of the events, headache/headache that felt like migraine, was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested post-vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Myalgia, Night sweats, Pyrexia
Clinical narrative: night sweats; myalgia; weakness; fatigue; fever Hours; This is a spontaneous report from a contactable physician. This 36- year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EK9231), via intramuscular route of administration, on 28Dec2020 at 01:00 pm (at the age of 36-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a workplace clinic and anatomically located on the left arm. The medical history was not reported. Concomitant medications included Levothyroxine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Dec2020 at 11:00PM, she experienced a "Fever hours", night sweats, myalgias, weakness and fatigue. The patient did not receive treatment for the events. The clinical outcome of the events "Fever hours", night sweats, myalgias, weakness and fatigue were recovered without treatment. On 31Dec2020, the patient was tested for COVID-19 via Nasal Swab since having the vaccine, with a negative result.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: night sweats; myalgia; weakness; fatigue; fever Hours; This is a spontaneous report from a contactable physician. This 36- year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EK9231), via intramuscular route of administration, on 28Dec2020 at 01:00 pm (at the age of 36-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a workplace clinic and anatomically located on the left arm. The medical history was not reported. Concomitant medications included Levothyroxine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Dec2020 at 11:00PM, she experienced a "Fever hours", night sweats, myalgias, weakness and fatigue. The patient did not receive treatment for the events. The clinical outcome of the events "Fever hours", night sweats, myalgias, weakness and fatigue were recovered without treatment. On 31Dec2020, the patient was tested for COVID-19 via Nasal Swab since having the vaccine, with a negative result.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: His blood sugar is just staying up a little high/elevated blood sugar; This is a spontaneous report from a contactable consumer (patient) reported that a male 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 a single dose for Covid-19 immunization. Medical history included diabetes that the patient had for 16 years and he was on oral medication only. The patient stated that his blood sugar was just staying up a little high. He explained that he didn't have any starch of any kind this morning (18Jan2021). The patient wanted to know if there's has had any complaints about elevated blood sugar after receiving the vaccine. The outcome of the event was unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Fever; fatigue; headache; sore arm; This is a spontaneous report from a contactable other health professional (patient).  A 34-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176), via an unspecified route of administration at right arm on 16Jan2021 at 10:00 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at right arm on 27Dec2020 at 12:00 for COVID-19 immunization and experienced sore arm. On an unspecified date after second dose, the patient experienced sore arm, fever, fatigue, headache. The patient outcome of the events was recovered.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Eating disorder, Insomnia, Off label use, Palpitations, Product use issue
Clinical narrative: soreness on arm where shot was administered; heart palpitations; difficulty in eating; difficulty in sleeping; Concomitant drugs: INFLUENZA VIRUS (influenza immunisation); Concomitant drugs: INFLUENZA VIRUS (influenza immunisation); This is a spontaneous report from a contactable consumer, the patient. An 85-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose number 1, via an unspecified route of administration in the left arm on 11Jan2021 at 12:00 (at the age of 85-years-old) as a single dose for COVID-19 vaccination. Medical history included high blood pressure from an unknown date and unknown if ongoing. Concomitant medication included influenza vaccine (FLU), hydrochlorothiazide, losartan potassium (HYZAAR) and metoprolol succinate (TOPROL XL). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient reported having received the flu vaccine within 4 weeks prior to the Covid-19 vaccine. The patient did not have any allergies to medications, food, or other products. On an unspecified date in Jan2021, the patient experienced soreness in the arm where the shot was administered; and Concomitant drugs: INFLUENZA VIRUS (influenza immunisation). She took ibuprofen (ADVIL) for the soreness. In approximately 49 hours, the patient experienced heart palpitations that lasted about 24 hours, leading to difficulty in eating and sleeping. The clinical outcome of the soreness in the arm where the shot was administered, heart palpitations, difficulty eating and difficulty sleeping. The clinical outcome of Concomitant drugs: INFLUENZA VIRUS (influenza immunisation) was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness on arm where shot was administered; heart palpitations; difficulty in eating; difficulty in sleeping; Concomitant drugs: INFLUENZA VIRUS (influenza immunisation); Concomitant drugs: INFLUENZA VIRUS (influenza immunisation); This is a spontaneous report from a contactable consumer, the patient. An 85-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose number 1, via an unspecified route of administration in the left arm on 11Jan2021 at 12:00 (at the age of 85-years-old) as a single dose for COVID-19 vaccination. Medical history included high blood pressure from an unknown date and unknown if ongoing. Concomitant medication included influenza vaccine (FLU), hydrochlorothiazide, losartan potassium (HYZAAR) and metoprolol succinate (TOPROL XL). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient reported having received the flu vaccine within 4 weeks prior to the Covid-19 vaccine. The patient did not have any allergies to medications, food, or other products. On an unspecified date in Jan2021, the patient experienced soreness in the arm where the shot was administered; and Concomitant drugs: INFLUENZA VIRUS (influenza immunisation). She took ibuprofen (ADVIL) for the soreness. In approximately 49 hours, the patient experienced heart palpitations that lasted about 24 hours, leading to difficulty in eating and sleeping. The clinical outcome of the soreness in the arm where the shot was administered, heart palpitations, difficulty eating and difficulty sleeping. The clinical outcome of Concomitant drugs: INFLUENZA VIRUS (influenza immunisation) was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: Lymph nodes under arm, on injection site swollen so bad that I could barely lift my arm up it was so painful; Swollen lymph nodes; Lymph nodes under arm, on injection site swollen so bad that I could barely lift my arm up it was so painful; Swollen lymph nodes; Coughing; Fever; Body aches; I still have body aches; Chills; This is a spontaneous report from a contactable consumer. A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunisation. Medical history included blood pressure abnormal, blood cholesterol abnormal and COVID-19 from Jun2020 and was hospitalized, and double pneumonia. Concomitant medications included trandolapril for blood pressure, rosuvastatin calcium (CRESTOR) for cholesterol, and tadalafil (CIALIS). The patient stated, "I experienced fever, body ache and chills in the evening, which I took some Tylenol (treatment) for and then this morning when I woke up my lymph nodes under my arm on the injection site were swollen so bad that's I could barely lift my arm up it was so painful and I have body aches and the cough I have been coughing quite this morning too, which some slightly concerned what the looks swollen lymph nodes." Clinical outcome of event body aches was not recovered, while for the rest of the events was unknown.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Lymph nodes under arm, on injection site swollen so bad that I could barely lift my arm up it was so painful; Swollen lymph nodes; Lymph nodes under arm, on injection site swollen so bad that I could barely lift my arm up it was so painful; Swollen lymph nodes; Coughing; Fever; Body aches; I still have body aches; Chills; This is a spontaneous report from a contactable consumer. A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunisation. Medical history included blood pressure abnormal, blood cholesterol abnormal and COVID-19 from Jun2020 and was hospitalized, and double pneumonia. Concomitant medications included trandolapril for blood pressure, rosuvastatin calcium (CRESTOR) for cholesterol, and tadalafil (CIALIS). The patient stated, "I experienced fever, body ache and chills in the evening, which I took some Tylenol (treatment) for and then this morning when I woke up my lymph nodes under my arm on the injection site were swollen so bad that's I could barely lift my arm up it was so painful and I have body aches and the cough I have been coughing quite this morning too, which some slightly concerned what the looks swollen lymph nodes." Clinical outcome of event body aches was not recovered, while for the rest of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Contracted COVID-19 11 days after first jab; Contacted COVID-19 11 days after first jab; This is a spontaneous report from a contactable nurse (patient) via a Pfizer sales representative. A patient of unspecified age and gender received the first dose of bnt162b2 (BNT162B2) 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. The patient contracted COVID-19 11 days after first jab. Outcome of the event was unknown.  Information about Lot/Batch number is requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported events.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: patient took the PCR COVID test for the purpose of travelling  and it was positive; patient took the PCR COVID test for the purpose of travelling  and it was positive; This is a spontaneous report from a Pfizer-sponsored program, IBCC (Inbound Call Center for HCPs). A contactable physician (patient) reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on  unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported the patient was antibody-antigen negative before taking the vaccine. Then the patient took the PCR COVID test for the purpose of travelling  and it was positive on an unknown date. Outcome of the events was unknown.    Information about Lot/Batch number is requested.; Sender's Comments: Based on the time association, the lack of efficacy cannot be excluded for vaccine BNT162B2.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Angiogram abnormal, Asthenia, Dyspnoea, Electrocardiogram abnormal
Clinical narrative: felt tired; nausea; headache; short of breath; rapid/shallow breathing; rapid/shallow breathing; fast heart rate (100 bpm); low grade fever; felt very weak; pleuralpericardial effusion; pleuralpericardial effusion; This is a spontaneous report from a contactable consumer. A non-pregnant 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 16Jan2021 10:30 at a single dose for COVID-19 immunization.  Medical history included allergic to opioids, allergy to fish, cirrhosis with portal hypertension, parkinsonism, heart blockage, type 2 diabetes, depression, early dementia.  The patient previously took morphine and experienced drug hypersensitivity.  There was unspecified concomitant medication.  The patient previously took morphine (MANUFACTURER UNKNOWN) and experienced allergic to morphine.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced felt tired, nausea, headache, short of breath, rapid/shallow breathing, fast heart rate (100 bpm), low grade fever, felt very weak, pleuralpericardial effusion on 16Jan2021.  All the events were reported with the seriousness criteria of disability, hospitalization and being life-threatening.  The patient was hospitalized for the events for 4 days.  After the injection, from 0 to 24 hours the patient felt tired, had nausea, a headache, short of breath then at about 24 hours post injection developed rapid/shallow breathing, fast heart rate (100 bpm) low grade fever and felt very weak. The patent was taken to the emergency room (ER) at 30 hours post injection and it was determined (Xray, CTA & EKG) that she had a pleuralpericardial effusion. She was flown by air life to another ER for treatment.  The patient underwent lab tests and procedures on 16Jan2021 which included angiogram (CTA): had a pleuralpericardial effusion; body temperature: low grade fever; electrocardiogram (EKG): had a pleuralpericardial effusion; heart rate: 100 beats per minute (bpm); X-ray: had a pleuralpericardial effusion.  The patient had a rapid nasal swab on 17Jan2021 which was negative.  Therapeutic measures were taken as a result of the events and included unspecified medications & oxygen therapy.  The outcome of the events was recovering.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.