chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Lethargy, Pyrexia, Vaccination site pain
Clinical narrative: Fever of 102; Chills; Lethargy; Pain at injection site; This is a spontaneous report from a contactable Other HCP.   This female patient (age not provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on unknown date at single dose for COVID-19 immunisation, administered at hospital. No relevant medical history and concomitant medications were provided. On 17Jan2021 (at 02:30 AM) she developed fever of 102, chills, lethargy and pain at injection site. She was not treated for the events. She was recovering from the events.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Feeling hot, Pyrexia, Tremor
Clinical narrative: Feels hot; Fevers/Her temperature is currently 102 degrees; Shakes; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer reported for self. This 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0142) via unspecified route of administration on 12Jan2021 at single dose in left arm for COVID-19 immunization. The patient worked front line in the emergency room (ER). The patient medical history included stage 4 metastatic melanoma from 2013. The patient concomitant medications included nivolumab (OPDIVO) for stage 4 metastatic melanoma. The patient previously received first dose of BNT162B2 (Lot: EJ1685) on 22Dec2020 at single dose for COVID-19 immunization and she didn't feel anything with that dose. The patient experienced shakes, fever, diarrhea, vomiting on 13Jan2021. The patient reported that she had been having shakes and fevers that started at 2:00 AM this morning 13Jan2021. Her temperature is currently 102 degrees on 13Jan2021. It was better but she let herself go 5-6 hours without taking anything. She had been alternating paracetamol (TYLENOL) and ibuprofen (MOTRIN). When it wore off she instantly felt hot and shaky. She also had started having diarrhea and vomiting. The outcome of the events was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Feels hot; Fevers/Her temperature is currently 102 degrees; Shakes; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer reported for self. This 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0142) via unspecified route of administration on 12Jan2021 at single dose in left arm for COVID-19 immunization. The patient worked front line in the emergency room (ER). The patient medical history included stage 4 metastatic melanoma from 2013. The patient concomitant medications included nivolumab (OPDIVO) for stage 4 metastatic melanoma. The patient previously received first dose of BNT162B2 (Lot: EJ1685) on 22Dec2020 at single dose for COVID-19 immunization and she didn't feel anything with that dose. The patient experienced shakes, fever, diarrhea, vomiting on 13Jan2021. The patient reported that she had been having shakes and fevers that started at 2:00 AM this morning 13Jan2021. Her temperature is currently 102 degrees on 13Jan2021. It was better but she let herself go 5-6 hours without taking anything. She had been alternating paracetamol (TYLENOL) and ibuprofen (MOTRIN). When it wore off she instantly felt hot and shaky. She also had started having diarrhea and vomiting. The outcome of the events was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives starting from my head down to face and chest; This is a spontaneous report from a non-contactable Other HCP. This Other HCP reported for a 35-year-old female patient that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route on 12Jan2021 04:45 PM at single dose for COVID-19 immunization. Medical history included known allergies: latex and avocado. Concomitant drugs were not reported. Patient was not pregnant. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 12Jan2021 07:30 PM, patient had hives starting from her head down to face and chest. Diphenhydramine (BENADRYL) was given as treatment. Outcome of event was recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: headaches; bodyaches; This is a spontaneous report from a contactable consumer. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunization. Facility type vaccine was at Hospital. Medical history and concomitant medications were not reported. The patient experienced headaches and bodyaches on 13Jan2021. It was unknown if treatment received for the events. The outcome of the events were resolving. If COVID prior vaccination was reported as No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: her husband contracted SARS-Cov-2 10 days after vaccination; her husband contracted SARS-Cov-2 10 days after vaccination; This is a spontaneous report from a contactable Physician (patient's wife). This physician reported similar events for two patients. This is the second of two reports. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient (reporter's husband) contracted sars-cov-2 10 days after vaccination in Jan2021. The physician was looking for direction on receiving the second dose. Outcome of the event was unknown.   Information about Batch/Lot number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.,Linked Report(s) : US-PFIZER INC-2021025409 same reporter/drug/events, different patients
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Tremor
Clinical narrative: uncontrollable shaking; fever up to 103; This is a spontaneous report from a contactable Other HCP (patient). This 55-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284) intramuscularly on 11Jan2021 06:00 at SINGLE DOSE on left arm for covid-19 immunisation.  Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history was unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included atorvastatin. The patient previously received first dose of BNT162B2 (lot number EH9899) intramuscularly on 21Dec2020 06:00 AM at SINGLE DOSE on left arm for covid-19 immunisation, and experienced sore arm. The patient experienced uncontrollable shaking, fever up to 103 on 12Jan2021. No treatment received for the adverse event. The outcome was recovered. The events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Feeling abnormal, Gastrointestinal disorder, Limb discomfort
Clinical narrative: feeling tight in my lungs; feel tired; spacy; body aches; my limbs felt heavy; gastrointestinal issues; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received the second dose of BNT162B2 (lot number: Ek4176), via an unspecified route of administration on 13Jan2021 08:00 in right arm at single dose for COVID-19 immunization. Medical history included asthma, thyroid cancer, thyroidectomy, attention deficit hyperactivity disorder (ADHD), and known allergies: Penicillin. Concomitant medications included levothyroxine sodium (SYNTHROID), paracetamol (TYLENOL), salbutamol (ALBUTEROL HFA), budesonide/formoterol fumarate (SYMBICORT), and tiotropium bromide (SPIRIVA). The patient previously took azithromycin (ZPACK), and benzonatate and experienced drug allergy, and first dose of BNT162B2 (lot number: EJ1685) on 23Dec2020 08:00 in arm for COVID-19 immunization. The patient experienced feeling tight in lungs 45 min after on 13Jan2021 09:00, it lasted approximately 30 minutes. Around 3-4 hours after started to feel tired, spacy and body aches. Her limbs felt heavy, and gastrointestinal issues, nausea (ondansetron (ZOFRAN) took care of that issue) no vomiting on 13Jan2021, was brought home from work. And slept for 3 hours. Woke up and have continued body aches. The patient underwent lab tests and procedures which included nasal swab: negative on 04Jan2021. Therapeutic measures were taken as a result of nausea. Outcome of event body aches was not resolved and of other events was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, SARS-CoV-2 test
Clinical narrative: feeling tight in my lungs; feel tired; spacy; body aches; my limbs felt heavy; gastrointestinal issues; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received the second dose of BNT162B2 (lot number: Ek4176), via an unspecified route of administration on 13Jan2021 08:00 in right arm at single dose for COVID-19 immunization. Medical history included asthma, thyroid cancer, thyroidectomy, attention deficit hyperactivity disorder (ADHD), and known allergies: Penicillin. Concomitant medications included levothyroxine sodium (SYNTHROID), paracetamol (TYLENOL), salbutamol (ALBUTEROL HFA), budesonide/formoterol fumarate (SYMBICORT), and tiotropium bromide (SPIRIVA). The patient previously took azithromycin (ZPACK), and benzonatate and experienced drug allergy, and first dose of BNT162B2 (lot number: EJ1685) on 23Dec2020 08:00 in arm for COVID-19 immunization. The patient experienced feeling tight in lungs 45 min after on 13Jan2021 09:00, it lasted approximately 30 minutes. Around 3-4 hours after started to feel tired, spacy and body aches. Her limbs felt heavy, and gastrointestinal issues, nausea (ondansetron (ZOFRAN) took care of that issue) no vomiting on 13Jan2021, was brought home from work. And slept for 3 hours. Woke up and have continued body aches. The patient underwent lab tests and procedures which included nasal swab: negative on 04Jan2021. Therapeutic measures were taken as a result of nausea. Outcome of event body aches was not resolved and of other events was unknown.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: having a sore arm; headaches; This is a spontaneous report from a contactable Consumer (patient). This 89-year-old male patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiration date: 30Apr2021) via an unspecified route of administration on 12Jan2021 12:15 at single dose for covid-19 immunisation. Medical history included ongoing hearing issue from 10 years ago and wearing hearing aids, surgery for dislocated vertebrae in neck two years ago, currently having 6 screws in his neck, ongoing Spinal stenosis, ongoing allergic to penicillin and sulfa. Concomitant medications included paracetamol (TYLENOL) from an unspecified date and ongoing for pain from spinal stenosis. The patient went on a 0.5 mile walk everyday in his neighborhood. He got his pain in his back and shoulders after he finished the walk so he took Tylenol. He didn't take it on a regular basis though. He just took a couple of tablets. The patient got his first injection of the COVID 19 vaccine at 12:15 on 12Jan2021. After he got home , he went online to find out more information on the vaccine. He was originally concerned about having a sore arm, headaches, and all this on Jan2021. He asked about the medication online. It said you can take Tylenol after the vaccine, but do not take it before the vaccine, and that was exactly what he did. He took 2 Tylenol an hour before the vaccine. The doctor was concerned about his age because of his immune system being borderline. That was why he got the vaccine. Outcome of the events was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Lymphadenopathy, Pyrexia
Clinical narrative: Chills; Temperature max of 100.4; Swollen axillary lymph nodes in same side of injection; Fatigue; This is a spontaneous report from a contactable Nurse reporting for herself. A 36-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at Left arm on 07Jan2021 16:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient's medical history included COVID-19 prior vaccination. Concomitant medications included dextromethorphan hydrobromide, paracetamol, phenylephrine hydrochloride (TYLENOL COLD AND FLU DAYTIME), naproxen sodium (ALEVE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. The patient historic vaccine included the first dose BNT162B2, via an unspecified route of administration at Left arm received on 22Dec2020 16:30 for covid-19 immunization and Covid test was Positive on 28Dec2020. The patient experienced Chills, Temperature max of 100.4, Swollen axillary lymph nodes in same side of injection, Fatigue on 08Jan2021 11:30. No treatment received for the events. The outcome of the events was recovered on an unknown date in Jan2020.  Information on Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Myalgia; Fatigue; This is a spontaneous report from a non-contactable physician (patient). A 32-year-old male patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EK9231), via an unspecified route of administration on 12Jan2021 09:30 in left arm at single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 on 22Dec2020 for COVID-19 immunization. There were no medical history or concomitant medications. No known allergies. There was no other vaccine in four weeks. There was no other medication in two weeks. On 13Jan2021 01:00, the patient experienced fever, chills, myalgia, fatigue. No treatment was received for these adverse events. No COVID prior vaccination. No COVID tested post vaccination. The adverse event did not result in 'doctor or other HCP visit or emergency room or urgent care, hospitalization or prolongation, life threatening illness, disability or death or congential anomaly'. The outcome of all the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Facial pain, Vaccination site pain
Clinical narrative: Covid vaccine- injection site pain; her face and neck is red like a sunburn; her face stings; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number not known) via an unspecified route of administration on 11Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had been allergic to Bactrim since that age of 20 and she had she blisters on her lips. The patient had her first dose of Pfizer Covid vaccine on Monday, 11Jan2021 and after that in Jan2021, her face and neck were red like a sunburn. She said she had injection site pain, her face stings and it has been two days out. She wanted to know if she should get her second shot. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Disease recurrence, Headache, Myalgia
Clinical narrative: loss of smell; Loss of taste; feeling like a sinus infection; pain at the injection site; muscle pain; Headache; Headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 23-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248, expiration date: Nov2021), via an unspecified route of administration on 11Jan2021 at 11:00 AM in the left deltoid at single dose for work as behavioral technician. Medical history included Chronic headaches predates his treatment with bnt162b2. Family Medical History was none. There were no concomitant medications. There were no prior vaccinations (within 4 weeks). Patient reported he got the first dose of the bnt162b2 on 11Jan2021. He noticed one and a half hours later (12:30) pain at the injection site and muscle pain; then 12Jan2021, the next day lost his sense of smell and taste and it felt like a sinus infection. Added he didn't know exactly what a sinus infection felt like but he felt like he had jumped into a pool without holding his nose. Added twelve later (on 12Jan2021) the muscle pain resolved; his injection site was still a little painful and he still couldn't smell or taste. He was planning to get the second dose of the vaccine on 03Feb2021. Added he took ibuprofen for a headache later the night of the vaccine 11Jan2021. He had headache multiple times a week. This headache started that day. After taking the ibuprofen his headache resolved that same day. There were not any events require a visit to physician or ER. Therapeutic measures were taken as a result of events headache. No investigation assessment. The outcome of the event headache was recovered on 11Jan2021, muscle pain was recovered on 12Jan2021; outcome of events pain at the injection site and feeling like a sinus infection was recovering; outcome of the other events was not recovered.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis, Vaccination site pain
Clinical narrative: loss of smell; Loss of taste; feeling like a sinus infection; pain at the injection site; muscle pain; Headache; Headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 23-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248, expiration date: Nov2021), via an unspecified route of administration on 11Jan2021 at 11:00 AM in the left deltoid at single dose for work as behavioral technician. Medical history included Chronic headaches predates his treatment with bnt162b2. Family Medical History was none. There were no concomitant medications. There were no prior vaccinations (within 4 weeks). Patient reported he got the first dose of the bnt162b2 on 11Jan2021. He noticed one and a half hours later (12:30) pain at the injection site and muscle pain; then 12Jan2021, the next day lost his sense of smell and taste and it felt like a sinus infection. Added he didn't know exactly what a sinus infection felt like but he felt like he had jumped into a pool without holding his nose. Added twelve later (on 12Jan2021) the muscle pain resolved; his injection site was still a little painful and he still couldn't smell or taste. He was planning to get the second dose of the vaccine on 03Feb2021. Added he took ibuprofen for a headache later the night of the vaccine 11Jan2021. He had headache multiple times a week. This headache started that day. After taking the ibuprofen his headache resolved that same day. There were not any events require a visit to physician or ER. Therapeutic measures were taken as a result of events headache. No investigation assessment. The outcome of the event headache was recovered on 11Jan2021, muscle pain was recovered on 12Jan2021; outcome of events pain at the injection site and feeling like a sinus infection was recovering; outcome of the other events was not recovered.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Had significant painful axillary lymphadenopathy on the injection side; This is a spontaneous report from a contactable Other HCP. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 11Jan2021 at single dose for COVID-19 immunization. None Medical history. No covid prior vaccination. The patient's concomitant medications were not reported. On 13Jan2021, patient had significant painful axillary lymphadenopathy on the injection side that resulted in doctor/other healthcare professional office visit. No treatment received. The event outcome was unknown. No covid tested post vaccination.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling in her arm; This is a spontaneous report from a non-contactable physician (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), intramuscularly in left arm on 26Dec2020 18:30 at single dose for COVID-19 immunization. The patient medical history was not reported.  The patient was not pregnant when receiving the vaccine. If COVID prior vaccination: No. If COVID tested post vaccination: No. Concomitant medication in two weeks included ibuprofen, lansoprazole, levocetirizine. The patient experienced tingling in her arm on 26Dec2020 with outcome of not recovered. After the injection the patient experienced tingling in her arm which she described as "the patient thought they hit a nerve. That's what it felt like." The tingling was "kind a constant very full light tingling most of the day/constant." No treatment received for the event. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Palpitations
Clinical narrative: palpitations; fatigue; stomach cramping; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249), via an unspecified route of administration in left arm on 11Jan2021 12:00 at single dose for COVID-19 immunization.  Medical history included Congenital Heart Disease, Transposition of the Great Arteries, Mustard Procedure. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. Concomitant medication included losartan, ethinylestradiol, norethisterone acetate (JUNEL), bifidobacterium lactis (PROBIOTIC), ergocalciferol (VIT D). The patient experienced palpitations, fatigue, stomach cramping on 05Jan2021 14:00 (as reported, pending clarification) with outcome of recovering. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pyrexia
Clinical narrative: Fever of 102 F; she didn't feel comfortable receiving the vaccine at that time; This is a spontaneous report from a contactable Nurse (patient).  This 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 19Dec2020 at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. The patient had fever of 102 Fahrenheit two weeks ago (Jan2021).  She waited 29 days instead of the 21-day recommended to receive the second dose as she didn't feel comfortable receiving the vaccine at that time.  The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Erythema, Feeling hot, Ocular hyperaemia
Clinical narrative: intermittent sharp pain in left arm, chest and shoulder blade; intermittent sharp pain in left arm, chest and shoulder blade; intermittent sharp pain in left arm, chest and shoulder blade; redness in face and eyes; redness in face and eyes; feels warm; This is a spontaneous report from a contactable consumer (patient is girlfriend). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EKH176), via an unspecified route of administration on 12Jan2021 morning at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on unspecified date for covid-19 immunization. The patient medical history was none. There were no concomitant medications. The patient was currently having side effects, stated she was having on and off, intermittent, sharp pain in her left arm, left chest and left shoulder blade, feeling the pain all on her left side on 13Jan2021. The reporter stated the patient looked worse than she did 2 hours ago, that her face was turning red and her eyes were turning red and she felt a little warm on 12Jan2021. The reporter wants to know when she should take the patient to the hospital. The reporter was encouraged to reach out to a health care provider. The outcome of events was not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: intermittent sharp pain in left arm, chest and shoulder blade; intermittent sharp pain in left arm, chest and shoulder blade; intermittent sharp pain in left arm, chest and shoulder blade; redness in face and eyes; redness in face and eyes; feels warm; This is a spontaneous report from a contactable consumer (patient is girlfriend). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EKH176), via an unspecified route of administration on 12Jan2021 morning at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on unspecified date for covid-19 immunization. The patient medical history was none. There were no concomitant medications. The patient was currently having side effects, stated she was having on and off, intermittent, sharp pain in her left arm, left chest and left shoulder blade, feeling the pain all on her left side on 13Jan2021. The reporter stated the patient looked worse than she did 2 hours ago, that her face was turning red and her eyes were turning red and she felt a little warm on 12Jan2021. The reporter wants to know when she should take the patient to the hospital. The reporter was encouraged to reach out to a health care provider. The outcome of events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Off label use, Product use issue, Vaccination site pain
Clinical narrative: Pregnant at the time of vaccination?: Yes/is pregnant: Yes; Pregnant at the time of vaccination?: Yes/is pregnant: Yes; Pregnant at the time of vaccination?: Yes/is pregnant: Yes; some tenderness at injection site day of; This is a spontaneous report from a contactable consumer. A 28-year-old female patient  received the first dose of BNT162B2 (lot number unknown), via an unspecified route of administration, on an unknown date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. The patient was pregnant and gestational period was 34 weeks. On an unknown date, the patient experienced some tenderness at injection site day of. No treatment was received for the events. The outcome of the events was unknown.  Information about lot/batch has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test with no symptoms; positive COVID-19 test with no symptoms; This is a spontaneous report from a contactable Nurse reporting for herself.  A 36-year-old female patient received the first dose of bnt162b2 (BNT162B2) vaccine,  via an unspecified route of administration in the left arm, on 22Dec2020 16:30 at single dose for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported. On 28Dec2020 the patient resulted positive to Covid-19 test (nasal swab), but the patient did not show symptoms.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia, Thirst
Clinical narrative: fatigue; fever of 101 F; extreme thirst; headache; This is a spontaneous report from a contactable consumer. This consumer reported for a 28-year-old male patient that received second dose of bnt162b2 (BNT162B2, COVID 19), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunisation. The patient previously took first dose of bnt162b2 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. Other vaccine in four weeks was unknown. Manufacturer contractor reporting on behalf of so media post observed from a medical student who received second round of vaccine. Per post, 12 hours after vaccination, patient woke up with fever of 101 F, extreme thirst, headache, and fatigue. Patient posted follow-up saying that 26 hours after the vaccination, symptoms have resolved and he has returned to "feeling like himself." The events started from 12Jan2021. The outcome of the events was recovered in Jan2021. Treatment was received included Per media post, patient self treated with OTC Tylenol. Covid prior vaccination was unknown. Covid tested post vaccination was unknown  Information of lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Hyperhidrosis
Clinical narrative: Severe low back and hip pain; Severe low back and hip pain; malaise; woke up soaking wet in the middle of the night with chills; Extremely tired; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EK5730), intramuscularly on 07Jan2021 10:30 at a single dose in left arm for COVID-19 immunization. The patient is not pregnant. Medical history included hypothyroidism, hypertension, known allergies: penicillin. The patient previously took first dose of bnt162b2 (lot number: EK5730) via intramuscular on 18Dec2020 13:30 at a single dose in left arm for COVID-19 immunization. There was no other vaccine administrated in four weeks. Concomitant medication included losartan, bupropion hydrochloride (WELLBUTRIN), levothyroxine, colecalciferol (VITAMIN D 3), estradiol (ESTROGEN), and progesterone. On 09Jan2021 15:45, the patient experienced severe low back and hip pain along with general malaise, woke up soaking wet in the middle of the night with chills, and extremely tired. No fever. The adverse event did not result in 'doctor or other HCP visit or emergency room or urgent care, hospitalization or prolongation, life threatening illness, disability or death or congential anomaly'. No treatment received for adverse event. There was no COVID prior vaccination. There was no COVID tested post vaccination. The outcome of events was recovered on an unspecified date in Jan2021.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Sleep disorder
Clinical narrative: Severe low back and hip pain; Severe low back and hip pain; malaise; woke up soaking wet in the middle of the night with chills; Extremely tired; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EK5730), intramuscularly on 07Jan2021 10:30 at a single dose in left arm for COVID-19 immunization. The patient is not pregnant. Medical history included hypothyroidism, hypertension, known allergies: penicillin. The patient previously took first dose of bnt162b2 (lot number: EK5730) via intramuscular on 18Dec2020 13:30 at a single dose in left arm for COVID-19 immunization. There was no other vaccine administrated in four weeks. Concomitant medication included losartan, bupropion hydrochloride (WELLBUTRIN), levothyroxine, colecalciferol (VITAMIN D 3), estradiol (ESTROGEN), and progesterone. On 09Jan2021 15:45, the patient experienced severe low back and hip pain along with general malaise, woke up soaking wet in the middle of the night with chills, and extremely tired. No fever. The adverse event did not result in 'doctor or other HCP visit or emergency room or urgent care, hospitalization or prolongation, life threatening illness, disability or death or congential anomaly'. No treatment received for adverse event. There was no COVID prior vaccination. There was no COVID tested post vaccination. The outcome of events was recovered on an unspecified date in Jan2021.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Diarrhoea, Gait disturbance, Myalgia
Clinical narrative: abdominal cramping; Diarrhea; she could hardly walk this morning; muscle ache; arm is a little sore; nausea; GI problems; This is a spontaneous report from contactable consumer (patient). This 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL0142), via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications included ongoing evolocumab (REPATHA, Expiration Date: 04Nov2021), ongoing amlodipine besilate (NORVASC, Strength: 10 mg) as high blood pressure medication, and ongoing amlodipine (Strength: 5 mg) as high blood pressure medication. The patient previously took first dose of BNT162B2 (Lot number: EJ1685) for COVID-19 immunisation. On 12Jan2021, patient got the second dose of the Pfizer COVID vaccine. She did fine all day, but then she started to feel a little nauseous off and on. Then at 4 o'clock before she left for work she developed muscle ache on 12Jan2021. It persisted to the point she could hardly walk this morning (13Jan2021). Patient has not had a fever. She hasn't really had a headache. It has just been muscle aches. Her arm was a little sore on 12Jan2021 but not bad. She has had muscle ache and GI problems with it. She had waves of nausea like she could throw up. She was hydrating really well. The nausea came and went. The muscle aches started at 3:30 to 4 with muscles aching. She got the vaccine to help prevent the spread of COVID and to protect herself as well. Patient experienced abdominal cramping and diarrhoea on 13Jan2021. Outcome of nausea and arm was a little sore was recovering, outcome of muscle ache, abdominal cramping and diarrhea was not recovered, outcome of other events was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: abdominal cramping; Diarrhea; she could hardly walk this morning; muscle ache; arm is a little sore; nausea; GI problems; This is a spontaneous report from contactable consumer (patient). This 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL0142), via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications included ongoing evolocumab (REPATHA, Expiration Date: 04Nov2021), ongoing amlodipine besilate (NORVASC, Strength: 10 mg) as high blood pressure medication, and ongoing amlodipine (Strength: 5 mg) as high blood pressure medication. The patient previously took first dose of BNT162B2 (Lot number: EJ1685) for COVID-19 immunisation. On 12Jan2021, patient got the second dose of the Pfizer COVID vaccine. She did fine all day, but then she started to feel a little nauseous off and on. Then at 4 o'clock before she left for work she developed muscle ache on 12Jan2021. It persisted to the point she could hardly walk this morning (13Jan2021). Patient has not had a fever. She hasn't really had a headache. It has just been muscle aches. Her arm was a little sore on 12Jan2021 but not bad. She has had muscle ache and GI problems with it. She had waves of nausea like she could throw up. She was hydrating really well. The nausea came and went. The muscle aches started at 3:30 to 4 with muscles aching. She got the vaccine to help prevent the spread of COVID and to protect herself as well. Patient experienced abdominal cramping and diarrhoea on 13Jan2021. Outcome of nausea and arm was a little sore was recovering, outcome of muscle ache, abdominal cramping and diarrhea was not recovered, outcome of other events was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, SARS-CoV-2 test
Clinical narrative: Night sweats x 3 weeks, on-going, negative work up; This is a spontaneous report from a contactable physician (patient). A 30-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ELD140), via an unspecified route of administration in right arm on 22Dec2020 16:00 at single dose for COVID-19 immunisation. Facility type vaccine was hospital. Medical history included depression. No known allergies. No Covid prior vaccination.  Concomitant medications included duloxetine hydrochloride (CYMBALTA), bupropion hydrochloride (WELLBUTRIN).  The patient experienced night sweats x 3 weeks, on-going, negative work up (non-serious) on 24Dec2020.  AE resulted in ''Doctor or other healthcare professional office/clinic visit''. No treatment received for the event. Patient was not pregnant. Patient not received other vaccine in four weeks. The patient underwent lab tests and procedures which included nasal swab: negative on 07Jan2021.  The outcome of the event was reported as recovered/resolved with sequel.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Inappropriate schedule of product administration, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Swelling redness and soreness at injection site; Swelling redness and soreness at injection site; Swelling redness and soreness at injection site; body aches; low grade fever; First dose on 21Dec2020, second dose on 05Jan2021; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 05Jan2021 at single dose for covid-19 immunization. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination. The patient had no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EH9899 on 21Dec2020 07:45 PM, at age of 26 years old, via Intramuscular in right arm for covid-19 immunization and experienced itching, nausea, headache, body ache, site soreness and swelling. Medical history included sciatica. The patient's concomitant medications were not reported. The patient experienced swelling redness and soreness at injection site, body aches, low grade fever all on 05Jan2021 with outcome of recovered in Jan2021.  The patient underwent lab tests and procedures which included PCR nasal swab for COVID-19 negative on 04Jan2021. The patient received paracetamol (TYLENOL) 500mg for treatment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling redness and soreness at injection site; Swelling redness and soreness at injection site; Swelling redness and soreness at injection site; body aches; low grade fever; First dose on 21Dec2020, second dose on 05Jan2021; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 05Jan2021 at single dose for covid-19 immunization. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination. The patient had no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EH9899 on 21Dec2020 07:45 PM, at age of 26 years old, via Intramuscular in right arm for covid-19 immunization and experienced itching, nausea, headache, body ache, site soreness and swelling. Medical history included sciatica. The patient's concomitant medications were not reported. The patient experienced swelling redness and soreness at injection site, body aches, low grade fever all on 05Jan2021 with outcome of recovered in Jan2021.  The patient underwent lab tests and procedures which included PCR nasal swab for COVID-19 negative on 04Jan2021. The patient received paracetamol (TYLENOL) 500mg for treatment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: body rash over stomach, back and left side of neck area.; This is a spontaneous report from a contactable other hcp report self. This 54-year-old not pregnant female patient receive second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration in left arm on 15Jan2021 13:00 at single dose for covid-19 immunization. Medical history included osteoporosis and overactive bladder, lactose intolerant. Patient not diagnosed with COVID-19 prior to vaccination. Concomitant medications within 2 weeks include omeprazole (PRILOSEC), fesoterodine fumarate (TOVIAZ), Vitamin D3, cyanocobalamin (VITAMIN B12), lactobacillus nos (CULTURELLE). Patient received first dose of bnt162b2 (lot number: EK9231) in left arm on 28Dec2020 12:30 PM. No other vaccines within 4 weeks prior to the COVID vaccine. Approximately 48 hours after injection on 17Jan2021 09:00 AM, patient developed body rash over stomach, back and left side of neck area. Symptoms persisting over the last 10 hours and continuing. Outcome of event was not recovered. No treatment received for the adverse event. Patient has not tested for COVID-19 post to vaccination.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID virus; tested positive for COVID virus; This is a spontaneous report from a Pfizer-sponsored program. A contactable other HCP (health care worker, patient) reported that a 31-year-old female patient received 1st dose of BNT162B2 (COVID 19 Vaccine, Batch/lot number: EL0140) on 23Dec2020 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. She received the first dose of the vaccine 23Dec2020. Then, on 05Jan2021, she tested positive for the COVID virus. She was supposed to get the second dose of the Vaccine on 13Jan2021. She was put on quarantine. She is wondering if she can she still get the vaccine or does she need to wait. Outcome of the event was unknown.  No further information is expected. Information about lot/batch number has been obtained.; 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.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: May be allergic to the latex from the bandage that they put on her afterwards- she left the bandage on afterwards and it started to itch; This is a spontaneous report from a contactable consumer (patient). A 93-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 11Jan2021 at site of left arm at single dose for COVID-19 immunzation. Medical history included allergic to the latex. The patient's concomitant medications were not reported. The patient left the bandage on afterwards and it started to itch on 11Jan2021, it may be allergic to the latex from the bandage that they put on her afterwards. She knew she was allergic to the latex, but she forgot to put that on her paper before getting the shot. Other than that, she was fine. The patient put some hydrocortisone cream on it to make it stop itching. The outcome of event was recovered on 11Jan2021.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Facial numbness; This is a spontaneous report from a contactable other HCP. A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142) , via an unspecified route of administration in right upper arm on 12Jan2021 16:50 at a single dose for COVID-19 immunization. Vaccination was done in the clinic. There were no relevant medical history and concomitant medications. On 12Jan2021 17:15, the patient experienced facial numbness that started 25 minutes after she got the shot.  The outcome of the event was recovered on 12Jan2021. The event was assessed s non-serious and the patient reported that the event was 100% related to the vaccine.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; shortness of breath; fatigue; This is a spontaneous report from a contactable other health professional (patient). A 32-year-old female (not pregnant) patient received second dose of bnt162b2, intramuscularly in right arm on 08Jan2021 16:00 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previous received first dose of bnt162b2 on 18Dec2020 for covid-19 immunization and experienced fever. The patient experienced fever, shortness of breath, fatigue on 10Jan2021. No treatment received. The event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included body temperature: 102.8 in Dec2020, body temperature: 100.5 in Jan2021, body temperature: 103 in Jan2021, nasal swab: negative on 13Jan2021 (COVID test result negative). About 20 hours after the first vaccine, she ran a fever to 102.8, lasted about 12 hours. She received the second vaccine and ran a 100.5 fever the following day. Her husband woke up with COVID 3 days after her vaccine, she also woke up with a fever of 103, 58 hours after my second dose. Associated with shortness of breath and fatigue. lasted 3 days. The outcome of events was resolving. No other vaccine in four weeks. No COVID prior vaccination. COVID test type post vaccination: Nasal Swab PCR (polymerase chain reaction) on 13Jan2021 with result negative.  Information on the Lot/Batch number has been requested.