chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Pain was stabbing and burning/Body ache; Shingles; Left lower shoulder blade pain; Stabbing pain that was radiating around her rib cage to her left breast; High fever/Fever was 102, fluctuated from 102-103; Nausea; Freezing/Chills; Shaking/Trembling; Burning up; Patient received 1st dose on 07Jan2021 and the 2nd dose 18 days after on 24Jan2021; Patient received 1st dose on 07Jan2021 and the 2nd dose 18 days after on 24Jan2021; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: BL9262), dose 2, via an unspecified route of administration on 24Jan2021 (at the age of 42-years-old) as 2nd dose, single for COVID-19 immunization. Medical history included chickenpox when she was a kid. The patient has no concomitant medications. The patient received the 1st dose of BNT162B2 (lot number: EK4176) on 07Jan2021 for COVID-19 immunization. The patient had no prior vaccinations within 4 weeks of the administration of BNT162B2. The patient received the 1st dose on 07Jan2021 and the 2nd dose 18 days after on 24Jan2021. The patient reported she was a healthy individual and hasn't gone to the doctor or anything. She hasn't call out of work or anything, but she called out for work after her 2nd vaccine dose, she was out for a week. On 25Jan2021, she had a high fever (fever was 102, fluctuated from 102-103) that would not break and nausea. The fever started 12-13 hours after the vaccine which stayed at 102-103 and made her feel nauseous. The patient felt she was freezing, shaking, and burning up. She believed the body aches and nausea aches came from trembling. The patient also had the chills. The patient drank lots of fluids, had soup, and Tylenol with the high fever. These symptoms all happened at the same time and she recovered completely. On 20Mar2021, a month and a half after the patient's 2nd dose, the patient started getting symptoms after her 43rd birthday. She started to develop pain in her lower left shoulder blade. She didn't know if she pulled or twisted it wrong. The pain increased by 21Mar2021. On 24Mar2021 at work, the patient's supervisor asked why she was using a heat pack. She told her supervisor that she was having stabbing pain that was radiating around her rib cage to her left breast. The supervisor asked if it was burning and she had a rash. The patient confirmed she had no rash. It was a deep excruciating pain like someone is hitting her with a bat or stabbing her. The patient added that the pain started medially, on the inner part of her shoulder blade. She was later diagnosed with shingles. No relevant tests were performed. Therapeutic measures were taken as a result of the events shoulder blade pain and chest pain (heat pack); and fever (Tylenol). The outcome of the events shoulder blade pain and shingles was not recovered while the outcome of the events fever, nausea, chills, tremor, and burning sensation was recovered on 29Jan2021. The outcome of the remaining events was unknown.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: After second dose on 16Mar2021, patient underwent lab tests and procedures which included Nasal Swab/Covid 19 test: positive; i received the 2nd covid 19 vaccination on 16Mar2021. I tested positive for covid 19 on 06Apr2021.; This is a spontaneous report from a contactable consumer (patient). A 50-Year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6203), via unspecified route of administration in left arm on 16Mar2021 at 03:15 (at the age of 50-years-old) as a single dose and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247) via unspecified route of administration in left arm on 23FEB2021 at 03:00 (at the age of 50-year-old) as a single dose, both the doses for COVID-19 immunisation. The patient did not have any known allergies. The patient did not receive any medication within two weeks of vaccination. The patient medical history and concomitant medication were not reported. The patient did not receive any vaccine within four weeks prior to the vaccine. After second dose on 16Mar2021, patient underwent lab tests and procedures which included Nasal Swab/Covid 19 test: positive on 06Apr2021. The patient did not receive any treatment for the events. The outcome of the event vaccination failure was unknown while for another event was recovering. On 27Apr2021, the investigation results was received from Group.  The product is BNT162B2, Batch numbers for 1st and 2nd dose: EN6203, EL3247.  Description of Complaint: I received the 2nd covid 19 vaccination on 16Mar2021. I tested positive for Covid 19 on 06Apr2021.  Special or Common Cause: Common Cause Root Cause is always present to some degree in the process. Special Cause Root Cause is something different happening at a certain time or place in the process. Conclusion: The complaint for an adverse event requested by safety with the use of the PFIZER-BIONTECH COVID-19 VACCINE lot EL3247 was investigated. The investigation included reviewing the manufacturing and packaging batch records, retained reference samples, deviation investigations and an analysis of the complaint history for the reported lot and product type. The final scope was expanded to the reported finished goods lot EL3247, fill lot EL3230, and the bulk formulated drug product lot EL3223. A complaint sample or photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. The complaint was not confirmed.  The events occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency  Follow-up (27Apr2021): New information received from the Group, included: product quality complaint investigation summary and conclusion.  No follow-up attempts are needed. No further information is expected
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: tiredness; headache; muscle pain; fever; nausea; chills; feeling unwell; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 10Apr2021 at 10:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy from an unknown date and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in the four weeks prior to the COVID vaccine. Concomitant medications included sertraline hydrochloride from an unknown date for an unknown indication. On 10Apr2021 at 22:00 the patient experienced tiredness, headache, muscle pain, fever, nausea, chills, and feeling unwell. The patient reported she was unable to get out of bed for 24 hours and seated. No treatment was received for the events. The clinical outcomes of tiredness, headache, muscle pain, fever, nausea, chills, and feeling unwell were recovering. It was also reported that since vaccination the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: tiredness; headache; muscle pain; fever; nausea; chills; feeling unwell; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 10Apr2021 at 10:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy from an unknown date and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in the four weeks prior to the COVID vaccine. Concomitant medications included sertraline hydrochloride from an unknown date for an unknown indication. On 10Apr2021 at 22:00 the patient experienced tiredness, headache, muscle pain, fever, nausea, chills, and feeling unwell. The patient reported she was unable to get out of bed for 24 hours and seated. No treatment was received for the events. The clinical outcomes of tiredness, headache, muscle pain, fever, nausea, chills, and feeling unwell were recovering. It was also reported that since vaccination the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Lymphadenitis, Mass, SARS-CoV-2 test
Clinical narrative: 1 cm mass; inflamed supraclavicular lymph node on left side/nodule; This is a spontaneous case received from a contactable consumer (patient's mother). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 19Mar2021 at 11:30 (at the age of 16-years-old) as a single dose on the left side for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient had not been diagnosed with COVID-19 prior to the vaccine. The patient did not take any concomitant medications. The patient did not have any allergies to medications, food, or other products. On 25Mar2021, the patient experienced an inflamed supraclavicular lymph node on left side (same side as vaccine administration). On 26Mar2021, the patient visited her primary care physician (PCP) as a result of the event. The physician documented a 1 cm mass. The patient was referred to another doctor for follow-up. On 07Apr2021 the patient saw another doctor who reviewed the case. The patient underwent lab tests and procedures which included a COVID-19 nasal swab on 25Mar2021 with result of negative, chest X-ray on 26Mar2021 with results of "clear" and lab work on 07Apr2021 with results of "clear." The patient did not receive any treatment for the events. The patient was told to follow-up in six weeks if the nodule was not gone. The outcome of inflamed supraclavicular node was not recovered. The outcome of 1cm mass was unknown. The patient received dose 2 of BNT162B2 on 09Apr2021 at 13:30 and was told to contact the doctor with any changes in the lymph node (smaller, larger, etc.).   No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Oesophageal irritation, Rash, Rash erythematous, Throat irritation, Urticaria
Clinical narrative: developed an all-over body rash about 9 days later; The rash was a combination of red rash and hives; red rash; irritation in the throat and esophagus; irritation in the throat and esophagus; This is a spontaneous report received from a contactable consumer. A 58-year-old male patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date 9 days after the vaccine, the patient experienced an all-over body rash. The rash started under the arm and worked its way across his torso and back, neck, face, buttocks, back of knees, and groin. The rash was a combination of red rash and hives. The patient also had some irritation in the throat and esophagus on an unspecified date. The patient had ruled out everything else including food, soaps, etc and nothing had changed. The patient saw an allergist who believed that his reaction was due to his body building an antibody response to the vaccine. The allergist advised the patient wait two additional weeks before receiving dose 2 of BNT162B2. The outcomes of all-over body rash, red rash, hives, and irritation in throat and esophagus were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 03Feb2021 as single dose for COVID-19 immunisation. Medical history included sickle cell anemia from an unknown date and unknown if ongoing, Addison's disease from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, diabetes from an unknown date and unknown if ongoing, and pacemaker from an unknown date. The patient's concomitant medications were not reported. The patient called to schedule her second dose of BNT162B2 and reported that she had her first dose on 03Feb2021 and had not returned for her second dose yet. She reported that she became very sick the evening after her first vaccination and had not wanted to get her second dose until now; further reporting she had a number of underlying medical conditions. The clinical outcome of became very sick was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: extremely tired; extreme arm pain; This is a spontaneous report from a contactable nurse (patient). A 76-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date (two weeks ago) as a single dose for COVID-19 immunization. Medical history included chemotherapy. The patient's concomitant medications were not reported. On an unspecified date the patient experienced multiple ongoing adverse events (AEs). She experienced extreme arm pain, felt extremely tired and stayed in bed for the first 7 days. Now she could only get up and do things every other day. The patient was treated with paracetamol (TYLENOL)  which did not give her any relief from her extreme arm pain. The outcomes of extreme arm pain and felt extremely tired were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pain, Rash, Rash erythematous
Clinical narrative: Rash on one side of my stomach, it was red and sore/ two red spots on my stomach; Rash on one side of my stomach, it was red and sore; pain; burning sensation; This is a spontaneous report from a contactable consumer (patient). This male patient of unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 02Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported that he received BNT162B2 on 02Apr2021 and 3 or 4 days later he noticed a rash on one side of his stomach, further specified as red and sore as if it had been burnt with hot water; further reporting two separate red spots on his stomach, a burning sensation and pain. He inquired what he could take for this to go away. He reported calling his doctor who told him to call Pfizer. The clinical outcomes of rash on one side of his stomach, it was red and sore, two red spots on his stomach, burning sensation and pain were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Malaise, Nasal congestion, Pain, Pyrexia
Clinical narrative: feeling ill last night; fever; body aches; stuffy nose; coughing; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date (last Thursday) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date (last night), the patient experienced feeling ill in which his symptoms proceeded to become worse. The patient experienced a fever, body aches, stuffy nose, and coughing. The patient was treated with paracetamol (TYLENOL). The outcomes of feeling ill, fever, body aches, stuffy nose, and coughing were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from contactable consumer (patient) via the Pfizer-sponsored program. A (currently) 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 74-years-old) in Arm on 19Mar2021 (Lot Number: ER8727) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shingles on an unspecified date. She received her first vaccine and now she is diagnosed with Shingles and wanted to know she can get her second vaccine. Her doctor had said that the Shingles mess with your immune system and so does this Covid shot Pfizer. No treatment received for the event. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Sunburn
Clinical narrative: spent 3 days in the sun and got burned and wanted to knowif it was due to Xeljanz or her COVID vaccine; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sponsored Program XELSOURCE.   A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number not reported), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation and tofacitinib citrate (XELJANZ XR 11 mg), via an unspecified route of administration from an unspecified date and ongoing, at 11 mg unknown frequency for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient stated she spent 3 days in the sun and got burned on an unknown date and wanted to know if it was due to tofacitinib or her covid vaccine. The outcome of the event was unknown.The action taken for tofacitinib citrate was dose not changed.No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: This is a spontaneous report from a contactable consumer (reporting for cousin of mother). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient passed out either the next day or shortly after receiving dose of BNT162B2 on an unspecified date, a medically significant event.  The outcome of the event, passed out was unknown.   Information on the lot/batch number has been requested.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: Pt states she cannot hear out of her left ear; This is a spontaneous report from a contactable pharmacist. A 17-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscularly, administered in left arm on 24Apr2021 05:00 (Batch/Lot Number: EN5318) as a single dose (at the age of 17 years old) for COVID-19 immunization. Prior to vaccination, was the patient was not diagnosed with COVID-19. The patient's medical history and concomitant medications were not reported.  On 26Apr2021 13:00,  the patient experienced she could not hear out of her left ear. The event resulted in a doctor or other healthcare professional office/clinic visit. There was no hospitalization for the event. The outcome of the event could not hear out of her left ear was unknown.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of "could not hear out of her left ear" cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID19/symptoms lasted 5-6 days; tested positive for COVID19/symptoms lasted 5-6 days; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 07Apr2021 (Batch/Lot number was not reported) as single for COVID-19 immunisation. Medical history included exposure to COVID-19 from an unknown date. The patient's concomitant medications were not reported. The patient had his first dose of bnt162b2 on 07Apr2021. He had exposure and two weeks later, on 21Apr2021, he tested positive for COVID19. Furthermore, he mentioned that he has not showed any symptoms as of the moment and all symptoms lasted 5-6 days. Outcome of the events was reported as unknown.  Information on the batch/lot number has been requested.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer. A 23-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EP7534), via an intramuscularly in the left arm, on 22Apr2021 at 14:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included gluten intolerant. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EP7534), intramuscularly in the left arm, on 01Apr2021 at 14:00 (at the age of 23-years-old) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced appendicitis on 25Apr2021 at 04:00, which required hospitalization for one day from an unspecified date to an unspecified date. The patient underwent lab tests and procedures which included COVID-19 nasal swab: negative on 25Apr2021. Therapeutic measures were taken as a result of the appendicitis, which included an appendectomy. The clinical outcome of appendicitis was recovered in Apr2021.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol increased, Blood pressure measurement, Dizziness, Hypertension
Clinical narrative: Dizziness none stop 24/7; High blood pressure; High cholesterol; This is a spontaneous report from a contactable consumer. A 58-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 31Mar2021 at 11:00 (Batch/Lot Number: ER8737) at 58-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient did not have COVID prior to the vaccination. The patient's medical history included migraine, vertigo, and psoriasis; all from an unknown date and unknown if ongoing. Concomitant medications were not reported.  The patient previously received bnt162b2 for COVID-19 immunisation on 10Mar2021 (lot number: EN6207, administration time: 11:00, vaccine location: Right arm, dose number: 1); and morphine and ciprofloxacin and experienced allergy on an unspecified date. On 18Apr2021 at 04:00, the patient experienced: dizziness none stop 24/7, high blood pressure, and high cholesterol, and resulted in an emergency room/department or urgent care visit.  The patient was hospitalized for the events from 18Apr2021 to 21Apr2021. The patient underwent lab tests and procedures which included blood pressure measurement: 197/133 in Apr2021, blood pressure measurement: high on 18Apr2021. Therapeutic measures were taken as a result of dizziness none stop 24/7, high blood pressure, and high cholesterol, which included losartan 50 mg and metoprolol 25 mg. It was reported that the patient was not stable on the medications. The clinical outcome of the events was not recovered. Since the vaccination, it was unknown if the patient had been tested for COVID-19.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Muscular weakness, Paralysis
Clinical narrative: complete paralysis/paralyzed/can't move anywhere/can't move her arms and legs; muscle weakness; This is a spontaneous report from two contactable consumers (patient herself and her husband). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, administered in the right arm (also reported as right shoulder), on 13Apr2021, as 1st dose, single, for COVID-19 immunization, at a pharmacy/drug store. Medical history included allergies to latex, bulimia, depression, and COVID-19 (prior to vaccination). The patient previously took codeine and experienced allergies. The patient was not pregnant at the time of vaccination. The patient was not tested for COVID-19 since the vaccination. Concomitant medications were unspecified (taking other medications). The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 16Apr2021, the patient experienced complete paralysis which started with muscle weakness 3 days after the vaccine. The events resulted in emergency room visit, hospitalization (also reported as prolonged hospitalization, pending clarification), disability or permanent damage. The patient was still in the hospital at the time of the report. Treatment for the events included spinal tap, IV fluids, and potassium intake treatment. On 29Apr2021, it was reported that the patient was having a really bad reaction (unspecified), was paralyzed, could not move anywhere and in the hospital from 25Apr2021 and ongoing. The patient underwent lab tests in Apr2021 with unknown results. On 08May201, it was reported that the patient could not move her arms and legs and is "nursing home" (pending clarification). The reporter assessed the events as serious (hospitalization and disability). The outcome of the events was not recovered.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Clostridium difficile infection, Culture stool
Clinical narrative: she had developed C. Diff after she had the vaccine; This is a spontaneous report from a contactable consumer (patient).  A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 67-years-old via an unspecified route of administration, administered in arm left on 09Feb2021 11:00 (Batch/Lot Number: EL9264) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Jan2021 11:00 (lot number: EL23247) at the age of 67-years-old for covid-19 immunisation. The patient reported that she had developed C. Diff after she had the vaccine and has no idea how she got the bacteria. She states that she developed Clostridium difficile or also known as C-diff. She states that it is the only thing that happened to her after receiving the second dose of the vaccine. She states that it happened 6-8 weeks on 01Apr2021 after receiving the vaccine. She states she did have to have a culture, a stool culture done because she wasn't feeling well and that is how it was determined it was C-diff. She states that's how it was determined that it was C-DIFF. She states the culture was positive. The patient underwent lab tests and procedures which included culture stool: positive (C. Diff.) on an unspecified date. She states that she is under a doctor's care and is taking medication for the C-diff. She states that until the antibiotic is complete, which will be another 7 days, then has to be retested the C-diff is still ongoing. The patient did not recover from the event.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, White blood cell count, White blood cell count increased
Clinical narrative: white blood count "shot up to 18"; severely swollen lymph nodes; sick; This is a spontaneous report from a contactable consumer (parent). A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot Number: UNKNOWN) as unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced a reaction after having her first vaccine dose. The patient was sick for 2 weeks and was seen at the Urgent care, ER and the doctors office for severely swollen lymph nodes in her neck. The patient was placed on steroids and her white blood count "shot up to 18". The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Lipase, Pancreatitis acute
Clinical narrative: This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the right arm on 09Apr2021 12:45 as 1st dose, single for COVID-19 immunisation. Medical history included GERD and allergy to eggs. Concomitant medication included pantoprazole taken for GERD from 2017 and ongoing. The patient was in the ER (emergency room) after the first dose of Pfizer vaccine and diagnosed with acute pancreatitis on 17Apr2021. Patient was in the ER (emergency room) a week after she had the Covid-19 Vaccine and was diagnosed with acute pancreatitis. She was wondering if others have had this too. She was due to get her second shot on Monday. Her primary physician doesn't know what's going on. She took a nap and woke up in excruciating pain on 17Apr2021. It was on and off but not like it was. She went to urgent care first, and then they sent her to the ER for a CAT (Computerised tomogram) scan. The events required a visit to the emergency room and urgent care. She has a follow up with her GI (Gastrointestinal) doctor. She has an appointment in June, and he wanted her to get an MRI before he sees her. She had bloodwork and a CAT scan on 17Apr2021. Her lipase was 80 something which was double the normal. There were no additional vaccines administered on same date of Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Eye discharge, Fatigue, Feeling abnormal, Gastrointestinal disorder, Headache
Clinical narrative: back of my head was tingly/a constant feeling of a tingling sensation in my head almost; my motor function was off; speech had an impediment; digestive issues; mucus eyes; I felt a little out of it; tired; headaches; legs are shaky; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date (at an unspecified age) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date (at an unspecified age) as a single dose for COVID-19 immunisation. On an unspecified date the patient experienced back of my head was tingly/a constant feeling of a tingling sensation in my head almost, my motor function was off, speech had an impediment, digestive issues, mucus eyes, I felt a little out of it, tired, headaches and legs are shaky. The patient called to report side effects from one of the shots and the course was reported as follows: "The side effects started mild and then went severe. The day after my shot I started experiencing digestive issues and mucus eyes. I felt a little out of it, not terrible. It lasted 5 days to a week. I felt fine for about a week and then I woke up almost two weeks after and the back of my head was tingly, my motor function was off, speech had an impediment, and I did not have control over my body, could not talk right for about 2 days. I lost control over my whole body for about 30 seconds. I still have a constant feeling of a tingling sensation in my head almost and something just is not right when I try to talk. There is a disconnect between my brain and my mouth. I am very tired, nowhere near the energy I used to have. I get random pounding headaches like someone hits me in the head with a bat, other days my legs are shaky. It is off and on. It is not constant, but it is consistent. I got rushed to the hospital but there was no sign of a stroke." The patient inquired as to how long should he expect these symptoms to last. The clinical outcomes of the events back of my head was tingly/a constant feeling of a tingling sensation in my head almost, my motor function was off, speech had an impediment, digestive issues, mucus eyes, I felt a little out of it, tired, headaches and legs are shaky were all unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Motor dysfunction, Paraesthesia, Speech disorder, Tremor
Clinical narrative: back of my head was tingly/a constant feeling of a tingling sensation in my head almost; my motor function was off; speech had an impediment; digestive issues; mucus eyes; I felt a little out of it; tired; headaches; legs are shaky; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date (at an unspecified age) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date (at an unspecified age) as a single dose for COVID-19 immunisation. On an unspecified date the patient experienced back of my head was tingly/a constant feeling of a tingling sensation in my head almost, my motor function was off, speech had an impediment, digestive issues, mucus eyes, I felt a little out of it, tired, headaches and legs are shaky. The patient called to report side effects from one of the shots and the course was reported as follows: "The side effects started mild and then went severe. The day after my shot I started experiencing digestive issues and mucus eyes. I felt a little out of it, not terrible. It lasted 5 days to a week. I felt fine for about a week and then I woke up almost two weeks after and the back of my head was tingly, my motor function was off, speech had an impediment, and I did not have control over my body, could not talk right for about 2 days. I lost control over my whole body for about 30 seconds. I still have a constant feeling of a tingling sensation in my head almost and something just is not right when I try to talk. There is a disconnect between my brain and my mouth. I am very tired, nowhere near the energy I used to have. I get random pounding headaches like someone hits me in the head with a bat, other days my legs are shaky. It is off and on. It is not constant, but it is consistent. I got rushed to the hospital but there was no sign of a stroke." The patient inquired as to how long should he expect these symptoms to last. The clinical outcomes of the events back of my head was tingly/a constant feeling of a tingling sensation in my head almost, my motor function was off, speech had an impediment, digestive issues, mucus eyes, I felt a little out of it, tired, headaches and legs are shaky were all unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had Covid; had Covid; This is a spontaneous report  from a non-contactable consumer (patient herself). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had Covid last week on Apr2021. She wanted to know if she can still receive the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine even if she had Covid. Outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Drug ineffective, Nasopharyngitis, Oxygen saturation
Clinical narrative: may be because he has come in contact with COVID-19 since his first dose; may be because he has come in contact with COVID-19 since his first dose; symptoms of a cold including "cough, chills, body aches, etc." that continued for 3 days; symptoms of a cold including "cough, chills, body aches, etc." that continued for 3 days; symptoms of a cold including "cough, chills, body aches, etc." that continued for 3 days; symptoms of a cold including "cough, chills, body aches, etc." that continued for 3 days; oxygen levels are going down; This is a spontaneous report from a contactable consumer. A 37-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The reporter stated that his brother (patient) has started having symptoms of a cold including cough, chills, body aches (on unspecified date) that continued for 3 days. His brother reached out to his doctor who told him it may not be related to the shot but may be because he has come in contact with COVID-19 since his first dose. The patient is waiting on a COVID-19 test (unknown (pending) result) but caller is concerned because he state that his oxygen levels were going down. The caller would like to know if the patient can take vitamin supplements after or in between doses of the Pfizer BioNTech COVID-19 vaccine. The reporter specifically asked about vitamins E, C, B, and echinacea. They responded that there is no information regarding a potential interaction between the vaccine and vitamin supplements such as E, C, B, and echinacea. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Pain, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: may be because he has come in contact with COVID-19 since his first dose; may be because he has come in contact with COVID-19 since his first dose; symptoms of a cold including "cough, chills, body aches, etc." that continued for 3 days; symptoms of a cold including "cough, chills, body aches, etc." that continued for 3 days; symptoms of a cold including "cough, chills, body aches, etc." that continued for 3 days; symptoms of a cold including "cough, chills, body aches, etc." that continued for 3 days; oxygen levels are going down; This is a spontaneous report from a contactable consumer. A 37-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The reporter stated that his brother (patient) has started having symptoms of a cold including cough, chills, body aches (on unspecified date) that continued for 3 days. His brother reached out to his doctor who told him it may not be related to the shot but may be because he has come in contact with COVID-19 since his first dose. The patient is waiting on a COVID-19 test (unknown (pending) result) but caller is concerned because he state that his oxygen levels were going down. The caller would like to know if the patient can take vitamin supplements after or in between doses of the Pfizer BioNTech COVID-19 vaccine. The reporter specifically asked about vitamins E, C, B, and echinacea. They responded that there is no information regarding a potential interaction between the vaccine and vitamin supplements such as E, C, B, and echinacea. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Blood test
Clinical narrative: Bell's palsy/droopiness on the left side of her face; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 08Apr2021 (at the age of 28-years-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 24Apr2021, she had drooping on the left side of her face. On the 25th, she went to the ER and it was Bell's Palsy. Her second dose will be on Thursday, 29Apr2021, and is wondering if she should get the second dose. On 27Apr2021, she reported the droopiness in her face is staying about the same. She had blood work done in the emergency department and her bloodwork was all normal. The patient underwent lab tests and procedures which included blood test: normal on 25Apr2021. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diagnosed with COVID; diagnosed with COVID; This is a spontaneous report from a contactable consumer (patient herself). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Mar2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient  received the first dose of Pfizer's COVID vaccine on 08Mar2021. On 04Apr2021, 1 day before her second vaccination, she was diagnosed with COVID. Patient was wondering if she needed to start all over since she was past the 42 days. She asked what she should do for the second vaccine. Outcome of the event was unknown.  Information about the batch/lot number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased, Syncope
Clinical narrative: feeling like I might faint; Heart beating very fast; feeling dizzy; This is a spontaneous report from contactable consumer (patient).  A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: Ew0170), dose 1, single dose,  via an unspecified route of administration, administered in the left arm on 21Apr2021 at 09:45 (at the age of 39 years-old) for covid-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. The patient did not receive any concomitant medications. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. The patient experienced feeling like I might faint, heart beating very fast and feeling dizzy on 21Apr2021 at 12:00. The patient underwent lab tests and procedures which included heart rate: heart beating very fast on 21Apr2021. No treatment was received for feeling like I might faint, heart beating very fast and feeling dizzy. The outcome of feeling like I might faint, heart beating very fast and feeling dizzy was recovering.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot in left leg; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 25Jan2021 10:30 (lot: EL3302) as 1ST DOSE, SINGLE then on 17Feb2021 10:30 (lot: EL9264) as 2ND DOSE, SINGLE; both via an unspecified route of administration in left arm (at the age of 46-years-old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient was not tested for COVID-19. Medical history included covid-19 (prior to vaccination, diagnosed with COVID) and no past drug event. The patient's concomitant medications were not reported. The reported event was blood clot in left leg on 18Apr2021 at 22:00. The event resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse event was an unspecified medication. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Exposure to SARS-CoV-2, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: positive for Covid; positive for Covid; suspected COVID-19 Virus symptoms from 15Apr2021 to 18Apr2021; She said she came in contact with someone on 10Apr2021 who was sick (with the COVID-19 Virus).; This is a spontaneous report from Medical Information. A 20-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 08Apr2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation (Age at vaccination: 20 years). The patient's medical history and concomitant medications were not reported. The patient reported that she had received her first COVID-19 Vaccine dose on 08Apr2021. She said she came in contact with someone on 10Apr2021 who was sick (with the COVID-19 Virus). She said on 13Apr2021 she started to quarantine. She also stated that she had suspected covid-19 virus symptoms from 15Apr2021 to 18apr2021 on 15Apr2021. She said she found out on 21Apr2021 that she was positive for the COVID-19 Virus. The patient underwent lab tests and procedures which included COVID-19 PCR test: negative on 15Apr2021 and 19Apr2021 and tested positive on 21Apr2021. Outcome of the event suspected covid-19 was recovered on 18Apr2021 while outcome of the remaining events was unknown.   Information on the lot/batch number has been requested.