chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, No adverse event
Clinical narrative: the  is not able to schedule any more vaccination appointments.; This case is considered as invalid as there is no indication that the patient experienced an event under BNT162b2.  This is a spontaneous report from a contactable consumer. This consumer reported for a 87-year-old male patient (Father).  An 87-year-old male patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EK9231, Expiration date: 30Apr2021), via unspecified route, administered in left arm on 12Jan2021 (at the age of 87-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes Alzheimer's disease and concomitant medications were not reported. The second dose of vaccination was scheduled on 02Feb2021, but they had to cancel that appointment because the caller's father was in the hospital from a fall he had where he bruised his hip and bruised his rib. Caller states that the facility said they are not able to make any more appointments for him at that moment. Caller is wondering if there are consequences of, or a danger in, getting the second dose outside of the recommended timeframe. The patient lab data includes Magnetic resonance imaging on an unspecified date which showed some spots. it was indicated that there were some spots from a past stroke. Patient received no other vaccine on the same day the COVID vaccine. The outcome of the event was unknown.  No follow-up attempts possible. No further information expected.  Follow-up (PRD/SRD (12May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Amendment: This follow up is being submitted to amend previously reported information: Case reassessed as invalid. This case is being deleted from the database for the following reason: Non-existence of an adverse event.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Groin pain, Pain assessment, Pain in extremity
Clinical narrative: had painful, aching quads in both legs and also in the groin area; had painful, aching quads in both legs and also in the groin area; This is a spontaneous report from a contactable consumer (patient herself). A 68-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318), via an unspecified route of administration, administered in left arm on 02Jan2021 14:00 (age at vaccination: 68 years) as dose 1, single for covid-19 immunisation. The patient's medical history included osteomyelitis from ten years ago, blood infection landed in pelvic area. The patient's concomitant medications were not reported. There were no known allergies. The patient did not receive any other vaccine in four weeks or any other medication in 2 weeks. The patient took Advil but it does not give much relief. She constantly massage and apply pressure on certain pressure points and still the pain does not go away. On 02Feb2021, the patient had painful, aching quads in both legs and also in the groin area. The patient on an unknown date had pain assessment at 7 on a scale of 1-10. The patient did not have covid prior vaccination nor was tested positive since vaccination. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Blood test, Muscle spasms, Muscle tightness, Nervousness
Clinical narrative: tightness in my jaw; feeling shaky, tense, muscle spasms, and back pain; feeling shaky, tense, muscle spasms, and back pain; feeling shaky, tense, muscle spasms, and back pain; feeling shaky, tense, muscle spasms, and back pain; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 25Jan2021 09:30 (at the age of 37-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. Patient reported that shortly after receiving the vaccine, he felt tightness in his jaw (25Jan2021). Within a few hours he was feeling shaky, tense, muscle spasms, and back pain (25Jan2021). These issues had persisted for two weeks now. His provider and the ER did blood work which was normal, and were saying it could be lingering side effects or just anxiety and stress. He would like to know if similar symptoms had been reported and could be related. Patient visited doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care for adverse events. Patient received treatment for adverse events was unknown. The patient underwent lab tests and procedures which included blood work: normal. The clinical outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Tension
Clinical narrative: tightness in my jaw; feeling shaky, tense, muscle spasms, and back pain; feeling shaky, tense, muscle spasms, and back pain; feeling shaky, tense, muscle spasms, and back pain; feeling shaky, tense, muscle spasms, and back pain; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 25Jan2021 09:30 (at the age of 37-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. Patient reported that shortly after receiving the vaccine, he felt tightness in his jaw (25Jan2021). Within a few hours he was feeling shaky, tense, muscle spasms, and back pain (25Jan2021). These issues had persisted for two weeks now. His provider and the ER did blood work which was normal, and were saying it could be lingering side effects or just anxiety and stress. He would like to know if similar symptoms had been reported and could be related. Patient visited doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care for adverse events. Patient received treatment for adverse events was unknown. The patient underwent lab tests and procedures which included blood work: normal. The clinical outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis, Condition aggravated, Diarrhoea
Clinical narrative: The diarrhea has continued on into a colitis flare. The diarrhea now has mucus and blood in it; Diarrhea was reported as worsened; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL1283), via an unspecified route of administration in right arm on 12Jan2021 (at the age of 72 years old) as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included she takes medication to control her Colitis and has taken it for many years. She has not had a flare in a solid 6 years. It is very under control. The vaccine is the only thing that could have brought this on. She takes nothing else, had no other vaccinations, has no new medications, no dose changes, no changes to her lifestyle, nothing. She has received both doses of the vaccine. Her first adverse event started after her first dose. She did not realize it at the time but looking back now she was feeling that all of it was from the vaccine. She started having diarrhea on Jan2021. She does have a colitis history but has not had an attack/flare in 6 years. The diarrhea started within 24 hours of the first dose. She cannot be exactly sure of the date. Other than that she felt fine. The diarrhea has continued on into a colitis flare. The diarrhea now has mucus and blood in it. That was how she knows it turned into a colitis flare. Diarrhea was reported as worsened. She has been reading online about colitis and she read that it can be brought on by an immune response which leads her to believe this was her response to the vaccine. She got the second dose on 02Feb2021. She realized that the diarrhea had turned into a colitis flare once she saw blood and mucus. It was around last Friday, 05Feb2021 that it started to occur. The outcome of diarrhea was not recovered, while with other events was unknown.  Follow-up (07MAY2021): Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Choking sensation, Lip swelling, Swollen tongue
Clinical narrative: Swollen tongue, lips; Swollen tongue, lips; Swallowing, choking feeling in throat; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 74-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9265), via an unspecified route of administration (at the age of 74-years), administered in arm right on 02Feb2021 11:00 as dose 1, single for COVID-19 immunization. Medical history included thyroid removed and known allergies numerous from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken as 125mcg tablet for an unspecified indication, start and stop date were not reported. The patient did not have covid prior vaccination and had not been tested for covid post vaccination. The patient did not receive and any other vaccine in four weeks. On 02Feb2021 at 11:15, the patient experienced swollen tongue, lips and swallowing, choking feeling in throat. The treatment was not received for the event. The facility type of vaccine was reported as other. The clinical outcome of the event swollen tongue, lips and swallowing, choking feeling in throat was reported as recovered in 2021.  Follow-up attempts completed. No further information expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Diarrhoea, Muscle spasms, Nausea
Clinical narrative: cramps; abdominal pains; Weak with low energy; Severe watery diarrhea; nausea; vomiting; This is a spontaneous report from a contactable physician (Patient). A 42-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: el3248) via an unspecified route of administration, administered in Arm Right on 22Jan2021 22:00 (Age at Vaccination 42-years-old) as single dose for COVID-19 immunization. Medical history included gastrooesophageal reflux disease (GERD) from 22Jan2021 to an unknown date. Patient had known allergies sensitive to doxy. Concomitant medication was not provided. No other vaccine in four weeks. other medications in two weeks Protonix; 7ketosteroidDHEA. No covid prior vaccination and no covid tested post vaccination. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ek5730) via intramuscular route of administration, administered in Arm left on 04Jan2021 10:00 AM as single dose for COVID-19 immunization. On 22Jan2021 the patient experienced abdominal pains, weak with low energy, severe watery diarrhea, nausea and vomiting. On an unspecified date patient experienced cramp. It was reported that abdominal pains and cramps starting about 12 hours after injection. Weak with low energy. Severe watery diarrhea along with nausea and vomiting. Symptoms lasted 72 hours then completely resolved. Patient received treatment of IV fluids, zofran, phenergan and pepcid. The outcome of the events was in 2021.while outcome of cramps was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: cramps; abdominal pains; Weak with low energy; Severe watery diarrhea; nausea; vomiting; This is a spontaneous report from a contactable physician (Patient). A 42-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: el3248) via an unspecified route of administration, administered in Arm Right on 22Jan2021 22:00 (Age at Vaccination 42-years-old) as single dose for COVID-19 immunization. Medical history included gastrooesophageal reflux disease (GERD) from 22Jan2021 to an unknown date. Patient had known allergies sensitive to doxy. Concomitant medication was not provided. No other vaccine in four weeks. other medications in two weeks Protonix; 7ketosteroidDHEA. No covid prior vaccination and no covid tested post vaccination. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ek5730) via intramuscular route of administration, administered in Arm left on 04Jan2021 10:00 AM as single dose for COVID-19 immunization. On 22Jan2021 the patient experienced abdominal pains, weak with low energy, severe watery diarrhea, nausea and vomiting. On an unspecified date patient experienced cramp. It was reported that abdominal pains and cramps starting about 12 hours after injection. Weak with low energy. Severe watery diarrhea along with nausea and vomiting. Symptoms lasted 72 hours then completely resolved. Patient received treatment of IV fluids, zofran, phenergan and pepcid. The outcome of the events was in 2021.while outcome of cramps was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Loss of personal independence in daily activities, Speech disorder, Tremor
Clinical narrative: really bad; shaking; whole body tremor; she would stand up with cane; she can barely talk; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced really bad, shaking, whole body tremor, she would stand up with cane, she can barely talk. She has called many times; she doesn't think anybody is listening. They are still putting it on the news, they are still giving the vaccine that is causing many problems she has videos of what these people are going through. She is calling about the Covid 19 Vaccine. She gets in-formation every day from the nursing home. She will provide the name of the Nursing home, she just forgot to put it down. The nursing home people are reporting a lot of thing as well as people in the hospital. They Won't put this in the news, it is not being reported, there are thousands of people online on social media. People are not being warned, people are going and doing it in other ways. She can give all the videos and have it all documented. It's not all in ER's and Hospitals. She has proof. It's a safety issue, she has videos. Most people die. It effects the body causing tremors. There's one where she was really bad, shaking, whole body tremor, she would stand up with cane, and she can barely talk. A lot of people are getting it, they are getting paralysis of the face, bell's palsy, a lot of that sometimes, that symptom goes away, it's a lifetime effect, people in bed with diarrhoea gas. There were 600 deaths just the other day, deaths in a lot of people 30 deaths in a nursing home in the (country name). There was a death of a 42-year-old doctor, he stated his name, and within 2 days dead from it, he was perfectly healthy. There's a whole school closed down completely, she has tried calling. She had Lot number of the covid vaccine that she is referring to in any of the cases. she has all the people's names, and they can be contacted, but she does not have the Lot number on hand with her. Caller responds stating that whatever the Lot number is, it isn't working. Caller states that the vaccine is very dangerous, and many doctors came on social media and said do not take this vaccine. Caller states that the vaccine is not fully tested. Caller was informed that Pfizer has submitted a request for Emergency Use Authorization for our potential COVID-19 vaccine and it is now in the FDA's hands. For more information, please go to (Web ad-dress). Call was then disconnected per guidance. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Muscle disorder
Clinical narrative: Quick, involuntary muscle jerks of both legs; Gas and bloating; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient (consumer) received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: EM9809), dose 1 via an unspecified route of administration, administered in Arm Left on 09Feb2021 09:00 (at the age of 76-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The medical history included rheumatoid arthritis and peripheral neuropathy from 09Feb2021 to an unknown date, and allergies to sulfa, levofloxazone from an unknown date and unknown if ongoing. The concomitant medications included gabapentin, doxazosin mesilate (CARDURA), finasteride, ibuprofen, paracetamol (TYLEN) taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks, no prior vaccinations and not tested for covid test post vaccination. The patient experienced quick, involuntary muscle jerks of both legs as he tried to sleep the night of his vaccination also, severe gas and bloating the afternoon after vaccination on 09Feb2021 21:00. The patient received no treatment in response to events. The clinical outcome of events was not recovered.  Follow-up (11May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: body aches; Swollen lymph node in armpit of injection site; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via unspecified route of administration on 08Feb2021 (age at the time of vaccination was 31, pregnant at the time of vaccination) as DOSE NUMBER UNKNOWN, SINGLE for COVID 19 Immunisation at Clinic. The patient's medical history included hypothyroidism. The patient received other medications in two weeks. Patients had no known allergies. No other vaccines within 4 weeks PRIOR to the COVID-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, had not been tested for COVID-19. The patient experienced Swollen lymph node in armpit of injection site and body aches on 09Feb2021. The patient had not received treatment for events. The outcome of events was not recovered.  No follow-up attempts were possible; information about lot/batch number could not be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dizziness, Dyspnoea, Hyperhidrosis
Clinical narrative: nausea; dizzy; fever; chill; body aches; difficulty breathing; chest pain; sweating; This is a spontaneous report from a contactable consumer (patient herself). A 67-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL9263; Expiration date: unknown) via an unspecified route of administration, administered in Arm Right on 03Feb2021 12:15 (at age of 67-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included breast cancer female, drug hypersensitivity; known allergies: antibiotic. Concomitant medications included letrozole (LETROZOLE), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), bupropion hydrochloride (WELLBUTRIN), trazodone (TRAZODONE) and fluoxetine hydrochloride (PROZAC) taken for an unspecified indication. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took levaquin and experienced drug hypersensitivity. On 04Feb2021 13:00 the patient experienced nausea, dizzy, fever, chill, body aches, difficulty breathing, chest pain and sweating. Patient did not receive any treatment for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of all events was recovered on an unspecified date in Feb2021.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: nausea; dizzy; fever; chill; body aches; difficulty breathing; chest pain; sweating; This is a spontaneous report from a contactable consumer (patient herself). A 67-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL9263; Expiration date: unknown) via an unspecified route of administration, administered in Arm Right on 03Feb2021 12:15 (at age of 67-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included breast cancer female, drug hypersensitivity; known allergies: antibiotic. Concomitant medications included letrozole (LETROZOLE), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), bupropion hydrochloride (WELLBUTRIN), trazodone (TRAZODONE) and fluoxetine hydrochloride (PROZAC) taken for an unspecified indication. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took levaquin and experienced drug hypersensitivity. On 04Feb2021 13:00 the patient experienced nausea, dizzy, fever, chill, body aches, difficulty breathing, chest pain and sweating. Patient did not receive any treatment for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of all events was recovered on an unspecified date in Feb2021.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Nausea, Pain in extremity
Clinical narrative: Very sore arm; metallic taste in mouth; nauseous; intense chills; This is a spontaneous report from a non-contactable consumer (the patient). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: 9809), via an unspecified route of administration, administered in left arm on 08Feb2021 12:30 (at the age of 42-years-old) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications included rabeprazole taken for an unspecified indication, start and stop date were not reported; telmisartan taken for an unspecified indication, start and stop date were not reported; rosuvastatin taken for an unspecified indication, start and stop date were not reported. The patient did not received any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID. Post vaccination, the patient has not been tested for COVID. On 08Feb2021 15:00, the patient experienced very sore arm, metallic taste in mouth, nauseous. On an unspecified date in Feb2021, the patient experienced intense chills. It was reported that on day 1 the adverse events are very sore arm, metallic taste in mouth, nauseous. On night 1 after vaccination, he had sore arm. On Day 2 of vaccination, very mild sore arm. On night 2 of vaccination, very sore arm, intense chills. The patient did not receive any treatment for adverse events. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Fatigue; This is a spontaneous report from a contactable consumer (patient). An 83-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9264), via an unspecified route of administration in the left arm on 08Feb2021 at 08:00 (at the age of 83-years-old) as a single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included pulmonary fibrosis and shellfish allergy from an unknown date and unknown if ongoing. List of any other medications the patient received within 2 weeks of vaccination reported as yes (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced sore arm and fatigue on 09Feb2021 15:00 (reported as Sore arm next day and fatigue by late afternoon). The patient did not receive any treatment. The clinical outcome for events was recovered on 10Feb2021.  Follow-up attempts completed. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site paraesthesia
Clinical narrative: I have pain and paralysis at injection site; I have pain and paralysis at injection site; This is a spontaneous report from a contactable Nurse. A 39-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: EL3246, Expiration date: Not reported), via intramuscular route of administration, administered in arm Left on 20Jan2021 14:15 (at the age of 39-Year-old) as dose 1, single for an unspecified indication. Facility where vaccine was administered was reported as hospital. Medical history included known allergies: pineapple. There were no concomitant medications. No other vaccine was received in four weeks and no other medications within two weeks of COVID vaccine. No COVID prior vaccination and not tested for COVID post vaccination. The patient experienced pain and paralysis at injection site on 22Jan2021 07:00. No treatment was received for the reported event. The outcome of the events were not recovered.  Follow-up attempts completed. No further information expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Lymphadenopathy, Swelling face
Clinical narrative: Right axillary painful tender lymphadenopathy; Right eye facial swelling; Right eye facial swelling; This is a spontaneous report from a contactable physician (patient). A 31-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9264) via an unspecified route of administration in arm right on 08Feb2021 12:00 (at the age of 31 years old) as dose 2, single for COVID-19 immunisation. The patient medical history was reported as none. Concomitant medication(s) received within two weeks of COVID vaccine included ethinylestradiol, etonogestrel (NUVARING) taken for birth control, start and stop date were not reported. The patient previously took benzoyl peroxide and experienced Allergy. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL1283) via an unspecified route of administration in arm right on 12Jan2021 16:00 (at the age of 31 years old) as single for COVID-19 immunisation. Patient did not received other vaccine within four weeks of COVID vaccine. Patient did not have COVID prior to vaccination. The patient experienced right axillary painful tender lymphadenopathy, right eye facial swelling on 09Feb2021. No treatment were given for the adverse events. Patient was not tested for COVID post vaccination. Outcome of all the events were not recovered.  Follow-up attempts completed. No further information expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Crying, Dry throat, Ocular hyperaemia, Rhinorrhoea
Clinical narrative: mild swelling on face, arms and legs; nasal discharge; dry scratching throat; weeping; blood shot eyes; gastrointestinal upset; This is a spontaneous report from a contactable consumer or other non-Health Care Professional.A 58-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EMP9810 and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 09Feb2021 18:00 as DOSE 1, SINGLE for Covid-19 immunization. Medical history included eosinophilic oesophagitis from an unknown date and unknown if ongoing, atrial fibrillation from an unknown date and unknown if ongoing resolved due to sleep apnea, hypertension from an unknown date and unknown if ongoing long term controlled, irritable bowel syndrome from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Concomitant medication(s) included montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; clarithromycin (CLARITIN [CLARITHROMYCIN]) taken for an unspecified indication, start and stop date were not reported; flecainide taken for an unspecified indication, start and stop date were not reported; bisoprolol taken for an unspecified indication, start and stop date were not reported. The patient received other medications of vaccination. The patient was not diagnosed with Covid 19 and has not been tested for Covid-19 Since the vaccination. On 10Feb2021 04:00 the patient experienced mild swelling on face, arms and legs, nasal discharge, dry scratching throat, weeping, blood shot eyes, gastrointestinal upset. The outcome of events was recovering.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: mild swelling on face, arms and legs; nasal discharge; dry scratching throat; weeping; blood shot eyes; gastrointestinal upset; This is a spontaneous report from a contactable consumer or other non-Health Care Professional.A 58-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EMP9810 and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 09Feb2021 18:00 as DOSE 1, SINGLE for Covid-19 immunization. Medical history included eosinophilic oesophagitis from an unknown date and unknown if ongoing, atrial fibrillation from an unknown date and unknown if ongoing resolved due to sleep apnea, hypertension from an unknown date and unknown if ongoing long term controlled, irritable bowel syndrome from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Concomitant medication(s) included montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; clarithromycin (CLARITIN [CLARITHROMYCIN]) taken for an unspecified indication, start and stop date were not reported; flecainide taken for an unspecified indication, start and stop date were not reported; bisoprolol taken for an unspecified indication, start and stop date were not reported. The patient received other medications of vaccination. The patient was not diagnosed with Covid 19 and has not been tested for Covid-19 Since the vaccination. On 10Feb2021 04:00 the patient experienced mild swelling on face, arms and legs, nasal discharge, dry scratching throat, weeping, blood shot eyes, gastrointestinal upset. The outcome of events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Back disorder, Feeling abnormal
Clinical narrative: miserable and from the back that is already bad; miserable and from the back that is already bad; This is a spontaneous report from a contactable consumer(patient). A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on an unspecified as dose 1, single for COVID-19 immunization. Medical history included ongoing back pain Caller stated she has back pain for 3 years due to she fell down the stairs. She said she took the first shot of Pfizer covid vaccine and they told her no Tylenol. She said she takes Tylenol 4 times a day for her back pain , ongoing fall Caller stated she has back pain for 3 years due to she fell down the stairs. She said she took the first shot of Pfizer covid vaccine and they told her no Tylenol. She said she takes Tylenol 4 times a day for her back pain. The patient's concomitant medications were not reported. Patient have a question. Yesterday she had her first shot, the Pfizer one and right when she was leaving they said something, no Tylenol. Then she go, but then she did not get to ask a question because she have been taking Tylenol for severe back pain. she fell down the basement stairs and she have been taking 650mg, Four times a day. So she said okay. Patient guess she just cannot take Tylenol then. So, then she got up and of course miserable and from the back that is already bad. So can she not take that it all. Should she go, she mean that's 650, she know was a lot, 4 times a day or should I try ibuprofen. she think they said something, she briefly heard something. she thought that they said something that if you take Tylenol with Pfizer it was less effective. Therapeutic measures were taken as a result of miserable and from the back that is already bad. The outcome of the events was miserable and from the back that is already bad unknown and for event miserable and from the back that is already bad was not recovered.     Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Neck pain, Oropharyngeal pain, Pain in extremity
Clinical narrative: sore left arm; headache; fatigue; sore neck; sore throat; This is a spontaneous report from a Non-contactable Consumer. This 56-Year-old female consumer reported that:  A 56-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 09Feb2021 16:15 (at the age of 56-years-old) as dose 1, single for an unspecified indication. Medical history included total thyroidectomy - due to cancer, cancer. Patient had no Known allergies. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication from unknown start date; liothyronine (LIOTHYRO-NINE) taken for an unspecified indication from unknown start date; lamotrigine (LAMOTRIGINE) taken for an unspecified indication from unknown start date; cyanocobalamin (B12 GUMMIES) taken for an unspecified indication from unknown start date. Patient had not received any other vaccines within 4 weeks. No prior to vaccination, patient was not tested with COVID-19. On 09Feb2021 23:00, the patient experienced sore left arm started during the evening after the dose, headache, fatigue, sore neck, sore throat. No treatment received for the events. At the time of report, the outcome of events were not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Seasonal allergy
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient, of an unspecified age, received the BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Feb 5, 2021, single dose, for COVID-19 immunization. Medical history included seasonal allergies, from an unknown date and unknown if ongoing. The patient's concomitant medications not reported. Patient reported she received the first dose last Friday Feb 5, 2021. Her seasonal allergies arrived on an unspecified date, which she would normally treat with a Claritin. Reporter indicated she had a root canal tomorrow. Therapeutic measures were taken as a result of seasonal allergies. The event assessed as non-serious, with outcome of unknown. Follow-up attempts completed. No further information expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat
Clinical narrative: Clammy on his back; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 82-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot number: EL183), via intramuscular route in left arm, on 09Feb2021 at 02:10 (82-year-old at the time of vaccination), as dose 1, single for covid-19 immunisation. Medical history included has a pacemaker and diabetes from an unknown date and unknown if ongoing. The patient has allergy to iodine. The concomitant medications were reported as none. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination. On 09Feb2021 at 06:30 am, the patient experienced clammy on his back. No relevant tests was conducted. No treatment was received for the events. The event reported as non-serious. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via intramuscular in Right upper arm, on 02Mar2021 at 10:15 (82-year-old at the time of vaccination), as dose 2, single for covid-19 immunisation. The outcome of the event was recovered an unspecified date on 2021.  It was reported as the Pfizer product had a causal effect to the adverse event was yes  Follow up attempts are completed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: Chills; Headache; 100.6F fever; body aches; This is a spontaneous report from a contactable consumer (patient herself).   A 22-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration in Arm Left on 09Feb2021 13:45, as DOSE 2, SINGLE (age at vaccination was 22-years-old) for covid-19 immunisation. Medical history included eczema. Concomitant medication(s) included ibuprofen, calcium carbonate (TUMS [CALCIUM CARBONATE]), triamcinolone and ascorbic acid, colecalciferol, cyanocobalamin, pyridoxine hydrochloride, retinol palmitate, tocopherols mixed (MULTIVITAMIN GUMMY BEARS), dosing details and therapy dates unknown for all. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration in Arm Left on 19Jan2021 13:30, as DOSE 1, SINGLE for covid-19 immunisation. On 10Feb2021, 01:00 the patient experienced chills throughout the first night after receiving the second dosage. Woke up with a headache, body aches, 100.6F fever. No treatment was received by the patient. It was reported that the patient did not have Covid prior to vaccination and Covid was not tested post vaccination. At the time of this report, the outcome of all the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain
Clinical narrative: Bilateral burning pins; needles pain in hands and feet after the 2nd dose; This is a spontaneous report from a contactable Physician. A 36-Year-old female Physician reported for herself. A 36-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot Number: EL1284) via an unspecified route of administration in arm left on 06Jan2021 07:00 as dose 2, single (age at vaccination: 36 years) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot Number: EJ1685) via an unspecified route of administration on 18Dec2020 07:00 AM as dose 1, single for COVID-19 immunisation. No other vaccine in four weeks, no other medications in two weeks. No covid prior vaccination and did not tested covid post vaccination. No known allergies. On 08Jan2021, bilateral burning pins and needles pain in hands and feet after the 2nd dose on 06Jan2021. No treatment was received. The adverse resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events was resolving.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Joint swelling
Clinical narrative: swollen ankles; headache; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced swollen ankles and headache on an unspecified date with outcome of unknown. Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: After about 30 minutes, my cheeks and lips started to tingle/go numb.  It was on the surface of my skin, not inside of my mouth.  It slowly spread on my face, and then about a hour later, subsided.; After about 30 minutes, my cheeks and lips started to tingle/go numb.  It was on the surface of my skin, not inside of my mouth.  It slowly spread on my face, and then about a hour later, subsided.; This is a spontaneous report from a contactable consumer (patient herself). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number EM9809 and expiration date unknown), via an unspecified route of administration in Right Arm on 04Feb2021 at dose number unknown, single for COVID-19 immunization. The patient's medical history included Cancer in 2000, chemo and radiation. Concomitant medication included Apple Cider vinegar for Immunity vitamins. Patient previously took codeine for which she was experienced with allergies. It was reported as patient stated that on 04Feb2021 after about 30 minutes her cheeks and lips started to tingle/go numb. It was on the surface of her skin, not inside of her mouth. It slowly spread on her face and then about an hour later it was subsided. Patient did not receive any treatment. Outcome of events was recovered on 04Feb2021.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Lymph node pain
Clinical narrative: swollen & painful left axillary lymph node; swollen & painful left axillary lymph node; nausea; epigastric pain; extreme fatigue; chills; severe body ache; headache; mild fever; This is a spontaneous report from a contactable nurse (patient). A 46-year-old non-pregnant female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL1283), via an unspecified route of administration in left arm on 07Feb2021 at 11:45 (at the age of 46 years old) as single for covid-19 immunisation. Medical history included heart valve incompetence from an unknown date and unknown if ongoing, gastrooesophageal reflux disease from an unknown date and unknown if ongoing. The patient had known allergies to morphine. Concomitant medications included metoprolol; pantoprazole; ergocalciferol (VIT D); triamcinolone acetonide (NASACORT); calcium; vitamins nos (MVI [VITAMINS NOS]). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 21Jan2021 at 02:00 PM (at the age of 46 years old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 07Feb2021 at 20:00, patient experienced swollen and painful left axillary lymph node, nausea and epigastric pain, extreme fatigue, chills, severe body aches, headache, mild fever. The patient did not received treatment due to the events. The outcome of events was recovering.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Pain, Pyrexia
Clinical narrative: swollen & painful left axillary lymph node; swollen & painful left axillary lymph node; nausea; epigastric pain; extreme fatigue; chills; severe body ache; headache; mild fever; This is a spontaneous report from a contactable nurse (patient). A 46-year-old non-pregnant female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL1283), via an unspecified route of administration in left arm on 07Feb2021 at 11:45 (at the age of 46 years old) as single for covid-19 immunisation. Medical history included heart valve incompetence from an unknown date and unknown if ongoing, gastrooesophageal reflux disease from an unknown date and unknown if ongoing. The patient had known allergies to morphine. Concomitant medications included metoprolol; pantoprazole; ergocalciferol (VIT D); triamcinolone acetonide (NASACORT); calcium; vitamins nos (MVI [VITAMINS NOS]). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 21Jan2021 at 02:00 PM (at the age of 46 years old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 07Feb2021 at 20:00, patient experienced swollen and painful left axillary lymph node, nausea and epigastric pain, extreme fatigue, chills, severe body aches, headache, mild fever. The patient did not received treatment due to the events. The outcome of events was recovering.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.